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NCT07797075

Digital Rehabilitation With Wearable Monitors for Sequential Lung Cancer Resection

Sponsor: West China Hospital

View on ClinicalTrials.gov

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.

Official title: A Clinical Trial of Rehabilitation During Sequential Resection of Multiple Primary Non-Small Cell Lung Cancer Based on Wireless Wearable Mobile Monitoring Devices

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

222

Start Date

2026-08-31

Completion Date

2028-08-31

Last Updated

2026-09-01

Healthy Volunteers

Conditions

Non-Small Cell Lung Cancer (NSCLC)Rehabilitation Thoracic Surgery

Interventions

DEVICE

Wireless Wearable Vital Sign and Activity Monitor

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

BEHAVIORAL

Digital 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.

OTHER

Standard 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.

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

Locations (1)

West China Hospital

Chengdu, Sichuan, China