胃肠道癌手术前的预康复：一项实施研究方案

Prehabilitation Before Gastrointestinal Cancer Surgery: Protocol for an Implementation Study.

作者信息

Raso Kristy-Lee, Suen Michael, Turner Jane, Khatri Sonia, Lin Yanlan, Wildbore Carolyn, Becerril-Martinez Guillermo, Le Page Philip, Tan Sim Yee, Egger Sam, Vardy Janette

机构信息

Department of Nutrition and Dietetics, Concord Repatriation General Hospital, Concord, Australia.

Sydney Medical School, University of Sydney, Sydney, Australia.

出版信息

JMIR Res Protoc. 2023 Mar 27;12:e41101. doi: 10.2196/41101.

DOI:10.2196/41101

PMID:36972114

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10131732/

Abstract

BACKGROUND

Surgery remains the standard curative treatment for early-stage colorectal and upper gastrointestinal cancer. Reduced preoperative functional capacity, nutritional status, and psychological well-being are associated with poor postoperative outcomes. Prehabilitation aims to improve preoperative functional reserves through physical, nutritional, and psychological interventions. Yet, how it transitions from a trial setting to being integrated into a real-world health setting is unknown.

OBJECTIVE

The primary aim is to evaluate the implementation of a multimodal (supervised exercise, nutrition, and nursing support) prehabilitation program into standard care for patients with gastrointestinal cancer (colorectal and upper gastrointestinal cancer) scheduled for curative intent surgery. The secondary aim is to determine the impact of a multimodal prehabilitation program on functional capacity, nutritional and psychological status, and surgical outcomes.

METHODS

This is an implementation study that will investigate a multimodal prehabilitation intervention, in a nonblinded, nonrandomized, single-group, pre-post design. Patients diagnosed with colorectal and upper gastrointestinal cancer scheduled for potentially curative intent surgery at Concord Repatriation General Hospital, with ≥14 intervention days prior to surgery and are medically cleared to exercise will be eligible. The study will be evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance Evaluation Framework.

RESULTS

The protocol was approved in December 2019 by the Concord Repatriation General Hospital Human Research Ethics Committee (reference number 2019/PID13679). Recruitment commenced in January 2020. In response to the COVID-19 pandemic, recruitment was paused in March 2020 and reopened in August 2020 with remote or telehealth intervention adaptations. Recruitment ended on December 31, 2021. Over the 16-month recruitment period, a total of 77 participants were recruited.

CONCLUSIONS

Prehabilitation represents an opportunity to maximize functional capacity and improve surgical outcomes. The study will provide guidance and contribute to the evidence on the integration of prehabilitation into standard care using adaptive models of health care delivery including telehealth.

TRIAL REGISTRATION

Australian and New Zealand Clinical Trials Registry ACTR 12620000409976; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378974&isReview=true.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/41101.

摘要

背景

手术仍然是早期结直肠癌和上消化道癌的标准治愈性治疗方法。术前功能能力、营养状况和心理健康状况下降与术后不良结局相关。术前康复旨在通过身体、营养和心理干预来改善术前功能储备。然而，它如何从试验环境过渡到融入现实世界的医疗环境尚不清楚。

目的

主要目的是评估将多模式（监督运动、营养和护理支持）术前康复计划纳入计划进行根治性手术的胃肠道癌（结直肠癌和上消化道癌）患者的标准护理中的实施情况。次要目的是确定多模式术前康复计划对功能能力、营养和心理状态以及手术结局的影响。

方法

这是一项实施研究，将采用非盲、非随机、单组、前后设计来研究多模式术前康复干预。在康科德遣返总医院被诊断为结直肠癌和上消化道癌且计划进行可能根治性手术、术前有≥14个干预日且医学上允许进行运动的患者将符合条件。该研究将使用可及性、有效性、采用率、实施情况和维持情况评估框架进行评估。

结果

该方案于2019年12月获得康科德遣返总医院人类研究伦理委员会批准（参考编号2019/PID13679）。招募工作于2020年1月开始。由于COVID-19大流行，招募工作于2020年3月暂停，并于2020年8月重新开始，同时对干预措施进行了远程或远程医疗方面的调整。招募工作于2021年12月31日结束。在为期16个月的招募期间，共招募了77名参与者。