A Prospective, Randomized Trial to Compare Telegenetics to Counseling Via a Novel Genetic Information Assistant in High-risk Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- To assess feasibility of using a chatbot (GIA) for pre-test genetic counseling compared to standard of care GC
研究概览
简要总结
The goal of this clinical trial is to learn about different ways cancer genetic screening can be provided to rural communities in participants at high risk for certain cancers. The main question it aims to answer is:
• Does receiving pre-genetic test education with a chat bot or genetic counselor affect if the participant decides to get genetic testing?
Participants will:
- have a pre-test genetic counselling session with a genetic counselor or the GIA chatbot
- answer questions about their cancer genetic knowledge and how they are doing
- provide a saliva sample for genetic testing to test for cancer gene mutations
- have their genetic testing results provided to them.
- have the option to share their genetic testing results with family members
Researchers will compare how many participants who had pre-genetic counseling with the chatbot received genetic testing to how many participants who had pre-genetic counseling with a genetic counselor received genetic testing.
详细描述
High risk patients will be randomized to standard of care telegenetics with a UVA Genetic Counselor (GC) for pre-test counseling or to the novel interventional arm of pre-test counseling via Genetic Information Assistant (GIA). Participants in the study will receive their link for a telegenetics appointment or GIA link based on randomization and patients will complete pre-test genetic counseling via their assigned treatment arm. Participants will not be masked to their trial arm assignment. In the telegenetics arm, patients will be offered a video visit scheduled through Epic zoom or a phone visit in our cancer genetics clinic per standard of care. Patients randomized to the GIA arm will receive a personalized link based on their family history. At the completion of counseling, participants will be offered genetic testing. If they agree, they will be mailed a saliva kit via Invitae Genetics for panel based genetic testing via The Invitae Common Hereditary Cancers panel to analyze 47 genes associated with cancers of the breast, ovary, uterus, and gastrointestinal system, which includes the stomach, colon, rectum, small bowel, and pancreas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- 是
入选标准
- •At high risk for having a genetic pathogenic variant as assessed by a GC or physician according to the NCCN guidelines
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, aged 18 and over.
- •Subjects must have a smartphone with access to cellular and/or internet service or a computer with internet service.
- •Subjects must have technological competency/proficiency to use their Smartphone and/or computer in conjunction with the communication aid GIA.
排除标准
- •Cannot communicate in English or Spanish.
- •Subjects must not have completed panel-based cancer genetic testing in the past.
结局指标
主要结局
To assess feasibility of using a chatbot (GIA) for pre-test genetic counseling compared to standard of care GC
时间窗: 3 months
dichotomous measurement of whether the randomized participant completes genetic testing within three months.
次要结局
- To assess differences of SURE scale(6 months)
- To assess differences of Decisional Conflict scale(6 months)
- To assess differences of Comprehensive Score of Financial Toxicity scale(6 months)
- To assess differences of Multi-dimensional Impact of Cancer Risk Assessment (MICRA) scale(6 months)
- To test cancer knowledge following the pre-test genetic counseling with GIA versus GC(3 months)
研究者
Kari Ring, MD
Assistant Professor
University of Virginia