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

NCT06831838 | Recruiting

• 1 other identifier: 24-011941
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Adherence to Aromatase Inhibitors (AIs)

  Adherence to Aromatase Inhibitors (AIs) medications will be collected as a self-reported question asking the patients if they have taken their medications as prescribed during the past month (yes vs. no).

  Baseline, 3 months, 6 months

• AIMSS Follow-up Questionnaire

  Subjects will complete the study follow-up questionnaire with study staff to indicate whether they are adhering to medications and to report symptoms.

  Baseline, 3 months, 6 months

Secondary Outcomes (8)

• Brief Pain Inventory

  Baseline, 3 months, 6 months

• Center for Epidemiologic Studies of Depression - Revised Questionnaire

  Baseline, 3 months, 6 months

• Pain Catastrophizing Scale

  Baseline, 3 months, 6 months

• Brief Resilience Scale

  Baseline, 3 months, 6 months

• Social Support Survey

  Baseline, 3 months, 6 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

Subjects randomized to the treatment group will participate in a multicomponent pain treatment program in addition to standard of care treatment.

Behavioral: Cognitive Behavioral Therapy based Pain Management Program

Control Group

NO INTERVENTION

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.

Interventions

Cognitive Behavioral Therapy based Pain Management Program BEHAVIORAL

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Barbara Bruce, Ph.D., LP

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandra Cuartas-Abril, M.S.

CONTACT

904-956-8885; Cuartas-Abril.Alejandra@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 18, 2025
• Study Start: February 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)