Trial Outcomes & Findings for STAMP+CBT mHealth for Cancer Pain (NCT NCT05403801)

Results Overview

\>70% of subjects complete \>4 of the 6 pain-CBT modules and patients will complete 50% of surveys by the end of 4 weeks (completion of the 4-week intervention study period)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

4 Weeks

Results posted on

2025-01-01

Participant Flow

Patients were recruited from outpatient palliative care clinics

Participant milestones

Participant milestones
Measure	Pilot Cohort Patients will use the STAMP+CBT app for 4 weeks (or 6 weeks if they request to review content further). During this 4 week intervention period participants will engage in pain CBT content including a goal-setting module, relaxation exercises, and reviewing educational content on cancer pain and psychological concepts. Patients will also use the app daily to report symptoms or pain, catastrophizing, mood, and sleep, and their usage of prescribed opioid medications. Patients will complete survey assessments at baseline, 4 weeks (end of intervention period), and 6 weeks (end of 2-week post intervention period) assessing feasibility, acceptability, and usability of the of the STAMP+CBT app.
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pilot Cohort Patients will use the STAMP+CBT app for 4 weeks (or 6 weeks if they request to review content further). During this 4 week intervention period participants will engage in pain CBT content including a goal-setting module, relaxation exercises, and reviewing educational content on cancer pain and psychological concepts. Patients will also use the app daily to report symptoms or pain, catastrophizing, mood, and sleep, and their usage of prescribed opioid medications. Patients will complete survey assessments at baseline, 4 weeks (end of intervention period), and 6 weeks (end of 2-week post intervention period) assessing feasibility, acceptability, and usability of the of the STAMP+CBT app.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

STAMP+CBT mHealth for Cancer Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pilot Cohort n=8 Participants Patients will use the STAMP+CBT app for 4 weeks (or 6 weeks if they request to review content further). During this 4 week intervention period participants will engage in pain CBT content including a goal-setting module, relaxation exercises, and reviewing educational content on cancer pain and psychological concepts. Patients will also use the app daily to report symptoms or pain, catastrophizing, mood, and sleep, and their usage of prescribed opioid medications. Patients will complete survey assessments at baseline, 4 weeks (end of intervention period), and 6 weeks (end of 2-week post intervention period) assessing feasibility, acceptability, and usability of the of the STAMP+CBT app.
Age, Continuous	52 Years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 Weeks

Population: Participants who tested the app for 4 weeks (n=8) completed daily their daily EMA surveys.

\>70% of subjects complete \>4 of the 6 pain-CBT modules and patients will complete 50% of surveys by the end of 4 weeks (completion of the 4-week intervention study period)

Outcome measures

Outcome measures
Measure	Pilot Cohort n=28 Total EMA App Surveys Patients will use the STAMP+CBT app for 4 weeks (or 6 weeks if they request to review content further). During this 4 week intervention period participants will engage in pain CBT content including a goal-setting module, relaxation exercises, and reviewing educational content on cancer pain and psychological concepts. Patients will also use the app daily to report symptoms or pain, catastrophizing, mood, and sleep, and their usage of prescribed opioid medications. Patients will complete survey assessments at baseline, 4 weeks (end of intervention period), and 6 weeks (end of 2-week post intervention period) assessing feasibility, acceptability, and usability of the of the STAMP+CBT app.
Overall Intervention Adherence Rate	15.75 EMA App Surveys Standard Deviation 6.76

PRIMARY outcome

Timeframe: 4 weeks

Population: Evaluate each acceptability items that were rated as 4 or higher out of 5 for all patients

Participants completed a modified version of the Acceptability E-scale, rating the app on a 5-point Likert scale (1-5), across 5 unique items on the following 5 domains: understandability, enjoyability, ease of use, time required to use it, and overall satisfaction.\[Tariman, 2011\] Higher scores indicated greater acceptability. Acceptability was pre-defined as \>80% across all acceptability items rated as \>4 or higher out of 5. Acceptability was evaluated by determining the mean score of all items for all participants (range of scale of score 1-5).

Outcome measures

Outcome measures
Measure	Pilot Cohort n=8 Participants Patients will use the STAMP+CBT app for 4 weeks (or 6 weeks if they request to review content further). During this 4 week intervention period participants will engage in pain CBT content including a goal-setting module, relaxation exercises, and reviewing educational content on cancer pain and psychological concepts. Patients will also use the app daily to report symptoms or pain, catastrophizing, mood, and sleep, and their usage of prescribed opioid medications. Patients will complete survey assessments at baseline, 4 weeks (end of intervention period), and 6 weeks (end of 2-week post intervention period) assessing feasibility, acceptability, and usability of the of the STAMP+CBT app.
Acceptability Rate	4.26 scores on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: 7 Months

Population: 10 patients were recruited in 7 months and 8 remained in the study and completed all study activities and measures.

