NCT06089421

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Apr 2025Aug 2027

First Submitted

Initial submission to the registry

October 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

October 11, 2023

Last Update Submit

September 17, 2025

Conditions

Gene Mutation-Related CancerGenetic Predisposition

Outcome Measures

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.

    3 months

Secondary Outcomes (5)

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

    3 months

  • To assess differences of Comprehensive Score of Financial Toxicity scale

    6 months

  • To assess differences of SURE scale

    6 months

  • To assess differences of Decisional Conflict scale

    6 months

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

    6 months

Study Arms (2)

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

ACTIVE COMPARATOR

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

Other: Telegenetics with UVA genetic counselor

Novel interventional arm of pre-test counseling via GIA

EXPERIMENTAL

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

Other: Genetic Information Assistant

Interventions

Genetic Information AssistantOTHER

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

Novel interventional arm of pre-test counseling via GIA
Telegenetics with UVA genetic counselorOTHER

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22930, United States

RECRUITING

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kari Ring, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evelyn Villalobos

CONTACT

(434) 297-4579EV4PD@uvahealth.org

Joseph Petruzziello

CONTACT

(434) 323-1749BNW4RM@uvahealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 18, 2023

Study Start

April 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)