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

Not Applicable

Recruiting

• Conditions: Patient Reported Outcome Measures; Telerehabilitation; Exercise Therapy; Postoperative Complications; Lung Neoplasms, Non-Small Cell Lung Cancer

• 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.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-08-06
• Study First Submitted QC: 2023-08-06
• Study First Posted: 2023-08-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-11
• Last Update Posted: 2024-05-14
• Primary Completion: 2025-03-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 736

Inclusion Criteria

• Age 18-75 years old
• Undergoing minimally invasive lung cancer resection
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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