Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing
NCT ID: NCT00165152
Last Updated: 2012-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
1998-07-31
2005-06-30
Brief Summary
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Detailed Description
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* Patients participating in this study have either: 1) expressed an interest in testing for an underlying genetic factor that may account for the breast or ovarian cancer in their family; 2) have at least one relative that has been found to have a BRCA1 or BRCA2 alteration; 3) have a personal or family history of breast or ovarian cancer that is suggestive of a BRCA1 and BRCA2 alteration; or 4) has breast or ovarian cancer, or has at least one close relative with a history of breast or ovarian cancer and are a member of an ethnic group with increased frequency of BRCA1 and BRCA2 alterations.
* Patients will be randomized into one of two counseling groups. 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.
* Throughout this study patients will be asked to complete questionnaires and psychological measures. These forms will be completed before and after the first visit, and a subset of them again at 2-4 weeks after the second visit, and at 4, 6, and 12 months.
* In addition 30 women will be asked to complete a 20-30 minute telephone interview with the program psychologist.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Genetic Counseling
Genetic Counseling
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.
Informed Consent Counseling
Informed Consent Counseling
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.
Interventions
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Genetic Counseling
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.
Informed Consent Counseling
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.
Eligibility Criteria
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Inclusion Criteria
* Member of a family in which a BRCA1 or BRCA2 deleterious germline mutation has been identified, whether or not the individual has had cancer herself; written documentation of the family mutation must be available for laboratory purposes during the testing process.
* Personal and/or family history of breast/ovarian/other cancer consistent with BRCA 1/2 heredity with posterior probability of carrying an altered gene
* Documentation of key family member cancer diagnoses is required
Exclusion Criteria
* Individuals unable to speak or write English
* Already participated in a genetic counseling program for BRCA1 or BRCA2 testing
* Life expectancy of less than 12 months.
18 Years
FEMALE
No
Sponsors
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Massachusetts General Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
Medical University of South Carolina
OTHER
National Cancer Institute (NCI)
NIH
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Judy E. Garber, MD
Principal Investigator
Principal Investigators
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Judy Garber, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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98-120
Identifier Type: -
Identifier Source: org_study_id