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
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
Patients recovering from lung cancer surgery commonly experience postoperative symptoms such as pain, cough, shortness of breath, fatigue, disturbed sleep, reduced physical activity, and anxiety. These symptoms may affect recovery experience, daily function, adherence to respiratory rehabilitation, and timely initiation of subsequent anticancer treatment. Conventional postoperative management usually relies on inpatient nursing care, discharge education, scheduled outpatient follow-up, and patient-initiated contact with healthcare professionals. However, symptoms can change rapidly during the early postoperative period and after discharge, and conventional follow-up may not provide continuous and individualized identification of symptom burden, recovery needs, or potential risks.
This trial will evaluate whether a multimodal AI-guided postoperative recovery management system can improve early recovery after lung cancer surgery. The AI-guided system is designed to integrate multiple types of patient-generated data, including patient-reported symptoms, vital signs, physical activity, respiratory rehabilitation completion, medication and nursing adherence, and, when needed, wound, drainage-site, or chest-related images or short videos. The system will provide postoperative recovery feedback, general nursing advice, respiratory rehabilitation reminders, activity guidance, symptom management suggestions, and risk stratification alerts.
The AI system is not intended to diagnose postoperative complications, prescribe medication, recommend self-adjustment of prescription drugs, or replace the clinical judgment of physicians or nurses. For red-flag symptoms or high-risk conditions, the system will advise patients to contact the clinical team or seek medical care. Both study groups will retain access to usual clinical safety pathways throughout the trial.
Participants will be randomly assigned in a 1:1 ratio to the AI-guided recovery management group or the usual postoperative care group. The AI-guided group will receive usual postoperative care plus the multimodal AI recovery management system from postoperative intervention initiation to postoperative day 30. The usual-care group will receive standard postoperative management, including routine inpatient care, pain management, respiratory exercise instruction, activity and diet advice, medication guidance, discharge education, outpatient follow-up arrangements, and routine telephone or online follow-up where applicable. To ensure consistent outcome measurement, participants in both groups will complete patient-reported symptom assessments at the same prespecified time points.
The primary outcome is the number of MDASI-LC-derived target symptom threshold events per patient within 30 days after surgery. 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. The study will also evaluate overall target symptom burden, postoperative quality of recovery, time to recovery to a mild-symptom state, MDASI-LC functional interference, adherence to respiratory rehabilitation exercises, adherence to physical activity recommendations, unplanned healthcare utilization, pulmonary complications, unplanned readmission, and AI-related safety and feasibility outcomes.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Jianxing He
- Número de telefone: +8618320729913
- E-mail: drjianxing.he@gmail.com
Locais de estudo
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Guangdong
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Guangzhou, Guangdong, China
- Recrutamento
- the First Affiliated Hospital of Guangzhou Medical University, Guangzhou,Guangdong 510120
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Conventional Internet Group
Participants in this group will receive routine postoperative rehabilitation nursing and use conventional internet-based information resources for rehabilitation-related information after thoracic surgery.
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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.
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Experimental: Large Language Model-Assisted Rehabilitation Nursing Group
Participants 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of MDASI-LC-Derived Target Symptom Threshold Events Within 30 Days After Surgery
Prazo: From postoperative intervention initiation to postoperative day 30
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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.
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From postoperative intervention initiation to postoperative day 30
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Overall Target Symptom Burden Within 30 Days After Surgery
Prazo: From postoperative intervention initiation to postoperative day 30
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Overall target symptom burden will be assessed using MDASI-LC target symptom items, including pain, fatigue, disturbed sleep, shortness of breath, and cough.
The outcome may be summarized as the mean score of the five target symptoms at each prespecified time point or as the area under the symptom burden curve over 30 days.
Higher scores indicate greater symptom burden.
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From postoperative intervention initiation to postoperative day 30
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Postoperative quality of recovery score
Prazo: Postoperative baseline, day 7, day 14, and day 30
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Postoperative quality of recovery will be assessed using the QoR-15 or QoR-40 questionnaire.
The questionnaire evaluates domains such as pain, physical comfort, emotional state, physical independence, and psychological support.
Higher scores indicate better postoperative recovery quality.
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Postoperative baseline, day 7, day 14, and day 30
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Time to Recovery to a Mild-Symptom State
Prazo: From postoperative intervention initiation to postoperative day 30
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Time to recovery to a mild-symptom state is defined as the time from postoperative intervention initiation to the first day when all target symptom scores are below 4 and remain below 4 for at least 3 consecutive days.
Target symptoms include pain, fatigue, disturbed sleep, shortness of breath, and cough.
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From postoperative intervention initiation to postoperative day 30
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MDASI-LC Functional Interference Score
Prazo: Postoperative baseline, day 7, day 14, and day 30
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Functional interference will be assessed using MDASI-LC interference items.
These items evaluate the extent to which postoperative symptoms interfere with daily function, including general activity, walking, work or household tasks, mood, relations with others, and enjoyment of life.
Higher scores indicate greater functional interference.
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Postoperative baseline, day 7, day 14, and day 30
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Adherence to Respiratory Rehabilitation Exercises
Prazo: From postoperative intervention initiation to postoperative day 30
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Adherence to respiratory rehabilitation exercises will be assessed as the proportion of prescribed or recommended respiratory training sessions completed by the patient.
Exercises may include deep breathing, effective coughing, pursed-lip breathing, incentive spirometer training, or other center-specific postoperative pulmonary rehabilitation exercises.
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From postoperative intervention initiation to postoperative day 30
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Adherence to Postoperative Physical Activity Recommendations
Prazo: From postoperative intervention initiation to postoperative day 30
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Adherence to postoperative physical activity recommendations will be assessed using patient self-report, smartphone step counts, wearable device records, or study logs, where available.
Activities may include early ambulation, walking, home-based light physical activity, or achievement of prespecified daily step goals.
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From postoperative intervention initiation to postoperative day 30
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Unplanned Healthcare Utilization Within 30 Days After Surgery
Prazo: Within 30 days after surgery
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Unplanned healthcare utilization is defined as any unplanned healthcare contact related to postoperative recovery within 30 days after surgery.
Events may include unplanned outpatient visits, urgent telephone or online consultations, emergency department visits, or unplanned hospital readmissions.
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Within 30 days after surgery
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Pulmonary Complications and Unplanned Readmission Within 30 Days After Surgery
Prazo: Within 30 days after surgery
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This outcome includes pulmonary complications and unplanned readmission within 30 days after surgery.
Pulmonary complications may include pneumonia, atelectasis requiring clinical intervention, respiratory failure, need for noninvasive or invasive ventilation, clinically significant pleural effusion, pneumothorax requiring treatment, prolonged air leak, or other pulmonary complications recorded by the clinical team.
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Within 30 days after surgery
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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AI High-Risk Alert Performance
Prazo: From postoperative intervention initiation to postoperative day 30
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This outcome evaluates the performance of AI-generated high-risk alerts in the AI-guided recovery management group.
It includes the incidence of AI-generated high-risk alerts and the missed high-risk alert rate.
The incidence is defined as the proportion of participants who receive at least one AI-generated high-risk alert during the postoperative monitoring period.
The missed high-risk alert rate is defined as the proportion of participants with clinically confirmed postoperative complications, severe symptom deterioration, or conditions requiring escalation of care who did not receive an AI-generated high-risk alert within the prespecified monitoring window.
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From postoperative intervention initiation to postoperative day 30
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Incidence of Clinically Inappropriate AI-Generated Recommendations
Prazo: From postoperative intervention initiation to postoperative day 30
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This outcome evaluates the proportion of AI-generated recommendations judged by an independent clinical safety review committee to be clinically inappropriate, unsafe, potentially misleading, or inconsistent with prespecified postoperative recovery management rules.
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From postoperative intervention initiation to postoperative day 30
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AI Monitoring Feasibility and Data Quality
Prazo: From postoperative intervention initiation to postoperative day 30
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This outcome evaluates the feasibility of AI-based recovery monitoring and the adequacy of uploaded data in the AI-guided recovery management group.
It includes patient adherence to AI-based recovery monitoring and the data quality adequacy rate.
Patient adherence is defined as the proportion of prespecified monitoring days on which participants complete symptom reporting, vital sign upload, rehabilitation behavior recording, and required image or video upload, where applicable.
Data quality adequacy is defined as the proportion of uploaded symptom data, vital sign data, rehabilitation records, and image or video data that meet prespecified quality criteria, including completeness, clarity, interpretability, and timestamp completeness.
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From postoperative intervention initiation to postoperative day 30
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Colaboradores e Investigadores
Datas de registro do estudo
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Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- ES-2025-144-01
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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.
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