Clinical trial NCT02873377
Conditions: Smoking Cessation
Keywords: Hispanics Construction workers Tobacco Quitline Nicotine replacement therapy
Sponsor: University of Miami
Start date: 2017-04-13; Completion date: 2018-10-11
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Nicorette Gum intervention 2: Nicoderm CQ intervention 3: Smoking Quitline Referral intervention 4: Behavioral Smoking Cessation Counseling
Intervention descriptions: intervention 1: GlaxoSmithKline Nicorette Gum (nicotine replacement therapy) intervention 2: GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy) intervention 3: Fax referral to the State smoking Quitline intervention 4: One time face-to-face smoking cessation counseling and follow-up phone call

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
Study Protocol and Analysis Plan 
A Novel Worksite Smoking 
Cessation Intervention for 
Hispanic Construction Workers 
Date: August 8, 2018 
NCT Number:  NCT02873377 


STUDY PROTOCOL AND ANALYSIS PLAN 
 
Page 1 of 15 
Revised: 8/8/18 
1) Protocol Title 
A Novel Worksite Smoking Cessation Intervention for Hispanic Construction 
Workers 
 
2) Objectives* 
The objective of this study is to develop a brief, culturally sensitive face-to-face 
smoking cessation intervention for Hispanic construction workers and conduct 
a pilot two-arm, cluster-randomized clinical trial (RCT) to test the developed 
intervention for acceptability and potential efficacy- A two-arm, cluster-
randomized controlled trial will be conducted with at least 14 construction sites 
(dependent on how many smokers can be recruited from each site), 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. Computer-generated random selection will be used to randomize 
construction sites. Then, construction sites will be randomly assigned to the 
intervention (enhanced care) or the control group (usual care), and study 
participants working in these sites will receive treatment accordingly. In 
conjunction with the site safety manger, we will recruit at least 126 adult Hispanic 
construction workers who smoke ≥5 cigarettes/day.  Participants in the enhanced 
care will receive one culturally adapted brief face-to-face behavioral counseling 
session developed in phase 1 and delivered during breaks, two brief follow-up 
phone counseling calls, fax referral to the Florida quitline (QL), and provision of up 
to 8 weeks of free NRT. Participants in the usual care will receive fax referral to the 
Florida QL, and provision of up to 8 weeks of free NRT. Main outcomes include: 1) 
estimating yield (number of workers available divided by number eligible; and 
number eligible divided by number randomized), 2) facilitators and barriers to 
delivering the intervention in the proposed setting, 3) willingness of participants to 
be randomized and acceptability of the intervention, 4) follow-up rates, response 
rates to questionnaires, adherence/compliance rates, and the time needed to collect 
and analyze data, 5) QL enrollment rates, and 6) exploring the willingness of the 
target population in involving in the research design and conduct. Potential efficacy 
outcomes include the difference in prolonged abstinence, and point-prevalence 
abstinence rates at 6-month follow up confirmed by saliva cotinine < 15ng/ml.  
 
This study will be the first to develop and evaluate a novel, low cost recruitment 
and intervention strategy in a hard-to-reach and underserved population of Hispanic 
male construction workers. Our data will inform a larger study of the effectiveness 
of cessation approaches that have great potential for translation and dissemination 
to minority construction workers throughout the US. 
 
3) Background* 
According to the US Surgeon General’s report, cigarette smoking causes more 
death and disability among American workers than their workplace environment 
(e.g., workplace injuries). Construction workers have the highest rate of smoking 
among all occupations, and are frequently exposed to a wide range of workplace 


STUDY PROTOCOL AND ANALYSIS PLAN 
 
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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). Given that construction 
trades remain overwhelmingly male dominated, male Hispanic workers constitute a 
large and increasing group in need for smoking cessation and health promotion. 
 
High mobility and turnover rates among construction workers are major challenges 
to delivering smoking cessation interventions.  An additional challenge is that 
cessation interventions have yet to be tailored culturally or to the often difficult 
work/life circumstances of minority construction workers, although culturally 
sensitive smoking cessation interventions are more effective in minority groups. 
Therefore, novel methods are needed to reach and intervene with this at-risk 
population. A novel approach that was recently piloted by our team, is to partner 
with the lunch truck that routinely visits construction sites to deliver brief, effective 
interventions. Further development and evaluation of this promising approach is 
warranted, and should meaningfully involve the target population in these efforts to 
optimize its cultural relevancy and potential for success and dissemination.  
 
Our approach is guided by recent developments in how to address smoking 
cessation in underserved smokers, defined as: 1) having high smoking rate and 
disproportionate tobacco-related health burden, 2) lacking access to effective 
treatment and/or barriers to treatment, and 3) being underrepresented in cessation 
clinical trials. This framework stresses the need for innovative approaches for 
underserved smokers based on cultural adaptation of evidence-based treatments. 
Guided by this framework, we have assembled a team with years of experience in 
smoking cessation development and work with minority construction workers in 
order to develop and pilot test a culturally sensitive smoking cessation intervention 
for Hispanic construction workers. 
 
4) Inclusion and Exclusion Criteria* 
• Inclusion criteria:  1) Hispanic male, 2) 18 years and older, 3) current 
smoker, 4) have access to a telephone, 5) have no plans to move in the 
next six months, 6) interested in making a serious quit attempt in the 
next 30 days, and 7) have no contraindication to NRT. 
• Exclusion criteria: 1) Inability to understand consent procedures, 2) 
non-Hispanic, 3) female, 4) under 18 years of age, 5) non-smoker, 6) 
not interested in making a serious quit attempt in the next 30 days, 7) 
no access to a telephone, and 8) have a contraindication to NRT. 
 


STUDY PROTOCOL AND ANALYSIS PLAN 
 
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5) Procedures Involved* 
 
Design- This study is a two-arm cluster RCT designed to evaluate the main outcomes 
and potential efficacy of the brief behavioral intervention developed in Phase 1 plus 
NRT, compared to referral to the State Quitline (QL). At least 14 construction sites 
will be randomly assigned into two groups: Enhanced Care (treatment group), and 
Usual Care (control group). Participants in the “Enhanced Care” intervention arm will 
receive a single face-to-face behavioral counseling session delivered at the 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 NRT (up to 6 weeks provided by 
the study and 2 weeks provided by the QL). The comparison group, called “Usual 
Care,” will receive fax referral to the Florida QL and provision of up to 8 weeks of 
free NRT (up to 6 weeks provided by the study and 2 weeks provided by the QL). 
Participants in both groups will receive two follow-up phone assessments at 3-, and 6-
months of enrolment. Information about number and time of total contact in both 
groups will be collected at 3- and 6-month follow-ups. 
 
Recruitment, Study Participants, and Procedures- Our target sample size is up to 150 
Hispanic smokers. We will coordinate with the safety managers of the participating 
construction sites to identify smokers who are interested in quitting smoking and 
arrange a visit to meet these workers. On day 1, two bilingual PH graduate assistants 
will approach these workers during their break to explain the study, complete the 
screening, and then obtain the consent form from those who are eligible. To 
participate in the study participant should be Hispanic male construction workers on 
site who are ≥ 18 year old and have smoked ≥ 5 cigarettes/day in the past year. 
Additionally, potential participants need to be available on site in the following two 
days, have access to telephone, have no plans to move in the next six months, and be 
interested in making a serious quit attempt in the next 30 days, and have no 
contraindication to NRT. Exhaled carbon monoxide levels and saliva cotinine will be 
tested among eligible participants to verify the self-reported smoking status. 
Individuals who decline to participate or who are ineligible (e.g., non-Hispanics, 
women) will be referred to the QL and provided with brochures that include 
information about the QL contact number and services. They will also be given a 
flyer about the UM Quitville smoking cessation study for which they may be eligible 
(only for English speakers). Those who are potentially eligible and interested in 
participating in the study will sign a consent form, then undergo a baseline screening 
to confirm eligibility and to collect information about: demographics, job 
characteristics, acculturation,41 smoking history, nicotine dependence,42 stages of 
change,43 quit ladder,44 smoking self-efficacy,45 depression,46 social support,47 
exposure to secondhand smoke, and quality of life. All questionnaires, informed 
consent, and educational materials will be available in English and Spanish and will 
be administrated by the bilingual graduate assistants. After completing the baseline 
assessment, a second visit in the following day will be scheduled to provide the 
intervention. If time does not permit to complete the entire baseline assessment, the 
exhaled carbon monoxide and saliva cotinine test, demographics and smoking 
behavior questions will be administered on-site and the remainder will be given to the 


