Smoking Cessation in Hispanic Construction Workers

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-13

Study Completion Date

2018-10-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study arms will be conducted simultaneously.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Nicorette Gum

Intervention Type DRUG

GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)

Nicoderm CQ

Intervention Type DRUG

GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)

Smoking Quitline Referral

Intervention Type OTHER

Fax referral to the State smoking Quitline

Behavioral Smoking Cessation Counseling

Intervention Type BEHAVIORAL

One time face-to-face smoking cessation counseling and follow-up phone call

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.

Group Type ACTIVE_COMPARATOR

Nicorette Gum

Intervention Type DRUG

GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)

Nicoderm CQ

Intervention Type DRUG

GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)

Smoking Quitline Referral

Intervention Type OTHER

Fax referral to the State smoking Quitline

Interventions

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Nicorette Gum

GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)

Intervention Type DRUG

Nicoderm CQ

GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)

Intervention Type DRUG

Smoking Quitline Referral

Fax referral to the State smoking Quitline

Intervention Type OTHER

Behavioral Smoking Cessation Counseling

One time face-to-face smoking cessation counseling and follow-up phone call

Intervention Type BEHAVIORAL

Other Intervention Names

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NRT NRT Quitline Counseling

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes