Arthralgia | Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors
Arthralgia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:aromatase inhibition therapy - OBSERVATIONAL ONLYObservational only - as prescribed
Other:medical chart reviewObservational only
Other:questionnaire administrationObservational only
Procedure:assessment of therapy complicationsObservational only
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: June 2009
Completed Date: May 2014
Primary Outcome: 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
Secondary Outcome: Symptom trajectories over the course of treatment
Study sponsors, principal investigator, and references
Principal Investigator: Liana Castel, PhD, MSPH
Lead Sponsor: Vanderbilt University Medical Center
Collaborator: National Center for Research Resources (NCRR)