Trial Outcomes & Findings for R21 India Pal-Care Evaluation (NCT NCT04972630)
NCT ID: NCT04972630
Last Updated: 2024-11-27
Results Overview
Multidimensional palliative care outcomes will be measured with Palliative Care Outcomes (POS) Scale that measures physical and psychological symptoms; spiritual, practical and emotional concerns; and psychosocial needs of patient/family. The overall POS scale included 10 items, it is a 5-point Likert scale, scored from 0 to 4, with a total summed score ranging from 0-40. A score of 0 indicates that the particular issue is not a problem at all and a score of 4 indicates that the issue is an overwhelming burden/concern for the patient. The higher the total score, the worser the palliative care outcomes are.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
6-month
Results posted on
2024-11-27
Participant Flow
Post-intervention interviews: The participants were people who had in some way engaged in the Pal-Care intervention as a provider, community health worker or patient. Hence for the research purpose, we only needed to know if they had engaged in the intervention and NO additional demographics/OUTCOME DATA were counted twice for research. All participants were informed through a statement of research (waiver of signed consent in place) and verbally consented prior to conducting interviews.
Participant milestones
| Measure |
Control
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. The patients were a part of the intervention group. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
22
|
|
Overall Study
COMPLETED
|
8
|
8
|
22
|
|
Overall Study
NOT COMPLETED
|
37
|
37
|
0
|
Reasons for withdrawal
| Measure |
Control
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. The patients were a part of the intervention group. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Overall Study
Death due to disease progression, lost to follow-up, consent withdrawal
|
37
|
37
|
0
|
Baseline Characteristics
Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
Baseline characteristics by cohort
| Measure |
Control
n=43 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=43 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
n=22 Participants
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 12.8 • n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
60.4 years
STANDARD_DEVIATION 15.9 • n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
60.1 years
STANDARD_DEVIATION 14.3 • n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Sex: Female, Male
Female
|
20 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
19 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
39 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Sex: Female, Male
Male
|
23 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
24 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
47 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Race (NIH/OMB)
Asian
|
43 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
43 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
86 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Race (NIH/OMB)
White
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Region of Enrollment
India
|
43 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
43 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
86 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Marital Status
Single
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
2 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
2 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Marital Status
Married
|
36 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
29 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
65 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Marital Status
Widowed
|
7 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
12 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
19 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Religion
Hindu
|
36 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
35 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
71 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Religion
Muslim
|
5 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
8 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
13 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Religion
Christian
|
2 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
2 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Highest level of education completed
Less than high school degree
|
5 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
7 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
12 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Highest level of education completed
High school degree
|
16 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
18 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
34 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Highest level of education completed
Some college but no degree
|
1 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
1 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Highest level of education completed
Bachelor degree (B.S, B.A, B.Com etc.)
|
17 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
16 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
33 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Highest level of education completed
Master's degree or above
|
4 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
1 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
5 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Highest level of education completed
Prefer not to answer
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
1 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
1 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Employment status
Employed with an organization
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
1 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
1 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Employment status
Self-Employed
|
4 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
4 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
8 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Employment status
Not employed, looking for work
|
1 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
1 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Employment status
Not employed, NOT looking for work
|
16 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
13 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
29 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Employment status
Retired
|
10 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
13 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
23 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Employment status
Disabled, not able to work
|
12 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
11 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
23 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Employment status
Prefer not to answer
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
1 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
1 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Income
Less than INR 5,000
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
3 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
3 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Income
INR 5,000 to INR 24,999
|
17 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
17 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
34 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Income
INR 25,000 to INR 49,999
|
12 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
9 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
21 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Income
INR 50,000 to INR 99,999
|
7 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
4 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
11 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Income
INR100, 000 (1 lacs) or more
|
2 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
7 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
9 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Income
Prefer not to answer
|
5 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
3 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
8 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Living location
Rural village
|
10 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
12 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
22 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Living location
Suburban town
|
11 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
10 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
21 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Living location
Urban city
|
22 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
21 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
