Recruiting
Phase 2

Pain Coping

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06728579

Conditions

Breast Cancer Survivor

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mindfulness Oriented Recovery Enhancement (MORE)

Questionnaires

Supportive Psychotherapy (SG)

Study Details

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

Study ID

NCT06728579

Start date

Dec 6, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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

Primary outcome measure

  • Pain Interference [ Time Frame: up to 24 weeks ]

Central Contacts and Locations

Central contacts

Jun Mao, MD, MSCE

646-608-8553maoj@mskcc.org

Karolina Bryl, PhD

646-608-8573brylk@mskcc.org

Locations

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

Recruiting

San Diego, California, United States, 92103

Contacts

Eric Garland, PhD, LCSW

801-581-3826

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Jun Mao, MD, MSCE

646-888-0863

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Jun Mao, MD, MSCE

646-888-0863

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Jun Mao, MD, MSCE

646-888-0863

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Jun Mao, MD, MSCE

646-888-0863

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Jun Mao, MD, MSCE

646-888-0863

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Jun Mao, MD, MSCE

646-888-0863

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Jun Mao, MD, MSCE

646-888-0863

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-04-17.