Managing joint pain in breast cancer survivors
Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors
This study tests whether two different group therapy approaches can help breast cancer survivors manage joint pain from their medication and improve their overall well-being.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 9 sites (San Diego, California and 8 other locations) |
| Trial ID | NCT06728579 on ClinicalTrials.gov |
What this trial studies
This study compares two types of group therapy to help breast cancer survivors manage joint pain caused by aromatase inhibitors. Participants will engage in weekly 2-hour sessions over 8 weeks, focusing on either Mindfulness Oriented Recovery Enhancement or Supportive Psychotherapy. The study aims to assess the impact of these therapies on pain, fatigue, anxiety, and overall quality of life, as well as the participants' ability to continue their medication regimen. Data will be collected through questionnaires to evaluate the effectiveness of each approach.
Who should consider this trial
Good fit: Ideal candidates are English-proficient women aged 18 and older with a history of stage I, II, or III breast cancer who are experiencing joint pain related to aromatase inhibitor therapy.
Not a fit: Patients with metastatic breast cancer or those who have recently completed chemotherapy, surgery, or radiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective coping strategies for managing joint pain, improving the quality of life for breast cancer survivors.
How similar studies have performed: Other studies have shown promise in using mindfulness and supportive therapies for pain management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * English-proficient women with a history of stage I, II, or III breast cancer * Free of oncologic disease by clinical examination and history; * Receiving third-generation AI therapy (anastrozole, letrozole, or exemestane) for at least 28 days prior to consent with plan to continue for at least another 12 months; * Worst joint pain rated at least 4 or greater on a 0-10 numeric rating scale in the preceding week prior to consent; * Reporting at least 15 days with pain in the preceding 30 days prior to consent; * Experiencing joint pain for at least one month; * Pain attributed to AI therapy; * Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: Mindfulness-Oriented Recovery Enhancement (MORE) or Supportive Group Psychotherapy (SG); * Able to attend video-call sessions in a quiet/private location. Exclusion Criteria: * Metastatic breast cancer (stage IV); * Completed chemotherapy, surgery, or radiation therapy less than 4 weeks prior to enrollment; * Pain attributed to inflammatory arthritis (i.e. rheumatoid arthritis, gout, pseudogout); * Surgery or joint injection involving the affected joints within the last month or planned within the next six months; * Active suicidality or psychosis as determined by the Mini-International Neuropsychiatric Interview.
Where this trial is running
San Diego, California and 8 other locations
- University of California San Diego (Data collection and Data analysis) — San Diego, California, United States (Recruiting)
- Florida State University — Tallahassee, Florida, United States (Not_yet_recruiting)
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jun Mao, MD, MSCE — Memorial Sloan Kettering Cancer Center
- Study coordinator: Jun Mao, MD, MSCE
- Email: maoj@mskcc.org
- Phone: 646-608-8553
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.