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: 10378052
• 负责人: DIANA REDWOOD
• 金额: $ 19.65万
• 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 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10378052
• 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; 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; 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; process evaluation; 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％）的阿拉斯加土著人被充分筛查结肠癌（CRC）， 尽管CRC在世界上发生了最多的事件，但可以挽救生命。一个新的家庭 多目标粪便DNA筛选测试（MT-SDNA;Cologuard®）对癌前息肉的灵敏度高 CRC现在可用。 MT-SDNA尚未测试阿拉斯加部落内的可行性或可接受性 医疗保健提供系统，尚不清楚使用这种新测试是否会增加阿拉斯加本地CRC 筛选率。我们的长期目标是改善筛查并降低CRC侵蚀死亡率。这 该应用的目的是测试MT-SDNA对增加阿拉斯加CRC筛查的有效性 使用混合方法的本地社区，基于社区的参与研究（CBPR）方法。这 研究将与负责的区域部落卫生组织合作进行 为地理上偏远的阿拉斯加土著社区提供医疗保健。已要求这项研究 由部落组织。尽管拟议的实施策略是证据并承诺的，但 新颖的是，在部落健康环境或农村/远程人群中尚未评估MT-SDNA。 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（THOS）。这项研究将追求两个具体目标：（1）确定患者 - ， 提供商和系统级因素与CRC筛选偏好，吸收和随访相关； （2） 测试在阿拉斯加本地社区环境中分级强度MT-SDNA干预的有效性。为了 第一个目标是与阿拉斯加原住民的焦点小组，他们不遵守CRC筛查 指南，调查和对医疗保健提供者的访谈将用于识别个人， 人际关系（提供者）和卫生系统因素，用于将来干预。对于第二个目标，三臂 群集随机对照试验（患者导航高强度，中等强度与邮寄 提醒，通常的护理）将提供有关mt-sdna在偏远部落社区的有用性的证据 以及有关MT-SDNA诊断随访依从性率的第一个数据。这 AIM还将通过评估MT-SDNA来提供有关阿拉斯加环境中MT-SDNA的可用性的证据 样本质量和肿瘤收益率，这将为计划扩展干预模型的计划提供信息。这个项目是 创新性，因为实现比当前实践更高的筛查率的有效策略可能会导致 增加对阿拉斯加土著人民中CRC病例的预防或早期发现。拟议的研究 之所以重要，是因为它将解决社区关注的健康差异。这项研究有可能 可持续改善公共卫生，通过提高CRC筛查率，以提高粗糙/偏远的部落人口 并为其他综合卫生系统提供模型，该系统为高风险或服务不足提供护理 美国和全球的人口。