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RecruitingNCT07576595Updated May 11, 2026

Multilevel Intervention for LDCT Lung Cancer Screening and Smoking Cessation Among African Americans

An interventional study of Smoking cessation multilevel Intervention in Lung Cancer Screening, Tobacco Use Disorder and Smoking Cessation, sponsored by Louisiana State University Health Sciences Center in New Orleans. Recruiting at 2 sites in United States. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Louisiana State University Health Sciences Center in New Orleans · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Lung Cancer Screening
  • Tobacco Use Disorder
  • Smoking Cessation

Keywords

  • African American
  • Health Disparities
  • Lung Cancer Screening
  • Smoking Cessation
  • Tobacco Use
  • Low-Dose Computed Tomography
  • LDCT
  • Behavioral Intervention
03

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • African American
  • 20+ pack years of smoking
  • eligible for or received LDCT screening
  • current smoker
  • English speaking

Exclusion criteria

Exclusion Criteria:

  • N/A
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • No intervention
    Control

    No intervention

  • Experimental
    Screening

    LDCT lung cancer screening

    Behavioral: Smoking cessation multilevel Intervention

Interventions

  • BehavioralSmoking cessation multilevel Intervention

    The intervention will utilize a multilevel intervention based on the Social Ecological Model's individual, institutional, and community levels.

05

What researchers measure

Primary outcomes

  1. Stage of Change for Smoking Cessation

    Stage of change in smoking cessation behavior

    Time frame: Baseline, immediately post-intervention, and 6-month follow-up

  2. 7-Day Point Prevalence Abstinence Rate

    Proportion of participants reporting no smoking in the past 7 days

    Time frame: Baseline, immediately post-intervention, and 6-month follow-up

  3. 24-Hour Point Prevalence Abstinence Rate

    Proportion of participants reporting no smoking in the past 24 hours

    Time frame: Baseline, immediately post-intervention, and 6-month follow-up

  4. Daily Cigarette Consumption

    Number of cigarettes smoked per day

    Time frame: Baseline, immediately post-intervention, and 6-month follow-up

  5. 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

    Time frame: Baseline, immediately post-intervention, and 6-month follow-up

Secondary outcomes

  1. Lung Cancer Screening (LDCT) Uptake

    Completion of low-dose computed tomography (LDCT) lung cancer screening, assessed using a validated questionnaire.

    Time frame: Baseline, immediately post-intervention, 6 months

  2. Intent to Undergo Lung Cancer Screening

    Participant-reported intention to obtain lung cancer screening, assessed using a previously validated questionnaire.

    Time frame: Baseline, immediately post-intervention, 6 months

06

Study locations

2 of 2 sites recruiting
  • LSUHSC School of Public Health
    New Orleans, Louisiana 70112, United States
    Recruiting
  • University Medical Center
    New Orleans, Louisiana 70112, United States
    Recruiting
07

References and documents

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 documents

  • Study protocol · Jan 6, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

08

Registry details

Key details

Study ID
NCT07576595
Lead sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Responsible party
Tung Sung Tseng (Associate Professor, Louisiana State University Health Sciences Center in New Orleans) — Principal investigator
First posted
May 8, 2026
Start date
Apr 17, 2025
Primary completion
Jun 2029 (estimated)
Completion
Jun 2030 (estimated)
Last update
May 11, 2026

Study contacts

Jessica Kassner, MS, MPH
Contact
jkassn@lsuhsc.edu
504-568-5724
Tung Sung Tseng, DrPH, MS
principal investigator · LSUHSC New Orleans

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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