Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery
Conditions
Keywords
Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery
Brief summary
This is a prospective, open-label, parallel-group, 1:1 randomized controlled trial designed to evaluate whether a digital rehabilitation program integrated with wireless wearable continuous monitoring devices can shorten the time to functional recovery in patients with multiple primary non-small cell lung cancer (MPLC) who undergo sequential (two-stage) curative-intent resection. Eligible participants will be randomly assigned to either the intervention group or the control group. Both groups will receive standard enhanced recovery after surgery (ERAS) care. In addition, the intervention group will receive continuous vital sign monitoring (using a wearable patch during hospitalization and a wrist-worn device after discharge), personalized exercise prescriptions with daily step targets, and high-frequency electronic patient-reported outcome (ePRO) follow-up with threshold-triggered response. The control group will receive standard intermittent vital sign monitoring and conventional rehabilitation education. The primary endpoint is the time from the first surgery to attainment of functional recovery criteria sufficient for second-stage surgery readiness (assessed by a composite of step count recovery, functional interference score combined with 6-minute walk distance, or multidisciplinary team determination). Secondary endpoints include pulmonary function recovery (FEV1%, FVC%, DLCO% at 3 months), physical activity (daily steps, moderate-to-vigorous physical activity, 6-minute walk distance), symptom burden and quality of life (EORTC QLQ-C30/LC13, PROMIS), 30- and 90-day complication and readmission rates, second-surgery-related outcomes, adherence, safety, and healthcare resource utilization. A total of 222 participants (111 per group) will be enrolled. The study will be conducted at West China Hospital of Sichuan University from June 2026 to October 2027. The findings are expected to provide high-quality evidence on the clinical utility of wearable-integrated digital rehabilitation in the perioperative management of MPLC patients undergoing sequential resection.
Detailed description
Study Design This is a prospective, open-label, parallel-group, 1:1 randomized controlled trial conducted at a single center (West China Hospital of Sichuan University). Enrollment is planned from June 2026 to August 2027, with final data analysis completed by October 2027. The study protocol has been approved by the local ethics committee (Approval No. 2025-2642, dated January 13, 2026). Study Population We will enroll 222 patients aged 18-85 years with histopathologically confirmed multiple primary non-small cell lung cancer (MPLC) scheduled for sequential (two-stage) curative-intent resection. Eligible participants must have ECOG performance status 0-2, be clinically stable for home-based rehabilitation (discharge planned between POD2-7), and be able to use a smartphone and wearable devices independently or with caregiver support. Randomization and Blinding Participants are randomized 1:1 using central block randomization stratified by surgical approach, lesion laterality, and preoperative functional status. This is an open-label trial; however, the primary endpoint adjudication and statistical analysis will be performed blinded to group assignment. Intervention Both groups receive standard enhanced recovery after surgery (ERAS) care. Intervention group additionally receives: (1) continuous vital sign monitoring via a wireless wearable patch (in-hospital) and wrist-worn activity tracker (post-discharge); (2) a digital rehabilitation prescription with individualized exercise plans and progressive step goals; (3) high-frequency electronic patient-reported outcome (ePRO) symptom surveillance; and (4) threshold-triggered graded responses (e.g., SpO₂ \<90%, persistent tachycardia, or symptom escalation) to prompt telephone follow-up, outpatient visit, or emergency care. Control group receives standard intermittent vital sign monitoring and conventional rehabilitation education without wearable devices or digital prescriptions. Follow-up and Assessments The observation period spans from the first surgery until the primary event, second surgery, or 12 weeks (whichever occurs first). Assessments include pulmonary function (FEV1%, FVC%, DLCO%), 6-minute walk distance, physical activity metrics, ePRO symptoms and quality of life (EORTC QLQ-C30/LC13, PROMIS-PF), perioperative complications (30/90 days), re-admission, second-surgery outcomes, adherence, device-related adverse events, and healthcare resource utilization. Primary Endpoint The primary endpoint is the time from first surgery (POD0) to attainment of functional recovery criteria sufficient for second-stage surgery readiness, defined as the first date meeting any of: (a) 7-day rolling average step count ≥80% of baseline; (b) ePRO functional interference ≤2/10 AND 6MWD ≥90% of baseline; or (c) multidisciplinary team determination of readiness. Participants not reaching the event by 12 weeks are censored; non-recovery-related cancellations or tumor progression are treated as competing events. Sample Size With two-sided α=0.05, 80% power, a target HR of 0.65, an estimated event rate of 0.90 over 12 weeks, and 15% dropout, a total of 222 participants (111 per group) are required. Statistical Analysis The primary analysis will use the intention-to-treat population. Time-to-event will be compared using the stratified log-rank test, and the hazard ratio with 95% CI will be estimated from a Cox proportional hazards model adjusting for pre-specified covariates. Kaplan-Meier curves and restricted mean survival time (RMST) sensitivity analyses will be performed. Secondary endpoints will be analyzed using appropriate generalized linear or mixed models, with multiple imputation for missing data. Competing risks will be handled using Fine-Gray models. All tests are two-sided with α=0.05 for the primary endpoint. Safety and Data Quality Adverse events are graded per CTCAE v5.0 or Clavien-Dindo; serious adverse events are reported within 24 hours. An independent Data Safety Monitoring Board will oversee safety. All study personnel follow standardized operating procedures, and electronic data capture with logic checks and source data verification ensures quality.
