Project CARE: CAncer Risk Evaluation (CARE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Proportion of Patients Completing the Hereditary Cancer Risk Assessment
研究概览
简要总结
The purpose of Project CARE (cancer risk assessment and evaluation) research study is to explore the acceptance and feasibility of a study-initiated proactive outreach and digital care delivery model for conducting hereditary cancer risk assessment in primary care settings and facilitating genetic risk evaluation for patients flagged as high risk. Potential participants will be recruited from Rutgers Health primary care sites (family practice and general internal medicine). EPIC will be used to identify all potential participants and they will be invited to participate in the study. Consented participants will be provided a link via email, and or text message to engage with a Relational Agent (RA, chatbot), through the patient portal for cancer risk assessment and genetic education. Those identified as high risk will be offered genetic counseling and testing.
The research questions the study aims to answer are:
- What percent of patients who completed the RA are identified as high risk?
- What percent of patients who engaged with the risk assessment were identified as high risk?
- What percent of high-risk patients had genetic counseling or genetic testing within 4 months of completing the risk assessment?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 70 years
- •Able to read and speak English
- •Have an email address or mobile phone number in EPIC and/or are enrolled in MyChart
- •Receiving health care in Family Medicine or General Internal Medicine at Rutgers Health within the past 2 years
- •Have not opted out of receiving research-related communications
- •Have internet access (via smartphone, tablet, or computer)
排除标准
- •Dementia (e.g., Alzheimer's disease) as indicated in EPIC
- •Unable to access the Internet (via smartphone, tablet, or computer)
- •Previous germline genetic testing for hereditary cancer risk
- •Opted out of research participation in EPIC
- •Have a personal history of cancer
研究组 & 干预措施
Feasibility and Acceptability of Relational Agent Chatbot
干预措施: Relational Agent ( RA) Alex (Behavioral)
结局指标
主要结局
Proportion of Patients Completing the Hereditary Cancer Risk Assessment
时间窗: Up to 3 months from enrollment
The proportion of patients who successfully complete the hereditary cancer risk assessment within the genetic care delivery portal. Completion is defined as receiving a final result statement, regardless of whether all assessment questions in the risk assessment module were answered.
Proportion of Patients Identified as High Risk
时间窗: Through study completion, an average of 12 months.
The percent of patients who completed the RA and are identified as high risk.
次要结局
- RA Engagement Rate(Up to 3 months from enrollment)
- Retention Rate of High-risk Participants at 1-Month(1-month post high-risk identification)
- Satisfaction with the Risk Assessment Feature of the Relational Agent(Through study completion, an average of 12 months.)
研究者
Anita Y. Kinney, PhD, RN
Director at Rutgers Cancer Institute
Rutgers, The State University of New Jersey