Actively Recruiting
Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen
Led by IRCCS San Raffaele · Updated on 2025-09-03
144
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
Sponsors
I
IRCCS San Raffaele
Lead Sponsor
A
AOU Città della Salute e della Scienza di Torino - Presidio Molinette
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Diagnosis of Stage IV NSCLC with PD-L1 <50%, without actionable genomic alterations
- Signed Informed Consent Form (ICF) to the study
- Eligible to receive first-line combo chemo-immunotherapy treatments as standard care
You will not qualify if you...
- Unable to fill in questionnaires due to neurological comorbidities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Ospedale San Raffaele
Milan, Italy, Italy, 20132
Actively Recruiting
Research Team
S
Sara Oresti, Medical Oncologist
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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