Impact of Early Palliative Care on Quality of Life and Survival of Patients With Non-small-cell Metastatic Lung Cancer in Northern France
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- quality of life
研究概览
简要总结
Single-center, prospective, controlled, open-label, randomized, two parallel arms comparing early Palliative care versus Standard care in patients with non-small-cell metastatic lung cancer
详细描述
144 patients will be included; 72 per arm.
- "Standard" Control arm: patient supported by the onco-respiratory service.
- Intervention arm: patients benefit from early palliative care in addition to standard onco-pneumologic care.
The main criterion of judgment is the TOI score measured at 12 weeks.
FACTL questionnaires, HADS and PHQ-9 will be filled out before randomization , at 12 weeks and 21 weeks
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
- •Being diagnosed with non-small cell lung cancer
- •Proven histologically
- •Metastatic proven imaging (MRI, CT Scanner, PET scan)
- •Stage IV (any T, any N, M1)
- •prior to secondary chemotherapy treatment.
- •Age> 18 years
- •Patient able to understand the nature, purpose and methodology of the study
- •signed Informed consent
排除标准
- •Age <18 years
- •Patient already supported by palliative care
- •Patient with an activating EGFR mutation or EML4-ALK rearrangement or ROS1 gene translocation
- •Patient under trusteeship / guardianship
研究组 & 干预措施
Control arm
Patient supported by the onco respiratory service for the treatment of their disease by chemotherapy and for the treatment of complications.
intervention arm
Multi disciplinary palliative care monthly consultations with a doctor, a nurse, a psychologist and posibility of a physical therapist and a chaplain in addition to standard onco-pneumologic care.
干预措施: multi disciplinary palliative care monthly consultations (Other)
结局指标
主要结局
quality of life
时间窗: 12 weeks
quality of life is measured at 12 weeks by the TOI score
次要结局
- EVENTS(14 days before deaths)
- QUALITY OF LIFE(12 and 21 weeks)
- SURVIVAL(from baseline)