This clinical trial evaluates different workplace smoking cessation programs to determine which is best at improving quit rates among construction workers. Cigarette smoking poses a significant health risk for construction workers. The smoking rate among construction workers is double that of the general population, and almost half of construction workers are racial/ethnic minorities, with low income and limited access to smoking cessation services. Smoking cessation programs often use different approaches to assist the participant to quit. These can include the use of a tobacco quitline (TQL), behavioral counseling sessions, or nicotine replacement therapy (NRT). The TQL provides tobacco cessation counseling over the phone in which a health professional provides education, recommendations, or interventions to help clients stop using tobacco products. Behavioral counseling sessions seek to identify and help change potentially self-destructive or unhealthy behaviors. NRT uses an agent, such as gum, that systemically delivers nicotine with the intent to reduce the urge to smoke or to chew tobacco. Offering smoking cessation programs in the workplace may help to improve quit rates among construction workers.
Additional locations may be listed on ClinicalTrials.gov for NCT06098144.
Locations matching your search criteria
United States
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer CenterStatus: Active
Contact: Taghrid Asfar
Phone: 305-243-3826
PRIMARY OBJECTIVE:
I. To identify the optimal adaptive smoking cessation program for the construction sector in terms of effectiveness, cost-effectiveness, and potential implementation.
OUTLINE:
STUDY 1 (DEVELOPMENT AND TESTING IMPLEMENTATION STRATEGIES): Participants complete surveys throughout the study and may complete 3 semi-structured interviews over 20-30 minutes to develop and test the workplace smoking cessation programs on study.
STUDY 2 (SEQUENTIAL, MULTIPLE ASSIGNMENT, RANDOMIZED TRIAL):
PHASE 1: Participants are randomized to 1 of 2 groups.
GROUP A1: Participants complete 3 tobacco cessation counseling sessions via the TQL and receive up to 12 weeks of NRT gum.
GROUP B1: Participants complete 3 tobacco cessation counseling sessions via the TQL and 1 behavioral group counseling session over 20 minutes on study. Participants also receive 2 brief follow ups, either in person or over the phone, 1 day before quit date and 2 weeks after quit date. Additionally, participants also receive up to 18 weeks of NRT gum.
PHASE 2: Participants who quit smoking at the 3-month assessment continue to receive the same treatment group as in Phase 1. Participants that did not quit smoking at 3-month assessment, are re-randomized to 1 of 3 groups.
GROUP A2: Participants receive the same intervention as in phase 1/group A1.
GROUP B2: Participants receive the same intervention as in phase 1/group B1.
GROUP C: Participants receive an extra 6-week free supply of NRT gum and complete 4 behavioral counseling sessions over 20 minutes on study. Participants also receive 2 brief follow ups, either in person or over the phone, 6 and 8 weeks after quit date.
All participants also undergo carbon monoxide breath test and may undergo collection of saliva samples throughout the study.
After completion of study intervention, participants are followed up at 3, 6, 9, and 12 months after enrollment.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorTaghrid Asfar
