Addressing Genomic Disparities in Cancer Survivors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRutgers, The State University of New Jersey

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

428 Participants
are divided into 2 treatment groups
Group A: Relational Agent (RA)Experimental treatment 1 intervention
Group B: Enhanced Usual Care (EUC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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;

Time frame
6-months
2

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.

Time frame
1-month and 6-month survey
3

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.

Time frame
Baseline, 1-month and 6-month surveys

Secondary outcomes

1

Survey Assessment of Engagement with Genetic Education

Engagement with genetic education/counseling via survey measures of related constructs at 1-month survey. Multiple scales are used to measure this outcome and each scale has a unique scoring system.

Time frame
1-month survey

Other outcomes

Sponsors and contacts

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Rutgers, The State University of New Jersey

Lead sponsor

Georgetown University

Collaborator

National Cancer Institute (NCI)

Collaborator