Extended Self-Help for Smoking Cessation

描述（由申请人提供）：扩展戒烟自助项目概述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对帮助戒烟都有独立的和附加的效果，但吸烟者很少选择咨询。相比之下，最低限度的自助干预，如戒烟小册子或小册子，有更广泛的潜在影响，但其效果非常令人失望，平均只有1%的戒烟率。自助效果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。这个研究小组之前的努力已经促成了一系列8本自助手册的开发，旨在减少戒烟后的复吸。两项临床试验表明，这些“永远免费”小册子通过对新近戒烟者进行为期两年的随访，显著减少了吸烟复发，而且这种干预措施极具成本效益。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，而且还提高了吸烟者的戒烟率，他们要求这些小册子戒烟而不是预防复发。增量戒断率比典型的自助戒断率要高得多。这些分析还表明，与预防复吸相反，这些小册子只有在分发给吸烟者超过12个月的情况下才有效。我们提出了一个一般的两过程“过渡戒毒方法”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。二次分析的结论是有限的，因为这些研究没有能力检测戒烟的结果差异，而且样本可能不能代表一般的吸烟者。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)通过一项足够有力的随机临床试验，测试永久免费戒烟手册的功效；(2)测试延长和增加接触频率的增量效果；(3)比较干预措施的成本效益；(4)测试我们模型的预测子集。吸烟者将被随机分配到三个干预组之一：(1)常规护理，一个单一的NCI戒烟小册子；(2)标准重复邮寄，12个月内8本永久免费小册子；(3)密集重复邮寄，这将增加6个月的邮寄时间，并在小册子邮寄之间增加额外的支持性联系。随访将在入组后的6个月至30个月之间进行。主要的假设是，与常规护理相比，标准重复邮寄将产生显著（e5%）更高的戒断率，并且强化条件将改善持续戒断。

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.