Quality of Life and Supportive Care Needs After Oesophageal or Gastric Cancer Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Quality of Life
研究概览
简要总结
This study aim to assess quality of life of patients 0-5 years after oesophageal or gastric cancer surgery and to develop and test an information and support program aiming to enhance the patients quality of life (QOL) after surgery. The project contains 3 part-studies focusing on the patients life after surgery.
Data will be collected through focus group interviews and a randomized controlled trial (RCT) study.
详细描述
Introduction:
Patients who have undergone oesophageal resections for cancer have shown reduced quality of life (QOL) during substantial time after surgery. Postoperatively, patients are faced with extensive changes in their daily life including reduced physical and sometimes psychological capacities, problems that may be underestimated by the health care providers.
Worldwide oesophageal cancer is the 8th and gastric cancer the 4th most common cancer diagnoses (National Board of Health and Welfare, 2009). In 2009 in Sweden there were 443 new cases of oesophageal cancer and 882 of gastric cancer (total number of inhabitants in 2009, 9.4 million). Surgery, alone or in combination with chemotherapy or radiotherapy, is the only established treatment and thus offers the only possibility of a cure. After oesophagectomy or gastrectomy the planned hospital stay is approximately two to three weeks, and the expected recovery period is at least one year. The prolonged recovery period is pointed out as an energy-requiring process including physiological, psychological, social and habitual recovery, which increases the challenges for this group of patients after surgery. Even though survival after surgery, for both oesophageal and gastric cancer, has gradually improved, the 5-year survival rate remains at only 28% respectively 27%.
Aim:
The aim of this project is to assess quality of life of patients 0-5 years after oesophageal or gastric cancer surgery and to develop and test an information and support program aiming to enhance the patients QOL after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
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 with any stage tumours in the distal third of the oesophagus including type II tumours at the gastro-oesophageal junction
- •Transthoracic oesophageal resection with gastric tube reconstructions and circular stapled anastomoses in the upper right chest Postoperative clinical courses without complications, and postoperative anastomotic radiograms without anastomotic leakage
- •Macro and microscopically tumour free upper resection margins Willingness, physical and mental capability to comply with the result of the randomization, and ability to follow the study protocol
- •Adult >18 years
- •Living in the southern of Sweden (Skåne county)
排除标准
- •Preoperative or planned postoperative chemotherapy or radiotherapy to the tumour area known at the time of discharge from the hospital.
- •Postoperative need for continuous treatment with proton pump inhibitors (PPIs) or histamine-2 blockers. Treatment with steroidal or non steroidal anti inflammatory drugs other than occasionally
- •Known allergy or side effects to PPIs preventing continuous treatment for one year
- •Present drug or alcohol abuse
- •Failure to attend at least one postoperative visit
结局指标
主要结局
Quality of Life
时间窗: Change of QOL from discharge (discharge= approximately 2-4 weeks after surgery) to 6 months after discharge
Quality of life will be measured at discharge, 2 weeks, 2, 4 and 6 months after discharge (discharge= approximately 2-4 weeks after surgery). Quality of life is evaluated using EORTC quality of life instruments at discharge and 2 weeks, 2,4 and 6 months after discharge.
次要结局
- Satisfaction with care(At dischage, 2 weeks, 2, 4 and 6 months after discharge.)
- Informational need(At dischage, 2 weeks, 2, 4 and 6 months after discharge.)
- sense of coherence (KASAM)(At dischage, 2 weeks, 2, 4 and 6 months after discharge.)
- Contacts with the health care system(At dischage, 2 weeks, 2, 4 and 6 months after discharge.)