Primary CareNCT07130487
Project CARE: CAncer Risk Evaluation
A study testing Relational Agent ( RA) Alex in people with Primary Care, run by Anita Y. Kinney, PhD, RN at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Care
- What is being tested?
- Relational Agent ( RA) Alex
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers, The State University of New Jersey
New Brunswick, New Jersey, 08901
Julie Chapman-Greene, PhD, MPH, 732-865-3375, chapmaje@cinj.rutgers.edu
Anita Y Kinney, PhD, RN
About this study
Official title: Project CARE: CAncer Risk Evaluation (CARE)
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:
- What percent of patients who completed the RA are identified as high risk?
- What percent of patients who engaged with the risk assessment were identified as high risk?
- What percent of high-risk patients had genetic counseling or genetic testing within 4 months of completing the risk assessment?
- Conditions
- Primary Care
- Being tested
- Relational Agent ( RA) Alex
- Keywords
- Genetic Counseling, Genetic Testing, Primary Care Provider, High-risk patients in primary care settings, Genetic Education, Relational Agent, Chatbot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relational Agent ( RA) AlexBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility and Acceptability of Relational Agent Chatbot | Experimental | Not described Receives: Behavioral: Relational Agent ( RA) Alex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 12 months.
Secondary outcomes (3)
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.
Measured: Up to 3 months from enrollment
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.
Measured: 1-month post high-risk identification
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.
Measured: Through study completion, an average of 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start19 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anita Y. Kinney, PhD, RN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anita Y. Kinney, PhD, RN, Rutgers, The State University of New Jersey
- Investigators
- Anita Y Kinney, PhD, RN, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130487
- Sponsor's protocol ID
- Pro2024002233
- Status last verified
- Nov 2025
- First submitted
- 31 Jul 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared due to privacy concerns and to protect participants' confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project CARE: CAncer Risk Evaluation (CARE)
- ClinicalTrials.gov ID
- NCT07130487
- Acronym / sponsor ID
- Pro2024002233
- Conditions
- Primary Care
- Keywords
- Genetic Counseling, Genetic Testing, Primary Care Provider, High-risk patients in primary care settings, Genetic Education, Relational Agent, Chatbot
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Anita Y. Kinney, PhD, RNUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What percent of patients who completed the RA are identified as high risk?
- What percent of patients who engaged with the risk assessment were identified as high risk?
- What percent of high-risk patients had genetic counseling or genetic testing within 4 months of completing the risk assessment?
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Feasibility and Acceptability of Relational Agent Chatbot | Experimental | Behavioral: Relational Agent ( RA) Alex |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relational Agent ( RA) AlexThe 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. | Behavioural | Feasibility and Acceptability of Relational Agent Chatbot |
Primary outcome
Proportion of Patients Completing the Hereditary Cancer Risk Assessment
Time frame: Up to 3 months from enrollment
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.
Proportion of Patients Identified as High Risk
Time frame: Through study completion, an average of 12 months.
The percent of patients who completed the RA and are identified as high risk.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared due to privacy concerns and to protect participants' confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anita Y Kinney, PhD, RN principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relational Agent ( RA) Alex in people with Primary Care, run by Anita Y. Kinney, PhD, RN at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Chapman-Greene, PhD, MPH (732-865-3375, chapmaje@cinj.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Completing the Hereditary Cancer Risk Assessment (time frame: Up to 3 months from enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.