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
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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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-02-06
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* ECOG ≤ 2
* Stage 0-III HR+ breast cancer in need of strategies to reduce symptoms and improve quality of life
Exclusion Criteria
\- Stage 4 HR+ breast cancer
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Alejandra Cuartas-Abril, M.S.
Role: primary
Related Links
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Mayo Clinic Clinical Trials
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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