Arthralgia and Medication Adherence in Women With Early Stage Breast Cancer Taking Aromatase Inhibitors: The Breast Cancer Adjuvant Therapy (BCAT) Longitudinal Cohort Study.
35 Years
90 Years
Female
Arthralgia, Breast Cancer
Trial Information
Arthralgia and Medication Adherence in Women With Early Stage Breast Cancer Taking Aromatase Inhibitors: The Breast Cancer Adjuvant Therapy (BCAT) Longitudinal Cohort Study.
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.
Inclusion Criteria
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
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
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Liana Castel, PhD, MSPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
CDR0000650647
NCT ID:
NCT00954564
Start Date:
June 2009
Completion Date:
June 2017
Related Keywords:
- Arthralgia
- Breast Cancer
- arthralgia
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- Arthralgia
- Breast Neoplasms
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
