Digital Rehabilitation With Wearable Monitors for Sequential Lung Cancer Resection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorWest China Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Wireless Wearable Vital Sign and Activity Monitor
DeviceWireless 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
Digital Pulmonary Rehabilitation Program
BehavioralA 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.
Standard ERAS Perioperative and Rehabilitation Care
Other interventionStandard 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.
Treatment groups
222 Participants
are divided into 2 treatment groupsGroup A: Digital Rehabilitation with Wearable MonitoringExperimental treatment 2 interventions
Group B: Standard ERAS Perioperative CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to Attainment of Functional Recovery Threshold for Second-Stage Surgery Readiness
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).
Time frame
From the day of first surgery (POD0) up to 12 weeks postoperatively, assessed continuouslySecondary outcomes
1
Change in FEV1% Predicted
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.
Time frame
Baseline, 1 month, and 3 months postoperatively2
Change in FVC% Predicted
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.
Time frame
Baseline, 1 month, and 3 months postoperatively3
Change in DLCO% Predicted
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.
Time frame
Baseline, 1 month, and 3 months postoperatively4
Daily Step Count
Mean daily step count derived from wrist-worn activity tracker, reported as 7-day rolling average.
Time frame
Continuously from discharge up to 12 weeks postoperativelyOther outcomes
1
Wearable Device Adherence Rate
Proportion of valid wear days, defined as days with ≥80% of available monitoring data from the wrist-worn activity tracker or wearable patch.
Time frame
From discharge to 12 weeks postoperatively2
ePRO Questionnaire Completion Rate
Proportion of scheduled electronic patient-reported outcome (ePRO) symptom diary entries that are successfully completed by the participant.
Time frame
From discharge to 12 weeks postoperatively3
Alert Response Timeliness
Time (in hours or minutes) from threshold-triggered alert generation to documented clinical action (telephone call, outpatient visit, or emergency evaluation).
Time frame
From discharge to 12 weeks postoperatively4
Permanent Device Discontinuation Rate
Proportion of participants who permanently discontinue use of the wearable monitoring device due to intolerance, skin reaction, or other device-related adverse events.
Time frame
From discharge to 12 weeks postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: