- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00666822
Compliance to a Hormone Therapy Regimen in Breast Cancer
Adherence to Endocrine Therapy in Women With Breast Cancer in Clinical Practice Settings
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adherence to endocrine therapy
Time Frame: at 5 yrs
|
at 5 yrs
|
Effects of categorical predictors of compliance
Time Frame: at 5 yrs
|
at 5 yrs
|
Comparison of the means of each continuous predictor between compliers and non-compliers
Time Frame: at 5 yrs
|
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
|
5 yrs
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to discontinuation of tamoxifen as a time-to-event outcome
Time Frame: 5 yrs
|
5 yrs
|
Univariate and multivariate associations of covariates with risk of noncompliance
Time Frame: 5 yrs
|
5 yrs
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lois C. Friedman, PhD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE6107 (Other Identifier: Case Comprehensive Cancer Center)
- P30CA043703 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Clinical Trials on compliance monitoring
-
University of Sao PauloCompletedIntracranial Hypertension | Cerebral Circulatory FailureBrazil
-
Fox Chase Cancer CenterNational Cancer Institute (NCI)Completed
-
University of Sao PauloBrain4Care USA Corp.RecruitingIntracranial HypertensionBrazil
-
Michel BurnierCompletedHyperparathyroidism | Chronic Kidney DiseaseSwitzerland
-
Barts and the London School of Medicine and DentistryCompletedPrecancerous Condition | Health Status UnknownUnited Kingdom
-
Kuopio University HospitalWithdrawnOpiate Dependence
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedCervical Cancer | Endometrial Cancer | Radiation Toxicity | Sexuality and Reproductive IssuesUnited States
-
Kuopio University HospitalUniversity of Eastern FinlandCompleted
-
Johns Hopkins UniversityBill and Melinda Gates Foundation; St. Louis University; Bal Umang Drishya Sanstha... and other collaboratorsCompleted
-
Makerere UniversitySwedish International Development Cooperation Agency (SIDA)Unknown