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| ID | Type | Description | Link |
|---|---|---|---|
| UL1RR024975 | U.S. NIH Grant/Contract | View source | |
| VU-VICC-BRE-0939 | Other Identifier | Vanderbilt Ingram Cancer Center | |
| 119475-MRSG-10-169-01-PCSM | Other Grant/Funding Number | American Cancer Society |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
| American Cancer Society, Inc. | OTHER |
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RATIONALE: Gathering information over time about joint pain and stiffness from postmenopausal women with early-stage breast cancer who are receiving aromatase inhibitors may help doctors plan treatment and help patients live more comfortably.
PURPOSE: This observational epidemiologic cohort is designed to study arthralgia, patient-reported outcomes, and medication adherence in postmenopausal women with early-stage breast cancer who are receiving aromatase inhibitors.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients complete questionnaires about joint pain and stiffness, sleep, depression, physical function, medications and treatment, exercise and social support, demographics, comorbidities, body mass index (BMI), and performance status at baseline and then periodically for approximately 1 year after beginning aromatase inhibitor (AI) therapy.
Patient medical records are reviewed for comorbidities, BMI, use of prior hormone replacement therapy, vitamin D levels and deficiency, performance status, histological stage, prior treatment, and medications at baseline and then periodically for approximately 1 year after beginning AI therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aromatase inhibition therapy - OBSERVATIONAL ONLY | Other | Observational only - as prescribed | ||
| medical chart review | Other | Observational only | ||
| questionnaire administration | Other | Observational only | ||
| assessment of therapy complications | Procedure | Observational only |
| Measure | Description | Time Frame |
|---|---|---|
| Arthralgia incidence, defined as proportion of the baseline population (those who have taken ≥ 9 doses of aromatase inhibitor [AI]) in which new or worsening joint pain or stiffness is observed at 1, 3, and 12 months after beginning AI therapy | 12 months | |
| Time to onset of arthralgia (continuous variable in weeks) among baseline population | 12 months | |
| Arthralgia point prevalence, defined as proportion of the baseline population with a score of ≥ 2 on any one dimension of the outcome measure at 1, 3, and 12 months after beginning AI therapy | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom trajectories over the course of treatment | 12 months | |
| Patient well-being: sleep quality, mood, and physical function | 12 months |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Postmenopausal women with breast cancer initiating aromatase inhibitor therapy
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| Name | Affiliation | Role |
|---|---|---|
| Liana Castel, PhD, MSPH | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37203 | United States | ||
| Vanderbilt-Ingram Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23575918 | Derived | Castel LD, Hartmann KE, Mayer IA, Saville BR, Alvarez J, Boomershine CS, Abramson VG, Chakravarthy AB, Friedman DL, Cella DF. Time course of arthralgia among women initiating aromatase inhibitor therapy and a postmenopausal comparison group in a prospective cohort. Cancer. 2013 Jul 1;119(13):2375-82. doi: 10.1002/cncr.28016. Epub 2013 Apr 10. |
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| Nashville |
| Tennessee |
| 37232-6838 |
| United States |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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