Longitudinal Analysis of the Health-related Quality of Life in Glioma Patients
ConditionGlioma of Brain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥ 18 years
patients diagnosed and treated for a high- or low grade glioma
treatment in UZ Leuven
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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).
Time frame
Every 3 months, from diagnosis until date of decease or up to 10 year, whichever came first2
Survival
Date of decease will be reported in a prospective database
Time frame
At time of decease or up to 10 yearSecondary outcomes
1
Treatment strategy
All treatment details will be reported in a prospective database
Time frame
From date of first diagnoses until date of decease or up to 10 year, whichever came firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov