Breast Cancer Survivors Who Experience Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)

Last updated: March 4, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Ductal Carcinoma In Situ (Dcis)

Treatment

Non-Interventional Study

Clinical Study ID

NCT06106282
23-003085
NCI-2023-06241
23-003085
  • Ages > 18
  • Female

Study Summary

This study evaluates the effectiveness of a cognitive behavioral multicomponent treatment program in improving pain, mood, and functioning while reducing medication non-adherence in breast cancer patients with Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients are 18 years old or more.

  • A breast cancer survivor ECOG =< 2, stage 0-III HR+ who is experiencingmusculoskeletal symptoms associated with aromatase inhibitors intake

  • Patients must be at least 6 months on aromatase inhibitors and for no more than 7 years

Exclusion

Exclusion Criteria:

  • Breast cancer survivor patients that are not in aromatase inhibitor treatment orhave less than 6 months of treatment or more than 7 years of treatment.

  • Asymptomatic patients

  • Patients less than 18 years old

  • Patient that are not being followed as a Mayo Clinic patient

  • Patients with stage IV breast carcinoma

  • Patients that are HR -

  • Patients that are ECOG 3 or more

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Non-Interventional Study
Phase:
Study Start date:
July 12, 2023
Estimated Completion Date:
July 12, 2028

Study Description

PRIMARY OBJECTIVES:

I. To evaluate the effectiveness of a Multidisciplinary Pain Program for AIMSS, specifically determine the impact of the program on level of pain, functional status, and adherence to prescribed medication.

II. To identify predictors of improvement in pain, functional status, and mood following participation in the program.

OUTLINE: This is an observational study.

Patients attend a 2-day treatment program and complete questionnaires on study. Patients also have their medical records reviewed on study.

Connect with a study center

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224-9980
    United States

    Active - Recruiting

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