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NCT06728579 · ClinicalTrials.gov registry record · Phase 2
Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors
A Phase 2 study of Breast Cancer Survivor, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 9
- Study locations
NCT06728579: Recruiting Phase 2 study of Breast Cancer Survivor, sponsored by Memorial Sloan Kettering Cancer Center.
NCT06728579 is a Phase 2 study of Breast Cancer Survivor that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 200 participants, above the 66-participant average among 5 other Breast Cancer Survivor trials with a reported enrollment target (203% higher). The trial reports 9 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06728579, a Phase 2 study of Breast Cancer Survivor, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 9
- Study locations
Study 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).
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Questionnaires
- BEHAVIORAL Mindfulness Oriented Recovery Enhancement (MORE)
- BEHAVIORAL Supportive Psychotherapy (SG)
Study Locations (9)
New York
- Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (All Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Nassau (All Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (All Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (All Protocol Activities) - Montvale
California
- University of California San Diego (Data collection and Data analysis) - San Diego
Florida
- Florida State University - Tallahassee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-12-06 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What NCT06728579 shows while recruiting
NCT06728579 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 66-participant average among 5 other Breast Cancer Survivor trials with a reported enrollment target (203% higher).
The record links to 1 condition, with Breast Cancer Survivor appearing as the primary indexed condition, and to 3 interventions - of which Questionnaires is the first listed.
NCT06728579 lists 9 locations in 4 states (New York, New Jersey, California).
Frequently Asked Questions
What is clinical trial NCT06728579 about?
NCT06728579 is a clinical study titled "Enhanced Pain Coping in Cancer (EPIC): A Study of Managing Treatment-Related Joint Pain in Breast Cancer Survivors". 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 i...
What is the current status of trial NCT06728579?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2024-12-06. Estimated completion is 2028-12.
What conditions does trial NCT06728579 study?
This clinical trial studies the following conditions: Breast Cancer Survivor.
What interventions are being tested in trial NCT06728579?
The interventions under investigation include: Questionnaires (OTHER), Mindfulness Oriented Recovery Enhancement (MORE) (BEHAVIORAL), Supportive Psychotherapy (SG) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06728579?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06728579 being conducted?
This trial has 9 study locations across California, Florida, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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