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

Mayo Clinic

Status: Enrolling

Conditions: Breast Cancer

Treatments: Behavioral: Cognitive Behavioral Therapy based Pain Management Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06831838

NCI-2025-01395 (Registry Identifier)

24-011941

Details and patient eligibility

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. We want to identify predictors of improvement in pain, functional status, subjective cognition and mood following participation in the program.

Enrollment: 115 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

Treatment Group

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Behavioral Therapy based Pain Management Program

Control Group

No Intervention group

Description:

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.