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Given high rates of smoking among cancer patients, smoking cessation treatment is crucial; yet limited data exist to guide integration of such trials into the oncologic context. In order to determine the feasibility of conducting smoking cessation clinical trials with cancer patients, screening and baseline data from a large randomized placebo-controlled pharmacotherapy trial were analyzed. Descriptive statistics and regression analyses were used to compare enrollees to decliners, describe program enrollees, and assess correlates of confidence in quitting smoking. Out of 14,514 screened patients, 263 ( 30%) African Americans; participants had extensive smoking histories; many were highly nicotine dependent; and participants consumed about seven alcoholic beverages/week on average. Head and neck and breast cancer were the most common tumors. About 52 (25%) reported depressive symptoms. A higher level of confidence to quit smoking was related to lower depression and lower tumor stage. Integrating a smoking cessation clinical trial into the oncologic setting is challenging, yet feasible. Recruitment strategies are needed for patients with advanced disease and specific cancers. Once enrolled, addressing participant’s depressive symptoms is critical for promoting cessation.

Many cancer patients continue to smoke post diagnosis, yet there have been few smoking cessation trials for this population. Depression, which is prevalent among cancer patients, may be a barrier to cessation. This double-blind placebo-controlled trial randomized 246 cancer patients to 9 weeks of placebo or bupropion, stratifying by pre-treatment depression symptoms. In addition, all patients received transdermal nicotine and behavioral counseling. Primary outcomes were 7-day point-prevalence abstinence, biochemically confirmed, at the end of treatment (Week 12), and at 6 months post quit day (Week 27). Additional outcomes included: withdrawal, affect, quality of life, compliance, and side effects. There was no main effect of bupropion vs. placebo on abstinence (Odds Ratio [OR] = 1.36, 95% CI: 0.38–4.81, p = .64). Patients with depression symptoms reported significantly lower abstinence rates vs. patients without depression symptoms (OR = .14, 95% CI: 0.02–0.80, p = .03). Bupropion increased abstinence rates, vs. placebo, more for participants with depression vs. those without depression symptoms. For patients with depression symptoms, bupropion reduced withdrawal symptoms and improved quality of life vs. placebo. For patients with depression symptoms, bupropion increases abstinence rates, lowers withdrawal, and increases quality of life. However, abstinence rates among patients with depression symptoms were low vs. patients without depression symptoms, who exhibited similar abstinence rates when treated with bupropion or transdermal nicotine and counseling alone. These results can guide future smoking cessation intervention studies with cancer patients.