Multimodal AI-Guided Recovery Management After Lung Cancer Surgery
AI-LungRecover
Multimodal Artificial Intelligence-Guided Symptom Monitoring and Recovery Management After Lung Cancer Surgery: A 20-Center Prospective Randomized Controlled Trial
1 other identifier
interventional
868
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2025
CompletedFirst Submitted
Initial submission to the registry
May 9, 2026
CompletedFirst Posted
Study publicly available on registry
May 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 15, 2026
May 1, 2026
1.8 years
May 9, 2026
May 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of MDASI-LC-Derived Target Symptom Threshold Events Within 30 Days After Surgery
The outcome is the number of target symptom threshold events per patient from postoperative intervention initiation to postoperative day 30. Target symptoms include pain, fatigue, disturbed sleep, shortness of breath, and cough. Each target symptom will be assessed using MDASI-LC items or equivalent 0-10 numeric rating scales. A target symptom threshold event is defined as any target symptom score of 4 or higher at a prespecified assessment time point.
From postoperative intervention initiation to postoperative day 30
Secondary Outcomes (8)
Overall Target Symptom Burden Within 30 Days After Surgery
From postoperative intervention initiation to postoperative day 30
Postoperative quality of recovery score
Postoperative baseline, day 7, day 14, and day 30
Time to Recovery to a Mild-Symptom State
From postoperative intervention initiation to postoperative day 30
MDASI-LC Functional Interference Score
Postoperative baseline, day 7, day 14, and day 30
Adherence to Respiratory Rehabilitation Exercises
From postoperative intervention initiation to postoperative day 30
- +3 more secondary outcomes
Other Outcomes (3)
AI High-Risk Alert Performance
From postoperative intervention initiation to postoperative day 30
Incidence of Clinically Inappropriate AI-Generated Recommendations
From postoperative intervention initiation to postoperative day 30
AI Monitoring Feasibility and Data Quality
From postoperative intervention initiation to postoperative day 30
Study Arms (2)
Conventional Internet Group
ACTIVE COMPARATORParticipants in this group will receive routine postoperative rehabilitation nursing and use conventional internet-based information resources for rehabilitation-related information after thoracic surgery.
Large Language Model-Assisted Rehabilitation Nursing Group
EXPERIMENTALParticipants in this group will receive artificial intelligence-assisted postoperative rehabilitation nursing through a large language model-based system. The system will analyze postoperative patient data and provide individualized rehabilitation recommendations, including pain management, pulmonary function training, and exercise rehabilitation.
Interventions
Participants in the conventional internet group will receive routine postoperative rehabilitation nursing and use conventional internet-based information resources for rehabilitation-related information after thoracic surgery.
Participants in the large language model-assisted rehabilitation nursing group will receive artificial intelligence-assisted postoperative rehabilitation nursing. The system will analyze postoperative patient data and generate individualized rehabilitation recommendations, including pain management, pulmonary function training, and exercise rehabilitation. The rehabilitation module will support digital entry and feedback of standardized scales and recovery-related information, including pain scores, activity monitoring, step count, symptom self-assessment, cough frequency, and dyspnea level. Healthcare professionals will remain responsible for clinical oversight and safety management.
Eligibility Criteria
You may qualify if:
- Age 18 years or older.
- Clinically or pathologically diagnosed with lung cancer.
- Undergoing lung cancer-related thoracic surgery.
- Surgical procedures may include video-assisted thoracoscopic surgery, robot-assisted thoracic surgery, or open thoracic surgery.
- Surgical extent may include wedge resection, segmentectomy, lobectomy, sleeve resection, combined resection, bilobectomy, or pneumonectomy.
- Clinically stable after surgery and able to participate in symptom assessment and postoperative recovery management.
- Able to use a smartphone or study device, or has a caregiver who can assist with use.
- Able to complete patient-reported symptom assessments and postoperative recovery information reporting.
- Provides written informed consent.
You may not qualify if:
- Patients receiving non-surgical treatment only.
- Patients undergoing bronchoscopy, percutaneous biopsy, or other non-surgical diagnostic or therapeutic procedures only.
- Clinically unstable after surgery and unable to participate in symptom assessment or recovery management.
- Requiring prolonged intensive care unit treatment, continuous advanced life support, or continuous intensive medical management.
- Severe cognitive impairment, psychiatric disorder, language communication disorder, or other conditions that preclude completion of study assessments.
- Unable to use a smartphone or study device and without a caregiver who can assist with use.
- Currently participating in another interventional clinical study that may affect the primary outcome of this trial.
- Any other condition judged by the investigator to make the patient unsuitable for participation in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Affiliated Hospital of Guangzhou Medical University, Guangzhou,Guangdong 510120
Guangzhou, Guangdong, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 9, 2026
First Posted
May 15, 2026
Study Start
March 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 15, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
De-identified individual participant data underlying the results reported in the primary trial publication may be shared with qualified researchers upon reasonable request and approval by the study steering committee. Shared data may include baseline characteristics, group allocation, prespecified outcome data, adverse event data, and analysis datasets used for the primary and secondary outcome analyses. Data sharing will exclude directly identifiable information, raw images or videos that may contain identifiable information, free-text data with privacy risks, and proprietary components of the AI system. Data requestors will be required to submit a methodologically sound proposal, obtain approval from the study steering committee, and sign a data use agreement before data access is granted.