Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer, Orthopedic |
Therapuetic Areas: | Oncology, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 35 - 90 |
Updated: | 4/2/2016 |
Start Date: | June 2009 |
End Date: | June 2017 |
Arthralgia and Medication Adherence in Women With Early Stage Breast Cancer Taking Aromatase Inhibitors: The Breast Cancer Adjuvant Therapy (BCAT) Longitudinal Cohort 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.
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.
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.
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.
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
We found this trial at
2
sites
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
Click here to add this to my saved trials