Department of Family Medicine and Community Health, Duke School of Medicine, 2200 W. Main Street, Durham, NC, 27710, USA.
Duke Global Health Institute, 310 Trent Drive, Durham, NC, 27710, USA.
BMC Cancer. 2020 Mar 29;20(1):254. doi: 10.1186/s12885-020-6611-3.
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.
在高收入国家（HICs），通过采用基于方案的治疗，儿科癌症患者的生存率得以提高。与 HICs 相比，基础设施、支持性护理和人力资源方面的差异使得在中低收入国家（LMICs）中遵循基于方案的治疗具有挑战性。为了成功实施基于方案的治疗，必须针对 LMIC 环境对治疗方案进行资源调整，并开发额外的支持工具来促进方案的遵守。在坦桑尼亚，作为一个拥有资源调整治疗方案的 LMIC，数字健康应用程序可以通过纳入系统决策支持算法、与患者就诊相关的提醒和警报以及最新的护理协调数据来促进方案的遵守。然而，关于数字健康应用程序在提高儿科癌症患者对基于方案的治疗的依从性方面的证据有限。本研究方案描述了一个数字健康应用程序 mNavigator 的开发和评估，该应用程序旨在促进坦桑尼亚儿科癌症的基于方案的治疗。
mNavigator 是一个数字病例管理系统，其中纳入了坦桑尼亚两种儿科癌症（伯基特淋巴瘤和视网膜母细胞瘤）的国家批准的资源调整治疗方案。mNavigator 是从一个名为 CommCare 的开源数字健康平台开发而来的，并由实施研究综合框架指导。2019 年 7 月至 2020 年 7 月，在坦桑尼亚姆万扎的布干达医疗中心，所有新的儿科癌症患者都将使用 mNavigator 进行注册和管理，作为新的患者入组和结果评估的标准。将邀请患有伯基特淋巴瘤或视网膜母细胞瘤临床诊断的儿科癌症患者参与评估 mNavigator 的研究。mNavigator 用户将使用数字表格和检查表记录研究参与者的治疗前和治疗细节，以促进基于方案的治疗。使用 mNavigator 治疗方案的依从性将作为主要结果与历史依从率进行比较。在整个实施期间，我们将记录促进或抑制 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，目标是促进基于方案的治疗。
该研究方案于 2018 年 9 月 19 日在 ClinicalTrials.gov（NCT03677128）注册。
