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NCT Number: NCT07576595

Multilevel 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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LSUHSC School of Public Health, New Orleans, Louisiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

Smoking cessation multilevel Intervention

Behavioral

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

Primary outcomes

  1. Stage of Change for Smoking Cessation

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

    Stage of change in smoking cessation behavior

  2. 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

  3. 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

  4. Daily Cigarette Consumption

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

    Number of cigarettes smoked per day

  5. 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

Secondary outcomes

  1. Lung Cancer Screening (LDCT) Uptake

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

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

  2. Intent to Undergo Lung Cancer Screening

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Kassner, MS, MPH

CONTACT

[email protected]

504-568-5724

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Effectiveness of a Multilevel Integrated Intervention for LDCT Lung Cancer Screening and Smoking Cessation Among African Americans

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
May 8, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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