Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Trial
Phase: NA
Conditions: Smoking Cessation
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

MCC# 18633 
 
Expanding the reach of a validated smoking-cessation intervention: A Spanish-language trial. 
 
 
 
 
Sponsor: NIH &  Florida Department of Health: James and Esther King Biomedical Research Program 
 
Multiple Principal Investigators: 
Vani Nath Simmons, Ph.D. 
 
Thomas H. Brandon, Ph.D. 
 
 
Co-Investigators: 
Cathy Meade Ph.D.  
 
 
 
Statistician: 
Steven Sutton, Ph.D. 
 
 
 
 
Protocol Version: 13 
Date: 10/30/2018 

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Tobacco smoking is the leading preventable cause of cancer mortality. 
Pharmacotherapy and behavioral counseling have demonstrated independent and additive effects toward 
aiding smoking cessation; however, counseling is rarely chosen by smokers. In contrast, minimal self-help 
interventions, such as smoking cessation pamphlets or booklets have much wider potential reach, yet their 
efficacy has been largely disappointing, with incremental abstinence rates averaging only 1%. Given the 
high dissemination potential, any significant improvement in the efficacy of self-help would have large 
public health impact with respect to smoking and smoking-related illness and mortality. 
 
A notable exception to the historically poor efficacy of self-help has been the extended self-help 
smoking interventions developed by our research team.  Originally developed to prevent post-cessation 
relapse to smoking, these booklets entitled, Forever Free, significantly reduced smoking relapse through 
two years of follow-up among individuals who had recently quit smoking.  In addition, the intervention was 
found to be extremely cost-effective. Based on its efficacy and cost-effectiveness, we expanded the 
intervention to include initial smoking cessation as well as relapse prevention, 18 months of contact, and a 
written social support component.  Results of a recently completed National Cancer Institute (NCI) funded 
trial of this intervention, Forever Free: Stop Smoking for Good, revealed high efficacy throughout the 24- 
month follow-up period, further supporting the utility of extended self-help for promoting and maintaining 
tobacco abstinence. We recognize, however, that wide-scale implementation, and therefore public health 
impact, would be enhanced the availability of a Spanish-language version to reach the largest and fastest 
growing ethnic minority population of smokers. 
 
The current smoking prevalence among Hispanic/Latino adults varies by cultural subgroup, with 
highest prevalence among those of Puerto Rican (35%, men; 33% women) and Cuban origins (31%, 30%) 
and lowest among Dominicans (11%, 12%). Greater smoking prevalence is also associated with lower 
income and education, and greater US acculturation. Prior work by our research team and others has 
demonstrated that Hispanic/Latino smokers face unique challenges such as lower awareness and 
acceptability of nicotine replacement therapies and receiving less assistance with smoking cessation from 
their health providers. As highlighted in the Clinical Practice Guidelines for Treating Tobacco Use and 
Dependence, additional research is needed to develop and validate interventions for racial and ethnic 
minority smokers. 
 
The goal of this study is to address this gap by testing a Spanish-language version of the validated 
self-help smoking cessation intervention. If demonstrated effective, the proposed intervention would 
represent an easily disseminable and low-cost intervention with significant public health impact for 
Hispanic/Latino smokers throughout the United States. The aims of this project are to test the efficacy of a 
Spanish-language version of a validated, extended self-help intervention for smoking cessation among 
Spanish-speaking smokers against usual care control. Participants (N = 1400) recruited nationally will be 
randomized to the two arms. 
 
 
Specific Aim 1:  To test the efficacy of a Spanish-language extended self-help intervention 
compared to usual care. 
 
Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-
SP) intervention distributed over 18 months.  Those in the second arm, Usual Care (UC), will receive a 
single, credible, NCI-produced Spanish-language self-help booklet. Outcomes will be assessed through 24 
months. 
 
Hypothesis 1: The SS-SP booklets, compared with UC, will produce higher rates of tobacco abstinence that 

3 
 
will be maintained through the 24-month assessment. 
 
 
Secondary Aim: To evaluate moderator variables that may aid in refining and targeting of the 
intervention to maximize impact. 
 
Demographic moderator variables include gender, age, income, country of origin, and generational status.  
Psychological moderators include nicotine dependence, acculturation, cessation motivation, trait affect, and 
cessation self-efficacy.  Moderator analyses will be exploratory, without strong a priori hypotheses. 
 
 
Public Health Significance: This would be the first study to test a Spanish-language adaptation of a 
validated and easily implemented self-help smoking cessation intervention in a nation-wide RCT, with the 
potential to reduce ethnic health disparities associated with tobacco smoking. 

