|

Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen

RECRUITINGSponsored by IRCCS San Raffaele
Actively Recruiting
SponsorIRCCS San Raffaele
Started2025-07-24
Est. completion2027-06
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

A multicenter, national pharmacological observational study that has as its overall goal to implement a set of validated and agreed upon European-wide questionnaires (PROMs - patient's reported outcomes) to assess patients' perceptions of aspects of their lives based on the treatment they are receiving. Specifically, with the research we present here, we aim to obtain data on patients' health and condition, including quality of life, symptom status, physical function, mental health (anxiety and depression), sleep quality, and sexuality as useful indicators not only of patient well-being but also of the effectiveness of the treatment itself. The study involves the following: patients will be asked to complete online questionnaires at the following timepoints: before the start of treatment, after 4 and 8 treatment cycles, and at disease progression. Data will also be collected regarding the patient's oncological medical history, treatment performed, response to treatment at CT/PET reevaluations, any toxicities that arose during treatment.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Age \> 18 years
* Diagnosis of Stage IV NSCLC with PD-L1 \<50%, without actionable genomic alterations
* Signed Informed Consent Form (ICF) to the study
* Patients eligible to receive first line treatment with combo chemo-immuno treatments as standard of care

Exclusion Criteria:

\- Patients unable to fill the questionnaires due to neurological comorbidities

Conditions3

CancerLung CancerPROMs

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.