GliomaNCT06327048
Application of Cognitive Training Based on the Remind Strategy in Glioma Patients With Cognitive Impairment
A study testing Individual cognitive rehabilitation training based on Remind strategy was given in people with Glioma, run by YuanYuan Ma at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Individual cognitive rehabilitation training based on Remind strategy was given
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2024to 12 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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 .
- Conditions
- Glioma
- Being tested
- Individual cognitive rehabilitation training based on Remind strategy was given
- Keywords
- cognitive training, cognitive impairment, Quality of Life
- Medical subject headings
- Glioma, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual cognitive rehabilitation training based on Remind strategy was givenOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Individual cognitive rehabilitation training based on Remind strategy was given |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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 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.
Measured: The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.
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.
Measured: The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.
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.
Measured: The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.
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.
Measured: The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start21 Jan 2024
- Primary completion12 Jan 2025
- Study completion12 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized intervention study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- YuanYuan Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YuanYuan Ma, LanZhou University
- Investigators
- peifen ma, Master, Study director, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327048
- Sponsor's protocol ID
- LZUHLXY20230110
- Status last verified
- Oct 2024
- First submitted
- 29 Feb 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research data is being preserved by the research team and will be presented in the published paper after the study is completed.
Publications
Ma Y, Zhou R, Ma Y, Mou C, He B, Sun D, Wu X, Dai Y, Ma P. Application of multidimensional cognitive training in the early postoperative period for glioma patients with cognitive impairment. J Neurooncol. 2026 Apr 27;177(3):128. doi: 10.1007/s11060-026-05575-7.
PubMed 42043588
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Cognitive Training Based on Remind Strategy in Glioma Patients With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06327048
- Acronym / sponsor ID
- LZUHLXY20230110
- Conditions
- Glioma
- Keywords
- cognitive training, cognitive impairment, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- YuanYuan MaUniversity, hospital or other
- Study start
- 21 Jan 2024 (actual)
- Primary completion
- 12 Jan 2025 (actual)
- Study completion
- 12 Jan 2025 (actual)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Non-randomized intervention study
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Routine rehabilitation nursing |
| Intervention group | Experimental | Other: Individual cognitive rehabilitation training based on Remind strategy was givenOn the basis of routine rehabilitation nursing, individual cognitive rehabilitation training based on Remind strategy was given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual cognitive rehabilitation training based on Remind strategy was givenThis 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 | Other | Intervention group |
Primary outcome
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.
5 secondary outcomes
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 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.
Self-Rating Anxiety Scale(SAS)
Time frame: 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.
Modified Barthel Index(MBI)
Time frame: The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Derived from this study: PubMed 42043588Ma Y, Zhou R, Ma Y, Mou C, He B, Sun D, Wu X, Dai Y, Ma P. Application of multidimensional cognitive training in the early postoperative period for glioma patients with cognitive impairment. J Neurooncol. 2026 Apr 27;177(3):128. doi: 10.1007/s11060-026-05575-7.
- Individual participant dataSharing planned: No. The research data is being preserved by the research team and will be presented in the published paper after the study is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
peifen ma, Master study director
Lanzhou University Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual cognitive rehabilitation training based on Remind strategy was given in people with Glioma, run by YuanYuan Ma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment(MoCA) (time frame: The day after admission, 7 days after surgery (baseline), at 4-week and 12-week of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06327048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.