Cancer Health Assessments Reaching Many (CHARM): A clinical trial assessing a multimodal cancer genetics services delivery program and its impact on diverse populations

https://doi.org/10.1016/j.cct.2021.106432Get rights and content
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Abstract

Advances in the application of genomic technologies in clinical care have the potential to increase existing healthcare disparities. Studies have consistently shown that only a fraction of eligible patients with a family history of cancer receive recommended cancer genetic counseling and subsequent genetic testing. Care delivery models using pre-test and post-test counseling are not scalable, which contributes to barriers in accessing genetics services. These barriers are even more pronounced for patients in historically underserved populations. We have designed a multimodal intervention to improve subsequent cancer surveillance, by improving the identification of patients at risk for familial cancer syndromes, reducing barriers to genetic counseling/testing, and increasing patient understanding of complex genetic results. We are evaluating this intervention in two large, integrated healthcare systems that serve diverse patient populations (NCT03426878). The primary outcome is the number of diagnostic (hereditary cancer syndrome) findings. We are examining the clinical and personal utility of streamlined pathways to genetic testing using electronic medical record data, surveys, and qualitative interviews. We will assess downstream care utilization of individuals receiving usual clinical care vs. genetic testing through the study. We will evaluate the impacts of a literacy-focused genetic counseling approach versus usual care genetic counseling on care utilization and participant understanding, satisfaction, and family communication. By recruiting participants belonging to historically underserved populations, this study is uniquely positioned to evaluate the potential of a novel genetics care delivery program to reduce care disparities.

Keywords

Genetics
Genetic counseling
Hereditary cancer
Family history
Underserved populations

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1

These authors contributed equally.

2

Collaborators: Jake Allen, Frank Angelo, Briana L. Arnold, Cecelia Bellcross, David P. Bui, Mikaella Caruncho, Phillip Crain, Michael Dauer, James V. Davis, Sonia Deutsch, Beth Devine, Amanda S. Freed, Inga Gruss, Claudia Guerra, Boya Guo, He Guo, Cindy Hernandez, Joan Holup, Chalinya L. Ingphakorn, Paige Jackson, Charisma L. Jenkins, Leah S. Karliner, Erin Keast, Sarah Knerr, Alyssa H. Koomas, Mi H. Lee, Robin Lee, Hannah S. Lewis, Jennifer Livaudais-Toman, Frances Lynch, Lena Mathew, Elizabeth Medina, Carmit McMullen, Deborah A. Nickerson, Angela R. Paolucci, Anh Pham, Daniela Ramos, Alexander Rangel-Humphrey, Chelese L. Ransom, Ana Reyes, Sperry Robinson, Rosse Rodriguez Perez, Emily Schield, Jennifer L. Schneider, Kelly J. Shipman, Elizabeth Shuster, Sapna Syngal, Britta N. Torgrimson-Ojerio, Chinedu Ukaegbu, Meredith L. Vandermeer, David L. Veenstra, Chris Whitebirch.