Participants were defined as individuals who consented and enrolled in the trial and completed 28 days of app use and completed study measures.

Outcome measures

Outcome measures
Measure	Pilot Cohort n=10 Participants Patients will use the STAMP+CBT app for 4 weeks (or 6 weeks if they request to review content further). During this 4 week intervention period participants will engage in pain CBT content including a goal-setting module, relaxation exercises, and reviewing educational content on cancer pain and psychological concepts. Patients will also use the app daily to report symptoms or pain, catastrophizing, mood, and sleep, and their usage of prescribed opioid medications. Patients will complete survey assessments at baseline, 4 weeks (end of intervention period), and 6 weeks (end of 2-week post intervention period) assessing feasibility, acceptability, and usability of the of the STAMP+CBT app.
Number of Enrolled Participants Who Consented and Completed the Study	8 participants

SECONDARY outcome

Timeframe: 6 Months

Population: Percent of patients who consented and also completed 4 weeks of app use and surveys at 4 and 6 weeks after enrollment

The goal of the study was to have 60% of patients who enroll to the app will complete app use (use the app for 28 days) at the end of the 4 weeks and surveys at 4 and 6 weeks after enrollment

Outcome measures

Outcome measures
Measure	Pilot Cohort n=10 Participants Patients will use the STAMP+CBT app for 4 weeks (or 6 weeks if they request to review content further). During this 4 week intervention period participants will engage in pain CBT content including a goal-setting module, relaxation exercises, and reviewing educational content on cancer pain and psychological concepts. Patients will also use the app daily to report symptoms or pain, catastrophizing, mood, and sleep, and their usage of prescribed opioid medications. Patients will complete survey assessments at baseline, 4 weeks (end of intervention period), and 6 weeks (end of 2-week post intervention period) assessing feasibility, acceptability, and usability of the of the STAMP+CBT app.
Study Retention	8 Participants

SECONDARY outcome

Timeframe: 6 Weeks

Population: Patients rated the app's perceived acceptability on understandability, enjoyability, ease of use, time required to use it, and overall satisfaction on a 5-point Likert scale.

Overall acceptability will be determined based on composite evaluation of acceptability ratings using the modified items from the Acceptability E-Scale \[Tariman 2011\]. Participants completed a modified version of the Acceptability e-scale, rating the app on a 5-point Likert scale on the following 5 domains: understandability, enjoyability, ease of use, time required to use it, and overall satisfaction. Higher scores indicated higher acceptability. Acceptability was pre-defined as \>80% of all acceptability items being rated individually as \>4 out of 5 (possible scores on this scale range between 1-5). Acceptability was evaluated by determining the mean score on each item individually, across all participants (range of scale of score 1-5).

Outcome measures

Outcome measures
Measure	Pilot Cohort n=8 Participants Patients will use the STAMP+CBT app for 4 weeks (or 6 weeks if they request to review content further). During this 4 week intervention period participants will engage in pain CBT content including a goal-setting module, relaxation exercises, and reviewing educational content on cancer pain and psychological concepts. Patients will also use the app daily to report symptoms or pain, catastrophizing, mood, and sleep, and their usage of prescribed opioid medications. Patients will complete survey assessments at baseline, 4 weeks (end of intervention period), and 6 weeks (end of 2-week post intervention period) assessing feasibility, acceptability, and usability of the of the STAMP+CBT app.
COMPREHENSIVE ENDPOINT Ease of use	4.29 scores on a scale Standard Deviation 0.45
COMPREHENSIVE ENDPOINT Understandability	5.0 scores on a scale Standard Deviation 0
COMPREHENSIVE ENDPOINT Enjoyability	4.14 scores on a scale Standard Deviation 0.64
COMPREHENSIVE ENDPOINT Time acceptability	4.14 scores on a scale Standard Deviation 0.99
COMPREHENSIVE ENDPOINT overall Satisfaction	4.29 scores on a scale Standard Deviation 0.45

Adverse Events

Pilot Cohort

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

Desiree Azizoddin

Dana Farber Cancer Institute

Phone: (617) 632-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place