Preoperative contingency management intervention for smoking abstinence in cancer patients: trial protocol for a multisite randomised controlled trial.
Preoperative contingency management intervention for smoking abstinence in cancer patients: trial protocol for a multisite randomised controlled trial.
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DOI：
10.1136/bmjopen-2021-051226
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发表时间：
2021-06-29
期刊：
影响因子：
2.9
通讯作者：
Toll BA
中科院分区：
文献类型：
--
作者：
Rojewski AM;Fucito LM;Baker NL;Palmer AM;Foster MG;Warren GW;Bernstein SL;Toll BA
在癌症诊断后继续吸烟具有重大的健康风险，包括总体和癌症特异性死亡率增加，继发性恶性肿瘤的风险，癌症治疗毒性和手术并发症的风险。这些风险可以通过戒烟来减轻。术前阶段是实施强有力的戒烟治疗以改善健康和支持并改善手术结果的主要机会。我们将进行一项随机临床试验，以评估在接受手术的癌症患者中根据经生化验证的戒烟情况（应急管理（CM））提供的经济激励的有效性。该研究将在两个研究中心进行，吸烟、被诊断为或疑似患有任何类型的可手术癌症并计划在未来10天至5周内进行外科手术的受试者（N=282）将在手术前随机接受标准治疗加仅监测或CM。所有患者将每周接受三次呼吸一氧化碳（CO）测试，尼古丁替代治疗和咨询。CM组还将获得通过CO呼吸测试≤4 ppm确认的自我报告戒烟的报酬，并按照逐步升级的强化计划进行（如果他们吸烟，则重置）。将在手术当天和术后6个月评估点患病率戒烟（PPA）结局（通过CO≤4 ppm和/或毒藜碱≤2 ng/mL证实的7天戒烟的自我报告）。将使用广义线性混合效应模型对手术时和6个月随访时CM对7天PPA的影响进行建模。本研究已经过南卡罗来纳州医科大学机构审查委员会的审查和批准。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，例如在科学会议上的演讲和在同行评审期刊上的出版物。NCT 04605458。
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.
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影响因子：
6.9
作者：
Harper, A;Power, M
通讯作者：
Power, M
影响因子：
4.2
作者：
Carroll, KM;Nich, C;Rounsaville, BJ
通讯作者：
Rounsaville, BJ
影响因子：
2.3
作者：
Blanchard, CM;Denniston, MM;Hann, DM
通讯作者：
Hann, DM
DOI：
10.1097/coc.0000000000000522
发表时间：
2019-04
期刊：
American journal of clinical oncology
影响因子：
--
作者：
Day AT;Tang L;Karam-Hage M;Fakhry C
通讯作者：
Fakhry C
DOI：
10.1136/bmj.e7586
发表时间：
2013-01-08
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Chan AW;Tetzlaff JM;Gøtzsche PC;Altman DG;Mann H;Berlin JA;Dickersin K;Hróbjartsson A;Schulz KF;Parulekar WR;Krleza-Jeric K;Laupacis A;Moher D
通讯作者：
Moher D