Randomized controlled trial of the stool DNA test to improve colorectal cancer screening among Alaska Native people

项目总结 只有59%(29%-73%)的阿拉斯加原住民接受了结直肠癌(CRC)的充分筛查， 这可能会拯救生命，尽管报告的CRC发病率是世界上最高的。一个新的居家环境 多靶点粪便DNA筛查试验(MT-sDNA；Cologuard®)对癌前息肉的高灵敏度 现在，CRC已可用。Mt-sDNA尚未在阿拉斯加部落内部进行可行性或可接受性测试 医疗保健提供系统，目前尚不清楚这种新测试的使用是否会增加阿拉斯加原住民CRC 筛查率。我们的长期目标是改进筛查，降低结直肠癌可归因性死亡率。这个 本应用的目的是测试MT-sDNA在阿拉斯加州增加结直肠癌筛查的有效性 土著社区采用混合方法、基于社区的参与性研究(CBPR)方法。这个 研究将与区域部落卫生组织合作进行，这些组织负责 为地理位置偏远的阿拉斯加原住民社区提供医疗保健。这项研究已被要求进行 被部落组织。虽然拟议的执行战略是有证据的和有希望的，但它 MT-sDNA的创新之处在于，尚未在部落卫生环境或农村/偏远人口中对MT-sDNA进行评估。 使用社会生态模型，我们的研究将是多层次的，检查对患者、提供者、 和部落卫生组织(TOS)。这项研究将追求两个具体目标：(1)确定患者-- 与结直肠癌筛查偏好、摄取和随访相关的提供者和系统层面的因素；以及(2) 在阿拉斯加原住民社区环境中测试分级强度MT-sDNA干预的有效性。为 第一个目标是，与没有或不完全遵守结直肠癌筛查的阿拉斯加原住民组成焦点小组 指南，以及对医疗保健提供者的调查和采访将被用来确定个人， 未来干预的人际(提供者)、卫生系统因素。对于第二个目标，三臂 整群随机对照试验(高强度引导患者，中等强度引导邮寄 提醒，日常护理)将提供证据，证明MT-sDNA在偏远部落社区的有用性 以及关于阿拉斯加土著人口MT-sDNA诊断随访依从率的第一个数据。这 AIM还将通过评估MT-sDNA，为MT-sDNA在阿拉斯加环境中的可用性提供证据 样本质量和肿瘤产量，这将为扩大干预模式的计划提供信息。这个项目是 创新是因为实现比当前做法更高筛查率的有效战略可能会导致 加强预防或及早发现阿拉斯加原住民中的CRC病例。拟议的研究 意义重大，因为它将解决社区关注的健康差距问题。这项研究有可能 通过提高农村/边远部落人口的CRC筛查率来可持续地改善公共卫生 并为其他为高危或未得到充分服务的人提供护理的综合卫生系统提供模式 美国和世界各地的人口。

PROJECT SUMMARY Only 59% (29-73%) of Alaska Native people have been adequately screened for colorectal cancer (CRC), which could save lives, despite having the highest reported incidence of CRC in the world. A new at-home multi-target stool DNA screening test (MT-sDNA; Cologuard®) with high sensitivity for pre-cancerous polyps and CRC is now available. MT-sDNA has not been tested for feasibility or acceptability within the Alaska tribal health care delivery system, and it is unknown whether use of this new test will increase Alaska Native CRC screening rates. Our long-term goal is to improve screening and reduce CRC-attributable mortality. The objective of this application is to test the effectiveness of MT-sDNA for increasing CRC screening in Alaska Native communities using a mixed methods, community-based participatory research (CBPR) approach. The study will be conducted in collaboration with regional Tribal health organizations who are responsible for providing health care to geographically remote Alaska Native communities. This research has been requested by Tribal organizations. Although the proposed implementation strategy is evidence-informed and promising, it is novel in that MT-sDNA has not been evaluated in the tribal health setting or among rural/remote populations. Using the Social Ecological Model, our research will be multi-level, examining influence on patients, providers, and tribal health organizations (THOs). This research study will pursue two specific aims: (1) Identify patient-, provider-, and system-level factors associated with CRC screening preferences, uptake, and follow-up; and (2) test the effectiveness of graded intensity MT-sDNA intervention in the Alaska Native community setting. For the first aim, focus groups with Alaska Native people who are non- or inadequately adherent to CRC screening guidelines, and surveys and interviews with healthcare providers will be used to identify individual, interpersonal (provider), and health system factors for future intervention. For the second aim, a three-arm cluster randomized controlled trial (high intensity with patient navigation, medium intensity with mailed reminders, usual care) will provide evidence on the usefulness of MT-sDNA in remote tribal communities as well as the first data on MT-sDNA diagnostic follow up adherence rates in the Alaska Native population. This aim will also provide evidence on the usability of MT-sDNA in the Alaska setting by evaluating MT-sDNA sample quality and neoplastic yield, which will inform plans to scale-up the intervention model. This project is innovative because an effective strategy for achieving higher screening rates than current practice could lead to increased prevention or early detection of CRC cases among Alaska Native people. The proposed research is significant because it will address a health disparity of community concern. This research has the potential to sustainably improve public health by increasing CRC screening rates among a rural/remote tribal population as well as provide a model for other integrated health systems that provide care to high-risk or underserved populations in the U.S. and worldwide.