In this Phase II project Imbio proposes to analyze the National Lung Screening Trial (NLST) data to better characterize the relationship between Imbio's quantitative measures of CT-detected emphysema and health risks to inform the Comparative and Outcomes sections of the Imbio Smoking Cessation Report (Report) designed in Phase I; to incorporate the Report effectively into a proven smoking cessation telephone counseling methodology; and, to clinically validate the impact of the Report on high-risk smokers' smoking behaviors in the context of a lung cancer screening program Cigarette smoking is the leading preventable cause of premature disease and death in the United States[1]. Cigarette smoking affects nearly every organ of the body [1] with cigarette smokers more likely than nonsmokers to develop respiratory and pulmonary diseases, lung and other cancers, and cardiovascular disease [1]. The total economic cost due to tobacco in the U.S. is over $289 billion a year, which includes at least $133 billion in direct medical care [1]. The Report based on the Health Belief Model [38] includes five sections: 1) Image Section, visual feedback and quantitative results based on the LDA, 2) Comparative Section, mapping of the patient's lung status to a corresponding cohort of participants, 3) Health Outcomes Section, information about the long-term health outcomes for the associated participant cohort, 4) Quit Now section, benefits of making a quit attempt, and 5) Outreach section, contact information for smoking cessation support. LDA is a CT image processing application that quantifies the extent of tissue damage in patients. Specifically, LDA is compatible with recommended lung cancer screening protocols, and offers a scalable, cost-effective solution for centers ranging from minimal to significant patient volume. A randomized controlled trial will be conducted to clinically validate the Report's impact on: (a) Lung screening participants' motivation to make a quit attempt by calling a Quitline, and (b) the effectiveness of a 45- minute telephone smoking cessation counseling session for motivating an actual quit attempt and abstinence. It is hypothesized that incorporation of the Imbio Report into lung cancer screening can improve a patient's readiness to quit, motivation to make a quit attempt, and increase their use of a Smoking Cessation Quitline and/or other smoking cessation resources including medications. More specifically, it is hypothesized that incorporation of the Imbio report into smoking cessation counseling can improve the effectiveness of the behavioral intervention. The Imbio Smoking Cessation Report will be the only smoking cessation product in the market providing truly personalized information and comparative detail.
The goal of this project is to create markers for health outcomes to refine the Imbio Smoking Cessation Report (Report) designed in Phase I, establish a telephone smoking cessation protocol incorporating the Report, and clinically validate the impact of the Report on smokers enrolled in a lung cancer screening program. The resulting Report will be the only smoking cessation product in the market providing truly personalized information and comparative detail.
