Discipline of Physiotherapy, School of Medicine, Trinity College, the University of Dublin, Dublin, Ireland.
School of Medicine, Trinity College, the University of Dublin, Dublin, Ireland.
BMC Cancer. 2020 May 13;20(1):415. doi: 10.1186/s12885-020-06889-z.
Curative treatment for upper gastrointestinal (UGI) and hepatopancreaticobiliary (HPB) cancers, involves complex surgical resection often in combination with neoadjuvant/adjuvant chemo/chemoradiotherapy. With advancing survival rates, there is an emergent cohort of UGI and HPB cancer survivors with physical and nutritional deficits, resultant from both the cancer and its treatments. Therefore, rehabilitation to counteract these impairments is required to maximise health related quality of life (HRQOL) in survivorship. The initial feasibility of a multidisciplinary rehabilitation programme for UGI survivors was established in the Rehabilitation Strategies following Oesophago-gastric Cancer (ReStOre) feasibility study and pilot randomised controlled trial (RCT). ReStOre II will now further investigate the efficacy of that programme as it applies to a wider cohort of UGI and HPB cancer survivors, namely survivors of cancer of the oesophagus, stomach, pancreas, and liver.
The ReStOre II RCT will compare a 12-week multidisciplinary rehabilitation programme of supervised and self-managed exercise, dietary counselling, and education to standard survivorship care in a cohort of UGI and HPB cancer survivors who are > 3-months post-oesophagectomy/ gastrectomy/ pancreaticoduodenectomy, or major liver resection. One hundred twenty participants (60 per study arm) will be recruited to establish a mean increase in the primary outcome (cardiorespiratory fitness) of 3.5 ml/min/kg with 90% power, 5% significance allowing for 20% drop out. Study outcomes of physical function, body composition, nutritional status, HRQOL, and fatigue will be measured at baseline (T0), post-intervention (T1), and 3-months follow-up (T2). At 1-year follow-up (T3), HRQOL alone will be measured. The impact of ReStOre II on well-being will be examined qualitatively with focus groups/interviews (T1, T2). Bio-samples will be collected from T0-T2 to establish a national UGI and HPB cancer survivorship biobank. The cost effectiveness of ReStOre II will also be analysed.
This RCT will investigate the efficacy of a 12-week multidisciplinary rehabilitation programme for survivors of UGI and HPB cancer compared to standard survivorship care. If effective, ReStOre II will provide an exemplar model of rehabilitation for UGI and HPB cancer survivors.
The study is registered with ClinicalTrials.gov, registration number: NCT03958019, date registered: 21/05/2019.
上消化道（UGI）和肝胆胰腺（HPB）癌症的治疗方法为复杂的外科切除术，通常结合新辅助/辅助化疗/放化疗。随着生存率的提高，出现了一群 UGI 和 HPB 癌症幸存者，他们存在身体和营养缺陷，这是癌症及其治疗的结果。因此，需要进行康复治疗来对抗这些损伤，以最大限度地提高生存质量。在康复策略治疗胃食管癌症（ReStOre）可行性研究和试点随机对照试验（RCT）中，已经确定了 UGI 幸存者多学科康复计划的初步可行性。现在，ReStOre II 将进一步研究该计划在更广泛的 UGI 和 HPB 癌症幸存者（即食管癌、胃癌、胰腺癌和肝癌幸存者）中的疗效。
ReStOre II RCT 将比较 12 周的多学科康复计划，包括监督和自我管理的运动、饮食咨询和教育，与 UGI 和 HPB 癌症幸存者的标准生存护理进行比较，这些幸存者在接受食管切除术/胃切除术/胰十二指肠切除术或主要肝切除术后 > 3 个月。将招募 120 名参与者（每组 60 名），以建立主要结局（心肺功能）平均增加 3.5ml/min/kg，功率为 90%，5%的显著性，允许 20%的脱落率。在基线（T0）、干预后（T1）和 3 个月随访（T2）时测量身体功能、身体成分、营养状况、生存质量和疲劳等研究结果。在 1 年随访（T3）时，仅测量生存质量。通过焦点小组/访谈（T1、T2）定性研究 ReStOre II 对幸福感的影响。从 T0 到 T2 收集生物样本，以建立国家 UGI 和 HPB 癌症生存者生物库。还将分析 ReStOre II 的成本效益。
这项 RCT 将研究与标准生存护理相比，12 周多学科康复计划对 UGI 和 HPB 癌症幸存者的疗效。如果有效，ReStOre II 将为 UGI 和 HPB 癌症幸存者提供康复典范模式。
该研究在 ClinicalTrials.gov 注册，注册号：NCT03958019，注册日期：2019 年 5 月 21 日。
