Abstract
Abstract
Purpose
This study aimed to develop a patient-centered and partner-centered core outcome set (COS) reflecting the health-related quality of life (HRQoL) outcomes most important to patients with vulvar cancer following surgical treatment and their partners. Identifying these outcomes enables healthcare professionals to better support patients’ HRQoL during and after treatment.
Methods
A mixed-methods study conducted in the Netherlands from December 2021 to March 2024 among patients with vulvar cancer, their partners, and healthcare professionals involved in their care. The study followed a three-step approach: (1) a literature review to identify HRQoL concepts and existing questionnaires; (2) interviews with patients, partners, and healthcare professionals to extract important outcomes; and (3) an online Delphi study, followed by an online consensus meeting, to prioritize outcomes. The primary outcomes were the development of patient-centered and partner-centered COS and the identification of validated questionnaires for HRQoL assessment.
Results
The patient-centered COS comprised 45 outcomes in the domains of physiological functioning, including physical symptoms, as well as physical, sexual, and emotional functioning. The COS also included topics that are less often included in studies, i.e., wound healing, body image, and fear of recurrence. The partner-centered COS included six outcomes only focusing on information provision, not on their own HRQoL. Recommended patient HRQoL questionnaires were (scales from) EORTC QLQ-C30/VU34/SH22/INFO25 and WOUND-Q.
Conclusions
This is the first patient-centered COS for vulvar cancer, enabling targeted HRQoL assessments and improved daily clinical care. The provision of information was the only aspect deemed important as an outcome for partners.