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

Mayo Clinic

Status: Completed

Conditions: Anatomic Stage III Breast Cancer AJCC v8; Hormone Receptor-Positive Breast Carcinoma; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage 0 Breast Cancer AJCC v8

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06106282

NCI-2023-06241 (Registry Identifier)

23-003085 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 105 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients are 18 years old or more.

  • A breast cancer survivor ECOG =< 2, stage 0-III HR+ who is experiencing musculoskeletal symptoms associated with aromatase inhibitors intake
  • Patients must be at least 6 months on aromatase inhibitors and for no more than 7 years

Exclusion criteria

• Breast cancer survivor patients that are not in aromatase inhibitor treatment or have 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

Trial design

105 participants in 1 patient group

Observational

Description:

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

Treatment:

Other: Non-Interventional Study