Project CARE: CAncer Risk Evaluation (NCT07130487) | Clinical Trial Compass
RecruitingNot Applicable
Project CARE: CAncer Risk Evaluation
United States210 participantsStarted 2025-11-19
Plain-language 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?
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Patients Completing the Hereditary Cancer Risk Assessment
Timeframe: Up to 3 months from enrollment
2
Proportion of Patients Identified as High Risk
Timeframe: Through study completion, an average of 12 months.