DESCRIPTION (provided by applicant): About 60,000 individuals undergo surgery for lung cancer in the US annually. For these patients, whether, or not, cancer has spread to their lymph nodes is the main determinant of their prognosis and guides post- operative treatment decision-making. Unfortunately, most lung cancer operations done in the US do not provide a sufficient sample of lymph nodes to make an accurate determination of pathologic lymph node stage. Therefore, a larger number of patients die of lung cancer than would have been predicted by their post- operative stage. Examination of the quality of lung cancer surgical resections in the greater Memphis Metropolitan Area reveals close approximation to the US national quality-of-care gap. Deploying a specially designed lymph node specimen collection kit for use in lung cancer resections significantly improves the quality of pathologic lymph node staging and increases the detection of patients with lymph node metastasis. We now want to test the implementation of the routine use of this unique specimen collection kit in the tri-state area of Eastern Arkansas, Northern Mississippi and Western Tennessee, which has the combination of challenging socio-economic demographics and some of the highest lung cancer mortality rates in the US. Based on our prior work, we hypothesize that successful implementation of this surgical lymph node specimen collection kit will improve the quality of pathologic staging of lung cancer and increase the detection of lymph node metastasis in a diverse mix of patients operated on by a diverse mix of surgeons in a diverse mix of institutions. Our objective is to study the implementation process of routine use of this kit in a demographically diverse, high lung cancer incidence region of the US, in order to maximize its impact in future dissemination. We propose to achieve this by performing the following Specific Aims: 1.) Recruit at least 90% of eligible hospitals (those within our defined catchment area with >5 lung resection operations annually) and surgeons to participate in an implementation study of the lymph node specimen collection kit for lung cancer resections; 2.) Evaluate the effectiveness of the kit in surgery performed in a diverse mix of institutions, using a staggered implementation, multiple baseline study design; 3.) Study the implementation process using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. Our study will demonstrate the practical possibility of significantly improving the quality and outcomes of surgical lung cancer care across heterogeneity of practice settings. General improvement in pathologic staging will set the stage for future translational work on development of independently prognostic gene and protein expression profiles by optimizing the use of the Tumor, Node, and Metastasis (TNM) staging system, which is currently our best risk stratification system. The ultimate goal of this project i to provide the clinical infrastructure to support future studies of such prognostic molecular signatures that will supplement, and eventually supersede the current TNM staging system.
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