Evaluation of Effects of Early Palliative Care on Quality of Life of Advanced Cancer Patients. A Multicenter Controlled Randomised Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 281
- 主要终点
- Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure)
研究概览
简要总结
This study compares two types of care - Standard Oncology Care (SOC) and SOC with early palliative care (EPC) (started within 8 weeks after diagnosis of advanced disease) to see which is better for improving the quality of life of patients with advanced lung, pancreas, gastric and biliary tract cancer. The study will use FACT-G questionnaire to measure patients' quality of life.
详细描述
The patients will complete a baseline FACT-G questionnaire and then will be randomized to a study group.
Subjects who are randomized to Standard Oncology Care (SOC) will follow up with their treating oncologist. They will consult with the palliative care team at their request or at the request of the treating oncologist or of the family. They will complete FACT-G questionnaire at 12 weeks after enrollment.
Subjects who are randomized to the SOC with Early Palliative Care (EPC) will meet with a palliative care team (basically composed by a palliative care physician and a palliative care specialized nurse) at their next medical oncology or infusion visit. They will meet with the palliative care team at least every three weeks. They will complete FACT-G questionnaire at 12 weeks after enrollment.
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
- •Pathologically confirmed metastatic lung (NSCLC), pancreatic, gastric and biliary tract cancer, diagnosed within the previous 8 weeks; an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2; age ± 18 years; metastatic or locally advanced disease (but not susceptible of loco-regional treatments); eligibility to first-line chemotherapy ± biological agents; life expectancy more than three months; written informed consent provided; FACT-G questionnaire filled in at enrollment, before the randomization.
排除标准
- •Patients already receiving care from the PC service or pretreated with chemotherapy ± biological
结局指标
主要结局
Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure)
时间窗: Change from baseline to 12 weeks
compare change in QOL from baseline to 12 weeks between study arms
次要结局
- Survival(from date of randomization until date of death or for a minimum of six months)
- Resource utilization at the end of life (EOL): chemotherapy utilization(From date of randomization until death or for a minimum of six months after enrollment)
- Resource utilization at the end of life (EOL): hospital admissions(From date of randomization until death or for a minimum of six months after enrollment)
- Resource utilization at the end of life (EOL): emergency room admissions(From date of randomization until death or for a minimum of six months after enrollment)
研究者
Vittorio Franciosi
M.D.
Azienda Ospedaliero-Universitaria di Parma