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.

中文翻译：

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持续戒烟咨询和药物提供与短期咨询和药物建议对最近诊断出癌症患者戒烟的影响

重要性 持续吸烟可能会导致癌症患者出现不良后果。许多癌症中心尚未将循证烟草治疗完全纳入常规护理。目的 确定与短期电话咨询和药物建议（标准治疗）相比，持续电话咨询和药物治疗（强化治疗）在帮助新近诊断出癌症患者戒烟方面的有效性。设计、设置和参与者 这项非盲随机临床试验在马萨诸塞州总医院/丹娜法伯/哈佛癌症中心和纪念斯隆凯特琳癌症中心进行。在 30 天内吸过 1 支烟或更多，会说英语或西班牙语，并且最近诊断出患有乳腺、胃肠道、泌尿生殖系统、妇科、头颈部、肺、淋巴瘤、或黑色素瘤癌症符合条件。入学时间为 2013 年 11 月至 2017 年 7 月；评估于 2018 年 2 月底完成。 干预 随机接受强化治疗（n = 153）和标准治疗（n = 150）的参与者每周接受 4 次电话咨询和药物建议。强化治疗组还接受了 4 次每两周一次和 3 次每月一次的电话咨询，并选择了食品和药物管理局批准的戒烟药物（尼古丁替代疗法、安非他酮或伐尼克兰）。主要结果和措施 主要结果是 6 个月随访时生化证实的 7 天点戒烟率。次要结果是治疗利用率。结果 在随机分组的 303 名患者中（平均年龄 58.3 岁；170 名女性 [56.1%]），221 名 (78. 1%) 完成了试验。六个月生化证实戒烟率为 34.5%（强化治疗组 n = 51）与 21.5%（标准治疗组 n = 29）（差异，13.0% [95% CI，3.0%-23.3%]；优势比，1.92 [95% CI，1.13-3.27]；P < .02）。强化治疗组完成的咨询次数中位数为 8 次（四分位距，4-11）。共有 97 名强化治疗参与者 (77.0%) 与 68 名标准治疗参与者 (59.1%) 报告了戒烟药物使用情况（差异，17.9% [95% CI，6.3%-29.5%]；优势比，2.31 [95% CI， 1.32-4.04]；P = .003）。强化治疗组和标准治疗组最常见的不良事件分别是恶心（n = 13 和 n = 6）、皮疹（n = 4 和 n = 1）、打嗝（n = 4 和 n = 1）、口腔刺激（n = 4 和 n = 0），难以入睡（n = 3 和 n = 2）和生动的梦（n = 3 和 n = 2）。结论和相关性 在最近在 2 个国家癌症研究所指定的综合癌症中心被诊断出患有癌症的吸烟者中，与 4 周咨询和药物建议相比，持续咨询和免费戒烟药物的提供导致更高的 6 个月生化确认戒烟率。然而，研究结果的普遍性尚不确定，需要进一步研究。试验注册 ClinicalTrials.gov 标识符：NCT01871506。与 4 周咨询和药物建议相比，持续咨询和提供免费戒烟药物导致 6 个月生化确认戒烟率更高。然而，研究结果的普遍性尚不确定，需要进一步研究。试验注册 ClinicalTrials.gov 标识符：NCT01871506。与 4 周咨询和药物建议相比，持续咨询和提供免费戒烟药物导致 6 个月生化确认戒烟率更高。然而，研究结果的普遍性尚不确定，需要进一步研究。试验注册 ClinicalTrials.gov 标识符：NCT01871506。