Smartphone-based Remote Symptom Monitoring to Improve Postoperative Rehabilitation Exercise Adherence After Video-assisted Thoracic Surgery (VATS) for Lung Cancer
- Conditions
- Patient Reported Outcome MeasuresTelerehabilitationExercise TherapyPostoperative ComplicationsLung Neoplasms, Non-Small Cell Lung Cancer
- Interventions
- Device: ePRO based Remote Symptom Management provide by a mobile phone app
- Registration Number
- NCT05990946
- Lead Sponsor
- Zhongshan People's Hospital, Guangdong, China
- Brief 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.
- Detailed Description
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 224 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 736
- Age 18-75 years old
- Undergoing minimally invasive lung cancer resection
- Able to use smartphones and complete electronic questionnaires
- Signed informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group ePRO based Remote Symptom Management provide by a mobile phone app 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Post-discharge pulmonary complication rate From the day of discharge to 30 days after discharge 30-day hospital readmission rate From the day of discharge to 30 days after discharge Changes in symptom severity scores from discharge to 30 days From the day of discharge to 30 days after discharge Patient satisfaction scores From the day of discharge to 30 days after discharge
Trial Locations
- Locations (1)
No.2 Sunwen East Rd.
🇨🇳Zhongshan, Guangdong, China