Lung Cancer
Conditions
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.
Interventions
OTHERNon Small Cell Lung Cancer (NSCLC)
Application of value based medicine predictive model
Sponsors
European Institute of Oncology
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactMonica Casiraghi
Outcome results
None listed