Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA
Hollings Cancer Center, Charleston, South Carolina, USA.
BMJ Open. 2021 Jun 29;11(6):e051226. doi: 10.1136/bmjopen-2021-051226.
Continued smoking following a cancer diagnosis has substantial health risks including increased overall and cancer-specific mortality, risk of secondary malignancies, cancer treatment toxicity and risk of surgical complications. These risks can be mitigated by quitting smoking. The preoperative period represents a prime opportunity in which to administer robust smoking cessation treatment to both improve health and support and improve surgical outcomes. We will conduct a randomised clinical trial to evaluate the effectiveness of financial incentives delivered contingent on biochemically verified smoking abstinence (contingency management (CM)) in patients with cancer undergoing surgery.
The study will take place across two study sites, and participants (N=282) who smoke, are diagnosed with or suspected to have any type of operable cancer and have a surgical procedure scheduled in the next 10 days to 5 weeks will be randomised to receive standard care plus Monitoring Only or CM prior to surgery. All patients will receive breath carbon monoxide (CO) tests three times per week, nicotine replacement therapy and counselling. The CM group will also earn payments for self-reported smoking abstinence confirmed by CO breath test ≤4 ppm on an escalating schedule of reinforcement (with a reset if they smoked). Point prevalence abstinence (PPA) outcomes (self-report of 7-day abstinence confirmed by CO≤4 ppm and/or anabasine ≤2 ng/mL) will be assessed on the day of surgery and 6 months after surgery. The effect of CM on 7-day PPA at the time of surgery and 6-month follow-up will be modelled using generalised linear mixed effects models.
This study has been reviewed and approved by the Medical University of South Carolina Institutional Review Board. We will disseminate our scientific results through traditional research-oriented outlets such as presentations at scientific meetings and publications in peer-reviewed journals.
NCT04605458.
癌症诊断后继续吸烟会带来严重的健康风险，包括总体死亡率和癌症特异性死亡率增加、发生继发性恶性肿瘤的风险、癌症治疗毒性和手术并发症风险。戒烟可以降低这些风险。术前阶段是一个提供强有力戒烟治疗的重要机会，可以改善健康状况，支持和改善手术结果。我们将进行一项随机临床试验，以评估基于生物化学验证的吸烟戒断的经济激励（条件管理（CM））对接受手术的癌症患者的有效性。
该研究将在两个研究地点进行，参与者（N=282）为吸烟者，患有或疑似患有任何类型的可手术癌症，并且在接下来的 10 天至 5 周内有手术计划，将被随机分配接受标准护理加手术前仅监测或 CM。所有患者将每周接受三次呼吸一氧化碳（CO）测试、尼古丁替代疗法和咨询。CM 组还将根据自我报告的戒烟情况获得报酬，CO 呼气测试≤4ppm 确认（如果吸烟，则重置）。点患病率（PPA）结果（自我报告的 7 天戒断，CO≤4ppm 确认，和/或阿那巴碱≤2ng/ml）将在手术当天和手术后 6 个月进行评估。CM 对手术时和 6 个月随访时 7 天 PPA 的影响将使用广义线性混合效应模型进行建模。
本研究已通过南卡罗来纳医科大学机构审查委员会审查和批准。我们将通过传统的以研究为导向的渠道传播我们的科学成果，如在科学会议上的演讲和在同行评议期刊上的发表。
NCT04605458。
