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Clinical Trial

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

NCT: NCT05990946 · RECRUITING

NCT IDNCT05990946
StatusRECRUITING
Start Date2023-12-01
Completion2027-06-30
SponsorZhongshan People's Hospital, Guangdong, China (OTHER)
First posted
Last updated

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. Before any unblinded between-group efficacy analysis, a blinded review of recruitment progress, data completeness, and outcome-data structure was conducted. Mean weekly exercise duration was subsequently added as a co-primary endpoint to complement the threshold-based exercise adherence outcome. The amendment and revised interim statistical framework were approved by the Ethics Committee before the formal interim analysis and incorporated into the updated study record.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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