Revision EORTC QLQ-BN20 module
Research type
Research Study
Full title
Revision of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-BN20 brain tumour module
IRAS ID
252358
Contact name
Florien Boele
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
Research Summary
Rationale: Despite the fact that use of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-BN20 has tremendously contributed to insight into the health-related quality of life (HRQoL) of brain tumour 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.
Objective: The aim of this project is to update the current EORTC QLQ-BN20 questionnaire.
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).
Study population: The study population consists of adult patients with a histologically proven or suspected glioma or radiologically verified metastatic brain tumours.
Intervention: Not applicable.
Main study parameters/endpoints: The main study parameters are item selection and generation, and psychometric properties of the module such as scale structure, validity and reliability.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no direct benefits for patients participating in this study. Nevertheless, their participation will contribute to the development of a valid and reliable questionnaire to measure HRQoL of patients with brain tumors. On the other hand, participation in this study has possible risks for the patients. Patients are confronted with issues that brain tumor patients have, which may pose a psychological burden on them. Moreover, it will cost patients time to attend the interviews and complete the questionnaires, although this is not substantial.
This ethics application is for the UK sites only and the University of Leeds is acting as sponsor for the study taking place in the UK sites.Summary of Results
A brain tumour, but also its treatment, may cause several symptoms and signs. These symptoms and signs may consequently impact a person's health-related quality of life. Currently, there is a questionnaire available that measures health-related quality of life of brain tumour patients, the EORTC QLQ- BN20. However, this questionnaire has been developed more than 20 years ago, and since then treatment has changed considerably, including the adverse effects that patients’ experience. These new symptoms or signs are not sufficiently covered in the existing questionnaire. In addition, some items are poorly formulated, which could be improved. Based on these findings, it seems warranted to revise the current questionnaire. Therefore, the aim of this study is to update the current EORTC QLQ-BN20 questionnaire, to better measure health-related quality of life of brain tumour patients. Data collection has completed and the study team is preparing data analysis.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
19/ES/0010
Date of REC Opinion
29 Jan 2019
REC opinion
Further Information Favourable Opinion