Electronic cigarette use in lung cancer patients

项目摘要/摘要 这项提议的总体目标是促进西奥多·布拉斯基博士发展成为一名成熟的 烟草控制的独立调查员。对于这项研究，他将重点关注癌症患者及其影响 电子烟(e-cig)对吸烟、戒烟和健康后果的影响。现已确定 吸烟在许多方面对癌症患者都有不利影响。电子烟有可能减少 香烟烟雾暴露、相关毒性和促进戒烟。然而，几乎没有研究 证实这一假说的存在。布拉斯基博士是癌症流行病学家，俄亥俄州议员 大学综合癌症中心(OSUCCC)，在分析和分析方面拥有丰富的专业知识 纵向资料解释。由于强大的制度环境，他一直在参与 在过去的两年里，各种以烟草为重点的研究项目。对此感到兴奋的是，他想利用 与电子烟有关的烟草控制方面的非凡机遇。拟议的培训计划将使 他需要获得烟草研究方面的专门知识和经验(例如，烟草监管科学的课程)， 干预研究(例如，临床研究方法和翻译行为研究的课程)，以及 补充研究中的主要数据收集。这项培训将利用特殊的机构 俄亥俄州立大学的环境和由彼得·希尔兹博士领导的烟草控制专家指导小组， OSUCCC主任和健康行为与健康促进教授Mary Ellen Wewers博士 俄亥俄州立大学公共卫生学院。希尔兹博士和威尔斯博士是俄亥俄州立大学的多名首席研究员 NCI资助的P50烟草管制科学中心。在这里，布拉斯基博士将解决关键的研究空白 这将有助于了解电子烟对癌症患者的总体影响，特别是对 食品和药物管理局制定合理的政策决定。这个应用程序将解决 吸烟的肺癌患者将接受与吸烟、吸烟有关的香烟和电子烟使用情况的评估 减少、戒烟、生活质量和治疗毒性。具体目标是：1)建立一个 300例肺癌患者的观察队列及电子烟与吸烟的关系 减少吸烟、戒烟、生活质量和治疗毒性；以及2)建立一项试点随机试验 一项新开发的电子烟与尼古丁替代疗法(标准护理)在30期I-IIIA中的对比研究 计划接受手术切除的肺癌患者，以促进对建议的遵守 并减少手术并发症。这项试点研究将利用新实施的国家癌症中心 OSUCCC的戒烟网络指南，以及由 国家药物滥用研究所。这些相辅相成的实验和“真实世界”观测研究 将首先检查肺癌患者的相关性，并将分享评估措施。结果 这项研究将产生关键数据，以便提供关于电子烟的可靠和有证据的决策。

PROJECT SUMMARY/ABSTRACT 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.