A multisite randomized controlled trial of an early palliative care intervention in children with advanced cancer: The PediQUEST Response Study Protocol.
A multisite randomized controlled trial of an early palliative care intervention in children with advanced cancer: The PediQUEST Response Study Protocol.
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DOI：
10.1371/journal.pone.0277212
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发表时间：
2022
期刊：
影响因子：
3.7
通讯作者：
中科院分区：
文献类型：
--
作者：
儿科生活质量和症状评估技术应对儿科肿瘤症状体验(PQ-Response)干预旨在将专门的儿科姑息治疗整合到患有晚期癌症的儿童、青少年和年轻人(AYA)的常规护理中。评估与常规护理相比，PQ反应是否改善了患者的健康相关生活质量(HRQL)和症状负担(目标1)、父母心理困扰和症状相关压力(目标2)以及家庭和症状治疗的积极性(目标3)。多点、随机(1：1)、对照、非盲法、有效性试验，比较儿科QUEST反应(干预)与常规癌症护理(对照)。五个美国大型三级儿科癌症中心。在任何参与地点接受治疗的儿童(≥，2岁)/AYA，因为晚期癌症或任何进展/复发的实体或脑瘤而接受治疗，并且是姑息治疗的“幼稚”。目标：200名登记的患者-父母二元组(最低目标：136个随机二元组，N=68个/组)。儿科QUEST反应：将患者中介的激活(每周向使用PediQUEST网络系统的家庭和提供者反馈患者和父母报告的症状和HRQOL)与姑息治疗团队的整合相结合。通常的癌症护理：参与者接受通常的护理，其中包括姑息治疗咨询，并使用儿科QUEST网络回答调查，没有反馈。登记后，患者(如果≥5年)和父母之一每周接受儿科QUEST调查，评估HRQOL(儿科生活质量调查表4.0)和症状负担(儿科QUEST-纪念症状评估量表)。在2周的磨合期后，回答每个参与者(应答者)的≥2儿科QUEST调查的DYAD被随机(隐蔽分配)并跟踪16周。父母回答另外六项调查(父母的结果)。主要内容：由a)父母和b)患者(如果≥为5岁)所报告的16周内患者的平均生存质量评分。其次：患者的症状负担；父母的焦虑、抑郁症状、症状相关压力；家庭激活；症状治疗激活。临床试验网站(NCT03408314)18年1月24日。https://clinicaltrials.gov/ct2/show/NCT03408314.
The Pediatric Quality of Life and Evaluation of Symptoms Technology Response to Pediatric Oncology Symptom Experience (PQ-Response) intervention aims to integrate specialized pediatric palliative care into the routine care of children, adolescents, and young adults (AYAs) with advanced cancer. To evaluate whether PQ-Response, compared to usual care, improves patient’s health related quality of life (HRQoL) and symptom burden (aim 1), parent psychological distress and symptom-related stress (aim 2), and family and symptom treatment activation (aim 3). Multisite, randomized (1:1), controlled, un-blinded, effectiveness trial comparing PediQUEST Response (intervention) vs usual cancer care (control). Five US large, tertiary level pediatric cancer centers. Children (≥2 years old)/AYAs who receive care at any of the participating sites because of advanced cancer or any progressive/recurrent solid or brain tumor and are palliative care “naïve.” Target: 200 enrolled patient-parent dyads (minimum goal: 136 dyads randomized, N = 68/arm). PediQUEST Response: combines patient-mediated activation (weekly feedback of patient- and parent-reported symptoms and HRQoL to families and providers using the PediQUEST web system) with integration of the palliative care team. Usual Cancer Care: participants receive usual care, which can include palliative care consultation, and use PediQUEST web to answer surveys, with no feedback. Following enrollment, patients (if ≥5 years) and one parent receive weekly PediQUEST-Surveys assessing HRQoL (Pediatric Quality of Life Inventory 4.0) and symptom burden (PediQUEST-Memorial Symptom Assessment Scale). After a 2-week run-in period, dyads who answer ≥2 PediQUEST surveys per participant (responders), are randomized (concealed allocation) and followed up for 16-weeks. Parents answer six additional surveys (parent outcomes). Primary: mean patient HRQoL score over 16-weeks as reported by a) the parent; and b) the patient if ≥5 years-old. Secondary: patient’s symptom burden; parent’s anxiety, depressive symptoms, symptom-related stress; family activation; and symptom treatment activation. ClinicalTrials.gov (NCT03408314) 1/24/18. https://clinicaltrials.gov/ct2/show/NCT03408314.
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