Genetic Information Assistant in Telegenetics

NCT ID: NCT06089421

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-08-01

Brief Summary

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.

Detailed Description

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.

Conditions

Gene Mutation-Related Cancer; Genetic Predisposition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Standard of care telegenetics with a UVA genetic counselor (GC) for pre-test counseling

Pre-genetic test counselling with a genetic counselor from the University of Virginia

Group Type: ACTIVE_COMPARATOR

Telegenetics with UVA genetic counselor

Intervention Type: OTHER

Participants assigned will have a pre-test counseling session via a telegentics visit with a genetic counselor.

Novel interventional arm of pre-test counseling via GIA

Pre-genetic test counselling through novel chat bot Genetic Information Assistant (GIA)

Group Type: EXPERIMENTAL

Genetic Information Assistant

Intervention Type: OTHER

Participants assigned will receive a link to Genetic Information Assistant for pre-test counseling.

Interventions

Genetic Information Assistant

Participants assigned will receive a link to Genetic Information Assistant for pre-test counseling.

Intervention Type: OTHER

Telegenetics with UVA genetic counselor

Participants assigned will have a pre-test counseling session via a telegentics visit with a genetic counselor.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• At high risk for having a genetic pathogenic variant as assessed by a GC or physician according to the NCCN guidelines
• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 18 and over.
• Subjects must have a smartphone with access to cellular and/or internet service or a computer with internet service.
• Subjects must have technological competency/proficiency to use their Smartphone and/or computer in conjunction with the communication aid GIA.

Exclusion Criteria

• Cannot communicate in English or Spanish.
• Subjects must not have completed panel-based cancer genetic testing in the past.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Kari Ring, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kari Ring, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Evelyn Villalobos

Role: CONTACT

EV4PD@uvahealth.org

(434) 297-4579

Joseph Petruzziello

Role: CONTACT

BNW4RM@uvahealth.org

(434) 323-1749

Facility Contacts

Joseph Petruzziello

Role: primary

Other Identifiers

HSR230209

Identifier Type: -

Identifier Source: org_study_id