Gender Neutral
Type Module
Testing Phase IV - in development
Principal investigator(s)
Pernille Tine Jensen
Aarhus University Hospital
Aarhus, Denmark
Study coordinator(s)
Louise Krog
Aarhus University Hospital
Aarhus, Denmark

Project summary

The EORTC vulva cancer module is developed as a disease and treatment specific questionnaire module for vulva cancer patients to supplement the EORTC QLQ-C30. The aim of the 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 aim to develop a questionnaire module that will allow broad international cross-cultural and cross-country adaptation which can be used in clinical trials.

Achievements

The three first phases of development and validation is completed. The questionnaire is now undergoing formal field testing with psychometric analyses to ensure it works as intended.
We have now recruited a sufficient number of patients and will close recruitment after this coming meeting.

Current status:

Phase 4, recruitment ends at the end of September 2025

Future plans

Analyses will start during autumn 2025 once all legal permission to transfer data has been obtained.

The first meeting with statistician has been held and a statistical anlaysis plan (SAP) has been agreed on .

For patients

The EORTC vulva cancer module is a questionnaire developed in collaboration with patients with cancer in their outer genitals (vulva cancer). To make sure the questionnaire works as intended we need to test it in women from different countries and cultures, with different disease stages and who have undergone different treatments. This will allow us to use the questionnaire in the clinic and in future studies.

Translations

A

Arabic (Jordan)

C

Croatian

D

Danish
Dutch

E

English

F

French (Europe)

G

German

H

Hebrew
Hindi

I

Italian

M

Marathi

N

Norwegian

P

Polish
Portuguese (Brazil)

S

Swedish

Publications

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 May;28(4):808-817. doi: 10.1097/IGC.0000000000001211. PMID: 29420364.

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