Grant Number:	5U01CA254832-05 Interpret this number
Primary Investigator:	Pal, Tuya
Organization:	Vanderbilt University Medical Center
Project Title:	Improving Care After Inherited Cancer Testing (IMPACT) Study
Fiscal Year:	2024

IMPACT Abstract Despite the tremendous advances in genetic testing for inherited cancer, the promise of this technology cannot be realized through testing alone. Rather, it is critical to access appropriate follow-up care that may include cancer risk management (CRM) options for individuals and their at-risk family members. Current gaps in implementation of guideline-adherent follow-up care based on inherited cancer genetic test results include both over and under treatment among those with pathogenic and likely pathogenic (P/LP) variants or a variant of uncertain significance (VUS). Furthermore, we are missing the opportunity to magnify the uptake and impact of testing among family members who are at high risk due to suboptimal family communication (FC) of genetic test results and cancer family history. Our highly innovative and practice-changing study is designed to shift the paradigm by which individuals with P/LP variants and VUS in inherited cancer genes are provided with information to enhance guideline-adherent CRM and FC of test results. Through our proposed type I effectiveness-implementation hybrid randomized control mixed methods study, we will test two interventions with a diverse group of 600 individuals with a P/LP variant or a VUS result in a variety of inherited cancer genes for which CRM guidelines are available. Intervention A is focused on increasing guideline- adherent CRM (LivingLabReport), and Intervention B is focused on increasing FC and subsequent family testing (GeneSHARE). Alongside developing, refining, and testing interventions to improve guideline-adherent CRM and FC, we will study the implementation of these interventions across racially, geographically, and socio- economically diverse populations and settings. The information gathered through testing effectiveness and implementation of the interventions will be used to develop, modify and pilot test adaptive stepped interventions with the potential to efficiently maximize effectiveness in improving guideline-adherent CRM and FC. This transdisciplinary effort, enriched for accrual of Blacks, rural dwellers, and other underserved populations, will inform policy and the development of scalable models for delivering evidence-based care. Ultimately, our study will help address the need for access to effective information to guide CRM and enhance FC in diverse populations across various genes and settings which is greatly needed if the population at large is to benefit from genomic advances in this era of personalized medicine.




The Development and Evaluation of Novel Patient Educational Material for a Variant of Uncertain Significance (VUS) Result in Hereditary Cancer Genes.
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