护士主导的（FOCUS+）和基于网络的（iFOCUS）心理教育干预对晚期癌症患者及其家庭照护者的有效性（DIAdIC）：一项国际随机对照试验的研究方案。
Effectiveness of a nurse-delivered (FOCUS+) and a web-based (iFOCUS) psychoeducational intervention for people with advanced cancer and their family caregivers (DIAdIC): study protocol for an international randomized controlled trial.
机构信息
End-of-life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium.
Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium.
出版信息
BMC Palliat Care. 2021 Dec 28;20(1):193. doi: 10.1186/s12904-021-00895-z.
BACKGROUND
Worldwide, millions of people with advanced cancer and their family caregivers are experiencing physical and psychological distress. Psychosocial support and education can reduce distress and prevent avoidable healthcare resource use. To date, we lack knowledge from large-scale studies on which interventions generate positive outcomes for people with cancer and their informal caregivers' quality of life. This protocol describes the DIAdIC study that will evaluate the effectiveness of two psychosocial and educational interventions aimed at improving patient-family caregiver dyads' emotional functioning and self-efficacy.
METHODS
We will conduct an international multicenter three-arm randomized controlled trial in Belgium, Denmark, Ireland, Italy, The Netherlands, and the United Kingdom. In each country, 156 dyads (936 in total) of people with advanced cancer and their family caregiver will be randomized to one of the study arms: 1) a nurse-led face-to-face intervention (FOCUS+), 2) a web-based intervention (iFOCUS) or 3) a control group (care as usual). The two interventions offer tailored psychoeducational support for patient-family caregiver dyads. The nurse-led face-to-face intervention consists of two home visits and one online video session and the web-based intervention is completed independently by the patient-family caregiver dyad in four online sessions. The interventions are based on the FOCUS intervention, developed in the USA, that addresses five core components: family involvement, optimistic outlook, coping effectiveness, uncertainty reduction, and symptom management. The FOCUS intervention will be adapted to the European context. The primary outcomes are emotional functioning and self-efficacy of the patient and the family caregiver, respectively. The secondary outcomes are quality of life, benefits of illness, coping, dyadic communication, and ways of giving support of the patient and family caregiver.
DISCUSSION
DIAdIC aims to develop cost-effective interventions that integrate principles of early palliative care into standard care. The cross-country setup in six European countries allows for comparison of effectiveness of the interventions in different healthcare systems across Europe. By focusing on empowerment of the person with cancer and their family caregiver, the results of this RCT can contribute to the search for cost-effective novel interventions that can relieve constraints on professional healthcare.
TRIAL REGISTRATION
Registration on ClinicalTrials.gov on 12/11/2020, identifier NCT04626349 .
DATE AND VERSION IDENTIFIER
20211209_DIAdIC_Protocol_Article.
背景
在全球范围内，数以百万计的晚期癌症患者及其家庭照顾者正在经历身体和心理上的痛苦。社会心理支持和教育可以减轻痛苦，防止不必要的医疗资源使用。迄今为止，我们缺乏来自大规模研究的知识，这些研究针对哪些干预措施能为癌症患者及其非专业护理人员的生活质量带来积极的结果。本方案描述了 DIAdIC 研究，该研究将评估两种社会心理和教育干预措施的有效性，这些措施旨在改善患者-家庭照顾者双方的情绪功能和自我效能。
方法
我们将在比利时、丹麦、爱尔兰、意大利、荷兰和英国进行一项国际多中心三臂随机对照试验。在每个国家，将随机分配 156 对（共 936 对）晚期癌症患者及其家庭照顾者到以下研究组之一：1）护士主导的面对面干预（FOCUS+），2）基于网络的干预（iFOCUS）或 3）对照组（常规护理）。这两种干预措施都为患者-家庭照顾者双方提供了量身定制的心理教育支持。护士主导的面对面干预包括两次家访和一次在线视频会议，而基于网络的干预则由患者-家庭照顾者双方在四个在线会议中独立完成。这些干预措施是基于在美国开发的 FOCUS 干预措施，该干预措施解决了五个核心组成部分：家庭参与、乐观态度、应对有效性、减少不确定性和症状管理。FOCUS 干预措施将根据欧洲的情况进行调整。主要结果是患者和家庭照顾者的情绪功能和自我效能，次要结果是患者和家庭照顾者的生活质量、疾病获益、应对方式、双通讯方式和支持方式。
讨论
DIAdIC 的目的是开发经济有效的干预措施，将早期姑息治疗原则融入标准护理中。在六个欧洲国家进行的跨国研究可以比较不同欧洲国家的医疗保健系统中干预措施的有效性。通过关注癌症患者和他们的家庭照顾者的赋权，这项 RCT 的结果可以为寻找减轻专业医疗保健限制的经济有效的新干预措施做出贡献。
试验注册
于 2020 年 12 月 11 日在 ClinicalTrials.gov 上注册，标识符为 NCT04626349。
日期和版本标识符
20211209_DIAdIC_Protocol_Article。
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