Genetics Navigator for Genetic Conditions

Not yet recruiting at 2 trial locations

Overseen By Marc Clausen, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: Ineligible for testing, Urgent testing, Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the Genetics Navigator, a digital tool designed to simplify and reduce the stress of genetic testing. It helps patients and their families understand and manage the genetic testing process, from education to results. The trial will compare the Genetics Navigator to standard care, which involves meetings with genetic counselors. Adults or parents of children referred for genetic testing at Mount Sinai Hospital or SickKids, who are comfortable with English, might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could simplify genetic testing for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on genetic testing and does not mention medication changes.

What prior data suggests that the Genetics Navigator is safe for use in genetic service delivery?

Research has shown that the Genetics Navigator (GN) is a digital tool designed to assist patients with genetic testing. It provides information, supports decision-making, and helps collect medical history. Initial studies found no safety concerns for users of this platform. As a digital tool, not a medication or surgery, GN poses a very low risk of physical side effects, making it easy for users to handle.

The platform enhances patient experiences without causing harm. It guides patients through the genetic testing process, reducing stress and making information more accessible. Overall, based on current evidence, the Genetics Navigator appears safe to use and focuses on improving genetic services. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Genetics Navigator because it integrates technology to streamline genetic services, making the process more efficient and user-friendly. Unlike traditional methods that rely on in-person or virtual consultations with genetic counselors and medical geneticists, the Genetics Navigator offers a comprehensive platform that supports everything from intake and education to pre- and post-test counseling and management recommendations. This approach not only enhances accessibility and convenience for patients but also promises to make the delivery of genetic services more consistent and personalized, potentially transforming how genetic counseling and testing are experienced.

What evidence suggests that the Genetics Navigator is effective for genetic service delivery?

Research has shown that the Genetics Navigator, a digital tool for genetic services, can greatly enhance patient experiences. In this trial, participants in the experimental arm will use the Genetics Navigator to support the delivery of genetic services, reducing the stress and worry of waiting for genetic test results. Studies indicate that this tool improves patient access to information and reduces wait times. The platform collects medical history, offers genetic counseling, and presents results clearly. This can lead to more efficient use of healthcare resources and ease the workload on genetic counselors. Early findings suggest it makes the genetic testing process smoother and less stressful for patients. ^{1 3 4 6 7}

Who Is on the Research Team?

Robin Hayeems, PhD

Principal Investigator

The Hospital for Sick Children and University of Toronto

Yvonne Bombard, PhD

Principal Investigator

St. Michael's Hospital and University of Toronto

Are You a Good Fit for This Trial?

This trial is for patients or parents of patients with neurodevelopmental disorders, retinal disease, connective tissue disease, cardiac conditions, or childhood epilepsy who are being offered genetic testing. It aims to evaluate a digital platform called Genetics Navigator.

Inclusion Criteria

I am 18 or older and referred for genetic testing at UHN.

I am the parent or legal guardian of a child referred for genetic testing at SickKids.

Exclusion Criteria

I am not eligible for genetic testing in Ontario.

I need urgent genetic testing.

I am not fluent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm will use the Genetics Navigator to support the delivery of genetic services, including intake, education, pre- and post-test counselling, and physician-generated management recommendations.

9 months

In-person/phone/video-conferencing consults

Control

Participants in the control arm will receive their genetic counselling and test results through usual care, which consists of in-person/phone/video-conference consults with genetic counsellors and medical geneticists.

9 months

In-person/phone/video-conferencing consults

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Genetics Navigator

Trial Overview The study compares the use of the Genetics Navigator—a digital support tool for genetic service delivery—with standard care provided by genetics professionals. The goal is to see if it reduces distress and improves patient experience.

How Is the Trial Designed?

Group I: Genetics Navigator Experimental Treatment 1 Intervention

Participants in the intervention arm will use the Genetics Navigator to support the delivery of genetic services, including intake, education, pre- and post-test counselling, return of results, and physician-generated management recommendations. Participants in the experimental arm will also receive standard of care genetics care.

Group II: Standard Care with Genetics Professionals Active Control 1 Intervention

Participants in the control arm will receive their genetic counselling and test results through usual care, which consists of in-person/phone/video-conference consults with genetic counsellors and medical geneticists.

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Published Research Related to This Trial

A systematic review of 87 studies found that 84% reported positive outcomes for patients using digital genetics tools, enhancing knowledge, psychosocial well-being, and engagement in genetic service delivery.

Digital tools not only improved patient outcomes but also increased workflow efficiency for healthcare providers, suggesting they can effectively support patient-centered care in the growing demand for genetic services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-facing digital tools for delivering genetic services: a systematic review. Whiwon, L., Salma, S., Daniel, A., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06455384

The Genetics Navigator: Evaluating a Digital Platform for ... The objective of this study is to evaluate the effectiveness of the GN in an RCT in reducing distress with patients and parents of patients being offered ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39231549/

Genetics Navigator: protocol for a mixed methods ... The Genetics Navigator is a digital platform for collecting medical history, providing genetic counseling, and returning results. It will be ...

3. lab.research.sickkids.ca lab.research.sickkids.ca/hayeems/system-outcomes/

System Outcomes – Hayeems Lab The Genetics Navigator aims to improve access, reduce wait times, and remove administrative burdens. It collects medical/family history, ...

4. gimopen.org gimopen.org/article/S2949-7744(24)00561-2/pdf

P516: The Genetics Navigator Conclusion: The Genetics Navigator is a new, comprehensive, patient-centered application to support the delivery of care for pre- and post-test genetic.

5. withpower.com withpower.com/trial/phase-neurodevelopmental-disorders-6-2024-b2e54

Genetics Navigator for Genetic Conditions The objective of this study is to evaluate the effectiveness of the GN in an RCT in reducing distress with patients and parents of patients being offered ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11407190/

Genetics Navigator: protocol for a mixed methods ... A mixed methods randomized controlled trial evaluating a digital platform to deliver genomic services in Canadian pediatric and adult populations.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823183

Uptake of Cancer Genetic Services for Chatbot vs Standard ... This randomized clinical trial examines whether chatbot and standard-of-care delivery models are equivalent in completion of pretest cancer ...