Genetic Testing Clinical Trial
— PROPELOfficial title:
Personalized Oncology Promoting Equity for Black Lives
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. 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.
Status | Recruiting |
Enrollment | 428 |
Est. completion date | August 31, 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 18-80 years of age - 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 received treatment or follow-up oncology care at one of the participating sites in the prior two years. - Meet National Comprehensive Cancer Network criteria for germline GT - Able to read and speak in English. Exclusion Criteria: - Do not speak English - Unable to access the Internet - Have previously undergone germline genetic testing for hereditary cancer risk - Are unable to provide informed consent |
Country | Name | City | State |
---|---|---|---|
United States | Rutgers Cancer Institute | New Brunswick | New Jersey |
United States | Georgetown Lombardi Comprehensive Cancer Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Rutgers, The State University of New Jersey | Georgetown University, National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | 1-month survey |
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