NCT06722014 Integrating Pain-CBT Into an mHealth Analgesic Support Intervention for Patients With Chronic Pain From Advanced Cancers
| NCT ID | NCT06722014 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-27 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-03-27 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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.
Contact & Investigator
Desiree Azizoddine, PsyD
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT06722014 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06722014 currently recruiting?
Yes, NCT06722014 is actively recruiting participants. Contact the research team at Desiree_Azizoddin@dfci.harvard.edu for enrollment information.
Where is the NCT06722014 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06722014 clinical trial?
NCT06722014 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Desiree Azizoddine, PsyD at Dana-Farber Cancer Institute. The trial plans to enroll 60 participants.