RecruitingPhase 2NCT06728579

Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

200 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two types of group therapy — mindfulness-based (MORE) and supportive group therapy — to help breast cancer survivors manage joint pain caused by hormone-blocking medications called aromatase inhibitors (like anastrozole, letrozole, or exemestane). Joint pain is a common side effect that causes many women to stop taking these important medications. **You may be eligible if...** - You are a woman aged 18 or older with a history of stage I, II, or III breast cancer - You are currently taking an aromatase inhibitor and have been for at least 28 days - You plan to continue taking the medication for at least 12 more months - You have significant joint pain (rated 4 or higher out of 10) that you believe is related to your medication - You have had pain on at least 15 days in the past month, lasting at least one month - You have access to video calls from a private space **You may NOT be eligible if...** - You have metastatic (stage IV) breast cancer - You completed chemotherapy, surgery, or radiation less than 4 weeks ago - Your joint pain is due to inflammatory arthritis (like rheumatoid arthritis or gout) - You've had joint surgery or injections recently or have them planned soon - You have active suicidal thoughts or psychosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMindfulness Oriented Recovery Enhancement (MORE)

eight weekly two-hour MORE sessions

OTHERQuestionnaires

filled out up to 24 weeks

BEHAVIORALSupportive Psychotherapy (SG)

eight weekly two-hour SG sessions


Locations(9)

University of California San Diego (Data collection and Data analysis)

San Diego, California, United States

Florida State University

Tallahassee, Florida, United States

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

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NCT06728579


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