Health TrialsbyHealthPanel

Genetic Information Assistant in Telegenetics

ConditionsGene Mutation-Related CancerGenetic Predisposition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Cannot communicate in English or Spanish.

Subjects must not have completed panel-based cancer genetic testing in the past.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Genetic Information Assistant

    Other intervention

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

  • Telegenetics with UVA genetic counselor

    Other intervention

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

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Standard of care telegenetics with a UVA genetic counselor (GC) for pre-test counselingActive comparator 1 intervention
Group B: Novel interventional arm of pre-test counseling via GIAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months

Secondary outcomes

1

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.

Time frame
3 months
2

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)

Time frame
6 months
3

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.

Time frame
6 months
4

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)

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

Source ClinicalTrials.gov
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