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| Sponsored by: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019877 |
Purpose
RATIONALE: Genetics education and counseling may be effective when provided by two different methods.
PURPOSE: Randomized clinical trial to compare the effectiveness of two methods of education and counseling for participants who may undergo genetic testing for breast cancer.
| Condition | Intervention |
|
Ovarian Epithelial Cancer Male Breast Cancer Breast Cancer |
Procedure: Genetic Analysis |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer Male Breast Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Randomized Study of Methods in Education for Breast Cancer Genetics |
| Study Start Date: | April 1999 |
OBJECTIVES:
I. Compare the effect of two different methods of providing education to persons enrolling in a breast cancer genetics program.
PROTOCOL OUTLINE: This is a randomized study. Participants are randomized to one of two different education methods.
All participants complete a pretest questionnaire, then attend a breast cancer genetics education and counseling session. A posttest questionnaire is also completed.
Participants may then choose to undergo germline BRCA testing. Participants are followed at 1 week and 3, 6, and 12 months after receiving results of BRCA germline testing.
PROJECTED ACCRUAL:
A total of 120 participants (60 per arm) will be accrued for this study within 18-24 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Diagnosis of breast cancer or ductal carcinoma in situ at age 45 or under OR Diagnosis of ovarian cancer at age 50 or under OR Diagnosis of breast cancer with bilateral disease or multiple primaries or breast cancer and ovarian cancer in the same individual OR Diagnosis of breast or ovarian cancer AND At least one first or second degree relative with breast cancer diagnosed at age 45 or under or ovarian cancer at age 50 or under OR Three relatives in the same lineage with breast or ovarian cancer where each affected individual is a first or second degree relative to another of the affected individuals OR First or second degree male relative with breast cancer diagnosed at any age OR Women of Ashkenazi Jewish descent who meets any of the above criteria with specified ages of onset of 50 for breast cancer and any age for ovarian cancer OR Male with breast cancer diagnosed at any age OR Documented BRCA mutation in the family Hormone receptor status: Not specified --Prior/Concurrent Therapy-- Not specified --Patient Characteristics-- Age: 18 and over Sex: Male or female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No psychological disorder that may preclude study
Contacts and Locations| United States, Maryland | |||||
| Medicine Branch | |||||
| Bethesda, Maryland, United States, 20892 | |||||
| National Naval Medical Center | |||||
| Bethesda, Maryland, United States, 20889-5000 | |||||
| Study Chair: | Pamela Klein | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000067273, NCI-99-C-0081, MB-NAVY-B99-015, NCI-NMOB-9811 |
| First Received: | March 2, 2007 |
| Last Updated: | March 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00019877 |
| Health Authority: | United States: Federal Government |
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