Using a mobile app to help manage pain in advanced cancer patients
Integrating Pain-CBT Into an mHealth Analgesic Support Intervention for Patients With Chronic Pain From Advanced Cancers
This study is testing a mobile app that uses therapy techniques to help people with advanced cancer manage their pain better over four weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06722014 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and test a mobile health application that integrates cognitive behavioral therapy (CBT) to support patients with chronic pain due to advanced cancers. Participants will use the STAMP+CBT app for four weeks, providing feedback on its usability and effectiveness in managing pain. The study will assess outcomes related to pain levels, quality of life, and healthcare utilization. It involves two cohorts to refine the intervention followed by a randomized pilot comparing the app to standard care.
Who should consider this trial
Good fit: Ideal candidates include adults aged 22 and older with an active cancer diagnosis experiencing chronic pain and using opioid medication.
Not a fit: Patients who have completed cancer treatment or are in remission, as well as those with cognitive impairments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve pain management and quality of life for patients with advanced cancer.
How similar studies have performed: Other studies have shown promise in using mobile health technologies for pain management, but this specific integration of CBT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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.
Where this trial is running
Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Desiree Azizoddine, PsyD — Dana-Farber Cancer Institute
- Study coordinator: Desiree Azizoddin, PsyD
- Email: Desiree_Azizoddin@dfci.harvard.edu
- Phone: 626-826-7984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.