Compliance to a Hormone Therapy Regimen in Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00666822
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
RATIONALE: Understanding how well patients comply with their treatment regimen may help doctors plan the best treatment and ongoing care.
PURPOSE: This clinical trial is studying whether patients comply with their hormone therapy regimen in women with estrogen receptor-positive stage I, stage II, or stage IIIA breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* To examine the relationship between adherence to endocrine therapy and variables from the Health Belief Model (i.e., perceived risk, barriers to and benefits of adherence, and cues to action such as physician recommendation) as well as measures of patient's perceptions of patient- and family-centered care in women with estrogen receptor-positive stage I-IIIA breast cancer.
OUTLINE: Patients complete a 15 minute questionnaire on-line or by mail comprising questions of demographic and medical variables (i.e., age, race/ethnicity, marital and educational status, and medication side effects) as well as health beliefs and selected aspects of patient- and family-centered care. Data collected from the questionnaire will be stored in an Excel database.
Patient's medical records are reviewed for information about the time since diagnosis, tumor characteristics, treatment, and comorbidity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 178
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of the means of each continuous predictor between compliers and non-compliers at 5 yrs Adherence to endocrine therapy at 5 yrs Effects of categorical predictors of compliance at 5 yrs Effects of continuous and categorical variables on compliance, controlling for other factors including age at diagnosis, race, education, and type of surgery 5 yrs
- Secondary Outcome Measures
Name Time Method Time to discontinuation of tamoxifen as a time-to-event outcome 5 yrs Univariate and multivariate associations of covariates with risk of noncompliance 5 yrs
Trial Locations
- Locations (1)
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States