Longitudinal Analysis of the Health-related Quality of Life in Glioma Patients

NCT03849430 | Recruiting

• 1 other identifier: S58343
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

Gliomas are the most common primary intracranial tumors, representing at least 75% of all primary malignant brain tumors. Histopathologically, gliomas are classified into different subgroups including astrocytomas (60-70%), oligodendrogliomas (10-30%), ependymomas (\<10%) and mixed gliomas (i.e. oligoastrocytomas) depending on the cell type from which they originate. The World Health Organization currently classifies gliomas based on histopathological analysis in which the presence (or absence) and the degree of specific histopathological features determines the grade of malignancy. Grade I (pilocytic astrocytoma) and grade II (diffuse astrocytoma, oligodendroglioma, mixed oligoastrocytoma, and pleomorphic xanthoastrocytoma) are termed low-grade gliomas (LGGs), whereas grade III (anaplastic astrocytoma, anaplastic oligodendroglioma or anaplastic oligoastrocytoma) and grade IV (glioblastoma) represent high-grade gliomas (HGGs). Given the incurable nature of gliomas, the maintenance or improvement of the patient's quality of life are extremely important. The benefits of multimodal treatment strategies, in terms of prolonged survival or delay of progression, have to be carefully balanced against the side effects of the treatment, which may adversely influence patient's functioning and well-being during his/her remaining life span. Measuring a brain tumor patients functioning and well-being goes far beyond assessing (progression-free) survival or tumor response to treatment on imaging. A more integrated way to measure patients functioning and well-being is the assessment of a patient's health-related quality of life (HRQOL). HRQOL is defined as a personal self-assessed ability to function in the physical, psychological, emotional, and social domains of day-to-day life. The main goal of this study is to perform a large-scale, prospective and long-term analysis of the HRQOL in patients diagnosed with glioma.

Conditions

Glioma of Brain

Keywords

Low grade glioma; High grade glioma; HRQOL

Outcome Measures

Primary Outcomes (2)

• Change over time of quality of life from diagnosis until end of active treatment

  Quality of life is assessed using the EQ-5D-5L (EuroQol 5 Dimensions 5 Level scale), which has 2 components. The description component measures health status in terms of 5 dimensions; mobility (ability to walk), self-care (ability to wash or dress by oneself), usual activities (performance in work, study, housework, family or leisure activities), pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The respondents self-rate their level of severity for each dimension. Each level of each dimension corresponds to a 1-digit number. All together a 5-digit number describes the patient's health state (3,125 (55) different health states are possible). In the evaluation component, the respondents evaluate their overall health status by valuing health-related quality of life from 0 (corresponding to the worst health you can imagine) to 100 (corresponding to the best health you can imagine).

  Every 3 months, from diagnosis until date of decease or up to 10 year, whichever came first

• Survival

  Date of decease will be reported in a prospective database

  At time of decease or up to 10 year

Secondary Outcomes (1)

• Treatment strategy

  From date of first diagnoses until date of decease or up to 10 year, whichever came first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The GLIOMA-2015 study will include adult patients that will be diagnosed and/or operated and/or treated and followed-up for a low- or high grade glioma in UZ Leuven.

You may qualify if:

• age ≥ 18 years
• patients diagnosed and treated for a high- or low grade glioma
• treatment in UZ Leuven

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Steven De Vleeschouwer, MD Phd

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven De Vleeschouwer, MD Phd

CONTACT

+3216344290; steven.devleeschouwer@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Member of Staff Neurosurgery, Clinical Professor

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 21, 2019
• Study Start: December 14, 2015
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)