Compliance to a Hormone Therapy Regimen in Breast Cancer
NCT ID: NCT00666822
Last Updated: 2016-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
178 participants
OBSERVATIONAL
2007-12-31
2015-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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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.
medical chart review
Patient's medical records are reviewed for information about the time since diagnosis, tumor characteristics, treatment, and comorbidity.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lois C. Friedman, PhD
Role: PRINCIPAL_INVESTIGATOR
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Locations
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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE6107
Identifier Type: OTHER
Identifier Source: secondary_id
CASE6107
Identifier Type: -
Identifier Source: org_study_id
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