The Construction and Clinical Application of an Integrated Perioperative Management System for Lung Cancer Based on Wearable Devices and Intelligent Platforms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wearable-Based Digital Perioperative Rehabilitation System, Standard Perioperative Rehabilitation Guidance.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery, Perioperative Management. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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 rat - Behavioral 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
Primary outcome measures
- Change in Forced Expiratory Volume in 1 Second (FEV₁) [Time frame: Baseline (preoperative), 30 days after surgery, and 3 months after surgery]
Secondary outcome measures (7)
- Six-Minute Walk Distance (6MWD) [Time frame: Baseline (preoperative), 30 days after surgery, and 3 months after surgery]
- Change in Forced Vital Capacity (FVC) [Time frame: Baseline (preoperative), 30 days after surgery, and 3 months after surgery]
- Change in FEV₁/FVC Ratio [Time frame: Baseline (preoperative), 30 days after surgery, and 3 months after surgery]
- Peak Oxygen Consumption (VO₂ peak) [Time frame: 30 days and 3 months after surgery]
- Postoperative Complication Rate [Time frame: From surgery to 30 days after surgery]
- Length of Postoperative Hospital Stay [Time frame: From the date of surgery until the date of hospital discharge, assessed up to 90 days after surgery.]
- Quality of Life (MDASI-LC) [Time frame: Baseline (preoperative), 30 days after surgery, and 3 months after surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07310056 · Approval No. 1647 (2024)