University of Virginia
Charlottesville, Virginia, 22930, United States
Location status: Recruiting
Location contact
Joseph Petruzziello
CONTACT
NCT Number: NCT06089421
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Charlottesville, Virginia, 22930, United States
Location status: Recruiting
Joseph Petruzziello
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants assigned will receive a link to Genetic Information Assistant for pre-test counseling.
Participants assigned will have a pre-test counseling session via a telegentics visit with a genetic counselor.
Time frame: 3 months
dichotomous measurement of whether the randomized participant completes genetic testing within three months.
Time frame: 3 months
National Center for Human Genome Research Knowledge scale taken at baseline and one month after genetic testing.
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)
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.
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)
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
Contact information is provided by the study sponsor or research team.
Evelyn Villalobos
CONTACT
Joseph Petruzziello
CONTACT
University of Virginia
Other
A Prospective, Randomized Trial to Compare Telegenetics to Counseling Via a Novel Genetic Information Assistant in High-risk Cancer Patients.
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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