Compliance to a Hormone Therapy Regimen in Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Adherence to Endocrine Therapy in Women With Breast Cancer in Clinical Practice Settings

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: compliance monitoring
* Other: medical chart review
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Women diagnosed with breast cancer Stage I-IIIA disease Estrogen receptor (ER)-positive disease Must have begun prescribed hormonal therapy between December 2000 and December 2002 No prior history of breast cancer PATIENT CHARACTERISTICS: Female Menopausal status not specified Able to read and understand English PRIOR CONCURRENT THERAPY: See Disease Characteristics Prior breast surgery, axillary surgery, and radiotherapy to the breast or chest wall allowed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: compliance monitoring|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.|
|Other: medical chart review|Patient's medical records are reviewed for information about the time since diagnosis, tumor characteristics, treatment, and comorbidity.|
|Other: questionnaire administration|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to endocrine therapy |  | at 5 yrs | 
| Effects of categorical predictors of compliance |  | at 5 yrs | 
| Comparison of the means of each continuous predictor between compliers and non-compliers |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer, stage IIIA breast cancer