Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors

Completed

• Conditions: Arthralgia; Breast Cancer

• Registration Number: NCT00954564
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-08-06
• Study First Submitted QC: 2009-08-06
• Study First Posted: 2009-08-07
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 351

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Symptom trajectories over the course of treatment	12 months
Patient well-being: sleep quality, mood, and physical function	12 months

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States