4 
 
B. SIGNIFICANCE 
B1. Smoking Burden and Cessation 
Tobacco smoking is responsible for approximately 400,000 premature deaths annually in the United 
States, and 5 million worldwide, with causal links to cancers at 18 different organ sites, as well as coronary 
heart disease, chronic obstructive pulmonary disease, cardiovascular disease, and stroke (CDC, 2008; 
Rostron, 2013; USDHHS, 2014).  Despite the well-known health consequences of smoking and the benefits 
of quitting (Jha et al., 2013), 18% of American adults continue to smoke (CDC, 2014) primarily because they 
have developed dependence to nicotine, the major psychoactive substance in tobacco.  Smoking-related 
mortality is a distal consequence of this substance dependence. Therefore, the treatment of tobacco 
(nicotine) dependence remains a public health priority of paramount significance.  The U.S. Public Health 
Service (USPHS) Clinical Practice Guidelines for Treating Tobacco Use and Dependence (Fiore et al., 2008) 
and the CDC’s Healthy People 2020 (USDHHS, 2014) draw greater attention to key risk factors for tobacco 
use and associated disease and mortality, including race/ethnicity and socioeconomic status. There is need 
for the development and delivery of smoking cessation interventions for special populations of smokers, 
including ethnic and racial minority groups, who incur high mortality rates related to smoking-related 
diseases. 
B2. Self-Help Approaches to Smoking Cessation 
Self-help refers to very minimal intensity types of interventions, such as print and electronic media 
provided to smokers.  Because few smokers seek more intensive interventions, self-help materials have the 
potential for high public health impact if they can reach large numbers of smokers and aid them in achieving 
cessation. Their ease of administration and distribution maximizes the Adoption, Implementation, and 
Maintenance variables within the RE-AIM model of implementation (Glasgow et al., 1999; Glasgow, 
Lichtenstein, & Marcus, 2003).  Curry et al. (2003) summarized the appealing features of self- help manuals, 
including: (1) They package state-of-the-art, cognitive-behavioral intervention components in a format that 
can be disseminated. (2) Distribution can occur through a variety of channels at a relatively low cost. (3) 
Smokers can customize program recommendations to their specific needs and interests. (4) Written 
materials are easy to keep so that smokers can refer back to them or use them again in a future quit attempt.  
Unfortunately, recent meta-analyses indicate little efficacy for self-help interventions. Both the Clinical 
Practice Guidelines (Fiore et al., 2008) and a Cochrane Review (Hartmann-Boyce et al., 2014) concluded 
that self-help materials have at best marginal efficacy, improving cessation rates by about 1% compared to 
no-treatment controls. 
In summary, self-help interventions have potential for vast reach, but their public health impact has 
been limited by low efficacy.  This contrasts with greater efficacy, but much poorer reach, of intensive 
behavioral interventions (Fiore et al., 2008).  A logical goal is to develop self- help interventions with high 
reach that draw upon cognitive-behavioral counseling to enhance their efficacy. Toward this goal, our team 
has developed several efficacious self-help tobacco interventions over the past decade, as described in 
section B3. 
B3. The “Forever Free” Self-Help Interventions 
B3.1. Smoking Relapse Prevention. To achieve the goal of increasing the efficacy of self-help, our 
research team made two very significant changes to the typical self-help approach.  First, we initially 
focused on the prevention of smoking relapse. Second, rather than a single brief self-help intervention (e.g., 
a pamphlet), we developed an extended self-help intervention—specifically, an evidence based, eight 
booklet series entitled, Forever Free, delivered over the course of a year. The content of these booklets was 
based on cognitive- behavioral theory (e.g., Bandura, 1977; Marlatt, 1985) and empirical evidence regarding 
the nature of tobacco dependence, cessation, and relapse (e.g., Baker et al., 2004). The booklets were 
conceptualized as a means of translating the cognitive-behavioral counseling that occurs in a clinic into a 
written format that would be much more accessible to smokers. The booklets were sent over an extended 
period of time (12 months) to maintain abstinence motivation. 
Across three randomized controlled trials (RCTs), this intervention was found to be highly efficacious and 
cost-effective among self-quitting smokers (Brandon et al., 2000, 2004; Chirikos et al., 2004), and among 
low-income pregnant and postpartum women, using a modified version (Brandon et al., 2012). Moreover, a 
recent meta-analysis found self-help to be the only efficacious relapse-prevention modality (Agboola et al., 

