The Construction and Clinical Application of an Integrated Perioperative Management System for Lung Cancer Based on Wearable Devices and Intelligent Platforms

NCT ID: NCT07310056

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-12-01

Brief Summary

This study aims to develop and evaluate an integrated perioperative management system based on wearable devices and a digital rehabilitation platform for patients with non-small cell lung cancer (NSCLC) undergoing thoracic surgery. By combining preoperative functional assessment using the six-minute walk test (6MWT), continuous perioperative physiological monitoring, and structured postoperative home-based digital rehabilitation, this randomized controlled trial will investigate whether the wearable-based digital management model improves short-term postoperative pulmonary function, functional recovery, and clinical outcomes compared with standard perioperative care.

Detailed Description

With the rapid development of wearable sensor technology and digital health platforms, continuous physiological monitoring and remote rehabilitation have become feasible throughout the perioperative period. However, current perioperative management for lung cancer patients remains fragmented, with limited integration of preoperative functional assessment, intraoperative monitoring, and postoperative home-based rehabilitation. This study is designed to establish and validate a comprehensive wearable-based perioperative management system for patients with non-small cell lung cancer (NSCLC) undergoing surgical resection.

This study is a prospective, single-center, randomized, single-blind, superiority-controlled trial. A total of 126 eligible patients undergoing elective video-assisted thoracoscopic lobectomy or segmentectomy will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The control group will receive standard perioperative management and routine postoperative rehabilitation guidance. The intervention group will receive standard care plus a digital perioperative rehabilitation program supported by wearable devices and a remote monitoring platform.

During the preoperative phase, patients in the intervention group will undergo personalized prehabilitation including aerobic exercise training, respiratory muscle training, and resistance exercise. The six-minute walk test (6MWT), portable pulmonary function testing, and non-contrast functional lung MRI (PREFUL technology) will be performed for functional assessment. Wearable devices will continuously collect heart rate, blood oxygen saturation, step count, and activity level.

During the intraoperative phase, standardized surgical procedures and anesthetic management will be applied. Key intraoperative indicators including blood loss, ventilation time, anesthesia duration, and complications will be recorded through the anesthesia and surgical information systems.

During the postoperative phase, patients in the intervention group will receive 30-day home-based digital rehabilitation, including daily exercise tasks, real-time wearable data upload, electronic patient-reported outcomes (ePROs) reporting of symptoms (pain, fatigue, dyspnea), and remote review and guidance by medical staff via the digital platform. The control group will receive routine discharge education and outpatient follow-up.

The primary endpoint of the study is the between-group difference in pulmonary function (FEV₁, FVC, FEV₁/FVC) at 30 days and 3 months after surgery. Secondary endpoints include six-minute walk distance, peak oxygen consumption (VO₂ peak), postoperative complications, chest tube duration, length of hospital stay, time to first ambulation, 30-day readmission rate, analgesic consumption, symptom burden assessed using the MD Anderson Symptom Inventory-Lung Cancer module (MDASI-LC), and rehabilitation adherence based on platform usage data.

By integrating wearable-based continuous monitoring, objective functional assessment, and structured digital rehabilitation, this study aims to establish a closed-loop, data-driven perioperative management model. The results are expected to provide high-quality clinical evidence for the effectiveness, safety, and feasibility of wearable-assisted perioperative rehabilitation in lung cancer patients, and to promote the clinical translation of digital health technologies into thoracic surgery practice.

Conditions

Non-Small Cell Lung Cancer (NSCLC); Rehabilitation; Thoracic Surgery; Perioperative Management

Keywords

Non-Small Cell Lung Cancer; Lung Cancer Surgery; Wearable Devices; Perioperative Management; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental

Patients in this arm receive standard perioperative care plus a wearable-based digital perioperative rehabilitation program. The intervention includes preoperative personalized exercise training (aerobic exercise, respiratory muscle training, and resistance training), real-time six-minute walk test monitoring, portable pulmonary function testing, and continuous physiological monitoring using wearable devices (heart rate, oxygen saturation, and activity level). After discharge, patients undergo a 30-day home-based digital rehabilitation program with daily exercise tasks, real-time data upload, electronic patient-reported outcomes (ePROs), and remote guidance via a digital platform. Rehabilitation plans are dynamically adjusted based on patient performance and physiological data.

