Smoking Cessation
Conditions
Keywords
Hispanics, Construction workers, Tobacco Quitline, Nicotine replacement therapy
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.
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.
Interventions
DRUGNicorette Gum
GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
DRUGNicoderm CQ
GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
OTHERSmoking Quitline Referral
Fax referral to the State smoking Quitline
BEHAVIORALBehavioral Smoking Cessation Counseling
One time face-to-face smoking cessation counseling and follow-up phone call
Sponsors
National Cancer Institute (NCI)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study arms will be conducted simultaneously.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prolonged Abstinence Rates | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate | Baseline | Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened. |
| Quitline Response Rate | 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. |
| Follow-Up Rate | 3-month, 6-month | Follow up rate will be reported as the percentage of participants that completed their follow up visit. |
| 7-day Point- Prevalence Prolonged Abstinence Rate | 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. |
| Rate of Compliance to Intervention | 6-month | Rate of compliance to intervention is reported as the percentage of participants who self-reported following intervention components at follow-up. |
| Change in Number of Cigarettes Smoked | 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 |
| Questionnaire Response Rate | 6-month | Questionnaire response rate will be reported by the percentage of participants that completed the initial and follow up questionnaire. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 65 |
| 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 | 69 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period Title 2: 3 Months Follow up | Lost to Follow-up | 22 | 22 |
| Period Title 3: 6 Months Follow up | Lost to Follow-up | 15 | 23 |
Baseline characteristics
| Characteristic | Standard Care | Total | Enhanced Care |
|---|---|---|---|
| Age, Continuous | 38.2 years STANDARD_DEVIATION 1.4 | 39.5 years STANDARD_DEVIATION 1.8 | 40.9 years STANDARD_DEVIATION 1.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 69 Participants | 134 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 57 Participants | 115 Participants | 58 Participants |
| Race (NIH/OMB) White | 10 Participants | 16 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 69 Participants | 134 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 69 |
| other Total, other adverse events | 0 / 65 | 0 / 69 |
| serious Total, serious adverse events | 0 / 65 | 0 / 69 |
Outcome results
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.
Time frame: 6-month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Care | Prolonged Abstinence Rates | 36.00 Percentage of participants |
| Standard Care | Prolonged Abstinence Rates | 30.43 Percentage of participants |
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.
Time frame: 6-month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Care | 7-day Point- Prevalence Prolonged Abstinence Rate | 36.00 Percentage of participants |
| Standard Care | 7-day Point- Prevalence Prolonged Abstinence Rate | 30.43 Percentage of participants |
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
Time frame: Baseline, 6-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Care | Change in Number of Cigarettes Smoked | -13.5 Cigarettes smoked per day | Standard Deviation 1.5 |
| Standard Care | Change in Number of Cigarettes Smoked | -11.5 Cigarettes smoked per day | Standard Deviation 1.3 |
Secondary
Enrollment Rate
Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened.
Time frame: Baseline
Population: Number of workers screened
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enhanced Care | Enrollment Rate | Eligible Participants | 85.9 Percentage of participants |
| Enhanced Care | Enrollment Rate | Randomized participants | 85.9 Percentage of participants |
Secondary
Follow-Up Rate
Follow up rate will be reported as the percentage of participants that completed their follow up visit.
Time frame: 3-month, 6-month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enhanced Care | Follow-Up Rate | 3-month follow-up | 66.15 Percentage of participants |
| Enhanced Care | Follow-Up Rate | 6-month follow-up | 76.92 Percentage of participants |
| Standard Care | Follow-Up Rate | 3-month follow-up | 68.12 Percentage of participants |
| Standard Care | Follow-Up Rate | 6-month follow-up | 66.67 Percentage of participants |
Secondary
Questionnaire Response Rate
Questionnaire response rate will be reported by the percentage of participants that completed the initial and follow up questionnaire.
Time frame: 6-month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enhanced Care | Questionnaire Response Rate | completed initial questionnaire | 93.85 Percentage of participants |
| Enhanced Care | Questionnaire Response Rate | Completed follow-up questionnaire | 76.92 Percentage of participants |
| Standard Care | Questionnaire Response Rate | completed initial questionnaire | 88.41 Percentage of participants |
| Standard Care | Questionnaire Response Rate | Completed follow-up questionnaire | 66.67 Percentage of participants |
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.
Time frame: 6-month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enhanced Care | Quitline Response Rate | Contacted by tobacco Quitline | 49.2 Percentage of participants |
| Enhanced Care | Quitline Response Rate | Enrolled in tobacco Quitline | 29.23 Percentage of participants |
| Enhanced Care | Quitline Response Rate | Completed at least 1 phone calls from tobacco QL | 23.08 Percentage of participants |
| Standard Care | Quitline Response Rate | Contacted by tobacco Quitline | 40.6 Percentage of participants |
| Standard Care | Quitline Response Rate | Enrolled in tobacco Quitline | 23.19 Percentage of participants |
| Standard Care | Quitline Response Rate | Completed at least 1 phone calls from tobacco QL | 11.59 Percentage of participants |
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.
Time frame: 6-month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enhanced Care | Rate of Compliance to Intervention | Counseling session + 2 phone calls | 43.08 Percentage of participants |
| Enhanced Care | Rate of Compliance to Intervention | 4 Quitline counseling sessions | 6.15 Percentage of participants |
| Enhanced Care | Rate of Compliance to Intervention | 6 weeks NRT | 93.85 Percentage of participants |
| Enhanced Care | Rate of Compliance to Intervention | 2 weeks NRT from Quitline | 15.38 Percentage of participants |
| Standard Care | Rate of Compliance to Intervention | 2 weeks NRT from Quitline | 13.04 Percentage of participants |
| Standard Care | Rate of Compliance to Intervention | Counseling session + 2 phone calls | 88.40 Percentage of participants |
| Standard Care | Rate of Compliance to Intervention | 6 weeks NRT | 88.41 Percentage of participants |
| Standard Care | Rate of Compliance to Intervention | 4 Quitline counseling sessions | 2.9 Percentage of participants |