- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07576595
Multilevel Intervention for LDCT Lung Cancer Screening and Smoking Cessation Among African Americans
7 maj 2026 uppdaterad av: Tung Sung Tseng, Louisiana State University Health Sciences Center in New Orleans
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
250
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jessica Kassner, MS, MPH
- Telefonnummer: 504-568-5724
- E-post: jkassn@lsuhsc.edu
Studieorter
-
-
Louisiana
-
New Orleans, Louisiana, Förenta staterna, 70112
- Rekrytering
- University Medical Center
-
New Orleans, Louisiana, Förenta staterna, 70112
- Rekrytering
- LSUHSC School of Public Health
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- African American
- 20+ pack years of smoking
- eligible for or received LDCT screening
- current smoker
- English speaking
Exclusion Criteria:
- N/A
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Kontrollera
Inget ingripande
|
|
|
Experimentell: Screening
LDCT lung cancer screening
|
The intervention will utilize a multilevel intervention based on the Social Ecological Model's individual, institutional, and community levels.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Stage of Change for Smoking Cessation
Tidsram: Baseline, immediately post-intervention, and 6-month follow-up
|
Stage of change in smoking cessation behavior
|
Baseline, immediately post-intervention, and 6-month follow-up
|
|
7-Day Point Prevalence Abstinence Rate
Tidsram: Baseline, immediately post-intervention, and 6-month follow-up
|
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
Tidsram: Baseline, immediately post-intervention, and 6-month follow-up
|
Proportion of participants reporting no smoking in the past 24 hours
|
Baseline, immediately post-intervention, and 6-month follow-up
|
|
Daily Cigarette Consumption
Tidsram: Baseline, immediately post-intervention, and 6-month follow-up
|
Number of cigarettes smoked per day
|
Baseline, immediately post-intervention, and 6-month follow-up
|
|
Nicotine Dependence (Fagerström Test for Nicotine Dependence)
Tidsram: 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
|
Baseline, immediately post-intervention, and 6-month follow-up
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Lung Cancer Screening (LDCT) Uptake
Tidsram: Baseline, immediately post-intervention, 6 months
|
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
Tidsram: Baseline, immediately post-intervention, 6 months
|
Participant-reported intention to obtain lung cancer screening, assessed using a previously validated questionnaire.
|
Baseline, immediately post-intervention, 6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Tung Sung Tseng, DrPH, MS, LSUHSC New Orleans
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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(
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
17 april 2025
Primärt slutförande (Beräknad)
1 juni 2029
Avslutad studie (Beräknad)
1 juni 2030
Studieregistreringsdatum
Först inskickad
24 april 2026
Först inskickad som uppfyllde QC-kriterierna
30 april 2026
Första postat (Faktisk)
8 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 maj 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 7750 (Fred Hutch/University of Washington Cancer Consortium)
- 1R01MD019690-01 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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