5 
 
2010).  Based on the results of our prior studies, the booklets have been adopted by NCI (distributed by the 
Cancer Information Service, available for free download at www.smokefree.gov, and identified as a 
Research Tested Intervention Program on cancercontrolplanet.cancer.gov), as well as by hospitals and 
health departments throughout the country.  Additionally, an anglicized version of the booklets is currently 
being tested in Great Britain for possible adoption by the National Health Service. 
B3.2. Smoking Cessation. Based on the success of extended self-help for preventing smoking 
relapse, we have since developed a version, Forever Free: Stop Smoking for Good, to assist current 
smokers with both initial cessation and maintenance of abstinence. We recently completed an NCI-funded 
RCT testing this English-language intervention (described further in D1.2.3 below).  Compared to Usual 
Care, our intervention produced significantly greater smoking abstinence rates through the 24 months of 
follow-up.  Additional details regarding these studies are presented in the Preliminary Studies section (D1.2). 
In summary, this line of research supports that extended self-help is an efficacious tool for 
promoting and maintaining tobacco abstinence. 
B4. Hispanic/Latino Smokers 
Hispanic/Latinos are the largest and fastest growing minority group in the United States (Ennis, 
Rios-Vargas, & Albert, 2011). The current smoking prevalence among Hispanic/Latino adults varies by 
cultural subgroup, with highest prevalence among those of Puerto Rican (35%, men; 33% women) and 
Cuban origins (31%, 30%) and lowest among Dominicans (11%, 12%) (Kaplan et al., 2014).  Higher 
prevalence of smoking is also observed within medically underserved communities and low SES 
communities (Báezconde-Garbanati et al., 2007). In addition to language limitations due to scarce Spanish-
language smoking resources (Santisteban et al., 2006), Hispanic/Latinos are disproportionately represented 
in the lower SES groups. Low income and financial strain can operate as distracters from efforts at self-
directed health behavior change and are associated with poorer success rates among those attempting to 
quit smoking (Barbeau et al., 2004; Kendsor et al., 2010; Sheffer, 2012).  Low-income smokers may be 
hampered in their quitting attempts because of the practical limitations (e.g., cost and transportation) of 
attending smoking cessation programs and lack of availability of self- help interventions that are salient with 
respect to their everyday concerns and realities. 
Hispanic/Latino smokers also appear to have less access to the full range of smoking cessation assistance.  
For example, Hispanic/Latinos are less likely to receive tobacco screening and counseling from their 
physicians (Lopez-Quintero et al., 2006; Sonnenfeld et al., 2009).  Access to evidence-based smoking 
cessation treatments is further restricted for individuals with limited or no English proficiency (Wetter et al., 
2007). A recent study conducted with bilingual Hispanic smokers demonstrated higher intended utilization of 
smoking cessation intervention materials if they were received in their preferred language, supporting the 
need for the availability of Spanish-language materials for bilingual smokers as well (Rodriguez-Esquivel et 
al., 2015). 
Among underserved populations, the absence of readily available Spanish-language evidence- based 
materials has been cited as a key barrier to primary care providers assisting with smoking cessation 
(Blumenthal, 2007).  More generally, there is very little research evaluating      smoking cessation 
interventions for Hispanic/Latinos (Doolan & Froelicher, 2006). In fact, only a handful of randomized trials 
have been conducted testing the efficacy of targeted interventions for Hispanic/Latino smokers (Webb et al., 
2010). Therefore, the USPHS Clinical Practice Guidelines called for more research on the development and 
validation of interventions for racial/ethnic minority smokers, with attention to appropriate language and 
sociocultural factors such as acculturation and socioeconomic status (Fiore et al., 2008). Moreover, 
extending the reach of smoking cessation interventions to Hispanic/Latino smokers aligns with NCI priorities 
for reducing health disparities. In summary, there is a critical need for evidence-based smoking-
cessation interventions for Hispanic/Latino smokers—interventions that are culturally-sensitive, 
relevant and responsive to the sociocultural needs of diverse subcultural groups of Hispanic/Latinos 
(Barrera et al., 2011). 
B5. Culture, Language, and Linguistics:  Spanish Transcreation 
Reducing tobacco use among minority populations is an essential step for eliminating 
cancer health disparities. Toward this end, extending the reach of validated smoking cessation 
interventions to the largest and fastest growing minority population is paramount. 
Direct translations of health education materials from English to Spanish, without appropriate 
linguistic, literacy and cultural considerations, can result in the development of interventions that contain 

6 
 
inaccuracies, awkward language, and mismatched cultural content, consequently reducing acceptability and 
impact (Solomon et al., 2005). Because simple translation is insufficient, we intend to “transcreate” the 
existing English-language intervention components (10 Stop Smoking for Good Booklets and 9 supportive 
My Story pamphlets) for Hispanic/Latino smokers. Transcreation involves both translating and culturally 
adapting materials for a Spanish-speaking Hispanic/Latino audience (Marcario & Boyt, 2008; Solomon et 
al., 2005; Castro, Barrera, & Steiker, 2010). With transcreation, the text is not merely translated into another 
language, but reconstructed to meet the informational needs and health literacy of the target audience 
(Quinn et al., 2006). Research suggests that health education efforts focused on encouraging behavior 
change are more successful when transcreated and available to the intended population in their native 
language (Bender, Harbour et al., 2001), and with message content that is relevant and engaging for 
members of the targeted cultural group. 
Importantly, research indicates that, when culturally tailored, cognitive-behavioral interventions are equally 
effective for Hispanic/Latino populations (e.g., Miranda et al., 2005; Muñoz & Mendelsen, 2005). 
Our research team has been successful in utilizing transcreation processes to adapt self-help 
relapse-prevention interventions that were linguistically and culturally suitable for heterogeneous 
Hispanic/Latino, Spanish-language preferring populations (Simmons et al., 2011a, 2011b; Litvin et al., 
2011).  Key findings from our transcreation work are summarized in the Preliminary Studies section 
(D1.3.1). 
In summary, the creation of effective interventions for Hispanic/Latino populations requires 
not only quality translation, but systematic adaptation informed by the unique cultural context and 
informational needs of the target audience, followed by empirical validation via an RCT. 
C. INNOVATION 
The proposed research has several innovative features. First, the study continues the team’s 
expansion of the definition of self-help interventions by increasing the “dose” of self-help in return for 
potentially large gains in efficacy, while obtaining very favorable cost-effectiveness, as seen in our previous 
research (Brandon et al., 2000, 2004, 2012). It adapts a common communication channel to deliver a more 
intensive and focused intervention—one that is highly accessible to underserved populations.  Second, by 
testing a Spanish-language smoking cessation resource, our intervention has the potential to reach the 
largest and fastest growing underserved population of smokers, one for which few evidence-based cessation 
resources exist.  Moreover, the US Census data indicate that 45.7% of Spanish-speaking individuals speak 
English less than “very well.” This percentage is higher among the low SES individuals most likely to smoke 
(Ryan, 2013). Therefore, the need is great for novel and efficacious cessation interventions to reach this 
sector of the Hispanic/Latino population. We will be the first to test the efficacy of a “transcreated” and 
evidence-based self-help intervention for a diverse Hispanic/Latino population. Third, the study represents 
an advance in translational research by increasing the reach of smoking cessation interventions to an 
underserved population (Spoth et al, 2013). Importantly, if shown to be efficacious, a written self-help 
intervention modality would be especially beneficial for low-income and underserved populations who 
experience unique barriers to obtaining smoking cessation treatments or medications (e.g., cost, 
transportation issues), and it would be ready for immediate dissemination. 
D. APPROACH 
D1. Preliminary Studies 
D1.1. The Research Team (see biosketches for relevant citations) D1.1.1.  The 
Investigators 
We have assembled a team of investigators with significant expertise and experience in all aspects 
of the proposed:  study conceptualization, the development and evaluation of smoking interventions for 
special populations (Brandon, Simmons), health disparities, health communication and literacy, and 
development and adaptation of multi-language educational interventions (Meade, Simmons), community-
engaged research (Simmons, Meade), health disparities and tobacco (Simmons), and statistical methods 
(Sutton). The two PIs, Vani Nath Simmons, Ph.D., and Thomas Brandon, Ph.D., are longstanding 
collaborators on the development of self-help interventions for tobacco dependence, with attention to the 
specific needs of special populations of smokers.  Cathy Meade, R.N., Ph.D., F.A.A.N., is a nationally 
recognized expert in the areas of health literacy and communications, and she has collaborated on our 

