NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, SO16 6YD, UK.
School of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, SO16 6YD, UK.
F1000Res. 2021 Sep 21;10:952. doi: 10.12688/f1000research.55324.2. eCollection 2021.
Surgical resection remains the primary curative treatment for intra-cavity cancer. Low physical fitness and psychological factors such as depression are predictive of post-operative morbidity, mortality and length of hospital stay. Prolonged post-operative morbidity is associated with persistently elevated risk of premature death. We aim to investigate whether a structured, responsive exercise training programme, a psychological support programme or combined exercise and psychological support, delivered between treatment decision and major intra-cavity surgery for cancer, can reduce length of hospital stay, compared with standard care. WesFit is a pragmatic 2x2 factorial-design, multi-centre, randomised-controlled trial, with planned recruitment of N=1560. Participants will be randomised to one of four groups. Group 1 (control) will receive usual pre-operative care, Group 2 (exercise) patients will undergo 2/3 aerobic, high-intensity interval training sessions per week supervised by personal trainers. Group 3 (psychological support) patients are offered 1 session per week at a local cancer support centre. Group 4 will receive both exercise and psychological support. All patients undergo baseline and pre-operative cardiopulmonary exercise testing, complete self-report questionnaires and will be followed up at 30 days, 12 weeks and 12 months post-operatively. Primary outcome is post-operative length-of-stay. Secondary outcomes include disability-adjusted survival at 1-year postoperatively, post-operative morbidity, and health-related quality of life. Exploratory investigations include objectively measured changes in physical fitness assessed by cardiopulmonary exercise test, disease-free and overall mortality at 1-year postoperatively, longer-term physical activity behaviour change, pre-operative radiological tumour regression, pathological tumour regression, pre and post-operative body composition analysis, health economics analysis and nutritional characterisation and its relationship to post-operative outcome. The WesFit trial will be a randomised controlled study investigating whether a high-intensity exercise training programme +/- psychological intervention results in improvements in clinical and patient reported outcomes in patients undergoing major inter-cavity resection of cancer. NCT03509428 (26/04/2018).
手术切除仍然是腔内癌症的主要治愈性治疗方法。身体状况不佳和抑郁等心理因素可预测术后发病率、死亡率和住院时间。术后长期发病率与过早死亡的风险持续升高有关。我们旨在研究在癌症腔内大手术后,与标准护理相比,在治疗决策和主要腔内手术之间,进行结构化、响应式的锻炼训练计划、心理支持计划或综合锻炼和心理支持,是否可以减少住院时间。WesFit 是一项实用的 2x2 析因设计、多中心、随机对照试验,计划招募 1560 名参与者。参与者将被随机分为四组。第 1 组(对照组)将接受常规术前护理,第 2 组(锻炼组)患者将由私人教练每周监督进行 2/3 次有氧运动、高强度间歇训练。第 3 组(心理支持组)患者每周在当地癌症支持中心接受 1 次治疗。第 4 组将接受锻炼和心理支持。所有患者均接受基线和术前心肺运动测试,完成自我报告问卷,并在术后 30 天、12 周和 12 个月进行随访。主要结局是术后住院时间。次要结局包括术后 1 年残疾调整生存,术后发病率和健康相关生活质量。探索性研究包括通过心肺运动试验评估的身体适应性变化、术后 1 年无病和总死亡率的客观测量、长期体力活动行为改变、术前影像学肿瘤消退、病理性肿瘤消退、术前和术后身体成分分析、卫生经济学分析和营养特征及其与术后结果的关系。WesFit 试验将是一项随机对照研究,旨在研究高强度运动训练计划 +/- 心理干预是否可改善接受癌症主要腔内切除术的患者的临床和患者报告结局。NCT03509428(2018 年 4 月 26 日)。