The Genetics Update

Sponsor
Unity Health Toronto
Study ID
NCT07795879
Status
Not Yet Recruiting

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Conditions

  • Cancer
  • Genetic Diseases
  • Genetic Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Genetics Update Platform plus standard genetic counselling — BEHAVIORAL
    Patients in this arm will have continual access to the genetics update platform while they wait for the updated genomic sequencing results. The platform will provide access to relevant educational materials and eventually, results of their genetic tests.
  • Standard Genetic Counselling — BEHAVIORAL
    Standard Genetic counseling to learn and understand results from genomic sequencing.

Study Details

Genomic sequencing (GS) can reveal thousands of genetic variants in each patient. As our understanding of these variants evolves, some may be reclassified, which could have significant implications for a patient's health. However, notifying patients about these changes is challenging and can lead to delays in their care. Patients often feel anxious while waiting for updates, especially when they know their results might change but aren't sure when or how it will affect them. To address this, a new study aims to develop and test a digital platform called "The Genetics Update." This platform will help keep patients informed about their genomic results in a timely manner, potentially reducing the stress and uncertainty that many experience. The study will compare this new approach to the traditional methods of providing updates, such as genetic counseling sessions and letters, to see which is more effective at reducing patient distress. As the use of genomic sequencing continues to grow, finding better ways to communicate updates will become increasingly important.

Key Dates

First listed
Aug 31, 2026
Start date
Jan 1, 2027
Status verified
Aug 2026
Primary completion
May 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Intervention - Genetics Update Platform plus standard genetic counselling
    Arm Description: Participants in this intervention arm will be consented by the study coordinator and then use the Genetics Update platform to support the delivery of their updated genetic test results. Once their updated results are ready, participants will be notified via email and will use the patient platform to access their updated results and recommendations. All participants will have the option to request a meeting with a study genetic counsellor (GC) if needed. Participants who receive a pathogenic, likely pathogenic, or variant of uncertain significance as a result will have a mandatory virtual or telephone meeting with a genetic counsellor to discuss the result and follow up steps.
  • Active Comparator: Standard Genetic Counselling Only
    Arm Description: Participants in the control arm will be consented by the study coordinator. Once their results are ready, participants will receive their genetic testing result report through a password protected file via email. The genetic counsellor will be notified once the email has been opened. Participants will have been given the password during their consent process verbally. Should they have misplaced this, they can contact the study coordinator to request the password. If the participant does not open the email to review results, they will be contacted by the study coordinator via phone. Participants who receive a pathogenic, likely pathogenic, or variant of uncertain significance as a result will have a mandatory virtual or telephone meeting with a genetic counsellor to discuss the result and follow up steps.

Primary Outcome Measure

Reduce test-specific distress [ Time Frame: At 0, 2 and 4 weeks of receiving genetic test results for both study arms ]

Central Contacts

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