Improving Lung Cancer Screening Adherence by Overcoming Barriers for Vulnerable Populations

Sponsor
Thomas Jefferson University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04969341
Collaborator
(none)
1,707
1
32.9
51.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Survey Administration
  • Other: Electronic Health Record Review

Study Design

Study Type:
Observational
Anticipated Enrollment :
1707 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Improving Lung Cancer Screening Barriers for Vulnerable Populations
Actual Study Start Date :
May 5, 2021
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm 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.

Other: Survey Administration
Complete survey

Other: Electronic Health Record Review
Review of medical records

Outcome Measures

Primary Outcome Measures

  1. Associations between health insurance availability and financial burdens as factors in lung cancer screening adherence [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.

  2. Individual-level cost-related factors associated with screening adherence [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.

  3. Convenience-related factors that impact lung cancer screening adherence [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Thomas Jefferson University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT04969341
Other Study ID Numbers:
  • 21G.139
First Posted:
Jul 20, 2021
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022