Improving Lung Cancer Screening Adherence by Overcoming Barriers for Vulnerable Populations

Lung Carcinoma Clinical Trial

Official title:

Improving Lung Cancer Screening Barriers for Vulnerable Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04969341
• Other study ID #: 21G.139
• Status: Recruiting
• Start date: May 5, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study investigates multi-level barriers to lung cancer screening uptake and adherence to lung cancer screening. Identifying cost- and convenience-related barriers to lung cancer screening may help researchers develop targeted strategies to facilitate screening adherence specifically among vulnerable populations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1707
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients referred to the Jefferson LCSP and eligible for lung cancer screening by our standard criteria (United States Preventive Services Task Force, Center for Medicaid and Medicare Services, and/or National Comprehensive Cancer Network group II guidelines) will be eligible for inclusion in the study
• Additionally, individuals must provide a signed and dated informed consent form to participate in the survey portion of this study

Exclusion Criteria:

• Non-English-speaking individuals
• Individuals who lack consent capacity

Related Conditions & MeSH terms

• Lung Carcinoma
• Lung Neoplasms

Intervention

Other:
• Survey Administration
Complete survey
• Electronic Health Record Review
Review of medical records

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Associations between health insurance availability and financial burdens as factors in lung cancer screening adherence	Individual-level insurance status will be analyzed for association with lung cancer screening adherence. Descriptive analyses of neighborhood factors will be conducted to characterize residential computed tomography (CT)s. Multilevel logistic regression models examining the relationship between screening adherence and each neighborhood factor (i.e., one per model for each CT) and will be adjusted for important individual-level covariates, such as patient age, sex, and smoking status. To address the dependence of the neighborhood factors on race in predicting screening adherence, the modeling results will be focused on interaction terms to examine interactions between race and neighborhood factors.	Up to study completion; 15 months
Primary	Individual-level cost-related factors associated with screening adherence	Will use generalized linear mixed effects logistic regression to model the longitudinal adherence to lung cancer screening as a function of cost-related variables, race, and their interactions. The model will be used to estimate odds ratios representing how adherence associated with financial variables depends on race at each follow-up CT scan.	Up to study completion; 15 months
Primary	Convenience-related factors that impact lung cancer screening adherence	Will assess convenience-related factors that may affect lung cancer screening uptake and adherence. Survey items will address technology and internet accessibility; preferred methods for patient communication; effectiveness of patient navigation; and identification of logistical barriers along each step of the screening workflow including referral, eligibility assessment, scheduling, shared decision-making (SDM) visit, low dose CT (LDCT), results review, and follow-up instructions.	Up to study completion; 15 months