Expanding access to cancer genetic care for cancer survivors: Rationale and design for a randomized controlled trial of a chatbot-based genetic education and testing.
Jinghua An, Maisha Huq, Erin Speiser...
https://pubmed.ncbi.nlm.nih.gov/41554333Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06073626
Addressing Genomic Disparities in Cancer Survivors
Led by Rutgers, The State University of New Jersey · Updated on 2025-10-28
428
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
Sponsors
R
Rutgers, The State University of New Jersey
Lead Sponsor
G
Georgetown University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to improve genetic education and testing for hereditary cancer risk among Black cancer survivors. It compares a chatbot intervention called a relational agent (RA) to enhanced usual care (EUC) to see which approach better encourages genetic education engagement and testing requests. The study also looks at how these methods affect decision-making processes and psychosocial well-being, and explores ways to support family communication of positive genetic test results through a Family Sharing Portal (FSP). Participants will be randomly assigned to one of two groups: the RA group or the EUC group. The RA group receives a clinical letter and access to the chatbot, which offers tailored genetic education, videos, decision support, and real-time answers, with options to request genetic testing directly through the chatbot. The EUC group receives a clinical letter recommending genetic testing and counseling, with access to clinic websites and support for testing requests. Both groups will have genetic testing results shared with them and their oncologists, with follow-up care tailored accordingly. During the study, participants will complete surveys at baseline, 1 month, and 6 months to assess engagement with genetic education, uptake of genetic testing, decision quality, and psychosocial outcomes. Researchers will monitor how participants use the interventions and their experiences. The study includes adults aged 18 to 80 who self-identify as Black or African American cancer survivors meeting specific criteria. Participation involves online access and comfort with digital tools. The study will last through August 2027, with ongoing data collection and analysis.
CONDITIONS
Brief Title
Addressing Genomic Disparities in Cancer Survivors
Who Can Participate
Age: 18Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 18 to 80 years of age
- Self-identify as Black or African American
- At least 6 months post diagnosis with breast, ovarian, uterine, prostate, colorectal, or pancreatic cancer
- Have not had genetic testing for hereditary cancer
- Received care at one of the participating sites within the last 5 years
- Meet National Comprehensive Cancer Network criteria for germline genetic testing
- Able to read and speak English
- Able to provide informed consent
- Have internet access via smartphone, tablet, or computer
- Comfortable using a computer or mobile phone independently to access information
You will not qualify if you...
- Do not speak English
- Unable to access the internet
- Previously had germline genetic testing for hereditary cancer risk or genetic counseling and declined testing
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Outpatient Treatment
Duration - Up to 6 months
Participants receive either the Relational Agent (RA) intervention, which includes engagement with genetic education, decision support, and access to genetic testing, or Enhanced Usual Care (EUC) involving a clinical letter and recommendation for genetic testing. Participants may interact with the RA or follow usual care pathways to consider genetic testing.
Surveys at baseline, 1 month, and 6 months; genetic testing if requested
Trial Site Locations
Total: 2 locations
1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
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Research Team
E
Erin Speiser, PhD, MA
J
Julie Chapman Greene, PhD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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