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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA202993-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicorette Gum | Drug | GlaxoSmithKline Nicorette Gum (nicotine replacement therapy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Enrollment Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J Lee, PhD | University of Miami | Principal Investigator |
| Taghrid Asfar, MD | University of Miami | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Building University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33063570 | Derived | 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. | |
| 31426671 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy) Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy) Smoking Quitline Referral: Fax referral to the State smoking Quitline Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call |
| FG001 | 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. Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy) Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy) Smoking Quitline Referral: Fax referral to the State smoking Quitline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Enrollment |
| |||||||||||||
| Period Title 2: 3 Months Follow up |
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| Period Title 3: 6 Months Follow up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy) Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy) Smoking Quitline Referral: Fax referral to the State smoking Quitline Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Percentage of participants | 6-month |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy) Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy) Smoking Quitline Referral: Fax referral to the State smoking Quitline Behavioral Smoking Cessation Counseling: One time face-to-face smoking cessation counseling and follow-up phone call |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taghrid Asfar | University of Miami | 305-243-3826 | tasfar@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2018 | Oct 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000074164 | Nicotine Chewing Gum |
| D009538 | Nicotine |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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Study arms will be conducted simultaneously.
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| Nicoderm CQ | Drug | GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy) |
|
|
| Smoking Quitline Referral | Other | Fax referral to the State smoking Quitline |
|
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| Behavioral Smoking Cessation Counseling | Behavioral | One time face-to-face smoking cessation counseling and follow-up phone call |
|
|
Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened.
| Baseline |
| 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 |
| Follow-Up Rate | Follow up rate will be reported as the percentage of participants that completed their follow up visit. | 3-month, 6-month |
| Questionnaire Response Rate | 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 | 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 | 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 |
| 29454141 | 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. |
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| NOT COMPLETED |
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| BG001 | 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. Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy) Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy) Smoking Quitline Referral: Fax referral to the State smoking Quitline |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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. Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy) Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy) Smoking Quitline Referral: Fax referral to the State smoking Quitline |
|
|
| 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. | Posted | Number | Percentage of participants | 6-month |
|
|
|
| Secondary | Enrollment Rate | Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened. | Number of workers screened | Posted | Number | Percentage of participants | 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. | Posted | Number | Percentage of participants | 6-month |
|
|
|
| Secondary | Follow-Up Rate | Follow up rate will be reported as the percentage of participants that completed their follow up visit. | Posted | Number | Percentage of participants | 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. | Posted | Number | Percentage of participants | 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. | Posted | Number | Percentage of participants | 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 | Posted | Mean | Standard Deviation | Cigarettes smoked per day | Baseline, 6-month |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | 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. Nicorette Gum: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy) Nicoderm CQ: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy) Smoking Quitline Referral: Fax referral to the State smoking Quitline | 0 | 69 | 0 | 69 | 0 | 69 |
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| Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061485 | Tobacco Use Cessation Devices |
| D013812 | Therapeutics |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Completed at least 1 phone calls from tobacco QL |
|
| 4 Quitline counseling sessions |
|
| 2 weeks NRT from Quitline |
|