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

NCT07387263 | Recruiting

• 1 other identifier: 4066
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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; Ovarian Cancer; Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Test Specific Distress - Multi-Dimensional Impact of Cancer Risk Assessment (MICRA)

  The Multi-Dimensional Impact of Cancer Risk Assessment (MICRA) is a 25-item standardized, validated scale that measures the impact of result disclosure from genetic tests. There are three subscales: Distress (6 items), Uncertainty (9 items) and Positive Experiences (4 items). Total scores range from 0-125, with higher scores indicating worse outcome. Scores on the Distress subscale range from 0-30, with higher scores indicating worse outcome. Scores on the Uncertainty subscale range from 0-45, with higher scores indicating worse outcome. Scores on the Positive Experiences Subscale range from 0-20, with higher scores indicating worse outcomes. (PMID: 12433008)

  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.

Secondary Outcomes (9)

• Generalized Distress - Hospital Anxiety & Depression Scale (HADS)

  Everyone: a)Baseline; b) 3-weeks post-baseline; c) 2-weeks post-return of genetic results; d) 6-weeks post-return of results. Intervention arm: e) Post-first digital tool use (after baseline); f) immediately post-return of results via intervention.

• Knowledge - KnowGene

  Everyone: a)Baseline; b) 3-weeks post-baseline; c) 2-weeks post-return of genetic results; d) 6-weeks post-return of results. Intervention arm: e) Post-first digital tool use (after baseline); f) immediately post-return of results via intervention.

• Empowerment - Genomics Outcome Scale (GOS-6)

  Everyone: a)Baseline; b) 3-weeks post-baseline; c) 2-weeks post-return of genetic results; d) 6-weeks post-return of results. Intervention arm: e) Post-first digital tool use (after baseline); and f) immediately post-return of results via intervention.

• Self-Efficacy - Genetic Self Efficacy Scale

  Everyone: a)Baseline; b) 3-weeks post-baseline; c) 2-weeks post-return of genetic results; d) 6-weeks post-return of results. Intervention arm: e) Post-first digital tool use (after baseline); and f) immediately post-return of results via intervention.

• Quality of Life - Short Form Health Survey (SF-12)

  Assessed at: a) baseline; b) 2-weeks post-return of genetic test results (primary timepoint); and c) 6-weeks post-return of results.

Other Outcomes (7)

• Qualitative interviews with a subset of participants and providers

  1-6 months following return of results.

• Health Literacy - BRIEF

  Assessed at baseline.

• Digital Health Literacy - Digital Health Care Literacy Scale

  Assessed at baseline.

Study Arms (2)

Intervention arm - GA-Mainstream tool users

EXPERIMENTAL

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.

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

Mainstreaming Standard of Care

ACTIVE COMPARATOR

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.

Behavioral: Mainstreaming Standard of Care

Interventions

Genetics Adviser for Mainstream Care (GA-Mainstream) BEHAVIORAL

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.

Also known as: GA-Mainstream

Intervention arm - GA-Mainstream tool users

Mainstreaming Standard of Care BEHAVIORAL

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.

Intervention arm - GA-Mainstream tool users; Mainstreaming Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving germline testing related to primary cancer condition initiated by oncologist
• years old or older.
• Speak and read English

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (2)

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Prostatic Neoplasms; Colonic Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders; Pancreatic Diseases

Study Officials

• Yvonne Bombard, PhD

  St. Michael's Hospital and University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Clausen, MA

CONTACT

416-864-6060; marc.clausen@unityhealth.to

Daniel Assamad, MHSc

CONTACT

d.abdassamad@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Data will be made available to research who are interested in / conducting similar research in this field. This data will be available upon request, keeping with research ethics procedures.

Locations

CA (2)