Using a chatbot or genetic counselor for cancer genetic screening in rural areas
A Prospective, Randomized Trial to Compare Telegenetics to Counseling Via a Novel Genetic Information Assistant in High-risk Cancer Patients.
This study is testing whether a chatbot or a genetic counselor is better at helping people in rural areas understand cancer genetic screening and decide to get tested for gene mutations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06089421 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore how different methods of providing cancer genetic screening can impact the decision-making process for individuals at high risk of gene mutation-related cancers. Participants will be randomly assigned to receive pre-genetic test education either from a genetic counselor or through a Genetic Information Assistant (GIA) chatbot. They will then provide a saliva sample for genetic testing to identify potential cancer gene mutations. The study will compare the rates of genetic testing uptake between the two groups to determine the effectiveness of the GIA compared to traditional counseling methods.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 and over who are at high risk for genetic cancer mutations and have the technological capability to use a smartphone or computer.
Not a fit: Patients who cannot communicate in English or Spanish or who have previously undergone panel-based cancer genetic testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance access to genetic testing for cancer predisposition in rural communities, potentially leading to earlier detection and better management of cancer risks.
How similar studies have performed: Other studies have shown promising results using telehealth and digital tools for genetic counseling, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Kari Ring, MD — University of Virginia
- Study coordinator: Evelyn Villalobos
- Email: EV4PD@uvahealth.org
- Phone: (434) 297-4579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.