Multidisciplinary pain management program for breast cancer survivors
A Randomized Controlled Trial (RCT) to Determine the Efficacy of a Multidisciplinary CBT Based Pain Management Program for the Treatment of Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) in Breast Cancer Survivors
This study tests a new pain management program using therapy for breast cancer survivors who have muscle and joint pain from their medication to see if it helps them feel better and stick to their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06831838 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a multidisciplinary cognitive behavioral therapy (CBT) based pain management program specifically designed for breast cancer survivors experiencing Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS). The program aims to reduce pain, cognitive complaints, psychological distress, and improve functional status, thereby enhancing adherence to Aromatase Inhibitor medications compared to standard care. The study will also identify predictors of improvement in these areas following participation in the program.
Who should consider this trial
Good fit: Ideal candidates for this study are breast cancer survivors aged 18 and older with stage 0-III hormone receptor-positive breast cancer who are seeking strategies to manage their symptoms.
Not a fit: Patients with stage 4 hormone receptor-positive breast cancer are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life for breast cancer survivors by alleviating pain and psychological distress.
How similar studies have performed: Other studies have shown promising results with multidisciplinary approaches to pain management in cancer survivors, indicating potential success for this program.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years old * ECOG ≤ 2 * Stage 0-III HR+ breast cancer in need of strategies to reduce symptoms and improve quality of life Exclusion Criteria: • Less than 18 years of age. \- Stage 4 HR+ breast cancer
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Barbara Bruce, Ph.D., LP — Mayo Clinic
- Study coordinator: Alejandra Cuartas-Abril, M.S.
- Email: Cuartas-Abril.Alejandra@mayo.edu
- Phone: 904-956-8885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.