Recruiting

Genetics Navigator

Sponsor:

Unity Health Toronto

Code:

NCT06455384

Conditions

Cardiac Conditions

Connective Tissue Diseases

Retinal Disease

Epilepsy in Children

Neurodevelopmental Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Genetics Navigator

Standard Care with Genetics Professionals

Study Details

Brief summary:

Genetic testing (GT) (including targeted panels, exome and genome sequencing) is increasingly being used for patient care as it improves diagnosis and health outcomes. In spite of these benefits, genetic testing is a complex and costly health service. This results in unequal access, increased wait times and inconsistencies in care. The use of e-health tools to support genetic testing delivery can result in a better patient experience and reduced distress associated with waiting for results and empower patients to receive and act on medical results. We have previously developed and tested an interactive, adaptable and patient-centred digital decision support tool (Genetics ADvISER) to be used for genetic testing decision making, and have now developed the Genetics Navigator (GN), a patient-centred e-health navigation platform for end-to-end genetic service delivery. 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 genetic testing. Results of this trial will be used to establish whether the GN is effective to use in practice. If effective, GN could fill a critical clinical care gap and improve health outcomes and service use by reducing counselling burden as well as overuse, underuse and misuse of services. These are concerns policy makers seek to address through the triple aims of health care1. This study represents a significant advance in personalized health by assessing the effectiveness of this novel, comprehensive e-health platform to ultimately improve genetic service delivery, accessibility, patient experiences, and patient outcomes.

Conditions

Cardiac Conditions

Connective Tissue Diseases

Retinal Disease

Epilepsy in Children

Neurodevelopmental Disorders

Study ID

NCT06455384

Start date

Oct 28, 2025

Status verified date

Dec, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion:

  • Adult patients (18 years of age or older) who are referred to participating clinicians at Mount Sinai Hospital for clinical genetic testing.
  • Parents/legal guardians (18 years of age or older) of pediatric patients who are referred to participating clinicians at SickKids for clinical genetic testing.

Exclusion:

  • Known not to be eligible for clinical genetic testing in Ontario
  • Requires urgent clinical genetic testing or prenatal genetic testing
  • Not fluent in English (speaking and reading)

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Genetics Navigator

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.

active comparator: Standard Care with Genetics Professionals

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.

Interventions

Genetics Navigator

The Genetics Navigator will be used to support patients during the delivery of genetic services, including intake, education, pre- and post-test counselling, and physician-generated management recommendations

Standard Care with Genetics Professionals

Standard care for the delivery of genetic services, including receiving genetic counselling and test results

Primary outcome measure

  • Multi-Dimensional Impact of Cancer Risk Assessment (MICRA) [ Time Frame: At 6 months and 9 months after baseline ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Principal Investigator:

Melyssa Aronson, MS (C)CGC

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Principal Investigator:

Robin Hayeems, PhD

Sunnybrook Hospital

Recruiting

Toronto, Canada

Contacts

Principal Investigator:

Andrea Eisen, MD

More Information

Sponsor

Unity Health Toronto

Last update posted

Jun 24, 2026

Last verified

Dec, 2025

Keywords

  • Genomic Sequencing
  • Randomized Controlled Trial
  • Clinical Utility
  • Personal Utility
  • Decision Aid
  • Incidental Findings

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2026-06-24.