STUDY PROTOCOL AND ANALYSIS PLAN 
 
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participant to be completed. Participants will receive a text-message reminder about 
the second visit at the evening. If time permits on the first day of recruitment to 
deliver the intervention, all aspects will be completed on that day rather than on day 
2. Dr. Asfar, who has years of experience in training and supervising cessation 
trials,37,38,48 will be responsible for the training of PH graduate students in recruitment 
and conduct of the cessation trial such as 1) human subjects protection, 2) 
consequences of smoking, 3) motivational strategies, 4) pharmacotherapies used in 
smoking cessation, and 5) the study’s protocol. Photographs and/or video may be 
taken during the sessions to be used for progress reports and presentations. 
 
Participants in the Usual Care will receive up to six week supply of NRT, brochures 
about the QL services, and will be referred to the QL using the “fax referral form”. 
Participants will be informed that the QL is free, and the QL counselor will work with 
them to devise a specific plan to quit smoking and will arrange the delivery of free 2-
week NRT for their quit attempt. Participants will have access to free NRT for a total 
of eight weeks (2-week supply from the QL, and 6-week supply from the study). 
 
Participants in the Enhanced Care will receive in addition to the above, a brief one 
face-to-face behavioral counseling session delivered at the “lunch truck”, and two 
brief follow-up phone calls. The face-to-face session will be an evidence-based 
intervention that is culturally adapted based on focus groups,17 and expected to 
feature three key processes: 1) preparing to quit, 2) the quitting process, and 3) 
relapse prevention and proper use of NRT.34 Additionally, participants will be given a 
“Patient Card” that summarizes “take home” messages for the most important points 
of each of the three phases. During the preparation-to-quit discussion, we will focus 
on reducing the number of cigarettes, stimulus control, and other quit preparation 
strategies (e.g., disposal of cigarettes before the quit date). We will also emphasize 
the importance of a quit date and discuss when a good quit date would be.34 During 
the quitting discussion, we will emphasize proper use of NRT, reinforce the use of 
NRT, and what to expect during the first few days of being a nonsmoker and how to 
cope. Finally, during the relapse prevention discussion, we will discuss the 5A’s for 
preventing relapse (Avoid high temptation situations, Alter those situations you can’t 
avoid, use Alternatives, Anticipate high risk situations, and become Active).34 The 
first phone call will occur one day before the quit date to remind participants about 
their quit date and provide more support, and the second will occur two weeks after 
quit date to review progress and skills to prevent relapse 
 
Nicotine Replacement Therapy (NRT)- Participants in both trial arms will receive a 
free supply of NRT to enhance their chances of quitting. Participants in the QL 
referral group will receive up to 8 (up to 6 weeks provided by the study and 2 weeks 
provided by the QL). Participants in the brief intervention group will receive a free up 
to 8 weeks supply of NRT after enrollment (up to 6 weeks provided by the study and 
2 weeks provided by the QL- type will depend on participants’’ preference elicited at 
focus groups). Participants will be provided information on the side effects of NRT 
and will receive detailed instructions regarding proper use. In addition, potential 
participants will be screened for NRT contraindications. Individuals will be 


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disqualified from the study if they report a history of hypersensitivity to nicotine, 
recent (past month) myocardial infarction, or any history of serious arrhythmias or 
unstable angina pectoris, consistent with Clinical Practice Guidelines. In addition, 
individuals will not be eligible if they have a generalized chronic dermatological 
disorder (e.g, psoriasis), a contraindication for patch use, unless they are able to use 
nicotine gum.  If there are no contraindications, participants will be given their 
preferred form and will be provided information on the side effects and proper use. 
Concomitant smoking and NRT use, as well as use of additional prescription and/or 
OTC NRT or cessation drugs (e.g., bupropion) will be tested at recruitment, and 3- 
and 6- month follow ups. 
 
