EORTC Metastatic Breast Cancer Module Development
Research type
Research Study
Full title
The European Organisation for Research and Treatment of Cancer: Module Development for Metastatic Breast Cancer (Phase I-III)
IRAS ID
264748
Contact name
Galina Velikova
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
001-2017, EORTC Project Number
Duration of Study in the UK
1 years, 7 months, 0 days
Research summary
European Organisation for Research and Treatment of Cancer (EORTC): Quality of Life (QOL) module development for Metastatic Breast Cancer (MBC). A qualitative interview study of patients and professionals (phase I-III) \nBackground\nDespite significant progress being made in the management of Metastatic Breast Cancer (MBC), it remains an incurable disease which affects multiple organs and requires continuous therapy, resulting in a wide range of physical symptoms and psychological burden. Quality of life (QOL) has been identified by patients as an area of care in need of significantly more focus and attention. There is an unmet need for tools that can better evaluate QOL in this population as current measures may not account for the unique experiences associated with MBC.\n\nA mixed-methods approach will be adopted throughout the project, utilising qualitative and quantitative methods to explore and address the research objectives. This is an international project coordinated by the University of Leeds and funded by the EORTC Quality of Life Group. The project comprises of three phases. Phase I Issue Generation, involves conducting a systematic review and semi-structured interviews with approximately 36 MBC patients and 5 healthcare professionals (UK) to generate a comprehensive list of QOL related issues associated with MBC. Phase II Item Development, the list of issues is then operationalised into items forming a provisional list of items. Phase III Pre-testing, approximately 72 (UK) patient interviews will be conducted to assess the overall acceptability of the provisional questionnaire. Preliminary psychometric testing will be completed in Phase III. Module development will be guided by the published framework set by the EORTC Quality of Life Group. Completion of this project will result in a phase III validated EORTC module for assessing the QOL of patients with MBC.\nThis ethics application is for the UK sites only and the University of Leeds is acting as sponsor.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0350
Date of REC Opinion
9 Dec 2019
REC opinion
Further Information Favourable Opinion