Digital Home-Based Prehabilitation Before Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 主要终点
- 6MWT
研究概览
简要总结
This clinical trial compares two different prehabilitation programs, with no organized prehabilitation, prior to major colorectal cancer surgery. The prehabilitation programs include intensive and coached physical exercise and optimized nutritional intake coupled with smoking cessation, physiological support and correction of poly-pharmacy.
详细描述
Patients are randomized to either a digital home-based program, a physical hospital-based program or no-organized prehabilitation. The eligible patients are anyone scheduled for colorectal cancer surgery who are fluent in Norwegian able to consent and to understand questionnaires. The main question the study aims to answer is whether a digital home-based program is non-inferior to a hospital-based program in terms of improved physical capacity and maintenance of life-quality. In addition, blood samples will be drawn at three time points, at inclusion, after intervention (prior to surgery) and 6 weeks after surgery to analyze and search for biomarkers reflecting patients' individual surgical risk profile and response to prehabilitation. Participants randomized to intervention, will be given psychological coaching and support, individualized nutritionist counselling, coached, structured and repeated 60 minutes daily exercises for three weeks prior to surgery. The control group will receive no organized prehabilitation in the period of time between diagnose and surgery.
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
- •Planned for major gastrointestinal cancer surgery
- •Fluent in Norwegian and able to consent and to understand questionnaires
排除标准
- •Inability to walk for six minutes or to rise independently from a chair
- •Inability to comprehend exercise program or to comply with written and oral instructions
- •Presence of a cardio-pulmonary condition that precludes exercise
- •Living in very remote areas making a hospital-based intervention group impossible to implement
- •Being without a permanent address
- •Admittance to a hospital facility for > 50% of the time from diagnosis to surgery
结局指标
主要结局
6MWT
时间窗: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
Distance (in meters) walked in 6 minutes
次要结局
- EuroQol Group Questionnaire 5D (EQ-5D)(At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery)
- Need of additional health care support(4-6 weeks after surgery)
- Cost-effectiveness(3 months after surgery)
- European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire(At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery)
- Complications(3 months after surgery)
- Generic Short Patient Experiences Questionnaire (GS-PEQ)(At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery)
- Mortality(3 months after surgery)
- Aggregated length-of-stay (aLoS)(4-6 weeks after surgery)