Revision of the EORTC QLQ-BN20 Questionnaire

NCT04689321 | Unknown

• 1 other identifier: P18.095
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma; Brain Metastases, Adult

Keywords

health-related quality of life; patient-reported outcome; brain tumor

Outcome Measures

Primary Outcomes (1)

• Number of relevant items of the EORTC QLQ-BN101

  Construction of the final item list, based on predefined decision rules

  Baseline

Secondary Outcomes (4)

• Number of multi-item and single-item scales

  Baseline

• Internal consistency

  Baseline

• Convergent validity

  Baseline

• Discriminant validity

  Baseline

Study Arms (2)

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

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

Interventions

No intervention OTHER

This is not an interventional study.

Phase 1; Phase 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Medical Center Haaglanden: collaborator
• Regina Elena Cancer Institute: collaborator
• San Giovanni Addolorata Hospital: collaborator
• NHS Lothian: collaborator
• University Hospital Regensburg: collaborator
• University Hospital, Bonn: collaborator
• University of Zurich: collaborator
• National Cancer Center, Japan: collaborator
• King Hussein Cancer Center: collaborator
• Clinical Hospital Center Rijeka: collaborator
• Leeds Cancer Centre at St. James's University Hospital: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Linda Dirven, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Dirven, PhD

CONTACT

+31715296735; l.dirven@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 30, 2020
• Study Start: December 19, 2018
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)