Project CARE: CAncer Risk Evaluation

NCT07130487 | Recruiting DMC

• 1 other identifier: Pro2024002233
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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. 1.What percent of patients who completed the RA are identified as high risk?
2. 2.What percent of patients who engaged with the risk assessment were identified as high risk?
3. 3.What percent of high-risk patients had genetic counseling or genetic testing within 4 months of completing the risk assessment?

Conditions

Primary Care

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients Completing the Hereditary Cancer Risk Assessment

  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.

  Up to 3 months from enrollment

• Proportion of Patients Identified as High Risk

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

  Through study completion, an average of 12 months.

Secondary Outcomes (3)

• 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.

Study Arms (1)

Feasibility and Acceptability of Relational Agent Chatbot

EXPERIMENTAL

Behavioral: Relational Agent ( RA) Alex

Interventions

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.

Feasibility and Acceptability of Relational Agent Chatbot

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Anita Y. Kinney, PhD, RN: lead

Study Sites (1)

Rutgers, The State University of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Interventions

Darbepoetin alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Anita Y Kinney, PhD, RN

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Chapman-Greene, PhD, MPH

CONTACT

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

Emily Heidt, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director at Rutgers Cancer Institute

Model Details: This single-arm study intervention is Alex , a proactive digital relational agent developed through community participatory research and user-centered design. It provides interactive, literacy-conscious content that simulates traditional hereditary cancer risk assessment. High-risk patients, once identified, receive genetic education and counseling (GC), enabling direct access to genetic testing (GT) after engaging with the platform. Alex is HIPAA-compliant and aligned with NCCN guidelines. The chatbot evaluates patient-reported personal and family history to determine hereditary cancer GT eligibility. Its clinical content was designed by ABGC-certified genetic counselors (with expertise in hereditary cancer syndromes), behavioral scientists, and an epidemiologist.

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 19, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)