Outcomes of Patients With Early and Locally Advanced Lung Cancer: Protocol for the Italian Lung Cancer Observational Study (LUCENT)

Overview

Journal JMIR Res Protoc

Publisher JMIR Publications

Specialty General Medicine

Date 2024 Oct 8

PMID 39378423

Authors

Luca Bertolaccini

Oriana Ciani

Marco Lucchi

Francesco Zaraca

Alessandro Bertani

Roberto Crisci

Lorenzo Spaggiari

Affiliations

Soon will be listed here.

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 patients with early and locally advanced lung cancer in Italy.

Objective: With a focus on real-world data and patient registries, this study aims to provide comprehensive insights into clinical, psychosocial, and economic impacts, contributing to informed decision-making in health care.

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 outcome data. The primary objectives include performance assessment through the establishment of national benchmarks based on risk-adjusted outcomes and processes of care indicators. The secondary objectives encompass economic and psychosocial impact assessments of innovative technologies and treatment pathways. The multicenter design ensures a diverse and representative study population.

Results: The evolving landscape of NSCLC treatment necessitates a nuanced approach with consideration of the dynamic shifts in therapeutic strategies. LUCENT strives to fill existing knowledge gaps by providing a platform for collecting and analyzing real-world data, emphasizing the importance of patient-reported outcomes in enhancing the 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. Recruitment will be conducted from January 01, 2024, to December 31, 2026. Follow-up will be performed for a minimum of 2 years. The study will be completed in the year 2028.

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 optimizing 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 utilization, and patient well-being, thereby contributing to the ongoing refinement of lung cancer management.

Trial Registration: ClinicalTrials.gov NCT05851755; https://clinicaltrials.gov/study/NCT05851755. ISRCTN 67197140; https://www.isrctn.com/ISRCTN67197140.

International Registered Report Identifier (irrid): PRR1-10.2196/57183.

References

Jacobs J, Shahian D, DAgostino R, Mayer Jr J, Kozower B, Badhwar V . The Society of Thoracic Surgeons National Database 2018 Annual Report. Ann Thorac Surg. 2018; 106(6):1603-1611. DOI: 10.1016/j.athoracsur.2018.10.001. View

Basch E, Deal A, Kris M, Scher H, Hudis C, Sabbatini P . Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2015; 34(6):557-65. PMC: 4872028. DOI: 10.1200/JCO.2015.63.0830. View

Bertolaccini L, Casiraghi M, Bardoni C, Diotti C, Chiari M, Mazzella A . Revamping Non-Small Cell Lung Cancer Treatments in Stages II and III: Preparing Healthcare for Cutting-Edge Immuno-Oncology Regimens. Cancers (Basel). 2024; 16(16). PMC: 11352981. DOI: 10.3390/cancers16162842. View

Shahian D, Fernandez F, Badhwar V . The Society of Thoracic Surgeons National Database at 30: Honoring Our Heritage, Celebrating the Present, Evolving for the Future. Ann Thorac Surg. 2019; 107(4):1259-1266. DOI: 10.1016/j.athoracsur.2019.02.002. View

Jemal A, Thun M, Ries L, Howe H, Weir H, Center M . Annual report to the nation on the status of cancer, 1975-2005, featuring trends in lung cancer, tobacco use, and tobacco control. J Natl Cancer Inst. 2008; 100(23):1672-94. PMC: 2639291. DOI: 10.1093/jnci/djn389. View

Shapira O, Blumenfeld O, Bolotin G, Grover F, Shahian D . International Participation in The Society of Thoracic Surgeons Adult Cardiac Surgery Database: From Institutional to National. Ann Thorac Surg. 2017; 103(6):1683-1686. DOI: 10.1016/j.athoracsur.2017.01.010. View

Finch A, Meregaglia M, Ciani O, Roudijk B, Jommi C . An EQ-5D-5L value set for Italy using videoconferencing interviews and feasibility of a new mode of administration. Soc Sci Med. 2021; 292:114519. DOI: 10.1016/j.socscimed.2021.114519. View

Paul S, Altorki N, Sheng S, Lee P, Harpole D, Onaitis M . Thoracoscopic lobectomy is associated with lower morbidity than open lobectomy: a propensity-matched analysis from the STS database. J Thorac Cardiovasc Surg. 2010; 139(2):366-78. DOI: 10.1016/j.jtcvs.2009.08.026. View

Farjah F, Kaji A, Chu D . Practical Guide to Surgical Data Sets: Society of Thoracic Surgeons (STS) National Database. JAMA Surg. 2018; 153(10):955-956. DOI: 10.1001/jamasurg.2018.0545. View

10.

Aronson S, Mathew J, Cheung A, Shore-Lesserson L, Troianos C, Reeves S . The rationale and development of an adult cardiac anesthesia module to supplement the society of thoracic surgeons national database: using data to drive quality. Anesth Analg. 2014; 118(5):925-32. DOI: 10.1213/ANE.0000000000000184. View

11.

Bray F, Ferlay J, Soerjomataram I, Siegel R, Torre L, Jemal A . Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018; 68(6):394-424. DOI: 10.3322/caac.21492. View