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

NCT07310056 | Not Yet Recruiting

• 1 other identifier: Approval No. 1647 (2024)
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Forced Expiratory Volume in 1 Second (FEV₁)

  Change in forced expiratory volume in 1 second (FEV₁), measured by spirometry, comparing postoperative pulmonary function recovery between the wearable-based digital rehabilitation group and the standard care group. Unit of Measure: Liters (L)

  Baseline (preoperative), 30 days after surgery, and 3 months after surgery

Secondary Outcomes (7)

• Six-Minute Walk Distance (6MWD)

  Baseline (preoperative), 30 days after surgery, and 3 months after surgery

• Change in Forced Vital Capacity (FVC)

  Baseline (preoperative), 30 days after surgery, and 3 months after surgery

• Change in FEV₁/FVC Ratio

  Baseline (preoperative), 30 days after surgery, and 3 months after surgery

• Peak Oxygen Consumption (VO₂ peak)

  30 days and 3 months after surgery

• Postoperative Complication Rate

  From surgery to 30 days after surgery

Other Outcomes (1)

• Regional Lung Function by Functional MRI (PREFUL)

  Baseline (preoperative), 1 and 3 months after surgery

Study Arms (2)

Experimental

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.

Device: Wearable-Based Digital Perioperative Rehabilitation System

Standard Perioperative Care

ACTIVE COMPARATOR

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.

Behavioral: Standard Perioperative Rehabilitation Guidance

Interventions

Standard Perioperative Rehabilitation Guidance 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.

Standard Perioperative Care

Wearable-Based Digital Perioperative Rehabilitation System 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

Experimental

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Biotherapy, West China Hospital, Sichuan University

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12