Early palliative care in metastatic uveal melanoma (early together): protocol of a prospective randomized Phase III trial

Abstract

Metastatic uveal melanoma (UM) patients often initially present with limited symptoms despite a poor prognosis, complicating communication with patients and caregivers. Early Together (NCT04728113) is a randomized Phase III trial that integrates early palliative care through systematic joint visits involving the palliative care team and the medical oncologist, compared with standard oncological care, in 162 metastatic UM patients beginning systemic treatment. This collaboration aims to enhance patient functioning, improve quality of life and facilitate coping mechanisms. Patients' quality of life and needs for information, care and support are assessed over 12 months using validated questionnaires in both groups. Investigators receive training throughout the study to improve communication skills in addressing uncertainty and poor prognosis. This article describes the trial protocol.