Smoking Cessation in Hispanic Construction Workers

NCT02873377 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 201400191R21CA202993-01A1
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

Hispanics; Construction workers; Tobacco Quitline; Nicotine replacement therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 7-day Point- Prevalence Prolonged Abstinence Rate

  6-month

• Enrollment Rate

  Baseline

• Quitline Response Rate

  6-month

• Follow-Up Rate

  3-month, 6-month

• Questionnaire Response Rate

  6-month

Study Arms (2)

Enhanced Care

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

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; Drug: Nicoderm CQ; Other: Smoking Quitline Referral

Interventions

Nicorette Gum DRUG

GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)

Also known as: NRT

Enhanced Care; Standard Care

Nicoderm CQ DRUG

GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)

Also known as: NRT

Enhanced Care; Standard Care

Smoking Quitline Referral OTHER

Fax referral to the State smoking Quitline

Also known as: Quitline

Enhanced Care; Standard Care

Behavioral Smoking Cessation Counseling BEHAVIORAL

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

Also known as: Counseling

Enhanced Care

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Miami: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Clinical Research Building University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (3)

• Asfar T, Arheart KL, McClure LA, Ruano-Herreria EC, Dietz NA, Ward KD, Caban-Martinez AJ, Samano Martin Del Campo D, Lee DJ. Implementing a Novel Workplace Smoking Cessation Intervention Targeting Hispanic/Latino Construction Workers: A Pilot Cluster Randomized Trial. Health Educ Behav. 2021 Dec;48(6):795-804. doi: 10.1177/1090198120960395. Epub 2020 Oct 16.

  PMID: 33063570 DERIVED

• Asfar T, McClure LA, Arheart KL, Ruano-Herreria EC, Gilford CG Jr, Moore K, Dietz NA, Ward KD, Lee DJ, Caban-Martinez AJ. Integrating Worksite Smoking Cessation Services Into the Construction Sector: Opportunities and Challenges. Health Educ Behav. 2019 Dec;46(6):1024-1034. doi: 10.1177/1090198119866900. Epub 2019 Aug 19.

  PMID: 31426671 DERIVED

• Asfar T, Caban-Martinez AJ, McClure LA, Ruano-Herreria EC, Sierra D, Gilford Clark G Jr, Samano D, Dietz NA, Ward KD, Arheart KL, Lee DJ. A cluster randomized pilot trial of a tailored worksite smoking cessation intervention targeting Hispanic/Latino construction workers: Intervention development and research design. Contemp Clin Trials. 2018 Apr;67:47-55. doi: 10.1016/j.cct.2018.02.007. Epub 2018 Feb 14.

  PMID: 29454141 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Chewing Gum; Nicotine; Counseling

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Therapeutics; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Taghrid Asfar
• Organization: University of Miami

tasfar@med.miami.edu

305-243-3826

Study Officials

• David J Lee, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Taghrid Asfar, MD

  University of Miami

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Study arms will be conducted simultaneously.

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 19, 2016
• Study Start: April 13, 2017
• Primary Completion: October 11, 2018
• Study Completion: October 11, 2018
• Last Updated: November 7, 2019
• Results First Posted: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)