Lung CarcinomaNCT04969341
Improving Lung Cancer Screening Adherence by Overcoming Barriers for Vulnerable Populations
An observational study of Lung Carcinoma, run by Thomas Jefferson University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Survey Administration and Electronic Health Record Review
- How many people
- 947 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2021to 30 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred to the Jefferson Lung Cancer Screening Program (LCSP) and eligible for lung cancer screening
Who may be able to join
- 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
Who cannot join
- Non-English-speaking individuals
- Individuals who lack consent capacity
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
- Conditions
- Lung Carcinoma
- Being tested
- Survey Administration, Electronic Health Record Review
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete survey
Electronic Health Record ReviewOther
Review of medical records
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Survey Administration; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to study completion; 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start5 May 2021
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 947 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Prevent Cancer Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969341
- Sponsor's protocol ID
- 21G.139
- Other IDs
- JT 16804
- Status last verified
- May 2025
- First submitted
- 6 Jul 2021
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Lung Cancer Screening Barriers for Vulnerable Populations
- ClinicalTrials.gov ID
- NCT04969341
- Acronym / sponsor ID
- 21G.139
- Conditions
- Lung Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 947 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Prevent Cancer Foundation
- Study start
- 5 May 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (survey, medical record review) | – | Other: Survey Administration, Other: Electronic Health Record ReviewPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred to the Jefferson Lung Cancer Screening Program (LCSP) and eligible for lung cancer screening
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Non-English-speaking individuals
- Individuals who lack consent capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey AdministrationComplete survey | Other | Screening (survey, medical record review) |
| Electronic Health Record ReviewReview of medical records | Other | Screening (survey, medical record review) |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Carcinoma, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Associations between health insurance availability and financial burdens as factors in lung cancer screening adherence (time frame: Up to study completion; 15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.