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Life sciences · Interventional Study
ClinicalTrials.gov · October 30, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07387263). This is a study registration, not published results. Lead sponsor: Unity Health Toronto. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 180 participants (ESTIMATED). Conditions: Cancer, Breast Cancer, Prostate Cancer, Colon Cancer, GI Cancers, Ovarian Cancer, Pancreatic Cancer. Interventions: BEHAVIORAL: Genetics Adviser for Mainstream Care (GA-Mainstream); BEHAVIORAL: Mainstreaming Standard of Care. Primary outcome measures: Test Specific Distress - Multi-Dimensional Impact of Cancer Risk Assessment (MICRA) , Assessed immediately after return of results via intervention (intervention arm only). Assessed at 2-weeks (primary timepoint) and 6 weeks post-return of results for everyone.. Brief summary: 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.