STAMP+CBT mHealth for Cancer Pain

NCT05403801 | Completed Results

• 1 other identifier: 21-719
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Active Cancer; Active Cancer Treatment; Advanced Cancer; Palliative Care; Chronic Pain Due to Cancer

Keywords

Active cancer; Active cancer treatment; Advanced Cancer; Palliative care; Chronic Pain due to Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of Enrolled Participants Who Consented and Completed the Study

  7 Months

• Study Retention

  6 Months

• COMPREHENSIVE ENDPOINT

  6 Weeks

Study Arms (1)

STAMP+CBT PILOT

EXPERIMENTAL

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

Interventions

STAMP+CBT application BEHAVIORAL

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

STAMP+CBT PILOT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Palliative Care Research Center: collaborator

Study Sites (3)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Dana-Farber at Merrimack Valley

Methuen, Massachusetts, 01844, United States

Location

Dana-Farber at Londonderry

Londonderry, New Hampshire, 03053, United States

Location

Related Publications (1)

• Azizoddin DR, DeForge SM, Baltazar A, Edwards RR, Allsop M, Tulsky JA, Businelle MS, Schreiber KL, Enzinger AC. Development and pre-pilot testing of STAMP + CBT: an mHealth app combining pain cognitive behavioral therapy and opioid support for patients with advanced cancer and pain. Support Care Cancer. 2024 Jan 22;32(2):123. doi: 10.1007/s00520-024-08307-7.

  PMID: 38252172 DERIVED

Results Point of Contact

• Title: Desiree Azizoddin
• Organization: Dana Farber Cancer Institute

desiree_azizoddin@dfci.harvard.edu

(617) 632-3000

Study Officials

• Desiree Azizoddin, PsyD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 3, 2022
• Study Start: July 1, 2022
• Primary Completion: June 8, 2023
• Study Completion: June 27, 2023
• Last Updated: January 1, 2025
• Results First Posted: January 1, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (3)