Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors

• 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 ] [ Designated as safety issue: No ]
  
• Time to onset of arthralgia (continuous variable in weeks) among baseline population [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• 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 ] [ Designated as safety issue: No ]
  

• Symptom trajectories over the course of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• Patient well-being: sleep quality, mood, and physical function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  

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

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.