STAMP+CBT mHealth for Cancer Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer; Palliative Care; Active Cancer; Active Cancer Treatment; Chronic Pain Due to Cancer
• Intervention / Treatment: Behavioral: STAMP+CBT application

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
    • Methuen, Massachusetts, United States, 01844
      • Dana-Farber at Merrimack Valley
  • New Hampshire
    • Londonderry, New Hampshire, United States, 03053
      • Dana-Farber at Londonderry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STAMP+CBT PILOT; 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; 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

What is the study measuring?

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 50% of surveys by the end of 4 weeks (completion of the 4-week intervention study period)	4 Weeks
Acceptability Rate	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).	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Palliative Care Research Center
• Investigators: Principal Investigator: Desiree Azizoddin, PsyD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): June 8, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Palliative care; Advanced Cancer; Active cancer; Active cancer treatment; Chronic Pain due to Cancer
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 21-719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No