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

August 6, 2025 updated by: YuanYuan Ma

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China
        • Yuanyuanma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Routine rehabilitation nursing
Experimental: Intervention group
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire (EORTC QLQ-C30)
Time Frame: The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.
The European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire (EORTC QLQ-C30) includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health and QoL scale, as well as individual items to assess other symptoms commonly experienced by cancer patients (such as dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), and the perceived economic impact of the disease and treatment. All items are scored using a 4-point Likert scale (1: 'not at all'; to 4: 'very much'), except for two items in the global health/QoL scale which use a modified 7-point linear analog scale. Higher scores indicate poorer quality of life.
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)
Time Frame: 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) is a tool specifically designed to assess the quality of life of patients with brain tumors. The instrument consists of four multi-item scales covering: future uncertainty; visual disorders; motor dysfunction; communication deficit. Additionally, seven individual items assess headache, seizures, drowsiness, hair loss, itching, weakness of legs, and bladder control. All items and scores are evaluated on a scale of 0-100, with higher scores reflecting more severe symptoms.
The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.
Self-Rating Anxiety Scale(SAS)
Time Frame: The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.
The Self-Rating Anxiety Scale (SAS) is used to assess the subjective feelings of anxiety patients. The scale consists of 20 items aimed at quantifying the severity of anxiety-related symptoms experienced by patients. It is divided into four levels on a Likert four-point scale: None or rarely, Sometimes, Often, and Always. Scores range from 20 to 80, with 20-44 considered normal, 45-59 indicating mild to moderate anxiety levels, 60-74 indicating severe anxiety levels, and extreme anxiety levels falling between 75 and 80.
The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.
Self-Rating Depression Scale(SDS)
Time Frame: The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.
The Self-Rating Depression Scale (SDS) is used to assess an individual's subjective feelings of depression. The scale consists of 20 items rated on a Likert four-point scale: None or rarely, Sometimes, Often, and Always. Higher scores indicate higher levels of depression in the individual.
The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.
Modified Barthel Index(MBI)
Time Frame: The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.
The Modified Barthel Index (MBI) is widely used in clinical practice to assess activities of daily living (ADL). It reflects patients' ability to perform self-care activities such as dressing, feeding, personal hygiene, as well as mobility activities such as sitting, standing, and walking. This scale is straightforward, easy to administer, and has good reliability and validity.
The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
YuanYuan Ma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: peifen ma, Master, Lanzhou University Second Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LZUHLXY20230110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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