Development of EORTC QoL questionnaire in UK,UM patients V1.0
Research type
Research Study
Full title
An international field study for the reliability and validity of the European Organization of Research and Treatment of Cancer (EORTC) Ophthalmic Oncology Quality of Life(QoL) Questionnaire Module: the EORTC QLQ-OPT XX (Phase 4 including an update of Phase 1-3): Development of an EORTC Questionnaire to assess quality of life of patients with uveal melanoma (UM)
IRAS ID
343507
Contact name
Peter Fisher
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
4 years, 11 months, 29 days
Research summary
The purpose of this study is to develop and update a questionnaire to assess the quality of life of patients with Uveal Melanoma (UM) (eye cancer). The questionnaire is the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire Ophthalmic-(EORTC QLQ OPT30);originally published in 2004 after developing it with the support of patients and healthcare professionals.Preliminary work indicates there is a need to refine the questionnaire to more accurately assess the impact of UM and treatment on patients’ quality of life. The 30-item EORTC QLQ-OPT30 addresses ophthalmic and disease related concerns, symptoms, and functional problems. It has not been validated in a large-scale cross-cultural study. Most studies addressing QoL in UM have been performed in the UK or USA, Thus, a rigorous cross-culturally validated questionnaire would allow for international collaborative research in this rare tumour group. This 5-year study aims to update ( phases 1-3) and test the reliability and validity of the content of the EORTC QLQ-OPT30 in a large-scale cross-cultural study (phase 4). The study is being funded by the EORTC Quality of Life Group (QLG).
The UK sample will be recruited from Liverpool Ocular Oncology Centre, (LOOC) Liverpool University Hospitals NHS Foundation Trust (LUHFT)
Phase 1 Up to N= 8 patients & 2 Health Care Professionals (HCPs) will be asked to participate in an interview to evaluate the content of the questionnaires
Phase 3: Up to N= 60 patients and will involve completing questionnaires to evaluate the psychometric properties; N=4 will be asked to complete 3 debriefing questionnaires
The update will establish suitability of the QLQ-OPT30 for UM patients with metastatic disease ( cancer that has spread outside of the eye). Based on the outcome, these patients will be included/excluded in phase 4
Phase 4 validation study: up to N=100 patients to complete questionnaires once; 60% twice, 40% three times.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
25/LO/0235
Date of REC Opinion
20 May 2025
REC opinion
Further Information Favourable Opinion