Co-designing primary and secondary outcome measures for an international phase 3 trial of surgical de-escalation in vulvar cancer through a consumer workshop.

backgroundConsumer involvement in clinical trials has developed to be a critical driver of feasibility and real-world translation. In gynaecological oncology, patient and clinician priorities can differ, particularly regarding acceptable risks and treatment burden. Vulvar cancer treatment typically involves a groin lymph node dissection, which carries significant morbidity, effecting the long-term health of patients. To address these harms, the Australian National Vulvar Cancer (ANVU) Phase 3 international randomised clinical trial (NCT06476639) will compare standard upfront groin lymph node dissection with serial groin ultrasound monitoring, a less invasive option, to reduce treatment burden without compromising survival. In this paper, research methodologists collaborated to bring consumer perspectives into the trial design to ensure the outcomes reflect what matters most to patients. MAIN BODY: We conducted a structured co-design workshop involving patients with lived experience of vulvar cancer as well as a multidisciplinary research team. The workshop explored priorities across three stages of care to determine the outcome measures for a clinical trial: before treatment, during treatment, and after treatment. Priority in the short-term was complete cancer removal, with acceptance of some short-term adverse effects. Medium-term priorities focused more on quality of life and functional recovery, as well as fear of recurrence. While long-term priorities identified avoiding chronic harms such as lymphoedema and maintaining a normal daily life, as important. These insights informed the trial's primary endpoint (survival following nodal metastasis at 30 months) and patient-centred secondary outcomes such as health-related quality of life, return to usual activities, and reduced chronic harms.

conclusionsPatient priorities shift as they progress through the various stages of cancer treatment, highlighting the need for dynamic, patient-centred clinical trial designs. The ANVU trial aims to incorporate true co-design in complex surgical oncology research. With consumers as research partners, the team has produced a trial protocol that is scientifically robust as well as grounded in lived experience, increasing its potential for real-world impact. The current paper focuses on co-design of the outcome measures of the trial, however consumer involvement will remain ongoing throughout the ANVU trial to ensure that the research outcomes are accessible and enable women to be provided with treatment options which suit their needs.