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Evaluation of a Decision Aid for Incidental Genomic Findings

NCT03244202 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2018-04-17

No results posted yet for this study

Summary

Health care providers (HCP) are increasingly using genomic sequencing (GS) to target treatment for patients. However, GS may incidentally reveal inherited risks for thousands of current and future diseases. Guidelines recommend HCP inform patients of incidental GS results. No decision aid (DA) exists to guide patients' decisions about which incidental GS results they wish to learn. This study will evaluate whether the DA followed by genetic counselling (GC) reduces decisional conflict compared to GC alone in a randomized controlled trial (RCT) with 128 patients with a family history of cancer, who have had a negative genetic test and may eligible for GS. A qualitative component with a subset of participants (n=40) will explore patients' preferences for the types of incidental results they wish to receive and their decision making process.

Conditions

Interventions

OTHER

Decision Aid Plus Counselling

The Genomics ADViSER is an decision aid designed to inform patients about genomic sequencing (GS) and aid them selecting which incidental findings they would like to receive from GS.

OTHER

Genetic Counselling Only

Participants will learn about genomic sequencing and incidental findings by speaking directly with a genetic counsellor and select which incidental findings they would like to receive with a genetic counsellor.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • 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
2016-09-12
Primary Completion
2018-04-02
Completion
2018-04-02

Countries

  • Canada

Study Locations

More Related Trials

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 NCT03244202 on ClinicalTrials.gov