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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07576595
Enrollment
250
Registered
2026-05-08
Start date
2025-04-17
Completion date
2030-06-01
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer Screening, Smoking Cessation, Tobacco Use Disorder

Keywords

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

Brief 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.

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.

Interventions

BEHAVIORALSmoking cessation multilevel Intervention

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

Sponsors

Louisiana State University Health Sciences Center in New Orleans
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Stage of Change for Smoking CessationBaseline, immediately post-intervention, and 6-month follow-upStage of change in smoking cessation behavior
7-Day Point Prevalence Abstinence RateBaseline, immediately post-intervention, and 6-month follow-upProportion of participants reporting no smoking in the past 7 days
24-Hour Point Prevalence Abstinence RateBaseline, immediately post-intervention, and 6-month follow-upProportion of participants reporting no smoking in the past 24 hours
Daily Cigarette ConsumptionBaseline, immediately post-intervention, and 6-month follow-upNumber of cigarettes smoked per day
Nicotine Dependence (Fagerström Test for Nicotine Dependence)Baseline, immediately post-intervention, and 6-month follow-upNicotine dependence measured using the Fagerström Test for Nicotine Dependence (FTND), range 0-10, higher scores indicate greater dependence

Secondary

MeasureTime frameDescription
Lung Cancer Screening (LDCT) UptakeBaseline, immediately post-intervention, 6 monthsCompletion of low-dose computed tomography (LDCT) lung cancer screening, assessed using a validated questionnaire.
Intent to Undergo Lung Cancer ScreeningBaseline, immediately post-intervention, 6 monthsParticipant-reported intention to obtain lung cancer screening, assessed using a previously validated questionnaire.

Countries

United States

Contacts

CONTACTJessica Kassner, MS, MPH
jkassn@lsuhsc.edu504-568-5724
PRINCIPAL_INVESTIGATORTung Sung Tseng, DrPH, MS

LSUHSC New Orleans

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026