Genetic Information Assistant in Telegenetics

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.

Study Overview

• Status: Recruiting
• Conditions: Genetic Predisposition; Gene Mutation-Related Cancer
• Intervention / Treatment: Other: Telegenetics with UVA genetic counselor; Other: Genetic Information Assistant

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evelyn Villalobos; Phone Number: (434) 297-4579; Email: EV4PD@uvahealth.org
• Study Contact Backup: Name: Joseph Petruzziello; Phone Number: (434) 323-1749; Email: BNW4RM@uvahealth.org

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22930
      • Recruiting
      • University of Virginia
      • Contact: Joseph Petruzziello

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: Telegenetics with UVA genetic counselor; Participants assigned will have a pre-test counseling session via a telegentics visit with a genetic counselor.
Experimental: Novel interventional arm of pre-test counseling via GIA; Pre-genetic test counselling through novel chat bot Genetic Information Assistant (GIA)	Other: Genetic Information Assistant; Participants assigned will receive a link to Genetic Information Assistant for pre-test counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess feasibility of using a chatbot (GIA) for pre-test genetic counseling compared to standard of care GC	dichotomous measurement of whether the randomized participant completes genetic testing within three months.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To test cancer knowledge following the pre-test genetic counseling with GIA versus GC	National Center for Human Genome Research Knowledge scale taken at baseline and one month after genetic testing.	3 months
To assess differences of Comprehensive Score of Financial Toxicity scale	To assess the difference in comprehensive score between one- and six-months of Comprehensive Score for Financial Toxicity (COST) survey. Scoring: 0 (Poor Financial well-being) to 48 (Better financial well-being)	6 months
To assess differences of SURE scale	To assess the difference in comprehensive scores of the following surveys between one- and six-months of SURE scale. Scoring 0-4: Score <4 is a positive result for decisional conflict.	6 months
To assess differences of Decisional Conflict scale	To assess the difference in comprehensive scores of the following surveys between one- and six-months Decisional Conflict Scale. Scoring: 0 (no decisional conflict) to 100 (extremely high decisional conflict)	6 months
To assess differences of Multi-dimensional Impact of Cancer Risk Assessment (MICRA) scale	To assess the difference in comprehensive scores of the following surveys between one- and six-months Multi-dimensional Impact of Cancer Risk Assessment (MICRA) survey	6 months

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Kari Ring, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; Pathological Conditions, Signs and Symptoms; Genetic Predisposition to Disease
• Other Study ID Numbers: HSR230209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No