Digital Rehabilitation With Wearable Monitors for Sequential Lung Cancer Resection
NCT07797075 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 222
Last updated 2026-09-01
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
Interventions
- 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
- 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.
- OTHER
-
Standard ERAS Perioperative and Rehabilitation Care
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.
Sponsors & Collaborators
-
West China Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2028-08-31
- Completion
- 2028-08-31
Countries
- China
Study Locations
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