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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• 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)

Locations
United States
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Desiree Azizoddin, PsyD
Desiree_Azizoddin@dfci.harvard.edu
626-826-7984
Time Frame
Start Date: 2025-03-27
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 60
Treatments
Experimental: Cohort C: STAMP + CBT App
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
Other: Cohort D: Digital Cancer Pain Education Packet + Usual Care
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
Related Therapeutic Areas
Sponsors
Leads: Dana-Farber Cancer Institute
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov