EORTC Vulva Cancer Module (EORTC VU34)
Research type
Research Study
Full title
An international field study of the reliability and validity of the EORTC Vulva Cancer Module (EORTC VU34)
IRAS ID
236436
Contact name
Andrew Nordin
Contact email
Sponsor organisation
East Kent Hospitals University NHS Foundation Trust
Clinicaltrials.gov Identifier
00, Not applicable
Duration of Study in the UK
1 years, 9 months, 2 days
Research summary
Carcinoma of the vulva is an uncommon gynaecological malignancy, primarily affecting elderly, menopausal women with an incidence of 2-3/100.000 women. However, the incidence of vulva cancer among younger women has increased over recent decades and today 15-25% of the patients diagnosed with vulva cancer are under the age of 50. The surgical procedures for vulva cancer are mutilating and the morbidity associated to primary surgery to the vulva and the groin and adjuvant (chemo) irradiation is considerable. There are several unresolved treatment related issues that are currently being tested.
The EORTC vulva cancer module was developed as a disease- and treatment specific questionnaire module for vulva cancer patients to supplement the EORTC QLQ-C30. The purpose with the developmental project was to develop a questionnaire module that allowed broad international cross-cultural and cross-country adaptation and use in clinical trials. The instrument was intended to be a robust instrument with sensitive sub-scales. The first 3 phases of questionnaire development have been completed successfully. The provisional EORTC Vulva Cancer module (VU34) consists of, 10 multi-item scales and 1 single item.
The aim of this international field study is to test the scale structure, reliability, and validity of the EORTC VU34 in patients diagnosed with vulva cancer, at different stages of disease, and with different treatment modalities. We will investigate the cross-cultural applicability and acceptability in a balanced sample of vulva cancer patients from 10 European countries.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
18/WM/0136
Date of REC Opinion
17 May 2018
REC opinion
Favourable Opinion