STAMP+CBT mHealth for Cancer Pain

Study Overview
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Brief Summary
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The purpose of this study is to test whether a mobile application developed to help people with cancer pain is useful and helpful to patients with cancer.

Detailed Description
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This research study involves the use of a smartphone app at home in addition to surveys and potentially an interview at the end of the study. The research study procedures include screening for eligibility, study interventions include surveys at the beginning of the study, after 4 weeks, and after 6 weeks and use of the smartphone app. Participants will be on this research study for up to 6 weeks. It is expected that about 15 people will take part in this research study This research study is a Feasibility Study, which is the first-time investigators are examining this mobile application meant to help participant to learn behavioral techniques to manage cancer pain. The purpose is to make sure the app is usable and helpful for patients with cancer, and to get feedback about patient experiences after using the app for four weeks.

Official Title
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Harnessing Mobile Technology to Deliver Tailored, Brief Pain-CBT for Advanced Cancer Patients on Opioids for Pain

Conditions
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Active Cancer, Active Cancer Treatment, Advanced Cancer, Palliative Care, Chronic Pain Due to Cancer

Intervention / Treatment
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* Behavioral: STAMP+CBT application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - PILOT COHORT Age ≥ 18 years Patients diagnosed with an active cancer diagnosis, either undergoing active cancer treatment or receiving treatment for an advanced cancer or are receiving palliative care Treatment managed at participating clinic (DFCI outpatient palliative care, gastrointestinal cancer center, and DFCI satellite clinic Merrimack Valley or Londonderry) Chronic pain related to cancer or treatment (> pain score of 4) Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain) Own a compatible smartphone (android) or is willing to use an android device provided by the study team Completes baseline survey Exclusion Criteria: Patients in survivorship: patients who have completed their treatment regimens, are not actively receiving treatment for an advanced cancer, or have a cancer that is in remission Cognitive impairment that would interfere with study participation, as judged by treating clinician Inability to speak English: the intervention has not yet been translated to Spanish History of opioid use disorders Enrolled in hospice Currently hospitalized Use of transmucosal fentanyl, given safety concerns and ongoing risk mitigation program required to prescribe these (TIRF REMS). Pain primarily related to a recent surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STAMP+CBT PILOT<br>Patients in this Pilot Cohort will be in the research study for 6 weeks total including: a 4-week intervention period and 2-week post intervention period. Patients will use the app for a total of 4 weeks (4-week intervention period), and will complete surveys at baseline, 4 weeks (end of intervention period), and at 6 weeks (end of 2-week post intervention period). | Behavioral: STAMP+CBT application<br>* Use the STAMP+CBT mobile app for 4 weeks (intervention period, 4 weeks for content introduction, extended 2 weeks for review of content if patient's request this<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Intervention Adherence Rate | >70% of subjects complete >4 of the 6 pain-CBT modules and patients will complete 60% of surveys by the end of 4 weeks (completion of the 4-week intervention study period)(completion of the 4-week intervention study period) | 4 Weeks | 
| Acceptability Rate | >80% of the acceptability items are rated 4 or higher/5; lower ratings will lead to app refinements | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Accrual Rate | 15 patients will be enrolled to the trial within 6 months | 6 Months | 
| Study retention | 60% of patients who enroll to the app with complete app use at the end of the 4 weeks and surveys at 4 and 6 weeks after enrollment | 6 Months | 
| COMPREHENSIVE ENDPOINT | Overall acceptability will be determined based on composite evaluation of acceptability ratings using the e-Acceptability scale, app content completion rates, and qualitative patient feedback. | 6 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Active cancer, Active cancer treatment, Advanced Cancer, Palliative care, Chronic Pain due to Cancer