Multimodal Artificial Intelligence-Guided Symptom Monitoring and Recovery Management After Lung Cancer Surgery: A 20-Center Prospective Randomized Controlled Trial
Trial ID: NCT07588737
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-03-01
Completion date: 2026-12-31
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Conditions: Postoperative Care; Rehabilitation; Artificial Intelligence (Al); Randomized Controlled Trial (RCT)
Interventions: Conventional Internet-Based Rehabilitation Information; Large Language Model-Assisted Rehabilitation Nursing
Locations: the First Affiliated Hospital of Guangzhou Medical University, Guangzhou,Guangdong 510120
Countries: China
Enrollment: 868
Age range: 18 Years - 80 Years
Sex: ALL

Summary:
This study is a multicenter, prospective, randomized controlled trial designed to evaluate the effectiveness and safety of a multimodal artificial intelligence (AI)-guided postoperative recovery management system in patients after lung cancer surgery. Eligible patients will be enrolled after surgery when their clinical condition is stable and will be randomly assigned to either an AI-guided recovery management group or a usual postoperative care group.

Patients in the AI-guided group will receive usual postoperative care plus a multimodal AI-based recovery management system. The system will collect patient-reported symptoms, vital signs, physical activity, respiratory rehabilitation information, recovery-related data, and, when needed, wound or chest-related images or short videos. Based on these data, the system will provide recovery feedback, general nursing advice, respiratory rehabilitation reminders, activity guidance, and risk stratification alerts. For red-flag symptoms or high-risk conditions, the system will advise patients to contact the clinical team or seek medical care.

Patients in the usual-care group will receive standard postoperative management after lung cancer surgery and will complete symptom assessments at the same prespecified time points, but they will not receive AI-generated individualized recovery feedback or AI-generated risk alerts.

The primary outcome is the number of MDASI-LC-derived target symptom threshold events within 30 days after surgery. Target symptoms include pain, fatigue, disturbed sleep, shortness of breath, and cough. Secondary outcomes include overall target symptom burden, quality of recovery, time to recovery to a mild-symptom state, functional interference, respiratory rehabilitation adherence, physical activity adherence, unplanned healthcare utilization, pulmonary complications, and unplanned readmission.

Eligibility criteria:
Inclusion Criteria:

1. Age 18 years or older.
2. Clinically or pathologically diagnosed with lung cancer.
3. Undergoing lung cancer-related thoracic surgery.
4. Surgical procedures may include video-assisted thoracoscopic surgery, robot-assisted thoracic surgery, or open thoracic surgery.
5. Surgical extent may include wedge resection, segmentectomy, lobectomy, sleeve resection, combined resection, bilobectomy, or pneumonectomy.
6. Clinically stable after surgery and able to participate in symptom assessment and postoperative recovery management.
7. Able to use a smartphone or study device, or has a caregiver who can assist with use.
8. Able to complete patient-reported symptom assessments and postoperative recovery information reporting.
9. Provides written informed consent.

Exclusion Criteria:

1. Patients receiving non-surgical treatment only.
2. Patients undergoing bronchoscopy, percutaneous biopsy, or other non-surgical diagnostic or therapeutic procedures only.
3. Clinically unstable after surgery and unable to participate in symptom assessment or recovery management.
4. Requiring prolonged intensive care unit treatment, continuous advanced life support, or continuous intensive medical management.
5. Severe cognitive impairment, psychiatric disorder, language communication disorder, or other conditions that preclude completion of study assessments.
6. Unable to use a smartphone or study device and without a caregiver who can assist with use.
7. Currently participating in another interventional clinical study that may affect the primary outcome of this trial.
8. Any other condition judged by the investigator to make the patient unsuitable for participation in this study.

Outcomes:
Number of MDASI-LC-Derived Target Symptom Threshold Events Within 30 Days After Surgery