NCT05990946 Smartphone-based Remote Symptom Monitoring to Improve Postoperative Rehabilitation Exercise Adherence After Video-assisted Thoracic Surgery (VATS) for Lung Cancer
| NCT ID | NCT05990946 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhongshan People's Hospital, Guangdong, China |
| Condition | Lung Neoplasms, Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 736 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 736 participants in total. It began in 2023-06-01 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05990946 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Lung Neoplasms, Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05990946 currently recruiting?
Yes, NCT05990946 is actively recruiting participants. Contact the research team at 1002381745@qq.com for enrollment information.
Where is the NCT05990946 trial being conducted?
This trial is being conducted at Zhongshan, China.
Who is sponsoring the NCT05990946 clinical trial?
NCT05990946 is sponsored by Zhongshan People's Hospital, Guangdong, China. The trial plans to enroll 736 participants.
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