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临床试验/NCT06327048
NCT06327048已完成不适用

Application of Cognitive Training Based on Remind Strategy in Glioma Patients With Cognitive Impairment

YuanYuan Ma1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2024年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
69
试验地点
1
主要终点
Montreal Cognitive Assessment(MoCA)

研究概览

简要总结

The purpose of this study is to form an interdisciplinary team to dynamically evaluate patient cognitive outcomes and develop an individualized cognitive training program for Chinese brain tumor patients

详细描述

Adult patients diagnosed with glioma who meet the inclusion criteria will be enrolled in this study. Patients admitted to Neurosurgery Ward 1 will be assigned to the intervention group, while those admitted to Neurosurgery Ward 2,ward 3 and Ward 4 will serve as the control group. The intervention group will receive cognitive rehabilitation training based on the Remind strategy in addition to standard rehabilitation care, whereas the control group will receive only standard rehabilitation care. Assessment of patients' cognitive function, quality of life, psychological status, and the effectiveness of cognitive training intervention will be conducted on the first day of admission, before intervention, at the end of the 4-week and 12-week intervention .

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Blind the evaluator

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Conforming to the diagnostic criteria outlined in the "Chinese Clinical Guidelines for Diagnosis and Treatment of Central Nervous System Gliomas (2015)" ;
  • Patients diagnosed with brain gliomas through histopathological and/or cytological examination;
  • MoCA (Montreal Cognitive Assessment) score ≤ 26;
  • Karnofsky Performance Status (KPS) score ≥ 60, with no history of past illnesses;
  • Age ≥ 18 years;
  • Clear consciousness;
  • Willingness to participate and signed informed consent form.

排除标准

  • Diagnosed with neurological or psychiatric disorders within the past two years;
  • Impaired consciousness;
  • Accompanied by severe complications such as infections;
  • Nursing Delirium Screening Checklist (Nu-DESC) score ≥ 2;
  • Patients with changes in condition or requiring repeat surgery;
  • Patients with multiple intracranial tumors;
  • Inability to effectively complete the questionnaire or withdrawal during the study.

结局指标

主要结局

Montreal Cognitive Assessment(MoCA)

时间窗: The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.

The Montreal Cognitive Assessment (MoCA) is commonly used to assess cognitive function, typically taking about 15 minutes to complete. It has a total score of 30 points, with a score of ≥26 considered normal. Lower scores indicate more severe cognitive impairment. MoCA is advantageous due to its ease of administration, short duration, and high reliability and validity.

次要结局

  • The European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire (EORTC QLQ-C30)(The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.)
  • Self-Rating Anxiety Scale(SAS)(The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.)
  • Self-Rating Depression Scale(SDS)(The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.)
  • The EORTC QLQ-Brain Neoplasms 20(EORTC QLQ-BN20)(The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.)
  • Modified Barthel Index(MBI)(The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.)

研究者

发起方
YuanYuan Ma
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

YuanYuan Ma

supervisor nurse

LanZhou University

研究点 (1)

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