Extended Self-Help for Smoking Cessation

描述(由申请人提供)：扩展戒烟自助项目摘要吸烟是导致癌症死亡的主要可预防原因。虽然药物治疗和行为咨询在帮助戒烟方面都有独立和相加的效果，但吸烟者很少选择咨询。相比之下，最低限度的自助干预措施，如戒烟小册子或小册子，潜在的影响范围要广得多，但它们的效果一直非常令人失望，递增戒烟率平均只有1%。自助功效的任何重大改进都可能对吸烟和与吸烟有关的疾病和死亡率产生重大的公共健康影响。这个研究小组之前的努力导致了一系列8本自助手册的开发，旨在减少戒烟后再次吸烟的现象。两项临床试验表明，通过对最近戒烟的人进行两年的跟踪调查，这些“永远免费”的小册子显著减少了吸烟复发，而且干预措施非常划算。此外，最近的二次分析表明，小册子不仅减少了最近戒烟者的复发，而且还提高了部分吸烟者的戒烟率，这些人要求小册子的目的是戒烟，而不是为了预防复发。递增的节欲比率比通常的自助要高得多。这些分析还表明，与预防复发相反，这些小册子只有在分发给吸烟者的时间超过12个月时才有效。我们提出了一个一般性的两个过程的“戒毒过渡方法”模型来解释这些差异。该模型强调持续接触对维持个人戒烟动机的作用。二次分析得出的结论是有限的，因为这些研究没有能力检测戒烟结果的差异，而且样本可能不能代表一般吸烟者。此外，在12个月的小册子分发结束后，没有保持显著的结果差异。这项拟议研究的目的是：(1)通过一项足够强大的随机临床试验，测试永久免费戒烟手册的有效性；(2)测试延长和增加接触频率的增量有效性；(3)比较干预措施的成本效益；以及(4)测试我们模型的预测子集。吸烟者将被随机分到三个干预部门之一：(1)普通护理，一本单一的NCI戒烟手册；(2)标准重复邮寄，在12个月内提供8本永久免费的小册子；(3)密集重复邮寄，在邮寄小册子之间增加6个月的邮寄和额外的支持联系。每隔6个月至注册后30个月进行一次跟踪。主要假设是，与平时护理相比，标准重复发送邮件将产生显著(e5%)更高的禁酒率，而且强化条件将改善持续禁欲。

DESCRIPTION (provided by applicant): Extended Self-Help for Smoking Cessation Project Summary Tobacco smoking is the leading preventable cause of cancer mortality. Although both pharmacotherapy and behavioral counseling have independent and additive effects toward aiding smoking cessation, counseling is rarely chosen by smokers. In contrast, minimal self-help interventions, such as smoking cessation pamphlets or booklets have much wider potential reach, but their efficacy has been very disappointing, with incremental abstinence rates averaging only 1 percent. Any significant improvement in the efficacy of self-help would have potentially large public health impact with respect to smoking and smoking-related illness and mortality. Previous efforts by this research team have led to the development of a series of 8 self-help booklets designed to reduce postcessation relapse to smoking. Two clinical trials have demonstrated that these "Forever Free" booklets significantly reduce smoking relapse through two years of follow-up among recent quitters, and that the intervention is extremely cost-effective. Moreover, recent secondary analyses suggest that the booklets not only reduced relapse among recent quitters, but they also improved cessation rates among a subset of smokers who requested the booklets for cessation rather than relapse-prevention purposes. The incremental abstinence rates were much larger than typically found from self-help. These analyses also indicated that-in contrast to relapse-prevention-the booklets were efficacious only when they their delivery to smokers was distributed over 12 months. We have proposed a general two-process "Transitional Approach to Drug Abstinence" model to account for these differences. The model emphasizes the role of continued contact to maintain individuals' motivation for smoking cessation. Conclusions from the secondary analyses are limited because the studies were not powered to detect outcome differences for smoking cessation, and the sample may not have been representative of smokers in general. In addition, the significant outcome differences were not maintained after the 12 months of booklet distribution ended. The aims of the proposed study are: (1) To test the efficacy of Forever Free booklets for smoking cessation, via a sufficiently powered randomized clinical trial; (2) To test the incremental efficacy of extending and increasing the frequency of contact; (3) To compare the cost-effectiveness of the interventions; and (4) to test a subset of predictions of our model. Smokers will be randomized to one of three intervention arms: (1) Usual Care, a single NCI smoking cessation booklet; (2) Standard Repeated Mailings, the 8 Forever Free booklets over 12 months; and (3) Intensive Repeated Mailings, which adds another 6 months of mailings and additional supportive contacts between the booklet mailings. Follow-up will occur at 6-month intervals through 30 months post-enrollment. The primary hypotheses are that Standard Repeated Mailings will produce significantly (e5 percent) greater abstinence rates compared to Usual Care, and that the Intensive condition will improve sustained abstinence beyond that.