Addressing Genomic Disparities in Cancer Survivors

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06073626
Status
Recruiting
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Conditions

  • Genetic Testing
  • Hereditary Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Relational agent (RA) / Chatbot — BEHAVIORAL
    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) — BEHAVIORAL
    Consists of clinical letter and recommendation for genetic testing for hereditary cancer risk among Black cancer survivors.

Study Details

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.

Key Dates

Start date
Jul 31, 2024
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
428 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

Uptake of Germline Genetic Testing [ Time Frame: 6-months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Georgetown Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007
Isabella Alvarez
[email protected]
Marc Schwartz, PhD (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer InstituteNew BrunswickNew Jersey08901
Erin Speiser, PhD, MA
[email protected]
Julie Chapman Greene, PhD, MPH
[email protected]

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By research site
Georgetown Lombardi Comprehensive Cancer Center· Washington D.C., DCRutgers Cancer Institute· New Brunswick, NJ

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