Clinical trial NCT06089421: Genetic Information Assistant in Telegenetics
Official title: A Prospective, Randomized Trial to Compare Telegenetics to Counseling Via a Novel Genetic Information Assistant in High-risk Cancer Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gene Mutation-Related Cancer
Genetic Predisposition
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To assess feasibility of using a chatbot (GIA) for pre-test genetic counseling compared to standard of care GC
timeFrame: 3 months
Secondary outcomes:
measure: To test cancer knowledge following the pre-test genetic counseling with GIA versus GC
timeFrame: 3 months
measure: To assess differences of Comprehensive Score of Financial Toxicity scale
timeFrame: 6 months
measure: To assess differences of SURE scale
timeFrame: 6 months
measure: To assess differences of Decisional Conflict scale
timeFrame: 6 months
measure: To assess differences of Multi-dimensional Impact of Cancer Risk Assessment (MICRA) scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Kari Ring, MD
role: PRINCIPAL_INVESTIGATOR
References: