Project CARE: CAncer Risk Evaluation
ConditionPrimary Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAnita Y. Kinney, PhD, RN
About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Relational Agent ( RA) Alex
BehavioralThe 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.
Treatment groups
210 Participants
are divided into 1 treatment groupGroup A: Feasibility and Acceptability of Relational Agent ChatbotExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 3 months from enrollment2
Proportion of Patients Identified as High Risk
The percent of patients who completed the RA and are identified as high risk.
Time frame
Through study completion, an average of 12 months.Secondary outcomes
1
RA Engagement Rate
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.
Time frame
Up to 3 months from enrollment2
Retention Rate of High-risk Participants at 1-Month
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.
Time frame
1-month post high-risk identification3
Satisfaction with the Risk Assessment Feature of the Relational Agent
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.
Time frame
Through study completion, an average of 12 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Anita Y. Kinney, PhD, RN
Lead sponsor
Rutgers, The State University of New Jersey
Sponsor institution
Source ClinicalTrials.gov