Group Type: EXPERIMENTAL

Wearable-Based Digital Perioperative Rehabilitation System

Intervention Type: DEVICE

This intervention consists of a wearable-based digital perioperative rehabilitation system designed for patients with non-small cell lung cancer undergoing thoracic surgery. The system integrates continuous physiological monitoring, functional assessment, and remote rehabilitation management. During the preoperative phase, patients receive personalized prehabilitation including aerobic exercise, respiratory muscle training, and resistance training. Wearable devices continuously monitor heart rate, oxygen saturation, activity level, and walking distance, including real-time monitoring during the six-minute walk test. Portable pulmonary function testing and functional MRI (PREFUL) are used for baseline assessment. During the postoperative phase, patients receive 30 days of home-based digital rehabilitation, including daily exercise tasks, real-time data upload, electronic patient-reported outcomes, and remote feedback from clinicians via a digital platform. Rehabilitation plans are dynam

Standard Perioperative Care

Patients in this arm receive standard perioperative management only. This includes routine preoperative assessment, standardized surgical and anesthesia care, and conventional postoperative rehabilitation guidance at discharge. No wearable device monitoring, prehabilitation training, or digital home-based rehabilitation platform is provided. Patients are followed according to routine outpatient follow-up schedules after discharge.

Group Type: ACTIVE_COMPARATOR

Standard Perioperative Rehabilitation Guidance

Intervention Type: BEHAVIORAL

This behavioral intervention consists of standard perioperative rehabilitation guidance provided to patients undergoing thoracic surgery for non-small cell lung cancer. Patients receive routine preoperative assessment, standardized postoperative discharge education, and conventional rehabilitation instructions including breathing exercises, early mobilization, pain management, and activity recommendations. No structured prehabilitation program, wearable device monitoring, remote digital platform, or continuous physiological monitoring is provided. Post-discharge follow-up is conducted according to routine outpatient clinical practice.

Interventions

Wearable-Based Digital Perioperative Rehabilitation System

This intervention consists of a wearable-based digital perioperative rehabilitation system designed for patients with non-small cell lung cancer undergoing thoracic surgery. The system integrates continuous physiological monitoring, functional assessment, and remote rehabilitation management. During the preoperative phase, patients receive personalized prehabilitation including aerobic exercise, respiratory muscle training, and resistance training. Wearable devices continuously monitor heart rate, oxygen saturation, activity level, and walking distance, including real-time monitoring during the six-minute walk test. Portable pulmonary function testing and functional MRI (PREFUL) are used for baseline assessment. During the postoperative phase, patients receive 30 days of home-based digital rehabilitation, including daily exercise tasks, real-time data upload, electronic patient-reported outcomes, and remote feedback from clinicians via a digital platform. Rehabilitation plans are dynam

Intervention Type: DEVICE

Standard Perioperative Rehabilitation Guidance

This behavioral intervention consists of standard perioperative rehabilitation guidance provided to patients undergoing thoracic surgery for non-small cell lung cancer. Patients receive routine preoperative assessment, standardized postoperative discharge education, and conventional rehabilitation instructions including breathing exercises, early mobilization, pain management, and activity recommendations. No structured prehabilitation program, wearable device monitoring, remote digital platform, or continuous physiological monitoring is provided. Post-discharge follow-up is conducted according to routine outpatient clinical practice.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Age ≥18 years and ≤85 years

Pathologically confirmed primary non-small cell lung cancer (NSCLC)

Scheduled to undergo elective curative-intent thoracoscopic lobectomy or segmentectomy

Postoperative clinical condition is stable and judged by investigators to be suitable for discharge within 2-7 days after surgery

Able to independently operate a smartphone and wearable device, or able to do so with caregiver assistance

Willing to comply with study procedures and follow-up requirements

Provided written informed consent prior to participation

Exclusion Criteria

Preoperative long-term home oxygen therapy or severe resting respiratory failure

Presence of severe or uncontrolled cardiopulmonary disease, cerebrovascular disease, hepatic insufficiency, or renal insufficiency

Severe comorbid conditions that significantly limit physical activity or adherence to rehabilitation

Known or suspected allergy to materials used in wearable devices or medical adhesives

Severe postoperative complications requiring reoperation or prolonged mechanical ventilation

Occurrence of serious adverse events during the six-minute walk test that prevent continuation of the study

Any other condition that, in the judgment of the investigators, makes the participant unsuitable for study participation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xuelei Ma MD

Department of Biotherapy, West China Hospital, Sichuan University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Approval No. 1647 (2024)

Identifier Type: -

Identifier Source: org_study_id