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| Tracking Information | |||||
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| First Received Date ICMJE | March 2, 2007 | ||||
| Last Updated Date | March 2, 2007 | ||||
| Start Date ICMJE | April 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Two Methods of Genetics Education and Counseling for Breast Cancer | ||||
| Official Title ICMJE | Randomized Study of Methods in Education for Breast Cancer Genetics | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: Genetic Analysis | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | |||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00019877 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067273, NCI-99-C-0081, MB-NAVY-B99-015, NCI-NMOB-9811 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | July 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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