Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Estimate the incidence, time to onset, prevalence, and clinical and demographic predictors of arthralgia in post-menopausal women with early-stage breast cancer receiving aromatase inhibitors (AI). Chart the trajectory of arthralgia symptom severity over the course of AI treatment in these patients. Secondary Measure the impact of arthralgia on sleep quality, depression, and physical function in these patients. Develop a roster of current physician-advised or prescribed treatments, including self-management techniques being used for AI-induced arthralgia, for intervention development. 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.

Official Title
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Arthralgia and Medication Adherence in Women With Early Stage Breast Cancer Taking Aromatase Inhibitors: The Breast Cancer Adjuvant Therapy (BCAT) Longitudinal Cohort Study.

Conditions
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Arthralgia, Breast Cancer

Intervention / Treatment
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* Other: aromatase inhibition therapy - OBSERVATIONAL ONLY
* Other: medical chart review
* Other: questionnaire administration
* Procedure: assessment of therapy complications


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Planning to begin aromatase inhibitor (AI) therapy or taken fewer than 10 doses of adjuvant AI therapy Hormone-receptor status not specified PATIENT CHARACTERISTICS: Postmenopausal ECOG performance status 0-1 Able to understand and respond to questions in English No condition that would impair the ability to provide informed consent No other non-breast cancer condition PRIOR CONCURRENT THERAPY: See Disease Characteristics No more than 9 prior doses of AI

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: aromatase inhibition therapy - OBSERVATIONAL ONLY|Observational only - as prescribed|
|Other: medical chart review|Observational only|
|Other: questionnaire administration|Observational only|
|Procedure: assessment of therapy complications|Observational only|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom trajectories over the course of treatment |  | 12 months | 
| Patient well-being: sleep quality, mood, and physical function |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthralgia, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer