The overall goal of this proposal is to facilitate Dr. Theodore Brasky?s development into an established and independent investigator for tobacco control. For this research, he will focus on cancer patients and the impact of electronic cigarettes (e-cigs) on cigarette smoking, quitting, and health outcomes. It is established that cigarette smoking adversely affects the cancer patient in many ways. E-cigs have the potential to reduce cigarette smoke exposures, related toxicities, and foster smoking cessation. However, almost no research exists to substantiate this hypothesis. Dr. Brasky is a cancer epidemiologist and member of the Ohio State University Comprehensive Cancer Center (OSUCCC) with considerable expertise in the analysis and interpretation of longitudinal data. Due to a strong institutional environment, he has been participating in various tobacco-focused research projects over the past 2 years. Excited by this, he wants to take advantage of the extraordinary opportunities in tobacco control related to e-cigs. The proposed training plan will enable him to obtain expertise and experience in tobacco research (e.g., coursework in tobacco regulatory science), intervention studies (e.g., coursework in clinical research methods and translational behavioral research), and primary data collection in complementary studies. This training will capitalize on the exceptional institutional environment at OSU and a mentoring team of experts in tobacco control led by Dr. Peter Shields, Deputy Director of the OSUCCC, and Dr. Mary Ellen Wewers, Professor of Health Behavior and Health Promotion at the OSU College of Public Health. Dr. Shields and Dr. Wewers are Multiple Principal Investigators of OSU?s NCI-funded P50 Tobacco Center of Regulatory Science. Herein, Dr. Brasky will address critical research gaps that will aid in the understanding for the impact of e-cigs on the cancer patient generally, and specifically for the creation of sound policy decisions by the Food and Drug Administration. This application will address the smoking lung cancer patient who will be assessed for cigarette and e-cig use in relation to uptake, smoking reduction, quitting, quality of life, and treatment toxicities.
The Specific Aims are: 1) to establish an observational cohort of 300 lung cancer patients and examine the associations of e-cigs with smoking reduction, smoking cessation, quality of life, and treatment toxicities; and 2) to establish a pilot randomized trial of a newly-developed research e-cig versus nicotine replacement therapy (standard of care) in 30 stage I-IIIA lung cancer patients planning to undergo surgical resection in order to foster adherence to recommendations and reduce surgical complications. This pilot study will leverage newly-implemented National Cancer Center Network guidelines for smoking cessation at the OSUCCC, and a new e-cig research device provided by the National Institute on Drug Abuse. These complementary experimental and ?real world? observational studies will be the first to examine associations in lung cancer patients and will share assessment measures. Results from this research will yield critical data in order to provide sound and evidence-based decisions on e-cigs.
Electronic cigarettes are increasingly used in cancer patients and despite marketing that suggests a health benefit, almost no data exist to corroborate such claims. This K07 will provide strong career development training in tobacco control, intervention study design and analysis, and primary data collection through didactic coursework and hands-on experiences. This training will support the implementation, analysis, and interpretation of the proposed research aims of examining in lung cancer patients the associations of electronic cigarette use with combustible cigarette smoking reduction and cessation, as well as for quality of life and treatment toxicities, using complementary study designs and shared assessment measures.
