Quit-smoking program for lung cancer patients' families

描述（由申请人提供）：肺癌是美国癌症死亡率的主要原因，也是吸烟的众所周知的健康后果。晚期肺癌的诊断对患者及其家属有着深远的影响，对吸烟的亲属可能特别有影响。提出了一项针对晚期肺癌患者吸烟亲属的双臂随机干预试验。将每周从自动数据库中识别新诊断为IIIb或IV期肺癌并在三个大型胸部肿瘤科（杜克、查佩尔山的北卡罗来纳州大学和弗吉尼亚州达勒姆）开始治疗的患者。将通过电话对这些患者（两年期间约950名）进行调查，以清点其吸烟亲属，并请求允许与这些亲属联系。将联系符合条件的亲属，要求他们参加干预试验。同意参与并完成基线调查的受试者将根据列举的合格亲属数量进行分层，并随机分配至标准自助组（n=240）或以应对为重点的自助组（n=240）。标准自助组的亲属将收到一封由患者肿瘤科医生签名的介绍信，一个戒烟工具包（例如，尼古丁贴片，放松磁带）和定制的小册子。以应对为重点的手臂中的亲属将接受为期12周的干预，其中包括上述相同的组成部分，外加顾问的6个电话。以应对为中心的干预的目标是通过教授吸烟者以接近为导向的应对方法（例如，放松技巧，重新定义自我挫败的评价，使用自助戒烟辅助工具）和阻止以回避为导向的应对（例如，远离和拒绝戒烟的个人利益），以提高他们采取戒烟措施的能力。该试验的主要结局是在治疗后2周、6个月和12个月的三次随访中，经生化证实的7天点普遍禁欲。此外，还将分析与情绪管理和戒烟相关的中介因素包括应对策略和自我效能的变化及其与干预结果的关联。最后，还将评估两种干预方法的成本效益。

DESCRIPTION (provided by applicant): Lung cancer is the leading cause of cancer mortality in the U.S. and a well-known health consequence of cigarette smoking. The diagnosis of late stage lung cancer has a profound effect on patients and their families and may be particularly impactful for relatives who smoke. Proposed is a two-arm randomized intervention trial that targets late stage lung cancer patients' relatives who smoke. Patients newly diagnosed with lung cancer at stages IIIb or IV who are initiating care at three large thoracic oncology units (Duke, University of North Carolina at Chapel Hill, and Durham VA) will be identified weekly from automated databases. These patients (approximately 950 over a two-year period) will be surveyed by telephone to enumerate their relatives who smoke and request permission to contact these relatives. Eligible relatives will be contacted to request their participation in the intervention trial. Those who agree to participate and complete the baseline survey will be stratified, based on the number of eligible relatives enumerated, and randomly assigned to either a Standard Self-help arm (n=240) or a Coping-focused Self-help arm (n=240). Relatives in the Standard Self-help arm will be sent an introductory letter signed by the patient's oncologist, a smoking cessation kit (e.g., nicotine patches, relaxation tapes) and a tailored booklet. Relatives in the Coping-focused arm will receive a 12-week intervention that includes the same components described above plus 6 calls from a counselor. The objective of the Coping-focused intervention is to help smokers reduce emotional distress by teaching them approach-oriented coping (e.g., relaxation techniques, reframing self-defeating appraisals, use of self-help cessation aids) and discourage avoidant-oriented coping (e.g., distancing and denial of personal benefits of smoking cessation) to enhance their ability to take steps toward quitting. The primary outcome of the trial is biochemically confirmed 7-day point prevalent abstinence at the three follow-ups, 2 weeks, 6- and 12- months post-treatment. In addition, changes in mediating factors including coping strategies and self- efficacy related to emotion management and smoking cessation and their association with intervention outcomes will be analyzed. Lastly, cost-effectiveness of the two intervention approaches also will be evaluated.