Recruiting

Genetics Adviser

Sponsor:

Unity Health Toronto

Code:

NCT07387263

Conditions

Cancer

Breast Cancer

Prostate Cancer

Colon Cancer

GI Cancers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Genetics Adviser for Mainstream Care (GA-Mainstream)

Mainstreaming Standard of Care

Study Details

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.

Conditions

Cancer

Breast Cancer

Prostate Cancer

Colon Cancer

GI Cancers

Study ID

NCT07387263

Start date

Apr 30, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention arm - GA-Mainstream tool users

Participants in the intervention arm will use the GA-Mainstream digital tool for cancer genetics education, providing cancer medical and family history, and to support the delivery of their genetic test results. This tool will be used to supplement usual care. Participants will continue to be supported by existing consultations with genetics professionals to discuss their results.

active comparator: Mainstreaming Standard of Care

Participants in the control arm will receive mainstream care as outlined by the clinic where the patient is being seen, which consists of a patient pamphlet, video and/or a clinician checklist for pre-test counseling. Results will be disclosed by either a genetic counselor or oncologist with post-test counseling of select patients.

Interventions

Genetics Adviser for Mainstream Care (GA-Mainstream)

The Genetics Adviser for Mainstream Care will educate participants on cancer genetic testing after oncologist-initiated genetic testing. Participants may also receive their results on the GA-Mainstream.

Mainstreaming Standard of Care

After oncologist-initiated genetic testing, participants may not receive additional information prior to the receipt of their results or they may receive educational materials on cancer genetic testing. Results will be disclosed by either a genetic counselor or oncologist with post-test counseling of select patients.

Primary outcome measure

  • Test Specific Distress - Multi-Dimensional Impact of Cancer Risk Assessment (MICRA) [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Hospital

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Andrea Eisen, MD

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Principal Investigator:

Christine Elser, MD

More Information

Sponsor

Unity Health Toronto

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • Cancer Genetic Testing
  • Randomized Controlled Trial
  • Digital Tool
  • Mainstreaming
  • Genetic counseling
  • Cancer
  • Genetic testing
  • Service Delivery
  • Alternative service delivery model

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2026-06-24.