Benefits of Early Collaboration Between Oncologists and Palliative Care Physicians in Cases of Unplanned Hospitalization for Patients With Metastatic Cancer

Обзор

This is a multicenter, national, interventional, cluster-randomized study, "stepped wedge" design. This study includes patients with metastatic or locally advanced digestive, gynecological, ENT, or sarcoma cancer, currently undergoing systemic palliative treatment and hospitalized on an unscheduled basis. The study will aim to evaluate the impact of early palliative care implementation for patients with metastatic or advanced cancer identified during an unplanned hospitalization.

Подробное описание

This study will aim to evaluate the effectiveness of early palliative care for patients with metastatic or advanced cancer identified through unscheduled hospitalization in terms of reducing "aggressive" treatment.

Other objectives of the study include :

Compare approaches in terms of overall survival, treatment toxicities, advance directives, quality of life, anxiety, and depression.

* Describing care according to the organization at the time of inclusion. * Evaluating the economic impact of early palliative care in patients with metastatic or advanced cancer through a medico-economic analysis combining cost-effectiveness and cost-utility analysis. * Evaluating interactions between the various stakeholders (palliative care physicians, supportive care physicians, oncologists).

Вмешательства

• Другое Early integrated palliative care
  Patients receive early integrated palliative care at the time of unplanned hospitalization for metastatic or advanced cancer. The intervention includes: * A palliative care consultation * A consultation with the treating oncologist * A multidisciplinary onco-palliative meeting to define a coordinated care plan
• Другое Usual oncological care
  Patients receive standard oncological care according to institutional practices. Palliative care is provided only when clinically indicated, without systematic early consultation at the time of unplanned hospitalization.

Первичные конечные точки

• Aggressiveness of end-of-life care (composite endpoint) [Срок оценки: Assessed during the last 30 days of life and up to 14 days before death]

Вторичные конечные точки (6)

• Components and additional indicators of aggressiveness of end-of-life care [Срок оценки: Assessed during the last 30 days of life and up to 14 days before death]
• Overall survival [Срок оценки: From study inclusion until death from any cause (follow-up up to 12 months)]
• Quality of life [Срок оценки: Baseline and every 3 months until death or up to 12 months]
• Quality of life [Срок оценки: Baseline and every 3 months until death or up to 12 months]
• Psychological distress and care pathway indicators [Срок оценки: Baseline and every 3 months until death or up to 12 months]
• Time Until Definitive Deterioration [Срок оценки: Baseline and every 3 months until death or up to 12 months]

Критерии участия

Критерии включения

• Subjects aged 18 years and older;
• Diagnosed with metastatic or locally advanced digestive, gynecological, ENT, or sarcoma cancer;
• Currently undergoing systemic palliative treatment (no prospect of cure);
• Hospitalized on an unscheduled basis (i.e., unplanned hospitalization for scheduled oncology treatments);
• Patient covered by the French social security system;
• Informed consent, written and signed.

Критерии исключения

• PS (WHO) = 4;
• Patient receiving end-of-life care;
• Patient opposed to the use of medical data for research purposes;
• Person deprived of liberty or under guardianship;
• Inability to undergo medical monitoring for the trial for geographical, social, or psychological reasons.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 1 центр

• Centre Oscar Lambret — Lille

Публикации

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Идентификаторы

NCT: NCT07490106 · SPPC-2503 · PREPS-24-0053 · 2025-A02238-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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