Project CARE: CAncer Risk Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Relational Agent ( RA) Alex.
- Who it may be relevant to
- Registry conditions: Primary Care. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Project CARE: CAncer Risk Evaluation (CARE)
Overview
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?
Interventions
- Behavioral 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
Primary outcome measures
- 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.]
Secondary outcome measures (3)
- RA Engagement Rate [Time frame: Up to 3 months from enrollment]
- Retention Rate of High-risk Participants at 1-Month [Time frame: 1-month post high-risk identification]
- Satisfaction with the Risk Assessment Feature of the Relational Agent [Time frame: Through study completion, an average of 12 months.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Rutgers, The State University of New Jersey — New Brunswick
Identifiers
NCT: NCT07130487 · Pro2024002233