In high-income countries (HICs), increased rates of survival among pediatric cancer patients are achieved through the use of protocol-driven treatment. Compared to HICs, differences in infrastructure, supportive care, and human resources, make compliance with protocol-driven treatment challenging in low- and middle-income countries (LMICs). For successful implementation of protocol-driven treatment, treatment protocols must be resource-adapted for the LMIC context, and additional supportive tools must be developed to promote protocol compliance. In Tanzania, an LMIC where resource-adapted treatment protocols are available, digital health applications could promote protocol compliance through incorporation of systematic decision support algorithms, reminders and alerts related to patient visits, and up-to-date data for care coordination. However, evidence on the use of digital health applications in improving compliance with protocol-driven treatment for pediatric cancer is limited. This study protocol describes the development and evaluation of a digital health application, called mNavigator, to facilitate compliance with protocol-driven treatment for pediatric cancer in Tanzania. mNavigator is a digital case management system that incorporates nationally-approved and resource-adapted treatment protocols for two pediatric cancers in Tanzania, Burkitt lymphoma and retinoblastoma. mNavigator is developed from an open-source digital health platform, called CommCare, and guided by the Consolidated Framework for Implementation Research. From July 2019–July 2020 at Bugando Medical Centre in Mwanza, Tanzania, all new pediatric cancer patients will be registered and managed using mNavigator as the new standard of care for patient intake and outcome assessment. Pediatric cancer patients with a clinical diagnosis of Burkitt lymphoma or retinoblastoma will be approached for participation in the study evaluating mNavigator. mNavigator users will document pre-treatment and treatment details for study participants using digital forms and checklists that facilitate compliance with protocol-driven treatment. Compliance with treatment protocols using mNavigator will be compared to historical compliance rates as the primary outcome. Throughout the implementation period, we will document factors that facilitate or inhibit mNavigator implementation. Study findings will inform implementation and scale up of mNavigator in tertiary pediatric cancer facilities in Tanzania, with the goal of facilitating protocol-driven treatment. The study protocol was registered in ClinicalTrials.gov (NCT03677128) on September 19, 2018.

中文翻译：

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利用数字健康促进坦桑尼亚标准的儿科癌症治疗指南的遵循：早期有效性实施混合研究的方案

在高收入国家（HIC），通过使用方案驱动的治疗，可以提高儿童癌症患者的生存率。与HIC相比，基础设施，支持性护理和人力资源的差异使得在低收入和中等收入国家（LMIC）遵守协议驱动的治疗面临挑战。为了成功实施协议驱动的治疗，治疗协议必须针对LMIC上下文进行资源适应，并且必须开发其他支持工具来促进协议的依从性。在坦桑尼亚的中低收入国家，那里有适应资源的治疗方案，数字医疗应用可以通过纳入系统的决策支持算法，与患者就诊相关的提醒和警报以及用于护理协调的最新数据来促进方案的遵守。然而，关于数字医疗应用程序在改善对小儿癌症的协议驱动治疗依从性方面的证据有限。本研究方案描述了称为mNavigator的数字健康应用程序的开发和评估，以促进对坦桑尼亚小儿癌症方案驱动治疗的依从性。mNavigator是一个数字病例管理系统，该系统结合了国家认可的和资源适应性的治疗方案，用于治疗坦桑尼亚的两种儿童癌症Burkitt淋巴瘤和成视网膜细胞瘤。mNavigator是从称为CommCare的开源数字健康平台开发的，并在实施研究的合并框架的指导下进行。从2019年7月至2020年7月，在坦桑尼亚姆万扎的Bugando医疗中心，所有新来的小儿癌症患者都将使用mNavigator进行注册和管理，以作为患者摄入和结果评估的新护理标准。临床诊断为Burkitt淋巴瘤或成视网膜细胞瘤的小儿癌症患者将被邀请参与评估mNavigator的研究。mNavigator用户将使用便于遵守方案驱动治疗的数字表格和检查表，为研究参与者记录治疗前和治疗的详细信息。使用mNavigator对治疗方案的依从性将与历史依从率作为主要结果进行比较。在整个实施期间，我们将记录有助于或禁止mNavigator实施的因素。研究结果将为坦桑尼亚三级儿科癌症设施中mNavigator的实施和扩大提供信息，以促进方案驱动的治疗。该研究方案已于2018年9月19日在ClinicalTrials.gov（NCT03677128）中进行了注册。