NCT06327048

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 29, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2025

Completed
Last Updated

August 12, 2025

Status Verified

October 1, 2024

Enrollment Period

12 months

First QC Date

February 29, 2024

Last Update Submit

August 6, 2025

Conditions

Keywords

cognitive trainingcognitive impairmentQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment(MoCA)

    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.

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

Secondary Outcomes (5)

  • 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.

  • 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.

  • 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.

  • Modified Barthel Index(MBI)

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

Study Arms (2)

Control group

NO INTERVENTION

Routine rehabilitation nursing

Intervention group

EXPERIMENTAL

On the basis of routine rehabilitation nursing, individual cognitive rehabilitation training based on Remind strategy was given

Other: Individual cognitive rehabilitation training based on Remind strategy was given

Interventions

This training educates and learns patients from the aspects of assessment of cognitive function and strategic compensation for the impact of cognitive impairment on patients, and then conducts attention, memory and executive function training and attention retraining based on patients' cognitive function to improve patients' cognitive function

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuanyuanma

Lanzhou, Gansu, China

Location

MeSH Terms

Conditions

GliomaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • peifen ma, Master

    Lanzhou University Second Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blind the evaluator
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Non-randomized intervention study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
supervisor nurse

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 25, 2024

Study Start

January 21, 2024

Primary Completion

January 12, 2025

Study Completion

January 12, 2025

Last Updated

August 12, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

The research data is being preserved by the research team and will be presented in the published paper after the study is completed.

Locations