Smoking Cessation in Hispanic Construction Workers

October 24, 2019 updated by: David Lee, PhD, University of Miami

A Novel Worksite Smoking Cessation Intervention for Hispanic Construction Workers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Clinical Research Building University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Nicorette Gum
GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Other Names:
  • NRT
Drug: Nicoderm CQ
GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Other Names:
  • NRT
Other: Smoking Quitline Referral
Fax referral to the State smoking Quitline
Other Names:
  • Quitline
Behavioral: Behavioral Smoking Cessation Counseling
One time face-to-face smoking cessation counseling and follow-up phone call
Other Names:
  • Counseling
Active Comparator: 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.
Drug: Nicorette Gum
GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
Other Names:
  • NRT
Drug: Nicoderm CQ
GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
Other Names:
  • NRT
Other: Smoking Quitline Referral
Fax referral to the State smoking Quitline
Other Names:
  • Quitline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prolonged Abstinence Rates
Time Frame: 6-month
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
7-day Point- Prevalence Prolonged Abstinence Rate
Time Frame: 6-month
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
Time Frame: Baseline
Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened.
Baseline
Quitline Response Rate
Time Frame: 6-month
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
Time Frame: 3-month, 6-month
Follow up rate will be reported as the percentage of participants that completed their follow up visit.
3-month, 6-month
Questionnaire Response Rate
Time Frame: 6-month
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
Time Frame: 6-month
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
Time Frame: Baseline, 6-month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David J Lee, PhD, University of Miami
  • Study Director: Taghrid Asfar, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20140019
  • 1R21CA202993-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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