Interventions
Wireless wearable patchs for continuous monitoring of heart rate, respiratory rate, SpO₂, and temperature during hospitalization; and a wrist-worn activity tracker for continuous monitoring of daily
BEHAVIORALDigital Pulmonary Rehabilitation Program
A home-based digital rehabilitation program including individualized aerobic, resistance, and inspiratory muscle training; weekly progressive step goals (e.g., +10-15% per week); and electronic patient-reported outcome (ePRO) symptom diaries completed daily for the first 2 weeks post-discharge, then at least 3 times per week thereafter. Threshold-triggered alerts prompt structured telephone calls, outpatient visits, or emergency evaluation.
OTHERStandard ERAS Perioperative and Rehabilitation Care
Standard enhanced recovery after surgery (ERAS/ERATS) care including routine intermittent vital sign monitoring, standardized pain management, nutritional support, early mobilization guidance, and conventional rehabilitation education, as per institutional practice.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
In this assessor-blinded trial, participants and the research team delivering the intervention cannot be masked due to the nature of the intervention (wearable devices vs. standard care). However, all outcome assessors responsible for the primary and key secondary endpoints-specifically the technicians performing pulmonary function tests (spirometry) and the physical therapists conducting the 6-minute walk tests-are fully masked to group allocation. These assessors are not involved in randomization, intervention delivery, or remote monitoring, and they remain blinded throughout all follow-up assessments to minimize detection bias.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 and ≤85 years * Histopathologically confirmed primary non-small cell lung cancer (NSCLC) meeting diagnostic criteria for multiple primary lung cancer (MPLC, unilateral or bilateral multifocal lesions), scheduled for elective sequential (two-stage) curative-intent resection; the first-stage surgery (lobectomy or segmentectomy) has been performed or is planned within 7 days after enrollment, with the second-stage surgery planned within 12 weeks postoperatively * Planned discharge between postoperative day 2 and day 7, and judged by the investigator to be clinically stable and suitable for home-based/out-of-hospital rehabilitation * Able to operate a smartphone application and wearable devices independently or with caregiver assistance, with stable cellular/broadband network access * Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and preoperatively assessed as able to tolerate routine rehabilitation training * Intact skin at the wearable device attachment sites, without severe skin diseases affecting device placement * Willing and able to provide written informed consent
Exclusion criteria
* Pre-existing long-term home oxygen therapy, or severe resting hypoxemia/ventilatory dysfunction (judged by the investigator to persistently affect safe rehabilitation) * Concurrent severe, uncontrolled cardiovascular disease (e.g., unstable angina, acute myocardial infarction or stroke within 3 months, NYHA class III-IV heart failure), severe hepatic insufficiency, or severe renal insufficiency * Other diseases or conditions that significantly affect motor function or compliance (e.g., severe neuromuscular/skeletal disorders, cognitive impairment, major psychiatric disorders) * Known or suspected contact allergy to medical adhesives or electrode materials used in the wearable devices, or skin conditions unsuitable for prolonged device attachment * Presence of implanted medical devices incompatible with the study wearable devices, or other contraindications as specified in the device instructions * Pregnancy or lactation, or women of childbearing potential who are unwilling to adopt effective contraceptive measures during the study period * Concurrent participation in another interventional clinical trial that may interfere with the outcomes of this study * Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Attainment of Functional Recovery Threshold for Second-Stage Surgery Readiness | From the day of first surgery (POD0) up to 12 weeks postoperatively, assessed continuously | The time from the first surgery (POD0) to the first date on which any of the following composite criteria is met: (1) 7-day rolling average daily step count ≥80% of preoperative baseline; OR (2) ePRO functional interference score ≤2/10 AND 6-minute walk distance (6MWD) ≥90% of preoperative baseline; OR (3) multidisciplinary team (MDT) written determination that the patient is ready for second-stage surgery. Participants not reaching the event by 12 weeks are censored. Non-recovery-related cancellation of second surgery or tumor progression are recorded as competing events and analyzed as sensitivity (Fine-Gray model). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in FEV1% Predicted | Baseline, 1 month, and 3 months postoperatively | Absolute value and percentage change from baseline in forced expiratory volume in 1 second (FEV1) as a percentage of predicted value, measured by spirometry according to standard guidelines. |
| Change in FVC% Predicted | Baseline, 1 month, and 3 months postoperatively | Absolute value and percentage change from baseline in forced vital capacity (FVC) as a percentage of predicted value, measured by spirometry according to standard guidelines. |
| Change in DLCO% Predicted | Baseline, 1 month, and 3 months postoperatively | Absolute value and percentage change from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO) as a percentage of predicted value, corrected for hemoglobin and alveolar volume per standard guidelines. |
