Incremental Cost-utility Study on Prehabilitation for Colon Cancer Surgery in Older Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 5
- 主要终点
- EQ-5D-5L
研究概览
简要总结
A prospective multicenter observational cost-utility study following older or high-risk patients with colorectal cancer with and without prehabilitation before surgery.
详细描述
This study will answer the question whether prehabilitation is cost-effective in colorectal cancer surgery among individual patients aged 70 years and above or patients with an American Society of Anesthesiologists (ASA) score of III. We also aim to identify factors facilitating or impairing implementation of prehabilitation such that it is cost-effective.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years or American Society of Anesthesiologists (ASA) score of III
- •Scheduled for colorectal cancer surgery
排除标准
- •Metastatic disease known preoperatively
- •ASA IV score or higher
- •Paralytic or immobilized patients (not capable to perform exercise)
- •Prior use of neoadjuvant therapy for the same indication
- •Not able or willing to provide written informed consent
结局指标
主要结局
EQ-5D-5L
时间窗: 0-6 months
Quality of life according to the EuroQol-5 dimensions-5 levels questionnaire. The 5 dimensions cover mobility, selfcare, daily activities, pain/discomfort and anxiety. All dimensions are rated on a 5 level scale ranging from 'I have no problems with ....(dimension)' to 'I am not able to/I am extremely...(dimension)'. The first option is considered 'better' and the latter as 'worse'.
Costs
时间窗: 0-6 months
From a societal perspective including health care consumption costs, patient out-of-pocket costs, and productivity losses of informal caregivers
次要结局
- Number of deceased patients(0-6 months)
- Morbidity(0-6 months)
- (I)ADL dependence by TOPICS-SF(0-6 months)
- (I)ADL dependence by GARS(0-6 months)
- Return to normal activity(0-6 months)
- Care-related burden among informal caregivers(0-6 months)