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This is a prospective observational monocentric trial. The primary endpoint is the validation of predictive models. These predictive models will be used to develop a personalized clinical-functional risk profile for estimating in advance, prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge.
The goal of this prospective observational monocentric study is to validate a predictive models in patients with diagnosis of non-small cell lung cancer eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy.
Participants will be asked to complete quality of life questionnaires before surgery and then at 30 days, 4 months, 8 months and 12 months post discharge.
The informations collected through questionnaires, along with clinical data will be used to validate the predictive models created.
These models will then be utilized to develop a personalized clinical-functional risk profile for estimating in advance, prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non Small Cell Lung Cancer (NSCLC) | Patients with diagnosis of Non Small Cell Lung Cancer (NSCLC) eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Small Cell Lung Cancer (NSCLC) | Other | Application of "value based medicine" predictive model |
|
| Measure | Description | Time Frame |
|---|---|---|
| Creation of a personalized clinical-functional risk profile | Developement of a personalized clinical-functional risk profile for estimating , prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge. The patient will be asked to complete questionnaires (EORTC QLQ-C30 / EORTC QLQ- LC13) on clinical-functional status and quality of life both before and after surgery, at 30 days, 4 months, 8 months and 12 months after discharge. The information acquired with the questionnaires, together with the clinical information acquired during the healthcare services, will be used to validate and refine the predictive models created and will be used to create a personalized clinical-functional risk profile. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with first diagnosis of non-small cell lung carcinoma eligible for surgical lung resection and available for follow up
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monica Casiraghi | Contact | +39 02 57489425 | monica.casiraghi@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Monica Casiraghi | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Recruiting | Milan | Italy |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |