Facilitating Comprehensive Self and Proxy Symptom Assessments for Children with Cancer

项目摘要/摘要 患有癌症的儿童的症状与他们的诊断和癌症治疗有关； 临床医生经常不能很好地识别并可能得不到治疗的症状。当症状出现时 如果持续或变得严重，它们可能会导致剂量减少，甚至过早停止癌症- 定向治疗，这反过来又会影响治疗效果和存活率。改进的第一步 症状管理就是开发一种更好的方法来评估和跟踪症状。儿科 患者报告的结果不良事件的通用术语标准(儿科PRO-CTCAE)是 最近开发的创新工具，包括与62种不同症状相关的130个问题，并 由孩子和/或家长填写。目前儿科PRO-CTCAE的使用涉及临床医生/ 研究人员根据预期的相关性预先选择了被询问的症状。不过，这个 这种方法可以防止孩子/父母报告所有症状，从而有可能遗漏症状。智能 症状儿科肿瘤学跟踪器(SPOTS)是一个创新的、基于网络的界面，申请者是 发展，使儿童和父母能够系统地完成儿科专业CTCAE，但没有 要求对全部130个问题作出答复。这项研究的总体目标是改进和试点试验点 用于对癌症儿童进行全面的自我/替代症状评估。根本的理由是 全面的症状评估和跟踪将提供识别症状趋势所需的数据， 促进药物毒性监测，加强症状管理。这一混合行动的具体目标 研究方法为：第一阶段：对初步点位进行可用性测试和细化 原型和斑点症状报告。目标1 A。评估儿童使用的SPOTS原型的可用性 与癌症和他们的父母在一个时间点(即如何使用和令人满意的地点是可用的)。目标1B。 评估每个儿童、父母和儿科肿瘤临床医生的斑点症状报告的格式 偏好。阶段2.对斑点进行纵向试点测试(在阶段1改进之后)。目标2 A。 评估孩子/父母使用斑点来报告孩子随着时间推移出现的症状的可行性。目标2B。 评估癌症儿童及其父母报告儿童症状的斑点的可用性 时间(即如何使用和令人满意的地点)。目标为2C。评价儿科医生的一致性程度 Pro-CTCAE核心症状报告1)儿童/父母使用SPOTS与当前调查格式相比 报告症状，以及2)儿童与父母症状报告之间的差异。申请者的目标是成为一名 独立的护士科学家，能够领导多地点、跨学科的研究，专注于改进 癌症儿童的症状评估。因此，这本K23包括消费者健康信息学方面的培训 研究、高级统计分析、儿科肿瘤学自我/替代症状评估和开发 以及管理复杂的儿科临床试验和干预。

Project Summary / Abstract Children with cancer suffer with symptoms related to their diagnosis and to cancer-directed therapies; symptoms that are frequently poorly recognized and may be under-treated by clinicians. When symptoms persist or become severe, they can lead to dose-reductions and even premature discontinuation of cancer- directed therapies, which, in turn, can affect treatment efficacy and survivorship. The first step to improving symptom management is to develop a better method for assessing and tracking symptoms. The Pediatric Patient Reported Outcome Common Terminology Criteria for Adverse Events (Pediatric PRO-CTCAE) is an innovative, recently developed tool that includes 130 questions related to 62 different symptoms and is completed by children and/or parents. Current use of the Pediatric PRO-CTCAE involves clinicians / researchers pre-selecting which symptoms are asked about, based on anticipated relevance. However, this approach prevents children/parents from reporting every symptom, risking symptoms being missed. Smart Pediatric Oncology Tracker of Symptoms (SPOTS) is an innovative, web-based interface that the applicant is developing that allows children and parents to systematically complete the Pediatric PRO-CTCAE, but without requiring responses to all 130 questions. The overall objective of this research is to refine and pilot test SPOTS for comprehensive self/proxy symptom assessment with children with cancer. The underlying rationale is that comprehensive symptom assessment and tracking will provide the data needed to identify symptom trends, facilitate surveillance for drug toxicities, and enhance symptom management. The specific aims of this mixed methods research are to: Phase 1. Conduct usability testing and refinement of the preliminary SPOTS prototype and SPOTS symptom reports. Aim 1A. Evaluate the usability of the SPOTS prototype for children with cancer and their parents at one timepoint (i.e. how usable and satisfying SPOTS is to use). Aim 1B. Evaluate the formatting of SPOTS symptom reports per children’s, parents’, and pediatric oncology clinicians’ preferences. Phase 2. Conduct longitudinal pilot testing of SPOTS (after Phase 1 refinement). Aim 2A. Evaluate the feasibility of children/parents using SPOTS to report the child’s symptoms over time. Aim 2B. Evaluate the usability of SPOTS for children with cancer and their parents to report the child’s symptoms over time (i.e. how usable and satisfying SPOTS is to use). Aim 2C. Evaluate the degree of agreement in Pediatric PRO-CTCAE core symptom reports 1) when children/parents use SPOTS versus the current survey format to report symptoms, and 2) between child versus parent symptom reports. The applicant’s goal is to become an independent nurse scientist capable of leading multisite, interdisciplinary research focused on improving symptom assessment for children with cancer. Thus, this K23 includes training in consumer health informatics research, advanced statistical analysis, pediatric oncology self/proxy symptom assessments, and developing and managing complex, pediatric clinical trials and interventions.