NCT06728579 Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors
| NCT ID | NCT06728579 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Breast Cancer Survivor |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-12-06 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2024-12-06 with a primary completion date of 2028-12.
⚠ 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
The researchers are doing this study to compare two different types of group therapy and find out whether they are effective approaches for helping breast cancer survivors manage joint pain caused by aromatase inhibitors (AI). This type of joint pain is called AI-associated arthralgia, or AIA, and it is common in people taking AIs. AIA and its associated symptoms can make some people decide to stop taking their medication. The study will look at the effects of two different types of group therapy on participants' cancer-related symptoms (such as pain, fatigue, and anxiety), their ability to continue taking AIs on a regular schedule, and their quality of life. We will measure participants' quality of life by having them fill out questionnaires. Both groups will have 2-hour group therapy sessions once a week, over the course of 8 weeks. During the sessions, you will be in a group of 6-10 participants, who may be a mixture of patients from both MSK and University of California San Diego (UCSD).
Eligibility 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.
Contact & Investigator
Jun Mao, MD, MSCE
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT06728579 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Survivor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06728579 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06728579 currently recruiting?
Yes, NCT06728579 is actively recruiting participants. Contact the research team at maoj@mskcc.org for enrollment information.
Where is the NCT06728579 trial being conducted?
This trial is being conducted at San Diego, United States, Tallahassee, United States, Basking Ridge, United States, Middletown, United States and 5 additional locations.
Who is sponsoring the NCT06728579 clinical trial?
NCT06728579 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Jun Mao, MD, MSCE at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 200 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.