Smartphone-based Remote Symptom Monitoring to Improve Postoperative Rehabilitation Exercise Adherence After Video-assisted Thoracic Surgery (VATS) for Lung Cancer
NCT ID: NCT05990946
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
736 participants
INTERVENTIONAL
2023-06-01
2026-06-30
Brief Summary
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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.
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Detailed Description
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Due to slower-than-expected recruitment, the study protocol was amended to introduce one interim analysis. The protocol amendment was reviewed and approved by the Ethics Committee before the analysis was conducted. The interim analysis was performed using aggregated, de-identified data by an independent monitoring group, without disclosing any individual-level unblinded outcomes to investigators. Based on the interim findings, mean weekly exercise duration was added as a co-primary endpoint alongside 1-month adherence. Statistical thresholds for interim testing were adjusted using an O'Brien-Fleming alpha-spending approach (interim p \< 0.006).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention Group
Participants randomized to the intervention group will complete ePRO symptom severity scores on the PSA-Lung questionnaire via the smartphone app 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 on symptom management.
ePRO 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.
Control Group
Participants randomized to the control group will complete ePRO symptom severity scores on the PSA-Lung questionnaire via the smartphone app on discharge and post-discharge days 3, 7, 14, 21, 28, without clinician alerts.
No interventions assigned to this group
Interventions
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ePRO 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing minimally invasive lung cancer resection
* Able to use smartphones and complete electronic questionnaires
* Signed informed consent
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Zhongshan People's Hospital, Guangdong, China
OTHER
Responsible Party
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Xiaojuan Yang
Nurse Practitioner
Locations
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No.2 Sunwen East Rd.
Zhongshan, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Yang X, Zhang Q, Ye C, Cheng Y, Wu J, Liang Y, Su J. Factors Influencing Symptom Severity at Discharge after Lobectomy and Sublobar Resection Through Video-assisted Thoracoscopic Surgery. Interdiscip Cardiovasc Thorac Surg. 2025 Aug 5;40(8):ivaf170. doi: 10.1093/icvts/ivaf170.
Su J, Ye C, Zhang Q, Liang Y, Wu J, Liang G, Cheng Y, Yang X. Impact of Remote Symptom Management on Exercise Adherence After Video-Assisted Thoracic Surgery for Lung Cancer in a Tertiary Hospital in China: Protocol for a Prospective Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 1;14:e60420. doi: 10.2196/60420.
Other Identifiers
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K2022-285
Identifier Type: -
Identifier Source: org_study_id
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