Non-Small Cell Lung Cancer (NSCLC)WEAR-MPLCNCT07797075
Digital Rehabilitation With Wearable Monitors for Sequential Lung Cancer Resection
A study testing Wireless Wearable Vital Sign and Activity Monitor, Digital Pulmonary Rehabilitation Program and Standard ERAS Perioperative and Rehabilitation Care in people with Non-Small Cell Lung Cancer (NSCLC) and Rehabilitation, run by West China Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery
- What is being tested?
- Wireless Wearable Vital Sign and Activity Monitor, Digital Pulmonary Rehabilitation Program and Standard ERAS Perioperative and Rehabilitation Care
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital
Chengdu, Sichuan, 610041
Xuelei ma, 18708305692, drmaxuelei@gmail.com
Hu Liao, Professor
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Wireless Wearable Vital Sign and Activity Monitor, Digital Pulmonary Rehabilitation Program, Standard ERAS Perioperative and Rehabilitation Care
- Keywords
- Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless Wearable Vital Sign and Activity MonitorDevice
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
Digital Pulmonary Rehabilitation ProgramBehavioural
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.
Standard ERAS Perioperative and Rehabilitation CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital Rehabilitation with Wearable Monitoring | Experimental | Participants receive standard ERAS/ERATS 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 <90%, persistent tachycardia, symptom escalation) prompting telephone follow-up, outpatient visit, or emergency care. Receives: Device: Wireless Wearable Vital Sign and Activity Monitor; Behavioral: Digital Pulmonary Rehabilitation Program |
| 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. Receives: Other: Standard ERAS Perioperative and Rehabilitation Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the day of first surgery (POD0) up to 12 weeks postoperatively, assessed continuously
Secondary outcomes (26)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From enrollment through 12 weeks postoperatively
All-Cause Mortality
Proportion of participants who die from any cause during the study observation period.
Measured: From enrollment through 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuelei Ma MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797075
- Sponsor's protocol ID
- 2025(2642)
- Acronym
- WEAR-MPLC
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07797075
- Acronym / sponsor ID
- WEAR-MPLC / 2025(2642)
- Keywords
- Non-Small Cell Lung Cancer (NSCLC), Rehabilitation, Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Rehabilitation with Wearable Monitoring | Experimental | Device: Wireless Wearable Vital Sign and Activity Monitor, Behavioral: Digital Pulmonary Rehabilitation ProgramParticipants receive standard ERAS/ERATS 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 <90%, persistent tachycardia, symptom escalation) prompting telephone follow-up, outpatient visit, or emergency care. |
| Standard ERAS Perioperative Care | Active comparator | Other: Standard ERAS Perioperative and Rehabilitation CareParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wireless Wearable Vital Sign and Activity MonitorWireless 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 | Device | Digital Rehabilitation with Wearable Monitoring |
| Digital Pulmonary Rehabilitation ProgramA 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. | Behavioural | Digital Rehabilitation with Wearable Monitoring |
| Standard ERAS Perioperative and Rehabilitation CareStandard 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. | Other | Standard ERAS Perioperative Care |
Primary outcome
Time to Attainment of Functional Recovery Threshold for Second-Stage Surgery Readiness
Time frame: From the day of first surgery (POD0) up to 12 weeks postoperatively, assessed continuously
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).
26 secondary outcomes
Change in FEV1% Predicted
Time frame: Baseline, 1 month, and 3 months postoperatively
Change in FVC% Predicted
Time frame: Baseline, 1 month, and 3 months postoperatively
Change in DLCO% Predicted
Time frame: Baseline, 1 month, and 3 months postoperatively
Daily Step Count
Time frame: Continuously from discharge up to 12 weeks postoperatively
Moderate-to-Vigorous Physical Activity (MVPA) Duration
Time frame: Continuously from discharge up to 12 weeks postoperatively
6-Minute Walk Distance (6MWD)
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks postoperatively
ePRO Symptom Composite Score
Time frame: Daily for first 2 weeks post-discharge, then at least 3 times per week up to 12 weeks
EORTC QLQ-C30 Score
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks postoperatively
EORTC QLQ-LC13 Lung Cancer Module Score
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks postoperatively
PROMIS Physical Function (PROMIS-PF) Score
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks postoperatively
30-Day Complication Rate (Clavien-Dindo ≥II)
Time frame: Within 30 days after the first surgery
90-Day Complication Rate (Clavien-Dindo ≥II)
Time frame: Within 90 days after the first surgery
Unplanned Re-Intervention Rate
Time frame: Within 90 days after the first surgery
ICU Transfer Rate
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)
Time frame: From the first surgery through discharge from the index hospitalization, up to 12 weeks after the first surgery
Unplanned Readmission Rate
Time frame: Within 90 days after the first surgery
Unplanned Emergency Department Visit Rate
Time frame: Within 90 days after the first surgery
Second-Stage Surgery Completion Rate
Time frame: Within 12 weeks after the first surgery
Time Interval Between First and Second Surgeries
Time frame: From first surgery to second surgery (within 12-week window)
Second Surgery Perioperative Complication Rate
Time frame: Up to 30 days after the second-stage surgery
Chest Tube Drainage Duration (Second Surgery)
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)
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)
Time frame: From enrollment through 12 weeks postoperatively
Incidence of Serious Adverse Events (SAE)
Time frame: From enrollment through 12 weeks postoperatively
Incidence of Device-Related Skin Reactions
Time frame: From enrollment through 12 weeks postoperatively
All-Cause Mortality
Time frame: From enrollment through 12 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
Active, not recruitingPhase 3
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
Lung Non-Small Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wireless Wearable Vital Sign and Activity Monitor, Digital Pulmonary Rehabilitation Program and Standard ERAS Perioperative and Rehabilitation Care in people with Non-Small Cell Lung Cancer (NSCLC) and Rehabilitation, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuelei Ma, MD (+86 18708305692, drmaxuelei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Attainment of Functional Recovery Threshold for Second-Stage Surgery Readiness (time frame: From the day of first surgery (POD0) up to 12 weeks postoperatively, assessed continuously). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.