New EORTC Questionnaire Module for Vulvar Cancer Quality of Life Undergoes Successful Cross-Cultural Pre-Testing

• The EORTC QLQ-VU34 is a new 34-item disease-specific quality-of-life module for vulvar cancer patients.

• Phases 1–3 followed EORTC guidelines with input from 47 patients, 18 healthcare professionals, and pre-testing in 77 patients across 12 centers in 9 European countries.

• The final module includes genital symptoms, treatment side effects, and daily functioning items.

• Phase 4 psychometric validation is currently underway.

Study Snapshot

• Study: Phase 1–3 cross-cultural development and pre-testing of the EORTC QLQ-VU

• Journal: Gynecologic Oncology (2026)

• Objective: Develop and pre-test a disease-specific QOL module for vulvar cancer patients

• Methods: Systematic literature review, expert appraisal by 25 EORTC Gynecological Cancer Group members, semi-structured patient/HCP interviews, pre-testing with debriefing at 12 centers in 9 European countries

• Participants: 47 patients and 18 HCPs for issue selection; 77 patients for pre-testing

• Outcome: Final 34-item module (EORTC QLQ-VU34) with high relevance, applicability, and comprehensiveness

• Limitation: Pre-testing phase; psychometric validation not yet completed

Introduction and Context

Vulvar cancer, though relatively rare, significantly impairs patients' quality of life (QOL) due to the sensitive anatomical location and the impact of surgery, radiotherapy, and chemotherapy on sexual function, body image, and daily activities. Until now, no disease-specific patient-reported outcome measure has been available for this population. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group has developed a vulvar cancer-specific questionnaire module (EORTC QLQ-VU34) to be used alongside the core EORTC QLQ-C30. This article summarizes the phases 1–3 cross-cultural development and pre-testing of the module, published in Gynecologic Oncology.

Study Design and Methods

The development followed the standard EORTC Quality of Life Group module development guidelines. First, a systematic literature review (phase 1) generated an initial list of 104 QOL issues relevant to vulvar cancer patients undergoing surgery and/or chemoradiotherapy. The issue list was critically appraised by 25 members of the EORTC Gynecological Cancer Group and then scored for relevance and priority by 47 patients and 18 healthcare professionals (HCPs) from multiple European countries. Using predetermined selection criteria, seven domains were retained for operationalization into a provisional 36-item questionnaire (phase 2). The provisional module underwent pre-testing (phase 3) in 77 patients across 12 centers in nine European countries (Austria, Belgium, Denmark, Germany, Italy, Norway, Poland, Spain, and the UK). Patients completed the questionnaire and participated in debriefing interviews to identify any conceptual or operational problems.

Key Findings

The pre-testing led to several modifications: four items were deleted, four were rephrased, five were made conditional (e.g., if applicable), and two clarifying items were added. The final module, the EORTC QLQ-VU34, consists of 34 items addressing domains such as genital symptoms, lymphedema, sexual function, body image, treatment side effects, and daily functioning. Patient feedback was incorporated to enhance acceptance and applicability across cultures. The authors concluded that the EORTC QLQ-VU34 demonstrates high relevance, applicability, and comprehensiveness for use in clinical research and practice, pending full psychometric validation.

Clinical Implications

The availability of a disease-specific QOL module for vulvar cancer fills an important gap. Clinicians and researchers can now more accurately capture the unique concerns of vulvar cancer survivors, including symptoms such as vulvar pain, itching, discharge, and sexual difficulties, as well as the psychosocial impact of the disease and its treatment. The EORTC QLQ-VU34 is expected to improve the assessment of patient-reported outcomes in clinical trials and observational studies, and eventually aid in shared decision-making and survivorship care.

Limitations and Next Steps

While the pre-testing confirms the module's face and content validity across diverse European populations, the study did not include patients from non-European or lower-resource settings, which may limit global applicability. Furthermore, the sample size for pre-testing (n=77) is relatively modest, though within EORTC guidelines. The most important next step is phase 4, which involves large-scale psychometric validation to assess reliability, validity, and responsiveness of the EORTC QLQ-VU34. The authors report that this validation is currently in progress.

Download: EORTC QLQ – VU34

References

1. Froeding LP, Greimel E, Nordin A, et al. Phase 1-3 cross-cultural development and pre-testing of the European Organisation of Research and Treatment of Cancer Vulva cancer questionnaire module (EORTC QLQ- VU). Gynecol Oncol. 2026;212:17-23. doi:10.1016/j.ygyno.2026.07.014.

2. Froeding LP, Greimel E, Lanceley A, et al. Assessing Patient-reported Quality of Life Outcomes in Vulva Cancer Patients: A Systematic Literature Review. Int J Gynecol Cancer. 2018;28(4):808-817. doi:10.1097/IGC.0000000000001211.