Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05990946

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

Led by Zhongshan People's Hospital, Guangdong, China · Updated on 2025-12-05

736

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-75 years old
  • Undergoing minimally invasive lung cancer resection
  • Able to use smartphones and complete electronic questionnaires
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Conversion to open thoracotomy during surgery
  • ECOG score greater than 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

No.2 Sunwen East Rd.

Zhongshan, Guangdong, China, 528403

Actively Recruiting

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Research Team

X

Xiaojuan Yang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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