- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07416838
Quality of Life and Cognitive Functioning in Patients With Glial Tumors
February 13, 2026 updated by: Institute of Oncology Ljubljana
Quality of Life and Cognitive Functioning as Prognostic Factor in Glial Tumours
The aim of this study is to introduce appropriate assessment instruments and to define patients with gliomas according to cognitive functioning and quality of life.
The study will evaluate cognitive functioning as a prognostic factor for survival in patients with glial tumors and will support optimization of treatment strategies to improve patients' quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This prospective cohort study will assess cognitive functioning and quality of life in patients with glial tumors.
The objective is to determine the prognostic value of cognitive functioning on survival, establish appropriate assessment instruments, and contribute to treatment adaptation with the goal of improving quality of life in these patients.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- 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 Locations
-
-
-
Ljubljana, Slovenia, 1000
- Institute of Oncology Ljubljana
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult participants (≥18 years)
- Patients with histologically confirmed glial tumour
- Ability to understand the study procedures and provide written informed consent
- Ability to complete quality of life questionnaires and cognitive testing
Exclusion Criteria:
- Age <18 years
- Inability to provide informed consent
- Severe cognitive impairment or clinical condition preventing completion of questionnaires and cognitive testing
- Insufficient language proficiency to complete the questionnaires and neuropsychological testing
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Glioma Patients
Patients with glial tumors assessed for quality of life and cognitive functioning as prognostic factors.
|
Assessment of cognitive functioning and quality of life in patients with glial tumors to evaluate their prognostic value and impact on survival outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality of Life Score (EORTC QLQ-C30 and QLQ-BN20)
Time Frame: Baseline (before treatment); 6 weeks; 3 months; 6 months; 12 months
|
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer questionnaires EORTC QLQ-C30 and the brain cancer module EORTC QLQ-BN20.
Scores range from 0 to 100 points.
The outcome will be reported as mean change in questionnaire score (points) from baseline to each follow-up assessment.
|
Baseline (before treatment); 6 weeks; 3 months; 6 months; 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cognitive Function Test Performance (Neuropsychological Test Battery)
Time Frame: Baseline (before treatment); 6 weeks; 3 months; 6 months; 12 months
|
Cognitive functioning will be assessed using a neuropsychological test battery evaluating multiple cognitive domains (e.g., language, memory, executive functioning).
The outcome will be reported as mean change in test scores from baseline to each follow-up assessment.
|
Baseline (before treatment); 6 weeks; 3 months; 6 months; 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 21, 2018
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
February 6, 2026
First Submitted That Met QC Criteria
February 13, 2026
First Posted (Actual)
February 18, 2026
Study Record Updates
Last Update Posted (Actual)
February 18, 2026
Last Update Submitted That Met QC Criteria
February 13, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OI-427-GLIAL-QOL-COG
- ERID-EK/158 (Other Identifier: Ethics Committee of the Institute of Oncology Ljubljana)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.