Follow-up and Retention- Participants in both arms will receive two follow-up phone 
calls at 3 and 6 months after enrollment to assess their smoking status. Those who 
report quitting smoking at 6 months will be visited at a mutually agreed-upon location 
to obtain a saliva sample to validate their smoking cessation status using saliva 
cotinine< 15 ng/ml.50,51 Saliva samples will be collected using NicAlertTM kits and 
analyzed by automated gas liquid chromatography using nitrogen-phosphorus 
detection and structural analogues of cotinine as internal standards.52 To increase 
completion of the 6-month follow-ups, for those participants that we are unable to 
meet in person we will mail the NicAlertTM kits with instructions on how to complete 
and mail back to us.  
 
To maintain active participation for the entire length of the study, extensive retention 
measures will be taken. These include collecting detailed contact information for 
relatives/friends, who would know the participant's whereabouts, contacting 
participants with personalized letters/cards, sending out study-relevant information at 
3-month, and individual case management. Participants who complete all portions of 
the intervention will be given a $50 incentive. Twenty dollars will be provided after 
completing the first treatment session, and $30 at the 6-month follow-up assessment. 
 
Protocol for Retention - After the participant received the intervention for their 
assigned group, the follow-up phone calls will vary in number. In the Enhanced 
care, the participant will receive 4 phone calls in total. The first will be the day 
before the quit date and the second will be 2 weeks after the quit date to provide 
them with additional support. The last two phone calls will be a 3 and 6 month 
follow-up phone call to review their status. The Usual care will only receive 2 
phone calls after their intervention. These phone calls will be placed 3 months 
and 6 months after their quit date to review their smoking status. If the 
participants fail to be contacted at any of their scheduled dates, we will proceed 
as follows: 
 
Every participant will receive up to 10 phone calls to their preferred phone 
number. Throughout these 10 calls, voicemails will be left to remind the 
participant that we are trying to get in contact with them. Within the 10 phone 
calls, 2 text messages will be sent. One text after 5 calls and the second text after 
the 10 phone calls. In the text, we will encourage participant to call us back to get 


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more support regardless of their smoking status. After we have completed the 2 
text messages, the voicemails and the 10 phone calls, we will send a “thinking of 
you” letter to their house indicating that we are still interested in speaking to 
them to assess their progress and provide additional support at any step they 
may be in the process. We will stress that we are here to help them and to 
increase their chances of quitting smoking in the future. We will also remind 
them that they must keep in contact with us until the 6 month follow up to 
receive the additional $30. After 2 weeks of not hearing back from the date of the 
card being sent, we will begin to contact their references that were written down 
in the baseline survey. 
 
Sample Size: Major goals of this pilot study are to explore acceptability of our 
intervention. These data also will help us to estimate the intervention’s effect size to 
help determine sample size needs for a future full-scale RCT. We will follow the 
general rule of thumb and recruit at least 126 participants (63 per group) to estimate 
the parameters. We will use a two-group comparison of proportions at the two-tailed 
alpha level and assume that the intra-cluster correlation will be low (0.01). This 
sample size will allow us to detect a 22% difference between the two groups (a 
moderate effect size of 0.46) at the two-tailed 0.05 alpha with 80% power. Expecting 
20% attrition rate this will leave us with a sample of 51 subjects per group.  We will, 
however, include all randomized participants in assessment of endpoints.  We realize 
limitations of using pilot data to power subsequent studies, related to the inherent 
imprecision of estimates with small sample sizes. It is important to note, though, that 
our sample size is large enough to estimate the effect with a reasonably tight 
confidence interval, and we will not rely exclusively on this effect to estimate power, 
but will also make use of the extant literature.   
 
