Digital Genetic Testing for Cancer

Not yet recruiting at 1 trial location
MC
DA
Overseen ByDaniel Assamad, MHSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Unity Health Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Genetic testing can alter therapy and surgical management for cancer patients and is therefore indicated as a first-line test for many newly diagnosed patients, including breast, ovarian, pancreatic, prostate and colon/GI patients. To reduce pressure on already constrained genetics clinics across Canada, some cancer centres are 'mainstreaming' genetic testing - whereby genetic testing is initiated and mediated by oncologists without traditional pre-test genetic counseling (GC) often using some form of paper-based patient pamphlets or videos. There is no standard, evidence-based approach to mainstreaming, leading to significant practice variation, a lack of coordinated care and ultimately, negative psychological impacts on patients. Digital solutions can address these gaps by providing a standardized, coordinated and patient-centered approach to deliver cancer genetic education. However, digital solutions for providing cancer genetics services are uncommon and clinical-effectiveness and service delivery outcomes have not been well-assessed. This study will test a digital mainstreaming platform called the Genetics Adviser for Mainstream care to assess its effectiveness in improving psychological outcomes and patient-centred care for mainstream cancer patients compared to standard of care.

Who Is on the Research Team?

YB

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 newly diagnosed with specific cancers such as breast, ovarian, pancreatic, prostate, and colon/GI cancer. They should be candidates for genetic testing as part of their treatment plan. Details on who can't join are not provided.

Inclusion Criteria

I am 18 years old or older.
My oncologist has started genetic testing for my cancer.
Speak and read English

Exclusion Criteria

I am getting genetic testing for cancer through a referral.
I cannot speak or read English.
I am under 18 years old.
See 2 more

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 use the GA-Mainstream digital tool for cancer genetics education and support the delivery of their genetic test results.

6 weeks
Ongoing digital platform access

Control

Participants in the control arm receive standard of care with pre-test counseling and results disclosure by a genetic counselor or oncologist.

6 weeks

Follow-up

Participants are monitored for psychological outcomes and patient-centered care improvements post-genetic testing.

6 weeks
2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Genetics Adviser for Mainstream Care (GA-Mainstream)

Trial Overview

The study is evaluating a digital platform called Genetics Adviser for Mainstream Care (GA-Mainstream) against the current standard of care which involves paper-based materials or videos without pre-test genetic counseling.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention arm - GA-Mainstream tool usersExperimental Treatment2 Interventions
Group II: Mainstreaming Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials
572
Recruited
470,000+