An interventional study of ePRO based Remote Symptom Management provide by a mobile phone app in Lung Neoplasms, Non-Small Cell Lung Cancer, Postoperative Complications and Patient Reported Outcome Measures, sponsored by Zhongshan People's Hospital, Guangdong, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Zhongshan People's Hospital, Guangdong, China · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
Participants randomized to the intervention group will complete ePRO symptom severity scores on the PSA-Lung questionnaire via the smartphone app 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 on symptom management.
Device: ePRO based Remote Symptom Management provide by a mobile phone app
Participants randomized to the control group will complete ePRO symptom severity scores on the PSA-Lung questionnaire via the smartphone app on discharge and post-discharge days 3, 7, 14, 21, 28, without clinician alerts.
Alerts 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.
Also known as: mobile phone app for Remote Symptom Management
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.
Time frame: From the day of discharge to 30 days after discharge
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.
Time frame: From discharge to 30 days after discharge.
Post-discharge pulmonary complication rate
Time frame: From the day of discharge to 30 days after discharge
30-day hospital readmission rate
Time frame: From the day of discharge to 30 days after discharge
Changes in symptom severity scores from discharge to 30 days
Time frame: From the day of discharge to 30 days after discharge
Patient satisfaction scores
Time frame: From the day of discharge to 30 days after discharge
Plan to share: No — Not available. The individual participant data collected in this study will not be shared with external researchers.
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Zhongshan People's Hospital, Guangdong, China