43 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Members in household (including self)
|
4.8 Members in household (including self)
STANDARD_DEVIATION 2.4 • n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
4.5 Members in household (including self)
STANDARD_DEVIATION 2.8 • n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
4.7 Members in household (including self)
STANDARD_DEVIATION 2.6 • n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Number of dependents in family
|
2.8 Number of dependents in family
STANDARD_DEVIATION 1.6 • n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
2.7 Number of dependents in family
STANDARD_DEVIATION 2.3 • n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
2.7 Number of dependents in family
STANDARD_DEVIATION 1.95 • n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Relationship with primary caregiver
Parent
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
2 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
2 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Relationship with primary caregiver
Spouse
|
25 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
18 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
43 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Relationship with primary caregiver
Sibling
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
1 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
1 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Relationship with primary caregiver
Other
|
18 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
22 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
40 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Has health insurance or funds
Yes
|
20 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
15 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
35 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Has health insurance or funds
No
|
23 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
28 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
51 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Health insurance
Governmental insurance
|
4 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
5 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
9 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Health insurance
Private insurance
|
16 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
10 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
26 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Health insurance
Self-pay
|
23 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
28 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
51 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Diagnosis based on system
Breast
|
4 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
5 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
9 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Diagnosis based on system
Cancer of Unknown Primary (CUP)
|
1 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
1 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
2 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Diagnosis based on system
Genitourinary
|
2 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
2 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
4 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Diagnosis based on system
GI Cancers
|
19 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
13 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
32 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Diagnosis based on system
Gynecological
|
6 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
8 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
14 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Diagnosis based on system
Head & Neck
|
6 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
4 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
10 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Diagnosis based on system
Skin
|
1 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
1 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Diagnosis based on system
Thoracic
|
4 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
10 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
14 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Body weight (kg)
|
57.8 kg
STANDARD_DEVIATION 13.6 • n=41 Participants • One patient in the "control" group could not be mobilized at the point of time, hence weight could not be taken. Additionally, baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
57.8 kg
STANDARD_DEVIATION 12.9 • n=42 Participants • One patient in the "control" group could not be mobilized at the point of time, hence weight could not be taken. Additionally, baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
57.8 kg
STANDARD_DEVIATION 13.2 • n=83 Participants • One patient in the "control" group could not be mobilized at the point of time, hence weight could not be taken. Additionally, baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Has reliable internet access
Yes
|
43 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
40 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
83 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Has reliable internet access
No
|
0 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
3 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
3 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Comfortable using
Computers
|
7 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
2 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
9 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Comfortable using
iPad/tablet
|
2 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
2 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
4 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Comfortable using
Smartphone
|
33 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
36 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
69 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Comfortable using
None
|
1 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
3 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
4 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
ECOG status
Well
|
2 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
2 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
4 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
ECOG status
Active - able to do light work
|
11 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
14 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
25 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
ECOG status
Self-caring - but unable to work
|
19 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
22 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
41 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
ECOG status
Bedridden >50% of the day
|
11 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
5 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
16 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Problems at identified at enrollment
Emotional issues
|
30 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
34 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
64 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Problems at identified at enrollment
Spiritual issues
|
18 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
16 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
34 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Problems at identified at enrollment
Social issues
|
32 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
30 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
62 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Discussion of non-escalation
Yes
|
21 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
18 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
39 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
|
Discussion of non-escalation
No
|
22 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
25 Participants
n=43 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
—
|
47 Participants
n=86 Participants • Baseline data was only meant to be collected for control and intervention participants. Hence no baseline information was collected for interview participants.
|
PRIMARY outcome
Timeframe: 6-monthPopulation: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
Multidimensional palliative care outcomes will be measured with Palliative Care Outcomes (POS) Scale that measures physical and psychological symptoms; spiritual, practical and emotional concerns; and psychosocial needs of patient/family. The overall POS scale included 10 items, it is a 5-point Likert scale, scored from 0 to 4, with a total summed score ranging from 0-40. A score of 0 indicates that the particular issue is not a problem at all and a score of 4 indicates that the issue is an overwhelming burden/concern for the patient. The higher the total score, the worser the palliative care outcomes are.
