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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-06241 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23-003085 | Other Identifier | Mayo Clinic in Florida |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients attend a 2-day treatment program and complete questionnaires on study. Patients also have their medical records reviewed on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-Interventional Study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Patients are 18 years old or more.
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
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Patients with stage 0-III HR+ breast cancer and AIMSS (Aromatase Inhibitor Associated Musculoskeletal Symptoms) at Mayo Clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Barbara K. Bruce, Ph.D., L.P. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| 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 |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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