Clinical trial NCT06728579: Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors
Official title: Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer Survivor
Keywords: Enhanced Pain Coping in Cancer
Mindfulness Oriented Recovery Enhancement
Aromatase inhibitors
Arthralgia
Ache
Cancer Pain
Cancer Survivors
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-12-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, parallel group, RCT
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Pain Interference
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Pain Severity
timeFrame: baseline, week 8, week 12, and week 24
measure: Pain Catastrophizing
timeFrame: baseline, week 8, week 12, and week 24
measure: Patient Global Impression of Change
timeFrame: week 8, week 12, and week 24
measure: Anxiety/Depression
timeFrame: baseline, week 8, week 12, and week 24
measure: Insomnia
timeFrame: baseline, week 8, week 12, and week 24
measure: Fatigue
timeFrame: baseline, week 8, week 12, and week 24
measure: Global Health
timeFrame: baseline, week 8, week 12, and week 24
measure: Perceptions of aging due to arthralgia
timeFrame: baseline, week 8, week 12, and week 24
measure: Pleasant and painful sensations in the body
timeFrame: baseline, week 8, week 12, and week 24.
measure: Reappraisal
timeFrame: baseline, week 8, week 12, and week 24
measure: Decentering
timeFrame: baseline, week 8, week 12, and week 24
measure: Nondual awareness
timeFrame: baseline, week 8, week 12, and week 24.
measure: Meaning in Life
timeFrame: baseline, week 8, week 12, and week 24
measure: Emotion Regulation
timeFrame: baseline, week 8, week 12, and week 24.
measure: Savoring
timeFrame: baseline, week 8, week 12, and week 24
measure: Compassion
timeFrame: baseline, week 8, week 12, and week 24.
measure: Global self-compassion
timeFrame: baseline, week 8, week 12, and week 24
measure: Treatment Credibility and Expectancy
timeFrame: baseline
measure: Treatment Expectancy
timeFrame: baseline
measure: Pain Medication Diary
timeFrame: baseline, week 8, 12 and 24.
measure: AI Adherence
timeFrame: baseline, week 8, 12 and 24.
measure: Mindfulness Daily Log
timeFrame: weekly throughout the 8-week intervention
measure: Journaling Daily Log
timeFrame: weekly throughout the 8-week interventio
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego (Data collection and Data analysis)
state: California
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jun Mao, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: