NCT06722014

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Detailed description

The purpose of the study is to make sure the app is usable and helpful for participants with cancer and to get feedback about participants experiences after using the app for four weeks. Outcomes related to pain, quality of life, and healthcare utilization will also be assessed. The cancer pain education packet and pain and medication monitoring survey are standard care. The app is intended to improve self-management of cancer-related pain. The study will begin with Cohort A, followed by Cohort B. These two cohorts are to refine the STAMP+CBT intervention. Then a randomized pilot will be performed, and participants will be randomized into one of two study groups for the pilot: Cohort C: STAMP+CBT versus Cohort D: Digital Cancer Pain Education Packet + Usual Care. Randomization means a participant is placed into a study group by chance. It is expected that about 60 people will take part in this research study. The National Institutes of Health, National Cancer Institute (NIH-NCI), is funding this research study.

Conditions

• Pain
• Pain Syndrome
• Advanced Cancer

Interventions

Type	Name	Description
BEHAVIORAL	STAMP + CBT	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.
BEHAVIORAL	Digital Cancer Pain Education Packet	Packet including Articles from the Association for Clinical Oncology and the National Cancer Institute and the pain and medication monitoring form.

Timeline

• Start date: 2025-03-27
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2024-12-09
• Last updated: 2025-05-16

Locations

1 site across 1 country: United States