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

粪便 DNA 测试改善阿拉斯加原住民结直肠癌筛查的随机对照试验

• 批准号: 10113567
• 负责人: DIANA REDWOOD
• 金额: $ 43.33万
• 依托单位: ALASKA NATIVE TRIBAL HEALTH CONSORTIUM
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10113567
• 关键词: Address; Adherence; Administrator; Age; Alaska; Alaska Native; Cancer Burden; Cancer Control; Caring; Cessation of life; Clinic Visits; Clinical; Collaborations; Colonoscopy; Colorectal Cancer; Communities; Community Health Aides; DNA; Data; Detection; Diagnostic; Disease; Educational Materials; Effectiveness; Evaluation; Fecal occult blood; Feces; Focus Groups; Future; Gastrointestinal Hemorrhage; Geography; Goals; Group Interviews; Guaiac; Health Personnel; Health system; Healthcare; Helicobacter Infections; Home; Incidence; Individual; Integrated Health Care Systems; Intervention; Interview; Lead; Leadership; Logistics; Malignant Neoplasms; Measures; Methods; Modeling; Native-Born; Navigation System; Participant; Patients; Policies; Population; Precancerous Polyp; Prevention; Process; Provider; Public Health; Quality Control; Randomized Controlled Trials; Reporting; Research; Research Design; Rural; Sampling; Subgroup; Surveys; System; Testing; Underserved Population; United States; Variant; Work; adherence rate; arm; attributable mortality; base; clinical practice; colorectal cancer screening; community based participatory research; community setting; effectiveness testing; feasibility testing; follow-up; formative assessment; health belief; health care delivery; health disparity; health organization; high risk; high risk population; implementation strategy; improved; individual patient; informant; innovation; insight; meetings; neoplastic; novel; outreach; preference; promoter; protocol development; provider-level barriers; recruit; remote communities; research study; response; rurality; scale up; screening; screening guidelines; sex; social; system-level barriers; theories; therapy development; treatment as usual; tribal community; tribal health; tribal healthcare; tribal organization; uptake; usability

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.

项目摘要 只有59%（29-73%）的阿拉斯加原住民接受了结肠直肠癌（CRC）的充分筛查， 这可以挽救生命，尽管它是世界上报告的CRC发病率最高的。一个新的在家 对癌前息肉具有高灵敏度的多靶点粪便DNA筛查试验（MT-sDNA;脑炎uard ®） CRC现在可用。MT-sDNA尚未在阿拉斯加部落中进行可行性或可接受性测试。 目前还不清楚使用这种新的测试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善筛查并降低CRC的死亡率。的 本申请的目的是测试MT-sDNA在阿拉斯加增加CRC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。的 研究将与负责以下工作的区域部落卫生组织合作进行： 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 部落组织。虽然拟议的执行战略是有据可依和有希望的， MT-sDNA尚未在部落健康环境或农村/偏远人群中进行评估。 使用社会生态模型，我们的研究将是多层次的，检查对患者，供应商， 部落健康组织（THO）本研究将追求两个具体目标：（1）识别患者， 与CRC筛查偏好、采用和随访相关的提供者和系统级因素;以及（2） 在阿拉斯加土著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，与阿拉斯加土著人谁是不遵守或不充分的CRC筛查焦点小组 指南，以及与医疗保健提供者的调查和访谈将用于识别个人， 人际关系（提供者）和卫生系统因素，以供未来干预。对于第二个目标，一个三臂 分组随机对照试验（高强度患者导航，中等强度邮寄 提醒，日常护理）将提供MT-sDNA在偏远部落社区有用的证据， 以及阿拉斯加原住民中MT-sDNA诊断随访依从率的第一个数据。这 美国宇航局还将通过评估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，因为一个有效的战略，实现更高的筛查率比目前的做法可能导致 在阿拉斯加原住民中增加CRC病例的预防或早期发现。拟议研究 这是重要的，因为它将解决社区关注的健康差距。这项研究有可能 通过提高农村/偏远部落人口CRC筛查率， 并为其他为高风险或服务不足的人提供护理的综合卫生系统提供了一个模式 在美国和世界各地的人口。