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Trial Title:
Smartphone-based Remote Symptom Monitoring to Improve Postoperative Rehabilitation Exercise Adherence After Video-assisted Thoracic Surgery (VATS) for Lung Cancer
NCT ID:
NCT05990946
Condition:
Lung Neoplasms, Non-Small Cell Lung Cancer
Postoperative Complications
Patient Reported Outcome Measures
Telerehabilitation
Exercise Therapy
Conditions: Official terms:
Lung Neoplasms
Postoperative Complications
Conditions: Keywords:
Exercise Adherence
ePRO
Remote Monitoring
Postoperative Rehabilitation
Symptom Management
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
ePRO based Remote Symptom Management provide by a mobile phone app
Description:
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.
Arm group label:
Intervention Group
Other name:
mobile phone app for Remote Symptom Management
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
No.2 Sunwen East Rd.
Address:
City:
Zhongshan
Zip:
528403
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojuan Yang
Phone:
+86 0760-88823566
Email:
1002381745@qq.com
Start date:
June 1, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Zhongshan People's Hospital, Guangdong, China
Agency class:
Other
Source:
Zhongshan People's Hospital, Guangdong, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05990946