| Daily Step Count | Continuously from discharge up to 12 weeks postoperatively | Mean daily step count derived from wrist-worn activity tracker, reported as 7-day rolling average. |
| Moderate-to-Vigorous Physical Activity (MVPA) Duration | Continuously from discharge up to 12 weeks postoperatively | Daily minutes of moderate-to-vigorous physical activity (MVPA) derived from wrist-worn activity tracker, reported as 7-day rolling average. |
| 6-Minute Walk Distance (6MWD) | Baseline, 4 weeks, 8 weeks, and 12 weeks postoperatively | Absolute 6-minute walk distance (in meters) and its percentage recovery relative to preoperative baseline, measured according to standardized protocols in a designated corridor. |
| ePRO Symptom Composite Score | Daily for first 2 weeks post-discharge, then at least 3 times per week up to 12 weeks | Electronic patient-reported outcome (ePRO) symptom diary scores for pain, dyspnea, cough, and fatigue, each rated on a 0-10 numeric rating scale. |
| EORTC QLQ-C30 Score | Baseline, 4 weeks, 8 weeks, and 12 weeks postoperatively | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores, including global health status, functional scales, and symptom scales. Reported as raw scores and standardized scores. |
| EORTC QLQ-LC13 Lung Cancer Module Score | Baseline, 4 weeks, 8 weeks, and 12 weeks postoperatively | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13-item module (EORTC QLQ-LC13) scores assessing lung cancer-specific symptoms (cough, hemoptysis, dyspnea, pain, and other targeted items). |
| PROMIS Physical Function (PROMIS-PF) Score | Baseline, 4 weeks, 8 weeks, and 12 weeks postoperatively | Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) short form scores (T-score metric). |
| 30-Day Complication Rate (Clavien-Dindo ≥II) | Within 30 days after the first surgery | Proportion of participants experiencing any postoperative complication graded Clavien-Dindo ≥II within 30 days after the first surgery. |
| 90-Day Complication Rate (Clavien-Dindo ≥II) | Within 90 days after the first surgery | Proportion of participants experiencing any postoperative complication graded Clavien-Dindo ≥II within 90 days after the first surgery. |
| Unplanned Re-Intervention Rate | Within 90 days after the first surgery | Proportion of participants requiring unplanned surgical or interventional re-intervention within 90 days after the first surgery. |
| ICU Transfer Rate | From the first surgery through discharge from the index hospitalization, up to 12 weeks after the first surgery | Proportion of participants requiring unplanned transfer to the intensive care unit (ICU) during the initial postoperative hospitalization. |
| Postoperative Hospital Length of Stay (First Surgery) | From the first surgery through discharge from the index hospitalization, up to 12 weeks after the first surgery | Total number of days from the date of first surgery to hospital discharge for the first surgery admission. |
| Unplanned Readmission Rate | Within 90 days after the first surgery | Proportion of participants with unplanned all-cause hospital readmission within 90 days after the first surgery. |
| Unplanned Emergency Department Visit Rate | Within 90 days after the first surgery | Proportion of participants with unplanned all-cause emergency department visits within 90 days after the first surgery. |
| Second-Stage Surgery Completion Rate | Within 12 weeks after the first surgery | Proportion of participants who successfully undergo the planned second-stage curative-intent resection within the 12-week observation window. |
| Time Interval Between First and Second Surgeries | From first surgery to second surgery (within 12-week window) | Number of days between the date of the first surgery and the date of the second-stage surgery. |
| Second Surgery Perioperative Complication Rate | Up to 30 days after the second-stage surgery | Proportion of participants experiencing any complication graded Clavien-Dindo ≥II during hospitalization for the second-stage surgery. |
| Chest Tube Drainage Duration (Second Surgery) | From the second-stage surgery through chest tube removal or hospital discharge, up to 30 days after the second-stage surgery | Total number of days with chest tube drainage during the second-stage surgery hospitalization. |
| Postoperative Hospital Length of Stay (Second Surgery) | From the second-stage surgery through hospital discharge, up to 30 days after the second-stage surgery | Total number of days from the date of the second-stage surgery to hospital discharge. |
| Incidence of Any Adverse Event (AE) | From enrollment through 12 weeks postoperatively | Proportion of participants experiencing at least one adverse event (AE) of any grade and any causality during the study period. AEs are graded per CTCAE v5.0 (general) and Clavien-Dindo (surgical complications). |
| Incidence of Serious Adverse Events (SAE) | From enrollment through 12 weeks postoperatively | Proportion of participants experiencing at least one serious adverse event (SAE), defined as death, life-threatening event, hospitalization or prolonged hospitalization, persistent disability, congenital anomaly, or other medically significant event. |
| Incidence of Device-Related Skin Reactions | From enrollment through 12 weeks postoperatively | Proportion of participants experiencing device-related skin reactions (e.g., erythema, pruritus, rash, contact dermatitis, skin breakdown, pressure injury) graded ≥2 by severity. |
| All-Cause Mortality | From enrollment through 12 weeks postoperatively | Proportion of participants who die from any cause during the study observation period. |
Countries
China
Contacts
CONTACTXuelei Ma, MD
Outcome results
None listed