Lambert Genevieve, Drummond Kenneth, Tahasildar Bhagya, Carli Francesco
Department of Experimental Surgery, Faculty of Medicine, McGill University, Montreal, QC, Canada.
Peri Operative Program, Department of Anesthesia, McGill University Health Center, Montreal, QC, Canada.
JMIR Res Protoc. 2022 May 6;11(5):e29936. doi: 10.2196/29936.
Since the beginning of the COVID-19 pandemic, preoperative care, also termed prehabilitation, has become increasingly relevant due to the decreasing functional and psychosocial health of patients with cancer, which is a result of the pandemic restrictions. Concurrently, access to telehealth has improved; telehealth comprises all remote care delivery facilitated by information technologies (ie, virtually).
The aim of this protocol is to describe the rationale and methodology for a major trial investigating the feasibility and safety of multimodal virtual prehabilitation services (ie, teleprehabilitation).
This single-arm feasibility trial aims to recruit 100 patients with cancer to receive teleprehabilitation throughout their preoperative period. The inclusion criteria are as follows: (1) 18 years of age or older, (2) scheduled for elective cancer surgery and referred by a surgeon, (3) medically cleared by the referring physician to engage in physical activity, and (4) have a good comprehension of the English or French language. Feasibility will be assessed by documenting recruitment, adherence, and retention rates, in addition to patients' motives for not participating in the trial, low participation, or discontinuation. The secondary outcome of safety will be assessed by reporting program-related adverse events.
The Montreal General Hospital Foundation funded the project in August 2020. The protocol was then approved by the Research Ethics Board of the McGill University Health Centre in January 2021 (ID No. 2021-6730). The first patient was recruited in March 2021, and recruitment is expected to end in September 2022. As of March 2022, 36 patients have been recruited, including 24 who have completed their participation. No adverse events have been reported. Data collection is expected to conclude in November 2022. Data analysis will be performed, and the results will be published by the beginning of 2023.
This trial will provide guidance on the use of telehealth in the administration of prehabilitation services. The trial will provide a large amount of information that will respond to gaps in the literature, as there are minimal reports on the use of telehealth rehabilitation and prehabilitation services among elderly populations and in acute contexts, such as the preoperative period.
ClinicalTrials.gov NCT0479956; https://clinicaltrials.gov/ct2/show/NCT04799561.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29936.
自新冠疫情开始以来,由于疫情限制导致癌症患者的功能和心理社会健康状况下降,术前护理(也称为术前康复)变得越来越重要。与此同时,远程医疗的可及性有所提高;远程医疗包括由信息技术推动的所有远程护理服务(即虚拟服务)。
本方案的目的是描述一项主要试验的基本原理和方法,该试验旨在研究多模式虚拟术前康复服务(即远程术前康复)的可行性和安全性。
这项单臂可行性试验旨在招募100名癌症患者,在其术前阶段接受远程术前康复。纳入标准如下:(1)18岁及以上;(2)计划进行择期癌症手术并由外科医生转诊;(3)经转诊医生医学评估可进行体育活动;(4)对英语或法语有良好理解能力。除记录招募、依从性和保留率外,还将通过记录患者不参与试验、参与度低或退出的原因来评估可行性。安全性的次要结果将通过报告与项目相关的不良事件来评估。
蒙特利尔总医院基金会于2020年8月资助了该项目。该方案随后于2021年1月获得麦吉尔大学健康中心研究伦理委员会的批准(编号2021 - 6730)。首例患者于2021年3月招募,预计招募工作于2022年9月结束。截至2022年3月,已招募36名患者,其中24名已完成参与。尚未报告不良事件。预计数据收集将于2022年11月结束。将进行数据分析,结果将于2023年初公布。
该试验将为远程医疗在术前康复服务管理中的应用提供指导。该试验将提供大量信息,以填补文献中的空白,因为关于老年人群以及急性情况下(如术前阶段)远程医疗康复和术前康复服务使用情况的报告极少。
ClinicalTrials.gov NCT0479956;https://clinicaltrials.gov/ct2/show/NCT04799561。
国际注册报告识别码(IRRID):DERR1 - 10.2196/29936。