 
6) Data and Specimen Banking* 
The following self-reported measures will be obtained specifically for research 
purposes.  These data will be stored in stored on a password-protected computer 
accessed only by approved study personnel. 
 
i. 
Demographic Data and Work Characteristics:  This will include:  Age, 
ethnicity, native borne, non native born, acculturation, income, education, 
health insurance status, and job activities. 
 
ii. 
Fagerstrom Test for Nicotine Dependence (FTND):  All participants will 
be given the FTND to assess nicotine dependence.  This instrument has 
been widely tested and used in smoking studies.   
 
iii. 
Tobacco Use History:  This will include: age when the participant began 
smoking, number of years as a smoker, the number of cigarettes smoked 
per day, whether the participant had made a quit attempt in the last year, 
the number of past year quit attempts, and the number of last year 
successful quit attempts (defined as being quit for at least one month).  


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iv. 
Depressive Symptomatology: will be assessed with the Center for 
Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977; Thomas 
et al., 2001).    
 
v. 
Additional measures such as: social support, smoking self-efficacy, 
nicotine dependence FTND, stages of change, quit ladder, exposure to 
secondhand smoke, and Hatsukami withdrawal scale will be also 
collected.  
 
vi. 
Medication Side Effects, Adverse Events and Participant Adherence:  
These will all be monitored on study participants throughout the study.  
These will be reported to the study’s PI and co-investigators for 
appropriate follow-up. 
 
vii. 
Concomitant Medication Use or Behavior Therapy During Follow-up 
Visits:  The use of additional gum, patch, nicotine nasal spray, inhaler or 
lozenge, or antidepressants prescribed for smoking cessation will be 
monitored as they can affect cessation rates.  Participation, in additional 
behavioral cessation programs, will also be carefully tracked for this 
reason. 
viii. 
Saliva cotinine: For participants claiming via self-report that they have 
quit smoking at 6-month follow up, we will obtain biomedical validation 
using salivary cotinine. The saliva cotinine test is noninvasive with 
virtually no risks.  This involves providing saliva. Participants will be 
visited at a mutually agreed-upon location to obtain a saliva sample. This 
procedure will be explained during administration of consent as well as in 
detail, during the 6- month follow up phone interview. Note that in the 
event that participants (a) report they are not smoking, but (b) refuse to 
provide a saliva sample, they will be considered smokers. A monetary 
incentive of $30 will be given to participants at 6-month follow-up after 
completing of the test. 
 
7) Data Management* 
Outcome Measures- This pilot study aims to explore the acceptability potential and 
efficacy of the developed intervention compared to QL. Main outcomes include: 1) 
estimating yield (number of workers available divided by number eligible; and 
number eligible divided by number randomized), 2) facilitators and barriers to 
delivering the intervention in the proposed setting, 3) willingness of participants to be 
randomized and acceptability of the intervention, 4) follow-up rates and response 
rates to questionnaires, adherence/compliance rates, and the time needed to collect 
and analyze data, and 5) exploring the “willingness” of the target population to be 
involved in the research design and conduct.60-62 Potential efficacy outcomes will 
focus on comparing prolonged abstinence (defined as no smoking, not even a puff, 
after a grace period of two weeks after quit date), and point-prevalent abstinence 
(defined as self-report of not smoking in the past 7-days; not even a puff) confirmed 


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by saliva cotinine level of <15ng/ml at 6-month between the two study arms. For 
individuals who do not quit entirely, the decrease in smoking (i.e., cigarettes/day) will 
be assessed.63,64 Relapse is defined as smoking at least once/week on two consecutive 
weeks.65 Secondary outcome measures will focus on differences in stage of 
change/readiness to quit,66 and treatment adherence according to intervention 
assignment.37 
 
All participant data will be coded with an identification number and only approved 
personnel will have access to the key linking identification numbers with participant 
names.  Data will be stored and managed in REDCap and accessed only by approved 
study personnel. Paper interview instruments will be stored in a locked filing cabinet.  
 
