[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654243":3},{"organization":4,"outcomesModule":7,"designInfo":119,"detailedDescription":127,"studyPopulation":122,"armGroups":128,"interventions":142,"overallOfficials":122,"centralContacts":157,"locations":163,"responsibleParty":183,"collaborators":122,"id":187,"slug":188,"hasResults":189,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":189,"sex":195,"minAge":196,"maxAge":197,"enrollmentInfo":198,"targetDuration":122,"studyType":201,"phases":202,"briefSummary":204,"conditions":205,"keywords":209,"overallStatus":210,"whyStopped":122,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"fullName":5,"class":6},"West China Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":105},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002F10 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).","From the day of first surgery (POD0) up to 12 weeks postoperatively, assessed continuously",[14,18,21,24,28,31,35,39,42,45,48,52,56,59,63,66,69,72,76,80,84,88,92,96,99,102],{"measure":15,"description":16,"timeFrame":17},"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.","Baseline, 1 month, and 3 months postoperatively",{"measure":19,"description":20,"timeFrame":17},"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.",{"measure":22,"description":23,"timeFrame":17},"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.",{"measure":25,"description":26,"timeFrame":27},"Daily Step Count","Mean daily step count derived from wrist-worn activity tracker, reported as 7-day rolling average.","Continuously from discharge up to 12 weeks postoperatively",{"measure":29,"description":30,"timeFrame":27},"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.",{"measure":32,"description":33,"timeFrame":34},"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.","Baseline, 4 weeks, 8 weeks, and 12 weeks postoperatively",{"measure":36,"description":37,"timeFrame":38},"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.","Daily for first 2 weeks post-discharge, then at least 3 times per week up to 12 weeks",{"measure":40,"description":41,"timeFrame":34},"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.",{"measure":43,"description":44,"timeFrame":34},"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).",{"measure":46,"description":47,"timeFrame":34},"PROMIS Physical Function (PROMIS-PF) Score","Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) short form scores (T-score metric).",{"measure":49,"description":50,"timeFrame":51},"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.","Within 30 days after the first surgery",{"measure":53,"description":54,"timeFrame":55},"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.","Within 90 days after the first surgery",{"measure":57,"description":58,"timeFrame":55},"Unplanned Re-Intervention Rate","Proportion of participants requiring unplanned surgical or interventional re-intervention within 90 days after the first surgery.",{"measure":60,"description":61,"timeFrame":62},"ICU Transfer Rate","Proportion of participants requiring unplanned transfer to the intensive care unit (ICU) during the initial postoperative hospitalization.","From the first surgery through discharge from the index hospitalization, up to 12 weeks after the first surgery",{"measure":64,"description":65,"timeFrame":62},"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.",{"measure":67,"description":68,"timeFrame":55},"Unplanned Readmission Rate","Proportion of participants with unplanned all-cause hospital readmission within 90 days after the first surgery.",{"measure":70,"description":71,"timeFrame":55},"Unplanned Emergency Department Visit Rate","Proportion of participants with unplanned all-cause emergency department visits within 90 days after the first surgery.",{"measure":73,"description":74,"timeFrame":75},"Second-Stage Surgery Completion Rate","Proportion of participants who successfully undergo the planned second-stage curative-intent resection within the 12-week observation window.","Within 12 weeks after the first surgery",{"measure":77,"description":78,"timeFrame":79},"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.","From first surgery to second surgery (within 12-week window)",{"measure":81,"description":82,"timeFrame":83},"Second Surgery Perioperative Complication Rate","Proportion of participants experiencing any complication graded Clavien-Dindo ≥II during hospitalization for the second-stage surgery.","Up to 30 days after the second-stage surgery",{"measure":85,"description":86,"timeFrame":87},"Chest Tube Drainage Duration (Second Surgery)","Total number of days with chest tube drainage during the second-stage surgery hospitalization.","From the second-stage surgery through chest tube removal or hospital discharge, up to 30 days after the second-stage surgery",{"measure":89,"description":90,"timeFrame":91},"Postoperative Hospital Length of Stay (Second Surgery)","Total number of days from the date of the second-stage surgery to hospital discharge.","From the second-stage surgery through hospital discharge, up to 30 days after the second-stage surgery",{"measure":93,"description":94,"timeFrame":95},"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).","From enrollment through 12 weeks postoperatively",{"measure":97,"description":98,"timeFrame":95},"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.",{"measure":100,"description":101,"timeFrame":95},"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.",{"measure":103,"description":104,"timeFrame":95},"All-Cause Mortality","Proportion of participants who die from any cause during the study observation period.",[106,110,113,116],{"measure":107,"description":108,"timeFrame":109},"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.","From discharge to 12 weeks postoperatively",{"measure":111,"description":112,"timeFrame":109},"ePRO Questionnaire Completion Rate","Proportion of scheduled electronic patient-reported outcome (ePRO) symptom diary entries that are successfully completed by the participant.",{"measure":114,"description":115,"timeFrame":109},"Alert Response Timeliness","Time (in hours or minutes) from threshold-triggered alert generation to documented clinical action (telephone call, outpatient visit, or emergency evaluation).",{"measure":117,"description":118,"timeFrame":109},"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.",{"allocation":120,"interventionModel":121,"interventionModelDescription":122,"primaryPurpose":123,"observationalModel":122,"timePerspective":122,"maskingInfo":124},"RANDOMIZED","SINGLE_GROUP",null,"TREATMENT",{"masking":125,"maskingDescription":126,"whoMasked":122},"NONE","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.","Study Design\n\nThis 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).\n\nStudy Population\n\nWe 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.\n\nRandomization and Blinding\n\nParticipants 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.\n\nIntervention\n\nBoth groups receive standard enhanced recovery after surgery (ERAS) care.\n\nIntervention 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 \\\u003C90%, persistent tachycardia, or symptom escalation) to prompt telephone follow-up, outpatient visit, or emergency care.\n\nControl group receives standard intermittent vital sign monitoring and conventional rehabilitation education without wearable devices or digital prescriptions.\n\nFollow-up and Assessments\n\nThe 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\u002FLC13, PROMIS-PF), perioperative complications (30\u002F90 days), re-admission, second-surgery outcomes, adherence, device-related adverse events, and healthcare resource utilization.\n\nPrimary Endpoint\n\nThe 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\u002F10 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.\n\nSample Size\n\nWith 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.\n\nStatistical Analysis\n\nThe 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.\n\nSafety and Data Quality\n\nAdverse 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.",[129,136],{"label":130,"type":131,"description":132,"interventionNames":133},"Digital Rehabilitation with Wearable Monitoring","EXPERIMENTAL","Participants receive standard ERAS\u002FERATS perioperative care plus a wireless wearable mobile monitoring and digital rehabilitation program. This includes: (1) continuous vital sign monitoring via a wearable patch during hospitalization and a wrist-worn activity tracker after discharge; (2) personalized exercise prescriptions (aerobic, resistance, and inspiratory muscle training) with progressive step goals; (3) high-frequency electronic patient-reported outcome (ePRO) symptom surveillance; and (4) threshold-triggered graded responses (e.g., SpO₂ \\\u003C90%, persistent tachycardia, symptom escalation) prompting telephone follow-up, outpatient visit, or emergency care.",[134,135],"Device: Wireless Wearable Vital Sign and Activity Monitor","Behavioral: Digital Pulmonary Rehabilitation Program",{"label":137,"type":138,"description":139,"interventionNames":140},"Standard ERAS Perioperative Care","ACTIVE_COMPARATOR","Participants receive standard perioperative care and conventional rehabilitation education according to institutional practice. This includes routine intermittent vital sign monitoring during