Digital app to support oncologist‑initiated genetic testing
Official title: Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Run by Unity Health Toronto · NCT07387263 · Data updated 2026-11-12
This project tests a digital app (GA‑Mainstream) to help oncologists offer germline genetic testing to adults with breast, prostate, colon, or other GI cancers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Status | Recruiting |
| Started | April 30, 2026 |
| Main results expected | December 2027 |
| Study ends | March 2028 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT07387263 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with a primary cancer who are receiving oncologist‑initiated germline genetic testing, who read and speak English and have internet access, are ideal candidates.
✕Probably not a fit
Patients referred directly to a genetics clinic, under 18, who do not speak/read English, lack internet/device access, or have impaired decisional capacity are unlikely to benefit from this digital approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional trial compares the GA‑Mainstream digital application to the current mainstreaming standard of care, where oncologists initiate genetic testing without formal pre‑test genetic counseling. The app delivers standardized education, decision support, and coordinated follow‑up to patients who are receiving oncologist‑initiated germline testing. The primary outcome focuses on patient psychological outcomes such as test‑specific distress, with additional measures of care coordination and service use. The trial enrolls adults who speak and read English and have internet access at two Toronto cancer centres (Sunnybrook and Mount Sinai).
Why it matters
Potential benefit: If successful, the app could reduce patient distress, standardize care, and lessen pressure on genetics clinics while keeping appropriate access to germline testing.
How similar studies have gone: Previous non‑randomized mainstreaming programs and digital decision tools have shown promising psychological and workflow benefits, but high‑quality randomized evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Receiving mainstream cancer germline testing related to primary cancer condition (ie. ovarian, pancreas, breast, prostate, or GI cancers) initiated by an oncologist. * 18 years old or older. * Speak and read English Exclusion Criteria: * Receiving genetic testing information via a referral to a genetics clinic * Do not speak or read English * Under 18 years of age * Determined to have diminished, marginal and or fluctuating decisional capacity * Lack access to internet or an electronic device
Where it's running
-
Sunnybrook Hospital
Toronto, Ontario, Canada Recruiting -
Mount Sinai Hospital
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Yvonne Bombard, PhD — St. Michael's Hospital and University of Toronto
- Study coordinator: Marc Clausen, MA
- Email: marc.clausen@unityhealth.to
- Phone: 416-864-6060
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.