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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA082346 | U.S. NIH Grant/Contract | View source | |
| P30CA051008 | U.S. NIH Grant/Contract | View source | |
| GUMC-2000-305 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Genetic counseling and using an interactive computer program may help women at risk for breast cancer make medical decisions about treatment.
PURPOSE: This randomized clinical trial is studying standard genetic counseling to see how well it works when given together with or without a medical decision-making computer program in women at risk for BRCA1 or BRCA2 mutations.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Eligible women are asked to participate in a baseline telephone interview over 30 minutes and then invited to a genetic counseling session over 1.5-2 hours that includes information about BRCA1/2 testing. Patients are then offered BRCA1/2 testing, and the test results (i.e., mutation carrier vs noncarrier) are presented at a subsequent in-person individual genetic counseling session over 1.5-2 hours. Patients who tested positive for BRCA1 or 2 mutation are randomized to 1 of 2 counseling arms. All other patients proceed to follow up.
Outcome assessments, including quality of life assessment, are conducted at 2, 6, and 12 months.
PROJECTED ACCRUAL: A total of 950 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| counseling intervention | Other | subjects will receive genetic counseling |
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction | subjects will complete questionnaires re; genetic counseling experience | 1 year |
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DISEASE CHARACTERISTICS:
Members of hereditary breast/ovarian cancer families (in which there is at least a 10-20% prior probability of a BRCA1/2 mutation) OR who have a first-degree relative with a known BRCA1 or BRCA2 mutation
Prior diagnosis of breast cancer allowed
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Schwartz, PhD | Lombardi Comprehensive Cancer Center | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D005159 | Health Care Facilities Workforce and Services |