Prevention Research Center, University of Kentucky, Lexington, KY 40522, USA.
Prevention Research Center, University of Kentucky, Lexington, KY 40522, USA.
Contemp Clin Trials. 2019 Jun;81:28-33. doi: 10.1016/j.cct.2019.04.007. Epub 2019 Apr 13.
Lung cancer is an important public health issue, particularly among American Indians (AIs). The reported decline in tobacco use for most racial/ethnic groups is not observed among AIs. This project was designed to address the research question, "Why don't more Northern Plains American Indians alter tobacco use behaviors known to increase the risk of cancer?"
Guided by the Theory of Planned Behavior, a multi-component intervention study was implemented. Adult AIs, age 18 years or older and currently smoking, were enrolled. Eligible subjects were randomized to one of 15 groups and exposed to either a MINIMAL or an INTENSE level of 4 intervention components. The intervention was delivered face-to-face or via telephone by Patient Navigators (PN). The primary outcome was self-reported abstinence from smoking verified by carbon monoxide measurement.
At 18 months post-quit date, 88% of those who were still in the study were abstinent. This included 6% of all participants who enrolled in the study (14/254) and 13% of those who made it to the quit date (14/108). No intervention groups were found to have significant proportions of participants who were abstinent from smoking at the quit date (visit 5) or primary outcome visit (18 months post-quit date, visit 11), but use of pharmacologic support for abstinence was found to be an effective strategy for individuals who continued participation throughout the study. Those who remained in the study received more visits and were more likely to be abstinent.
Use of NRT increased the odds of not smoking, as assessed at the 18-month follow-up visit, but no other interventions were found to significantly contribute to abstinence from smoking. Although the intervention protocol included numerous points of contact between CRRs and participants (11 visits) loss to follow-up was extensive with only 16/254 remaining enrolled. Additional research is needed to improve understanding of factors that influence enrollment and retention in smoking cessation interventions for AI and other populations.
肺癌是一个重要的公共卫生问题，尤其是在美国印第安人（AI）中。大多数种族/族裔群体的烟草使用报告下降情况并未在 AI 中观察到。本项目旨在解决研究问题，“为什么北平原印第安人不改变已知增加癌症风险的烟草使用行为？”
在计划行为理论的指导下，实施了一项多成分干预研究。年龄在 18 岁或以上且目前吸烟的成年 AI 被纳入研究。符合条件的受试者被随机分配到 15 个组中的一个，并暴露于 4 个干预成分中的一个 MINIMAL 或 INTENSE 水平。干预措施由患者导航员（PN）面对面或通过电话提供。主要结局是通过测量一氧化碳来验证自我报告的戒烟。
在戒烟日期后 18 个月，仍在研究中的 88%的人已经戒烟。这包括在研究中登记的所有参与者的 6%（254 人中 14 人）和达到戒烟日期的参与者的 13%（108 人中 14 人）。没有发现干预组在戒烟日期（第 5 次就诊）或主要结局就诊（戒烟后 18 个月，第 11 次就诊）时有显著比例的参与者戒烟，但使用戒烟的药物支持对持续参与整个研究的个人是一种有效的策略。那些继续留在研究中的人接受了更多的就诊，并且更有可能戒烟。
在 18 个月的随访中，使用 NRT 增加了不吸烟的可能性，但没有发现其他干预措施对戒烟有显著贡献。尽管干预方案包括 CRR 和参与者之间的多个接触点（11 次就诊），但随访失访率很高，只有 254 人中的 16 人仍在登记。需要进一步研究，以更好地了解影响 AI 和其他人群戒烟干预措施参与和保留的因素。
