Digital Genetic Testing for Cancer

Not yet recruiting at 1 trial location
MC
DA
Overseen ByDaniel Assamad, MHSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Unity Health Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a new digital tool can enhance genetic testing for cancer patients. It aims to streamline the process and reduce stress by using a digital platform called GA-Mainstream (Genetics Adviser for Mainstream Care) to educate and support patients. Participants will either use this tool alongside usual care or receive care that includes pamphlets or videos. The trial seeks individuals undergoing genetic testing for cancer through their oncologist, who speak and read English, and have internet access. As an unphased trial, it provides a unique opportunity to contribute to innovative approaches in genetic testing and patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Genetics Adviser for Mainstream Care is safe for cancer patients?

Research shows that the Genetics Adviser for Mainstream Care (GA-Mainstream) is generally well-liked by patients. Studies have found that about 91% of patients with various cancer types choose to participate in genetic testing, indicating widespread acceptance and use of the tool.

Patients report satisfaction with these genetic testing methods, and few negative effects have been noted. The digital platform helps patients better understand their genetic test results and reduces stress. Although this tool is relatively new, early data suggests it is safe and well-received by users.12345

Why are researchers excited about this trial?

Researchers are excited about the GA-Mainstream digital tool because it offers a new way to integrate genetics education and test result support into cancer care. Unlike the standard approach that relies on pamphlets and videos, this tool provides personalized education and allows patients to share their medical and family history digitally. This could make genetic consultations more efficient and accessible, potentially enhancing patient understanding and engagement with their genetic information.

What evidence suggests that the Genetics Adviser for Mainstream Care is effective for improving psychological outcomes and patient-centered care in cancer patients?

Research has shown that the Genetics Adviser for Mainstream Care (GA-Mainstream) tool, used by participants in the intervention arm of this trial, can greatly enhance genetic testing for cancer patients. One study found that digital tools for genetic testing led to 91% of patients completing the process. Patients reported greater satisfaction with these digital methods compared to traditional ones. Additionally, they received their test results much faster, with waiting times reduced by 1.5 to 6 times. These findings suggest that digital tools like GA-Mainstream can make genetic testing quicker and more satisfying for patients.12678

Who Is on the Research Team?

YB

Yvonne Bombard, PhD

Principal Investigator

St. Michael's Hospital and University of Toronto

Are You a Good Fit for This Trial?

This trial is for patients newly diagnosed with specific cancers such as breast, ovarian, pancreatic, prostate, and colon/GI cancer. They should be candidates for genetic testing as part of their treatment plan. Details on who can't join are not provided.

Inclusion Criteria

I am 18 years old or older.
My oncologist has started genetic testing for my cancer.
Speak and read English

Exclusion Criteria

I am getting genetic testing for cancer through a referral.
I cannot speak or read English.
I am under 18 years old.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm use the GA-Mainstream digital tool for cancer genetics education and support the delivery of their genetic test results.

6 weeks
Ongoing digital platform access

Control

Participants in the control arm receive standard of care with pre-test counseling and results disclosure by a genetic counselor or oncologist.

6 weeks

Follow-up

Participants are monitored for psychological outcomes and patient-centered care improvements post-genetic testing.

6 weeks
2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Genetics Adviser for Mainstream Care (GA-Mainstream)

Trial Overview

The study is evaluating a digital platform called Genetics Adviser for Mainstream Care (GA-Mainstream) against the current standard of care which involves paper-based materials or videos without pre-test genetic counseling.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention arm - GA-Mainstream tool usersExperimental Treatment2 Interventions
Group II: Mainstreaming Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials
572
Recruited
470,000+

Citations

Mainstreaming Genetics: Evaluation of a Digital Application ...

This study will test a digital mainstreaming platform called the Genetics Adviser for Mainstream care to assess its effectiveness in improving ...

Mainstreaming genetics: Evaluation of a digital application ...

We aim to evaluate the effectiveness of the Mainstream Adviser in improving psychological outcomes and patient empowerment.

Uptake and patient-related outcomes of mainstreaming ...

Key findings. The overall uptake of mainstreaming genetic testing across all cancer types was 91%. Mainstreaming was associated with high patient satisfaction ...

The impact of a mainstream genetic testing pathway ... - PMC

Overall genetic testing uptake was 67%: 78% for MGT versus 63% in referral to a genetics department (RGD) (p < 0.001) with significantly higher ...

Mainstreaming Cancer Genomic Testing: A Scoping ...

Time from diagnosis to result disclosure decreased 1.5–6-fold and pathogenic variant detection rates were ≥ 10%. GEM model studies evaluated ...

Uptake and patient-related outcomes of mainstreaming ...

Pooled genetic testing uptake was 91% (95% confidence interval=86–96, I2=99.6%, n=5942) across all cancers. Unselected testing uptake was 95% (95% confidence ...

Cancer Genetics Risk Assessment and Counseling (PDQ®)

Posttest genetic counseling helps patients understand their test results, including the medical implications for themselves and their relatives.

Development and Real‐World Evaluation of a Statewide ...

This translational quality improvement study evaluated a statewide pathway for mainstream genetic testing in South Australia.