Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast… (NCT06728579) | Clinical Trial Compass
RecruitingPhase 2
Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors
United States200 participantsStarted 2024-12-06
Plain-language 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).
Who can participate
Age range18 Years
SexFEMALE
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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.