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

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06831838
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-06
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-18
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adherence to Aromatase Inhibitors (AIs)	Baseline, 3 months, 6 months	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).
AIMSS Follow-up Questionnaire	Baseline, 3 months, 6 months	Subjects will complete the study follow-up questionnaire with study staff to indicate whether they are adhering to medications and to report symptoms.

Secondary Outcome Measures

Name	Time	Method
Brief Pain Inventory	Baseline, 3 months, 6 months	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.
Center for Epidemiologic Studies of Depression - Revised Questionnaire	Baseline, 3 months, 6 months	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.
Pain Catastrophizing Scale	Baseline, 3 months, 6 months	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.
Brief Resilience Scale	Baseline, 3 months, 6 months	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.
Social Support Survey	Baseline, 3 months, 6 months	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.
World Health Organization (WHO) Disability Assessment Schedule	Baseline, 3 months, 6 months	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.
State-Trait Inventory	Baseline, 3 months, 6 months	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).
Cognitive Functioning Index (CFI)	Baseline, 3 months, 6 months	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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States