Development of EORTC Quality of Life modules, Phase I-IV [Generic]
Research type
Research Study
Full title
Development and validation of an EORTC disease- or domain-specific quality of life questionnaire: Phases I/II, III, and IV
IRAS ID
289381
Contact name
Mieke Van Hemelrijck
Contact email
Sponsor organisation
King’s College London
Duration of Study in the UK
20 years, 0 months, 1 days
Research summary
The European Organisation of Research and Treatment of Cancer’s Quality of Life Group (EORTC QLG) has developed a four-phase framework that can be used to develop and validate quality of life questionnaires for individuals with cancer. These are developed as modules to supplement their existing EORTC core quality of life questionnaire, the ‘QLQ-C30’. For example, modules have previously been developed for endometrial cancer (QLQ-EN24), bone metastases (QLQ-BM22), and cancer-related fatigue (QLQ-FA12). The four-phase approach comprises a literature review followed by interviews with patients and clinicians (Phase 1), construction of a questionnaire (Phase 2), refinement of the questionnaire (Phase 3), and finally administration of the questionnaire to an international sample in a full validation study (Phase 4). Given that the procedures followed must follow this framework and are therefore extremely similar for every different module, this application seeks ethical approval for a generic description of the procedures involved in this four-phase approach. Approval of the general procedures will enable future module developers to submit their specific protocol as an amendment to this project, eliminating the need for module developers to submit individual ethics applications for each module.
Within the HRA, Tom Lucas will be responsible to make sure this study goes to the right committee.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
21/LO/0915
Date of REC Opinion
16 Feb 2022
REC opinion
Further Information Unfavourable Opinion