Project CARE: CAncer Risk Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-19

Study Completion Date

2026-11-30

Brief Summary

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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?

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Detailed Description

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Conditions

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Primary Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Feasibility and Acceptability of Relational Agent Chatbot

Group Type EXPERIMENTAL

Relational Agent ( RA) Alex

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes