Lung Cancer ScreeningNCT07576595
Multilevel Intervention for LDCT Lung Cancer Screening and Smoking Cessation Among African Americans
A study testing Smoking cessation multilevel Intervention in people with Lung Cancer Screening and Tobacco Use Disorder, run by Louisiana State University Health Sciences Center in New Orleans at 2 sites in United States.
Trial summary
This study aims to reduce disparities and the burden of lung cancer among African American smokers by supporting a Multiple-level intervention integrating lung cancer screening and smoking cessation (MILS), followed the NIH DEIA strategies using multilevel interventions that impact determinants of health and address… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lung Cancer Screening, Tobacco Use Disorder, Smoking Cessation
- What is being tested?
- Smoking cessation multilevel Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Apr 2025to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American
- 20+ pack years of smoking
- eligible for or received LDCT screening
- current smoker
- English speaking
Who cannot join
- N/A
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
LSUHSC School of Public Health
New Orleans, Louisiana, 70112
- Recruiting
University Medical Center
New Orleans, Louisiana, 70112
About this study
Official title: Effectiveness of a Multilevel Integrated Intervention for LDCT Lung Cancer Screening and Smoking Cessation Among African Americans
This study aims to reduce disparities and the burden of lung cancer among African American smokers by supporting a Multiple-level intervention integrating lung cancer screening and smoking cessation (MILS), followed the NIH DEIA strategies using multilevel interventions that impact determinants of health and address health disparities at appropriate time points across the life course.
Read the detailed description
African Americans have both the highest incidence and mortality of lung cancer compared to any other racial/ethnic group. A possible explanation for this disparity is that African Americans (AA) may be less likely to utilize preventative screenings such as Low-dose computed tomography (LDCT), which has the potential to encourage smokers to quit smoking successfully. In 2021, the USPSTF expanded their lung cancer screening (LCS) recommendations to include individuals ages 50-80 years with at least a 20 pack-year history, increasing the number of eligible U.S. adults. While the expanded criteria are expected to increase the number of high-risk individuals eligible for screening and reduce lung cancer mortality, the impact on racial and ethnic minorities, including African Americans, has shown mixed findings. This is problematic as previous research has found that African Americans may have different quit behaviors than whites. While use of LCS as a teachable moment for tobacco cessation is important, currently, there is no well- integrated, comprehensive, culturally relevant community-engaged, sustainable program. Still, it is not clear whether the synergy effect of smoking cessation and LDCT LCS intervention was observed in both quitting behaviors and LDCT uptake among African-American smokers. To address this urgent public health concern, this study aims to reduce disparities and the burden of lung cancer among AA smokers by supporting a Multiple-level intervention integrating lung cancer screening and smoking cessation(MILS), followed the NIH DEIA strategies using multilevel interventions that impact determinants of health and address health disparities at appropriate time points across the life course. Aim 1) Investigate smokers' and providers' attitudes, knowledge, and experiences with the expanded 2021 USPSTF LCS recommendations. Aim 2) Compare the effectiveness of a MILS vs. usual care on the biochemically-validated 7-day point-prevalence tobacco abstinence rates, LDCT uptake, nicotine dependence and stage of change was assessed. Aim 3) Explore barriers and facilitators that influence primary outcomes at the community, provider, and individual levels for the improvement of a multilevel intervention. To date, no study has evaluated the synergy effect of smoking cessation intervention and LDCT LCS in AA populations with multilevel strategies. We will move the field forward by providing effective, scalable interventions to improve both smoking cessation and LDCT lung cancer screening adherence to reduce health disparities promised by large clinical trials that motivated screening guidelines. The results of the study will directly guide the development of targeted strategies to improve lung cancer screening rates among minorities.
- Being tested
- Smoking cessation multilevel Intervention
- Keywords
- African American, Health Disparities, Lung Cancer Screening, Smoking Cessation, Tobacco Use, Low-Dose Computed Tomography, LDCT, Behavioral Intervention
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation multilevel InterventionBehavioural
The intervention will utilize a multilevel intervention based on the Social Ecological Model's individual, institutional, and community levels.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| Screening | Experimental | LDCT lung cancer screening Receives: Behavioral: Smoking cessation multilevel Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage of Change for Smoking Cessation
Stage of change in smoking cessation behavior
Measured: Baseline, immediately post-intervention, and 6-month follow-up
7-Day Point Prevalence Abstinence Rate
Proportion of participants reporting no smoking in the past 7 days
Measured: Baseline, immediately post-intervention, and 6-month follow-up
24-Hour Point Prevalence Abstinence Rate
Proportion of participants reporting no smoking in the past 24 hours
Measured: Baseline, immediately post-intervention, and 6-month follow-up
Daily Cigarette Consumption
Number of cigarettes smoked per day
Measured: Baseline, immediately post-intervention, and 6-month follow-up
Nicotine Dependence (Fagerström Test for Nicotine Dependence)
Nicotine dependence measured using the Fagerström Test for Nicotine Dependence (FTND), range 0-10, higher scores indicate greater dependence
Measured: Baseline, immediately post-intervention, and 6-month follow-up
Secondary outcomes (2)
Lung Cancer Screening (LDCT) Uptake
Completion of low-dose computed tomography (LDCT) lung cancer screening, assessed using a validated questionnaire.
Measured: Baseline, immediately post-intervention, 6 months
Intent to Undergo Lung Cancer Screening
Participant-reported intention to obtain lung cancer screening, assessed using a previously validated questionnaire.
Measured: Baseline, immediately post-intervention, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start17 Apr 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer ScreeningStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Group 1 will receive multiple levels intervention integrating lung cancer screening and smoking cessation (MILS). Group 2 will be a control group and receive treatment at a later date.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Tung Sung Tseng, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Tung Sung Tseng, DrPH, MS, Principal investigator, LSUHSC New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576595
- Sponsor's protocol ID
- 7750
- Other IDs
- 1R01MD019690-01
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ahmad, A., & Singh, J. (2022). Influence of Processes of Change on Stages of Change for Smoking Cessation. Journal of Applied Social Science, 16(1), 209-222. https://doi.org/10.1177/19367244211036994 Andritsou, M., Schoretsaniti, S., Litsiou, E., Saltagianni, V., Konstadara, K., Spiliotopoulou, A., Zakynthinos, S., & Katsaounou, P. (2016). Success rates are correlated mainly to completion of a smoking cessation program. European Respiratory Journal, 48. https://doi.org/10.1183/13993003.congress-2016.PA4599 Baker, T. B., Burris, J. L., & Fiore, M. C. (2022). Helping African American individuals quit smoking: Finally, some progress. JAMA, 327(22), 2192-2194. Baker, T. B., Mermelstein, R., Collins, L. M., Piper, M. E., Jorenby, D. E., Smith, S. S., Christiansen, B. A., Schlam, T. R., Cook, J. W., & Fiore, M. C. (2011). New methods for tobacco dependence treatment research. Annals of Behavioral Medicine, 41(2), pp.192-207. https://doi.org/10.1007/s12160-010-9252-y Collins, L. M., Baker, T. B., Mermelstein, R. J., Piper, M. E., Jorenby, D. E., Smith, S. S., ... & Fiore, M. C. (2011). The multiphase optimization strategy for engineering effective tobacco use interventions. Annals of Behavioral Medicine, 41(2), pp.208-226. Cornelius, M. E., Loretan, C. G., Jamal, A., Lynn, B. C. D., Mayer, M., Alcantara, I. C., & Neff, L. (2023). Tobacco Product Use Among Adults-United States, 2021. Morbidity and Mortality Weekly Report, 72(18), pg.475. Etter, J. F., Vu Duc, T., & Perneger, T. V. (1999). Validity of the Fagerström test for nicotine dependence and of the Heaviness of Smoking Index among relatively light smokers. Addiction (Abingdon, England), 94(2), 269-281. https://doi.org/10.1046/J.1360-0443.1999.94226910.X Fedewa, S. A., Kazerooni, E. A., Studts, J. L., Smith, R. A., Bandi, P., Sauer, A. G., ... & Silvestri, G. A. (2021). State variation in low-dose computed tomography scanning for lung cancer screening in the United States. Journal of the National Cancer Institute, 113(
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multilevel Integrated Intervention for LDCT Lung Cancer Screening and Smoking Cessation Among African Americans
- ClinicalTrials.gov ID
- NCT07576595
- Acronym / sponsor ID
- 7750
- Keywords
- African American, Health Disparities, Lung Cancer Screening, Smoking Cessation, Tobacco Use, Low-Dose Computed Tomography, LDCT, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 8 May 2026 (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 aims to reduce disparities and the burden of lung cancer among African American smokers by supporting a Multiple-level intervention integrating lung cancer screening and smoking cessation (MILS), followed the NIH DEIA strategies using multilevel interventions that impact determinants of health and address health disparities at appropriate time points across the life course.
Detailed description
African Americans have both the highest incidence and mortality of lung cancer compared to any other racial/ethnic group. A possible explanation for this disparity is that African Americans (AA) may be less likely to utilize preventative screenings such as Low-dose computed tomography (LDCT), which has the potential to encourage smokers to quit smoking successfully. In 2021, the USPSTF expanded their lung cancer screening (LCS) recommendations to include individuals ages 50-80 years with at least a 20 pack-year history, increasing the number of eligible U.S. adults. While the expanded criteria are expected to increase the number of high-risk individuals eligible for screening and reduce lung cancer mortality, the impact on racial and ethnic minorities, including African Americans, has shown mixed findings. This is problematic as previous research has found that African Americans may have different quit behaviors than whites. While use of LCS as a teachable moment for tobacco cessation is important, currently, there is no well- integrated, comprehensive, culturally relevant community-engaged, sustainable program. Still, it is not clear whether the synergy effect of smoking cessation and LDCT LCS intervention was observed in both quitting behaviors and LDCT uptake among African-American smokers. To address this urgent public health concern, this study aims to reduce disparities and the burden of lung cancer among AA smokers by supporting a Multiple-level intervention integrating lung cancer screening and smoking cessation(MILS), followed the NIH DEIA strategies using multilevel interventions that impact determinants of health and address health disparities at appropriate time points across the life course. Aim 1) Investigate smokers' and providers' attitudes, knowledge, and experiences with the expanded 2021 USPSTF LCS recommendations. Aim 2) Compare the effectiveness of a MILS vs. usual care on the biochemically-validated 7-day point-prevalence tobacco abstinence rates, LDCT uptake, nicotine dependence and stage of change was assessed. Aim 3) Explore barriers and facilitators that influence primary outcomes at the community, provider, and individual levels for the improvement of a multilevel intervention. To date, no study has evaluated the synergy effect of smoking cessation intervention and LDCT LCS in AA populations with multilevel strategies. We will move the field forward by providing effective, scalable interventions to improve both smoking cessation and LDCT lung cancer screening adherence to reduce health disparities promised by large clinical trials that motivated screening guidelines. The results of the study will directly guide the development of targeted strategies to improve lung cancer screening rates among minorities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1 will receive multiple levels intervention integrating lung cancer screening and smoking cessation (MILS). Group 2 will be a control group and receive treatment at a later date.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Screening | Experimental | Behavioral: Smoking cessation multilevel InterventionLDCT lung cancer screening |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- African American
- 20+ pack years of smoking
- eligible for or received LDCT screening
- current smoker
- English speaking
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Smoking cessation multilevel InterventionThe intervention will utilize a multilevel intervention based on the Social Ecological Model's individual, institutional, and community levels. | Behavioural | Screening |
Primary outcome
Stage of Change for Smoking Cessation
Time frame: Baseline, immediately post-intervention, and 6-month follow-up
Stage of change in smoking cessation behavior
7-Day Point Prevalence Abstinence Rate
