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转移性葡萄膜黑色素瘤的早期姑息治疗(早期联合):一项前瞻性随机III期试验方案

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

作者信息

Piperno-Neumann Sophie, Koning Leanne de, Marchal Timothée, Gastaud Lauris, Waechter Lorraine, Fogliarini Anne, Bouleuc Carole, Libert Yves, Seban Romain, Thery Laura, Ducoulombier Agnes, Rodrigues Manuel, Bredart Anne, Savignoni Alexia, Dolbeault Sylvie, Burnod Alexis

机构信息

Medical Oncology Dep, Institut Curie, Paris, France.

Translational Research Dep, Institut Curie, Paris, France.

出版信息

Melanoma Manag. 2024 Dec;11(1):2382080. doi: 10.1080/20450885.2024.2382080. Epub 2024 Aug 8.

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.

摘要

转移性葡萄膜黑色素瘤(UM)患者尽管预后较差,但最初往往症状有限,这使得与患者及其护理人员的沟通变得复杂。“早期协同”(NCT04728113)是一项III期随机试验,在162例开始全身治疗的转移性UM患者中,与标准肿瘤治疗相比,通过姑息治疗团队和医学肿瘤学家的系统联合访视整合早期姑息治疗。这种合作旨在提高患者的功能,改善生活质量并促进应对机制。使用经过验证的问卷在两组中对患者的生活质量以及信息、护理和支持需求进行为期12个月的评估。在整个研究过程中,研究人员接受培训以提高应对不确定性和不良预后时的沟通技巧。本文描述了试验方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8af/11318732/0648b079d9fd/IMMT_A_2382080_F0001_C.jpg

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