Prospective, Randomized Trial of the Effects on HRQoL, Cost-Utility and Reintervention Rate, of Nurse Home Visits, in Patients With SEMS Treated Malignant Disease in the Esophagus and Cardia.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- HRQoL, EORTC C-30, EOS-18
研究概览
简要总结
The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or cardia, who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness.
详细描述
The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or gastro-esophageal junction (cardia), who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness.
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
- Single (Participant)
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
- •Malignant obstruction of esophagus or cardia treated with SEMS due to non-operable disease.
排除标准
- •Mentally unable to fill out questionaire
研究组 & 干预措施
Home visit
After SEMS placement, 2 home visits and a phonecall are made by a specialist nurse
干预措施: Home visits (Behavioral)
Standard
Standard contact via Hotline and traditional referring methods
干预措施: standard (Behavioral)
结局指标
主要结局
HRQoL, EORTC C-30, EOS-18
时间窗: 2 years
次要结局
未报告次要终点
研究者
Michael Bau Mortensen
MD, PhD
Odense University Hospital