7 
 
previous self-help interventions.  Drs. Brandon, Simmons, and Meade are members of the Outreach 
Research Program for an NCI-funded U54 Comprehensive Partnerships to Reduce Cancer Health 
Disparities grant between Moffitt Cancer Center and the Ponce School of Medicine in Puerto Rico.  In 
addition, Dr. Meade leads an NCI-funded U54 Community Network Program Center, of which Dr. Simmons 
is the Community Outreach co-director. Thus, they have substantial experience working with community 
stakeholders and Spanish-speaking populations.  Steven Sutton, Ph.D., has expertise in data management 
and statistical analyses of tobacco-intervention trials.  Marina Unrod, Ph.D., has been a co-investigator on 
our prior self- help tobacco studies and has managed RCTs at TRIP for the past 8 years. 
D1.1.2.  Cultural Advisory Board 
We have supplemented and expanded the expertise and reach of the primary investigators by 
assembling a Cultural Advisory Board (CAB) comprising researchers from our key focused recruitment 
areas.  Each of these investigators has relevant experience developing interventions for the 
Hispanic/Latino community and recruiting Hispanic/Latino participants into research protocols.  
Members of the CAB include: Dr. Maria Fernandez (University of Houston), Dr. Felipe González Castro 
(University of Texas, El Paso), Dr. Monica Hooper (University of Miami), Dr. Julio Jimenez (Ponce 
School of Medicine, Puerto Rico), Dr. Kristen Wells (University of California, San Diego), and Dr. Anita 
Kinney (University of New Mexico). The CAB will use their local established community networks to 
assist in recruiting participants in their respective regions and will advise and provide feedback 
regarding the language and cultural appropriateness of the study instruments (See Letters of Support). 
D1.1.3.  Community Advisory Panel 
In addition to our CAB described above, we will also seek input from Hispanic community members 
on the proposed assessments, recruitment strategies, and clinical trial procedures, as needed. We are 
fortunate to have access to two existing partnerships that will facilitate and support this process. Dr. Meade 
leads an NCI-funded U54 Community Network Program Center (Tampa Bay Community Cancer Network; 
TBCCN), of which Dr. Simmons is the Community Outreach co-director. TBCCN is comprises 20 
community-based organizations that serve medically underserved communities. Importantly, we will be able 
to seek feedback from several of the partners included within TBCCN that represent Hispanic-serving 
organizations (e.g., Farmworkers self-help, Multicultural Resource Center, Latinos United for New 
Beginnings). 
Additionally, as noted above,, Drs. Brandon, Simmons, and Meade are members of the Outreach 
Research Program of the Ponce School of Medicine and Moffitt Cancer Center U54 Partnership. Within the 
context of this partnership, we will work closely with our established Hispanic Community Advisory Panel 
(CAP).  The CAP has offered their support of our project goals and will be able to provide valuable input on 
effective recruitment strategies for reaching Hispanics as well as our assessments.  The CAP currently 
comprises 10 members with diverse sub-ethnic backgrounds (Colombian, Puerto Rican, 
Venezuelan,Mexican). (See Letter of Support). 
D1.2. Prior Research on Self-Help Smoking Interventions 
Our team has conducted and published descriptive, intervention, and laboratory-based studies 
to investigate the nature of smoking cessation and to develop intervention strategies. Most relevant to 
the current proposal, three RCTs testing the efficacy of our self-help interventions are described below. 
D1.2.1.  Relapse Prevention I. The first of these studies (Brandon et al., 2000) involved a 2 X 
2 factorial design to test the independent and combined efficacy of two types of a minimal intervention 
that had been identified in an earlier feasibility study (Brandon & DeMichele, 1995): 
(1) access to a year-long relapse prevention hotline and (2) a series of eight empirically based relapse-
prevention booklets mailed to participants over the course of a year. We found that the repeated 
mailings of booklets significantly reduced 12-month relapse rates of recent quitters by two-thirds (12% 
vs. 35%, p = .001). 
D1.2.2.  Relapse Prevention II.  A second clinical trial (R01 CA80706; Brandon et al., 2004) 
parsed the effects of repeated contact and booklet content, and extended follow-up to 2 years.  The main 
findings were that the multiple booklets continued to produce reductions in smoking relapse through 2-year 
follow-up compared to a single-booklet control condition (22% vs. 32% relapsed, p = .02), and that booklet 
content was more potent than contact. The intervention was also highly cost-effective; cost per quality-
adjusted life-year (QALY) gained was estimated as low as $83 in the sample (Brandon et al., 2004; 

