中国一家三级医院中远程症状管理对肺癌电视辅助胸腔镜手术后运动依从性的影响：一项前瞻性随机对照试验方案

Impact of Remote Symptom Management on Exercise Adherence After Video-Assisted Thoracic Surgery for Lung Cancer in a Tertiary Hospital in China: Protocol for a Prospective Randomized Controlled Trial.

作者信息

Su Jianwei, Ye Cuiling, Zhang Qian, Liang Yi, Wu Jianwei, Liang Guixi, Cheng Yalan, Yang Xiaojuan

机构信息

Department of cardiothoracic Surgery, Zhongshan City People's Hospital, Zhongshan, China.

出版信息

JMIR Res Protoc. 2025 Jan 1;14:e60420. doi: 10.2196/60420.

DOI:10.2196/60420

PMID:39610048

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11736221/

Abstract

BACKGROUND

Regular pulmonary rehabilitation exercises are crucial for patients with lung cancer after surgery. However, poor adherence to outpatient exercises is difficult to address due to inadequate supervision. The integration of remote symptom management through electronic patient-reported outcomes (ePROs) offers a potential solution to improve adherence by enabling more effective monitoring and intervention.

OBJECTIVE

This study aims to evaluate the impact of ePRO-based remote symptom management on enhancing adherence to outpatient pulmonary rehabilitation exercises following video-assisted thoracic surgery for lung cancer.

METHODS

In this single-center, prospective, randomized controlled trial, 736 patients undergoing minimally invasive lung resection will be recruited. All patients will use a smartphone app for perioperative management, allowing periodic PRO measurement and recording of exercise participation. Upon discharge, patients will be randomly assigned 1:1 into either an intervention or control group. The intervention group will complete the Perioperative Symptom Assessment for Patients Undergoing Lung Surgery (PSA-Lung) scale on the day of discharge and postdischarge days 3, 7, 14, 21, and 28. Alerts will be triggered at the provider side if any of the 5 core symptoms (pain, cough, shortness of breath, sleep disturbance, and fatigue) scored ≥4, prompting remote symptom management. The control group will complete the PRO measures without triggering alerts. The primary outcome is the rehabilitation exercise adherence rate. Secondary outcomes include postdischarge pulmonary complication rate, 30-day readmission rate, trajectory of symptom severity changes, exercise participation rate, and patient satisfaction.

RESULTS

The enrollment of study participants started in December 2023 and is expected to end in March 2025. The final comprehensive analysis of the results is planned for May 2025, after all data have been collected and thoroughly reviewed.

CONCLUSIONS

This study is among the first to investigate the feasibility and effectiveness of ePRO-based remote symptom management in enhancing rehabilitation adherence after video-assisted thoracic surgery for lung cancer. If successful, this approach could significantly influence postoperative care practices and potentially be adopted in similar settings.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05990946; https://clinicaltrials.gov/study/NCT05990946.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60420.

摘要

背景

定期进行肺部康复锻炼对肺癌术后患者至关重要。然而，由于监督不足，门诊锻炼的依从性差难以解决。通过电子患者报告结局（ePROs）整合远程症状管理，通过实现更有效的监测和干预，为提高依从性提供了一种潜在的解决方案。

目的

本研究旨在评估基于ePROs的远程症状管理对提高肺癌电视辅助胸腔镜手术后门诊肺部康复锻炼依从性的影响。

方法

在这项单中心、前瞻性、随机对照试验中，将招募736例行微创肺切除术的患者。所有患者将使用智能手机应用程序进行围手术期管理，允许定期进行患者报告结局测量并记录锻炼参与情况。出院时，患者将按1:1随机分为干预组或对照组。干预组将在出院当天以及出院后第3、7、14、21和28天完成肺癌手术患者围手术期症状评估（PSA-Lung）量表。如果5种核心症状（疼痛、咳嗽、呼吸急促、睡眠障碍和疲劳）中的任何一种评分≥4，将在医护人员端触发警报，促使进行远程症状管理。对照组将完成患者报告结局测量但不触发警报。主要结局是康复锻炼依从率。次要结局包括出院后肺部并发症发生率、30天再入院率、症状严重程度变化轨迹、锻炼参与率和患者满意度。