Quality Assurance- Our research team is well versed in quality assurance processes for 
intervention studies.44,45,59 Following the strategy suggested by Sechrest,69 evaluation 
of any treatment program should involve satisfactory answers to three questions: 1) 
was the intervention both standardized and delivered as intended to the participant? 2) 
if so, did the participants receive it? and 3) if so, was the intervention efficacious in 
changing behavior? Sechrest's 3rd question involves the evaluation of outcomes, which 
is outlined in the Data Analysis section below. However, Sechrest's 1st and 2nd 
questions address treatment implementation issues. To ensure standardization of 
intervention 
content 
and 
delivery, 
we 
will 
use 
standardized 
treatment 
manuals/procedures developed particularly for this study. Participants will respond to 
a brief questionnaire at baseline and the 3- and 6- month follow-up to assess whether 
key points were learned, including the techniques and information discussed in the 
intervention sessions. Standard procedures will be used for instrument development, 
protocol and forms, and data management (e.g. entry, reconciliation, updating, and data 
security and confidentiality). Additionally, we will audiotape a random sample of 10% 
of counseling sessions for review and feedback. Participants will be asked for 
permission to audiotape these selected sessions as part of the consent process. 
 
Data Analysis 
The analyses of the outcomes were mainly descriptive. Chi-square tests and between-
group t-tests were used to compare between-group differences in baseline 
characteristics, and indices of treatment implementation, adherence, and retention. 
Intra-class correlation coefficients were used to adjust for clustering within sites.55 This 
adjustment accounted for within-site clustering of workers characteristics at each of the 
17 participating sites in the trial. Chi-square tests were used to compare cessation rates 
in the two arms. Analyses were performed on an intention-to-treat basis, with 
individuals with missing outcome data or self-reported abstinence not confirmed by 
eCO at 6-month follow-up classified as not quit. Logistic regression analyses were 
conducted to assess baseline predictors of prolonged abstinence at 6-months.   
 
 
8) Risks to Subjects* 
Potential risks and adverse effects of the study medication will be explained to each 
participant when informed consent is obtained.  Each participant will be instructed to 


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keep a record and notify the center of any potential adverse effects, illnesses, or 
hospitalizations.  Potential risks to study participants may include: 
 
i. 
Randomization:  Although it is expected that both the study treatments will 
be beneficial, it is possible that the treatment a participant is assigned to 
may later be shown to be less effective.   
 
ii. 
Nicotine Withdrawal:  Smoking cessation is associated with a variety of 
nicotine withdrawal symptoms including: depressed mood, difficulty 
sleeping, irritability, anxiety, difficulty concentrating, restlessness, and 
increased appetite or weight gain.  These symptoms are typically not severe 
and dissipate within a few weeks of cessation, with the exception of weight 
gain, which may persist for up to one year. 
 
iii. 
NRT Use: type of NRT will depend on participants’’ preference elicited at 
phase 1 (focus groups).  
 
Nicotine Patch Use:  Although most persons do not experience any major adverse 
effects from the nicotine patch, it is possible that a participant could experience any 
of the following side effects.  All participants will be questioned or evaluated for 
these specific side effects at each session. 
a. Skin erythema, pruritus, edema, burning, and rash at the 
application site of the patch 
b. Dizziness, dry mouth 
c. Arthralgia, myalgia, back pain 
d. Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, 
nausea, vomiting 
e. Impaired concentration, depression, headache, insomnia, 
abnormal dreams, nervousness 
f. Cough, sinusitis 
g. Allergy to nicotine 
h. Cardiovascular side effects (cardiac arrhythmia, tachycardia, 
vasospasm, elevated blood pressure) 
 
Nicotine Gum Use:  Although most persons do not experience any major adverse 
effects from the nicotine gum, it is possible that a participant could experience any of 
the following side effects.  All participants will be questioned or evaluated for these 
specific side effects at each follow-up visit. 
a. Mouth soreness.  Very rare; probability of occurrence is low 
and risk is low. 
b. Hiccups.  This typically occurs through improper use of the 
gum.  If participants report this, we work on how they are using 
the gum.  Probability is common in those who misuse the gum; 
risk is low 
c. Dyspepsia.  Probability and risk is low. 
d. Jaw ache.  Probability and risk is low. 


