Genetic Testing Clinical Trial
Official 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.
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). 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) and MedStar Washington Cancer Institute (MWCI) in DC and 2) Rutgers' Cancer Institute of NJ (Rutgers CINJ New Brunswick and Rutgers CINJ 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 treatment or follow-up oncology care at one of the participating sites in the prior two 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03988504 -
Impact of Predictive Genetic Testing
|
||
Not yet recruiting |
NCT05159011 -
Access to Genetic Information Leveraging Innovative Technology (AGILITY)
|
N/A | |
Recruiting |
NCT02691689 -
Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions
|
N/A | |
Completed |
NCT04704193 -
Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes
|
N/A | |
Completed |
NCT05545254 -
Health-promoting Lifestyle in a Genetic Counseling Clinic
|
||
Recruiting |
NCT05348564 -
Comparing Direct vs Indirect Methods for Cascade Screening
|
N/A | |
Recruiting |
NCT05360095 -
Comparing Game Facilitated Interactivity to Genetic Counseling for Prenatal Screening Education
|
N/A | |
Active, not recruiting |
NCT03869515 -
Genetic Causes and Clinical Features of Childhood Interstitial Lung Diseases in China
|
||
Recruiting |
NCT04856696 -
Clinical Application of Non-invasive PGT-A
|
N/A | |
Recruiting |
NCT04481061 -
Engaging Adolescents in Decisions About Return of Genomic Research Results
|
N/A | |
Recruiting |
NCT04656028 -
Genetic Testing and Motivational Counseling for FH
|
N/A | |
Completed |
NCT02742116 -
Evaluation of the Implementation of Expanded Carrier Screening Before Pregnancy in Hong Kong
|
N/A | |
Recruiting |
NCT03396341 -
Responses to Genetic Risk Modifier Testing Among Women With BRCA1/2 Mutations
|
||
Active, not recruiting |
NCT04245176 -
Genetic Testing for All Breast Cancer Patients (GET FACTS)
|
N/A | |
Active, not recruiting |
NCT02665195 -
Prospective Registry of Multiplex Testing (PROMPT)
|
||
Recruiting |
NCT05225428 -
Video Education With Result Dependent dIsclosure
|
N/A | |
Active, not recruiting |
NCT05265624 -
The Moran AMD Genetic Testing Assessment Study
|
Phase 2 | |
Withdrawn |
NCT01663584 -
Multi-disease Carrier Screening Test Validation
|
N/A | |
Recruiting |
NCT05055700 -
Impact of a Mobile App on Pregnant Women's Prenatal Genetic Testing Decision-making
|
N/A |