The Use of Digital Genetic Counselor (DGC) for BRCA1/2 Mutation Carrier Testing
试验速览
- 阶段
- 不适用
- 发起方
- Igentify Ltd
- 入组人数
- 300
- 主要终点
- Change in number of face-to-face pre-test and post-test genetic counseling sessions
研究概览
简要总结
The DGC provides an end-to-end solution to the Oncogenetics screening process from participant registration to receipt of the genetic test results and their interpretation. These steps are provided using personalized animated videos.
详细描述
Step 1. Registration: During the initial phone call with potential participants, qualified staff that are part of the study will explain the process and extend an invitation to participated in the study. The DGC process will begin when the Sheba MC Genetics Institute will send potential participants a link. Participant will undergo the standard two-factor authentication method based on phone number and last four digits of the ID number. At the end of this process a new user will be created in the system. Note: There are no physical risks associated with participation in this study.
Step 2. Interactive medical questionnaire: The interactive medical questionnaire is defined as the process of gathering personal information relevant to the specific clinical genetic scenario (e.g. personal information, personal and family medical information). The questionnaire is dynamic and is interactively adapted based on live information supplied by the participant. The questionnaire was approved by the Sheba MC PI.
Please note that the essence of the DGC system is to enable to conduct genetically relevant medical informatics processes in the context of digital sessions with secured and adaptive systems.
One of the major aims of the questionnaire is to enable the use of the scientific risk calculator "BRCAPRO" (a breast and ovarian cancer risk assessment algorithm accepted by Israel MOH). This allows the DGC to provide the participant with her risks for being a BRCA mutation carrier and the risk of developing breast/ovarian cancer prior to the oncogenetic test.
At the end of that phase of the DGC use, the participant will be informed that: "You are presented with a questionnaire regarding genetic test for having a mutation in BRCA1/2, by answering the questions you hereby accept the participation this medical questionnaire. Before the submission of DNA sample to the test you will be asked to sign an Informed Consent for the participation in the study, that this questionnaire is part of it." Note: The genetic test is part of a routine test performed at the Sheba MC Genetic Institute and is not part of this study. Participants will be asked to sign the routine Informed Consent for the genetic test.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants willing to undergo BRCA1/2 genotyping
- •Participants willing to use the DGC as part of their genetic screen
- •Participants willing to fill up follow up questionnaires about their experience and understanding of the genetic counseling, and share their clinical and DGC usage data with the study personnel
- •Fluent in Hebrew
- •Age 18 or above
排除标准
- •Individuals that underwent bone marrow transplantation.
- •Participants refusing to participate in the study.
结局指标
主要结局
Change in number of face-to-face pre-test and post-test genetic counseling sessions
时间窗: One year
The investigators expect that the pre-test session of all participants will be handled using the enrollment module of the system making the face-to-face session unneeded. In addition, the investigators expect that about 10% of BRCA negative, low risk women that received digital counseling will still request a face-to-face counseling session. Overall, the investigators estimate that the 55% of the women will not require a post-test face-to-face session.
次要结局
未报告次要终点