Facilitating Comprehensive Self and Proxy Symptom Assessments for Children with Cancer

项目总结/摘要 患有癌症的儿童患有与其诊断和针对癌症的治疗相关的症状; 这些症状通常认识不足，临床医生可能治疗不足。当症状 持续或变得严重，它们可能导致剂量减少，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生存率。改善的第一步 症状管理是开发一种更好的方法来评估和跟踪症状。儿科 不良事件的患者报告结局通用术语标准（儿科PRO-CTCAE）是一项 创新，最近开发的工具，包括130个问题，涉及62种不同的症状， 由孩子和/或家长填写。儿科PRO-CTCAE的当前使用涉及临床医生/ 研究人员根据预期的相关性预先选择被询问的症状。但这 这种方法防止儿童/父母报告每一个症状，有可能遗漏症状。智能 儿科肿瘤症状跟踪器（SPOTS）是一个创新的、基于网络的界面，申请人 开发允许儿童和父母系统完成儿科PRO-CTCAE，但不 要求回答所有130个问题。本研究的总体目标是完善和试点测试SPOTS 用于癌症儿童的全面自我/代理症状评估。其基本原理是， 全面的症状评估和跟踪将提供识别症状趋势所需的数据， 促进监测药物毒性，并加强症状管理。这种混合的具体目标 方法研究是：第一阶段。对初步SPOTS进行可用性测试和改进 原型和SPOTS症状报告。目标1A。评估儿童SPOTS原型的可用性 在一个时间点与癌症及其父母（即如何使用和满意的SPOTS）。目标1B。 根据儿童、父母和儿科肿瘤临床医生的要求，评估SPOTS症状报告的格式 喜好第二阶段。对SPOTS进行纵向试点测试（在第1阶段改进之后）。目标2A。 评估儿童/家长使用SPOTS报告儿童症状的可行性。目标2B 评估SPOTS对癌症儿童及其父母的可用性，以报告儿童的症状， 时间（即使用SPOTS的可用性和满意度）。目标2C。评价儿科中的一致性程度 PRO-CTCAE核心症状报告1）当儿童/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。申请人的目标是成为 独立护理科学家能够领导多地点，跨学科的研究，重点是提高 癌症儿童症状评估。因此，该K23包括消费者健康信息学培训 研究，高级统计分析，儿科肿瘤自我/代理症状评估，以及开发 管理复杂的儿科临床试验和干预措施。

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.