EORTC Phase 4 update from QLQ-BR23 to BR45
Research type
Research Study
Full title
An international Phase 4 field study to analyse the psychometric properties of the updated module on assessing quality of life of patients with breast cancer (EORTC QLQ-BR23, Update EORTC QLQ-BR45)
IRAS ID
275142
Contact name
Galina Velikova
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
NCT TBC, ClinicalTrials.gov Identifier (NCT number)
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
This study is for breast cancer patients with localised/locally advanced disease, metastatic disease or those on follow up. The objective is to test the psychometric properties of the newly updated EORTC QLQ-BR45, a breast cancer specific quality of questionnaire. This will be administered along with a general quality of life questionnaire called the EORTC QLQ-C30.\n\nAll participants will complete the questionnaires (consisting of 78 questions) at one time point whilst attending the hospital for a routine visit. If patients are no longer having a routine follow up, they can be contacted by an ethically approved invite letter. The questionnaires will assess patient’s quality of life. A small number will be asked to complete these questionnaires again at a second time point to test if the questionnaire is able to detect change and is reliable.\n\nThis study will take place in St James Hospital in Leeds, UK as part of a wider international study. This ethics application is for the UK only and the University of Leeds is acting as sponsor. The study is funded by the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation based in Brussels.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
20/YH/0083
Date of REC Opinion
27 Feb 2020
REC opinion
Favourable Opinion