8 
 
Chirikos et al., 2004). 
D1.2.3.  Cessation. The most relevant study (R01 CA134347) ended data-collection in May, 2014. 
This study was based on preliminary data suggesting that the Forever Free booklets, although developed to 
prevent relapse, were efficacious for current smokers. This contrasts with the general finding that self-help 
is minimally effective (1% additional cessation) for smoking cessation (Hartmann-Boyce et al., 2014). We 
modified the original Forever Free booklets to include instruction on smoking cessation, per se, creating a 
new version for current smokers titled, Stop Smoking for Good. We randomized 1874 current smokers to 
three conditions: (1) Usual Care (a standard smoking cessation booklet, Clearing the Air, published by NCI 
[NCI, 2008]); (2) Standard booklets (8 Stop Smoking For Good booklets mailed over 12 months); or (3) 
Enhanced booklets. 
The Enhanced intervention comprised 10 Stop Smoking for Good booklets and 9 supportive 
pamphlets. The Stop Smoking for Good booklets were sent separately upon enrollment and at 1, 2, 3, 5, 7, 
9, 12, 15, and 18 months. The first booklet provided a general overview about quitting smoking, and each of 
the remaining nine booklets included more extensive information on a topic related to quitting smoking 
maintaining abstinence: Smoking Urges; Smoking and Weight; What if You Have a Cigarette?; Your Health; 
Smoking, Stress, and Mood; Lifestyle Balance; Life without Cigarettes, The Benefits of Quitting Smoking, 
and The Road Ahead. 
In addition to the 10 booklets, we also made contact during non-booklet months to enhance 
perceived social support via 9 tri-fold color pamphlets (My Story: How I Quit Smoking) that reinforced key 
messages about quitting smoking (e.g., dealing with stress, keeping weight gain in perspective, finding 
other forms of positive reinforcement). To further approximate a sense of social support, the message was 
communicated via a first-person narrative from a former smoker, incorporating photographs of the 
purported speaker. All materials were written at the 5-6 grade reading level so as to maximize their 
accessibility to a wider range of smokers (Meade & Byrd, 1989). The existing English-language 10 Stop 
Smoking for Good booklets and 9 supportive pamphlets are accessible to reviewers at www.moffitt.org/PQ. 
We recently completed analyses of 7-day point-prevalence abstinence rates through 24 months 
following multiple imputation to manage missing data (Brandon et al., 2015). As seen in Table 1 below, the 
Enhanced Booklet condition produced consistently higher abstinence rates at all follow-up points compared 
to Usual Care. Even at 24 months, the differential abstinence rates were over 11%. Given the low cost of 
the intervention, these differences represent high clinical and public health significance and potential impact.  
In terms of cost per quitter, preliminary economic analyses indicate that the incremental cost-effectiveness 
ratios (i.e, the difference in cost between an intervention and Usual Care, divided by the difference in 
abstinence at 24 months) of the Standard and Enhanced conditions were $560 and $361, respectively—both 
far lower than most other smoking-cessation interventions, which tend to yield cost per quitter estimates 
between $1000 and $10,000 (e.g., Cromwell et al., 1997; Curry et al., 1998; Nohlert et al., 2013; Ronckers et 
al., 2005; Smit et al., 2013; Smith et al, 2007;  Song et al., 2002). This study demonstrates that a minimal, 
but extended, self-help intervention can significantly, and cost-effectively, improve smoking 
cessation rates, and it supports our plan to increase the reach and impact of this intervention by 
creating a Spanish-language version. 
 
 
Table 1: 7-Day Point Prevalence Abstinence Rates (%) at 6, 12, 18, and 24 Months in Cessation Study 
  
 
Percent Abstinent  
 
  Follow-Up 
Usual 
Care  Standard Condition Enhanced Condition 
 
p 6 Months 
 
11.54 
 
13.85 
16.09 
 
.03 
 
12 Months 
14.34 
19.40 
24.12 
.0001 
18 Months 
18.19 
20.25 
28.01 
.0002 
24 Months 
18.88 
24.35 
29.96 
<.0001 
Note:.  p-values are for comparison of the Enhanced vs. Usual Care conditions.  
 
 
D1.3. Interventions for Special Populations 
Our team has substantial experience creating interventions for special populations of smokers.  
Using formative research, we adapted the Forever Free intervention for pregnant women (Quinn et al., 
2006). In an RCT (R01 CA94256), we compared the Forever Free: For Baby and Me booklets against 
standard, booklets (Brandon et al., 2012). We found both main effects and moderation by SES.  For 

