Addressing Genomic Disparities in Cancer Survivors

NCT ID: NCT06073626

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 428 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2027-08-31

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.

Detailed Description

Research Design and Methods:

This study will employ a 2-arm parallel group randomized controlled trial to evaluate the efficacy of the RA intervention compared to EUC among 428 Black cancer survivors who meet the National Comprehensive Cancer Network's guidelines for genetic referral. Primary outcomes will be engagement with genetic education and uptake of genetic testing (Aim 1). The investigators will also evaluate the impact of the RA intervention on psychosocial and decision quality outcomes (Aim 2) and evaluate mediators and moderators of intervention impact (Aim 3). In response to patient identified needs, we will also explore the feasibility of incorporating a Family Sharing Portal (FSP). All participants who receive a positive test result will be input into the FSP (Aim 4).

Research Procedures:

The design for this study is a 2-arm parallel group trial. Randomization is at the patient level. The investigators will recruit eligible cancer survivors who will be randomized by computer to enhanced usual care (EUC) or RA. Randomization will be balanced in a 1:1 ratio - with 214 participants randomized to each arm. Because this study is designed to address the disparity of low genetic testing utilization in Black cancer patients, all study participants will be Black and approximately 10% will be Hispanic.

The investigators will utilize the EHRs at our participating sites to identify cancer survivors who have not been tested despite meeting GT eligibility criteria. Participants will be ascertained from 1) Georgetown Lombardi Comprehensive Cancer Center (LCCC), MedStar Washington Cancer Institute (MWCI) and MedStar Franklin Square Medical Center in DC and 2) Rutgers' Cancer Institute (in New Brunswick and at University Hospital Newark) including RWJ Barnabas Health community oncology sites. Participants will be women and men who self-identify as Black or African American, have a history of breast, ovarian, uterine, colorectal, prostate, or pancreatic cancer, are at least six-months post-diagnosis, and have received care at one of the participating sites in the prior five years. There is no limit on the years since diagnosis as genetic testing (GT) can guide treatment decisions and provide opportunities for cascade testing to guide screening and prevention in at-risk relatives.

Conditions

Hereditary Cancer; Genetic Testing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Relational agent (RA) / Chatbot

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care (EUC)

Intervention Type: BEHAVIORAL

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

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.

Intervention Type: BEHAVIORAL

Enhanced Usual Care (EUC)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Georgetown University

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Anita Y. Kinney, PhD, RN

Director at Rutgers Cancer Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anita Y Kinney, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Director at Rutgers Cancer Institute

Locations

Georgetown Lombardi Comprehensive Cancer Center

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

Site Status: RECRUITING

Rutgers Cancer Institute

New Brunswick, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erin Speiser, PhD, MA

Role: CONTACT

erin.speiser@rutgers.edu

732-675-1668

Julie Chapman Greene, PhD, MPH

Role: CONTACT

chapmaje@cinj.rutgers.edu

Facility Contacts

Lia Sorgen

Role: primary

lia.sorgen@georgetown.edu

Isabella Alvarez

Role: backup

ia507@georgetown.edu

Erin Speiser, PhD, MA

Role: primary

erin.speiser@rutgers.edu

Julie Chapman Greene, PhD, MPH

Role: backup

chapmaje@cinj.rutgers.edu

Other Identifiers

R01CA277599

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2022001513

Identifier Type: -

Identifier Source: org_study_id