Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04689321 |
| Other study ID # |
P18.095 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 19, 2018 |
| Est. completion date |
January 1, 2024 |
Study information
| Verified date |
December 2020 |
| Source |
Leiden University Medical Center |
| Contact |
Linda Dirven, PhD |
| Phone |
+31715296735 |
| Email |
l.dirven[@]lumc.nl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Despite the fact that use of the European Organisation for Research and Treatment of Cancer
(EORTC) Quality of Life Questionnaire - Brain Neoplasm (QLQ-BN20) has tremendously
contributed to insight into the health-related quality of life (HRQoL) of brain tumor
patients, certain items of the questionnaire have raised issues, and new treatments have been
introduced, with different toxicity profiles not covered by the current measure. These
observations have led to the recognition that a revision of the QLQ-BN20 is warranted.
The aim of this project is to update the current EORTC QLQ-BN20 questionnaire.
Description:
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life
Questionnaire - Brain Neoplasm (QLQ-BN20) brain tumor module was developed and validated in
1996, with a phase IV validation in 2010. The aim of this module was to evaluate the effects
of the tumor and its treatment on symptoms, functions and health-related quality of life
(HRQoL) of brain tumor patients, both in clinical trials and clinical practice.
An unpublished systematic review conducted by our group revealed that since the publication
of the QLQ-BN20 in 1996, there has been an increase in the use of this questionnaire, not
only in glioma patients for whom this questionnaire was developed, but also in meningioma
patients, patients with brain metastases or groups with mixed types of brain tumors. The use
of the QLQ-BN20 showed an increase over time: from 20 publications in the period 1996-2006,
to 98 publications in the period 2007-2016.
One of the reasons for updating the current QLQ-BN20 questionnaire is that were have
encountered limitations in the use of specific items. For example, the item referring to the
occurrence of seizures results in an underestimation of the true prevalence of seizures. In
previous clinical studies it was shown that 30-60% of the brain tumor patients experience
seizures. In contrast, large randomized controlled trials using the QLQ-BN20 to determine
seizure occurrence showed prevalences of only 6 to 14 percent. This is probably due to the
time frame that is used for this item, i.e. the 'last week'. Although seizures are frequent,
they often do not occur weekly. With the current response format, detection of seizures is
difficult and this should be taken into account in the revision of the QLQ-BN20
questionnaire. Second, several items show severe floor-effects. Probably the most important
reason to revise the current QLQ-BN20 questionnaire is because major advances in the
treatment of brain tumors have been made in the last 20 years. Compared to 20 years ago, when
the QLQ-BN20 was developed, current standard treatment (multimodal treatment including
surgery, radiotherapy and chemotherapy) is different and treatments have a different toxicity
profile. Moreover, new treatment opportunities are currently explored and include targeted
treatment and immunotherapy. These types of treatment bring new toxicities, e.g. eye, skin
and endocrine function problems. The current brain tumor module lacks sufficient coverage of
domains that are affected by current and new treatment options.
Thus, despite the fact that use of the QLQ-BN20 has tremendously contributed to insight into
the quality of life of brain tumor patients, several observations have led to the recognition
that a revision of the QLQ-BN20 is warranted. Therefore, the aim of this project is to update
the current EORTC QLQ-BN20 questionnaire.
Aim: The overall aim of this study is to update the current EORTC QLQ-BN20 questionnaire for
use in brain tumor patients.
Study design: The methods for this prospective study will follow the EORTC Quality of Life
Group guidelines for updating existing modules, including a literature review, interviews
with patients and health care professionals (for the identification of items relevant to
current/new treatments (phase I)), creation of a revised item list (phase II), and
psychometric pilot testing (phase III).
Phase 1: Semi-structured interviews with 27 patients and 6 healthcare professionals to
identify relevant issues for brain tumor patients (these issues are identified with a
systematic literature review and have to reflect the patients' functioning and well-being,
such as symptoms / impairments, activities in daily life and participation restrictions).
Phase 2: Construction of a comprehensive item list with items that are relevant for brain
tumor patients (including construction of items, and translations).
Phase 3: The draft item list resulting from phase II will be pretested in 108 patients from
at least 6 countries in 4 main European regions and Asia (Netherlands, Germany, Italy, United
Kingdom, Switzerland, Croatia, Jordan and Japan). The primary aim of pretesting the module is
to identify and solve potential problems (phrasing, sequence questions) and to identify
missing or redundant items. Second, preliminary psychometric testing will be performed.
The questionnaire resulting from phase III will subsequently be field-tested in a large,
international group of patients in order to determine its acceptability, reliability,
validity, responsiveness and cross-cultural applicability. This is currently not part of the
study protocol, but will commence after phase III is successfully completed.
