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一项评估基于证据的 iPad 应用程序对原发性脑肿瘤患者认知康复疗效的随机对照试验研究方案。

Study Protocol for a Randomized Controlled Trial Evaluating the Efficacy of an Evidence-Based iPad-App for Cognitive Rehabilitation in Patients with Primary Brain Tumors.

机构信息

Department of Neurosurgery, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.

Department of Cognitive Neuropsychology, Tilburg University, Tilburg, The Netherlands.

出版信息

Neurosurgery. 2019 Aug 1;85(2):273-279. doi: 10.1093/neuros/nyy254.

DOI:10.1093/neuros/nyy254
PMID:29917115
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6626705/
Abstract

BACKGROUND

Many patients with primary brain tumors suffer from cognitive deficits, which negatively impact their quality of life. However, cognitive rehabilitation programs for these patients are scarce. We developed an iPad-based cognitive rehabilitation program for brain tumor patients, which was based on our effective face-to-face cognitive rehabilitation program. After successful completion of a feasibility study, a randomized controlled trial has been started.

OBJECTIVE

To evaluate the immediate and long-term effects of the iPad-based program on cognitive performance and patient-reported outcome measures (PROMs) in patients with primary brain tumors in an early stage of the disease.

METHODS

Prior to surgery, patients with presumed low-grade glioma and meningioma are included. Before surgery and 3 mo after surgery, neuropsychological assessments are conducted. After the second neuropsychological assessment, patients are assigned to the intervention group or waiting-list control group. The intervention consists of psychoeducation, compensation training, and retraining. Patients are advised to spend 3 h per week on the program for 10 wk. Immediately after completion of the program and a half-year thereafter, postintervention assessments take place. Patients in the control group are offered the opportunity to follow the program after all study assessments.

EXPECTED OUTCOMES

We expect that early cognitive rehabilitation has beneficial effects on cognitive performance and PROMs in brain tumor patients.

DISCUSSION

The iPad-based program allows brain tumor patients to follow a cognitive rehabilitation program from their homes. Forthcoming results may contribute to further improvement of supportive care for brain tumor patients.

摘要

背景

许多原发性脑肿瘤患者存在认知缺陷,这对他们的生活质量产生负面影响。然而,针对这些患者的认知康复计划却很少。我们基于有效的面对面认知康复计划,为脑肿瘤患者开发了一种基于 iPad 的认知康复程序。在成功完成可行性研究后,已启动一项随机对照试验。

目的

评估基于 iPad 的程序对疾病早期原发性脑肿瘤患者认知表现和患者报告的结果测量(PROMs)的即时和长期影响。

方法

在手术前,纳入疑似低级别胶质瘤和脑膜瘤患者。在手术前和手术后 3 个月进行神经心理学评估。在第二次神经心理学评估后,患者被分配到干预组或等待名单对照组。干预包括心理教育、补偿训练和再训练。建议患者每周使用该程序 3 小时,持续 10 周。在完成该程序后立即和半年后进行干预后评估。对照组患者在所有研究评估后都有机会参加该计划。

预期结果

我们期望早期认知康复对脑肿瘤患者的认知表现和 PROMs 有有益的影响。

讨论

基于 iPad 的程序允许脑肿瘤患者在家中进行认知康复计划。即将公布的结果可能有助于进一步改善脑肿瘤患者的支持性护理。

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本文引用的文献

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Feasibility of the evidence-based cognitive telerehabilitation program Remind for patients with primary brain tumors.基于证据的认知远程康复计划 Remind 用于原发性脑肿瘤患者的可行性。
J Neurooncol. 2018 May;137(3):523-532. doi: 10.1007/s11060-017-2738-8. Epub 2018 Jan 10.
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Don't need help, don't want help, can't get help: How patients with brain tumors account for not using rehabilitation, psychosocial and community services.无需帮助、不想寻求帮助、无法获得帮助:脑瘤患者不使用康复、心理社会和社区服务的原因。
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J Neurooncol. 2021 Sep;154(3):315-326. doi: 10.1007/s11060-021-03828-1. Epub 2021 Sep 6.
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Cognitive outcomes in meningioma patients undergoing surgery: individual changes over time and predictors of late cognitive functioning.脑膜瘤患者手术治疗后的认知结果:随时间的个体变化及晚期认知功能的预测因素。
Neuro Oncol. 2019 Jul 11;21(7):911-922. doi: 10.1093/neuonc/noz039.
胶质瘤和其他脑肿瘤患者的认知康复:最新进展
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J Neurooncol. 2013 Aug;114(1):93-100. doi: 10.1007/s11060-013-1153-z. Epub 2013 May 16.