RecruitingNot ApplicableNCT06831838

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


Sponsor

Mayo Clinic

Enrollment

115 participants

Start Date

Feb 6, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria2

  • • Less than 18 years of age.
  • \- Stage 4 HR+ breast cancer

Interventions

BEHAVIORALCognitive 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.


Locations(1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

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NCT06831838


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