||5U01CA254832-02 Interpret this number
||Vanderbilt University Medical Center
||Improving Care After Inherited Cancer Testing (IMPACT) Study
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.
IMProving care After inherited Cancer Testing (IMPACT) study: protocol of a randomized trial evaluating the efficacy of two interventions designed to improve cancer risk management and family communication of genetic test results.
, Beckstead J.
, Farmer M.
, Hooker G.
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, Matloff E.
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, Whisenant J.G.
, et al.
BMC cancer, 2021-10-13; 21(1), p. 1099.