Digital Rehabilitation With Wearable Monitors for Sequential Lung Cancer Resection

NCT07797075 | Not Yet Recruiting DMC

• 1 other identifier: 2025(2642)
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open-label, parallel-group, 1:1 randomized controlled trial designed to evaluate whether a digital rehabilitation program integrated with wireless wearable continuous monitoring devices can shorten the time to functional recovery in patients with multiple primary non-small cell lung cancer (MPLC) who undergo sequential (two-stage) curative-intent resection. Eligible participants will be randomly assigned to either the intervention group or the control group. Both groups will receive standard enhanced recovery after surgery (ERAS) care. In addition, the intervention group will receive continuous vital sign monitoring (using a wearable patch during hospitalization and a wrist-worn device after discharge), personalized exercise prescriptions with daily step targets, and high-frequency electronic patient-reported outcome (ePRO) follow-up with threshold-triggered response. The control group will receive standard intermittent vital sign monitoring and conventional rehabilitation education. The primary endpoint is the time from the first surgery to attainment of functional recovery criteria sufficient for second-stage surgery readiness (assessed by a composite of step count recovery, functional interference score combined with 6-minute walk distance, or multidisciplinary team determination). Secondary endpoints include pulmonary function recovery (FEV1%, FVC%, DLCO% at 3 months), physical activity (daily steps, moderate-to-vigorous physical activity, 6-minute walk distance), symptom burden and quality of life (EORTC QLQ-C30/LC13, PROMIS), 30- and 90-day complication and readmission rates, second-surgery-related outcomes, adherence, safety, and healthcare resource utilization. A total of 222 participants (111 per group) will be enrolled. The study will be conducted at West China Hospital of Sichuan University from June 2026 to October 2027. The findings are expected to provide high-quality evidence on the clinical utility of wearable-integrated digital rehabilitation in the perioperative management of MPLC patients undergoing sequential resection.

Conditions

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

Keywords

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

Outcome Measures

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).

  From the day of first surgery (POD0) up to 12 weeks postoperatively, assessed continuously

Secondary Outcomes (26)

• Change in FEV1% Predicted

  Baseline, 1 month, and 3 months postoperatively

• Change in FVC% Predicted

  Baseline, 1 month, and 3 months postoperatively

• Change in DLCO% Predicted

  Baseline, 1 month, and 3 months postoperatively

• Daily Step Count

  Continuously from discharge up to 12 weeks postoperatively

• Moderate-to-Vigorous Physical Activity (MVPA) Duration

  Continuously from discharge up to 12 weeks postoperatively

Other Outcomes (4)

• Wearable Device Adherence Rate

  From discharge to 12 weeks postoperatively

• ePRO Questionnaire Completion Rate

  From discharge to 12 weeks postoperatively

• Alert Response Timeliness

  From discharge to 12 weeks postoperatively

Study Arms (2)

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.

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.

Other: Standard ERAS Perioperative and Rehabilitation Care

Interventions

Wireless Wearable Vital Sign and Activity Monitor DEVICE

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 Rehabilitation with Wearable Monitoring

Digital Pulmonary Rehabilitation Program BEHAVIORAL

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.

Digital Rehabilitation with Wearable Monitoring

Standard ERAS Perioperative and Rehabilitation Care OTHER

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.

Standard ERAS Perioperative Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Fitness Trackers; Rehabilitation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Xuelei Ma, MD

CONTACT

+86 18708305692; drmaxuelei@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: September 1, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)