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Mindfulness-Based Interventions for Managing Chronic Pain in Breast Cancer Survivors, EPIC Trial
Trial Status: active
This phase II trial tests the effectiveness of two different types of group therapy in managing aromatase inhibitor-associated arthralgia (AIA) in breast cancer survivors. AIA is a common type of joint pain in patients taking aromatase inhibitors (AIs). AIA and its associated symptoms can make some patients decide to stop taking their medication. Mindfulness-based interventions (MBIs) are therapeutic programs that use mindfulness meditation practices to cultivate present-moment focused attention and meta-awareness (focusing on the contents of one's thoughts), as well as encourage acceptance of thoughts, emotions, and body sensations. Mindfulness Oriented Recovery Enhancement (MORE) appears to be a particularly effective MBI for chronic pain treatment. MORE improves pain-related outcomes in non-cancer patients, suggesting that this new treatment may be effective as an intervention for reducing chronic pain among cancer patients. MORE may improve management of chronic pain in breast cancer survivors.
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
Additional locations may be listed on ClinicalTrials.gov for NCT06728579.
I. To evaluate the specific efficacy of MORE for managing AIA among breast cancer survivors.
II. To evaluate the specific effects of MORE on comorbid symptoms, quality of life, and adherence to AIs.
III. To elucidate the cognitive-affective mechanisms of MORE for pain management among breast cancer survivors.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients participate in MORE sessions involving instruction in 3 therapeutic skills: mindfulness to reduce pain and increase self regulation over maladaptive pain coping habits, reappraisal to decrease psychological distress and negative affect, and savoring to amplify natural reward processing and evoke positive emotion over 2 hours once a week (QW) for 8 weeks.
GROUP II: Patients participate in supportive psychotherapy group (SG) sessions involving discussions focused on themes pertinent to chronic pain and cancer survivorship over 2 hours QW for 8 weeks.
After completion of study intervention, patients are followed up at 8, 12, and 24 weeks.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
