EORTC Quality of Life Module for patients with vulva cancer
Research type
Research Study
Full title
Phase 3-4 development of a questionnaire to address treatment morbidity and assess the quality of life following treatment for vulva cancer.
IRAS ID
126460
Contact name
Andy Nordin
Contact email
Sponsor organisation
EAST KENT HOSPITALS UNIVERSITY NHS FOUNDATION TRUST
Research summary
Vulva cancer patients comprise a group with a comparatively favourable survival prognosis and a high risk of severe treatment induced negative effects on their quality of life. There is a need for an instrument to comprehensively address morbidity and quality of life aspects following treatment.
The vulva module will be developed according to the European Organisation of Research and Treatment of Cancer [EORTC] guidelines for developing questionnaire modules. The new EORTC vulva cancer questionnaire module will therefore be applicable for use in clinical studies with broad cross country and cross cultural involvement.
Phase 3
The aim of phase three of the module development is to pre-test the provisional module by recruiting 15 participants who will be asked to complete the EORTC QLQ-C30 with the preliminary vulval module. Following this a structured interview will take place between the collaborator and the participant to establish which questions they found difficult to answer, annoying, confusing, upsetting or intrusive.
The participants comments and views will be taken into consideration regarding issues that they felt to be irrelevant or relevant but had not been included.Phase 4
The aim of phase 4 of the study is to recruit a further 15 participants who were not involved in phase 1 or 3 to field –test the questionnaire module to determine its acceptability, reliability and validity. They will be asked to complete the EORTC QLQ C30 and the adjusted (following phase 3) vulval module. In a debriefing interview with the researcher the participants will be asked specific questions ie. How long did it take to complete, did you need assistance, did you find it confusing or difficult to answer or upsetting to answer. Other comments made will also be taken into consideration for the final analysis.
REC name
London - Harrow Research Ethics Committee
REC reference
13/LO/1585
Date of REC Opinion
24 Jan 2014
REC opinion
Further Information Favourable Opinion