Smoking Cessation in Hispanic Construction Workers

University of Miami

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Other: Smoking Quitline Referral; Drug: Nicoderm CQ; Drug: Nicorette Gum; Behavioral: Behavioral Smoking Cessation Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02873377

1R21CA202993-01A1 (U.S. NIH Grant/Contract)

20140019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Enhanced Care

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Smoking Cessation Counseling

Drug: Nicoderm CQ

Drug: Nicorette Gum

Other: Smoking Quitline Referral

Standard Care

Active Comparator group

Description:

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.

Treatment:

Drug: Nicoderm CQ

Drug: Nicorette Gum

Other: Smoking Quitline Referral