Smoking Cessation in Hispanic Construction Workers

Study Overview
=================
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.

Official Title
-----------------
A Novel Worksite Smoking Cessation Intervention for Hispanic Construction Workers

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: Nicorette Gum
* Drug: Nicoderm CQ
* Other: Smoking Quitline Referral
* Behavioral: Behavioral Smoking Cessation Counseling


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study arms will be conducted simultaneously.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Care<br>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<br>* GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)<br>* Other names: NRT;Drug: Nicoderm CQ<br>* GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)<br>* Other names: NRT;Other: Smoking Quitline Referral<br>* Fax referral to the State smoking Quitline<br>* Other names: Quitline;Behavioral: Behavioral Smoking Cessation Counseling<br>* One time face-to-face smoking cessation counseling and follow-up phone call<br>* Other names: Counseling;|
| Active Comparator: Standard Care<br>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<br>* GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)<br>* Other names: NRT;Drug: Nicoderm CQ<br>* GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)<br>* Other names: NRT;Other: Smoking Quitline Referral<br>* Fax referral to the State smoking Quitline<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hispanics, Construction workers, Tobacco Quitline, Nicotine replacement therapy