Compliance to a Hormone Therapy Regimen in Breast Cancer
|ClinicalTrials.gov Identifier: NCT00666822|
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : February 5, 2016
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Behavioral: compliance monitoring Other: medical chart review Other: questionnaire administration|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||178 participants|
|Official Title:||Adherence to Endocrine Therapy in Women With Breast Cancer in Clinical Practice Settings|
|Study Start Date :||December 2007|
|Primary Completion Date :||September 2009|
|Study Completion Date :||December 2015|
Behavioral: compliance monitoring
- Adherence to endocrine therapy [ Time Frame: at 5 yrs ]
- Effects of categorical predictors of compliance [ Time Frame: at 5 yrs ]
- Comparison of the means of each continuous predictor between compliers and non-compliers [ Time Frame: 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 [ Time Frame: 5 yrs ]
- Time to discontinuation of tamoxifen as a time-to-event outcome [ Time Frame: 5 yrs ]
- Univariate and multivariate associations of covariates with risk of noncompliance [ Time Frame: 5 yrs ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666822
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Lois C. Friedman, PhD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|