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
The purpose of this research is to evaluate the effectiveness of a multidisciplinary pain management program for AIMSS in reducing pain, subjective cognitive complaints, psychological distress, and impaired functional status resulting in improved adherence to Aromatase Inhibitor medications compared to usual care. We want to identify predictors of improvement in pain, functional status, subjective cognition and mood following participation in the program.
Conditions studied
Breast Cancer
About this study
The purpose of this research is to evaluate the effectiveness of a multidisciplinary pain management program for AIMSS in reducing pain, subjective cognitive complaints, psychological distress, and impaired functional status resulting in improved adherence to Aromatase Inhibitor medications compared to usual care. We want to identify predictors of improvement in pain, functional status, subjective cognition and mood following participation in the program.
Interventions
- Behavioral: Cognitive Behavioral Therapy based Pain Management Program — Subjects will participate in a two-day structured class that will focus on Cognitive-Behavioral skills and strategies to improve pain control, fatigue, sleep disturbance, cognitive symptoms, and stress while educating patients on the efficacy of Aromatase Inhibitors in prolonging cancer-free survival with the goal of eliminating non-adherence.
Primary outcomes
- Adherence to Aromatase Inhibitors (AIs) (Baseline, 3 months, 6 months)
- AIMSS Follow-up Questionnaire (Baseline, 3 months, 6 months)
Eligibility information
Study locations
- Mayo Clinic in Florida, Jacksonville, Florida 32224 United States
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.