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
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Contact Information
Primary
Alejandra Cuartas-Abril, M.S.
Cuartas-Abril.Alejandra@mayo.edu
904-956-8885
Time Frame
Start Date: 2025-02-06
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 115
Treatments
Experimental: Treatment Group
Subjects randomized to the treatment group will participate in a multicomponent pain treatment program in addition to standard of care treatment.
No_intervention: Control Group
Subjects randomized to the control group will continue to receive standard of care treatment. At the end of the study, the control group participants will be offered the multicomponent pain treatment program.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic