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Recruiting NCT07576595

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

No phase Interventional Lung Cancer Screening Tobacco Use Disorder Smoking Cessation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smoking cessation multilevel Intervention.
Who it may be relevant to
Registry conditions: Lung Cancer Screening, Tobacco Use Disorder, Smoking Cessation. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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

Primary outcome measures

  • Stage of Change for Smoking Cessation [Time frame: Baseline, immediately post-intervention, and 6-month follow-up]
  • 7-Day Point Prevalence Abstinence Rate [Time frame: Baseline, immediately post-intervention, and 6-month follow-up]
  • 24-Hour Point Prevalence Abstinence Rate [Time frame: Baseline, immediately post-intervention, and 6-month follow-up]
  • Daily Cigarette Consumption [Time frame: Baseline, immediately post-intervention, and 6-month follow-up]
  • Nicotine Dependence (Fagerström Test for Nicotine Dependence) [Time frame: Baseline, immediately post-intervention, and 6-month follow-up]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • N/A

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • LSUHSC School of Public Health — New Orleans
  • University Medical Center — New Orleans

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 smo

Identifiers

NCT: NCT07576595 · 7750 · 1R01MD019690-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