Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors
|ClinicalTrials.gov Identifier: NCT00954564|
Recruitment Status : Completed
First Posted : August 7, 2009
Last Update Posted : April 4, 2017
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.
|Condition or disease||Intervention/treatment|
|Arthralgia Breast Cancer||Other: aromatase inhibition therapy - OBSERVATIONAL ONLY Other: medical chart review Other: questionnaire administration Procedure: assessment of therapy complications|
- 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.
- 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|
|Actual Enrollment :||351 participants|
|Official Title:||Arthralgia and Medication Adherence in Women With Early Stage Breast Cancer Taking Aromatase Inhibitors: The Breast Cancer Adjuvant Therapy (BCAT) Longitudinal Cohort Study.|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
- Other: aromatase inhibition therapy - OBSERVATIONAL ONLY
Observational only - as prescribed
- Other: medical chart review
- Other: questionnaire administration
- Procedure: assessment of therapy complications
- 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 ]
- Symptom trajectories over the course of treatment [ Time Frame: 12 months ]
- Patient well-being: sleep quality, mood, and physical function [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954564
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37203|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Liana Castel, PhD, MSPH||Vanderbilt-Ingram Cancer Center|