Optimization of Smoking Cessation Strategies in Community Cancer Programs for Newly Diagnosed Lung and Head and Neck Cancer Patients

This is a randomized trial with the goal of identifying an optimal, implementable smoking-cessation strategy for patients beginning definitive cancer treatment with lung or head and neck cancer. It is a unique study in its multicenter community-based setting designed to analyze the real limitations of cessation implementation. It is designed for Kentucky, using the Kentucky Clinical Trials Network. Kentucky citizens are plagued with the highest rates of smoking in the nation, and the highest death rates from smoking related cancers. Not only does cigarette smoking cause cancers of the lung, and head and neck, it also impairs cancer treatment efficacy. Smoking cessation strategies have been investigated and preliminarily explored in this population. Efficacy of these has not been defined in a community-based population. This project is not limited to the category of a cancer prevention study, but elevates smoking cessation to a specific therapeutic cancer intervention. Many retrospective studies have shown smoking during cancer treatment has been linked to poorer treatment outcomes and increased therapy morbidity. This trial has goal of identifying a treatment that can be safely and realistically incorporated into future clinical trials. Perhaps more important, the study’s focus is on developing the optimal implementation scheme for our own Kentucky citizens being treated in their hometown community cancer treatment centers. It provides significant value by ensuring that every patient enrolled will receive cessation therapy recommended by the U.S. Department of Health and Human Services in Treating Tobacco Use and Dependence: 2008 Update. Approximately eleven independent cancer treatment centers in Kentucky belonging to the Kentucky Clinical Trials Network will enroll subjects to this study. We propose to enroll subjects (N = 176) who smoke and have been newly diagnosed with lung and head and neck cancer, who are to undergo curative intent cancer treatment. We will use the innovative multiphase optimization strategy (MOST) framework to facilitate the development of a potent smoking cessation treatment package for this population. An efficient factorial experiment will test the efficacy of two key potential intervention components: level of counseling and type of drug therapy. We will compare conditions in which participants receive high intensity versus low intensity smoking cessation counseling, as well as conditions in which they are treated with nicotine replacement therapy (NRT), bupropion (Zyban), bupropion (Zyban) combined with NRT, or varenicline (Chantix). The randomized experiment will allow us to identify the most promising combination of counseling and drug therapy for smoking cessation among patients who smoking and have been recently diagnosed with lung and head and neck cancer. This project should define a feasible, implementable, efficacious smoking cessation strategy for these complicated Kentucky citizens. This would be quite useful in future studies of smoking cessation as a form of cancer therapy in a community setting to further analyze the effects of smoking on cancer treatment therapeutic efficacy. This project will develop critical experience and infrastructure that will place us in very competitive position for NIH funding of community based cessation trials in all smoking related cancers and other smoking related diseases that afflict our Kentucky citizens. Our realistic goal is to use this data to develop phase 3 clinical cancer trials conducted regionally through KCTN and for application to conduct nationally through NCI sponsored cancer oncology cooperative groups.