JMIR Publications

ABSTRACT

Background:

Lung cancer, predominantly non-small cell lung cancer (NSCLC), remains a formidable challenge, necessitating an in-depth understanding of evolving treatment paradigms. The Italian Lung Cancer Observational Study (LUCENT) addresses this need by investigating the outcomes of early and locally advanced-stage lung cancer patients in Italy.

Objective:

With a focus on real-world data (RWD) and patient registries, this study aims to provide comprehensive insights into clinical, psychosocial, and economic impacts, contributing to informed decision-making in healthcare.

Methods:

LUCENT is a prospective observational multicenter cohort study enrolling patients eligible for minimally invasive manual, robot-assisted, or traditional open surgery. The study will develop a web-based registry to collect longitudinal surgical, oncological, and socioeconomic outcomes data. Primary objectives include performance assessment through establishing national benchmarks based on risk-adjusted outcomes and processes of care indicators. Secondary objectives encompass economic and psychosocial impact assessments of innovative technologies and treatment pathways. The multicenter design, with contributors listed in Annex 1, ensures a diverse and representative study population.

Results:

The evolving landscape of NSCLC treatment necessitates a nuanced approach, considering the dynamic shifts in therapeutic strategies. LUCENT strives to fill existing knowledge gaps by providing a platform for collecting and analysing RWD, emphasising the importance of patient-reported outcomes (PROs) in enhancing our understanding of the disease. By developing a web-based registry, the study not only facilitates efficient data collection but also addresses the limitations of traditional methods, such as suboptimal response rates and costs associated with paper-and-pencil questionnaires.

Conclusions:

LUCENT's potential implications are substantial. Establishing national benchmarks will enable a thorough evaluation of outcomes and care processes, guiding clinicians and policymakers in optimising patient management. Furthermore, the study's secondary objectives, focusing on economic and psychosocial impacts, align with the contemporary emphasis on holistic cancer care. Insights gained from this study may influence treatment strategies, resource utilisation, and patient well-being, thereby contributing to the ongoing refinement of lung cancer management. Clinical Trial: ClinicalTrials.gov ID: NCT05851755, ISRCTN: 67197140, DOI: 10.1186/ISRCTN67197140, Protocol Version: 3.2 (24/11/2023).