Managing joint pain in breast cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of California San Diego (Data collection and Data analysis)
  San Diego, California, United States 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.