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Postoperative CareAI-LungRecoverNCT07588737

Multimodal AI-Guided Recovery Management After Lung Cancer Surgery

A study testing Conventional Internet-Based Rehabilitation Information and Large Language Model-Assisted Rehabilitation Nursing in people with Postoperative Care and Rehabilitation, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Conventional Internet-Based Rehabilitation Information and Large Language Model-Assisted Rehabilitation Nursing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
868 participants
Where
1 siteChina
Study dates
1 Mar 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • the First Affiliated Hospital of Guangzhou Medical University, Guangzhou,Guangdong 510120

    Guangzhou, Guangdong

    Recruiting

Other trials in China

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Being tested
Conventional Internet-Based Rehabilitation Information, Large Language Model-Assisted Rehabilitation Nursing
Keywords
Artificial Intelligence, Large Language Model, Postoperative Rehabilitation, Thoracic Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional Internet-Based Rehabilitation InformationBehavioural

    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.

  • Large Language Model-Assisted Rehabilitation NursingBehavioural

    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.

Study groups in NCT07588737
Study groupRoleWhat they receive
Conventional Internet GroupActive comparatorParticipants in this group will receive routine postoperative rehabilitation nursing and use conventional internet-based information resources for rehabilitation-related information after thoracic surgery.
Receives: Behavioral: Conventional Internet-Based Rehabilitation Information
Large Language Model-Assisted Rehabilitation Nursing GroupExperimentalParticipants 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.
Receives: Behavioral: Large Language Model-Assisted Rehabilitation Nursing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From postoperative intervention initiation to postoperative day 30

Secondary outcomes (8)
  1. Overall Target Symptom Burden Within 30 Days After Surgery

    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.

    Measured: From postoperative intervention initiation to postoperative day 30

  2. Postoperative quality of recovery score

    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.

    Measured: Postoperative baseline, day 7, day 14, and day 30

  3. Time to Recovery to a Mild-Symptom State

    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.

    Measured: From postoperative intervention initiation to postoperative day 30

  4. MDASI-LC Functional Interference Score

    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.

    Measured: Postoperative baseline, day 7, day 14, and day 30

  5. Adherence to Respiratory Rehabilitation Exercises

    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.

    Measured: From postoperative intervention initiation to postoperative day 30

  6. Adherence to Postoperative Physical Activity Recommendations

    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.

    Measured: From postoperative intervention initiation to postoperative day 30

  7. Unplanned Healthcare Utilization Within 30 Days After Surgery

    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.

    Measured: Within 30 days after surgery

  8. Pulmonary Complications and Unplanned Readmission Within 30 Days After Surgery

    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.

    Measured: Within 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2026
  2. Study start1 Mar 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
868 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07588737
Sponsor's protocol ID
ES-2025-144-01
Acronym
AI-LungRecover
Status last verified
May 2026
First submitted
9 May 2026
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Internet-Based Rehabilitation Information and Large Language Model-Assisted Rehabilitation Nursing in people with Postoperative Care and Rehabilitation, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jianxing He (+8618320729913, drjianxing.he@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of MDASI-LC-Derived Target Symptom Threshold Events Within 30 Days After Surgery (time frame: From postoperative intervention initiation to postoperative day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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