Extended Self-Help for Smoking Cessation

描述（由申请人提供）：戒烟扩展自助项目摘要吸烟是癌症死亡的主要可预防原因。虽然药物治疗和行为咨询对帮助戒烟都有独立和累加的作用，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，具有更广泛的潜在影响，但其效果非常令人失望，戒烟率平均仅为1%。自助功效的任何显著改善都可能对吸烟和与吸烟有关的疾病和死亡率产生巨大的公共卫生影响。这个研究小组以前的努力已经导致了一系列8个自助小册子的开发，旨在减少戒烟后的复吸。两项临床试验表明，通过对最近戒烟者进行两年的随访，这些“永远免费”的小册子显著减少了吸烟复发，而且这种干预措施具有极高的成本效益。此外，最近的二次分析表明，这些小册子不仅减少了最近戒烟者的复发，而且还提高了一部分吸烟者的戒烟率，这些吸烟者要求小册子是为了戒烟而不是预防复发。增量禁欲率比通常发现的自助大得多。这些分析还表明，与预防复吸相反，这些小册子只有在12个月内分发给吸烟者时才有效。我们提出了一个一般的两个过程的“过渡性方法戒毒”模型来解释这些差异。该模型强调持续接触的作用，以保持个人的戒烟动机。次要分析的结论是有限的，因为研究没有把握度检测戒烟的结果差异，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，显著的结果差异没有保持。拟议研究的目的是：（1）通过一项具有充分把握度的随机临床试验，测试Forever Free小册子戒烟的疗效;（2）测试延长和增加接触频率的增量疗效;（3）比较干预措施的成本效益;（4）测试我们模型的一部分预测。吸烟者将被随机分配到三个干预组中的一个：（1）家庭护理，一本NCI戒烟手册;（2）标准重复邮寄，12个月内8本永远免费的手册;（3）强化重复邮寄，在手册邮寄之间增加另外6个月的邮寄和额外的支持联系。随访将每隔6个月进行一次，直至入组后30个月。主要假设是，标准重复邮寄将产生显着（e5%）更大的禁欲率相比，家庭护理，强化条件将改善持续禁欲超过。 公共卫生相关性：据估计，美国21%的死亡可归因于吸烟。易于传播的有效低成本干预措施在减少吸烟造成的公共卫生负担方面具有很大潜力。这项拟议的研究将测试一种自助干预措施，包括一系列邮寄的小册子，这些小册子在初步研究中显示出显着的疗效。

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. PUBLIC HEALTH RELEVANCE: It has been estimated that 21 percent of all US deaths can be attributed to tobacco smoking. Effective low-cost interventions that are easy to disseminate have high potential for reducing the public health burden of smoking. The proposed study will test a self-help intervention consisting of a series of mailed booklets that has shown evidence of significant efficacy in preliminary studies.