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Genetic Education for BRCA Families
Trial Status: active
This clinical trial develops and evaluates the effect of a web-based educational intervention for people from hereditary breast or ovarian cancer families who carry BRCA gene mutation. This study aims to test a new approach to communicating genetic information to untested relatives of BRCA1 and BRCA2 mutation carriers, and to streamline the process of communication and education so that relatives can more easily access genetic services.
Inclusion Criteria
In both phases individuals will be identified from the from the clinical genetic counseling programs at Georgetown Lombardi Comprehensive Cancer Center (GLCCC) and George Washington Cancer Institute (GWCI)
PHASE I: Men and women from families in which a BRCA1 or BRCA2 pathogenic BRCA variant (PV) has been identified (tested probands; tested and untested first- or second-degree relatives)
PHASE I: >= 21 years old
PHASE I: Ability to provide informed consent
PHASE II: Age 21-75
PHASE II: A first- (sibling, adult offspring) or 2nd-degree (aunt/uncle or niece/nephew) biological relative of an individual with a recently identified BRCA1 or BRCA2 mutation or A first- (sibling) or 2nd-degree (aunt/uncle or niece nephew) biological relative of an individual from a BRCA1/BRCA2 positive family who has recently received a negative BRCA1/BRCA2 genetic test
Exclusion Criteria
PHASE I: Personal diagnosis of metastatic cancer
PHASE I: Cannot participate in English
PHASE II: Personal diagnosis of metastatic cancer
PHASE II: Prior genetic testing for hereditary breast-ovarian cancer
PHASE II: One or more children who have tested positive for a BRCA1 or BRCA2 mutation
PHASE II: Cannot participate in English
In both phases, we will exclude participants who lack the capacity to provide informed consent
In both phases, we will exclude participants who are imprisoned
In both phases, we will exclude participants who are under the age of 21
In both phases, we will exclude participants who are pregnant
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03544983.
I. To develop and evaluate a web-based educational intervention for men and women from hereditary breast-ovarian cancer families. (Phase I)
II. Evaluate the impact of web-based intervention plus brief telephone counseling (W+T) versus (vs.) usual care (UC) on uptake of genetic counseling and targeted genetic testing. (Phase II)
III. Evaluate the impact of W+T vs UC on psychosocial outcomes. (Phase II)
IV. Evaluate mechanisms and moderators of W+T. (Phase II)
OUTLINE:
PHASE I: Participants attend an interview over 30-45 minutes to help develop and evaluate a web-based educational intervention.
PHASE II: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive interactive pre-test web-education with direct genetic counseling scheduling, streamlined telephone genetic counseling over 15 minutes, option for genetic testing, and telephone genetic counseling disclosure session.
ARM II: Participants receive usual care.
After completion of study, participants are followed up for 6 months after randomization.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationMedStar Georgetown University Hospital
