Trial Outcomes & Findings for Text-based Intervention to Minimize the Time Burden of Routine Cancer Care (NCT NCT05134636)
NCT ID: NCT05134636
Last Updated: 2025-03-06
Results Overview
Time spent commuting to, waiting for, and receiving healthcare over a 3 month follow up period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
3 months
Results posted on
2025-03-06
Participant Flow
Run-in period during which patients were sent a preliminary text message asking them to confirm study participation. 11 patients did not respond to this enrollment text.
Participant milestones
| Measure |
Treatment Arm
For patients in the intervention arm, symptoms and laboratory results will be assessed using the text-based e-triage 96 hours prior to their intended infusion date. The e-triage will consist of a standardized questionnaire and algorithm to evaluate symptoms and laboratory values. Patients with acceptable labs and minimal or no symptoms can opt to proceed directly to their immunotherapy infusion without an in-person office assessment.
Text triage: The e-triage will consist of 16 questions, modified from the validated NCI Pro-CTCAETM, which will be sent to patients via WaytoHealth©'s two-way texting system 96 hours prior to their scheduled immunotherapy infusion. Questions will pertain to common or emergent immune related adverse events as defined by the NCCN guidelines and two senior disease experts. Patients will be prompted via text to measure the presence and severity of symptoms over the week prior. A final question will be included to capture any additional symptoms patients wish to disclose.
|
Usual Care
Patients in the usual care arm will receive standard of care symptom monitoring including an in-person office assessment prior to their scheduled immunotherapy infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Text-based Intervention to Minimize the Time Burden of Routine Cancer Care
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=19 Participants
For patients in the intervention arm, symptoms and laboratory results will be assessed using the text-based e-triage 96 hours prior to their intended infusion date. The e-triage will consist of a standardized questionnaire and algorithm to evaluate symptoms and laboratory values. Patients with acceptable labs and minimal or no symptoms can opt to proceed directly to their immunotherapy infusion without an in-person office assessment.
Text triage: The e-triage will consist of 16 questions, modified from the validated NCI Pro-CTCAETM, which will be sent to patients via WaytoHealth©'s two-way texting system 96 hours prior to their scheduled immunotherapy infusion. Questions will pertain to common or emergent immune related adverse events as defined by the NCCN guidelines and two senior disease experts. Patients will be prompted via text to measure the presence and severity of symptoms over the week prior. A final question will be included to capture any additional symptoms patients wish to disclose.
|
Usual Care
n=21 Participants
Patients in the usual care arm will receive standard of care symptom monitoring including an in-person office assessment prior to their scheduled immunotherapy infusion.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=99 Participants
|
69 years
n=107 Participants
|
67 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Distance in Miles from Cancer Center
0-19.3 miles
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Distance in Miles from Cancer Center
19.31-33.13 miles
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Distance in Miles from Cancer Center
33.14-49.38 miles
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Distance in Miles from Cancer Center
49.39-150 miles
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Distance in Miles from Cancer Center
Missing
|
1 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Marital Status
Single
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Marital Status
Married
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Marital Status
Divorced
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Marital Status
Widowed
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Marital Status
Missing
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Highest Education
High school diploma/GED
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Highest Education
Technical or trade school
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Highest Education
Some college
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Highest Education
Associate degree
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Highest Education
Bachelor's degree
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Highest Education
Some graduate school
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Highest Education
Master's degree
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Highest Education
Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Income
$0-20,000
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Income
$20,001-40,000
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Income
$40,001-60,000
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Income
$60,001-80,000
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Income
$80,001-100,000
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Income
$100,001+
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Income
Missing
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Tumor Stage
1
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Tumor Stage
2
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Tumor Stage
3
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Tumor Stage
4
|
9 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Tumor Stage
Missing
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Tumor Type
Genitourinary
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Tumor Type
Thoracic
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Tumor Type
Skin
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Tumor Type
Head and Neck
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Tumor Type
Gastrointestinal
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Tumor Type
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
ICI Type
Pembrolizumab
|
13 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
ICI Type
Nivolumab
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
ICI Type
Avelumab
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
ICI Type
Atezolizumab
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
ICI Type
Cemiplimab
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
ICI Type
Durvalumab
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Lines of Prior Therapy
0
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Lines of Prior Therapy
1
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Lines of Prior Therapy
2
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Lines of Prior Therapy
3+
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Patient-reported ECOG PS
0-1
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Patient-reported ECOG PS
2+
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Patient-reported ECOG PS
Missing
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsTime spent commuting to, waiting for, and receiving healthcare over a 3 month follow up period.
