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NCT Number: NCT06089421

Genetic Information Assistant in Telegenetics

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22930, United States

Location status: Recruiting

Location contact

Joseph Petruzziello

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Genetic Information Assistant

Other

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

Telegenetics with UVA genetic counselor

Other

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

Primary outcomes

  1. To assess feasibility of using a chatbot (GIA) for pre-test genetic counseling compared to standard of care GC

    Time frame: 3 months

    dichotomous measurement of whether the randomized participant completes genetic testing within three months.

Secondary outcomes

  1. To test cancer knowledge following the pre-test genetic counseling with GIA versus GC

    Time frame: 3 months

    National Center for Human Genome Research Knowledge scale taken at baseline and one month after genetic testing.

  2. To assess differences of Comprehensive Score of Financial Toxicity scale

    Time frame: 6 months

    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)

  3. To assess differences of SURE scale

    Time frame: 6 months

    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.

  4. To assess differences of Decisional Conflict scale

    Time frame: 6 months

    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)

  5. To assess differences of Multi-dimensional Impact of Cancer Risk Assessment (MICRA) scale

    Time frame: 6 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Evelyn Villalobos

CONTACT

[email protected]

(434) 297-4579

Joseph Petruzziello

CONTACT

[email protected]

(434) 323-1749

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 18, 2023
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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