Longitudinal Analysis of the Health-related Quality of Life in Glioma Patients (Glioma2015)

• ClinicalTrials.gov Identifier: NCT03849430
• Recruitment Status: Recruiting
• First Posted: February 21, 2019
• Last Update Posted: November 25, 2020
• Sponsor: Universitaire Ziekenhuizen Leuven
• Information provided by (Responsible Party): Prof. Dr. Steven De Vleeschouwer, Universitaire Ziekenhuizen Leuven

Study Description

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.

Condition or disease
Glioma of Brain

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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 750 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 10 Years
• 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
• Actual Study Start Date: December 14, 2015
• Estimated Primary Completion Date: January 1, 2030
• Estimated Study Completion Date: January 1, 2030

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Change over time of quality of life from diagnosis until end of active treatment [ Time Frame: Every 3 months, from diagnosis until date of decease or up to 10 year, whichever came first ]
   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).
2. Survival [ Time Frame: At time of decease or up to 10 year ]
   Date of decease will be reported in a prospective database

Secondary Outcome Measures :

1. Treatment strategy [ Time Frame: From date of first diagnoses until date of decease or up to 10 year, whichever came first ]
   All treatment details will be reported in a prospective database

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

Inclusion criteria:

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

Contacts and Locations

Contacts

Contact: Steven De Vleeschouwer, MD Phd; +3216344290; steven.devleeschouwer@uzleuven.be

Locations

Belgium

UZ Leuven; Recruiting

Leuven, Vlaams-Brabant, Belgium, 3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

• Principal Investigator: Steven De Vleeschouwer, MD Phd; UZ Leuven

More Information

Additional Information:

• Responsible Party: Prof. Dr. Steven De Vleeschouwer, Member of Staff Neurosurgery, Clinical Professor, Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT03849430
• Other Study ID Numbers: S58343
• First Posted: February 21, 2019
• Last Update Posted: November 25, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Steven De Vleeschouwer, Universitaire Ziekenhuizen Leuven:

Low grade glioma; High grade glioma; HRQOL

Additional relevant MeSH terms:

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