Relapse-Prevention Booklets as Adjunct to a Tobacco Quitline

简介（由申请人提供）：作为戒烟计划附件的预防复吸小册子摘要吸烟是导致癌症和冠心病的主要可预防原因，也是因癌症而过早死亡的主要原因。因此，预防这些疾病的巨大潜力在于长期戒烟的努力。为应对这一公共卫生挑战，美国各州现已建立了戒烟“戒烟热线”，最近的荟萃分析表明，与对照条件相比，戒烟热线提供的服务显著提高了戒烟率。不幸的是，戒烟的特点是复发率很高，大约95%的自我戒烟者在戒烟后一年内又复发了。在正规项目中接受治疗的人，如戒烟热线，复发率略低，但大多数吸烟者都会在某个时候复吸。先前的研究发现，通过至少2年的随访，向最近戒烟的人邮寄一系列8本永久免费预防吸烟小册子，可显著降低吸烟复发率，这种干预措施具有很高的成本效益。由于这些发现，NCI一直在推广和分发“永远免费”小册子。然而，这些结果是基于通过反应性招募策略招募的自我选择的前吸烟者的有效性试验。一项控制效果的试验是，在一个州戒烟热线的电话中使用“永远免费”预防复发小册子，以测试干预对更普通的戒烟人群的影响。此外，考虑到最近戒烟线使用的增长，有效的最小干预措施以防止使用戒烟线戒烟的个人复发，将具有极高的公共卫生意义。这项拟议的研究是由佛罗里达州坦帕市H. Lee Moffitt癌症中心的研究人员开发的预防复发干预措施，以及纽约州布法罗市罗斯威尔公园癌症研究所（美国最繁忙的戒烟热线之一）的纽约州吸烟者戒烟热线（NYSSQL）相关人员合作进行的。大约3400名戒烟热线客户将在他们为期两周的随访电话中随机分为三种情况之一。三分之一的人将被随机分配到常规护理（UC）组，他们将接受定期的戒烟服务。三分之一的人将被随机分配到重复邮寄（RM）的条件下，他们将在12个月内定期收到8本永久免费的小册子。三分之一的人将被随机分配到批量邮寄（MM）条件，他们将在一次邮寄中收到所有8本小册子。主要的具体目标是：(1)测试自助，预防复发干预（永远免费小册子）作为国家电话戒烟热线的辅助手段的有效性；(2)比较以往研究中支持的两种不同的小册子分发计划；(3)计算和比较干预措施的成本效益。这种有效性研究代表了干预措施开发和验证的最后一步，然后才能通过州戒烟线进行广泛传播。

DESCRIPTION (provided by applicant): Relapse-Prevention Booklets as Adjunct to a Tobacco Quitline Project Summary Tobacco smoking is the leading preventable cause of cancer and coronary heart disease, and it is the primary cause of premature death due to cancer. Thus, great potential for prevention of these diseases lies with efforts toward long-term cessation of smoking. In response to this public health challenge, tobacco cessation "quitlines" have now been developed in every US state, and recent meta-analyses indicate that the services provided by quitlines significantly improve cessation rates compared to control conditions. Unfortunately, smoking cessation is characterized by high rates of subsequent relapse, with approximately 95 percent of self-quitters relapsing within a year of their cessation attempt. Relapse rates are slightly less among those receiving treatment in a formalized program, such as a quitline, yet the norm is that the vast majority of smokers will at some point relapse back to smoking. Previous research has found that a series of 8 Forever Free relapse-prevention booklets mailed to individuals who recently quit smoking significantly reduces rates of smoking relapse through at least 2 years of follow-up, and that this intervention is highly cost-effective. Because of these findings, the Forever Free booklets have been promoted and distributed by NCI. However, these results were based on efficacy trials with self-selected former smokers who were recruited via reactive recruitment strategies. A controlled effectiveness trial of the Forever Free relapse-prevention booklets with callers to a state quitline would test the effect of the intervention on a more general population of quitters. Moreover, given the recent growth in quitline usage, an effective minimal intervention to prevent relapse among individuals who quit smoking using a quitline would have extremely high public health significance. The proposed study is a collaboration between researchers who developed the relapse-prevention intervention, at the H. Lee Moffitt Cancer Center in Tampa, Florida, and those associated with the New York State Smokers' Quitline (NYSSQL), at Roswell Park Cancer Institute in Buffalo, New York, one of the busiest quitlines in the US. Approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call. One-third will be randomized to a Usual Care (UC) condition, which will receive regular quitline services. One-third will be randomized to a Repeated Mailings (RM) condition, which will receive the 8 Forever Free booklets sent by mail at regular intervals over a period of 12 months. And one- third will be randomized to a Massed Mailings (MM) condition, which will receive all 8 booklets in a single mailing. The primary specific aims are (1) to test the effectiveness of a self-help, relapse-prevention intervention (Forever Free booklets) as an adjunct to a state telephone quitline; (2) to compare two different booklet distribution schedules that have been supported in previous research; and (3) to calculate and compare the cost-effectiveness of the interventions. Such an effectiveness study represents the final step in intervention development and validation before widespread dissemination via state quitlines can be justified. 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 the effectiveness of distributing to clients of a large state tobacco quitline a self- help intervention for preventing smoking relapse.