Digital Rehabilitation With Wearable Monitors for Sequential Lung Cancer Resection

N/ANot Yet RecruitingNCT07797075

West China Hospital222 enrolled

Overview

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.

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 continuously

Secondary Outcomes

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 postoperatively

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 postoperatively

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 postoperatively

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 postoperatively

Moderate-to-Vigorous Physical Activity (MVPA) Duration

Daily minutes of moderate-to-vigorous physical activity (MVPA) derived from wrist-worn activity tracker, reported as 7-day rolling average.

Time frame: Continuously from discharge up to 12 weeks postoperatively

6-Minute Walk Distance (6MWD)

Absolute 6-minute walk distance (in meters) and its percentage recovery relative to preoperative baseline, measured according to standardized protocols in a designated corridor.

Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks postoperatively

ePRO Symptom Composite Score

Electronic patient-reported outcome (ePRO) symptom diary scores for pain, dyspnea, cough, and fatigue, each rated on a 0-10 numeric rating scale.

Time frame: Daily for first 2 weeks post-discharge, then at least 3 times per week up to 12 weeks

EORTC QLQ-C30 Score

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.

Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks postoperatively

EORTC QLQ-LC13 Lung Cancer Module Score

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).

Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks postoperatively

PROMIS Physical Function (PROMIS-PF) Score

Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) short form scores (T-score metric).

Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks postoperatively

30-Day Complication Rate (Clavien-Dindo ≥II)

Proportion of participants experiencing any postoperative complication graded Clavien-Dindo ≥II within 30 days after the first surgery.

Time frame: Within 30 days after the first surgery

90-Day Complication Rate (Clavien-Dindo ≥II)

Proportion of participants experiencing any postoperative complication graded Clavien-Dindo ≥II within 90 days after the first surgery.

Time frame: Within 90 days after the first surgery

Unplanned Re-Intervention Rate

Proportion of participants requiring unplanned surgical or interventional re-intervention within 90 days after the first surgery.

Time frame: Within 90 days after the first surgery

ICU Transfer Rate

Proportion of participants requiring unplanned transfer to the intensive care unit (ICU) during the initial postoperative hospitalization.

Time frame: From the first surgery through discharge from the index hospitalization, up to 12 weeks after the first surgery

Postoperative Hospital Length of Stay (First Surgery)

Total number of days from the date of first surgery to hospital discharge for the first surgery admission.

Time frame: From the first surgery through discharge from the index hospitalization, up to 12 weeks after the first surgery

Unplanned Readmission Rate

Proportion of participants with unplanned all-cause hospital readmission within 90 days after the first surgery.

Time frame: Within 90 days after the first surgery

Unplanned Emergency Department Visit Rate

Proportion of participants with unplanned all-cause emergency department visits within 90 days after the first surgery.

Time frame: Within 90 days after the first surgery

Second-Stage Surgery Completion Rate

Proportion of participants who successfully undergo the planned second-stage curative-intent resection within the 12-week observation window.

Time frame: Within 12 weeks after the first surgery

Time Interval Between First and Second Surgeries

Number of days between the date of the first surgery and the date of the second-stage surgery.

Time frame: From first surgery to second surgery (within 12-week window)

Second Surgery Perioperative Complication Rate

Proportion of participants experiencing any complication graded Clavien-Dindo ≥II during hospitalization for the second-stage surgery.

Time frame: Up to 30 days after the second-stage surgery

Chest Tube Drainage Duration (Second Surgery)

Total number of days with chest tube drainage during the second-stage surgery hospitalization.

Time frame: From the second-stage surgery through chest tube removal or hospital discharge, up to 30 days after the second-stage surgery

Postoperative Hospital Length of Stay (Second Surgery)

Total number of days from the date of the second-stage surgery to hospital discharge.

Time frame: From the second-stage surgery through hospital discharge, up to 30 days after the second-stage surgery

Incidence of Any Adverse Event (AE)

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).

Time frame: From enrollment through 12 weeks postoperatively

Incidence of Serious Adverse Events (SAE)

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.

Time frame: From enrollment through 12 weeks postoperatively

Incidence of Device-Related Skin Reactions

Proportion of participants experiencing device-related skin reactions (e.g., erythema, pruritus, rash, contact dermatitis, skin breakdown, pressure injury) graded ≥2 by severity.

Time frame: From enrollment through 12 weeks postoperatively

All-Cause Mortality

Proportion of participants who die from any cause during the study observation period.

Time frame: From enrollment through 12 weeks postoperatively

Digital Rehabilitation With Wearable Monitors for Sequential Lung Cancer Resection

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts