This clinical trial compares how well telegenetics to counseling via a novel genetic information assistant in high-risk cancer patients. Genetic screening is the process used to identify people who are at high risk to have a gene that makes them susceptible to a disease. Currently, when patients receive genetic testing results that may affect their relatives with a similar risk, they are given a standard paper letter to provide to family members. The letter explains the patient’s testing results, and describes the family member’s possible risks for cancer. Other education about the genetic result and genetic testing is left to the patient when discussing these results with family members. Chatbots, also known as conversation agents, are computer programs designed to have conversations with humans. Genetic Information Assistant (GIA) is a Chatbot designed as a tool for patients to use for sharing genetic results, education, and genetic counseling resources to their family members after they have received a genetic result that may affect family members. Researchers want to find out if two different methods of providing counseling, either from GIA or from a University of Virginia (UVA) genetic counselor, may be more useful in a rural setting to better educate and increase screening among high-risk cancer patients.
Additional locations may be listed on ClinicalTrials.gov for NCT06089421.
Locations matching your search criteria
United States
Virginia
Charlottesville
University of Virginia Cancer CenterStatus: Active
Contact: Kari Lassen Ring
Phone: 434-924-5197
PRIMARY OBJECTIVE:
I. To assess feasibility of using a chatbot (GIA) for pre-test genetic counseling compared to standard of care genetic counseling (GC).
SECONDARY OBJECTIVES:
I. To test cancer knowledge following genetic counseling with GIA versus GC.
II. To assess patient attitudes toward genetic testing.
III. To measure patient satisfaction with the chatbot utilization and downstream results sharing with family members.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive pre-test genetic counseling with a UVA genetic counselor by videoconferencing or phone call per standard of care. At the completion of counseling, participants will be offered genetic testing with a self-collected saliva sample kit. Patients who complete genetic testing with positive genetic results will have results disclosure with a GC/genetics expert specific to their identified pathogenic variant and will receive a GIA link for results dispersion to family members.
ARM II: Patients receive pre-test counseling via a GIA with a chatbot. At the completion of counseling, participants will be offered genetic testing. At the completion of counseling, participants will be offered genetic testing with a self-collected saliva sample kit. Patients who complete genetic testing with positive genetic results will have results disclosure with a GC/genetics expert specific to their identified pathogenic variant and will receive a GIA link for results dispersion to family members.
After completion of study intervention, patients are followed up at 6 months.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUniversity of Virginia Cancer Center
Principal InvestigatorKari Lassen Ring