9 
 
example, by 12 months postpartum, low-income women were particularly likely to benefit from the new 
intervention compared to standard booklets (72% vs 51% abstinent at 12 months postpartum, p = .003). 
Moreover, based on an analysis of predictors of post-treatment smoking among cancer patients 
(Simmons et al., 2013), we have adapted the Forever Free intervention for cancer patients by creating a 
supplemental informational and motivational video, Surviving Smokefree, and we are currently testing the 
combined intervention in an RCT (R01 CA154596).  Also, in an ongoing study, we are collaborating with 
Robert Klesges, Ph.D., to test booklets inspired by Forever Free for preventing smoking relapse among US 
Air Force recruits following involuntary cessation during basic military training (R01 HL095785; Brandon et 
al., 2014).  Finally, following systematic laboratory research (e.g., Simmons et al., 2004), we have 
developed a highly- interactive web-based intervention for college student smokers, who are loathe to 
participate in live, face-to-face counseling (Simmons, Heckman et al., 2013). 
D1.3.1. Interventions for Hispanic/Latino Smokers. Our research team also has prior experience 
adapting and translating (i.e., transcreating) evidence-based self-help interventions for Hispanic/Latino 
smokers. Both the original relapse-prevention and pregnancy-related Forever Free booklets were 
transcreated for Spanish-speaking smokers. Our work resulted in a Spanish-language series titled, Libres 
Para Siempre (Simmons et al., 2011b) for prevention of smoking relapse among recent quitters and a 
second series titled, Libres Para Siempre..por mi bebé y por mí, (Simmons et al., 2011a) for reducing 
relapse among pregnant women.  Both series of Spanish-language booklets have been adopted by NCI for 
dissemination and are available for free download at www.espanol.smokefree.gov. 
Findings from the formative data we collected (Simmons et al., 2011a, 2011b) were used to inform 
the transcreated versions based on reported cultural experiences.  For example, specific stressors 
mentioned by the Hispanic/Latino participants included difficulties with the immigration experience, feelings 
of isolation, lack of understanding of the health care system, and the use of coping strategies that often 
included prayer or family-oriented activities. 
Therefore, these concerns and barriers were integrated into the content of the booklets.  In addition, our 
findings were consistent with the conceptualization of cultural sensitivity-guided adaptations made at both 
deep and surface levels as outlined by Resnicow et al. (1999). For example, familismo, defined as a strong 
identification and attachment to the nuclear and extended family (Marin & Marin, 1991), was evident in our 
formative work. Specifically, participants’ expressed concerns for how their smoking behavior negatively 
affects family members, and how quitting could be beneficial for their family (Simmons et al., 2011a). This 
finding was consistent with prior work revealing “family’s health” as a primary motivator for quitting among 
Hispanic/Latino smokers (Sias et al., 2008). Thus, to enhance the cultural salience and relevance of the 
information presented, emerging themes such as these were used to modify the personal stories/vignettes 
throughout the booklets.  Another finding that impacted the visual appeal and acceptability of the booklets 
was the suggestion to include graphics that encompass a diversity of individuals from different countries of 
origin (e.g., Puerto Rico, Columbia, Mexico, Cuba). Overall, the qualitative research revealed great 
enthusiasm and interest in the Spanish-language relapse prevention materials; however, a common theme 
emerged in our prior research, in which Hispanic/Latino participants expressed the value and need for 
personal contact (i.e., personalismo) to be made part of the intervention delivery process (Menzie, Simmons 
et al., in press; Simmons et al., 2011b; Litvin, Rojas, Simmons et al., 2011; Bejarano et al., 2013). 
 
 
 
 
 
 
 
 
 
 
 
 

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D2. Ongoing Transcreation Study 
Since the original submission, we have received research funding form the Florida 
Biomedical Research Program which is allowing us to conduct our original Aim 1: To develop 
a culturally appropriate self-help intervention for racially and ethnically diverse Spanish-
speaking smokers, based on the successful Stop Smoking for Good intervention described 
above in 
D1.2.3.  Funding began in May, 2015, and the process described below 
should be complete by April, 2016 
The process of taking materials originally intended for an English-
language audience and translating and adapting them for a Spanish-speaking 
Hispanic audience has been termed “transcreation” (Marcario & Boyte, 2008; 
Card et al., 2012; Soloman et al., 2006; Buki et al., 2009). In the development 
of the new Spanish-language intervention, this involves translating the existing 
English-language Stop Smoking for Good materials into Spanish and 
adapting the intervention for a Hispanic/Latino audience using a series of 
iterative procedures. 
Importantly, our ongoing iterative process to transcreate the intervention 
parallels our previously employed methods used to develop the materials 
described above, and is guided by NCI’s Stages in Health Communication 
Model (USDHSS, 2008) and the ADAPT-ITT Model (Wingood et al. 2008). We 
are further guided by published recommendations for the linguistic, literacy, 
and cultural adaptation of evidence-based interventions (Marcario & Boyte, 
2008; Soloman et al., 2005; Castro et al., 2010; Barrera & Castro, 2006).  For 
example, Resnicow et al.’s (1999) conceptualization of cultural sensitivity is 
guiding adaptations made at both surface and deep levels. 
We are not developing a de novo intervention.  Rather, the 
Spanish-language smoking cessation intervention that we are in the 
process of transcreating is building upon content of the existing 
Figure 1 

