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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.
Adherence to postoperative pulmonary rehabilitation exercises is crucial but challenging to address in lung cancer patients after hospital discharge. Pain, fatigue, cough and other symptoms may hinder adherence. This study will enroll 224 patients undergoing Video-assisted thoracic surgery (VATS) for lung Cancer. All patients will use a smartphone app for perioperative care and periodic PRO measurement. Before discharge, patients will be randomized 1:1 to an intervention group or control group. The intervention group will complete ePRO symptom severity scores on the PSA-Lung Scale questionnaire 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. The control group will complete ePRO without clinician alerts. The primary outcome is rehabilitation exercise adherence rate over 1 month after discharge. Secondary outcomes include postoperative complications, hospital readmissions, symptom changes, exercise participation rate, and patient satisfaction. If proven effective, this innovative rehabilitation model can be scaled up to enhance recovery for more postoperative patients.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
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| Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ePRO based Remote Symptom Management provide by a mobile phone app | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rehabilitation exercise adherence rate over 1 month after discharge | Rehabilitation exercise adherence rate over 1 month after discharge, defined as the proportion of patients completing the prescribed outpatient exercise regimen. | From the day of discharge to 30 days after discharge |
| Mean weekly exercise duration over 1 month after discharge | Mean weekly exercise duration measured over the first 30 days post-discharge. This endpoint was added following a protocol amendment and interim review. Interim testing used an O'Brien-Fleming alpha-spending boundary. | From discharge to 30 days after discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-discharge pulmonary complication rate | From the day of discharge to 30 days after discharge | |
| 30-day hospital readmission rate | From the day of discharge to 30 days after discharge | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojuan Yang | Contact | +86 0760-88823566 | 1002381745@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.2 Sunwen East Rd. | Recruiting | Zhongshan | Guangdong | 528403 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40811025 | Derived | 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. | |
| 39610048 | Derived | 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. |
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Not available. The individual participant data collected in this study will not be shared with external researchers.
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| Changes in symptom severity scores from discharge to 30 days |
| From the day of discharge to 30 days after discharge |
| Patient satisfaction scores | From the day of discharge to 30 days after discharge |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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