Cancer Clinical Trial
Official title:
Randomized Controlled Trial of a Decision Aid for Incidental Genomic Findings
Verified date | April 2018 |
Source | St. Michael's Hospital, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 133 |
Est. completion date | April 2, 2018 |
Est. primary completion date | April 2, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital | Toronto | Ontario |
Canada | Sunnybrook Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Knowledge | Knowledge is measured using a genomics knowledge scale developed by Clinseq | Measured at baseline (before intervention) and immediately after intervention. | |
Secondary | Preparation for decision making | A 10 item scale measuring how useful a user finds the decision aid or other intervention | Immediately after intervention | |
Secondary | Satisfaction with decision | A six item scale measures a patient satisfaction with a health care decision | Immediately after intervention | |
Secondary | Anxiety | Mesured using the 20 item State-trait scale | Measured at baseline (before intervention) and immediately after intervention. |
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