移动健康和监督康复与单独移动健康在乳腺癌幸存者中的应用：随机对照试验。

Mobile health and supervised rehabilitation versus mobile health alone in breast cancer survivors: Randomized controlled trial.

机构信息

Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Avda. de la Ilustración, 60, 18016 Granada, Spain; Sport and Health Joint University Institute (iMUDS), Granada, Spain; Biohealth Research Institute in Granada (ibs.GRANADA), Granada, Spain; "Cuídate" Support Unit for Oncology Patients (UAPO-Cuídate), Granada, Spain.

出版信息

Ann Phys Rehabil Med. 2020 Jul;63(4):316-324. doi: 10.1016/j.rehab.2019.07.007. Epub 2019 Aug 24.

DOI:10.1016/j.rehab.2019.07.007

PMID:31454561

Abstract

BACKGROUND

Survival rates in cancer are increasing exponentially, with a corresponding increase/influence in disability-adjusted life-years. Efforts should be made to explore the optimal balance between unsupervised/distance-based and supervised/onsite approaches to cancer care.

OBJECTIVE

This study aimed to compare the clinical efficacy of the BENECA mobile Health (mHealth) lifestyle application combined with a supervised rehabilitation program (BENECA and supervised rehabilitation) versus the BENECA mHealth lifestyle application alone on quality of life (QoL) and functional outcomes of breast cancer survivors.

METHODS

This randomized controlled trial included 80 survivors of breast cancer diagnosed at stage I-IIIA, who completed adjuvant therapy and were overweight or obese at diagnosis. Participants were randomly allocated (ratio 1:1, 3 waves) to BENECA mHealth and rehabilitation for 2months (n=40) or BENECA mHealth and usual care (BENECA mHealth alone; n=40). Participants completed a questionnaire at baseline (T1), 8-weeks post-intervention (T2) and 6-month follow-up (T3). The primary outcome was QoL assessed with the EORT QLQ-C30. Secondary outcomes included upper-limb functionality and body composition. Statistical (between-group analyses of covariance) and clinical effects were analyzed by intention to treat.

RESULTS

Both groups showed improved outcomes, but global QoL was significantly better with BENECA mHealth and rehabilitation than BENECA mHealth alone (mean difference, 12.76; 95% confidence interval 4.85; 20.67; P=0.004), with a moderate-to-large effect size (d=72). The proportion of participants reporting reliable clinical improvement on global QoL at T2 was higher with BENECA mHealth and rehabilitation than BENECA mHealth alone (57.5% vs 26.3%, P=0.008). Improvement in subjective and objective upper-limb functionality was also higher with BENECA mHealth and rehabilitation.

CONCLUSIONS

The BENECA mHealth lifestyle application with a supervised rehabilitation program had a statistically and clinically significant effect on QoL and upper-limb functionality in breast cancer survivors and is a unique and important promising new approach.

摘要

背景

癌症患者的生存率呈指数级增长，相应地，失能调整生命年（DALY）也在增加。因此，应该努力探索癌症护理中无监督/远程方法和监督/现场方法之间的最佳平衡。

目的

本研究旨在比较 BENECA 移动健康（mHealth）生活方式应用程序联合监督康复计划（BENECA 和监督康复）与仅使用 BENECA mHealth 生活方式应用程序对乳腺癌幸存者生活质量（QoL）和功能结局的临床疗效。

方法

这项随机对照试验纳入了 80 名诊断为 I 期-III 期的乳腺癌幸存者，这些患者完成了辅助治疗，且在诊断时超重或肥胖。参与者被随机分配（比例为 1:1，分为 3 波）至 BENECA mHealth 和康复组（n=40）或 BENECA mHealth 和常规护理组（BENECA mHealth 单独组；n=40），接受为期 2 个月的干预。参与者在基线（T1）、干预后 8 周（T2）和 6 个月随访（T3）时完成问卷。主要结局为 EORT QLQ-C30 评估的 QoL。次要结局包括上肢功能和身体成分。采用意向治疗进行统计学（组间协方差分析）和临床效果分析。

结果

两组的结局均有所改善，但 BENECA mHealth 和康复组的全球 QoL 显著优于 BENECA mHealth 单独组（平均差异，12.76；95%置信区间，4.85；20.67；P=0.004），具有中到大的效应量（d=72）。BENECA mHealth 和康复组中报告 T2 时全球 QoL 具有可靠临床改善的参与者比例高于 BENECA mHealth 单独组（57.5% vs 26.3%，P=0.008）。BENECA mHealth 和康复组的主观和客观上肢功能改善也更高。