Trial Outcomes & Findings for Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain (NCT NCT05774197)

Last Updated: 2025-11-04

Results Overview

Patients will be assigned surveys at baseline, 4-week intervention period and 2 weeks post intervention period (6 weeks from baseline). Based on that patient's overall adherence rate/app retention rates will be calculated and intervention will be considered feasible if more than 70% of subjects complete any activity on the app at least 50% of days on study.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

4-weeks

Results posted on

2025-11-04

Participant Flow

Participants were recruited at 1 site from May 2023 to February 2024. The first patient was enrolled on May 4, 2023 and the last patient was enrolled on February 8, 2024.

Of 52 enrolled participants, 31 met inclusion criteria and assigned to the single arm study. Among 31 patients enrolled into the app, 16 completed all surveys.

Participant milestones

Participant milestones
Measure	STAMP+CBT App This app will allow the patient to access daily surveys designed to assess pain, stress, mood, and related symptoms. Based on patient-reported symptoms, this app will disseminate tailored education to manage the symptoms. Cognitive Behavioral Therapy for pain: Patients participating in this study will have survey assessments at baseline, 4 weeks (end of 4-week intervention period), and 6 weeks (end of 2-week post intervention period) assessing patient reported concerns, quality of life outcomes and usability of STAMP+CBT app. During this time, Patient will receive algorithm-based advice in response to their daily pain and mood surveys. These patients will be introduced to the extensive multi-media library of educational content covering medication support (e.g. using short and long-acting opioids, managing side effects, opioid safety); pain psychology (e.g. pain perception, pain and the stress response); health behaviors and pain (e.g. sleep hygiene); and skills training (e.g. activity pacing/ relaxation recordings).
Overall Study STARTED	31
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	STAMP+CBT App This app will allow the patient to access daily surveys designed to assess pain, stress, mood, and related symptoms. Based on patient-reported symptoms, this app will disseminate tailored education to manage the symptoms. Cognitive Behavioral Therapy for pain: Patients participating in this study will have survey assessments at baseline, 4 weeks (end of 4-week intervention period), and 6 weeks (end of 2-week post intervention period) assessing patient reported concerns, quality of life outcomes and usability of STAMP+CBT app. During this time, Patient will receive algorithm-based advice in response to their daily pain and mood surveys. These patients will be introduced to the extensive multi-media library of educational content covering medication support (e.g. using short and long-acting opioids, managing side effects, opioid safety); pain psychology (e.g. pain perception, pain and the stress response); health behaviors and pain (e.g. sleep hygiene); and skills training (e.g. activity pacing/ relaxation recordings).
Overall Study Did not complete all the surveys required for study.	15

Baseline Characteristics

Psychological Intervention Using Smartphone Technology to Alleviate Malignant Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STAMP+CBT App n=31 Participants This app will allow the patient to access daily surveys designed to assess pain, stress, mood, and related symptoms. Based on patient-reported symptoms, this app will disseminate tailored education to manage the symptoms. Cognitive Behavioral Therapy for pain: Patient participating in this study will have survey assessments at baseline, 4 weeks (end of 4-week intervention period), and 6 weeks (end of 2-week post intervention period) assessing patient reported concerns, quality of life outcomes and usability of STAMP+CBT app. During this time, Patient will receive algorithm-based advice in response to their daily pain and mood surveys. These patients will be introduced to the extensive multi-media library of educational content covering medication support (e.g. using short and long-acting opioids, managing side effects, opioid safety); pain psychology (e.g. pain perception, pain and the stress response); health behaviors and pain (e.g. sleep hygiene); and skills training (e.g. activity pacing/ relaxation recordings).
Age, Continuous	55.41 years STANDARD_DEVIATION 12.22 • n=15 Participants
Sex: Female, Male Female	17 Participants n=15 Participants
Sex: Female, Male Male	14 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=15 Participants
Race (NIH/OMB) Asian	0 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	3 Participants n=15 Participants
Race (NIH/OMB) White	24 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants
Rural Dwelling	10 Participants n=15 Participants

PRIMARY outcome

Timeframe: 4-weeks

Population: Patients who enrolled in the study and used the app

Outcome measures

Outcome measures
Measure	STAMP+CBT App n=31 Participants This app will allow the patient to access daily surveys designed to assess pain, stress, mood, and related symptoms. Based on patient-reported symptoms, this app will disseminate tailored education to manage the symptoms. Cognitive Behavioral Therapy for pain: Patients participating in this study will have survey assessments at baseline, 4 weeks (end of 4-week intervention period), and 6 weeks (end of 2-week post intervention period) assessing patient reported concerns, quality of life outcomes and usability of STAMP+CBT app. During this time, Patient will receive algorithm-based advice in response to their daily pain and mood surveys. These patients will be introduced to the extensive multi-media library of educational content covering medication support (e.g. using short and long-acting opioids, managing side effects, opioid safety); pain psychology (e.g. pain perception, pain and the stress response); health behaviors and pain (e.g. sleep hygiene); and skills training (e.g. activity pacing/ relaxation recordings).
Proportion of Patients Who Complete More Than 2/3rd of the Study Modules at the End of 4 Weeks of Intervention to Determine Feasibility of the STAMP+CBT App	19 Participants

PRIMARY outcome

Timeframe: 6-weeks

Population: Patients who enrolled in the study and used the app and completed the survey

Patients will be assigned surveys at baseline, 4-week intervention period and 2 weeks post intervention period (6 weeks from baseline). In response to the survey's patient will be assigned tailored psychological intervention for advanced cancer pain. During the trial, these interventions will be considered acceptable only if 80% or more of the acceptability items are rated 4 or higher/5; Lower rating will lead to app refinements.

Outcome measures

Outcome measures
Measure	STAMP+CBT App n=21 Participants This app will allow the patient to access daily surveys designed to assess pain, stress, mood, and related symptoms. Based on patient-reported symptoms, this app will disseminate tailored education to manage the symptoms. Cognitive Behavioral Therapy for pain: Patients participating in this study will have survey assessments at baseline, 4 weeks (end of 4-week intervention period), and 6 weeks (end of 2-week post intervention period) assessing patient reported concerns, quality of life outcomes and usability of STAMP+CBT app. During this time, Patient will receive algorithm-based advice in response to their daily pain and mood surveys. These patients will be introduced to the extensive multi-media library of educational content covering medication support (e.g. using short and long-acting opioids, managing side effects, opioid safety); pain psychology (e.g. pain perception, pain and the stress response); health behaviors and pain (e.g. sleep hygiene); and skills training (e.g. activity pacing/ relaxation recordings).
Proportion of Patients Who Rate the Acceptability Items 4 or Higher on the App.	15 Participants

Adverse Events

STAMP+CBT App

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, PsyD

Harvard Medical School

Phone: 4052718001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place