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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Telerehabilitation; Patient Reported Outcome Measures; Exercise Therapy; Lung Neoplasms, Non-Small Cell Lung Cancer
• Intervention / Treatment: Device: ePRO based Remote Symptom Management provide by a mobile phone app

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 Type: Interventional
• Enrollment (Estimated): 238
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaojuan Yang; Phone Number: +86 0760-88823566; Email: 1002381745@qq.com

Study Locations

• China
  • Guangdong
    • Zhongshan, Guangdong, China, 528403
      • Recruiting
      • No.2 Sunwen East Rd.
      • Contact: Xiaojuan Yang; Phone Number: +86 0760-88823566; Email: 1002381745@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	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.; Other Names: mobile phone app for Remote Symptom Management
No Intervention: Control Group; 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?

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	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

Collaborators and Investigators

• Sponsor: Zhongshan People's Hospital, Guangdong, China

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: August 6, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Exercise Adherence; Remote Monitoring; ePRO; Symptom Management; Postoperative Rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Postoperative Complications
• Other Study ID Numbers: K2022-285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not available. The individual participant data collected in this study will not be shared with external researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No