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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Randomized, Controlled Study to Evaluate the Impact of Remote Symptom Management Via Smartphone App Based on Electronic Patient-Reported Outcomes on Rehabilitation Exercise Adherence After Minimally Invasive Surgery in Lung Cancer Patients

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

Intervention / Treatment
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* Procedure: ePRO based Remote Symptom Management


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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. | Procedure: ePRO based Remote Symptom Management<br>* Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance on symptom management.<br>* Other names: Symptom Management;|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From the day of discharge to 30 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise Adherence, ePRO, Remote Monitoring, Postoperative Rehabilitation, Symptom Management