Clinical trial NCT02873377: Smoking Cessation in Hispanic Construction Workers
Official title: A Novel Worksite Smoking Cessation Intervention for Hispanic Construction Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: Hispanics
Construction workers
Tobacco Quitline
Nicotine replacement therapy
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-08-19
Enrollment: 134
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study arms will be conducted simultaneously.
Primary purpose: TREATMENT

Brief summary: Construction workers have the highest rate of smoking among all occupations, and are frequently exposed to a wide range of workplace hazards (e.g. toxins), which interact with smoking to increase their health risks. Minority construction workers, in particular, have higher smoking and lower cessation rates compared to other groups, and they generally show lower access and participation in cessation and health promotion services. The number of Hispanic workers employed in the construction industry in the US has tripled in the past decade to 2.6 million (23% of all construction workers). This study will develop, administer, and evaluate a novel smoking cessation program in a hard-to-reach and underserved population of Hispanic male construction workers using using pilot cluster randomized clinical trial (RCT) to test the developed intervention for feasibility and potential efficacy.

Detailed description: A two-arm, cluster-randomized controlled trial will be conducted with up to 15 construction sites, selected from one Construction Company in south Florida. Cluster randomization is used with construction site chosen as the unit of allocation because it is most practical in this setting and minimizes the risk of spillover effects from the intervention to the control group. In conjunction with the site's safety manager, the investigators will recruit 9 adult Hispanic construction workers per site (126 total) who smoke ≥5 cigarettes/day in the last year. Participants in the enhanced care will receive one culturally adapted brief face-to-face behavioral counseling session developed in phase 1 and delivered at a lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida quitline (QL), and provision of up to 6 weeks of free NRT. Participants in the standard care will receive fax referral to the Florida QL, and provision of up to 8 weeks of free NRT.

Eligibility criteria: Inclusion Criteria:

* Hispanic
* Construction worker
* Have smoked ≥ 5 cigarettes/day in the past year.
* Have access to telephone
* Have no plans to move in the next six months
* Are interested in making a serious quit attempt in the next 30 days
* Have no contraindication to NRT (e.g., history of hypersensitivity to nicotine, recent (past month) myocardial infarction, any history of serious arrhythmias or unstable angina pectoris, chronic dermatological disorder (e.g., psoriasis)).

Exclusion Criteria:

* Inability to understand consent procedures
* Not Hispanic
* Not a construction worker
* Haven't smoked ≥ 5 cigarettes/day in the past year.
* No access to telephone
* Has plans to move in the next six months
* Not interested in making a serious quit attempt in the next 30 days
* Has a contraindication to NRT
* Has a generalized chronic dermatological disorder (e.g., psoriasis)

Primary outcomes:
measure: Prolonged Abstinence Rates
timeFrame: 6-month
Secondary outcomes:
measure: 7-day Point- Prevalence Prolonged Abstinence Rate
timeFrame: 6-month
measure: Enrollment Rate
timeFrame: Baseline
measure: Quitline Response Rate
timeFrame: 6-month
measure: Follow-Up Rate
timeFrame: 3-month, 6-month
measure: Questionnaire Response Rate
timeFrame: 6-month
measure: Rate of Compliance to Intervention
timeFrame: 6-month
measure: Change in Number of Cigarettes Smoked
timeFrame: Baseline, 6-month
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Research Building University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: David J Lee, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Taghrid Asfar, MD
role: STUDY_DIRECTOR
References:
citation: Asfar T, Arheart KL, McClure LA, Ruano-Herreria EC, Dietz NA, Ward KD, Caban-Martinez AJ, Samano Martin Del Campo D, Lee DJ. Implementing a Novel Workplace Smoking Cessation Intervention Targeting Hispanic/Latino Construction Workers: A Pilot Cluster Randomized Trial. Health Educ Behav. 2021 Dec;48(6):795-804. doi: 10.1177/1090198120960395. Epub 2020 Oct 16.
citation: Asfar T, McClure LA, Arheart KL, Ruano-Herreria EC, Gilford CG Jr, Moore K, Dietz NA, Ward KD, Lee DJ, Caban-Martinez AJ. Integrating Worksite Smoking Cessation Services Into the Construction Sector: Opportunities and Challenges. Health Educ Behav. 2019 Dec;46(6):1024-1034. doi: 10.1177/1090198119866900. Epub 2019 Aug 19.
citation: Asfar T, Caban-Martinez AJ, McClure LA, Ruano-Herreria EC, Sierra D, Gilford Clark G Jr, Samano D, Dietz NA, Ward KD, Arheart KL, Lee DJ. A cluster randomized pilot trial of a tailored worksite smoking cessation intervention targeting Hispanic/Latino construction workers: Intervention development and research design. Contemp Clin Trials. 2018 Apr;67:47-55. doi: 10.1016/j.cct.2018.02.007. Epub 2018 Feb 14.