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Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes

Primary objective To determine if varenicline plus a behavioral intervention consisting of a brief clinician-delivered intervention and tobacco quitline follow-up, decreases postsurgical complications through 24 weeks after surgery when compared to placebo plus the behavioral intervention in lung cancer patients who undergo surgery and are motivated to stop smoking. Secondary objectives To compare changes from baseline to 12 and 24 weeks after surgery in the patient quality of life (LASA-12) domains between the intervention (varenicline) and control group (placebo). To compare changes from baseline to 6, 12 and 24 weeks after surgery in the patient quality of life related domains (LASA) for the PHQ-9 and SEQ12 between the intervention and control groups. To compare the proportion of patients 12 weeks and 24 weeks after surgery who endorse ( Was It Worth It ) each treatment (intervention vs. control groups). To compare post-operative care (as measured by length of hospital and high dependency unit stay) between the intervention and control groups. To compare treatment adherence between the intervention and control groups. To compare rates of smoking abstinence between the intervention and control groups as a covariate of the primary outcome only. Correlative science objectives To evaluate the predictive role of the nicotinic receptor gene cluster (CHRNA5-CHRNA3-CHRNB4) and CYP2A6 genotypes in smoking cessation among lung cancer patients undergoing surgery. To evaluate the potential moderating effect of these cessation-relevant genotypes on smoking cessation treatment between the intervention and control groups.

Primary objective To determine if varenicline plus a behavioral intervention consisting of a brief clinician-delivered intervention and tobacco quitline follow-up, decreases postsurgical complications through 24 weeks after surgery when compared to placebo plus the behavioral intervention in lung cancer patients who undergo surgery and are motivated to stop smoking. Secondary objectives To compare changes from baseline to 12 and 24 weeks after surgery in the patient quality of life (LASA-12) domains between the intervention (varenicline) and control group (placebo). To compare changes from baseline to 6, 12 and 24 weeks after surgery in the patient quality of life related domains (LASA) for the PHQ-9 and SEQ12 between the intervention and control groups. To compare the proportion of patients 12 weeks and 24 weeks after surgery who endorse ( Was It Worth It ) each treatment (intervention vs. control groups). To compare post-operative care (as measured by length of hospital and high dependency unit stay) between the intervention and control groups. To compare treatment adherence between the intervention and control groups. To compare rates of smoking abstinence between the intervention and control groups as a covariate of the primary outcome only. Correlative science objectives To evaluate the predictive role of the nicotinic receptor gene cluster (CHRNA5-CHRNA3-CHRNB4) and CYP2A6 genotypes in smoking cessation among lung cancer patients undergoing surgery. To evaluate the potential moderating effect of these cessation-relevant genotypes on smoking cessation treatment between the intervention and control groups.