Gender Neutral
Type Module
Testing Phase IV - in development
Principal investigator(s)
Pernille Tine Jensen
Odense University Hospital, Dept of Obstetrics and Gynecology
Study coordinator(s)
Malene K Larsen
Aarhus University Hospital
Aarhus, Denmark

Project summary

In this project we have developed and tested a new questionnaire module to be used in clinical trials involving women with vulva cancer. Women with vulva cancer patients has been part of the developmental process during the first three phases. In this final field validation study we will test the psychometric properties of the preliminary questionnaire in 400 women from several different countries to ensure broad cross-cultural adaptation.


The project has completed the first 3 phases of questionnaire development and validation.

Most collaborating countries have achieved or applied for ethical approval to start phase 4 of the study.

We have ensured safe data entering and storage.

The study has started patient recruitment in 4 countries by now. As soon as ethical approval has been achieved in the other countries, they will start recruitment.

The project is now in phase 4 which is the final field validation phase with psychometric testing and validation

Future plans

The project expects to be recruiting patients for another 1.5 years with 6 months follow up for the last patient. 400 patients are expected to be recruited.

For patients

This project aims to develop a questionnaire that can be used to evaluate quality of life and side-effect after treatment for vulva cancer (the female genital area). We have obtained feed-back from patients with vulva cancer that the questionnaire covers the relevant issues. In this part of the study, we ask 400 women with vulva cancer to complete a revised version of the questionnaire. We will analyze how the questions work together and how we may use them to evaluate the quality of life in clinical trials.





Froeding LP, Greimel E, Lanceley A, Oberguggenberger A, Schmalz C, Radisic VB, Nordin A, Galalaei R, Kuljanic K, Vistad I, Schnack TH, Jensen PT; European Organization of Research Treatment of Cancer Quality of Life Group the Gynecological Cancer group. Assessing Patient-reported Quality of Life Outcomes in Vulva Cancer Patients: A Systematic Literature Review. Int J Gynecol Cancer. 2018 Feb 8. doi: 10.1097/IGC.0000000000001211. [Epub ahead of print]