Smoking Cessation in Hispanic Construction Workers

Phase 4

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Nicorette Gum; Drug: Nicoderm CQ; Other: Smoking Quitline Referral; Behavioral: Behavioral Smoking Cessation Counseling

• Registration Number: NCT02873377
• Lead Sponsor: University of Miami

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Study Start: 2017-04-13
• Primary Completion: 2018-10-11
• Study Completion: 2018-10-11
• Status Verified: 2019-10
• Results First Submitted: 2019-10-03
• Results First Submitted QC: 2019-10-03
• Results First Posted: 2019-10-24
• Last Update Submitted: 2019-10-24
• Last Update Posted: 2019-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 134

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)).

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Care	Nicorette Gum	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.
Standard Care	Nicorette Gum	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.
Enhanced Care	Behavioral Smoking Cessation Counseling	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.
Standard Care	Smoking Quitline Referral	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.
Enhanced Care	Nicoderm CQ	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.
Enhanced Care	Smoking Quitline Referral	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.
Standard Care	Nicoderm CQ	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.

Primary Outcome Measures

Name	Time	Method
Prolonged Abstinence Rates	6-month	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.

Secondary Outcome Measures

Name	Time	Method
7-day Point- Prevalence Prolonged Abstinence Rate	6-month	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.
Quitline Response Rate	6-month	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.
Enrollment Rate	Baseline	Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened.
Follow-Up Rate	3-month, 6-month	Follow up rate will be reported as the percentage of participants that completed their follow up visit.
Change in Number of Cigarettes Smoked	Baseline, 6-month	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
Questionnaire Response Rate	6-month	Questionnaire response rate will be reported by the percentage of participants that completed the initial and follow up questionnaire.
Rate of Compliance to Intervention	6-month	Rate of compliance to intervention is reported as the percentage of participants who self-reported following intervention components at follow-up.

Trial Locations

Locations (1)

Clinical Research Building University of Miami; 🇺🇸 Miami, Florida, United States