EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy. The ENHANCE Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 154
- 试验地点
- 16
- 主要终点
- Complications
研究概览
简要总结
Currently, the potential value of a multimodal prehabilitation program in bladder cancer has not been extensively studied. The investigators designed the ENHANCE study to assess the effect of a structured multimodal prehabilitation program in 154 patients with bladder cancer on the number (primary endpoint) and severity of complications within 90 days, length of hospital stay, readmissions, physical fitness, muscle strength, physical functioning, nutritional status, smoking behaviour, anxiety and depression, fatigue, quality of life, physical activity, tumor tissue characteristics, and healthcare costs.
详细描述
The ENHANCE study is a multicenter, randomized controlled trial. The intervention group will participate in a prehabilitation program of 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The prehabilitation program consist of a tailored exercise program, nutritional support and if relevant smoking cessation and/or psychological counselling. The exercise program is under supervision of an oncology specialized physiotherapist and comprises aerobic-, resistance- and breathing- and relaxation exercises. Patients will be asked to be physically active for an additional 2 times a week for at least 30 minutes. A dietician will provide nutritional support and give dietary advice to increase protein intake to enhance the anabolic effect on muscle mass. Additionally, patients will receive a supplement containing 30 g of high quality whey-protein daily preferably before sleep and after the supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychological support. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke. Patients in the intervention group will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation. The physical activity level in both groups will be obtained via questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Histologically confirmed, primary, bladder cancer (cTa-4N0/N+M0),
- •Planned to undergo radical cystectomy,
- •Age ≥ 18 years.
排除标准
- •Subjects with severe cognitive or psychiatric disorders,
- •Subjects who are operated within 3 weeks,
- •Subjects with insufficient command of the Dutch language, which precludes them from following study instructions or completing study questionnaires,
- •Subjects who have contraindications to safely perform exercise training or testing (i.e., CPET),
- •Subject who are unable or unwilling to participate in the intervention.
结局指标
主要结局
Complications
时间窗: 0-12 weeks post-surgery (measured 4 weeks and 12 weeks post-surgery)
The proportion of patients having Clavien-Dindo grade 2 or higher perioperative complications; obtained from the medical records
次要结局
- Change in nutritional status(T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery))
- Change in muscle invasive bladder cancer specific scores(T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery))
- Duration of hospital stay(0-12 weeks post-surgery)
- Change in physical performance(T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery))
- Change in muscle strength(T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery))
- Change in body composition(T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery))
- Change in weight(T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery))
- Height(T0a (baseline) - T3 (12 weeks post-surgery))
- Healthcare resources consumption(T0a (baseline) - T3 (12 weeks post-surgery) (measured within 1 week before surgery, 4 and 12 weeks post-surgery and if applicable : after neoadjuvant chemotherapy))
- Change in cardiorespiratory fitness(T0a (baseline), T1 (within 1 week before surgery))
- Work status(T0a (baseline) - T3 (12 weeks post-surgery))
- Readmissions(0-12 weeks post-surgery)
- Disease status(0-12 weeks post-surgery)
- Nil per mouth consumption during hospitalization(0-12 weeks post-surgery)
- Change in smoking status(T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery))
- Change in fatigue(T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery))
- High grade complications(0-12 weeks post-surgery)
- Intervention costs(T0a (baseline) - T3 (12 weeks post-surgery))
- Change in HRQoL(T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery))
- Sense of coherence (SOC)(T0a (baseline))
- Change in physical activity(T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery))
- Hypoxia(T3 (12 weeks post-surgery))
- Change in health status(T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery))
- Change in anxiety and depression(T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery))
- Satisfaction with prehabilitation in intervention group and evaluation in control group(T3 (12 weeks post-surgery))
- Non participation analysis(T0a (baseline))