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

NCT06728579 | Recruiting Phase 2

• 1 other identifier: 24-171
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 9

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 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).

Conditions

Breast Cancer Survivor

Keywords

Enhanced Pain Coping in Cancer; Mindfulness Oriented Recovery Enhancement; Aromatase inhibitors; Arthralgia; Ache; Cancer Pain; Cancer Survivors

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 24 weeks

Secondary Outcomes (23)

• Pain Severity

  baseline, week 8, week 12, and week 24

• Pain Catastrophizing

  baseline, week 8, week 12, and week 24

• Patient Global Impression of Change

  week 8, week 12, and week 24

• Anxiety/Depression

  baseline, week 8, week 12, and week 24

• Insomnia

  baseline, week 8, week 12, and week 24

Study Arms (2)

MORE Treatment Group

EXPERIMENTAL

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.

Behavioral: Mindfulness Oriented Recovery Enhancement (MORE); Other: Questionnaires

Supportive Psychotherapy Control Group

ACTIVE COMPARATOR

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.

Other: Questionnaires; Behavioral: Supportive Psychotherapy (SG)

Interventions

Mindfulness Oriented Recovery Enhancement (MORE) BEHAVIORAL

eight weekly two-hour MORE sessions

MORE Treatment Group

Questionnaires OTHER

filled out up to 24 weeks

MORE Treatment Group; Supportive Psychotherapy Control Group

Supportive Psychotherapy (SG) BEHAVIORAL

eight weekly two-hour SG sessions

Supportive Psychotherapy Control Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breast Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (9)

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

San Diego, California, 92103, United States

RECRUITING

Florida State University

Tallahassee, Florida, 32306, United States

NOT YET RECRUITING

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Arthralgia; Pain; Cancer Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jun Mao, MD, MSCE

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Mao, MD, MSCE

CONTACT

646-608-8553; maoj@mskcc.org

Karolina Bryl, PhD

CONTACT

646-608-8573; brylk@mskcc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study where PIs, biostatisticians, and the CRC who performs outcome assessments are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, parallel group, RCT

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (9)