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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05990946
• Other study ID #: K2022-285
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Zhongshan People's Hospital, Guangdong, China
• Contact: Xiaojuan Yang
• Phone: +86 0760-88823566
• Email: 1002381745[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 736
• Est. completion date: June 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	No.2 Sunwen East Rd.	Zhongshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-discharge pulmonary complication rate		From the day of discharge to 30 days after discharge
Secondary	30-day hospital readmission rate		From the day of discharge to 30 days after discharge
Secondary	Changes in symptom severity scores from discharge to 30 days		From the day of discharge to 30 days after discharge
Secondary	Patient satisfaction scores		From the day of discharge to 30 days after discharge