About this trial
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. The amendment was approved by the Ethics Committee before conducting the analysis, and the plan was incorporated into the updated study record. The interim review evaluated feasibility and informed the addition of mean weekly exercise duration as a co-primary endpoint with adjusted statistical thresholds.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years old
Undergoing minimally invasive lung cancer resection
Able to use smartphones and complete electronic questionnaires
Signed informed consent
Disqualifiers
conversions to open thoracotomy during surgery
ECOG score > 1
Received neoadjuvant therapy
Previous lung resection surgery
Trial design
Parallel
Treatments tested in this trial
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.
Treatment groups
Trial outcomes
Primary outcomes
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 following a protocol amendment and interim review. Interim testing used an O'Brien-Fleming alpha-spending boundary.
Secondary outcomes
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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