Patients With Serious Mental Illness Can Engage in Tobacco Treatment Trials and Tobacco Cessation Interventions During Cancer Treatment.

PURPOSE: More than half of individuals with serious mental illness (SMI) smoke, contributing to premature cancer mortality. A cancer diagnosis provides an opportunity to assist with smoking cessation; however, supportive oncology trials frequently exclude patients with SMI. To fill this gap, we examined differences in engagement and tobacco cessation in a pragmatic clinical trial. METHODS: We recruited 303 participants from two National Cancer Institute-designated Comprehensive Cancer Centers, of which 10% had prior diagnoses of SMI (major depressive disorder, bipolar disorder, and schizophrenia spectrum disorders). We compared self-reported smoking behaviors, patient attitudes and beliefs about cessation, and rates of trial completion, engagement, and smoking abstinence among recently diagnosed patients with cancer with and without SMI. Six months after trial completion, we completed qualitative interviews on barriers and facilitators to tobacco cessation in a random sample of participants with SMI. RESULTS: Trial participants with SMI had similar motivation to quit smoking as those without SMI. Additionally, participants with SMI had a similar ability to engage in a tobacco treatment trial (6.5 counseling sessions completed v 7.3 sessions) and benefit from tobacco treatment as those without SMI (32.3% v 27.8% 6-month quit rates). CONCLUSION: Patients with cancer and SMI were able to engage in and benefit from a tobacco cessation trial integrated into cancer care. A cancer diagnosis provides an opportunity to assist patients with SMI with smoking cessation referrals and treatment. Pragmatic supportive oncology trials that include a diverse population of adults with SMI are needed to inform care delivery and improve cancer outcomes for patients with SMI and cancer.

Effect of Sustained Smoking Cessation Counseling and Provision of Medication vs Shorter-term Counseling and Medication Advice on Smoking Abstinence in Patients Recently Diagnosed With Cancer: A Randomized Clinical Trial.

Importance: Persistent smoking may cause adverse outcomes among patients with cancer. Many cancer centers have not fully implemented evidence-based tobacco treatment into routine care. Objective: To determine the effectiveness of sustained telephone counseling and medication (intensive treatment) compared with shorter-term telephone counseling and medication advice (standard treatment) to assist patients recently diagnosed with cancer to quit smoking. Design, Setting, and Participants: This unblinded randomized clinical trial was conducted at Massachusetts General Hospital/Dana-Farber/Harvard Cancer Center and Memorial Sloan Kettering Cancer Center. Adults who had smoked 1 cigarette or more within 30 days, spoke English or Spanish, and had recently diagnosed breast, gastrointestinal, genitourinary, gynecological, head and neck, lung, lymphoma, or melanoma cancers were eligible. Enrollment occurred between November 2013 and July 2017; assessments were completed by the end of February 2018. Interventions: Participants randomized to the intensive treatment (n = 153) and the standard treatment (n = 150) received 4 weekly telephone counseling sessions and medication advice. The intensive treatment group also received 4 biweekly and 3 monthly telephone counseling sessions and choice of Food and Drug Administration-approved cessation medication (nicotine replacement therapy, bupropion, or varenicline). Main Outcome and Measures: The primary outcome was biochemically confirmed 7-day point prevalence tobacco abstinence at 6-month follow-up. Secondary outcomes were treatment utilization rates. Results: Among 303 patients who were randomized (mean age, 58.3 years; 170 women [56.1%]), 221 (78.1%) completed the trial. Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P < .02). The median number of counseling sessions completed was 8 (interquartile range, 4-11) in the intensive treatment group. A total of 97 intensive treatment participants (77.0%) vs 68 standard treatment participants (59.1%) reported cessation medication use (difference, 17.9% [95% CI, 6.3%-29.5%]; odds ratio, 2.31 [95% CI, 1.32-4.04]; P = .003). The most common adverse events in the intensive treatment and standard treatment groups, respectively, were nausea (n = 13 and n = 6), rash (n = 4 and n = 1), hiccups (n = 4 and n = 1), mouth irritation (n = 4 and n = 0), difficulty sleeping (n = 3 and n = 2), and vivid dreams (n = 3 and n = 2). Conclusions and Relevance: Among smokers recently diagnosed with cancer in 2 National Cancer Institute-designated Comprehensive Cancer Centers, sustained counseling and provision of free cessation medication compared with 4-week counseling and medication advice resulted in higher 6-month biochemically confirmed quit rates. However, the generalizability of the study findings is uncertain and requires further research. Trial Registration: ClinicalTrials.gov Identifier: NCT01871506.