Feasibility of an Early Palliative Care Intervention for Metastatic Cancer Patients. A Phase 2 Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- percentage of cancer patients that accept and attend the early palliative care programme
研究概览
简要总结
The objective of this phase 2 study is to evaluate the feasibility of an early palliative care intervention for metastatic cancer patients. Feasibility will be assessed in terms of percentage of patients that accept the proposal of the early palliative care intervention and that effectively start to be followed in the palliative care out-patient clinic. The study will be performed in a consecutive series of newly diagnosed patients affected by lung cancer (NSCLC or SCLC, stage IIIb, IV), mesothelioma (stage II, IV), pancreas (stage IV), stomach (stage IIIb-IV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •patients within 8 weeks of cancer diagnosis confirmed by histology or cytology
- •lung cancer (NSCLC or SCLC) stage IIIb-IV OR mesothelioma stage III-IV OR pancreas cancer stage IV, OR gastric cancer stage IIIb-IV
- •age more than 18 years
- •performance status (ECOG) ≤ 2;
- •ability to read, understand and fill-in the questionnaires
- •written informed consent to the study
排除标准
- •any chemotherapy, radiotherapy or ormonotherapy for any tumour in the past 12 months
结局指标
主要结局
percentage of cancer patients that accept and attend the early palliative care programme
时间窗: up to 30 days after the diagnosis of cancer
percentage of eligible cancer patients that accept the proposal of the intervention (the early palliative care programme) and that, by 30 days after the diagnosis, effectively start to be followed by the Palliative Care Unit
次要结局
- percentage of cancer patients that receive the proposal of early palliative by the oncologists-pneumologists(up to 30 days after the diagnosis of cancer)