MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in overall symptom burden assessed by the ESAS.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of advanced/metastatic cancer
- •age > 18
- •Eastern Cooperative Oncology Group (ECOG) performance status ≥2
- •prognostic clinical prediction >1 month.
排除标准
- •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.
研究组 & 干预措施
Structured interventions tailored to PROMs cut-off
• Experimental group, which will follow a structured palliative care pathway (specific intervention defined in the protocol) based on the frailties identified at baseline PROMs (defined by cut-off).
干预措施: Structured Palliative Care (Other)
Classic Palliative Car interventions
• Control group, which will undergo standard unstructured palliative care (based on PROMs as usual, but without cut-off or interventions' checklists)
干预措施: Classical Palliative Care (Other)
结局指标
主要结局
Change in overall symptom burden assessed by the ESAS.
时间窗: 1, 3 months
\- Mean change in symptom burden from baseline to 1 month after initiation of palliative care, measured using the Edmonton Symptom Assessment System (ESAS) total score (range 0-90, higher scores indicating greater symptom burden). The analysis will compare the change in ESAS total score between the two randomized groups.
Change in psychological distress assessed by the Distress Thermometer (DT).
时间窗: 1, 3 Months
Mean change in psychological distress from baseline to 1 month after initiation of palliative care, measured using the Distress Thermometer (DT) (range 0-10, higher scores indicating greater distress). The analysis will compare the change in DT score between the two randomized groups.
次要结局
- Patients' satisfaction with care(1, 3 months)
- Healthcare resource utilization(3, 6 months)
- Differeces in End of Life (EoL) care aggressiveness criteria(3, 6 months)
- Caregivers' satisfaction with care(1, 3 months)
研究者
Augusto Caraceni
Professor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano