PREoPerAtive pREhabilitation in Patients With Head and Neck Cancer or Liver Cancer (PREPARE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of patients willing to participate in prehabilitation program
研究概览
简要总结
The objective of this study is to determine the feasibility (main aim) and effectiveness (secondary aim) of a prehabilitation program in patients with head and neck cancer or liver cancer. Participating patients will participate in a 3-to-6 week rehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.
详细描述
In patients diagnosed with head and neck cancer (HNC) or liver cancer, (major) surgery is the standard of care. Nevertheless, surgery may result in complications that have a substantial impact on the physical and psychological state of the patient. Detrimental postoperative outcomes are influenced by unhealthy lifestyle behaviors such as a sedentary lifestyle, smoking and malnutrition. Prehabilitation programs focusing on these lifestyle aspects have been suggested as a promising intervention to improve pre- and postoperative outcomes. Therefore, the obective of this study is to determine the feasibility (main aim) and effectiveness (secondary aim) of a prehabilitation program in patients with HNC or liver cancer
This study concerns a prospective cohort study in 60 patients with HNC or liver cancer that participate in a 3 to 6-week pilot prehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.
Data on feasibility (program satisfaction, program compliance and percentage of patients willing to participate in the prehabilitation program) and effectiveness (e.g. complications, health status, compliance to healthy lifestyle) is collected at three time points (pre- and post the prehabilitation program and 30 days post-surgery).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Age ≥18 years
- •Diagnosis of head and neck cancer or liver cancer
- •Scheduled for surgery in Erasmus MC
- •Provision of written informed consent
- •Only patient with a waiting time of at least 3 weeks till surgery can participate in this study
排除标准
- •Patients that do not understand the Dutch language
- •Patients with severe physical or psychological comorbidities that limit participation in the prehabilitation program
结局指标
主要结局
Percentage of patients willing to participate in prehabilitation program
时间窗: At completion of the prehabilitation program (3-6 weeks after baseline)
It will be registered which patient are willing and not willing to participate
Program satisfaction
时间窗: At completion of the prehabilitation program (3-6 weeks after baseline)
Self-designed questionnaire score (score between 1-10, higher score means higher satisfaction)
Program compliance
时间窗: At completion of the prehabilitation program (3-6 weeks after baseline)
Number of sessions that patient participates in the fitness training, the counselling on nutrition, smoking cessation and psychosocial sessions will be registered.
次要结局
- Work status(Baseline)
- Functional capacity(At baseline and at completion of the prehabilitation program (3-6 weeks after baseline))
- Smoking behaviour(At baseline and at completion of the prehabilitation program (3-6 weeks after baseline))
- Frailty(Outcomes will be collected twice: at baseline and at completion of the prehabilitation program (3-6 weeks after baseline))
- Physical activity level(At baseline and at completion of the prehabilitation program (3-6 weeks after baseline))
- Body composition(At baseline and at completion of the prehabilitation program (3-6 weeks after baseline))
- Alcohol consumptiom(At baseline and at completion of the prehabilitation program (3-6 weeks after baseline))
- Educational level(Baseline)
- Nutritional status(At baseline and at completion of the prehabilitation program (3-6 weeks after baseline))
- Length of hospital stay(30 days post surgery)
- Hand grip strength(At baseline and at completion of the prehabilitation program (3-6 weeks after baseline))
- Quadriceps strength(At baseline and at completion of the prehabilitation program (3-6 weeks after baseline))
- Anxiety and Depression(At baseline and at completion of the prehabilitation program (3-6 weeks after baseline))
- Self-efficacy(At baseline and at completion of the prehabilitation program (3-6 weeks after baseline))
- Self-reported smoking behaviour(At baseline and at completion of the prehabilitation program (3-6 weeks after baseline))
- Readmission rate in first 30 days(30 days post surgery)
- Age(Baseline)
- Health status(At baseline, at completion of the prehabilitation program (3-6 weeks after baseline), 30 days post surgery)
- Complications Clavien Dindo grade ≥3 in first 30 days(30 days post surgery)
- Sex(Baseline)
- Medical diagnosis(Baseline)
- Marital status(Baseline)
研究者
Roeland F. de Wilde
Principal Investigator
Erasmus Medical Center