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乳腺癌上肢功能障碍发展的预后因素:UPLIFT-BC 前瞻性纵向队列研究方案。

Prognostic factors for the development of upper limb dysfunctions after breast cancer: the UPLIFT-BC prospective longitudinal cohort study protocol.

机构信息

Department of Rehabilitation Sciences, KU Leuven, Leuven, Flanders, Belgium

Department of Rehabilitation Sciences, University of Antwerp, Antwerpen, Belgium.

出版信息

BMJ Open. 2024 May 15;14(5):e084882. doi: 10.1136/bmjopen-2024-084882.

Abstract

INTRODUCTION

Upper limb (UL) dysfunctions are highly prevalent in people after breast cancer and have a great impact on performing activities in daily living. To improve care, a more comprehensive understanding of the development and persistence of UL dysfunctions is needed. Therefore, the UPLIFT-BC study will primarily examine the prognostic value of different factors at the body functions and structures, environmental and personal level of the International Classification of Functioning, Disability and Health (ICF) framework at 1-month post-surgery for persisting UL dysfunctions at 6 months after finishing cancer treatment.

METHODS AND ANALYSIS

A prospective longitudinal cohort study, running from 1-week pre-surgery to 6 months post-local cancer treatment, is performed in a cohort of 250 women diagnosed with primary breast cancer. Different potentially prognostic factors to UL dysfunctions, covering body functions and structures, environmental and personal factors of the ICF, are assessed pre-surgically and at different time points post-surgery. The primary aim is to investigate the prognostic value of these factors at 1-month post-surgery for subjective UL function (ie, QuickDASH) at 6 months post-cancer treatment, that is, 6 months post-radiotherapy or post-surgery (T3), depending on the individuals' cancer treatment trajectory. In this, factors with relevant prognostic value pre-surgery are considered as well. Similar analyses are performed with an objective measure for UL function (ie, accelerometry) and a composite score of the combination of subjective and objective UL function. Second, in the subgroup of participants who receive radiotherapy, the prognostic value of the same factors is explored at 1-month post-radiotherapy and 6 months post-surgery. A forward stepwise selection strategy is used to obtain these multivariable prognostic models.

ETHICS AND DISSEMINATION

The study protocol was approved by the Ethics Committee of UZ/KU Leuven (reference number s66248). The results of this study will be published in peer-reviewed journals and will be presented at several research conferences.

TRIAL REGISTRATION NUMBER

NCT05297591.

摘要

简介

上肢(UL)功能障碍在乳腺癌患者中非常普遍,对日常生活活动的执行有很大影响。为了改善护理,需要更全面地了解 UL 功能障碍的发展和持续存在。因此,UPLIFT-BC 研究将主要检查国际功能、残疾和健康分类(ICF)框架的身体功能和结构、环境和个人层面的不同因素在手术后 1 个月对癌症治疗结束后 6 个月持续 UL 功能障碍的预后价值。

方法和分析

这是一项前瞻性纵向队列研究,从术前 1 周开始,持续到局部癌症治疗后 6 个月,纳入了 250 名诊断为原发性乳腺癌的女性患者。在术前和术后不同时间点评估不同的潜在预后因素,这些因素涵盖了 ICF 的身体功能和结构、环境和个人因素。主要目的是调查这些因素在手术后 1 个月对主观 UL 功能(即快速残疾评定量表)的预后价值,即癌症治疗结束后 6 个月(T3),这取决于个体的癌症治疗轨迹。在这方面,也考虑了术前有相关预后价值的因素。使用 UL 功能的客观测量(即加速度计)和主观和客观 UL 功能的组合的综合评分进行类似的分析。其次,在接受放疗的参与者亚组中,探讨了相同因素在放疗后 1 个月和手术后 6 个月的预后价值。采用逐步向前选择策略获得这些多变量预后模型。

伦理和传播

该研究方案已获得 UZ/KU Leuven 伦理委员会的批准(编号为 s66248)。本研究的结果将发表在同行评议的期刊上,并将在多个研究会议上展示。

试验注册编号

NCT05297591。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1cda/11097819/2c0cb7aea205/bmjopen-2024-084882f01.jpg

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