11 
 
efficacious English-language intervention (10 booklets + 9 pamphlets), which is based on 
cognitive behavioral theory. We believe that the success of the existing intervention is largely 
due to its theoretical and empirical basis, so we are maintaining that evidence base for the 
new booklets. However, we recognize the importance of cultural adaptation to enhance 
receptivity and the likelihood that the materials will be used (Barrera et al., 2013).To achieve 
this goal, we are employing a multi-phase process to create a usable, understandable, and 
acceptable intervention by engaging users.  (See Figure 1.) 
Phase I involves formative research via focus groups to gather data on culturally 
relevant impediments and facilitators to achieving smoking abstinence among a diverse group 
of Hispanic/Latino individuals. Findings are then being used to improve the saliency of the 
intervention among a new group, Hispanic/Latino smokers. Consistent with our prior work, 
and adapted from the Brislin Model of Translation (1970), the initial development of the 
materials involves a bilingual/bicultural team and CAP engaging in an extensive iterative 
process to identify possible concepts and words that may not translate well, might be 
misunderstood, or be inappropriate. This entails translating the documents from the source 
language (English) to the target (Spanish) language, and having a second bilingual expert 
blindly back-translating the documents. Next, the research team and the investigators meet to 
discuss any differences or inconsistencies identified through the translation and back-
translation processes. As a group, changes are made to ensure that the translated 
documents reflect cultural congruence and comparability in terms of meaning. The 
intervention then begins to take shape and becomes infused with the thematic findings from 
our qualitative work as well as relevant literature on smoking among Hispanic/Latinos. 
Then, in Phase II, initial drafts of the Spanish-language materials undergo learner 
verification, a process to assess suitability. This approach, modeled after the work of Doak et 
al., (1996) strives to reduce miscommunication of messages.  It involves verifying the newly 
translated and revised materials with the intended audience in relation to acceptability, 
attraction, understanding, self-efficacy, and persuasion via a series of questions relating to the 
elements to be verified. This procedure allows us to obtain reactions to the developing 
intervention materials (booklets and supportive stories) in terms of tone, character 
development and messaging design style so that we can make suitable adjustments. In 
consideration of regional variations in language and culture, our sample will include 
individuals from various ethnic backgrounds and countries of origin   (e.g., Puerto Rico, 
Guatemala, Cuba, Dominican Republic, Mexico, and Columbia). 
Through the booklets and pamphlets, we will attend to the diverse cultural backgrounds 
of our Hispanic/Latino audience by conveying stories and experiences with proper attention to 
diversity in age, generational and acculturation status, gender, and country of origin.  For 
example, unique stressors and relapse risk factors that are revealed are incorporated into the 
existing content. In addition, the stories conveyed in the booklets and pamphlets (i.e., first- 
person narratives) develop around the cultural relevant content and areas discovered during 
the focus group discussions. Revisions are evaluated by the team and advisors on importance 
(degree it can enhance effectiveness), feasibility (ease/burden of suggestion), and congruence 
(fit with core evidence-supported components) (Chen, 2013). In summary, the transcreation 
process helps us achieve a balance between preservation of essential, evidence-based 
intervention core elements that are crucial to the intervention’s effectiveness (e.g., cognitive- 
behavioral coping strategies) while infusing cultural relevance, and thereby enhancing appeal  
for the intended audience (Castro et al., 2004). The research team brings extensive 
experience and skill in these methods. 
As when it was an aim of the original submission, the transcreation process is projected 
to take 12 months, with a target completion date of April, 2016.  This coincides perfectly with the 
earliest funding start date of the present proposal, when the new intervention will be ready for 
testing in the RCT described next. 
D3. Methods 
D3.1. Design Overview.  A randomized 2-arm design, with 700 smokers recruited into each of 

12 
 
the conditions will be used to test the efficacy of our Spanish-language smoking cessation 
intervention. The 2 conditions are: (1) Usual care (UC), which will comprise a single, Spanish- 
language, smoking cessation booklet developed by NCI; and (2) the Stop Smoking for Good 
Intervention in Spanish (SS-SP), comprising a series of 11 booklets distributed over 18 months, 
plus additional monthly contacts via 9 supportive pamphlets. Assessments for both groups will 
occur at six-month intervals, through 24 months. An overview of the design and the timing of 
intervention components and assessments are depicted in Table 2. All conversations with 
participants, informed consent, intervention materials, and assessment instruments will be in 
Spanish. 
Table 2. Overview of Study Design: Interventions and Assessments 
 
Month 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
24 
Assessment (Both Groups) 
A 
A 
A 
A 
A 
Usual Care Condition 
N 
SS-SP Condition C,X 
X 
X 
X 
O 
X 
O 
X 
O 
X 
O 
O 
X 
O 
O 
X 
O 
O 
X 
Legend: SS-SP = Stop Smoking for Good Intervention in Spanish; A = Time of assessment; N = NCI booklet; C = 
Initial Phone Contact; X = Stop Smoking for Good booklet; O = Supportive letter and tri-fold pamphlet. L = Monthly 
supportive letter in Contact Control condition.  Shaded areas indicate the duration of the intervention. 
D3.2. Participants and Recruitment Feasibility.  Participants will be 1400 Spanish-speaking 
smokers recruited throughout the mainland United States and Puerto Rico. To ensure 
recruitment goals are met, we have developed a broad and thoughtful recruitment strategy that 
will include local, state, and national efforts. Our local and state efforts will be informed by input 
from our community advisory panel comprised of members of the Hispanic community, as well 
as our existing community and research partnerships in Central and South Florida.  At a  
national level, our recruitment efforts will be guided by our cultural advisory board members, all 
of whom have experience in recruiting Hispanic individuals for research studies and reside in 
regions of high Hispanic/Latino density (South Florida, Texas, California, New Mexico, and 
Puerto Rico). Our recruitment strategies will include, but are not limited to, national ads (e.g., 
on the Telemundo network) as well as local multimedia advertisements (Spanish newspapers, 
radio, and cable TV; social media, public transportation signage).  These recruitment strategies 
mirror potential avenues for future federal or state dissemination efforts if the intervention is 
deemed efficacious. To maximize generalizability, we have minimal inclusion criteria: (1) 
smoking ≥ 5 tobacco cigarettes/week over the past year; (2) age ≥ 18 years; (4) not currently 
enrolled in a face-to-face smoking cessation program; and (5) monolingual Spanish-speaking, 
or bilingual Spanish-English and prefer receiving educational health materials in Spanish. Initial 
screening will be conducted via telephone. Participants that are unable to provide a mailing 
address within the mainland United States or Puerto Rico, or are unable to provide a mailing 
address (i.e., do not have one), will be excluded from participating in the study. We will assess 
whether participants use any other smoking cessation services (e.g., state quitline, websites) 
or pharmacotherapy for analysis, but will not exclude smokers who utilize these widely 
available smoking cessation tools. 
Inclusion criteria will be confirmed with data provided in the baseline assessment. 
Participants who do not meet criteria based on baseline assessment will be withdrawn. Given that 
participants provided responses during the initial telephone contact that met the inclusion 
criteria, we created rules for 4 of the 5 inclusion criteria that required strong evidence from the 
baseline survey for exclusion. The rules acknowledge that participants may mark unintended 
responses. 
 
