Genetics Adviser: Evaluating a Digital Decision Support Tool for Genetic Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 6
- 主要终点
- Decisional Conflict Scale (DCS)
研究概览
简要总结
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.
详细描述
BACKGROUND: Genomic sequencing (GS) is a driver of precision oncology. Oncologists are increasingly using tumour GS for precision oncology care, which is often times accompanied by germline GS on normal control tissue. One complex feature of this technology is its capacity to generate incidental findings (IF). 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.
RATIONALE: There are limited decision support tools in genetics. Despite the long-standing practice of medical genetics, there are relatively few decision support tools for genetic testing and very few that have been rigorously evaluated. Even fewer decision support tools exist on possible results from genomic sequencing; existing tools target pediatric contexts, focus on genomic sequencing education-only or on the return of results; they do not cover all possible results with decision support to simulate genetic counselling, limiting their use and applicability in clinical care. Thus, there are no decision support tools to guide patients about all results available from genomic sequencing.
OBJECTIVES: Evaluate the effectiveness of the Genetics ADvISER vs standard genetic counseling (GC) with patients receiving incidental findings.
HYPOTHESIS: Use of the Genetics ADvISER will reduce patients' decisional conflict & anxiety, improve patient knowledge, satisfaction with decisions and preparedness for decision-making when selecting IF compared to GC alone.
PHASE 1: RCT to evaluate the Decision Aid
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
- •Previous control participants from the Incidental Genomics study who have given permission to be re-contacted for related research or a patient who has undergone germline genetic testing (single gene or panel) and received a negative or inconclusive result.
- •18 years old or older
- •Speak and read English.
排除标准
- •For participants newly recruited (not part of parent trial CTO# 0819)
- •Received positive panel testing or panel sequencing
- •Have not had germline 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 germline genetic test for a cancer gene mutation (e.g., BRCA1/2, MLH, MSH, PMS, APC, MUTYH, etc.)
- •Currently under cancer treatment
- •In stage 4, progressive metastatic cancer
- •Do not speak or read English
- •Under 18 years of age
结局指标
主要结局
Decisional Conflict Scale (DCS)
时间窗: 1 day
The Ottawa Decision Support Framework measure of decisional conflict, a 16 item scale - developed by O'Connor et al. Each item is scored 1-5 and a total score on the DCS is calculated by summing all items on the DCS and then dividing by 16, giving a final score between 1 and 5. A lower score on the DCS indicates lower level of decisional conflict.
次要结局
- State-Trait Anxiety Inventory(Assessed at baseline, immediately after baseline/ post intervention, at two weeks, 2 months and 4 months.)
- Hospital Anxiety and Depression Scale (HADS)(Assessed at baseline, immediately after baseline/post intervention, at two weeks, 2 months and 4 months.)
- Preparation for Decision Making scale (PrepDM)(Assessed immediately after baseline/ post intervention, at two weeks, 2 months and 4 months.)
- Knowledge(Assessed at baseline, immediately after baseline/ post intervention, at two weeks, 2 months and 4 months.)
- Satisfaction with Decision Scale (SWD)(Assessed immediately after baseline/ post intervention, at two weeks, 2 months and 4 months.)
- Time(Assessed at immediately after baseline/ post intervention, 2 months and 4 months.)
- Acceptability(Assessed immediately after baseline/ post intervention, at two weeks, 2 months and 4 months.)