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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioral Therapy based Pain Management Program.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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]
- AIMSS Follow-up Questionnaire [Time frame: Baseline, 3 months, 6 months]
Secondary outcome measures (8)
- Brief Pain Inventory [Time frame: Baseline, 3 months, 6 months]
- Center for Epidemiologic Studies of Depression - Revised Questionnaire [Time frame: Baseline, 3 months, 6 months]
- Pain Catastrophizing Scale [Time frame: Baseline, 3 months, 6 months]
- Brief Resilience Scale [Time frame: Baseline, 3 months, 6 months]
- Social Support Survey [Time frame: Baseline, 3 months, 6 months]
- World Health Organization (WHO) Disability Assessment Schedule [Time frame: Baseline, 3 months, 6 months]
- State-Trait Inventory [Time frame: Baseline, 3 months, 6 months]
- Cognitive Functioning Index (CFI) [Time frame: Baseline, 3 months, 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic in Florida — Jacksonville
Identifiers
NCT: NCT06831838 · 24-011941