Clinical Trial: Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Arthralgia and Medication Adherence in Women With Early Stage Breast Cancer Taking Aromatase Inhibitors: The Breast Cancer Adjuvant Therapy (BCAT) Longitudinal Cohort Stud

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 Summary:

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.


Sponsor: Vanderbilt University Medical Center

Current 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 [ 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 ]


Original 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
  • Time to onset of arthralgia (continuous variable in weeks) among baseline population
  • 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


Current Secondary Outcome:

  • Symptom trajectories over the course of treatment [ Time Frame: 12 months ]
  • Patient well-being: sleep quality, mood, and physical function [ Time Frame: 12 months ]


Original Secondary Outcome:

  • Symptom trajectories over the course of treatment
  • Patient well-being: sleep quality, mood, and physical function


Information By: Vanderbilt University Medical Center

Dates:
Date Received: August 6, 2009
Date Started: June 2009
Date Completion:
Last Updated: March 30, 2017
Last Verified: March 2017