Outcome measures
| Measure |
Treatment Arm
n=19 Participants
For patients in the intervention arm, symptoms and laboratory results will be assessed using the text-based e-triage 96 hours prior to their intended infusion date. The e-triage will consist of a standardized questionnaire and algorithm to evaluate symptoms and laboratory values. Patients with acceptable labs and minimal or no symptoms can opt to proceed directly to their immunotherapy infusion without an in-person office assessment.
Text triage: The e-triage will consist of 16 questions, modified from the validated NCI Pro-CTCAETM, which will be sent to patients via WaytoHealth©'s two-way texting system 96 hours prior to their scheduled immunotherapy infusion. Questions will pertain to common or emergent immune related adverse events as defined by the NCCN guidelines and two senior disease experts. Patients will be prompted via text to measure the presence and severity of symptoms over the week prior. A final question will be included to capture any additional symptoms patients wish to disclose.
|
Usual Care
n=21 Participants
Patients in the usual care arm will receive standard of care symptom monitoring including an in-person office assessment prior to their scheduled immunotherapy infusion.
|
|---|---|---|
|
Healthcare Time
|
265.97 minutes
Standard Deviation 77.6
|
339.54 minutes
Standard Deviation 108.29
|
SECONDARY outcome
Timeframe: 3 monthsTime spent waiting for healthcare over a 3 month follow up period.
Outcome measures
| Measure |
Treatment Arm
n=19 Participants
For patients in the intervention arm, symptoms and laboratory results will be assessed using the text-based e-triage 96 hours prior to their intended infusion date. The e-triage will consist of a standardized questionnaire and algorithm to evaluate symptoms and laboratory values. Patients with acceptable labs and minimal or no symptoms can opt to proceed directly to their immunotherapy infusion without an in-person office assessment.
Text triage: The e-triage will consist of 16 questions, modified from the validated NCI Pro-CTCAETM, which will be sent to patients via WaytoHealth©'s two-way texting system 96 hours prior to their scheduled immunotherapy infusion. Questions will pertain to common or emergent immune related adverse events as defined by the NCCN guidelines and two senior disease experts. Patients will be prompted via text to measure the presence and severity of symptoms over the week prior. A final question will be included to capture any additional symptoms patients wish to disclose.
|
Usual Care
n=21 Participants
Patients in the usual care arm will receive standard of care symptom monitoring including an in-person office assessment prior to their scheduled immunotherapy infusion.
|
|---|---|---|
|
Total Wait Time
|
124.79 minutes
Standard Deviation 44.35
|
154.71 minutes
Standard Deviation 72.34
|
SECONDARY outcome
Timeframe: 3 monthsTotal number of hospitalizations and emergency department encounters over a 3 month follow up.
Outcome measures
| Measure |
Treatment Arm
n=19 Participants
For patients in the intervention arm, symptoms and laboratory results will be assessed using the text-based e-triage 96 hours prior to their intended infusion date. The e-triage will consist of a standardized questionnaire and algorithm to evaluate symptoms and laboratory values. Patients with acceptable labs and minimal or no symptoms can opt to proceed directly to their immunotherapy infusion without an in-person office assessment.
Text triage: The e-triage will consist of 16 questions, modified from the validated NCI Pro-CTCAETM, which will be sent to patients via WaytoHealth©'s two-way texting system 96 hours prior to their scheduled immunotherapy infusion. Questions will pertain to common or emergent immune related adverse events as defined by the NCCN guidelines and two senior disease experts. Patients will be prompted via text to measure the presence and severity of symptoms over the week prior. A final question will be included to capture any additional symptoms patients wish to disclose.
|
Usual Care
n=21 Participants
Patients in the usual care arm will receive standard of care symptom monitoring including an in-person office assessment prior to their scheduled immunotherapy infusion.
|
|---|---|---|
|
Total Number of Hospitalization/Emergency Department Encounters
|
3 admissions
|
2 admissions
|
SECONDARY outcome
Timeframe: 3 monthsThe Patient Satisfaction Questionnaire Short Form (PSQ-18) is a self-reported measure capturing satisfaction with medical care across 7 dimensions, all subscales (no total). * General Satisfaction (3\&17) - higher scores represent greater satisfaction * Technical Quality (2, 4, 6, 14) -higher scores represent better technical quality * Interpersonal Manner (10\&11) - higher scores represent better interpersonal manner * Communication (1\&13) - higher scores represent better communication * Financial Aspects (5\&7) - higher scores represent better financial aspects * Time Spent with Doctor (12\&15) - higher scores represent better time spent w/ dr * Accessibility and Convenience (8, 9, 16, 18) - higher scores represent more accessibility Reverse scoring takes place for items 1, 2, 3, 5, 6, 8, 11, 15, and 18 such that a response of 1 has a score value of 5, and so on. After noting score values for each individual response, items are then averaged for each subscale to gain a subscale score.
Outcome measures
| Measure |
Treatment Arm
n=19 Participants
For patients in the intervention arm, symptoms and laboratory results will be assessed using the text-based e-triage 96 hours prior to their intended infusion date. The e-triage will consist of a standardized questionnaire and algorithm to evaluate symptoms and laboratory values. Patients with acceptable labs and minimal or no symptoms can opt to proceed directly to their immunotherapy infusion without an in-person office assessment.
Text triage: The e-triage will consist of 16 questions, modified from the validated NCI Pro-CTCAETM, which will be sent to patients via WaytoHealth©'s two-way texting system 96 hours prior to their scheduled immunotherapy infusion. Questions will pertain to common or emergent immune related adverse events as defined by the NCCN guidelines and two senior disease experts. Patients will be prompted via text to measure the presence and severity of symptoms over the week prior. A final question will be included to capture any additional symptoms patients wish to disclose.
|
Usual Care
n=21 Participants
Patients in the usual care arm will receive standard of care symptom monitoring including an in-person office assessment prior to their scheduled immunotherapy infusion.
|
|---|---|---|
|
Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)
General Satisfaction (0-5)
|
4.34 units on a scale of 5
Standard Deviation .59
|
4.5 units on a scale of 5
Standard Deviation 0.77
|
|
Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Technical Quality (0-5)
|
4.42 units on a scale of 5
Standard Deviation 0.77
|
4.48 units on a scale of 5
Standard Deviation 0.58
|
|
Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Communication (0-5)
|
4.25 units on a scale of 5
Standard Deviation 0.86
|
4.61 units on a scale of 5
Standard Deviation 0.45
|
|
Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Financial Aspects (0-5)
|
3.88 units on a scale of 5
Standard Deviation 0.87
|
3.82 units on a scale of 5
Standard Deviation 0.77
|
|
Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Time Spent with Doctor (0-5)
|
4.38 units on a scale of 5
Standard Deviation 0.59
|
4.32 units on a scale of 5
Standard Deviation 0.64
|
|
Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Accessibility and Convenience (0-5)
|
3.72 units on a scale of 5
Standard Deviation 0.58
|
3.93 units on a scale of 5
Standard Deviation 0.58
|
|
Patient Satisfaction as Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Interpersonal Manner (0-5)
|
4.19 units on a scale of 5
Standard Deviation 0.77
|
4.64 units on a scale of 5
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: 3 monthsThe Functional Assessment of Cancer Therapy-General (FACT-G) is a 27-item questionnaire comprised of four subscales to measure health-related quality of life: * physical well-being (PWB; 7-items, score range 0-28), higher score = better PWB * social/family well-being (SWB; 7-items, score range 0-28), higher score = worse SWB * emotional well-being (EWB; 6-items, score range 0-24), higher score = better EWB except item 2 where higher score = worse EWB * functional well-being (FWB; 7-items, score range 0-28), higher score = worse FWB All questions in the FACT-G use a 5-point rating scale (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Within a subscale, response are reversed for those where higher score = worse well-being, and then averaged for the scale score.
Outcome measures
| Measure |
Treatment Arm
n=19 Participants
For patients in the intervention arm, symptoms and laboratory results will be assessed using the text-based e-triage 96 hours prior to their intended infusion date. The e-triage will consist of a standardized questionnaire and algorithm to evaluate symptoms and laboratory values. Patients with acceptable labs and minimal or no symptoms can opt to proceed directly to their immunotherapy infusion without an in-person office assessment.
Text triage: The e-triage will consist of 16 questions, modified from the validated NCI Pro-CTCAETM, which will be sent to patients via WaytoHealth©'s two-way texting system 96 hours prior to their scheduled immunotherapy infusion. Questions will pertain to common or emergent immune related adverse events as defined by the NCCN guidelines and two senior disease experts. Patients will be prompted via text to measure the presence and severity of symptoms over the week prior. A final question will be included to capture any additional symptoms patients wish to disclose.
|
Usual Care
n=21 Participants
Patients in the usual care arm will receive standard of care symptom monitoring including an in-person office assessment prior to their scheduled immunotherapy infusion.
|
|---|---|---|
|
Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G)
Physical well-being (0-28)
|
23.21 units on a scale
Standard Deviation 5.31
|
23.4 units on a scale
Standard Deviation 4.27
|
|
Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G)
Social/family well-being (0-28)
|
22.48 units on a scale
Standard Deviation 5.04
|
25.71 units on a scale
Standard Deviation 5.39
|
|
Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G)
Emotional well-being (0-24)
|
17.66 units on a scale
Standard Deviation 5.45
|
20.6 units on a scale
Standard Deviation 3
|
|
Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G)
Functional well-being (0-28)
|
17.19 units on a scale
Standard Deviation 9
|
21 units on a scale
Standard Deviation 4.24
|
Adverse Events
Treatment Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place