Evaluation of a Decision Aid for Incidental Genomic Findings
Randomized Controlled Trial of a Decision Aid for Incidental Genomic Findings
1 other identifier
interventional
133
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Sep 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 12, 2016
CompletedFirst Submitted
Initial submission to the registry
August 6, 2017
CompletedFirst Posted
Study publicly available on registry
August 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2018
CompletedApril 17, 2018
April 1, 2018
1.6 years
August 6, 2017
April 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decisional Conflict
The Ottawa Decision Support Framework measure of decisional conflict, a 16 item scale - developed by O'Connor et al.
Immediately after intervention
Secondary Outcomes (4)
Knowledge
Measured at baseline (before intervention) and immediately after intervention.
Preparation for decision making
Immediately after intervention
Satisfaction with decision
Immediately after intervention
Anxiety
Measured at baseline (before intervention) and immediately after intervention.
Study Arms (2)
Decision Aid Plus Counselling
EXPERIMENTALParticipants will use a decision aid to learn about genomic sequencing and select which incidental findings they would like to receive from genomic sequencing. After using the decision aid the participants will speak with a genetic counsellor over the phone about their choice.
Genetic Counselling Only
ACTIVE COMPARATORParticipants will a genetic counsellor over the phone to learn about genomic sequencing and select which incidental findings they would like to receive from genomic sequencing.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients with a family history of cancer
- Received a negative single gene test for a cancer gene mutation (e.g., BRCA1/2, MLH, MSH, PMS, etc.) or received a negative panel test
- Speak and read English
You may not qualify if:
- Are in advanced stage cancer (stage 5)
- Received positive panel testing or panel sequencing
- Have not had single gene testing related to their primary cancer condition (e.g., BRCA1/2 for breast/ovarian cancer, MLH, MSH, PMS colorectal cancer, etc.)
- Received a positive genetic test for a cancer gene mutation (e.g., BRCA1/2, MLH, MSH, PMS, APC, MUTYH, etc.)
- Do not speak or read English
- Family member participating in the study
- Participant in usability study of the DA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mount Sinai Hospital
Toronto, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
Related Publications (1)
Shickh S, Clausen M, Mighton C, Casalino S, Joshi E, Glogowski E, Schrader KA, Scheer A, Elser C, Panchal S, Eisen A, Graham T, Aronson M, Semotiuk KM, Winter-Paquette L, Evans M, Lerner-Ellis J, Carroll JC, Hamilton JG, Offit K, Robson M, Thorpe KE, Laupacis A, Bombard Y. Evaluation of a decision aid for incidental genomic results, the Genomics ADvISER: protocol for a mixed methods randomised controlled trial. BMJ Open. 2018 Apr 26;8(4):e021876. doi: 10.1136/bmjopen-2018-021876.
PMID: 29700101DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yvonne Bombard, PhD
St. Michael's Hospital and University of Toronto
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
August 6, 2017
First Posted
August 9, 2017
Study Start
September 12, 2016
Primary Completion
April 2, 2018
Study Completion
April 2, 2018
Last Updated
April 17, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share