Improving Lung Cancer Screening Adherence by Overcoming Barriers for Vulnerable Populations

NCT04969341 | Completed

• 2 other identifiers: 21G.139JT 16804
• Study Type: observational
• Target: 947
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

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.

Other: Survey Administration; Other: Electronic Health Record Review

Interventions

Survey Administration OTHER

Complete survey

Screening (survey, medical record review)

Electronic Health Record Review OTHER

Review of medical records

Screening (survey, medical record review)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Additionally, individuals must provide a signed and dated informed consent form to participate in the survey portion of this study

You may not qualify if:

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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Prevent Cancer Foundation: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 20, 2021
• Study Start: May 5, 2021
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)