Clinical trial NCT06106282: Breast Cancer Survivors Who Experience Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
Official title: Breast Cancer Survivors Who Experience Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS): A Multidisciplinary Pain Program Designed to Decrease Pain and Improve Functioning, Mood, and Medication Adherence.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Hormone Receptor-Positive Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage 0-III HR+ breast cancer and AIMSS (Aromatase Inhibitor Associated Musculoskeletal Symptoms) at Mayo Clinic.

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to Aromatase Inhibitor (AI) treatment regimen
timeFrame: Baseline; up to 12 months post-treatment
measure: Functional impairment (quality of life)
timeFrame: Baseline; up to 12 months post-treatment
measure: Fatigue
timeFrame: Baseline; up to 12 months post-treatment
measure: Level of pain
timeFrame: Baseline; up to 12 months post-treatment
measure: Mood
timeFrame: Baseline; up to 12 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Barbara K. Bruce, Ph.D., L.P.
role: PRINCIPAL_INVESTIGATOR
References: