Smoking Cessation in Hispanic Construction Workers

Smoking Cessation Clinical Trial

Official title:

A Novel Worksite Smoking Cessation Intervention for Hispanic Construction Workers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873377
• Other study ID #: 20140019
• Secondary ID: 1R21CA202993-01A
• Status: Completed
• Phase: Phase 4
• Start date: April 13, 2017
• Est. completion date: October 11, 2018

Study information

• Verified date: October 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: October 11, 2018
• Est. primary completion date: October 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nicorette Gum
GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
• Nicoderm CQ
GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)

Other:
• Smoking Quitline Referral
Fax referral to the State smoking Quitline

Behavioral:
• Behavioral Smoking Cessation Counseling
One time face-to-face smoking cessation counseling and follow-up phone call

Locations

Country	Name	City	State
United States	Clinical Research Building University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Enrollment Rate	Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened.	Baseline
Secondary	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
Secondary	Follow-Up Rate	Follow up rate will be reported as the percentage of participants that completed their follow up visit.	3-month, 6-month
Secondary	Questionnaire Response Rate	Questionnaire response rate will be reported by the percentage of participants that completed the initial and follow up questionnaire.	6-month
Secondary	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
Secondary	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