Smoking Cessation Program in the Construction Sector

Study Overview
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Brief Summary
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The main objective of this study is to identify the optimal adaptive smoking cessation program for the construction sector in terms of effectiveness, cost-effectiveness, and potential implementation.

Official Title
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Expanding the Role of the Safety Manager to Implement a Workplace Smoking Cessation Program in the Construction Sector

Conditions
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Smoking Cessation, Tobacco Use Cessation, Tobacco Smoking

Intervention / Treatment
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* Drug: Nicoderm C-Q Gum
* Behavioral: Tobacco Quit-line
* Behavioral: Brief Behavioral Counseling
* Behavioral: Intensive Behavioral Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Company leaders: ≥ 18 years Involved in decision making Willing to participate in the implementation development and evaluation Safety Managers: ≥ 18 years Be a safety manager No plans to leave the company within the next year Bilingual Willing to receive training in smoking cessation treatment Willing to deliver the smoking cessation treatment to workers Construction Workers: ≥ 18 years Have smoked 5 or more cigarettes daily for the past year Willing to make a serious quit attempt in the next 30 days Planning to stay in the company for the next 12 months Own a telephone and plan to keep it active for the next 12 months Exclusion Criteria: Safety Managers: - Current cigarette smoker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster-randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tobacco Quit-line (TQL) Group<br>Participants will be referred to the TQL and will be followed up for up to 12 months. | Behavioral: Tobacco Quit-line<br>* The TQL is free, and the TQL counselor will provide three phone counseling sessions lasting approximately 15 minutes to devise a specific plan to quit smoking and arrange the delivery of 4 to 12 weeks of NRT based on need. Participants will be advised to request nicotine gums instead of patches to accommodate their job circumstances.<br>|
| Experimental: Brief Behavioral Counseling Group<br>Participants will receive one brief behavioral counseling session and be followed up for 12 months. | Drug: Nicoderm C-Q Gum<br>* Participants will receive an 8-week supply of nicotine replacement treatment (NRT). Based on participants' self-report on the number of cigarettes smoked, these are the possible dosages of NRT gum (2 mg and 4 mg). Participants should not smoke and use the nicotine gum at the same time. Nicotine gum should only be used when cravings for cigarettes arise and should not be treated like regular chewing gum. It is not to be constantly chewed NRT will be distributed based on the treatment condition.<br>Behavioral: Tobacco Quit-line<br>* The TQL is free, and the TQL counselor will provide three phone counseling sessions lasting approximately 15 minutes to devise a specific plan to quit smoking and arrange the delivery of 4 to 12 weeks of NRT based on need. Participants will be advised to request nicotine gums instead of patches to accommodate their job circumstances.<br>Behavioral: Brief Behavioral Counseling<br>* The counseling session will discuss preparing to quit, coping with job-related stress, getting social support, the 5A's for preventing relapse (Avoid, Alter, Alternatives, Anticipate, and Active), proper use of NRT, and last approximately 30 minutes.<br>|
| Experimental: Intensive Behavioral Counseling Group<br>Participants will receive four behavioral counseling sessions and be followed up for 12 months. | Drug: Nicoderm C-Q Gum<br>* Participants will receive an 8-week supply of nicotine replacement treatment (NRT). Based on participants' self-report on the number of cigarettes smoked, these are the possible dosages of NRT gum (2 mg and 4 mg). Participants should not smoke and use the nicotine gum at the same time. Nicotine gum should only be used when cravings for cigarettes arise and should not be treated like regular chewing gum. It is not to be constantly chewed NRT will be distributed based on the treatment condition.<br>Behavioral: Intensive Behavioral Counseling<br>* Participants will receive four weekly counseling sessions which include information about how to quit, challenges, and short and long-term relapse prevention. Each session will last approximately 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program Effectiveness Measure in Percentage | Will be collected as the difference in percentage of participants who quit smoking at the 12-month follow-up assessment between the three treatment groups. | Up to 4 years | 
| Program Cost-Effectiveness Measured by Number of U.S Dollars | Will be measured as the difference in the number of U.S. dollars between the three programs. | Up to 4 years | 
| Program Cost-Effectiveness Measured by Quality Adjusted Life Years | Will be measured by quality-adjusted life years defined as the difference in the number of years lived in perfect health between the three programs. | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program's Implementation- Acceptability Measured by Likert Scale | Using the Acceptability of Intervention Measure, acceptability will be scored on a 5-point Likert scale, with higher scores indicating greater acceptability. | Up to 4 years | 
| Program's Implementation- Feasibility Measured by Likert Scale | Using the Feasibility of Intervention Measure, feasibility will be scored on a 5-point Likert scale, with higher scores indicating greater feasibility. | Up to 4 years | 
| Program's Implementation- Sustainability Measured by Likert Scale | Using the Intervention Sustainability Assessment Tool, sustainability will be scored on a 7-point Likert scale, with higher scores indicating greater sustainability. | Up to 4 years |