Genetic Information Assistant in Telegenetics

Genetic Predisposition Clinical Trial

Official title:

A Prospective, Randomized Trial to Compare Telegenetics to Counseling Via a Novel Genetic Information Assistant in High-risk Cancer Patients.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06089421
• Other study ID #: HSR230209
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: March 15, 2025

Study information

• Verified date: October 2023
• Source: University of Virginia
• Contact: Graham Fowler
• Phone: (434) 323-1749
• Email: NVG4WM[@]uvahealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gene Mutation-Related Cancer
• Genetic Predisposition
• Genetic Predisposition to Disease

Intervention

Other:
• Genetic Information Assistant
Participants assigned will receive a link to Genetic Information Assistant for pre-test counseling.
• Telegenetics with UVA genetic counselor
Participants assigned will have a pre-test counseling session via a telegentics visit with a genetic counselor.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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