Value-Based Medicine (VBM) for Lung Cancer

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06703866
• Lead Sponsor: European Institute of Oncology

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-01-27
• Status Verified: 2024-03
• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Creation of a personalized clinical-functional risk profile	12 months	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.

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy