Improving Lung Cancer Screening Adherence by Overcoming Barriers for Vulnerable Populations

May 15, 2025 updated by: Thomas Jefferson University

Improving Lung Cancer Screening Barriers for Vulnerable Populations

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

947

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients referred to the Jefferson Lung Cancer Screening Program (LCSP) and eligible for lung cancer screening

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Screening (survey, medical record review)
Patients complete survey over 20 minutes consisting of validated and piloted items related to cost and convenience barriers in lung cancer screening, personal financial and lung cancer risk perception questions, and the Telehealth Satisfaction and Usefulness questionnaire. Patients also have their medical records reviewed retrospectively.
Complete survey
Review of medical records

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Associations between health insurance availability and financial burdens as factors in lung cancer screening adherence
Time Frame: Up to study completion; 15 months
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
Individual-level cost-related factors associated with screening adherence
Time Frame: Up to study completion; 15 months
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
Convenience-related factors that impact lung cancer screening adherence
Time Frame: Up to study completion; 15 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (Actual)

July 20, 2021

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 21G.139
  • JT 16804 (Other Identifier: JeffTrial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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