hospitalization and standard follow-up visits. No continuous wearable monitoring or digital rehabilitation prescription is provided.",[141],"Other: Standard ERAS Perioperative and Rehabilitation Care",[143,148,153],{"type":144,"name":145,"description":146,"armGroupLabels":147,"otherNames":122},"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",[130],{"type":149,"name":150,"description":151,"armGroupLabels":152,"otherNames":122},"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.",[130],{"type":6,"name":154,"description":155,"armGroupLabels":156,"otherNames":122},"Standard ERAS Perioperative and Rehabilitation Care","Standard enhanced recovery after surgery (ERAS\u002FERATS) care including routine intermittent vital sign monitoring, standardized pain management, nutritional support, early mobilization guidance, and conventional rehabilitation education, as per institutional practice.",[137],[158],{"name":159,"role":160,"phone":161,"phoneExt":122,"email":162},"Xuelei Ma, MD","CONTACT","+86 18708305692","drmaxuelei@gmail.com",[164],{"facility":5,"status":122,"city":165,"state":166,"zip":167,"country":168,"countryCode":169,"cosmosGeoPoint":170,"geoPoint":175,"contacts":176},"Chengdu","Sichuan","610041","China","CN",{"type":171,"coordinates":172},"Point",[173,174],104.06667,30.66667,{"lat":174,"lon":173},[177,180],{"name":178,"role":160,"phone":179,"phoneExt":122,"email":162},"Xuelei ma","18708305692",{"name":181,"role":182,"phone":122,"phoneExt":122,"email":122},"Hu Liao, Professor","SUB_INVESTIGATOR",{"type":184,"investigatorFullName":185,"investigatorTitle":186,"investigatorAffiliation":5,"oldNameTitle":122,"oldOrganization":122},"PRINCIPAL_INVESTIGATOR","Xuelei Ma MD","Clinical Professor","100654243","digital-rehabilitation-with-wearable-monitors-for-sequential-lung-cancer-resection-100654243",false,"NCT07797075","Digital Rehabilitation With Wearable Monitors for Sequential Lung Cancer Resection","A Clinical Trial of Rehabilitation During Sequential Resection of Multiple Primary Non-Small Cell Lung Cancer Based on Wireless Wearable Mobile Monitoring Devices","WEAR-MPLC","Inclusion Criteria:\n\n* Age ≥18 and ≤85 years\n* 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\n* Planned discharge between postoperative day 2 and day 7, and judged by the investigator to be clinically stable and suitable for home-based\u002Fout-of-hospital rehabilitation\n* Able to operate a smartphone application and wearable devices independently or with caregiver assistance, with stable cellular\u002Fbroadband network access\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and preoperatively assessed as able to tolerate routine rehabilitation training\n* Intact skin at the wearable device attachment sites, without severe skin diseases affecting device placement\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Pre-existing long-term home oxygen therapy, or severe resting hypoxemia\u002Fventilatory dysfunction (judged by the investigator to persistently affect safe rehabilitation)\n* 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\n* Other diseases or conditions that significantly affect motor function or compliance (e.g., severe neuromuscular\u002Fskeletal disorders, cognitive impairment, major psychiatric disorders)\n* Known or suspected contact allergy to medical adhesives or electrode materials used in the wearable devices, or skin conditions unsuitable for prolonged device attachment\n* Presence of implanted medical devices incompatible with the study wearable devices, or other contraindications as specified in the device instructions\n* Pregnancy or lactation, or women of childbearing potential who are unwilling to adopt effective contraceptive measures during the study period\n* Concurrent participation in another interventional clinical trial that may interfere with the outcomes of this study\n* Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation","ALL","18 Years","85 Years",{"count":199,"type":200},222,"ESTIMATED","INTERVENTIONAL",[203],"NA","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.\n\nEligible 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.\n\nThe 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\u002FLC13, PROMIS), 30- and 90-day complication and readmission rates, second-surgery-related outcomes, adherence, safety, and healthcare resource utilization.\n\nA 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.",[206,207,208],"Non-Small Cell Lung Cancer (NSCLC)","Rehabilitation","Thoracic Surgery",[206,207,208],"NOT_YET_RECRUITING","2026-08-29",{"date":213,"type":214},"2026-09-01","ACTUAL",{"date":216,"type":200},"2026-08-31",{"date":218,"type":200},"2028-08-31",{"name":5,"class":6},1]