Adherence to postoperative pulmonary rehabilitation exercises is crucial but challenging to address in lung cancer patients after hospital discharge. Pain, fatigue, cough and other symptoms may hinder adherence. This study will enroll 736 patients undergoing Video-assisted thoracic surgery (VATS) for lung Cancer. All patients will use a smartphone app for perioperative care and periodic PRO measurement. Before discharge, patients will be randomized 1:1 to an intervention group or control group. The intervention group will complete ePRO symptom severity scores on the PSA-Lung Scale questionnaire on discharge and post-discharge days 3, 7, 14, 21, 28. Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance. The control group will complete ePRO without clinician alerts. The primary outcome is rehabilitation exercise adherence rate over 1 month after discharge. Secondary outcomes include postoperative complications, hospital readmissions, symptom changes, exercise participation rate, and patient satisfaction. If proven effective, this innovative rehabilitation model can be scaled up to enhance recovery for more postoperative patients.
Due to slower-than-expected recruitment, the DSMB recommended a review of trial progress. Before any unblinded between-group efficacy analysis, a pooled, blinded review of recruitment progress, data completeness, and outcome-data structure was conducted without treatment-group efficacy estimates. Following this blinded review, and before database lock or release of treatment codes, the protocol was amended to introduce one formal interim efficacy analysis and to add mean weekly exercise duration as a co-primary endpoint alongside 1-month exercise adherence. The amendment was approved by the Ethics Committee and the amended statistical analysis plan was finalized before the first formal unblinded between-group analysis. The formal interim analysis subsequently used a Lan-DeMets O'Brien-Fleming alpha-spending approach.
