Strategies for Optimizing a Mailed FIT Program in Appalachia

项目摘要 结直肠癌（CRC）是男性和女性中第三常见的癌症， 美国癌症死亡的主要原因。CRC筛查现在建议平均- 年龄在45-75岁之间的风险成年人，但美国的许多成年人不在筛查指南范围内。一个建议的CRC 筛查方法是每年完成粪便免疫化学试验（FIT）。FIT可以在家里完成 并通过邮件发送/返回，使邮寄的FIT计划成为一种有希望的方式来接触人们并增加CRC 筛选这些计划对于医疗保健服务较少的地理区域可能尤为重要 缺乏公共交通，比如美国的阿巴拉契亚地区。邮寄的FIT计划已经 显示增加CRC筛查，但通常只有不到一半的参与者在这些计划谁是 发送FIT返回已完成的测试。这表明，邮寄的FIT计划可以大大改善后， 解决散客返回的共同障碍。这一研究领域的下一步关键是确定战略， 可以解决这些障碍，从而增加邮寄计划的FIT回报。 我们的研究团队将在我们过去研究的基础上，迈出关键的下一步。为此，我们将与 位于美国CRC“热点”的阿巴拉契亚县的健康中心（即，集群 CRC发病率高的县）。拟议的研究将涉及邮寄的FIT计划（称为“FIT从45岁开始”） 其中包括500名来自阿巴拉契亚的参与者，他们的年龄在45-74岁之间。康贝特人将以 提高FIT回报率的两种潜在战略的功效和成本效益：FIT套件材料（增强 FIT套件，包括视频手册与标准FIT套件）和患者导航（PN）输送模式（文本 消息PN与电话PN）。在一项2x2受试者间析因随机试验中，每名受试者将 随机分配至以下研究组之一：标准FIT套件+电话PN;标准FIT套件+文本 短信PN;增强型FIT套件加电话PN;或增强型FIT套件加短信PN。拟议 这项研究将是美国迄今为止最具创新性和最全面的邮寄FIT计划之一， 这项研究旨在作出重大的研究贡献。目的1将确定FIT试剂盒材料的功效， 增加FIT回报的PN交付模式。FIT返还定义为通过以下方式返还已完成的FIT： 参与者在FIT分发的六周内。目标2将确定各关键指标的疗效是否不同 参与者及其社区的特征（即，适度）。目标3将比较成本- FIT套件材料和PN交付模式对增加FIT返回的有效性。结果将产生影响， 提供证据基础，有助于优化设计、实施、可扩展性和可持续性， 未来邮寄的FIT计划，包括我们自己的努力，以传播FIT开始在45计划。

PROJECT SUMMARY Colorectal cancer (CRC) is the third most common cancer among both men and women and the second leading cause of cancer deaths in the United States (US). CRC screening is now recommended for average- risk adults ages 45-75, yet many adults in the US are not within screening guidelines. One recommended CRC screening approach is annual completion of a fecal immunochemical test (FIT). FIT can be completed at home and sent/returned via mail, making mailed FIT programs a promising way to reach people and increase CRC screening. Such programs may be especially important for geographic regions with lower access to healthcare and lack of public transportation, such as the Appalachian region of the US. Mailed FIT programs have been shown to increase CRC screening, but typically fewer than half of participants in these programs who were sent a FIT returned a completed test. This indicates that mailed FIT programs can be greatly improved upon by addressing common barriers to FIT return. A key next step in this field of research is to identify strategies that can address these barriers and subsequently increase FIT return in mailed programs. Our study team will build on our past research and take this key next step. In doing so, we will partner with health centers in Appalachian counties that are located in a CRC “hotspot” within the US (i.e., clusters of counties with high CRC rates). The proposed study will involve a mailed FIT program (called “FIT Starts at 45”) that includes 500 participants from Appalachia who are underscreened and ages 45-74. We will determine the efficacy and cost-effectiveness of two potential strategies for increasing FIT return: FIT kit materials (enhanced FIT kit that includes a video brochure vs. standard FIT kit) and patient navigation (PN) delivery mode (text message PN vs. telephone PN). In a 2x2 between-subjects factorial randomized trial, each participant will be randomized to one of the following study groups: standard FIT kit plus telephone PN; standard FIT kit plus text message PN; enhanced FIT kit plus telephone PN; or enhanced FIT kit plus text message PN. The proposed study will be one of the most innovative and comprehensive mailed FIT programs to date in the US, with each study aim making a significant research contribution. Aim 1 will determine the efficacy of FIT kit materials and PN delivery mode on increasing FIT return. FIT return will be defined as return of a completed FIT by participants within six weeks of FIT distribution. Aim 2 will determine if efficacy differs across key characteristics of participants and their communities (i.e., moderation). Aim 3 will compare the cost- effectiveness of FIT kit materials and PN delivery mode on increasing FIT return. Results will be impactful by providing an evidence base that can help optimize the design, implementation, scalability, and sustainability of future mailed FIT programs, including our own efforts to disseminate the FIT Starts at 45 program.