STAMP+CBT mHealth for Cancer Pain

Not Applicable

Completed

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

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
STAMP+CBT PILOT	STAMP+CBT application	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).

Primary Outcome Measures

Name	Time	Method
Overall Intervention Adherence Rate	4 Weeks	\>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)
Acceptability Rate	4 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Number of Enrolled Participants Who Consented and Completed the Study	7 Months	Participants were defined as individuals who consented and enrolled in the trial and completed 28 days of app use and completed study measures.
Study Retention	6 Months	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
COMPREHENSIVE ENDPOINT	6 Weeks	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).

Locations (3): Dana Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Dana-Farber at Merrimack Valley
🇺🇸
Methuen, Massachusetts, United States
Dana-Farber at Londonderry
🇺🇸
Londonderry, New Hampshire, United States