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Although these adverse events have been reported in those who use NRT, they have 
been infrequent and are less likely to be observed in persons who are regular cigarette 
smokers.  In addition, many of these same symptoms are reported by persons who quit 
smoking without NRT, and have been attributed to nicotine withdrawal from smoking 
cessation. 
 
9) Potential Benefits to Subjects* 
Participants will benefit by being involved in a no-cost program that may help them 
to quit smoking, reducing their risk for a variety of health conditions.  Given the 
substantial potential benefits and the minimal risks for participants involved in this 
project, it is felt that the benefits significantly outweigh the possible risks. 
 
10) 
Recruitment Methods 
Two bilingual (English, Spanish) public health graduate students will approach 
construction workers either at their morning or noon food break at multiple 
construction sites in South Florida in partnership with the lunch truck service. Using a 
verbal consent script, potential participants will be asked if they are interested in 
participating in our study.  If they agree, they will asked a series of questions to 
determine whether they are eligible (Hispanic male construction workers who are ≥ 
18 year old and have smoked ≥ 5 cigarettes/day in the past year). Additionally, 
potential participants need to have access to telephone, have no plans to move in the 
next six months, and be interested in making a serious quit attempt in the next 30 
days. Individuals who decline to participate will still be encouraged to quit smoking, 
and given a list of available cessation resources. Those willing to participate but who 
are ineligible (e.g., non-Hispanics, women) will be referred to the QL and provided 
with brochures that include information about the QL contact number and services. 
Those who are potentially eligible and interested in participating in the study will be 
consented, then undergo a baseline screening to confirm eligibility and to collect 
information. All questionnaires, informed consent, and educational materials will be 
available in English and Spanish and will be administrated by the bilingual graduate 
assistants.  
 
11) 
Local Number of Subjects 
We seek to enroll up to 150 participants who are eligible according to the 
inclusion criteria. 
 
To avoid intervention contamination within participating construction 
worksites, the RCT design will be a two-group cluster randomized design with 
seven sites per group. Our resources for this R21 allow seven subjects per 
group. We assume that the intra-cluster correlation will be low (0.01). We will 
use a two-group comparison of proportions at the two-tailed alpha level. 
Assuming that 10%-15% of the control group and 25% of the intervention 
group respond to the intervention, we will have 23% power to detect a 10% 
difference and 50% power to detect a 15% difference. To achieve 80% power 


STUDY PROTOCOL AND ANALYSIS PLAN 
 
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Revised: 8/8/18 
for a 10% and 15% difference under the same assumptions would require 
sample sizes of 64 and 16 subjects per site, respectively. 
 
12) 
Confidentiality 
Participant names will be replaced with ID numbers and a key linking the two will be 
kept separate from other data and accessed only by Drs. Lee and Asfar. Survey data 
will be stored on Dropbox and accessible only by approved study personnel. Survey 
data from the RCT will stored and managed in REDCap. These data will be stored for 
the duration of the study protocol and until all data analysis is complete and 
manuscripts have been published. 
 
13) 
Provisions to Protect the Privacy Interests of Subjects 
Participants will interact with only a limited number of approved study personnel and 
will be assured that their personal information will be kept private, will be used only 
for research purposes, and will not be accessible to non-study personnel. 
 
14) 
Consent Process 
Verbal consent will first be obtained after potential participants are screened on site. 
Those who verbally consent will then sign a written consent before the intervention 
begins.  Because we are recruiting Hispanic participants the consent documents will 
be available in both English and Spanish. 
 
 
 


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