Randomized Controlled Trial of a Decision Aid for Incidental Genomic Findings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Decisional Conflict
研究概览
简要总结
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.
详细描述
BACKGROUND: Health care providers are increasingly using GS to diagnose, prognose and treat diseases. GS offers increased sensitivity over classic genetic tests, decreasing time-consuming and costly diagnostic cascades. However, GS may also incidentally reveal inherited risks for many other cancers and diseases. Guidelines recommend doctors inform patients of their incidental GS results. Yet there are limited tools to communicate the scope and implications of the thousands incidental results available to help guide patients' decisions about which results they wish to learn.
Gaps: Decision aids (DAs) are best suited to meet this challenge, but no DA exists to guide patients' decisions about incidental GS results.
Rationale: It is not feasible to counsel patients on the thousands of incidental findings available to make informed choices about which incidental results they wish to receive because of the limited genomics expertise and capacity among oncologists, and the long wait times for genetic counseling. Our DA fills this critical care and translational gap by improving the quality of patients' decisions and saving oncologists time counseling patients on incidental findings.
Preliminary data: 1) DA development: We created an interactive online DA. It begins with a professional whiteboard video (by Dr. Mike Evans) that conveys the key concepts, risks and benefits of learning about incidental GS results to educate patients. It then prepares patients for decision-making using a values clarification exercise (with feedback of their preferences) and a knowledge questionnaire (with correct answers provided after). It ends by asking participants to select result categories they want to learn using a menu tool. 2) Usability testing: We also evaluated the DA's usability with 15 patients in 2 rounds. Interviews demonstrated strong face validity and content comprehension. Most patients found the amount of information 'just right' (11/15), clear (12/15) and balanced (14/15). All patients felt that the information was sufficient to reach a decision, that the DA was easy to use and would recommend it.
OBJECTIVES
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Decision Aid Plus Counselling
Participants 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.
干预措施: Decision Aid Plus Counselling (Other)
Genetic Counselling Only
Participants 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.
干预措施: Genetic Counselling Only (Other)
结局指标
主要结局
Decisional Conflict
时间窗: Immediately after intervention
The Ottawa Decision Support Framework measure of decisional conflict, a 16 item scale - developed by O'Connor et al.
次要结局
- Satisfaction with decision(Immediately after intervention)
- Anxiety(Measured at baseline (before intervention) and immediately after intervention.)
- Preparation for decision making(Immediately after intervention)
- Knowledge(Measured at baseline (before intervention) and immediately after intervention.)