Smartphone-based Remote Symptom Monitoring to Improve Postoperative Rehabilitation Exercise Adherence After Video-assisted Thoracic Surgery (VATS) for Lung Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

ePRO based Remote Symptom Management provide by a mobile phone app: 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.

Study 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

Primary outcome measure(s)

• Rehabilitation exercise adherence rate over 1 month after discharge — From the day of discharge to 30 days 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 — From discharge to 30 days 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.

Trial sites (1)

More Zhongshan People's Hospital, Guangdong, China trials in China

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