Tobacco Treatment Optimization and Preferences during Concurrent Cancer Treatment

Inclusion Criteria

• Patients must be >= 18 years of age
• Patient with newly diagnosed or recurrent, cancer diagnosis of any of the following tobacco related malignancies: * Lung or bronchus cancer or head & neck cancers (all sites) * Esophagus, stomach, pancreas, kidney, urinary bladder, colon, rectum, cervix, vulvar, vaginal * Carcinoma in situ of listed disease sites above undergoing definitive surgical resection or treatment (example [ex]: radiation of the larynx, and gynecologic tract hysterectomy, vulvectomy - except gynecologic patients undergoing ablative or local excisional therapies [laser ablation, cervical conization, loop electrosurgical excision procedure (LEEP)]
• Having smoked at least 1 cigarette within 4 weeks prior to study enrollment
• Having at least a 10-pack year history of cigarette smoking. (A “Pack Year” is defined as the number of packs of cigarettes smoked per day multiplied by the number of years the person has smoked. A pack for this definition is 20 cigarettes.)
• Having smoked at least one cigarette within 1 month prior to study
• Life expectancy is greater than 1 year
• Patient has an Alcohol Use Disorders Identification Test (AUDIT) score of =< 15. Patient must have AUDIT score of =< 10 to be treated with bupropion
• Patient has Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
• Patients must have the ability to understand and the willingness to provide signed written informed consent document

Exclusion Criteria

• Known allergy or intolerable reactions attributed to all of the following drugs: bupropion, varenicline, and transdermal nicotine. Patients must be able to receive at least one of these long-acting pharmaceutical treatments
• History of suicide attempt or preparation for attempt within the past 10 years
• Columbia-Suicide Severity Rating Scale (C-SSRS) baseline/screening: * Patient is EXCLUDED if they respond “Yes” to any question in column 2 except question 1 (Past 6 months for “Suicidal Ideation” and Past 10 years for “Suicidal Behavior”). Escalate Yes responses to treating Investigator for appropriate risk assessment and clinical care decisions * Patient response of "Yes" to any question in column one for their Lifetime, is not exclusionary unless judged by the investigator to be significant in ideation, intensity, behavior or attempts, and precludes participation. Escalate Yes responses to treating Investigator for appropriate risk assessment and clinical care decisions. * Patient response of “Yes” to question 1 for “Suicidal Ideation” for either timeframe does not exclude them from the study
• Hospitalized for psychiatric illness within the past two years
• Patient has an AUDIT score of > 15
• History of active or uncontrolled eating disorder such as anorexia or bulimia
• Uncontrolled epilepsy or seizure disorder
• Women must not be pregnant or lactating. Women of reproductive-potential must have negative serum or urine pregnancy test within 7 days prior to study enrollment and agree to use an effective method to avoid pregnancy during and for 30 days following last cessation drug dose
• Patients within three months of a myocardial infarction
• Patients with psychiatric disability judged by the investigator to be clinically significant so as to preclude informed consent or compliance with drug intake
• Patients with medical history or condition judged by the investigator to preclude study participation
• Patient taking varenicline or bupropion within one month of study enrollment
• Currently enrolled in other professional tobacco cessation therapeutic intervention
• Enrollment in a concurrent cancer therapeutic trial will require prior review and approval by the study site principal investigator (PI) to determine that there are no drug interaction concerns