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原发性脑肿瘤患者及其家属的远程心理支持干预评估:一项随机对照试验的研究方案。

Evaluation of a telehealth psychological support intervention for people with primary brain tumour and their family members: Study protocol for a randomised controlled trial.

机构信息

School of Applied Psychology, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.

University of Technology Sydney, Sydney, New South Wales, Australia.

出版信息

Eur J Cancer Care (Engl). 2019 Jul;28(4):e13132. doi: 10.1111/ecc.13132. Epub 2019 Jul 10.

Abstract

OBJECTIVE

There is a lack of research on interventions that address the specific psychosocial needs of people with brain tumour and their families. This paper describes the protocol for a pragmatic randomised control trial (RCT) evaluating the clinical efficacy and cost-effectiveness of the Making Sense of Brain Tumour program delivered via telehealth (Tele-MAST) relative to standard care.

METHODS

The 148 adults with primary brain tumour will be randomly allocated to the 10-session Tele-MAST videoconferencing program or standard care from a cancer counselling service. The primary outcome is level of depression and secondary outcomes are quality of life, mental health and incremental cost per quality-adjusted life year. The mental health and quality of life of family members will also be assessed. Assessments will be conducted at pre-intervention, post-intervention (primary endpoint), 6-weeks post-intervention and 6-months post-intervention. The main analysis will determine whether the Tele-MAST intervention is more effective than standard care at post-intervention, and whether these effects are sustained at follow-up.

CONCLUSION

Results will indicate whether the Tele-MAST program is associated with better clinical outcomes and is more cost-effective than existing cancer support services. Such outcomes will contribute to effective and accessible psychosocial care for the brain tumour population.

摘要

目的

针对脑肿瘤患者及其家属的特定心理社会需求,目前缺乏干预措施的研究。本文介绍了一项实用随机对照试验(RCT)的方案,该试验评估了通过远程医疗(远程 MAST)提供的脑肿瘤应对方案(Tele-MAST)相对于标准护理的临床疗效和成本效益。

方法

将 148 名原发性脑肿瘤患者随机分配到 10 节 Tele-MAST 视频会议计划或癌症咨询服务的标准护理中。主要结局是抑郁程度,次要结局是生活质量、心理健康和每质量调整生命年的增量成本。还将评估家庭成员的心理健康和生活质量。评估将在干预前、干预后(主要终点)、干预后 6 周和干预后 6 个月进行。主要分析将确定 Tele-MAST 干预是否比标准护理在干预后更有效,以及这些效果是否在随访中持续。

结论

结果将表明 Tele-MAST 计划是否与更好的临床结果相关,并且比现有的癌症支持服务更具成本效益。这些结果将有助于为脑肿瘤患者提供有效和可及的心理社会护理。

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