Outcome measures
| Measure |
Control
n=43 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=43 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Palliative Care Outcomes (POS Total Scores)
Baseline
|
23.5 score on a scale
Interval 18.7 to 28.3
|
22.9 score on a scale
Interval 18.1 to 27.7
|
—
|
|
Palliative Care Outcomes (POS Total Scores)
Week 4
|
22.2 score on a scale
Interval 16.9 to 27.5
|
22.1 score on a scale
Interval 15.9 to 28.3
|
—
|
|
Palliative Care Outcomes (POS Total Scores)
Week 12
|
22.1 score on a scale
Interval 16.9 to 27.3
|
20.8 score on a scale
Interval 15.0 to 26.6
|
—
|
|
Palliative Care Outcomes (POS Total Scores)
Week 24
|
21.3 score on a scale
Interval 15.1 to 27.5
|
19.4 score on a scale
Interval 12.4 to 26.4
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
Outcome measures
| Measure |
Control
n=31 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=29 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Average Score for Quality of Life (QOL) Physical Domain
|
55.6 score on a scale
Interval 35.7 to 75.5
|
56.1 score on a scale
Interval 43.1 to 69.1
|
—
|
PRIMARY outcome
Timeframe: Week 4Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
Outcome measures
| Measure |
Control
n=31 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=29 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Average Score for Quality of Life (QOL) Physical Domain
|
51.3 score on a scale
Interval 30.4 to 72.2
|
52.8 score on a scale
Interval 32.1 to 73.5
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
Outcome measures
| Measure |
Control
n=20 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=13 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Average Score for Quality of Life (QOL) Physical Domain
|
59.1 score on a scale
Interval 42.0 to 76.2
|
57.4 score on a scale
Interval 44.3 to 70.5
|
—
|
PRIMARY outcome
Timeframe: Week 12Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
Outcome measures
| Measure |
Control
n=20 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=13 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Average Score for Quality of Life (QOL) Physical Domain
|
55.6 score on a scale
Interval 33.1 to 78.1
|
52.8 score on a scale
Interval 34.5 to 71.1
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
Outcome measures
| Measure |
Control
n=8 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=8 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Average Score for Quality of Life (QOL) Physical Domain
|
69.4 score on a scale
Interval 58.4 to 80.4
|
60.2 score on a scale
Interval 52.1 to 68.3
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Physical Domain scale included 7 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 7 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for physical QOL and a score of 4 indicates that the highest level of physical QOL for the patient. Higher total score indicates better physical QOL for the patient.
Outcome measures
| Measure |
Control
n=8 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=8 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Average Score for Quality of Life (QOL) Physical Domain
|
59.7 score on a scale
Interval 33.4 to 86.0
|
62.9 score on a scale
Interval 40.1 to 85.7
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
Outcome measures
| Measure |
Control
n=31 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=29 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Average Score for Quality of Life (QOL) Psychological Domain
|
63.3 score on a scale
Interval 44.8 to 81.8
|
58.3 score on a scale
Interval 42.2 to 74.4
|
—
|
PRIMARY outcome
Timeframe: Week 4Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
Outcome measures
| Measure |
Control
n=31 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=29 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Average Score for Quality of Life (QOL) Psychological Domain
|
58.2 score on a scale
Interval 42.2 to 74.2
|
53.7 score on a scale
Interval 30.3 to 77.1
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
Outcome measures
| Measure |
Control
n=20 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=13 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Average Score for Quality of Life (QOL) Psychological Domain
|
67.3 score on a scale
Interval 50.4 to 84.2
|
60.9 score on a scale
Interval 45.0 to 76.8
|
—
|
PRIMARY outcome
Timeframe: Week 12Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
Outcome measures
| Measure |
Control
n=20 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=13 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Average Score for Quality of Life (QOL) Psychological Domain
|
59.6 score on a scale
Interval 38.6 to 80.6
|
55.8 score on a scale
Interval 39.6 to 72.0
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
Outcome measures
| Measure |
Control
n=8 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=8 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Average Score for Quality of Life (QOL) Psychological Domain
|
76.6 score on a scale
Interval 60.0 to 93.2
|
59.9 score on a scale
Interval 47.7 to 72.1
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Psychological Domain scale included 6 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 6 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for psychological QOL and a score of 4 indicates that the highest level of psychological QOL for the patient. Higher total score indicates better psychological QOL for the patient.
Outcome measures
| Measure |
Control
n=8 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=8 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Average Score for Quality of Life (QOL) Psychological Domain
|
62.0 score on a scale
Interval 39.4 to 84.6
|
62.5 score on a scale
Interval 39.2 to 85.8
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Outcome surveys/data collection were not conducted on Post-intervention interview participants.
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Social Domain scale included 3 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 3 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for social QOL and a score of 4 indicates that the highest level of social QOL for the patient. Higher total score indicates better social QOL for the patient.
Outcome measures
| Measure |
Control
n=43 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=43 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Total Score for Quality of Life (QOL) Social Domain
Week 24
|
80.2 score on a scale
Interval 58.5 to 101.9
|
82.8 score on a scale
Interval 65.2 to 100.4
|
—
|
|
Total Score for Quality of Life (QOL) Social Domain
Baseline
|
81.1 score on a scale
Interval 61.7 to 100.5
|
81.5 score on a scale
Interval 64.4 to 98.6
|
—
|
|
Total Score for Quality of Life (QOL) Social Domain
Week 4
|
73.3 score on a scale
Interval 50.1 to 96.5
|
78.7 score on a scale
Interval 59.8 to 97.6
|
—
|
|
Total Score for Quality of Life (QOL) Social Domain
Week 12
|
77.9 score on a scale
Interval 52.4 to 103.4
|
78.8 score on a scale
Interval 61.6 to 96.0
|
—
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: Outcome surveys/data collection were not conducted on Post-intervention interview participants
Quality of Life will be will be assessed with the 26-item WHOQOL-BREF(WHO-Quality of life-BREFF) Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. The Quality of Life (QOL) Environmental Domain scale included 8 items, it is a 5-point Likert scale, scored from 0 to 4, summed over the 8 domain items multiplied by 4, transformed to a 0-100 scale using the formula (score-4)x(100/16). A score of 0 indicates the poorest level for environmental QOL and a score of 4 indicates that the highest level of environmental QOL for the patient. Higher total score indicates better environmental QOL for the patient.
Outcome measures
| Measure |
Control
n=43 Participants
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=43 Participants
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Total Score for Quality of Life (QOL) Environment Domain
Baseline
|
68.6 score on a scale
Interval 55.1 to 82.1
|
66.4 score on a scale
Interval 53.1 to 79.7
|
—
|
|
Total Score for Quality of Life (QOL) Environment Domain
Week 4
|
65.8 score on a scale
Interval 53.5 to 78.1
|
66.4 score on a scale
Interval 49.7 to 83.1
|
—
|
|
Total Score for Quality of Life (QOL) Environment Domain
Week 12
|
67.1 score on a scale
Interval 53.3 to 80.9
|
66.1 score on a scale
Interval 51.7 to 80.5
|
—
|
|
Total Score for Quality of Life (QOL) Environment Domain
Week 24
|
72.7 score on a scale
Interval 59.5 to 85.9
|
71.9 score on a scale
Interval 52.2 to 91.6
|
—
|
Adverse Events
Control
Serious events: 19 serious events
Other events: 0 other events
Deaths: 17 deaths
Pal-Care
Serious events: 24 serious events
Other events: 0 other events
Deaths: 18 deaths
Post-Intervention Interviews
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=43 participants at risk
Control-Usual Care: The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.
|
Pal-Care
n=43 participants at risk
Pal-Care: Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.
|
Post-Intervention Interviews
Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. The patients were a part of the intervention group. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.
|
|---|---|---|---|
|
Gastrointestinal disorders
Progression of Disease
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Gastrointestinal disorders
Hypogastric plexus and Block
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
General disorders
Cancer Pain
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Blood and lymphatic system disorders
PR Bleeding and Generalized weakness
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Respiratory, thoracic and mediastinal disorders
severe anemia
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Injury, poisoning and procedural complications
Consumption of a liquid mosquito repellent
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Respiratory, thoracic and mediastinal disorders
Progression of Disease
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Metabolism and nutrition disorders
Progression of Disease
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
General disorders
Progression of Disease
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Blood and lymphatic system disorders
Dyselectrolytemia and Sepsis
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Gastrointestinal disorders
Subacute intestinal obstruction.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
General disorders
Progression of disease and Dyselectrolytemia
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
General disorders
Infection and Dyselectrolytemia
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Metabolism and nutrition disorders
Disorientation and Reduced intake of Food
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
General disorders
Ulcer proliferative Lesion
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
General disorders
Hypertension, Dehydrated, Cachectic, and Tense Ascites
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Blood and lymphatic system disorders
Sepsis
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Blood and lymphatic system disorders
Sepsis and Anemia
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
General disorders
Fluctuating BP and blood sugar
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Blood and lymphatic system disorders
Sepsis, Diabetic Ketoacidosis and Dyselectrolytemia
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Blood and lymphatic system disorders
Low hemoglobin
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Blood and lymphatic system disorders
Progression of Disease and Sepsis
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Cardiac disorders
Chest Infection
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis, Dyselectrolytemia, and Suspected Sepsis
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
General disorders
Progression Of Disease With Pneumonia
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Blood and lymphatic system disorders
Hypoproteinemia, Anemia and Sepsis
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Infections and infestations
Chickenpox
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Nervous system disorders
Cerebral metastases
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Metabolism and nutrition disorders
Electrolyte disturbance.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Cardiac disorders
ICD Block
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Respiratory, thoracic and mediastinal disorders
Sepsis and Hypoglycemia
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Infections and infestations
Infection and UTI
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Gastrointestinal disorders
Upper GI bleeding
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
Blood and lymphatic system disorders
Progression of Disease
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
0.00%
0/43 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
General disorders
Patient Expired at Home
|
37.2%
16/43 • Number of events 16 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
32.6%
14/43 • Number of events 14 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
|
General disorders
Patient Expired at Local Hospital
|
2.3%
1/43 • Number of events 1 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
9.3%
4/43 • Number of events 4 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
—
0/0 • Up to 24 Weeks
SAEs (patients could have more than 1 SAE, therefor does not add to total N of patients) All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for the "Post-Intervention Interviews" Arm/Group.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Suparna Qanungo
Medical University of South Carolina
Phone: (843) 876-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place