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Clinical Trials/NCT06327048
NCT06327048CompletedNot Applicable

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

YuanYuan Ma1 site in 1 country69 target enrollmentStarted: January 21, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
69
Locations
1
Primary Endpoint
Montreal Cognitive Assessment(MoCA)

Study Overview

Brief Summary

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

Detailed Description

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 .

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Masking Description

Blind the evaluator

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Montreal Cognitive Assessment(MoCA)

Time Frame: 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.

Secondary Outcomes

  • 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.)

Investigators

Sponsor
YuanYuan Ma
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

YuanYuan Ma

supervisor nurse

LanZhou University

Study Sites (1)

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