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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer Survivor

Treatments: Other: Questionnaires; Behavioral: Mindfulness Oriented Recovery Enhancement (MORE); Behavioral: Supportive Psychotherapy (SG)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06728579

24-171

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

MORE Treatment Group

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness Oriented Recovery Enhancement (MORE)

Other: Questionnaires

Supportive Psychotherapy Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Supportive Psychotherapy (SG)

Other: Questionnaires