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侵袭性淋巴瘤化疗后癌症相关认知障碍的基于网络的认知康复干预:一项随机试点试验方案

Web-based cognitive rehabilitation intervention for cancer-related cognitive impairment following chemotherapy for aggressive lymphoma: protocol for a randomised pilot trial.

作者信息

Gates Priscilla, Green Heather J, Gough Karla, Dhillon Haryana, Vardy Janette L, Dickinson Michael, Guarnera Jade, Krishnasamy Meinir, Livingston Patricia M, White Victoria, Ugalde Anna, Caeyenberghs Karen

机构信息

Cognitive Neuroscience Unit, Deakin University, Burwood, Victoria, Australia

Health Services Research, Peter MacCallum Cancer Institute, Melbourne, Victoria, Australia.

出版信息

BMJ Open. 2024 Apr 22;14(4):e081084. doi: 10.1136/bmjopen-2023-081084.

Abstract

INTRODUCTION

Cancer-related cognitive impairment is common among people diagnosed with and treated for cancer. This can be a distressing and disabling side effect for impacted individuals. Interventions to mitigate cognitive dysfunction are available, but, to date, most have been trialled in samples that are largely or exclusively composed of people with solid tumours. Intervention strategies to support cognitive functioning are needed, but there is a paucity of research in this area. The main aim of this study is to test the feasibility and acceptability of methods and procedures intended for use in a definitive trial of a web-based cognitive rehabilitation programme, Responding to Cognitive Concerns (eReCog), in people who have received chemotherapy for aggressive lymphoma.

METHODS AND ANALYSIS

The proposed study is a single-site, parallel-group, pilot randomised controlled trial, with one baseline and one follow-up (or postintervention) assessment. 38 people from the target population with low perceived cognitive function based on the Cognitive Change Screen will be recruited from a specialist cancer centre between July 2023 and June 2024. After baseline assessment, participants will be randomised one-to-one to receive usual care only (a factsheet about changes in memory and thinking for people with cancer) or eReCog plus usual care. The 4-week eReCog intervention consists of four online modules offering psychoeducation on cognitive impairment associated with cancer and its treatment, skills training for improving memory, and attention and relaxation training. Study outcomes will include the feasibility of recruitment and retention at follow-up assessment (primary outcomes), as well as adherence to, usability of and intrinsic motivation to engage with eReCog, and compliance with study measures. The potential efficacy of eReCog will also be evaluated.

ETHICS AND DISSEMINATION

Ethical approval was granted by the Peter MacCallum Cancer Centre Human Research Ethics Committee in Victoria, Australia (HREC/97384/PMCC). Study findings will be disseminated via peer-reviewed publications and conference presentations.

TRIAL REGISTRATION NUMBER

Australian New Zealand Clinical Trials Registry, ACTRN12623000705684.

摘要

引言

癌症相关的认知障碍在被诊断患有癌症并接受治疗的人群中很常见。对于受影响的个体来说,这可能是一种令人痛苦且致残的副作用。虽然有减轻认知功能障碍的干预措施,但迄今为止,大多数措施都是在主要或完全由实体瘤患者组成的样本中进行试验的。需要支持认知功能的干预策略,但该领域的研究很少。本研究的主要目的是测试用于基于网络的认知康复计划“应对认知问题(eReCog)”确定性试验的方法和程序在接受侵袭性淋巴瘤化疗的人群中的可行性和可接受性。

方法与分析

拟进行的研究是一项单中心、平行组、试点随机对照试验,有一次基线评估和一次随访(或干预后)评估。2023年7月至2024年6月期间,将从一家专业癌症中心招募38名基于认知变化筛查认知功能较低的目标人群。基线评估后,参与者将一对一随机分组,仅接受常规护理(一份关于癌症患者记忆和思维变化的情况说明书)或eReCog加常规护理。为期4周的eReCog干预包括四个在线模块,提供关于癌症及其治疗相关认知障碍的心理教育、改善记忆的技能培训以及注意力和放松训练。研究结果将包括随访评估时招募和留住参与者的可行性(主要结果),以及对eReCog的依从性、可用性和参与的内在动机,以及对研究措施的依从性。还将评估eReCog的潜在疗效。

伦理与传播

澳大利亚维多利亚州彼得·麦卡勒姆癌症中心人类研究伦理委员会已批准伦理许可(HREC/97384/PMCC)。研究结果将通过同行评审出版物和会议报告进行传播。

试验注册号

澳大利亚新西兰临床试验注册中心,ACTRN12623000705684。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e57e/11043699/32e197a6a258/bmjopen-2023-081084f01.jpg

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