Non-Small Cell Lung Cancer (NSCLC)NCT07310056
The Construction and Clinical Application of an Integrated Perioperative Management System for Lung Cancer Based on Wearable Devices and Intelligent Platforms
A study testing Wearable-Based Digital Perioperative Rehabilitation System and Standard Perioperative Rehabilitation Guidance in people with Non-Small Cell Lung Cancer (NSCLC) and Rehabilitation, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery
- What is being tested?
- Wearable-Based Digital Perioperative Rehabilitation System and Standard Perioperative Rehabilitation Guidance
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
- Any other condition that, in the judgment of the investigators, makes the participant unsuitable for study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu
Cyan Dr, 86 18559562107, lhy26cyan@163.com
About this study
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.
Read the 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) 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
- Being tested
- Wearable-Based Digital Perioperative Rehabilitation System, Standard Perioperative Rehabilitation Guidance
- Keywords
- Non-Small Cell Lung Cancer, Lung Cancer Surgery, Wearable Devices, Perioperative Management, Rehabilitation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable-Based Digital Perioperative Rehabilitation SystemDevice
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 Rehabilitation GuidanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Perioperative Rehabilitation Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from return to the ward to first postoperative ambulation
Time, measured in hours, from the patient's return to the surgical ward after surgery to the first postoperative out-of-bed ambulation. First ambulation is defined as the patient getting out of bed and standing or walking, with or without assistance.
Measured: From return to the surgical ward to first postoperative out-of-bed ambulation, censored at the date of hospital discharge, assessed up to the date of initial discharge (typically up to 14 days post-surgery).
Secondary outcomes (9)
Six-Minute Walk Distance (6MWD)
The change in six-minute walk distance will be used to evaluate functional exercise capacity and recovery after surgery.
Measured: Baseline (preoperative), 30 days after surgery, and 3 months after surgery
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)
Measured: Baseline (preoperative), 30 days after surgery, and 3 months after surgery
Change in Forced Vital Capacity (FVC)
Change in forced vital capacity (FVC), measured by spirometry, comparing postoperative pulmonary function recovery between the wearable-based digital rehabilitation group and the standard care group.
Measured: Baseline (preoperative), 30 days after surgery, and 3 months after surgery
Change in FEV₁/FVC Ratio
Change in the ratio of forced expiratory volume in 1 second to forced vital capacity (FEV₁/FVC), measured by spirometry, comparing postoperative pulmonary function recovery between the wearable-based digital rehabilitation group and the standard care group.
Measured: Baseline (preoperative), 30 days after surgery, and 3 months after surgery
Peak Oxygen Consumption (VO₂ peak)
Peak oxygen consumption measured by cardiopulmonary exercise testing will be used to assess cardiorespiratory fitness.
Measured: 30 days and 3 months after surgery
Postoperative Complication Rate
The incidence of postoperative complications including pulmonary infection, atelectasis, prolonged air leak, pain, postoperative nausea and vomiting, and venous thromboembolism.
Measured: From surgery to 30 days after surgery
Length of Postoperative Hospital Stay
Total number of days of hospitalization after surgery.
Measured: From the date of surgery until the date of hospital discharge, assessed up to 90 days after surgery.
Quality of Life (MDASI-LC)
Quality of life and symptom burden will be assessed using the MD Anderson Symptom Inventory-Lung Cancer module (MDASI-LC), which evaluates pain, fatigue, dyspnea, sleep disturbance, and overall symptom severity in patients with lung cancer.
Measured: Baseline (preoperative), 30 days after surgery, and 3 months after surgery
Patient satisfaction with postoperative monitoring
Patient satisfaction with postoperative monitoring will be assessed using a study-specific questionnaire administered before hospital discharge. The questionnaire evaluates overall satisfaction, monitoring comfort, convenience during mobilization, sleep disturbance, perceived safety, monitoring-related discomfort, satisfaction with nursing care, and willingness to use the monitoring method again. Common items applicable to both groups will be rated using a 5-point Likert scale, ranging from 1 (very dissatisfied/strongly disagree) to 5 (very satisfied/strongly agree), with higher scores indicating greater satisfaction. Device-specific items will be analyzed descriptively in the wearable monitoring group only.
Measured: Within 24 hours before discharge from the index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jan 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuelei Ma MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310056
- Sponsor's protocol ID
- Approval No. 1647 (2024)
- Status last verified
- Sep 2026
- First submitted
- 30 Nov 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No