- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04969341
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Lung Carcinoma
-
SWOG Cancer Research NetworkNational Cancer Institute (NCI)RecruitingExtensive Stage Lung Small Cell Carcinoma | Lung Small Cell Carcinoma, A Subtype | Lung Small Cell Carcinoma, I Subtype | Lung Small Cell Carcinoma, N Subtype | Lung Small Cell Carcinoma, P SubtypeUnited States
-
National Cancer Institute (NCI)CompletedLung Adenocarcinoma | Recurrent Non-Small Cell Lung Carcinoma | Adenosquamous Lung Carcinoma | Bronchioloalveolar Carcinoma | Large Cell Lung Carcinoma | Squamous Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingExtensive Stage Lung Small Cell Carcinoma | Limited Stage Lung Small Cell Carcinoma | Platinum-Resistant Lung Small Cell Carcinoma | Platinum-Sensitive Lung Small Cell Carcinoma | Extrapulmonary Small Cell Neuroendocrine Carcinoma | Recurrent Lung Small Cell CarcinomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingExtensive Stage Lung Small Cell Carcinoma | Limited Stage Lung Small Cell Carcinoma | Platinum-Resistant Lung Small Cell Carcinoma | Platinum-Sensitive Lung Small Cell Carcinoma | Recurrent Lung Small Cell Carcinoma | Recurrent Extensive Stage Lung Small Cell CarcinomaUnited States
-
University Health Network, TorontoCompletedNon-small Cell Lung CarcinomaCanada
-
National Cancer Institute (NCI)CompletedCarcinoma, Non-Small Cell Lung | Carcinoma, Small-Cell LungUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Society of Thoracic RadiologyCompletedStage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
Ohio State University Comprehensive Cancer CenterNational Institute on Aging (NIA)CompletedStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Advanced Lung Carcinoma | Stage IV Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Extensive Stage Lung Small Cell Carcinoma | Unresectable Lung Non-Small Cell Carcinoma | Unresectable Lung CarcinomaUnited States
-
Medical University of BialystokRecruitingNon-Small Cell Carcinoma of Lung | Small Cell Carcinoma of LungPoland
-
National Cancer Institute (NCI)Active, not recruitingMetastatic Lung Non-Small Cell Carcinoma | Stage IV Lung Cancer AJCC v8 | Advanced Lung Non-Small Cell CarcinomaUnited States
Clinical Trials on Survey Administration
-
Centre Oscar LambretCentre Hospitalier Universitaire de BesanconTerminated
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedHealth Status UnknownUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedSarcoma | Breast Carcinoma | Head and Neck CarcinomaUnited States
-
Boston UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
M.D. Anderson Cancer CenterRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingMalignant Vascular NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingMelanoma | COVID-19 InfectionUnited States
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)WithdrawnMelanoma | Breast Carcinoma | Lung Carcinoma | Colorectal Carcinoma | Community Practice | Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Institutes of Health (NIH)Active, not recruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
University of Rochester NCORP Research BaseNational Cancer Institute (NCI)WithdrawnCommunity Practice | StaffUnited States