Smartphone-based Remote Symptom Monitoring to Improve Postoperative Rehabilitation Exercise Adherence After Video-assisted Thoracic Surgery (VATS) for Lung Cancer
NCT05990946
Summary
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.
Eligibility
Inclusion Criteria: * 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 Exclusion Criteria: * conversions to open thoracotomy during surgery * ECOG score \> 1 * Received neoadjuvant therapy * Previous lung resection surgery * Unable to exercise due to physical limitations * Continuous systemic corticosteroid use within 1 month before enrollment * Unresolved toxicity above Grade 1 from previous treatments * Significant comorbidities or medical history
Conditions7
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NCT05990946