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
Conditions
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.
Interventions
OTHERNon-Interventional Study
Non-Interventional Study
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed