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

Zhongshan City People's Hospital

Status: Enrolling

Conditions: Postoperative Complications; Exercise Therapy; Telerehabilitation; Patient Reported Outcome Measures; Lung Neoplasms, Non-Small Cell Lung Cancer

Treatments: Device: ePRO based Remote Symptom Management provide by a mobile phone app

Study type: Interventional

Funder types: Other

Identifiers

NCT05990946

K2022-285

Details and patient eligibility

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.

Full description

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).

Enrollment: 736 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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736 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Device: ePRO based Remote Symptom Management provide by a mobile phone app

Control Group

No Intervention group

Description:

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.