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Sponsors and Collaborators: |
Lombardi Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00262899 |
RATIONALE: Genetics education and counseling may help patients make treatment decisions. It is not yet known how genetic counseling or usual care influence patient treatment decisions for breast cancer.
PURPOSE: This randomized clinical trial is studying how well genetic counseling works compared to usual care in helping patients with newly diagnosed ductal carcinoma in situ, stage I, stage II, or stage IIIA breast cancer make treatment decisions.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Cancer-Related Problem/Condition |
Procedure: counseling Procedure: educational intervention Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized |
Official Title: | Genetic Counseling for Newly Diagnosed Breast Cancer Patients |
Estimated Enrollment: | 360 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating site. Patients are randomized to 1 of 2 interventional arms.
In both arms, quality of life is assessed at baseline and at 1, 6, and 12 months.
After completion of the study, patients are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed breast cancer, meeting 1 of the following criteria:
Must meet 1 of the follwing criteria:
Diagnosis after 50 years of age AND has 1 of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Surgery
Other
United States, District of Columbia | |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381 | |
United States, Maryland | |
Recruiting | |
Chevy Chase, Maryland, United States, 20815 | |
Contact: Colette M. Magnant, MD 301-654-8060 jordanmagnant@yahoo.com | |
United States, New Jersey | |
Hackensack University Medical Center Cancer Center | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
Contact: Clinical Trials Office - Hackensack University Medical Center 201-996-2879 | |
United States, New York | |
Mount Sinai School of Medicine | Recruiting |
New York, New York, United States, 10029 | |
Contact: Clinical Trials Office - Mount Sinai School of Medicine 212-659-8050 |
Study Chair: | Marc Schwartz, PhD | Lombardi Cancer Research Center |
Responsible Party: | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center ( Marc Schwartz ) |
Study ID Numbers: | CDR0000450155, GUMC-2004-212 |
Study First Received: | December 6, 2005 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00262899 |
Health Authority: | Unspecified |
psychosocial effects/treatment ductal breast carcinoma in situ breast cancer in situ |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Carcinoma, Ductal Skin Diseases Carcinoma in Situ Breast Neoplasms Carcinoma, Ductal, Breast |
Carcinoma, Intraductal, Noninfiltrating Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary |