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

NCT ID: NCT06831838

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-06

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Treatment Group

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

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy based Pain Management Program

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Bruce, Ph.D., LP

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alejandra Cuartas-Abril, M.S.

Role: CONTACT

904-956-8885

Facility Contacts

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Alejandra Cuartas-Abril, M.S.

Role: primary

904-956-8885

Related Links

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Other Identifiers

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NCI-2025-01395

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-011941

Identifier Type: -

Identifier Source: org_study_id

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