MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care

Обзор

The goal of this clinical trial is to learn whether a structured, Patient-Reported Outcome Measures (PROMs)-tailored palliative care pathway improves clinical outcomes and care experience in adults with advanced cancer referred to outpatient palliative care. Patients with advanced cancer often experience multiple symptoms and complex needs. Standard outpatient palliative care is usually guided by clinical judgment on patient-reported questionnaires. In this study, researchers aim to test whether a more structured approach, based on predefined cut-offs from PROMs, can improve symptom control, satisfaction with care, and use of healthcare resources. The main questions the study aims to answer are: Does a structured, PROM-driven palliative care pathway reduce symptom burden and psychological distress compared with usual care? And through this, to improve patients' and caregivers' satisfaction with care or reduce emergency room visits, hospital admissions, healthcare costs, and aggressive treatments near the end of life? Researchers will compare two groups: Control group: Participants will receive standard outpatient palliative care. PROMs are collected as usual, but without predefined cut-offs or structured intervention checklists. Experimental group: Participants will receive a structured palliative care pathway tailored to symptoms/needs identified at baseline using PROM cut-offs. Specific multidisciplinary interventions are activated according to identified needs.

Вмешательства

• Другое Structured Palliative Care
  Symptoms/needs domains are defined according to protocol-specified cut-offs, followed by the activation of a tailored intervention based on structured checklists targeting the reported symptoms/needs.
• Другое Classical Palliative Care
  Multidisciplinary palliative care interventions are delivered according to usual clinical practice, without activation based on predefined cut-offs or structured algorithms.

Первичные конечные точки

• Change in overall symptom burden assessed by the ESAS. [Срок оценки: 1, 3 months]
• Change in psychological distress assessed by the Distress Thermometer (DT). [Срок оценки: 1, 3 Months]

Вторичные конечные точки (4)

• Patients' satisfaction with care [Срок оценки: 1, 3 months]
• Healthcare resource utilization [Срок оценки: 3, 6 months]
• Differeces in End of Life (EoL) care aggressiveness criteria [Срок оценки: 3, 6 months]
• Caregivers' satisfaction with care [Срок оценки: 1, 3 months]

Критерии участия

Критерии включения

• diagnosis of advanced/metastatic cancer
• age > 18
• Eastern Cooperative Oncology Group (ECOG) performance status ≥2
• prognostic clinical prediction >1 month.

Критерии исключения

• Serious medical or psychiatric illness that can interfere with informed consent and participation in this clinical study
• any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• IRCCS Istituto Nazionale dei Tumori, Via Venezian n1 — Milan

Идентификаторы

NCT: NCT07469761 · INT 101/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