Digital smoking cessation intervention for nationally-recruited American Indians and Alaska Natives: A full-scale randomized controlled trial

项目总结/摘要（描述） 自20世纪80年代初以来，美国印第安人和阿拉斯加原住民（AIAN）一直保持着最高的失业率。 在美国任何种族/民族的商业香烟吸烟。目前，27%的AIAN吸烟。 与其他种族/民族相比，他们患吸烟相关癌症的几率高出6倍。 与其他种族/民族相比，AIAN戒烟的可能性只有一半。结果是， 吸烟占全国AIAN死亡人数的一半。其中一个主要原因是， 长期存在的不平等是AIAN中缺乏有效的戒烟干预措施。 缺乏戒烟干预措施的障碍是缺乏研究的障碍 戒烟干预对AIAN的有效性。尽管吸烟率最高 在美国任何种族/民族群体中，40多年来，只有0.3%的人全面戒烟， 随机对照试验（RCT）集中于AIAN。关于无障碍环境，一个智能手机应用程序 （“应用程序”）有可能提供低成本的戒烟干预，具有广泛的地理覆盖范围， AIAN和美国地区的吸烟率高达57%（即，北方平原）。 关于疗效，我们的初步数据为我们的接受和承诺提供了有希望的证据。 基于治疗（ACT）的智能手机应用程序，称为iCanQuit，以帮助AIAN戒烟。我们比较了 AIAN子样本中的iCanQuit应用程序和NCI的QuitGuide应用程序（从美国32个州招募的N = 165） 参加了我们的全面RCT对AIAN的二次分析显示， 在12个月随访时停止（iCanQuit组为30%，QuitGuide组为18%; OR = 1.96; 95% CI = 0.90，4.26， p = .089）。虽然令人鼓舞，但分析是探索性的，不重要的，不能代替全面的 功效测试为了解决先前研究的弱点，iCanQuit的完全有效性比较RCT vs.现在需要全国范围内关注吸烟的AIAN。因此，本项目的目标是 进行一项全国招募的完全把握度双臂RCT，比较iCanQuit（n = 388）与QuitGuide（n = 388），以确定：（1）iCanQuit相对于QuitGuide应用程序的生物化学验证的有效性 30-随机化后12个月的日点戒烟率（PPA）和（2）iCanQuit是否（但 12个月的戒烟结果显著介导了核心 基于ACT的流程。这项研究将是第一个全面的随机对照试验的数字干预，以帮助AIAN 全国范围内停止吸烟。定性访谈（1）iCanQuit参与者的子样本，以主题化 他们的经验与iCanQuit和（2）AIAN成员从我们的研究社区咨询 委员会（CAB）将指导我们向全国AIAN成年人广泛传播iCanQuit的计划。积极成果 将通过提供一种高度可及和有效的干预措施来改善卫生公平， 可持续性和广泛传播。

PROJECT SUMMARY/ABSTRACT (DESCRIPTION) Since the early 1980s, American Indians and Alaska Natives (AIANs) have maintained the highest rates of commercial cigarette smoking of any racial/ethnic group in the US. Currently, 27% of AIANs smoke cigarettes. Compared to other racial/ethnic groups, they have 6 times higher rates of developing smoking-related cancers. AIANs are only half as likely to quit smoking compared to other races/ethnicities. The result is that commercial cigarette smoking accounts for half of all deaths among AIANs nationwide. A major cause of these longstanding inequities is the lack of access to efficacious smoking cessation interventions among AIANs. Compounding the barrier of lack of access to smoking cessation interventions is the barrier of lack of research on the efficacy of smoking cessation interventions for AIANs. Despite having the highest smoking prevalence of any racial/ethnic group in the US for over 40 years, a mere 0.3% of all full-scale smoking cessation randomized controlled trials (RCTs) have focused on AIANs. Regarding accessibility, a smartphone application (“app”) has the potential to deliver a low-cost smoking cessation intervention with wide geographic reach to AIANs and in regions of the US with smoking rates as high as 57% in this group (i.e., Northern Plains). Regarding efficacy, our preliminary data provides promising evidence for our Acceptance and Commitment Therapy (ACT)-based smartphone app, called iCanQuit, to help AIANs quit smoking. We compared the iCanQuit app with the NCI’s QuitGuide app among the AIAN subsample (N = 165 recruited from 32 US states) enrolled in our full-scale RCT. This secondary analysis of AIANs showed descriptively higher rates of smoking cessation at the 12-month follow-up (30% for iCanQuit vs. 18% for QuitGuide; OR = 1.96; 95% CI = 0.90, 4.26, p = .089). While encouraging, analyses were exploratory, non-significant, and not a substitute for a full-scale efficacy test. To address weaknesses of prior research, a fully-powered comparative efficacy RCT of iCanQuit vs. QuitGuide focusing nationwide on AIANs who smoke is now needed. Thus, the goal of this project is to conduct a nationally recruited and fully-powered two-arm RCT comparing iCanQuit (n = 388) to QuitGuide (n = 388), in order to determine: (1) the efficacy of iCanQuit relative to the QuitGuide app for biochemically verified 30-day point prevalence abstinence (PPA) at 12 months post-randomization and (2) whether iCanQuit’s (but not QuitGuide’s) 12-month smoking cessation outcomes are significantly mediated by improvements in core ACT-based processes. This study will be the first full-scale RCT of a digital intervention for helping AIANs nationwide stop smoking. Qualitative interviews with (1) a subsample of iCanQuit participants to thematize testimonials of their experience with iCanQuit and (2) AIAN members from our study Community Advisory Board (CAB) will guide our plan for broadly disseminating iCanQuit to AIAN adults nationwide. Positive results would improve health equity by providing a highly accessible and efficacious intervention with potential for sustainability and broad dissemination for AIANs nationwide.