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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| Medical University of South Carolina | OTHER |
| National Cancer Institute (NCI) |
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To evaluate two different ways of providing information about genetic testing for BRCA1 and BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed consent which cover similar material but are organized differently.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genetic Counseling | Active Comparator |
| |
| Informed Consent Counseling | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genetic Counseling | Procedure | Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine if genetic counseling yields better psycho-social and medical care utilization outcomes, compared to a medical model of informed consent for genetic testing. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the financial costs incurred in the implementation of the two models and examine the utilization of medical and mental health services by participants in each condition during the follow-up period. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judy Garber, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| C563980 | Fanconi Anemia, Complementation Group D1 |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D005817 | Genetic Counseling |
| ID | Term |
|---|---|
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| NIH |
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|
| Informed Consent Counseling | Procedure | Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing. |
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |