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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Novel interventional arm of pre-test counseling via GIA | Experimental | Pre-genetic test counselling through novel chat bot Genetic Information Assistant (GIA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genetic Information Assistant | Other | Participants assigned will receive a link to Genetic Information Assistant for pre-test counseling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| To assess differences of Comprehensive Score of Financial Toxicity scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evelyn Villalobos | Contact | (434) 297-4579 | EV4PD@uvahealth.org | |
| Joseph Petruzziello | Contact | (434) 323-1749 | BNW4RM@uvahealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Kari Ring, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22930 | United States |
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| ID | Term |
|---|---|
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Telegenetics with UVA genetic counselor | Other | Participants assigned will have a pre-test counseling session via a telegentics visit with a genetic counselor. |
|
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 |
| 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 |
| 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 |
| 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 |