Trial Outcomes & Findings for Online Information and Support for Distance Caregivers (NCT NCT02666183)
NCT ID: NCT02666183
Last Updated: 2022-02-22
Results Overview
Compare the direct effects of Closer, Video-C Only, and Web-Only on anxiety over time, controlling for DCG demographic variables. Anxiety will be measured using the 4-item tool from the Patient Reported Outcomes measurement Information System (PROMIS). Higher scores indicate greater anxiety. The PROMIS Item Bank v1.0-Emotional Distress-Anxiety - Short Form 4a, a 4 item instrument, is reported as a t-score and can range from 37.1 to 83.1 with higher t-scores representing more anxiety. The mean and standard deviation are as follows: M=50 (SD=10). T-scores from 55-60 represent mild anxiety, 61-70 moderate anxiety and \> 70 represent severe anxiety.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
397 participants
Primary outcome timeframe
At enrollment to end of intervention period (4 months)
Results posted on
2022-02-22
Participant Flow
Participant milestones
| Measure |
Closer
The full intervention (Closer) is a tested intervention that uses videoconferencing technology (WebEx) for delivery and delivers the highest dose of the intervention. This arm of the intervention will deliver personalized information to the DCG (aimed at enhancing self-efficacy) and emotional support via nurse coaching as well as the opportunity for the DCG to talk with the oncologist and patient in "real time" during a minimum of four patient-oncologist office visits over a 4-month period (at least once/month). For patients who have more than one oncologist-patient meeting/month, the study will use the videoconference technology to allow the DCG to join as many of the join in as many of the oncologist-patient office visits as desired.
Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
Nurse Coaching: structured conversations with registered nurses aimed at providing emotional support
|
Video-C Only
This arm will involve the delivery of information solely via the use of videoconference technology during the patient-oncologist-DCG visit. There is always the possibility that the DCG will receive emotional support from the oncologist during the office visit (as would potentially occur during a face-to-face meeting) - but this will not be "delivered" systematically as in the Closer intervention. As with the Closer intervention, the DCG will be able to participate in the patient-oncologist visit in "real time" during a minimum of four office visits over the 4-month study period (total dose \~5 hours). The procedure for these meetings will be the same as outlined for Closer but will not involve having the nurse involved in the videoconference sessions with the oncologist, patient, and DCG.
Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
|
Web-Only
This group will be provided access to a website that will provide the following major links: a) Caregiving Resources (links to National Family Caregiver Association," etc.), b)Resources for DCGs (links to the Caregiving from a Distance," etc.), c) Cancer Information (links to National Cancer Institute, etc.). DCGs will be told that the study team will track usage of the website in order to assess which areas of the website are used most frequently. Any questions or concerns regarding use of the website can be sent online to the study's technical site, and the support staff will respond within 24 hours. As is current practice, DCGs can call an oncology nurse or oncologist to ask specific questions. Web-Only will deliver the lowest dose of the intervention.
Web-Only: Access to a website with caregiving resources, resources for distant care givers, and cancer information
|
|---|---|---|---|
|
Overall Study
STARTED
|
137
|
141
|
119
|
|
Overall Study
COMPLETED
|
103
|
106
|
93
|
|
Overall Study
NOT COMPLETED
|
34
|
35
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Online Information and Support for Distance Caregivers
Baseline characteristics by cohort
| Measure |
Closer
n=103 Participants
The full intervention (Closer) is a tested intervention that uses videoconferencing technology (WebEx) for delivery and delivers the highest dose of the intervention. This arm of the intervention will deliver personalized information to the DCG (aimed at enhancing self-efficacy) and emotional support via nurse coaching as well as the opportunity for the DCG to talk with the oncologist and patient in "real time" during a minimum of four patient-oncologist office visits over a 4-month period (at least once/month). For patients who have more than one oncologist-patient meeting/month, the study will use the videoconference technology to allow the DCG to join as many of the join in as many of the oncologist-patient office visits as desired.
Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
Nurse Coaching: structured conversations with registered nurses aimed at providing emotional support
|
Video-C Only
n=106 Participants
This arm will involve the delivery of information solely via the use of videoconference technology during the patient-oncologist-DCG visit. There is always the possibility that the DCG will receive emotional support from the oncologist during the office visit (as would potentially occur during a face-to-face meeting) - but this will not be "delivered" systematically as in the Closer intervention. As with the Closer intervention, the DCG will be able to participate in the patient-oncologist visit in "real time" during a minimum of four office visits over the 4-month study period (total dose \~5 hours). The procedure for these meetings will be the same as outlined for Closer but will not involve having the nurse involved in the videoconference sessions with the oncologist, patient, and DCG.
Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
|
Web-Only
n=93 Participants
This group will be provided access to a website that will provide the following major links: a) Caregiving Resources (links to National Family Caregiver Association," etc.), b)Resources for DCGs (links to the Caregiving from a Distance," etc.), c) Cancer Information (links to National Cancer Institute, etc.). DCGs will be told that the study team will track usage of the website in order to assess which areas of the website are used most frequently. Any questions or concerns regarding use of the website can be sent online to the study's technical site, and the support staff will respond within 24 hours. As is current practice, DCGs can call an oncology nurse or oncologist to ask specific questions. Web-Only will deliver the lowest dose of the intervention.
Web-Only: Access to a website with caregiving resources, resources for distant care givers, and cancer information
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 13.6 • n=99 Participants
|
45.9 years
STANDARD_DEVIATION 12.7 • n=107 Participants
|
46.8 years
STANDARD_DEVIATION 12.4 • n=206 Participants
|
46.8 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
223 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
79 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
240 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
80 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
210 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=99 Participants
|
106 participants
n=107 Participants
|
93 participants
n=206 Participants
|
302 participants
n=7 Participants
|
|
PROMISR SFv1.0-ED-anxiety-SF8a
|
54.66 T-scores
STANDARD_DEVIATION 7.77 • n=99 Participants
|
54.68 T-scores
STANDARD_DEVIATION 7.14 • n=107 Participants
|
56.03 T-scores
STANDARD_DEVIATION 8.21 • n=206 Participants
|
55.09 T-scores
STANDARD_DEVIATION 7.70 • n=7 Participants
|
|
PROMISR SFv1.0-ED-depression-SF8a
|
49.64 T-scores
STANDARD_DEVIATION 7.73 • n=99 Participants
|
50.16 T-scores
STANDARD_DEVIATION 7.92 • n=107 Participants
|
52.28 T-scores
STANDARD_DEVIATION 7.42 • n=206 Participants
|
50.64 T-scores
STANDARD_DEVIATION 7.76 • n=7 Participants
|
|
NCCN distress thermometer
|
4.23 units on a scale
STANDARD_DEVIATION 2.61 • n=99 Participants
|
4.00 units on a scale
STANDARD_DEVIATION 2.68 • n=107 Participants
|
4.55 units on a scale
STANDARD_DEVIATION 2.39 • n=206 Participants
|
4.25 units on a scale
STANDARD_DEVIATION 2.57 • n=7 Participants
|
PRIMARY outcome
Timeframe: At enrollment to end of intervention period (4 months)Compare the direct effects of Closer, Video-C Only, and Web-Only on anxiety over time, controlling for DCG demographic variables. Anxiety will be measured using the 4-item tool from the Patient Reported Outcomes measurement Information System (PROMIS). Higher scores indicate greater anxiety. The PROMIS Item Bank v1.0-Emotional Distress-Anxiety - Short Form 4a, a 4 item instrument, is reported as a t-score and can range from 37.1 to 83.1 with higher t-scores representing more anxiety. The mean and standard deviation are as follows: M=50 (SD=10). T-scores from 55-60 represent mild anxiety, 61-70 moderate anxiety and \> 70 represent severe anxiety.
