Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors
NCT ID: NCT06728579
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2024-12-06
2028-12-31
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MORE Treatment Group
Participants randomized to the MORE arm will participate in eight weekly, two-hour group sessions following an established protocol. MORE sessions involve instruction in three therapeutic skills: 1) mindfulness to reduce pain and increase self regulation over maladaptive pain coping habits, (2) reappraisal to decrease psychological distress and negative affect, and 3) savoring to amplify natural reward processing and evoke positive emotion (see Figure 2). Participants will be asked to engage in 15 minutes per day of skill practice at home guided by audio recording, and to record the number of minutes they engaged in skill practice via a weekly Research Electronic Data Capture (REDCap) survey.
Mindfulness Oriented Recovery Enhancement (MORE)
eight weekly two-hour MORE sessions
Questionnaires
filled out up to 24 weeks
Supportive Psychotherapy Control Group
Participants randomized to SG will participate in eight weekly two-hour SG sessions led by the same instructors who deliver MORE interventions. The instructors will lead discussions on themes pertinent to chronic pain and cancer survivorship (see Figure 3) but will not teach MORE skills. To match the MORE homework requirement, SG participants will be asked to journal for 15 minutes/day on weekly session topics. Providers will employ empathic responding, elicit emotional expression, and promote a positive group climate.
Questionnaires
filled out up to 24 weeks
Supportive Psychotherapy (SG)
eight weekly two-hour SG sessions
Interventions
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Mindfulness Oriented Recovery Enhancement (MORE)
eight weekly two-hour MORE sessions
Questionnaires
filled out up to 24 weeks
Supportive Psychotherapy (SG)
eight weekly two-hour SG sessions
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
National Institutes of Health (NIH)
NIH
Responsible Party
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Principal Investigators
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Jun Mao, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Eric Garland, PhD, LCSW
Role: primary
Adam Hanley, PhD
Role: primary
Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
Jun Mao, MD, MSCE
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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24-171
Identifier Type: -
Identifier Source: org_study_id