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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy based Pain Management Program

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alejandra Cuartas-Abril, M.S.; Phone Number: 904-956-8885; Email: Cuartas-Abril.Alejandra@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic in Florida
      • Contact: Alejandra Cuartas-Abril, M.S.; Phone Number: 904-956-8885
      • Principal Investigator: Barbara K Bruce

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; 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; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory	The Brief Pain Inventory (BPI) allows participants to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. Possible scores range from 0 to 10 with higher scores indicating a worse outcome/more severe pain and interference.	Baseline, 3 months, 6 months
Center for Epidemiologic Studies of Depression - Revised Questionnaire	The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) is a 20-item, self-reported questionnaire, that measures symptoms of depression. Each item is rated on a Likert scale, with 0 = 'Not at all or less than one day", and 3 = "Nearly every day for 2 weeks". Scores range from 0-60, with a score of 16 or higher indicating a risk of clinical depression.	Baseline, 3 months, 6 months
Pain Catastrophizing Scale	he Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain. Items are rated on 5-point Likert scale, with 0 = "Not at all" and 4 = "All the time" Higher score indicates higher level of catastrophizing.	Baseline, 3 months, 6 months
Brief Resilience Scale	The Brief Resilience Scale is a 6 item, self-reported questionnaire, measuring how well a person recovers from stress. Each item is rated on a Likert scale, with 1 = "Strongly Disagree" and 5 = "Strongly Agree". The Brief Resilience Scale is scored by adding the value of all responses and dividing by 6. Higher scores indicate higher resilience to stress.	Baseline, 3 months, 6 months
Social Support Survey	The Social Support Survey is a 4 item, self-reported questionnaire, assessing the availability of support. Items are rated on a 4 point Likert scale, with 0 = "None of the time" and 4 = "All of the time". Higher scores indicate a greater level of support.	Baseline, 3 months, 6 months
World Health Organization (WHO) Disability Assessment Schedule	The WHO Disability Assessment Schedule is a 36-item, self-reported questionnaire, assessing health and disability. The questionnaire cover 6 domains: cognition, mobility, self-care, getting along, life activities, and participation. Each item is rated on a 5 point Likert scale, with 0 = "None" and 4 = "Extreme or Cannot do". Higher scores indicate greater disability.	Baseline, 3 months, 6 months
State-Trait Inventory	The State-Trait Inventory is a self-reported questionnaire, used to assess anxiety. Participants respond to 40 questions about how they are currently feeling on a scale of 1 "Not at all" to 4 "Very much so". Total possible scores range from 40 to 160. Higher scores indicate higher anxiety (a worse outcome) and lower scores indicate less anxiety (a better outcome).	Baseline, 3 months, 6 months
Cognitive Functioning Index (CFI)	The Cognitive Function Index (CFI) is a 14-item, self-reported questionnaire, used to assess cognitive status. Total scores range from 0-29, with higher scores indicating an increased perception about cognitive difficulties.	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Barbara Bruce, Ph.D., LP, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: July 31, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 24-011941; NCI-2025-01395 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No