PROMM Study version 1
Research type
Research Study
Full title
Patient-Reported Outcome Measure for Meningiomas study
IRAS ID
231405
Contact name
Thomas Santarius
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
A recent systematic review showed that existing health-related quality of life (HRQoL) questionnaires used in meningioma research are not developed for and/or validated in meningioma patients. This study also showed that in contrast to the current impression of patients and physicians, data are still insufficient and not conclusive on the effect of interventions on HRQoL in meningioma patients. In addition, results of a recently conducted pilot study suggest that existing HRQoL questionnaires used in meningioma research cover issues not relevant for meningioma patients and that these questionnaires also miss relevant issues for this patient group. Therefore, the development and validation of a meningioma-specific questionnaire is warranted.
Currently, a provisional meningioma-specific HRQoL questionnaire is cross-culturally being developed in the Netherlands, Italy and the United States. The aim of the current proposal is to run a parallel study in the UK. At the end of the study anonymised data will be pooled for further analysis at Leiden University in the Netherlands. Hereafter, the questionnaire will be validated in all six countries.
REC name
East of England - Essex Research Ethics Committee
REC reference
18/EE/0179
Date of REC Opinion
18 Jun 2018
REC opinion
Favourable Opinion