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A Prospective, Randomized Trial to Compare Telegenetics to Counseling Via a Novel Genetic Information Assistant in High-risk Cancer Patients.
The goal of this clinical trial is to learn about different ways cancer genetic screening can be provided to rural communities in participants at high risk for certain cancers. The main question it aims to answer is: • Does receiving pre-genetic test education with a chat bot or genetic counselor affect if the participant decides to get genetic testing? Participants will: * have a pre-test genetic counselling session with a genetic counselor or the GIA chatbot * answer questions about their cancer genetic knowledge and how they are doing * provide a saliva sample for genetic testing to test for cancer gene mutations * have their genetic testing results provided to them. * have the option to share their genetic testing results with family members Researchers will compare how many participants who had pre-genetic counseling with the chatbot received genetic testing to how many participants who had pre-genetic counseling with a genetic counselor received genetic testing.
High risk patients will be randomized to standard of care telegenetics with a UVA Genetic Counselor (GC) for pre-test counseling or to the novel interventional arm of pre-test counseling via Genetic Information Assistant (GIA). Participants in the study will receive their link for a telegenetics appointment or GIA link based on randomization and patients will complete pre-test genetic counseling via their assigned treatment arm. Participants will not be masked to their trial arm assignment. In the telegenetics arm, patients will be offered a video visit scheduled through Epic zoom or a phone visit in our cancer genetics clinic per standard of care. Patients randomized to the GIA arm will receive a personalized link based on their family history. At the completion of counseling, participants will be offered genetic testing. If they agree, they will be mailed a saliva kit via Invitae Genetics for panel based genetic testing via The Invitae Common Hereditary Cancers panel to analyze 47 genes associated with cancers of the breast, ovary, uterus, and gastrointestinal system, which includes the stomach, colon, rectum, small bowel, and pancreas.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
University of Virginia
Charlottesville, Virginia, United States
Start Date
April 1, 2025
Primary Completion Date
July 1, 2027
Completion Date
August 1, 2027
Last Updated
September 23, 2025
96
ESTIMATED participants
Genetic Information Assistant
OTHER
Telegenetics with UVA genetic counselor
OTHER
Lead Sponsor
University of Virginia
NCT06591260
NCT04521790
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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