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Genetics Adviser: Evaluating a Digital Decision Support Tool for Genetic Results

NCT04725565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2024-05-31

No results posted yet for this study

Summary

Oncologists are increasingly using genomic sequencing to diagnose and optimize care for their patients. A consequence of this technology is its capacity to detect a patient's risk for thousands of current and future conditions or diseases. Guidelines recommend doctors allow patients to choose which results they wish to receive before ordering the test. It is not feasible to counsel patients on the thousands of possible results because of the limited clinical resources and genomics expertise. Decision aids (DAs) can fill this gap, however there are no DAs to guide patients' decisions about results from genomic sequencing. A DA prototype was developed (GenomicsADvISER.com), the first DA of its kind. This study will transform the DA prototype into an interactive, adaptable and patient-centred digital decision support tool (Genetics ADvISER) via user-centred design methods. The objective of this study is to evaluate the effectiveness of Genetics ADvISER in an RCT with patients being offered results from genomic sequencing. Results of this trial will be used to establish whether the Genetics ADvISER is effective to use in practice. This could fill a critical clinical care gap, improve health outcomes and service use by reducing counselling burden as well as overuse, underuse and misuse - concerns of policy makers seeking to address the triple aims of health care.

Conditions

Interventions

BEHAVIORAL

Genetics ADvISER Decision Aid Plus Standard Genetic Counselling

The decision aid will educate patients about the types of incidental finding they can learn from genomic sequencing and will give them opportunity select what types of results they would like to receive.

BEHAVIORAL

Standard Genetic Counseling

Standard Genetic counseling to learn about and select incidental results from genomic sequencing.

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Yvonne Bombard, PhD · St. Michael's Hospital and University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-22
Primary Completion
2023-04-20
Completion
2024-04-06

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04725565 on ClinicalTrials.gov