NCT06831838 · Mayo Clinic
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
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Adherence to Aromatase Inhibitors (AIs)
Time frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- At least 18 years old
- 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
Where
- Jacksonville, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 4, 2026 · Source of record for eligibility and locations