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

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Tobacco Use Disorder; Lung Cancer Screening
• Intervention / Treatment: Behavioral: Smoking cessation multilevel Intervention

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 Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Kassner, MS, MPH; Phone Number: 504-568-5724; Email: jkassn@lsuhsc.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention
Experimental: Screening; LDCT lung cancer screening	Behavioral: Smoking cessation multilevel Intervention; The intervention will utilize a multilevel intervention based on the Social Ecological Model's individual, institutional, and community levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage of Change for Smoking Cessation	Stage of change in smoking cessation behavior	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	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	Baseline, immediately post-intervention, and 6-month follow-up
Daily Cigarette Consumption	Number of cigarettes smoked per day	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	Baseline, immediately post-intervention, and 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Cancer Screening (LDCT) Uptake	Completion of low-dose computed tomography (LDCT) lung cancer screening, assessed using a validated questionnaire.	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.	Baseline, immediately post-intervention, 6 months

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Tung Sung Tseng, DrPH, MS, LSUHSC New Orleans

Publications and helpful links

General 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 record dates

Study Major Dates

• Study Start (Actual): April 17, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: African American; Tobacco Use; Smoking Cessation; Behavioral Intervention; Health Disparities; LDCT; Lung Cancer Screening; Low-Dose Computed Tomography
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Health Behavior; Tobacco Use Disorder; Smoking Cessation; Tobacco Use
• Other Study ID Numbers: 7750 (Fred Hutch/University of Washington Cancer Consortium); 1R01MD019690-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No