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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106282
• Other study ID #: 23-003085
• Secondary ID: NCI-2023-0624123
• Status: Recruiting
• Start date: July 12, 2023
• Est. completion date: July 12, 2028

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 12, 2028
• Est. primary completion date: July 12, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Breast Carcinoma In Situ
• Breast Neoplasms

Intervention

Other:
• Non-Interventional Study
Non-Interventional Study

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials