Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors
Purpose
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).
Condition
- Breast Cancer Survivor
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy 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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Two-arm, parallel group, RCT
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
- Masking Description
- This is a double-blind study where PIs, biostatisticians, and the CRC who performs outcome assessments are blinded.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey 07920
Basking Ridge, New Jersey 07920
Contact:
Jun Mao, MD, MSCE
646-888-0863
Jun Mao, MD, MSCE
646-888-0863
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey 07748
Middletown, New Jersey 07748
Contact:
Jun Mao, MD, MSCE
646-888-0863
Jun Mao, MD, MSCE
646-888-0863
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey 07645
Montvale, New Jersey 07645
Contact:
Jun Mao, MD, MSCE
646-888-0863
Jun Mao, MD, MSCE
646-888-0863
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York 11725
Commack, New York 11725
Contact:
Jun Mao, MD, MSCE
646-888-0863
Jun Mao, MD, MSCE
646-888-0863
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York 10604
Harrison, New York 10604
Contact:
Jun Mao, MD, MSCE
646-888-0863
Jun Mao, MD, MSCE
646-888-0863
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
New York, New York 10065
Contact:
Jun Mao, MD, MSCE
646-888-0863
Jun Mao, MD, MSCE
646-888-0863
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York 11553
Uniondale, New York 11553
Contact:
Jun Mao, MD, MSCE
646-888-0863
Jun Mao, MD, MSCE
646-888-0863
More Details
- NCT ID
- NCT06728579
- Status
- Recruiting
- Sponsor
- Memorial Sloan Kettering Cancer Center