Addressing Genomic Disparities in Cancer Survivors
2 other identifiers
interventional
428
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedStudy Start
First participant enrolled
July 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
October 28, 2025
October 1, 2025
2.3 years
September 14, 2023
October 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Uptake of Germline Genetic Testing
As captured via internal RedCap form for the number or count of participants who opt for genetic testing, the investigators will test the efficacy of a culturally tailored and interactive electronic relational agent (RA) intervention vs. enhanced usual care (EUC) consisting of clinical letter and genetic recommendation on engagement in genetic testing uptake;
6-months
Survey Assessment of Impact of RA vs. EUC
Evaluate the impact of the RA vs. EUC on informed decision-making and psychosocial outcomes via survey measures of related constructs at 1-month and 6-month surveys. Multiple scales are used to measure this outcome and each scale has a unique scoring system.
1-month and 6-month survey
Survey Assessment of Mediators and Moderators of Efficacy
Explore potential mechanisms by assessing mediators and moderators of efficacy via survey measures of related constructs at baseline, 1-month and 6-month surveys. Multiple scales are used to measure this outcome and each scale has a unique scoring system.
Baseline, 1-month and 6-month surveys
Secondary Outcomes (1)
Survey Assessment of Engagement with Genetic Education
1-month survey
Study Arms (2)
Relational Agent (RA)
EXPERIMENTALParticipants 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.
Enhanced Usual Care (EUC)
ACTIVE COMPARATORParticipants 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
Consists of clinical letter and engagement with genetic education and uptake of genetic testing for hereditary cancer risk among Black cancer survivors.
Consists of clinical letter and recommendation for genetic testing for hereditary cancer risk among Black cancer survivors.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rutgers, The State University of New Jerseylead
- Georgetown Universitycollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901, United States
Related Publications (1)
An J, Huq M, Speiser E, Grumet S, Peshkin BN, Heidt E, Adams-Campbell L, Grisham C, Tundealao S, Yesha R, Toppmeyer D, Isaacs C, Sorgen L, Tan N, Hooda-Nehra A, Nix MA, Reed DJ, Staton J, Schwartz MD, Kinney AY. 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. Contemp Clin Trials. 2026 Jan 17:108217. doi: 10.1016/j.cct.2026.108217. Online ahead of print.
PMID: 41554333DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Anita Y Kinney, PhD, RN
Director at Rutgers Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Treating clinicians will be blind their patients group assignment. While participants cannot be blinded to group, they will be blinded to the study's specific hypotheses. Statisticians and outcome assessors will be blinded to allocation.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director at Rutgers Cancer Institute
Study Record Dates
First Submitted
September 14, 2023
First Posted
October 10, 2023
Study Start
July 31, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
October 28, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share