Outcomes of Education and Counseling for BRCA1 or BRCA2 Testing
Data Collection
Urogenital Diseases+22
+ Genital Diseases
+ Adnexal Diseases
Summary
Study start date: March 1, 1995
Actual date on which the first participant was enrolled.Women at increased risk for developing breast and/or ovarian cancer and their first degree relatives will be offered BRCA1/2 gene testing. This study proposes to evaluate psychological and behavioral aspects of their decision-making and the outcomes of the testing process. Knowledge and expectations will be assessed initially, followed by pre-test psychological assessment and an in person education and counseling session. Participants will be presented the choice of whether or not to undergo BRCA1/2 testing. Notification of test results will occur in person along with discussion of available surveillance options. Telephone interviews will assess psychological and behavioral outcome measures at 6 and/or twelve month time points. Aspects of this research endeavor have been designed to complement an NHGRI/NCI extramural consortium and an NHGRI/NCI intramural collaboration both of which will address various aspects of risk notification and follow-up for hereditary breast, ovarian and colon cancer.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Participants will be drawn from the families enrolled by Drs. Peggy Tucker and Jeff Struewing in the GEB of NCI (protocol 78-C-0039). Individual with a family history of verified breast and/or ovarian cancer that includes; two cases of ovarian cancer in first degree relatives, or three cases of breast cancer and at least one case of ovarian cancer (two of which have to be first degree relatives), or at least four cases of breast cancer.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Human Genome Research Institute (NHGRI)
Bethesda, United StatesOpen National Human Genome Research Institute (NHGRI) in Google Maps