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在伦敦一家教学医院接受肺癌肿瘤治疗的患者中实施个体化术前康复的可行性如何?一项可行性试验方案。

Is personalised prehabilitation feasible to implement for patients undergoing oncological treatment for lung cancer at a London teaching hospital? Protocol of a feasibility trial.

机构信息

Department of Nutrition and Dietetics, Imperial College Healthcare NHS Trust, London, UK

Department of Surgery, Cardiovascular and Cancer, Imperial College Healthcare NHS Trust, London, UK.

出版信息

BMJ Open. 2023 Jul 17;13(7):e072367. doi: 10.1136/bmjopen-2023-072367.

Abstract

INTRODUCTION

There is significant potential to improve outcomes for patients with lung cancer in terms of quality of life and survival. There is some evidence that prehabilitation can help, but, to date, this has only been tested in surgical populations, despite 70%-80% of patients with lung cancer in the UK receiving non-surgical treatment. The physiological and psychological benefits of prehabilitation seen in surgical patients could be extrapolated to those receiving non-surgical treatment, particularly in such a poor prognosis group. With patients and healthcare professionals, we have co-designed a personalised and evidence-based prehabilitation programme. This draws on a conceptual framework that aligns with patient values and needs as well as functional goals. We aim to investigate whether this programme is feasible to implement and evaluate in clinical practice.

METHODS AND ANALYSIS

An open-label, single-group feasibility study incorporating quantitative assessments, a qualitative free text questionnaire and reflective field notes. Thirty participants will be recruited over an eight-month period from a single London teaching hospital. All recruited participants will receive a personalised prehabilitation programme during their oncological treatment. This includes a one-hour face-to-face appointment prior to, at week three and at week six of their treatment regimen as well as a weekly telephone call. Interventions including nutrition, physical activity and psychological well-being are stratified according to a patient's priorities, level of readiness and expressed needs. The primary outcome will be feasibility of the personalised prehabilitation programme in clinical practice by investigating areas of uncertainty regarding patient recruitment, attrition, treatment fidelity, intervention adherence and acceptability of study outcome measures. Secondary outcomes will include quality of life, functional capacity and grip strength.

ETHICS AND DISSEMINATION

Ethical approval has been obtained from the Health Research Authority (reference number 22/PR/0390). Results of this study will be disseminated through publication in peer-reviewed articles, presentations at scientific conferences and in collaboration with patient and public involvement representatives.

TRIAL REGISTRATION NUMBER

NCT05318807.

摘要

简介

提高肺癌患者的生活质量和生存率方面存在巨大的潜力。有证据表明,预康复可能会有所帮助,但迄今为止,这仅在手术人群中进行了测试,尽管英国 70%-80%的肺癌患者接受的是非手术治疗。在接受手术治疗的患者中观察到的预康复的生理和心理益处可以外推到接受非手术治疗的患者,特别是在预后较差的患者中。我们与患者和医疗保健专业人员共同设计了一个个性化的基于证据的预康复计划。该计划借鉴了一个与患者价值观和需求以及功能目标相一致的概念框架。我们旨在研究该计划在临床实践中是否可行。

方法和分析

一项开放标签、单组可行性研究,包括定量评估、定性自由文本问卷和反思性实地记录。在八个月的时间里,将从伦敦的一家教学医院招募 30 名参与者。所有招募的参与者都将在肿瘤治疗期间接受个性化的预康复计划。这包括在治疗方案的前三周和第六周以及每周一次的电话咨询之前、期间和之后进行一次一小时的面对面预约。根据患者的优先级、准备程度和表达的需求,对营养、身体活动和心理健康等干预措施进行分层。主要结果将是个性化预康复计划在临床实践中的可行性,方法是调查患者招募、流失、治疗保真度、干预依从性和研究结果测量的可接受性方面的不确定性。次要结果将包括生活质量、功能能力和握力。

伦理和传播

已从健康研究管理局获得伦理批准(参考号 22/PR/0390)。该研究的结果将通过在同行评议的文章中发表、在科学会议上展示以及与患者和公众参与代表合作来传播。

试验注册号

NCT05318807。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d1aa/10357652/5d38d61df49a/bmjopen-2023-072367f01.jpg

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