Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors

Vanderbilt University Medical Center351 enrolled

Overview

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 * 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.

Study Type

OBSERVATIONAL

Enrollment

351

Conditions

Arthralgia Breast Cancer

Interventions

aromatase inhibition therapy - OBSERVATIONAL ONLYOTHER

Observational only - as prescribed

medical chart reviewOTHER

Observational only

questionnaire administrationOTHER

Observational only

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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

Time frame: 12 months

Time to onset of arthralgia (continuous variable in weeks) among baseline population

Time frame: 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

Time frame: 12 months

Secondary Outcomes

Symptom trajectories over the course of treatment

Time frame: 12 months

Patient well-being: sleep quality, mood, and physical function

Time frame: 12 months

Data from ClinicalTrials.gov

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