Integrating Pain-CBT Into an mHealth Analgesic Support Intervention for Patients With Chronic Pain From Advanced Cancers

NCT06722014 | Recruiting

• 2 other identifiers: 24-2865K08CA266937
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Smartphone Technology to Alleviate Malignant Pain (STAMP) + Cognitive Behavioral Therapy for Pain (STAMP+CBT) The purpose of the study is to develop and refine the mHealth pain-CBT app intervention and carry out a randomized pilot to test the novel mHealth (Mobile health technology) intervention, which harmonizes psychological and pharmacological support for advanced cancer pain. The name of the study smartphone application involved in this study is:

• STAMP+CBT

Conditions

Pain; Pain Syndrome; Advanced Cancer

Keywords

Pain; Pain Syndrome; Advanced Cancer

Outcome Measures

Primary Outcomes (4)

• Overall intervention adherence rate (Cohort C)

  \>70% of subjects complete any activity on the STAMP+CBT application at least 50% of days on study (4-week study period). The app will be considered feasible if this benchmark is achieved.

  Up to 4 weeks

• Overall intervention adherence rate (Cohort D)

  Defined as completion of the 14- and 28-days surveys, which assesses completion of the pain and medication monitoring reports by participants in the control group.

  Up to 4 weeks

• Proportion of participants who rate app acceptability at least 4/5 on the Acceptability E-Scale (Cohort C)

  Acceptability of the intervention is defined as \> 80% of the participants rate the application as satisfactory and useful with a mean 4 or higher score out of 5 on the Acceptability E-Scale (Tariman 2011). The Acceptability E-Scale a 7-item measure with answer ranging from 1 "Very Difficulty/Difficult to understand/Not at all/Very unacceptable/Very dissatisfied/Not useful/Very unlikely" to 5 "Very Easy/Easy to understand/Very much/ Very acceptable/Very satisfied/Very useful/Very likely" and with a total scores range of 7 to 35 with a higher score representing greater participant acceptability. Subjects will be assigned surveys at baseline, 4 weeks, and 6 weeks. Participants will rate the app on the following 5 domains: understandability, enjoyability, ease of use, time required to use the app, and overall satisfaction. Ratings lower than 4/5 will lead to refinements.

  Up to 6 weeks

• Proportion of participants who rate educational packet acceptability at least 4/5 on the Acceptability E-Scale (Cohort D)

  Acceptability of the intervention is defined as \> 80% of the participants rate the application as satisfactory and useful with a mean 4 or higher score out of 5 on the Acceptability E-Scale (Tariman 2011). The Acceptability E-Scale a 7-item measure with answer ranging from 1 "Very Difficulty/Difficult to understand/Not at all/Very unacceptable/Very dissatisfied/Not useful/Very unlikely" to 5 "Very Easy/Easy to understand/Very much/ Very acceptable/Very satisfied/Very useful/Very likely" and with a total scores range of 7 to 35 with a higher score representing greater participant acceptability. Subjects will be assigned surveys at baseline, 4 weeks, and 6 weeks. Participants will rate the app on the following 5 domains: understandability, enjoyability, ease of use, time required to use the app, and overall satisfaction. Ratings lower than 4/5 will lead to refinements.

  Up to 6 weeks

Secondary Outcomes (10)

• Number of Enrolled Participants who Consented and Completed the Study (Cohort C)

  18 months

• Number of Enrolled Participants who Consented and Completed the Study (Cohort D)

  18 months

• Study Retention (Cohort C)

  18 months

• Study Retention (Cohort D)

  18 months

• Median assessment score on the system usability scale at 4 weeks (Cohort C)

  Up to 6 weeks

Study Arms (2)

Cohort C: STAMP + CBT App

EXPERIMENTAL

Permutated-block randomization and a block size of 6 will be used to randomize 60 participants to this cohort, and participants will complete: * Baseline in-person or remote visit with an introduction to the STAMP+CBT application. * Surveys via the application 6 days per week. * Day 7 check in with study team * Day 14 survey * Day 28 follow-up surveys * Optional in-person or remote semi-structured, exit interview * Day 42 (Week 6) follow-up survey

Behavioral: STAMP + CBT

Cohort D: Digital Cancer Pain Education Packet + Usual Care

OTHER

Permutated-block randomization and a block size of 6 will be used to randomize 60 participants to this cohort, and participants will complete: * Baseline in-person or remote visit with introduction to the digital cancer pain education packet and pain tracker form. * Completion of pain tracker * Day 7 check in with study team * Day 14 survey * Day 28 surveys * Optional in-person or remote semi-structured, exit interview to review the educational packet * Day 42 (Week 6) follow-up survey

Behavioral: Digital Cancer Pain Education Packet

Interventions

STAMP + CBT BEHAVIORAL

A mobile health, smartphone application that provides tailored multi-media, cancer pain psycho-education and pain management coping skills using algorithm-based technology to provide in the moment symptom monitoring and feedback.

Also known as: Smartphone Technology to Alleviate Malignant Pain+Cognitive Behavioral Therapy for pain

Cohort C: STAMP + CBT App

Digital Cancer Pain Education Packet BEHAVIORAL

Packet including Articles from the Association for Clinical Oncology and the National Cancer Institute and the pain and medication monitoring form.

Cohort D: Digital Cancer Pain Education Packet + Usual Care

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 22 years
• Patient diagnosed with an active cancer diagnosis (locally advanced solid tumor malignancy, multiple myeloma, or other advanced hematologic malignancy), either undergoing active treatment or receiving treatment for an advanced cancer or are receiving supportive/palliative care
• Chronic pain related to cancer or treatment (\> pain score of 4 on a 0-10 scale)
• Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain)
• Own/use a compatible smartphone (iPhone or Android)

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 (e.g. delirium, dementia)
• Inability to speak English (the intervention has not yet been translated to Spanish)
• Currently in CBT treatment
• 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 (within the last 2 weeks)
• Conditions that hinder smartphone use
• The study will exclude adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Pain; Somatoform Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Desiree Azizoddine, PsyD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Desiree Azizoddin, PsyD

CONTACT

626-826-7984; Desiree_Azizoddin@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 9, 2024
• Study Start: March 27, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

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 (1)