Smoking Cessation in Hispanic Construction Workers

A Novel Worksite Smoking Cessation Intervention for Hispanic Construction Workers

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Nicorette Gum; Drug: Nicoderm CQ; Other: Smoking Quitline Referral; Behavioral: Behavioral Smoking Cessation Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Clinical Research Building University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced Care; Interventions: Nicorette Gum/Nicoderm CQ, Behavioral Smoking Cessation Counseling & Smoking Quitline Referral. Participants in the "Enhanced Care" intervention arm will receive a single face-to-face behavioral counseling session delivered at the construction site lunch truck, two brief follow-up phone counseling calls, fax referral to the Florida tobacco quitline (QL), and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants in will receive two follow-up phone assessments at 3-, and 6-months of enrollment.	Drug: Nicorette Gum; GlaxoSmithKline Nicorette Gum (nicotine replacement therapy); Other Names: NRT; Drug: Nicoderm CQ; GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy); Other Names: NRT; Other: Smoking Quitline Referral; Fax referral to the State smoking Quitline; Other Names: Quitline; Behavioral: Behavioral Smoking Cessation Counseling; One time face-to-face smoking cessation counseling and follow-up phone call; Other Names: Counseling
Active Comparator: Standard Care; Interventions: Nicorette Gum/Nicoderm CQ, Smoking Quitline Referral. The "Standard Care" group (NRT) will receive fax referral to the Florida QL and provision of up to 8 weeks of free Nicotine Replacement Therapy (up to 6 weeks provided by the study and 2 weeks provided by the QL). Participants will receive two follow-up phone assessments at 3-, and 6-months of enrollment.	Drug: Nicorette Gum; GlaxoSmithKline Nicorette Gum (nicotine replacement therapy); Other Names: NRT; Drug: Nicoderm CQ; GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy); Other Names: NRT; Other: Smoking Quitline Referral; Fax referral to the State smoking Quitline; Other Names: Quitline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolonged Abstinence Rates	Prolonged abstinence is defined as no smoking, not even a puff, after a grace period of two weeks after quit date. This will be assessed in follow up questionnaire and confirmed with saliva cotinine level of <15 ng/ml.	6-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-day Point- Prevalence Prolonged Abstinence Rate	Point prevalence abstinence rates is defined as self report of not smoking; in the past 7 days not even a puff) confirmed by saliva cotinine level of <15ng/ml.	6-month
Enrollment Rate	Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened.	Baseline
Quitline Response Rate	Quitline Response will be reported by the percentage of participants that contacted the Quitline, enrolled in the tobacco Quitline and the participants that completed at least 1 phone call from Tobacco Quitline.	6-month
Follow-Up Rate	Follow up rate will be reported as the percentage of participants that completed their follow up visit.	3-month, 6-month
Questionnaire Response Rate	Questionnaire response rate will be reported by the percentage of participants that completed the initial and follow up questionnaire.	6-month
Rate of Compliance to Intervention	Rate of compliance to intervention is reported as the percentage of participants who self-reported following intervention components at follow-up.	6-month
Change in Number of Cigarettes Smoked	For the participants that did not quit, the change in number of cigarettes smoked will be reported as the number of cigarettes smoked per day at the 6 months follow up visit minus the number of cigarettes smoked per day at baseline	Baseline, 6-month

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: David J Lee, PhD, University of Miami; Study Director: Taghrid Asfar, MD, University of Miami

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2017
• Primary Completion (Actual): October 11, 2018
• Study Completion (Actual): October 11, 2018

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): November 7, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Hispanics; Nicotine replacement therapy; Construction workers; Tobacco Quitline
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 20140019; 1R21CA202993-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No