A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors

Phase 2

Recruiting

• Conditions: Breast Cancer Survivor

• Registration Number: NCT06728579
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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 sym...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-06
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pain severity reduced analgesic medication use	up to 24 weeks	The Brief Pain Inventory Short Form (BPI-SF) is an 11-item questionnaire with two subscales: pain severity (4 items) and pain interference (7 items), all rated on a scale from 0 to 10 (higher ratings indicate worse pain intensity/interference). The 7 pain interference questions have response choices of 0 "does not interfere" to 10 "completely interferes", an...

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities); 🇺🇸 Uniondale, New York, United States