Halkett Georgia K B, Lobb Elizabeth A, Miller Lisa, Phillips Jane L, Shaw Thérése, Moorin Rachael, Long Anne, King Anne, Clarke Jenny, Fewster Stephanie, Hudson Peter, Agar Meera, Nowak Anna K
Faculty of Health Sciences, School of Nursing and Midwifery, Curtin University, Bentley, Perth, Western Australia, Australia.
Calvary Health Care Kogarah and Cunningham Centre for Palliative Care, Sydney, New South Wales, Australia School of Medicine, The University of Notre Dame, Sydney, New South Wales, Australia.
BMJ Open. 2015 Oct 26;5(10):e009477. doi: 10.1136/bmjopen-2015-009477.
High-grade glioma (HGG) is a rapidly progressive and debilitating disease. Primary carers experience significant levels of distress which impacts on their experience of caregiving, the quality of care received and the community in terms of the increased reliance on healthcare due to the potential development of complicated grief. This paper describes the protocol for testing the efficacy and feasibility of an intervention for primary carers of patients with HGG in order to improve preparedness to care and reduce carer distress.
Randomised controlled trial. The target population is carers of patients with HGG who are undergoing combined chemoradiotherapy. The intervention consists of 4 components: (1) initial telephone assessment of unmet needs of the carer, (2) tailoring of a personalised resource folder, (3) home visit, (4) ongoing monthly telephone contact and support for 12 months. The control arm will receive usual care.
This intervention will improve preparedness for caring and reduce carer psychological distress.
This intervention will reduce carer unmet needs. The longer term aim of the intervention is to reduce patient healthcare resource utilisation and, by doing so, reduce costs. Assessments will be obtained at baseline, 8 weeks post intervention, then 4, 6 and 12 months. Participants will also complete a healthcare utilisation checklist and proxy performance status which will be assessed at baseline and monthly. 240 carers will be recruited. The sample size is 180. Multilevel mixed effects regression models will be applied to test the effect of the intervention.
Ethics approval has been gained from Curtin University and the participating sites.
Results will be reported in international peer-reviewed journals.
Australian and New Zealand Clinical Trials Registration (ACTRN)12612001147875.
高级别胶质瘤（HGG）是一种进展迅速且使人衰弱的疾病。主要照顾者承受着极大的痛苦，这会影响他们的照顾体验、所接受护理的质量，以及由于可能出现复杂悲伤而导致对医疗保健依赖增加的社区。本文描述了一项针对HGG患者主要照顾者的干预措施的疗效和可行性测试方案，以提高护理准备并减轻照顾者的痛苦。
随机对照试验。目标人群是正在接受放化疗联合治疗的HGG患者的照顾者。干预措施包括4个部分：（1）对照顾者未满足需求的初始电话评估；（2）定制个性化资源文件夹；（3）家访；（4）为期12个月的每月一次电话联系及支持。对照组将接受常规护理。
该干预措施将改善护理准备并减轻照顾者的心理痛苦。
该干预措施将减少照顾者未满足的需求。干预措施的长期目标是减少患者对医疗资源的利用，从而降低成本。将在基线、干预后8周、然后在4、6和12个月时进行评估。参与者还将完成一份医疗资源利用清单和代理表现状态评估，将在基线和每月进行评估。将招募240名照顾者。样本量为180。将应用多水平混合效应回归模型来测试干预措施的效果。
已获得科廷大学和参与研究地点的伦理批准。
研究结果将在国际同行评审期刊上发表。
澳大利亚和新西兰临床试验注册中心（ACTRN）12612001147875。
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