Breast Cancer Survivors Who Experience Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVES:
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Non-Interventional Study
|
Outcome Measures
Primary Outcome Measures
- Adherence to Aromatase Inhibitor (AI) treatment regimen [Baseline; up to 12 months post-treatment]
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.
- Functional impairment (quality of life) [Baseline; up to 12 months post-treatment]
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.
- Fatigue [Baseline; up to 12 months post-treatment]
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.
- Level of pain [Baseline; up to 12 months post-treatment]
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.
- Mood [Baseline; up to 12 months post-treatment]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients are 18 years old or more.
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A breast cancer survivor ECOG =< 2, stage 0-III HR+ who is experiencing musculoskeletal symptoms associated with aromatase inhibitors intake
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Patients must be at least 6 months on aromatase inhibitors and for no more than 7 years
Exclusion Criteria:
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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.
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Asymptomatic patients
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Patients less than 18 years old
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Patient that are not being followed as a Mayo Clinic patient
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Patients with stage IV breast carcinoma
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Patients that are HR -
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Patients that are ECOG 3 or more
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Florida | Jacksonville | Florida | United States | 32224-9980 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Barbara K. Bruce, Ph.D., L.P., Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 23-003085
- NCI-2023-06241
- 23-003085