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NCT Number: NCT07130487

Project CARE: CAncer Risk Evaluation

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?

Recruiting

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Key information

Conditions

Primary Care

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers, The State University of New Jersey

New Brunswick, New Jersey, 08901, United States

Location status: Recruiting

Location contact

Anita Y Kinney, PhD, RN

PRINCIPAL_INVESTIGATOR

Julie Chapman-Greene, PhD, MPH

CONTACT

[email protected]

732-865-3375

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Relational Agent ( RA) Alex

Behavioral

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 outcomes

  1. Proportion of Patients Completing the Hereditary Cancer Risk Assessment

    Time frame: 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.

  2. Proportion of Patients Identified as High Risk

    Time frame: Through study completion, an average of 12 months.

    The percent of patients who completed the RA and are identified as high risk.

Secondary outcomes

  1. RA Engagement Rate

    Time frame: Up to 3 months from enrollment

    The number of patients invited to participate in the study who engaged with the RA link by clicking on the introductory response, divided by the total number of patients invited to the study, multiplied by 100.

  2. Retention Rate of High-risk Participants at 1-Month

    Time frame: 1-month post high-risk identification

    The number of high-risk participants who complete the 1-month follow-up survey divided by the number of high-risk participants, multiplied by 100.

  3. Satisfaction with the Risk Assessment Feature of the Relational Agent

    Time frame: Through study completion, an average of 12 months.

    Participant satisfaction will be assessed using a two-item questionnaire (Relational Agent Satisfaction Scale, adapted), with each item rated on a 1-5 scale (1 = very dissatisfied; 5 = very satisfied). Higher scores indicate greater satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Heidt, MPH

CONTACT

[email protected]

732-235-8930

Julie Chapman-Greene, PhD, MPH

CONTACT

[email protected]

732-865-3375

Sponsors and collaborators

Lead sponsor

Anita Y. Kinney, PhD, RN

Other

Registry information

Official study title

Project CARE: CAncer Risk Evaluation (CARE)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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