Digital app to support oncologist‑initiated genetic testing
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
NA · Unity Health Toronto · NCT07387263
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto (other) |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT07387263 on ClinicalTrials.gov |
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).
Who should consider this trial
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.
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.
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 performed: Previous non‑randomized mainstreaming programs and digital decision tools have shown promising psychological and workflow benefits, but high‑quality randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Receiving germline testing related to primary cancer condition initiated by oncologist * 18 years old or older. * Speak and read English Exclusion Criteria: * Receiving cancer genetic testing 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 this trial is running
Toronto, Ontario and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Breast Cancer, Prostate Cancer, Colon Cancer, GI Cancers, Ovarian Cancer, Pancreatic Cancer, Cancer Genetic Testing