Value-Based Medicine (VBM) for Lung Cancer

European Institute of Oncology

Status: Enrolling

Conditions: Lung Cancer

Treatments: Other: Non Small Cell Lung Cancer (NSCLC)

Study type: Observational

Funder types: Other

Identifiers

NCT06703866

IEO 1399

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged ≥ 18 years
• Patients with diagnosis of non-small cell lung carcinoma
• Only patients eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy
• Diagnosis of primary non-small cell lung cancer
• Signed Informed Consent
• Patients must be available for follow-up

Exclusion criteria

• Patients with benign lesion
• Patients with recurrence who have already undergone lung surgery
• Conditions/pathologies that prevent the ability to give consent

Trial design

200 participants in 1 patient group

Non Small Cell Lung Cancer (NSCLC)

Description:

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

Treatment:

Other: Non Small Cell Lung Cancer (NSCLC)