O'Neill Linda, Guinan Emer, Brennan Louise, Doyle Suzanne L, O'Connor Louise, Sheill Grainne, Smyth Emily, Fairman Ciaran M, Segurado Ricardo, Connolly Deirdre, O'Sullivan Jacintha, Reynolds John V, Hussey Juliette
Discipline of Physiotherapy, Trinity College Dublin, the University of Dublin, Dublin, Ireland.
Trinity St James's Cancer Institute, Dublin, Ireland.
HRB Open Res. 2021 May 4;3:86. doi: 10.12688/hrbopenres.13185.2. eCollection 2020.
Exercise rehabilitation programmes, traditionally involving supervised exercise sessions, have had to rapidly adapt to virtual delivery in response to the coronavirus disease 2019 (COVID-19) pandemic to minimise patient contacts. In the absence of an effective vaccine, the pandemic is likely to persist in the medium term and during this time it is important that the feasibility and effectiveness of remote solutions is considered. We have previously established the feasibility of the Rehabilitation Strategies following Oesophago-gastric Cancer (ReStOre) intervention - a face to face multidisciplinary rehabilitation programme for upper gastrointestinal (UGI) cancer survivors. This study will examine the feasibility of a virtually delivered 12-week multi-component ReStOre@Home programme. This single arm feasibility study will recruit 12 patients who have completed curative treatment for oesophago-gastric cancer. Participants will complete the 12-week ReStOre@Home programme consisting of exercise (aerobic and resistance training), 1:1 dietary counselling and group education sessions through virtual delivery. Underpinned by the Medical Research Council (MRC) Framework, feasibility will be determined by recruitment rates, adherence, retention, incidents, and acceptability. Acceptability will be assessed qualitatively through post-intervention interview and the Telehealth Usability Questionnaire. Secondary outcomes will be assessed pre and post-intervention and will include measures of physical performance (cardiopulmonary exercise test, short physical performance battery, hand grip strength, Godin Leisure Time Questionnaire, and body composition), health related quality of life (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) and oesophago-gastric cancer specific subscale (EORTC-QLQ-OG25), fatigue (Multidimensional Fatigue Inventory (MFI-20), and venous blood samples will be collected for the UGI Cancer Survivorship Biobank. The ReStOre@Home feasibility study will provide important data regarding the amenability of a multidisciplinary programme designed for UGI cancer survivors to virtual delivery. ClinicalTrials.gov NCT04603339 (26/10/2020).
传统上，运动康复计划需要在监督下进行训练课程，但为了应对2019年冠状病毒病（COVID-19）大流行，不得不迅速调整为虚拟授课，以尽量减少患者之间的接触。在缺乏有效疫苗的情况下，这种大流行可能会在中期持续存在，在此期间，考虑远程解决方案的可行性和有效性非常重要。我们之前已经确定了食管癌和胃癌康复策略（ReStOre）干预措施的可行性——这是一项针对上消化道（UGI）癌症幸存者的面对面多学科康复计划。本研究将检验虚拟提供的为期12周的多成分居家ReStOre计划的可行性。这项单臂可行性研究将招募12名已完成食管癌和胃癌根治性治疗的患者。参与者将完成为期12周的居家ReStOre计划，该计划包括运动（有氧和阻力训练）、一对一饮食咨询以及通过虚拟授课进行的小组教育课程。在医学研究理事会（MRC）框架的支持下，可行性将通过招募率、依从性、保留率、事件发生率和可接受性来确定。可接受性将通过干预后的访谈和远程医疗可用性问卷进行定性评估。次要结果将在干预前后进行评估，包括身体机能测量（心肺运动试验、简短身体机能测试、握力、戈丁休闲时间问卷和身体成分）、健康相关生活质量（欧洲癌症研究与治疗组织核心生活质量问卷（EORTC-QLQ-C30）和食管癌和胃癌特异性子量表（EORTC-QLQ-OG25））、疲劳（多维疲劳量表（MFI-20）），并将采集静脉血样用于上消化道癌症幸存者生物样本库。居家ReStOre可行性研究将提供重要数据，说明为上消化道癌症幸存者设计的多学科计划对虚拟授课的适应性。ClinicalTrials.gov NCT04603339（2020年10月26日）。
