儿科肿瘤学中向家长提供的以患者为中心的信息（PIFBO研究）：一项正在进行的随机对照试验的研究方案
Person-centred information to parents in paediatric oncology (the PIFBO study): A study protocol of an ongoing RCT.
作者信息
Ringnér Anders, Björk Maria, Olsson Cecilia, Graneheim Ulla Hällgren
机构信息
Department of Nursing, Umeå University, SE-901 87 Umeå, Sweden ; Department of Paediatrics, Umeå University Hospital, SE-901 85 Umeå, Sweden.
CHILD Research Group, Department of Nursing Science, School of Health Sciences, Jönköping University, Box 1026, SE-551 11 Jönköping, Sweden ; School of Life Sciences, University of Skövde, Box 408, SE-541 28 Skövde, Sweden.
出版信息
BMC Nurs. 2015 Dec 21;14:69. doi: 10.1186/s12912-015-0120-8. eCollection 2015.
BACKGROUND
Parents of children with cancer experience a demanding situation and often suffer from psychological problems such as stress. Trying to coping with the complex body of information about their child's disease is one factor that contributes to this stress. The aim of this study is to evaluate an intervention for person-centred information to parents of children with cancer that consists of four sessions with children's nurses trained in the intervention method.
METHODS/DESIGN: This is a multi-centre RCT with two parallel arms and a 1:1 allocation ratio. The primary outcome is illness-related parental stress. Secondary outcomes are post-traumatic stress symptoms, anxiety, depression, satisfaction with information, expected and received knowledge, and experiences with health care providers. A process evaluation is performed to describe experiences and contextual factors. Data are collected using web questionnaires or paper forms according to the parents' preference, audio recording of the intervention sessions, and qualitative interviews with parents and the intervention nurses.
DISCUSSION
Few studies have evaluated information interventions for parents of children with cancer using large multi-centre RCTs. This intervention is designed to be performed by regular staff children's nurses, which will facilitate implementation if the intervention proves to be effective.
TRIAL REGISTRATION
Clinical trials NCT02332226 (December 11, 2014).
背景
癌症患儿的父母面临着严峻的处境，常常遭受压力等心理问题。试图应对有关其孩子疾病的复杂信息是造成这种压力的一个因素。本研究的目的是评估一种针对癌症患儿父母的以患者为中心的信息干预措施，该措施包括由接受过干预方法培训的儿童护士进行的四次课程。
方法/设计：这是一项多中心随机对照试验，有两个平行组，分配比例为1:1。主要结局是与疾病相关的父母压力。次要结局是创伤后应激症状、焦虑、抑郁、对信息的满意度、预期和获得的知识以及与医疗服务提供者的经历。进行过程评估以描述经历和背景因素。根据父母的偏好，使用网络问卷或纸质表格收集数据，对干预课程进行录音，并对父母和干预护士进行定性访谈。
讨论
很少有研究使用大型多中心随机对照试验评估针对癌症患儿父母的信息干预措施。该干预措施旨在由普通儿童护士实施，如果干预措施被证明有效，将便于实施。
试验注册
临床试验NCT02332226（2014年12月11日）。
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