RecruitingNot ApplicableNCT05990946

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


Sponsor

Zhongshan People's Hospital, Guangdong, China

Enrollment

736 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • Age 18-75 years old
  • Undergoing minimally invasive lung cancer resection
  • Able to use smartphones and complete electronic questionnaires
  • Signed informed consent

Exclusion Criteria8

  • 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

Interventions

DEVICEePRO 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(1)

No.2 Sunwen East Rd.

Zhongshan, Guangdong, China

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NCT05990946


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