NCT07576595

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Apr 2025Jun 2030

Study Start

First participant enrolled

April 17, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

May 8, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

April 24, 2026

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • Lung Cancer Screening (LDCT) Uptake

    Baseline, immediately post-intervention, 6 months

  • Intent to Undergo Lung Cancer Screening

    Baseline, immediately post-intervention, 6 months

Study Arms (2)

Control

NO INTERVENTION

No intervention

Screening

EXPERIMENTAL

LDCT lung cancer screening

Behavioral: Smoking cessation multilevel Intervention

Interventions

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

Screening

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

LSUHSC School of Public Health

New Orleans, Louisiana, 70112, United States

RECRUITING

University Medical Center

New Orleans, Louisiana, 70112, United States

RECRUITING

Related Publications (1)

  • 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(

    BACKGROUND

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Tung Sung Tseng, DrPH, MS

    LSUHSC New Orleans

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Kassner, MS, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 8, 2026

Study Start

April 17, 2025

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2030

Last Updated

May 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Locations