Recruiting

CBT Pain Management

Sponsor:

Mayo Clinic

Code:

NCT06831838

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy based Pain Management Program

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT06831838

Start date

Feb 6, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Treatment Group

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

no intervention: 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.

Interventions

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 measure

  • Adherence to Aromatase Inhibitors (AIs) [ Time Frame: Baseline, 3 months, 6 months ]
  • AIMSS Follow-up Questionnaire [ Time Frame: Baseline, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Alejandra Cuartas-Abril, M.S.

904-956-8885Cuartas-Abril.Alejandra@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Alejandra Cuartas-Abril, M.S.

904-956-8885

Principal Investigator:

Barbara K Bruce

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-04.