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Grant Details

Grant Number: 5R01CA140377-05 Interpret this number
Primary Investigator: Goddard, Katrina
Organization: Kaiser Foundation Research Institute
Project Title: Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting
Fiscal Year: 2015
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Abstract

DESCRIPTION (provided by applicant): Screening tests for Hereditary Non-Polyposis Colorectal Cancer (HNPCC) [also called Lynch Syndrome], are among the few available validated genetic tests that have been recommended as an evidence-based practice that can save lives. However, more than half of patients who meet well-established and accepted screening criteria do not receive screening. This is a critical failure for patients and for the health-care delivery system because HNPCC mutation carriers are at exceptionally high risk for colorectal and other HNPCC-related cancers, and because clinical strategies can prevent future cancers, or provide early detection, for individuals affected with HNPCC and their relatives. HNPCC testing is also cost-effective compared to treating individuals with a diagnosis of colorectal cancer (CRC). To address this shortfall in practice, our proposed research mobilizes the resources of an integrated health- delivery system with extensive electronic clinical data to implement and evaluate a new strategy to maximize screening of CRC patients for HPNCC. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) working group recommended that all newly diagnosed CRC patients be screened for HPNCC, but was not able to recommend a best-strategy to accomplish this aim. Therefore, using the Practical Robust Implementation and Sustainability Model (PRISM), developed by one of our co-investigators, to guide the analyses, we will: Aim #1: Conduct a randomized controlled trial to determine the effectiveness of a universal laboratory test- based HNPCC screening program compared to the current practice of physician referral and self-referral. Aim #2: Elucidate patient, provider, and system factors important to success of implementation. Aim #3: Create, refine, and disseminate an implementation guide for HNPCC screening including informant interviews of key staff at seven future diverse dissemination-implementation sites. This study aims to evaluate implementation of a novel HNPCC screening program and assess, for all stakeholders, facilitators and barriers to program implementation and success. Results from this study will help achieve the Healthy People 2020 objective of reducing CRC mortality. It will add to the growing literature in the increasingly important area of translating research findings into real-world practice, a subject of the NIH Roadmap. Many of the findings will be useful in other clinical areas and will be broadly applicable to other health care organizations aiming to improve access to genetic tests for cancers.

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Publications

Implementation of a Systematic Tumor Screening Program for Lynch Syndrome in an Integrated Health Care Setting.
Authors: Clarke E.V. , Muessig K.R. , Zepp J. , Hunter J.E. , Syngal S. , Acheson L.S. , Wiesner G.L. , Peterson S.K. , Bergen K.M. , Shuster E. , et al. .
Source: Familial cancer, 2019 07; 18(3), p. 317-325.
PMID: 30729418
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Universal screening for Lynch syndrome among patients with colorectal cancer: patient perspectives on screening and sharing results with at-risk relatives.
Authors: Hunter J.E. , Arnold K.A. , Cook J.E. , Zepp J. , Gilmore M.J. , Rope A.F. , Davis J.V. , Bergen K.M. , Esterberg E. , Muessig K.R. , et al. .
Source: Familial cancer, 2017 07; 16(3), p. 377-387.
PMID: 28176204
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Stakeholder perspectives on implementing a universal Lynch syndrome screening program: a qualitative study of early barriers and facilitators.
Authors: Schneider J.L. , Davis J. , Kauffman T.L. , Reiss J.A. , McGinley C. , Arnold K. , Zepp J. , Gilmore M. , Muessig K.R. , Syngal S. , et al. .
Source: Genetics in medicine : official journal of the American College of Medical Genetics, 2016 Feb; 18(2), p. 152-61.
EPub date: 2015-04-16.
PMID: 25880440
Related Citations

Universal tumor screening for Lynch syndrome: Assessment of the perspectives of patients with colorectal cancer regarding benefits and barriers.
Authors: Hunter J.E. , Zepp J.M. , Gilmore M.J. , Davis J.V. , Esterberg E.J. , Muessig K.R. , Peterson S.K. , Syngal S. , Acheson L.S. , Wiesner G.L. , et al. .
Source: Cancer, 2015-09-15; 121(18), p. 3281-9.
EPub date: 2015-06-02.
PMID: 26036338
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Systematic review of the predictive effect of MSI status in colorectal cancer patients undergoing 5FU-based chemotherapy.
Authors: Webber E.M. , Kauffman T.L. , O'Connor E. , Goddard K.A. .
Source: BMC cancer, 2015-03-21; 15, p. 156.
EPub date: 2015-03-21.
PMID: 25884995
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