Recruiting

Observational Study

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT06073626

Conditions

Hereditary Cancer

Genetic Testing

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Relational agent (RA) / Chatbot

Enhanced Usual Care (EUC)

Study Details

Brief summary:

The goal of this observational study is to increase genetic education and genetic testing for hereditary cancer risk among Black cancer survivors. The study will:

1. Test the effectiveness of a chatbot intervention (also called relational agent, or RA) vs. enhanced usual care (EUC) on engagement in genetic education and requests for genetic testing.
2. Evaluate the impact of the chatbot vs. EUC on the process that participants use to make decisions and evaluate effects on well-being (also called psychosocial outcomes).
3. Explore the ways (methods) that influence how participants experience the intervention.
4. Explore the feasibility of incorporating a Family Sharing Portal (FSP) for participants who receive a positive test result, to facilitate family communication of these test results and genetic testing of first-degree biological relatives after they have received genetic education by the RA.

The main questions this study aims to answer are which group - the chatbot (RA) group or the EUC group - is more likely to request genetic testing and which group is more likely to get (engage with) genetic education.

Participants will be randomly assigned to either the chatbot (RA) group or EUC group. This means each participant has an equal chance of being placed in either group, just like flipping a coin. Each group will receive genetic education and have an opportunity to request genetic testing. Researchers will compare the chatbot (RA) group and the EUC group to see which may request more GT (genetic testing) and which group engages more with genetic education.

Conditions

Hereditary Cancer

Genetic Testing

Study ID

NCT06073626

Start date

Jul 31, 2024

Status verified date

Oct, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18-80 years of age
  • Self-identify as Black or African American
  • At least 6-months post diagnosis with any of the following cancers: breast, ovarian, uterine, prostate, colorectal, pancreatic
  • Have not had genetic testing for hereditary cancer
  • Have received care at one of the participating sites in the prior five years
  • Meet National Comprehensive Cancer Network criteria for germline GT
  • Able to read and speak in English
  • Capable of providing informed consent
  • Have internet access (via smartphone, tablet or computer)
  • Comfortable using a computer or mobile phone independently to access information

Exclusion Criteria:

  • Do not speak English
  • Unable to access the Internet
  • Have previously undergone germline genetic testing for hereditary cancer risk or previously had genetic counseling (GC) and declined genetic testing (GT)
  • Are unable to provide informed consent

Study Design

Enrollment

428 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Relational Agent (RA)

Participants in the RA arm will receive a clinical letter from the institution's clinical genetics program with a link to the RA. The fully HIPAA-compliant RA will provide comparable educational information to traditional genetic counseling (GC) but in a streamlined and tailored manner including video, education and decision support, patient testimonial and answers to questions in real-time. Participants will be informed that they may speak to a genetic risk specialist free of charge. For participants who wish to proceed directly to GT, the RA will alert staff to these requests and a GT kit will be mailed to them. Results will be shared with the participant, their oncologist and tailored per the result. Participants who indicate that they are unsure or do not want GT will be encouraged by RA to discuss their risk and GT options with their oncology provider and to schedule a GC appointment with the clinic.

active comparator: Enhanced Usual Care (EUC)

Participants in the EUC arm will also be mailed a clinical letter signed by the Medical Director of the institution's clinical genetics program. The letter sent to EUC participants will inform them of their own and their family's potential risk for carrying a pathogenic variant (PV) related to hereditary cancer. The letter will emphasize their eligibility for GT, include a recommendation to consider scheduling a GC appointment to obtain more information, and include a link to the Rutgers Cancer Institute or LCCC high-risk clinic website. The study team will help facilitate GT when requested by the participant. Results will be shared with the participant, their oncologist and tailored per the result.

Interventions

Relational agent (RA) / Chatbot

Consists of clinical letter and engagement with genetic education and uptake of genetic testing for hereditary cancer risk among Black cancer survivors.

Enhanced Usual Care (EUC)

Consists of clinical letter and recommendation for genetic testing for hereditary cancer risk among Black cancer survivors.

Primary outcome measure

  • Uptake of Germline Genetic Testing [ Time Frame: 6-months ]
  • Survey Assessment of Impact of RA vs. EUC [ Time Frame: 1-month and 6-month survey ]
  • Survey Assessment of Mediators and Moderators of Efficacy [ Time Frame: Baseline, 1-month and 6-month surveys ]

Central Contacts and Locations

Central contacts

Erin Speiser, PhD, MA

732-675-1668erin.speiser@rutgers.edu

Julie Chapman Greene, PhD, MPH

chapmaje@cinj.rutgers.edu

Locations

Georgetown Lombardi Comprehensive Cancer Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Lia Sorgen

lia.sorgen@georgetown.edu

Isabella Alvarez

ia507@georgetown.edu

Principal Investigator:

Marc Schwartz, PhD

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Erin Speiser, PhD, MA

erin.speiser@rutgers.edu

Julie Chapman Greene, PhD, MPH

chapmaje@cinj.rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Keywords

  • hereditary cancer
  • genetic testing
  • genetic education
  • relational agent
  • chatbot

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-10-28.