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
1 other identifier
interventional
736
1 country
1
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. Due to slower-than-expected recruitment, an interim analysis was introduced through a protocol amendment. The amendment was approved by the Ethics Committee before conducting the analysis, and the plan was incorporated into the updated study record. The interim review evaluated feasibility and informed the addition of mean weekly exercise duration as a co-primary endpoint with adjusted statistical thresholds.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
August 6, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedDecember 5, 2025
November 1, 2025
2.8 years
August 6, 2023
November 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Mean weekly exercise duration over 1 month after discharge
Mean weekly exercise duration measured over the first 30 days post-discharge. This endpoint was added following a protocol amendment and interim review. Interim testing used an O'Brien-Fleming alpha-spending boundary.
From discharge to 30 days after discharge.
Secondary Outcomes (4)
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
Study Arms (2)
Intervention Group
EXPERIMENTALParticipants 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.
Control Group
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age 18-75 years old
- Undergoing minimally invasive lung cancer resection
- Able to use smartphones and complete electronic questionnaires
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
No.2 Sunwen East Rd.
Zhongshan, Guangdong, 528403, China
Related Publications (2)
Yang X, Zhang Q, Ye C, Cheng Y, Wu J, Liang Y, Su J. Factors Influencing Symptom Severity at Discharge after Lobectomy and Sublobar Resection Through Video-assisted Thoracoscopic Surgery. Interdiscip Cardiovasc Thorac Surg. 2025 Aug 5;40(8):ivaf170. doi: 10.1093/icvts/ivaf170.
PMID: 40811025DERIVEDSu J, Ye C, Zhang Q, Liang Y, Wu J, Liang G, Cheng Y, Yang X. Impact of Remote Symptom Management on Exercise Adherence After Video-Assisted Thoracic Surgery for Lung Cancer in a Tertiary Hospital in China: Protocol for a Prospective Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 1;14:e60420. doi: 10.2196/60420.
PMID: 39610048DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nurse Practitioner
Study Record Dates
First Submitted
August 6, 2023
First Posted
August 14, 2023
Study Start
June 1, 2023
Primary Completion
March 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 5, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
Not available. The individual participant data collected in this study will not be shared with external researchers.