Outcome measures
| Measure |
Closer
n=103 Participants
The full intervention (Closer) is a tested intervention that uses videoconferencing technology (WebEx) for delivery and delivers the highest dose of the intervention. This arm of the intervention will deliver personalized information to the DCG (aimed at enhancing self-efficacy) and emotional support via nurse coaching as well as the opportunity for the DCG to talk with the oncologist and patient in "real time" during a minimum of four patient-oncologist office visits over a 4-month period (at least once/month). For patients who have more than one oncologist-patient meeting/month, the study will use the videoconference technology to allow the DCG to join as many of the join in as many of the oncologist-patient office visits as desired.
Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
Nurse Coaching: structured conversations with registered nurses aimed at providing emotional support
|
Video-C Only
n=106 Participants
This arm will involve the delivery of information solely via the use of videoconference technology during the patient-oncologist-DCG visit. There is always the possibility that the DCG will receive emotional support from the oncologist during the office visit (as would potentially occur during a face-to-face meeting) - but this will not be "delivered" systematically as in the Closer intervention. As with the Closer intervention, the DCG will be able to participate in the patient-oncologist visit in "real time" during a minimum of four office visits over the 4-month study period (total dose \~5 hours). The procedure for these meetings will be the same as outlined for Closer but will not involve having the nurse involved in the videoconference sessions with the oncologist, patient, and DCG.
Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
|
Web-Only
n=93 Participants
This group will be provided access to a website that will provide the following major links: a) Caregiving Resources (links to National Family Caregiver Association," etc.), b)Resources for DCGs (links to the Caregiving from a Distance," etc.), c) Cancer Information (links to National Cancer Institute, etc.). DCGs will be told that the study team will track usage of the website in order to assess which areas of the website are used most frequently. Any questions or concerns regarding use of the website can be sent online to the study's technical site, and the support staff will respond within 24 hours. As is current practice, DCGs can call an oncology nurse or oncologist to ask specific questions. Web-Only will deliver the lowest dose of the intervention.
Web-Only: Access to a website with caregiving resources, resources for distant care givers, and cancer information
|
|---|---|---|---|
|
Change in Anxiety T-scores
|
53.14 T-score
Standard Deviation 8.14
|
55.47 T-score
Standard Deviation 7.67
|
56.85 T-score
Standard Deviation 8.73
|
PRIMARY outcome
Timeframe: At enrollment to end of intervention period (4 months)Compare the direct effects of Closer, Video-C Only, and Web-Only on distress over time, controlling for DCG demographic variables. Distress is conceptually defined as a negative state in which coping and adaptation processes fail to return the individual to physiological and/or psychological homeostasis. It will be measured using the National Comprehensive Cancer Network (NCCN) distress thermometer - a clinical tool currently utilized with the cancer population. The National Comprehensive Cancer Network Distress Thermometer is a one-item, 11-point Likert scale represented on a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress), with which patients indicate their level of distress over the course of the week prior to assessment. Scores range from 0 to 10 with higher scores representing higher levels of distress. Scores \>4 indicate distress requiring further evaluation.
Outcome measures
| Measure |
Closer
n=103 Participants
The full intervention (Closer) is a tested intervention that uses videoconferencing technology (WebEx) for delivery and delivers the highest dose of the intervention. This arm of the intervention will deliver personalized information to the DCG (aimed at enhancing self-efficacy) and emotional support via nurse coaching as well as the opportunity for the DCG to talk with the oncologist and patient in "real time" during a minimum of four patient-oncologist office visits over a 4-month period (at least once/month). For patients who have more than one oncologist-patient meeting/month, the study will use the videoconference technology to allow the DCG to join as many of the join in as many of the oncologist-patient office visits as desired.
Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
Nurse Coaching: structured conversations with registered nurses aimed at providing emotional support
|
Video-C Only
n=106 Participants
This arm will involve the delivery of information solely via the use of videoconference technology during the patient-oncologist-DCG visit. There is always the possibility that the DCG will receive emotional support from the oncologist during the office visit (as would potentially occur during a face-to-face meeting) - but this will not be "delivered" systematically as in the Closer intervention. As with the Closer intervention, the DCG will be able to participate in the patient-oncologist visit in "real time" during a minimum of four office visits over the 4-month study period (total dose \~5 hours). The procedure for these meetings will be the same as outlined for Closer but will not involve having the nurse involved in the videoconference sessions with the oncologist, patient, and DCG.
Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
|
Web-Only
n=93 Participants
This group will be provided access to a website that will provide the following major links: a) Caregiving Resources (links to National Family Caregiver Association," etc.), b)Resources for DCGs (links to the Caregiving from a Distance," etc.), c) Cancer Information (links to National Cancer Institute, etc.). DCGs will be told that the study team will track usage of the website in order to assess which areas of the website are used most frequently. Any questions or concerns regarding use of the website can be sent online to the study's technical site, and the support staff will respond within 24 hours. As is current practice, DCGs can call an oncology nurse or oncologist to ask specific questions. Web-Only will deliver the lowest dose of the intervention.
Web-Only: Access to a website with caregiving resources, resources for distant care givers, and cancer information
|
|---|---|---|---|
|
Change in Distress Scores
|
3.37 score on a scale
Standard Deviation 2.80
|
3.89 score on a scale
Standard Deviation 2.64
|
4.86 score on a scale
Standard Deviation 2.66
|
PRIMARY outcome
Timeframe: At enrollment to end of intervention period (4 months)Compare the direct effects of Closer, Video-C Only, and Web-Only on depression over time, controlling for DCG demographic variables. Depression will be measured using the 4 item PROMIS Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a. The PROMIS Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a, a 4 item instrument, is reported as a t-score and can range from 38.2 to 81.3 with higher t-scores representing worse depression. T-scores from 55-60 represent mild depression, 61-70 moderate depression and \> 70 represent severe depression.
Outcome measures
| Measure |
Closer
n=103 Participants
The full intervention (Closer) is a tested intervention that uses videoconferencing technology (WebEx) for delivery and delivers the highest dose of the intervention. This arm of the intervention will deliver personalized information to the DCG (aimed at enhancing self-efficacy) and emotional support via nurse coaching as well as the opportunity for the DCG to talk with the oncologist and patient in "real time" during a minimum of four patient-oncologist office visits over a 4-month period (at least once/month). For patients who have more than one oncologist-patient meeting/month, the study will use the videoconference technology to allow the DCG to join as many of the join in as many of the oncologist-patient office visits as desired.
Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
Nurse Coaching: structured conversations with registered nurses aimed at providing emotional support
|
Video-C Only
n=106 Participants
This arm will involve the delivery of information solely via the use of videoconference technology during the patient-oncologist-DCG visit. There is always the possibility that the DCG will receive emotional support from the oncologist during the office visit (as would potentially occur during a face-to-face meeting) - but this will not be "delivered" systematically as in the Closer intervention. As with the Closer intervention, the DCG will be able to participate in the patient-oncologist visit in "real time" during a minimum of four office visits over the 4-month study period (total dose \~5 hours). The procedure for these meetings will be the same as outlined for Closer but will not involve having the nurse involved in the videoconference sessions with the oncologist, patient, and DCG.
Video-C: use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
|
Web-Only
n=93 Participants
This group will be provided access to a website that will provide the following major links: a) Caregiving Resources (links to National Family Caregiver Association," etc.), b)Resources for DCGs (links to the Caregiving from a Distance," etc.), c) Cancer Information (links to National Cancer Institute, etc.). DCGs will be told that the study team will track usage of the website in order to assess which areas of the website are used most frequently. Any questions or concerns regarding use of the website can be sent online to the study's technical site, and the support staff will respond within 24 hours. As is current practice, DCGs can call an oncology nurse or oncologist to ask specific questions. Web-Only will deliver the lowest dose of the intervention.
Web-Only: Access to a website with caregiving resources, resources for distant care givers, and cancer information
|
|---|---|---|---|
|
Change in Depression T-scores
|
49.29 T-score
Standard Deviation 8.00
|
50.72 T-score
Standard Deviation 7.89
|
52.62 T-score
Standard Deviation 8.75
|
Adverse Events
Closer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Video-C Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Web-Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sara L. Douglas, PhD, RN, Professor FPB School of Nursing
Case Western Reserve University
Phone: 216-368-0702
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place