Time frame: Baseline, immediately post-intervention, and 6-month follow-up
Proportion of participants reporting no smoking in the past 7 days
24-Hour Point Prevalence Abstinence Rate
Time frame: Baseline, immediately post-intervention, and 6-month follow-up
Proportion of participants reporting no smoking in the past 24 hours
Daily Cigarette Consumption
Time frame: Baseline, immediately post-intervention, and 6-month follow-up
Number of cigarettes smoked per day
Nicotine Dependence (Fagerström Test for Nicotine Dependence)
Time frame: Baseline, immediately post-intervention, and 6-month follow-up
Nicotine dependence measured using the Fagerström Test for Nicotine Dependence (FTND), range 0-10, higher scores indicate greater dependence
2 secondary outcomes
Lung Cancer Screening (LDCT) Uptake
Time frame: Baseline, immediately post-intervention, 6 months
Intent to Undergo Lung Cancer Screening
Time frame: Baseline, immediately post-intervention, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- BackgroundAhmad, A., & Singh, J. (2022). Influence of Processes of Change on Stages of Change for Smoking Cessation. Journal of Applied Social Science, 16(1), 209-222. https://doi.org/10.1177/19367244211036994 Andritsou, M., Schoretsaniti, S., Litsiou, E., Saltagianni, V., Konstadara, K., Spiliotopoulou, A., Zakynthinos, S., & Katsaounou, P. (2016). Success rates are correlated mainly to completion of a smoking cessation program. European Respiratory Journal, 48. https://doi.org/10.1183/13993003.congress-2016.PA4599 Baker, T. B., Burris, J. L., & Fiore, M. C. (2022). Helping African American individuals quit smoking: Finally, some progress. JAMA, 327(22), 2192-2194. Baker, T. B., Mermelstein, R., Collins, L. M., Piper, M. E., Jorenby, D. E., Smith, S. S., Christiansen, B. A., Schlam, T. R., Cook, J. W., & Fiore, M. C. (2011). New methods for tobacco dependence treatment research. Annals of Behavioral Medicine, 41(2), pp.192-207. https://doi.org/10.1007/s12160-010-9252-y Collins, L. M., Baker, T. B., Mermelstein, R. J., Piper, M. E., Jorenby, D. E., Smith, S. S., ... & Fiore, M. C. (2011). The multiphase optimization strategy for engineering effective tobacco use interventions. Annals of Behavioral Medicine, 41(2), pp.208-226. Cornelius, M. E., Loretan, C. G., Jamal, A., Lynn, B. C. D., Mayer, M., Alcantara, I. C., & Neff, L. (2023). Tobacco Product Use Among Adults-United States, 2021. Morbidity and Mortality Weekly Report, 72(18), pg.475. Etter, J. F., Vu Duc, T., & Perneger, T. V. (1999). Validity of the Fagerström test for nicotine dependence and of the Heaviness of Smoking Index among relatively light smokers. Addiction (Abingdon, England), 94(2), 269-281. https://doi.org/10.1046/J.1360-0443.1999.94226910.X Fedewa, S. A., Kazerooni, E. A., Studts, J. L., Smith, R. A., Bandi, P., Sauer, A. G., ... & Silvestri, G. A. (2021). State variation in low-dose computed tomography scanning for lung cancer screening in the United States. Journal of the National Cancer Institute, 113(
- Individual participant dataSharing planned: Yes
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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.
Tung Sung Tseng, DrPH, MS principal investigator
LSUHSC New Orleans
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation multilevel Intervention in people with Lung Cancer Screening and Tobacco Use Disorder, run by Louisiana State University Health Sciences Center in New Orleans at 2 sites 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Kassner, MS, MPH (504-568-5724, jkassn@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage of Change for Smoking Cessation (time frame: Baseline, immediately post-intervention, and 6-month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07576595, which also lists 1 linked publication.
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 11 May 2026.