Digital Rehabilitation With Wearable Monitors for Sequential Lung Cancer Resection

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.

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