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Revision of the EORTC QLQ-BN20 Questionnaire (QLQBN20)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04689321
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : December 30, 2020
Sponsor:
Collaborators:
Medical Center Haaglanden
Regina Elena Cancer Institute
San Giovanni Addolorata Hospital
NHS Lothian
University Hospital Regensburg
University Hospital, Bonn
University of Zurich
National Cancer Center, Japan
King Hussein Cancer Center
Clinical Hospital Center Rijeka
Leeds Cancer Centre at St. James's University Hospital
Information provided by (Responsible Party):
LindaDirven, Leiden University Medical Center

Brief 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.


Condition or disease Intervention/treatment
Glioma Brain Metastases, Adult Other: No intervention

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Study Type : Observational
Estimated Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Revision of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-BN20 Brain Tumour Module
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Group/Cohort Intervention/treatment
Phase 1
Patients recruited for phase 1 will undergo a semi-structured interview to identify issues that may be relevant to include in the revised EORTC QLQ-BN20 questionnaire.
Other: No intervention
This is not an interventional study.

Phase 3
Patients recruited for phase 3 will complete the draft questionnaire, and rate each item for relevance, and indicate the 10 most important items. Also, a semi-structured interview will be conducted including debriefing questions to determine if the questionnaire is complete and the questions are acceptable.
Other: No intervention
This is not an interventional study.




Primary Outcome Measures :
  1. Number of relevant items of the EORTC QLQ-BN101 [ Time Frame: Baseline ]
    Construction of the final item list, based on predefined decision rules


Secondary Outcome Measures :
  1. Number of multi-item and single-item scales [ Time Frame: Baseline ]
    Exploratory Factor Analysis to determine multi-item and single-item scales (scales not yet known; items are scored on a 4-point Likert scale ranging from 'Not at all' to 'Very much')

  2. Internal consistency [ Time Frame: Baseline ]
    The internal consistency of the scales will be explored using Cronbach's alpha (scales not yet known; response options for each item are based on a 4-point Likert scale ranging from 'Not at all' to 'Very much')

  3. Convergent validity [ Time Frame: Baseline ]
    Convergent validity of the final item list will be assessed by means of inter-item correlations

  4. Discriminant validity [ Time Frame: Baseline ]
    Discriminant validity of the final item list will be assessed by means of known-group comparisons



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of both patients with a primary brain tumor (histologically confirmed glioma) and metastatic brain tumor (brain metastases with a histologically confirmed primary tumor) who visit the outpatient clinic in The Netherlands, United Kingdom, Italy, Germany, Poland or Japan.
Criteria

Inclusion Criteria:

  • Histologically proven or suspected diffuse astrocytoma (Isocitrate Dehydrogenase-1 (IDH-1) wildtype or IDH-1 mutated), diffuse oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), anaplastic astrocytoma (IDH-1 wildtype or IDH-1 mutated), anaplastic oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), glioblastoma (IDH-1 wild-type or IDH-1 mutated), or diffuse astrocytoma not otherwise specified (NOS), anaplastic astrocytoma NOS, oligodendroglioma NOS, oligoastrocytoma NOS, anaplastic oligoastrocytoma NOS, anaplastic oligodendroglioma NOS or glioblastoma NOS; or radiologically verified metastatic brain tumour.
  • Adult patients: ≥18 years of age
  • Willing to provide written informed consent

Exclusion Criteria:

  • Patients without understanding of the official language of the country in which they live.
  • Patients with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper undergoing semi-structured interviews.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04689321


Contacts
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Contact: Linda Dirven, PhD +31715296735 l.dirven@lumc.nl

Locations
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Netherlands
Leiden University Medical Center Recruiting
Leiden, South-Holland, Netherlands, 2333 ZA
Contact: Martin Taphoorn, MD, PhD    +31715262197    m.j.b.taphoorn@lumc.nl   
Sponsors and Collaborators
Leiden University Medical Center
Medical Center Haaglanden
Regina Elena Cancer Institute
San Giovanni Addolorata Hospital
NHS Lothian
University Hospital Regensburg
University Hospital, Bonn
University of Zurich
National Cancer Center, Japan
King Hussein Cancer Center
Clinical Hospital Center Rijeka
Leeds Cancer Centre at St. James's University Hospital
Investigators
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Principal Investigator: Linda Dirven, PhD Leiden University Medical Center
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Responsible Party: LindaDirven, Principal Investigator, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT04689321    
Other Study ID Numbers: P18.095
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: December 30, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This study is funded by the European Organisation for Research and Treatment of Cancer, and data will be stored there. Researchers can request data according to the EORTC's data sharing policy.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LindaDirven, Leiden University Medical Center:
health-related quality of life
patient-reported outcome
brain tumor
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases