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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?

Arthralgia

Breast Cancer

Study Interventions

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

Study Arms

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.

Study Status

Completed

Start Date: June 2009

Completed Date: May 2014

Phase: N/A

Type: Observational

Design:

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)

More information:https://clinicaltrials.gov/show/NCT00954564

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