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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06722014
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Cancer
  • Pain
  • Pain Syndrome

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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

Key Dates

Start date
Mar 27, 2025
Status verified
May 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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

Primary Outcome Measure

Overall intervention adherence rate (Cohort C) [ Time Frame: Up to 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215
Desiree R Azizoddin, PsyD
[email protected]
626-826-7984
Desiree R Azizoddin, PsyD (PRINCIPAL_INVESTIGATOR)

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By research site
Dana Farber Cancer Institute· Boston, MA

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