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PediQUEST: Improving Children's Quality of Life through e-PROMS and Palliative Care

PediQUEST：通过 e-PROMS 和姑息治疗提高儿童的生活质量

基本信息

批准号：
10361845
负责人：
Joanne Wolfe
金额：
$ 12.86万
依托单位：
DANA-FARBER CANCER INST
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-06-08 至 2022-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10361845
关键词：
2 year old 5 year old Adult Advanced Malignant Neoplasm Anxiety Belief Caregivers Caring Child Child Health Childhood Clinic Clinic Visits Clinical Collaborations Complementary therapies Complex Computer software Consult Consultations Coupled Data Distress Education Enrollment Equipment and supply inventories Evaluation Face Family Feedback Frequencies Goals Hand Healthcare Impairment Infrastructure Interdisciplinary Study Intervention Knowledge Link Malignant Childhood Neoplasm Measures Mediating Mental Depression Modeling Monitor Oncologist Oncology Online Systems Outcome Palliative Care Parents Patient Outcomes Assessments Patient Self-Report Patients Pediatric Oncology Pediatrics Pharmacology Prevention strategy Provider Quality of life Randomized Randomized Controlled Trials Recommendation Reporting Research Research Design Research Personnel Self Management Series Site Standardization Strategic Planning Surveys Symptoms System Technology Teenagers Testing Time Training Training Programs Work anxiety states arm base center for epidemiological studies depression scale experience follow-up group intervention health related quality of life improved innovation meetings patient population programs psychological distress psychosocial public health relevance response secondary outcome standard care success survivorship symptom management symptom science symptom treatment symptomatic improvement tool treatment arm treatment as usual treatment strategy trend

项目摘要

ABSTRACT At any one time, tens of thousands of children are living with serious illness and they and their families endure a high degree of suffering. While national recommendations call for early palliative care (PC) integration for seriously ill children to ease suffering, very few randomized controlled trials (RCTs) have evaluated whether PC improves child and family outcomes. In prior work, the investigators developed the Pediatric Quality of Life and Evaluation of Symptoms Technology (PediQUEST/PQ), a software that collects electronic Patient-Reported Outcomes (e-PROMS) and generates feedback reports. The effect of using PQ to provide feedback on child's symptoms and health related quality of life (HRQoL) to families and providers was tested in a three-site RCT, within the well established Pediatric PC Research Network, among 104 children ≥2 years old with advanced cancer. The study demonstrated the feasibility of conducting a multisite RCT in this patient population, and an ability to obtain child self-report. Findings also included (a) high levels of child symptom distress, (b) association between higher symptom distress and worse HRQoL, (c) high parental psychological distress linked to child suffering, and (d) trends towards better HRQoL in the intervention arm. Subsequent formative research led to identification of barriers to improving symptom management including families and providers “normalizing distress”, limited use of non-pharmacological treatment strategies, and limited early involvement of PC. Based on Wilson-Cleary's HRQoL model, and informed by these results, the PI and research team developed PQ Response (Response to Pediatric Oncology Symptom Experience). The intervention includes an enhanced PQ system (web-based), coupled with early integration of a PC consulting team (Response team). This dual strategy seeks to standardize the report of symptom distress using PQ feedback, and the providers' response to such distress, trained to include a series of steps in their assessment and interaction with the family including treatment and preventive strategies and family activation regarding symptom control. Pilot work for PQ Response found it feasible, well received by families and oncologists, and potentially effective. Thus, the over-riding aim of this study is to conduct a RCT of PQ Response versus usual care at four large pediatric oncology centers among children ≥2 years old with advanced cancer (n=136). Hypotheses include a) children receiving the intervention will have better (higher) HRQoL scores b) parents of children in the intervention group will report better state-anxiety, depression and HRQoL and c) intervention group families will demonstrate higher levels of activation. Parents and children (if ≥5 years old) in both arms will answer weekly PQ- Surveys for 16 weeks; parent anxiety, depression, and HRQoL will be assessed every 4-weeks; and parent activation every 8 weeks. Hypotheses will be tested using mixed effects models. The study will provide data on outcomes of early PC integration, use of e-PROMS and parent activation strategies in pediatrics, which are important knowledge gaps in palliative care research, and is well aligned with three key themes defined in NINR's strategic plan: science of symptoms, increased self-management, and palliative care.

摘要在任何时候，都有成千上万的儿童患有严重的疾病，他们和他们的家人忍受着高昂的医疗费用。痛苦的程度。虽然国家建议呼吁对重病患者进行早期姑息治疗（PC），虽然PC可以减轻儿童的痛苦，但很少有随机对照试验（RCT）评估PC是否可以改善儿童的痛苦，家庭的结果。在先前的工作中，研究人员开发了儿科生活质量和症状技术（PediQUEST/PQ），一种收集电子患者报告结局（e-PROMS）的软件并生成反馈报告。使用PQ提供儿童症状和健康相关反馈的效果在一项三中心随机对照试验中对家庭和医疗服务提供者的生活质量（HRQoL）进行了测试， PC研究网络，在104名2岁以上晚期癌症儿童中。研究表明，在该患者人群中进行多中心RCT的可行性，以及获得儿童自我报告的能力。结果还包括（a）高水平的儿童症状困扰，（B）较高的症状困扰和更严重的症状困扰之间的关联， HRQoL，（c）与儿童痛苦相关的父母心理困扰高，以及（d）随后的形成性研究导致识别改善症状管理的障碍包括家庭和提供者“正常化痛苦”，有限使用非药物治疗策略， PC的早期参与有限。基于Wilson-Cleary的HRQoL模型，并根据这些结果，PI和研究小组开发了PQ响应（对儿科肿瘤症状经验的响应）。干预包括增强的PQ系统（基于Web），以及PC咨询团队的早期整合（响应团队）。这种双重策略旨在使用PQ反馈标准化症状困扰报告，对这种痛苦的反应，接受培训，在评估和与家庭互动中包括一系列步骤包括治疗和预防策略以及有关症状控制的家庭活动。PQ试点工作答复认为这是可行的，深受家庭和肿瘤学家的欢迎，并可能有效。因此，本研究的目的是在四个大型儿科肿瘤中心进行PQ反应与常规治疗的RCT 在患有晚期癌症的≥2岁儿童中（n=136）。假设包括：a）接受干预的儿童将有更好的（更高的）HRQoL评分B）干预组儿童的父母将报告更好的状态焦虑， c）干预组家庭将表现出更高的激活水平。父母和两组中的儿童（如果≥5岁）将回答每周PQ-调查，持续16周;父母焦虑、抑郁和将每4周一次评估HRQoL;每8周一次评估父母激活。假设将使用混合效应模型该研究将提供有关早期PC整合、e-PROMS的使用和父母的结果的数据。儿科激活策略，这是姑息治疗研究中的重要知识空白， NINR战略计划中定义的三个关键主题：症状科学，增强自我管理，姑息治疗