Recruiting

Genetic Risk Assessment

Sponsor:

Anita Y. Kinney, PhD, RN

Code:

NCT07130487

Conditions

Primary Care

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Relational Agent ( RA) Alex

Study Details

Brief 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

Study ID

NCT07130487

Start date

Nov 19, 2025

Status verified date

Nov, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion Criteria

1. Age 18 to 70 years
2. Able to read and speak English
3. Have an email address or mobile phone number in EPIC and/or are enrolled in MyChart
4. Receiving health care in Family Medicine or General Internal Medicine at Rutgers Health within the past 2 years
5. Have not opted out of receiving research-related communications
6. Have internet access (via smartphone, tablet, or computer)

Exclusion Criteria

1. Dementia (e.g., Alzheimer's disease) as indicated in EPIC
2. Unable to access the Internet (via smartphone, tablet, or computer)
3. Previous germline genetic testing for hereditary cancer risk
4. Opted out of research participation in EPIC
5. Have a personal history of cancer

Study Design

Enrollment

210 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Feasibility and Acceptability of Relational Agent Chatbot

Interventions

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.

Primary outcome measure

  • Proportion of Patients Completing the Hereditary Cancer Risk Assessment [ Time Frame: Up to 3 months from enrollment ]
  • Proportion of Patients Identified as High Risk [ Time Frame: Through study completion, an average of 12 months. ]

Central Contacts and Locations

Central contacts

Julie Chapman-Greene, PhD, MPH

732-865-3375chapmaje@cinj.rutgers.edu

Emily Heidt, MPH

732-235-8930ekh47@cinj.rutgers.edu

Locations

Rutgers, The State University of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Julie Chapman-Greene, PhD, MPH

732-865-3375chapmaje@cinj.rutgers.edu

Principal Investigator:

Anita Y Kinney, PhD, RN

More Information

Sponsor

Anita Y. Kinney, PhD, RN

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Keywords

  • Genetic Counseling
  • Genetic Testing
  • Primary Care Provider
  • High-risk patients in primary care settings
  • Genetic Education
  • Relational Agent
  • Chatbot

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Anita Y. Kinney, PhD, RN on 2025-11-25.