Clinical trial NCT06771947: Predicting Symptom Trajectories After Thoracoscopic Lung Cancer Surgery Using an Interpretable Machine Learning Model
Official title: Predicting Symptom Trajectories After Thoracoscopic Lung Cancer Surgery Using an Interpretable Machine Learning Model
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer
Keywords: Lung cancer
Machine learning
Patient-reported outcome
Thoracoscopy surgery
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung cancer patient underwent thoracoscopic surgery and completed the MD Anderson Symptom Inventory-Lung Cancer module postoperatively.

Brief summary: Patients suffer from a variety of symptoms after thoracoscopic surgery. However, there is a lack of validated predictive tools to identify potentially high-risk patients. This study is anticipated to include approximately 1,500 lung cancer patients who undergo thoracoscopic surgery. Latent class mixed modeling (LCMM) will be used to dentify subgroups of patients with similar symptom trajectories. Machine learning models were developed to predict postoperative symptom trajectories based on collected information. Effective prediction of postoperative symptoms can help identify high-risk patients and take preventive measures.

Detailed description: Thoracoscopic lung cancer surgery is a widely utilized approach for treating early and locally advanced lung cancer. Despite the advantages of thoracoscopic surgery, such as minimal invasion and rapid recovery, patients still suffer from a variety of symptoms such as pain, shortness of breath, sleep disorders or fatigue after surgery, which seriously affects the quality of life. However, there is a lack of validated predictive tools to identify potentially high-risk patients. This study is anticipated to include approximately 1,500 lung cancer patients who undergo thoracoscopic surgery. Patients are invited to fill out the MD Anderson Symptom Inventory-Lung Cancer module after thoracoscopic surgery. Symptoms of interest include pain, shortness of breath, sleep disturbance, and fatigue. Moderate to severe symptoms were defined as a score of ≥ 4. Latent class mixed modeling (LCMM), a clustering technique, can identify subgroups of patients with similar symptom trajectories based on longitudinal patient-reported outcome (PRO) data. Machine learning models were developed to predict postoperative symptom trajectories based on collected information including demographic and clinical information, and operative data. The machine learning models mainly include Random Forest, Support Vector Machines, Neural Networks, XGBoost, etc. The most appropriate model is selected, and model interpretation is performed using the SHAP method. Effective prediction of postoperative symptoms can help identify high-risk patients and take preventive measures.

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years old;
* Pathologically diagnosed lung cancer;
* Undergo thoracoscopic surgery, including video-assisted thoracoscopy and robotic-assisted thoracoscopic surgery;
* no prior history of malignancy or lung surgery;
* Have the ability to complete the scale.

Exclusion Criteria:

* Converted to thoracotomy during thoracoscopic surgery;
* Unable to complete the postoperative scale at least two times;
* Missing data values exceeding 30 percent.

Primary outcomes:
measure: Symptom trajectories after thoracoscopic surgery
timeFrame: Within four weeks after thoracoscopic surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Guangdong Provincial People's Hospital
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Guibin Qiao
role: PRINCIPAL_INVESTIGATOR
References: