Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing

Recruiting · NCT07387263 · Interventional (participants receive a specific treatment) · Lead sponsor: Unity Health Toronto

View the official record on ClinicalTrials.gov →

Colorectal cancer Breast Cancer Prostate Cancer Pancreatic Cancer

Interventions studied

Genetics Adviser for Mainstream Care (GA-Mainstream)Mainstreaming Standard of Care

What this trial is about

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 can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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 it is running

4 locations listed.

Sunnybrook Hospital - Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto, Ontario, Canada
Sunnybrook Hospital - Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto, Ontario, Canada

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →