Brief Summary: This randomized controlled trial aims to evaluate whether active remote symptom monitoring and management via a smartphone app utilizing electronic patient-reported outcomes (ePRO) can improve adherence to prescribed outpatient pulmonary rehabilitation exercises among postsurgical lung cancer patients. Eligible patients will use the app for perioperative care and be randomized to an intervention group receiving ePRO-based symptom monitoring with clinician feedback or a control group receiving ePRO without feedback. The primary outcome is rehabilitation exercise adherence rate over 1 month after discharge. If proven effective, the app-enabled remote rehabilitation model can be scaled up to enhance recovery for more postoperative patients.
Due to slower-than-expected recruitment, an interim analysis was introduced through a protocol amendment. Before any unblinded between-group efficacy analysis, a blinded review of recruitment progress, data completeness, and outcome-data structure was conducted. Mean weekly exercise duration was subsequently added as a co-primary endpoint to complement the threshold-based exercise adherence outcome. The amendment and revised interim statistical framework were approved by the Ethics Committee before the formal interim analysis and incorporated into the updated study record.
Age 18-75 years old
preoperative clinical diagnosis or suspicion of resectable primary lung cancer
Able to use smartphones and complete electronic questionnaires
Signed informed consent
conversions to open thoracotomy during surgery
ECOG score > 1
Received neoadjuvant therapy
Previous lung resection surgery
Parallel
ePRO based Remote Symptom Management provide by a mobile phone app
DeviceAlerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance on symptom management. This is facilitated through the "Shuyu" mobile application, which serves as the platform for monitoring symptoms and communication.
Rehabilitation exercise adherence rate over 1 month after discharge
Rehabilitation exercise adherence rate over 1 month after discharge, defined as the proportion of patients completing the prescribed outpatient exercise regimen.
Mean weekly exercise duration over 1 month after discharge
Mean weekly exercise duration measured over the first 30 days post-discharge. This endpoint was added through a protocol amendment before the formal unblinded interim efficacy analysis. Interim testing used a Lan-DeMets O'Brien-Fleming alpha-spending approach.
Post-discharge pulmonary complication rate
30-day hospital readmission rate
Changes in symptom severity scores from discharge to 30 days
Patient satisfaction scores
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