Clinical trial NCT06327048: Application of Cognitive Training Based on the Remind Strategy in Glioma Patients With Cognitive Impairment
Official title: Application of Cognitive Training Based on Remind Strategy in Glioma Patients With Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioma
Keywords: cognitive training
cognitive impairment
Quality of Life
Lead sponsor: LanZhou University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomized intervention study
Primary purpose: OTHER

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Montreal Cognitive Assessment(MoCA)
timeFrame: The day after admission, 7 days after surgery, 2 months after surgery
Secondary outcomes:
measure: The European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: The day after admission, 7 days after surgery, 2 months after surgery
measure: The EORTC QLQ-Brain Neoplasms 20(EORTC QLQ-BN20)
timeFrame: The day after admission, 7 days after surgery, 2 months after surgery
measure: Self-Rating Anxiety Scale(SAS)
timeFrame: The day after admission, 7 days after surgery, 2 months after surgery
measure: Self-Rating Depression Scale(SDS)
timeFrame: The day after admission, 7 days after surgery, 2 months after surgery
measure: Modified Barthel Index(MBI)
timeFrame: The day after admission, 7 days after surgery, 2 months after surgery
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Yuanyuanma
state: Gansu
Study officials:
affiliation: Lanzhou University Second Hospital
name: peifen ma, Master
role: STUDY_DIRECTOR
References: