Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility and Acceptability of Relational Agent Chatbot | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relational Agent ( RA) Alex | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Through study completion, an average of 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 3 months from enrollment |
| Retention Rate of High-risk Participants at 1-Month |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Chapman-Greene, PhD, MPH | Contact | 732-865-3375 | chapmaje@cinj.rutgers.edu | |
| Emily Heidt, MPH | Contact | 732-235-8930 | ekh47@cinj.rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anita Y Kinney, PhD, RN | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers, The State University of New Jersey | Recruiting | New Brunswick | New Jersey | 08901 | United States |
Individual Participant Data will not be shared due to privacy concerns and to protect participants' confidentiality.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
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. |
| 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. | Through study completion, an average of 12 months. |
| D002241 |
| Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |