Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 2

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

NCT ID: NCT06728579Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-04-17

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).

Arms & 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

Outcome measures

Primary

  • Pain Interference

    Pain interference will be assessed using the 7-item Pain Interference subscale from the Brief Pain Inventory Short Form (BPI-SF). Each item is rated on a scale from 0 ("does not interfere") to 10 ("completely interferes"), with higher scores indicating worse interference. The BPI is a widely used, reliable, valid, and responsive tool for measuring pain (Cronbach's α 0.77-0.91). The Pain Interference subscale will be administered at baseline, weekly during the 8-week intervention, and at weeks 12 and 24. Completing the survey requires approximately 1 minute.

    Time frame: up to 24 weeks

Secondary

  • Pain Severity

    Time frame: baseline, week 8, week 12, and week 24

  • Pain Catastrophizing

    Time frame: baseline, week 8, week 12, and week 24

  • Patient Global Impression of Change

    Time frame: week 8, week 12, and week 24

  • Anxiety/Depression

    Time frame: baseline, week 8, week 12, and week 24

  • Insomnia

    Time frame: baseline, week 8, week 12, and week 24

  • Fatigue

    Time frame: baseline, week 8, week 12, and week 24

  • Global Health

    Time frame: baseline, week 8, week 12, and week 24

  • Perceptions of aging due to arthralgia

    Time frame: baseline, week 8, week 12, and week 24

  • Pleasant and painful sensations in the body

    Time frame: baseline, week 8, week 12, and week 24.

  • Reappraisal

    Time frame: baseline, week 8, week 12, and week 24

  • Decentering

    Time frame: baseline, week 8, week 12, and week 24

  • Nondual awareness

    Time frame: baseline, week 8, week 12, and week 24.

  • Meaning in Life

    Time frame: baseline, week 8, week 12, and week 24

  • Emotion Regulation

    Time frame: baseline, week 8, week 12, and week 24.

  • Savoring

    Time frame: baseline, week 8, week 12, and week 24

  • Compassion

    Time frame: baseline, week 8, week 12, and week 24.

  • Global self-compassion

    Time frame: baseline, week 8, week 12, and week 24

  • Treatment Credibility and Expectancy

    Time frame: baseline

  • Treatment Expectancy

    Time frame: baseline

  • Pain Medication Diary

    Time frame: baseline, week 8, 12 and 24.

  • AI Adherence

    Time frame: baseline, week 8, 12 and 24.

  • Mindfulness Daily Log

    Time frame: weekly throughout the 8-week intervention

  • Journaling Daily Log

    Time frame: weekly throughout the 8-week interventio

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (9)

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

San Diego, California, 92103

Recruiting
Eric Garland, PhD, LCSW · Contact
801-581-3826

Florida State University

Tallahassee, Florida, 32306

Not Yet Recruiting
Adam Hanley, PhD · Contact
adam.hanley@fsu.edu

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920

Recruiting
Jun Mao, MD, MSCE · Contact
646-888-0863

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

Recruiting
Jun Mao, MD, MSCE · Contact
646-888-0863

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645

Recruiting
Jun Mao, MD, MSCE · Contact
646-888-0863

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, 11725

Recruiting
Jun Mao, MD, MSCE · Contact
646-888-0863

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

Recruiting
Jun Mao, MD, MSCE · Contact
646-888-0863

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Recruiting
Jun Mao, MD, MSCE · Contact
646-888-0863

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553

Recruiting
Jun Mao, MD, MSCE · Contact
646-888-0863