Relapse-Prevention Booklets as Adjunct to a Tobacco Quitline

描述(由申请人提供)：作为烟草专线项目附件的复发预防小册子概述吸烟是癌症和冠心病的主要可预防原因，也是癌症导致过早死亡的主要原因。因此，预防这些疾病的巨大潜力在于努力实现长期戒烟。为了应对这一公共卫生挑战，美国各州现在都开发了戒烟“戒烟线”，最近的荟萃分析表明，与对照条件相比，戒烟线提供的服务显著提高了戒烟率。不幸的是，戒烟的特点是随后复发的比率很高，大约95%的自我戒烟者在尝试戒烟后一年内复发。在那些接受正规计划(如戒烟热线)治疗的人中，复发率略低，但正常情况是，绝大多数吸烟者在某个时候会重新吸烟。先前的研究发现，邮寄给最近戒烟的人的一系列8本永远免费的预防复发小册子，通过至少2年的跟踪调查，显著降低了吸烟复发的比率，而且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的小册子。然而，这些结果是基于对自选的前吸烟者的疗效试验，这些吸烟者是通过反应性招募策略招募的。一项对拨打州戒烟热线的人进行的永久免费复发预防小册子的受控有效性试验将测试干预对更广泛的戒毒者群体的影响。此外，鉴于最近戒烟碱使用的增长，有效的最低限度的干预措施，以防止使用戒烟碱戒烟的个人复发，将具有极高的公共卫生意义。这项拟议的研究是佛罗里达州坦帕市H.Lee Moffitt癌症中心开发复发预防干预措施的研究人员与纽约州布法罗罗斯威尔公园癌症研究所(NYSSQL)与纽约州吸烟者专线(NYSSQL)相关的研究人员合作的，罗斯威尔公园癌症研究所是美国最繁忙的戒烟专线之一。大约3400名QUTOLINE客户将在他们为期2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普通护理(UC)条件下，他们将接受定期的戒烟服务。三分之一的人将随机进入重复邮寄(RM)状态，在12个月的时间内，将定期通过邮寄方式收到8本永久免费的小册子。三分之一的人将被随机分配到群发邮件(MM)状态，这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、预防复发干预措施(永远免费的小册子)作为州电话免费线路附件的有效性；(2)比较先前研究支持的两种不同的小册子分发时间表；以及(3)计算和比较干预措施的成本效益。这样的有效性研究代表着干预发展和验证的最后一步，然后才能证明通过国家戒烟热线广泛传播是合理的。与公共健康相关：据估计，美国21%的死亡可以归因于吸烟。易于传播的有效、低成本的干预措施在减轻吸烟对公众健康造成的负担方面具有很大潜力。这项拟议的研究将测试向一个大型州戒烟热线的客户分发防止吸烟复发的自助干预的有效性。

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.