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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE6107 | Other Identifier | Case Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| compliance monitoring | Behavioral | 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. | ||
| medical chart review | Other | Patient's medical records are reviewed for information about the time since diagnosis, tumor characteristics, treatment, and comorbidity. | ||
| questionnaire administration | Other | 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. |
| 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 |
| 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 |
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DISEASE CHARACTERISTICS:
Women diagnosed with breast cancer
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:
PRIOR CONCURRENT THERAPY:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Lois C. Friedman, PhD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |