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: Recruiting
• Conditions: Glioma
• Intervention / Treatment: Other: Individual cognitive rehabilitation training based on Remind strategy was given

Detailed Description

Adult patients diagnosed with glioma who meet the inclusion criteria will be enrolled in this study. Patients admitted to Neurosurgery Ward 1 and Ward 2 will be assigned to the intervention group, while those admitted to Neurosurgery 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, one day before discharge, and at the end of the intervention period.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yuanyuan ma, Bachelor; Phone Number: 0931-18809406184; Email: 1657107645@qq.com

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China
      • Recruiting
      • Yuanyuanma
      • Contact: yuanyuan ma, Bachelor; Phone Number: 15294126094; Email: 1657107645@qq.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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, 2 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire (EORTC QLQ-C30)	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, 2 months after surgery
The EORTC QLQ-Brain Neoplasms 20(EORTC QLQ-BN20)	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, 2 months after surgery
Self-Rating Anxiety Scale(SAS)	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, 2 months after surgery
Self-Rating Depression Scale(SDS)	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, 2 months after surgery
Modified Barthel Index(MBI)	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, 2 months after surgery

Collaborators and Investigators

• Sponsor: YuanYuan Ma
• Investigators: Study Director: peifen ma, Master, The Second Hospital of Lanzhou University

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; cognitive training; cognitive impairment
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neurocognitive Disorders; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Cognition Disorders; Glioma; Cognitive Dysfunction
• Other Study ID Numbers: School of Nursing (UW Madison)

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