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

NCT06106282 | Completed

• 2 other identifiers: 23-003085NCI-2023-06241
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (5)

• Adherence to Aromatase Inhibitor (AI) treatment regimen

  Adherence to AI treatment regimen will be recorded based on self-report. Patient self-report will categorize each subject as adherent or non-adherent to AI medication. Baseline and follow-up data from each timepoint will be compared to evaluate treatment impact on outcomes.

  Baseline; up to 12 months post-treatment

• Functional impairment (quality of life)

  Functional impairment (quality of life) will be assessed using the Symptom Impact Questionnaire (SIQR), which has three domains: Function, Overall and Symptoms. Domain 1 (Function) consists of 9 questions answered on a scale where respondent choose a box between "No difficulty" and "Very difficult." Domain 2 (Overall) consists of 2 questions answered on a scale where respondent choose a box between "Never" and "Always." Domain 3 (Symptoms) consists of 10 questions answered on a scale where respondents choose a box between two extremes (e.g., No pain/Unbearable pain or Awoke rested/Awoke very tired). Baseline and follow-up data from each timepoint will be compared to evaluate treatment impact on outcomes.

  Baseline; up to 12 months post-treatment

• Fatigue

  Fatigue will be measured using the Brief Fatigue Inventory (BFI) from MD Anderson. The BFI is a nine-question scale in which respondents rate each item on a 0-10 numeric scale, with 0 meaning "no fatigue" and 10 meaning "fatigue as bad as you can imagine." Baseline and follow-up data from each timepoint will be compared to evaluate treatment impact on outcomes.

  Baseline; up to 12 months post-treatment

• Level of pain

  Level of pain will be assesses using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire answered using a 5-point Likert scale ranging from 0 (never) to 4 (always). The final score is categorized as rumination, magnification, or helplessness.Baseline and follow-up data from each timepoint will be compared to evaluate treatment impact on outcomes.

  Baseline; up to 12 months post-treatment

• Mood

  Mood/depression will be assessed using the Center for Epidemiologic Studies Depression Scale Revised (CES-D-R). The CES-D-R is a 20-question survey with 4 available answers for each question: Rarely or none of the time (less than 1 day); Some or a little of the time (1-2 days); Occasionally or a moderate amount of time (3-4 days); or Most or all of the time (5-7 days). Baseline and follow-up data from each timepoint will be compared to evaluate treatment impact on outcomes.

  Baseline; up to 12 months post-treatment

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-Interventional Study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Barbara K. Bruce, Ph.D., L.P.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: July 12, 2023
• Primary Completion: October 27, 2025
• Study Completion: October 27, 2025
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (1)