Clinical trial NCT03849430: Longitudinal Analysis of the Health-related Quality of Life in Glioma Patients
Official title: Longitudinal Analysis of the Health-related Quality of Life in Glioma Patients and Setting Up a Large-scale, Prospective Database for Glioma Patients Treated in UZ Leuven
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioma of Brain
Keywords: Low grade glioma
High grade glioma
HRQOL
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Aims of the study

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 and to set up a database which contains general patient characteristics, tumor information, treatment strategy and follow-up data of each included patient. This large-scale database will allow the investigator to investigate several relevant research questions in a well-documented group of glioma patients.

Methodology

HRQOL is a multidimensional concept covering physical, psychological and social domains as well as symptoms induced by the disease and the treatment. Currently there is no single gold standard tool to measure HRQOL, and several valid measures of HRQOL in brain tumor patients are available. In this study the investigator will use the EQ-5D questionnaire to report patient's HRQOL. The EQ-5D is widely used and has been validated in many different patient populations. It has been designed so that patients can describe the extent to which they have a problem in each of the five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression The timing of the HRQOL questionnaires will depend on whether a patient will be diagnosed with either a LGG or a HGG. Moreover, as the current treatment strategies for LGG patients and for relapsed HGG patients are highly variable, the investigator scheduled the HRQOL measurements not in function of the treatment, but rather in function of the classical, standard-of-care patient follow-up (either 3 or 6 monthly).

Missing data

When there are missing data for some patients, the question arises as to whether patients with missing data differ from those who returned completed forms. As a consequence, missing data presents problems in the analysis and the interpretation of the results. Hence, the amount of missing data should be minimized. A regular check on missing data will be performed by the CTA. In case the HRQOL form was not completed by the included patient, the patient will be contacted by phone or e-mail and he/she will be asked to provide an answer to the different questions of the HRQOL questionnaire in order to avoid missing data. In case the patient is unable to complete the HRQOL questionnaire, the CTA will report the reason for non-completion in the database.

Eligibility criteria: Inclusion criteria:

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

Primary outcomes:
measure: Change over time of quality of life from diagnosis until end of active treatment
timeFrame: Every 3 months, from diagnosis until date of decease or up to 10 year, whichever came first
measure: Survival
timeFrame: At time of decease or up to 10 year
Secondary outcomes:
measure: Treatment strategy
timeFrame: From date of first diagnoses until date of decease or up to 10 year, whichever came first
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Steven De Vleeschouwer, MD Phd
role: PRINCIPAL_INVESTIGATOR
References: