Data Sheet 1_Multimodal group-based tele-prehabilitation for cancer patients and caregivers: a pragmatic multicentre hybrid implementation-effectiveness study protocol.pdf

BackgroundMultimodal prehabilitation can optimize the physical and psychological health of cancer patients, reduce treatment side effects, hospital stay, and accelerate recovery. The support provided by caregivers reduces the demands on the health care system and can be key in the uptake and maintenance of healthy lifestyle behaviours. However, caregivers support comes at a high cost to their own health. Physical activity can help caregivers maintain their health at the level required to successfully perform their vital roles. Our team has designed the first group-based multimodal tele-prehabilitation program targeting both patients and caregivers: coACTIF. This paper presents the protocol of this implementation-effectiveness study.
MethodsThis pragmatic, multicentre, hybrid implementation-effectiveness study uses a pre-post-follow-up mixed methods convergent parallel design. The prehabilitation program implementation and effectiveness will be tested in three cities of various sizes in Quebec, Canada. The prehabilitation program includes a virtual supervised group-based exercise program and a web-based educational platform providing learning opportunities and resources on healthy lifestyles and self-management strategies. The study aims to recruit a convenience sample of 100 units (a unit can be a dyad, a patient alone or a caregiver alone). Study participants are French-speaking, adults, preoperative cancer patients and/or their adult caregivers. The implementation and effectiveness are assessed through indicators of the RE-AIM framework: Reach, Effectiveness, Adoption, Implementation and Maintenance. Functional fitness and health outcomes are assessed pre-post intervention and 90-day post-surgery. Interviews with patients, caregivers and health professionals will be conducted to document implementation barriers, facilitators and strategies to facilitate scaling-up of the intervention across various health organisations using the Consolidated Framework for Implementation Research (CFIR).
Discussion and disseminationThis study will provide evidence from various real-world cancer care settings about the implementation and effectiveness of an innovative tele-prehabilitation intervention that aims to rapidly engage cancer patients and caregivers. This intervention has the potential to accelerate and facilitate behaviour change early in the cancer continuum with the objective of optimizing the whole cancer experience and future scaling-up across a variety of cancer care units. Our team will disseminate coACTIF results through reports to stakeholders, scientific manuscripts and presentation at clinical and scientific conferences.

背景 多模式预康复（multimodal prehabilitation）可优化癌症患者的身心健康水平，减轻治疗不良反应，缩短住院时长并加速康复进程。照护者提供的支持可降低医疗系统的负担，同时也是患者采纳并维持健康生活方式行为的关键因素。然而，照护者提供支持的同时，自身健康会付出高昂代价。体育活动可帮助照护者维持胜任重要职责所需的健康水平。本团队设计了首个面向患者与照护者的团体式远程多模式预康复项目：coACTIF。本文介绍该实施-效果研究的研究方案。

方法 本研究为务实型、多中心混合方法收敛平行设计的实施-效果研究，采用干预前-干预后-随访的研究架构。该预康复项目的实施与效果将在加拿大魁北克省三座不同规模的城市中开展测试。本预康复项目包含虚拟监督式团体运动课程，以及基于网页的教育平台，该平台可提供健康生活方式与自我管理策略相关的学习资源与机会。本研究计划通过便利性抽样招募100个研究单元（单元可定义为患者-照护者二人组、单独患者或单独照护者）。研究参与者为说法语的成年癌症术前患者及其/或成年照护者。本研究将通过RE-AIM框架（RE-AIM framework）的五项指标——覆盖度（Reach）、效果（Effectiveness）、采纳度（Adoption）、实施保真度（Implementation）与维持度（Maintenance），评估项目的实施情况与效果。分别在干预前、干预后以及术后90天时评估受试者的功能体能与健康结局。本研究将对患者、照护者与医疗专业人员开展访谈，结合综合实施研究框架（Consolidated Framework for Implementation Research, CFIR），梳理干预方案在各类医疗组织中推广落地所面临的实施障碍、促进因素及相关策略。

讨论与传播 本研究将从各类真实世界癌症诊疗场景中获取证据，旨在验证一款创新性远程预康复（tele-prehabilitation）干预方案的实施效果与可行性，该方案可快速吸引癌症患者与照护者参与。本干预方案有望在癌症诊疗全流程早期加速并推动行为改变，以优化整体癌症诊疗体验，并最终在各类癌症诊疗单元中实现规模化推广。本团队将通过向利益相关方提交研究报告、发表学术论文以及在临床与学术会议上作报告等方式，发布coACTIF项目的研究结果。