Project CARE: CAncer Risk Evaluation
Part of paid clinical trials in New Brunswick, New Jersey.
- Sponsor
- Anita Y. Kinney, PhD, RN
- Study ID
- NCT07130487
- Status
- Recruiting
Conditions
- Primary Care
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Accepted
Interventions
- Relational Agent ( RA) Alex — BEHAVIORALThe intervention is an RA (chatbot) integrated into a genetic care delivery portal for primary care patients. The RA provides hereditary cancer education and risk evaluation through an interactive interface. Primary care patients will use the RA to complete questionnaires about their hereditary cancer risk, track their progress through the education component and assessment process, and obtain downloadable summaries of their cancer risk and family tree. Additionally, the chat feature stores past conversations, and a menu guides participants through key steps.
Study Details
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: 1. What percent of patients who completed the RA are identified as high risk? 2. What percent of patients who engaged with the risk assessment were identified as high risk? 3. What percent of high-risk patients had genetic counseling or genetic testing within 4 months of completing the risk assessment?
Key Dates
- Start date
- Nov 19, 2025
- Status verified
- Nov 2025
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
Study Design
- Enrollment
- 210 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SCREENING
Arms
- Experimental: Feasibility and Acceptability of Relational Agent Chatbot
Primary Outcome Measure
Proportion of Patients Completing the Hereditary Cancer Risk Assessment [ Time Frame: Up to 3 months from enrollment ]
Central Contacts
- Julie Chapman-Greene, PhD, MPH732-865-3375
- Emily Heidt, MPH732-235-8930
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rutgers, The State University of New Jersey | New Brunswick | New Jersey | 08901 | Anita Y Kinney, PhD, RN (PRINCIPAL_INVESTIGATOR) |
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