NCT07130487

Project CARE: CAncer Risk Evaluation

Project CARE: CAncer Risk Evaluation (CARE)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Anita Y. Kinney, PhD, RN · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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?

Conditions

• Primary Care

Interventions

Type	Name	Description
BEHAVIORAL	Relational Agent ( RA) Alex	The 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.

Timeline

• Start date: 2025-11-19
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-08-19
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States