QLG Immune Checkpoint 1/2
Research type
Research Study
Full title
A phase 1/2 study to identify which health-related quality of life issues need to be assessed for cancer patients on immune checkpoint inhibitors
IRAS ID
314688
Contact name
Mieke Van Hemelrijck
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 7 months, 20 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 (QLQEN24), 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).
The present study aims to contribute to the development of a module designed to measure health-related quality of life in cancer patients receiving immune checkpoint inhibitor treatment. The study aims to undertake Phase 1 and 2 of the above module development process.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
22/LO/0336
Date of REC Opinion
27 May 2022
REC opinion
Further Information Favourable Opinion