Exclusion criterion #1: Insufficient smoking (<5 cigs per week) or have recently quit. 
            Rule #1: Page 4, Item 1 response is ‘I have not smoked any in the past week’ 
            Rule #2: Page 4, Drop if  2 of the following 3 items have the marked response. 
a) item 2 = ‘No use in past month’ 
                        b) item 3 = ‘No use in past month’ 
                        c) item 4 = ‘Do not smoke’ 

13 
 
            Rule #3: Page 4, responses to items 2 & 3 show less than 5 cigs per week. 
Exclusion criterion #2: Less than 18 years old. 
            Rules #1: Page 1, Date of birth is less than 18 from date of survey completion. 
Exclusion criterion #3: Currently enrolled in an ‘in-person’ cessation program. 
            Rule #1: From Quit Aids section on page 10, marked ‘Currently Use’ for In-person counseling or 
support program. 
 
Participants will be randomized into the two arms (700 each) using balanced-permuted block, 
stratified by: sex, smoking rate (daily vs. non-daily smoking), and income (household income < $10,000). We 
are stratifying on income based on previously observed treatment effects for our self-help interventions that 
were moderated by income.  Specifically, low-income participants derived greater benefit from the 
intervention (Brandon et al., 2012). Our smoking inclusion and stratification criterion are based on research 
demonstrating higher rates of non- daily and light smoking (e.g., less than 10 cigarettes per day) among 
Hispanic/Latinos (e.g., Kaplan et al., 2014, Okuyemi et al., 2002) and that different reasons for smoking exist 
among Hispanic/Latinos based on smoking level (Pulvers et al., 2014). To minimize treatment 
contamination, participation will be limited to one participant per household address. 
We believe that it is feasible to accrue the target N of 1400 in the 20 months allocated for accrual. In 
the previous self-help cessation study (D1.2.3), we successfully recruited 1874 smokers over the course of 
16 months.  Although the current study will be limited to Spanish- speaking smokers, which is a smaller 
population base, it is substantial and growing.  Because all contact with participants will be by telephone, 
internet, and mail, we are not geographically limited and are thus able to recruit participants throughout the 
country. The rate of accrual is limited only by the amount of advertising, staffing levels, and logistic 
requirements of screening callers and processing baseline data. We have a history of meeting our accrual 
goals with high rates of participant retention in trials, even with particularly hard-to-reach low-income 
populations that required adjustments to accrual strategies.  Most notably, we have recruited participants 
from a much smaller segment of the population: 700 women in months 4-8 of their pregnancy who had 
already quit smoking and were interested in relapse-prevention assistance (Brandon et al., 2012; Lopez et 
al., 2008). We also have a history of recruiting Hispanic/Latino smokers (Simmons et al., 2011a, 2011b). 
Moreover, as noted above, recruitment feasibility will be boosted by the assistance of our CAB members 
strategically located throughout the country. 
D3.3.  Study Arms 
In this section, we describe the rationale and form of the two intervention conditions. 
Note that in addition to hard copies of the intervention materials, participants in both conditions will have the 
option to also receive electronic versions via a link to a website managed by Moffitt Cancer Center’s Survey 
Methods Core. 
D3.3.1.  Stop Smoking for Good Intervention in Spanish (SS-SP). This condition will comprise the 
11 Stop Smoking for Good booklets and 9 supportive My Story pamphlets transcreated for Spanish speaking 
smokers to be delivered over 18 months (see Table 2). 
Consistent with the recommendations of the USPHS Clinical Practice Guidelines (Fiore et al., 2008), our 
prior formative work with Hispanic/Latino smokers and Hispanic/Latino health care providers (Simmons et 
al., 2011a; 2011b; Bejarano et al., 2013) identified high degrees of interest and enthusiasm for self-help 
smoking intervention materials to be available in Spanish. Additionally, a reoccurring emergent theme 
among Hispanic/Latino participants was a desire for some form of personal contact to be provided along 
with the booklets. To satisfy this identified need, while maintaining dissemination and reach potential, we 
have added a single, brief telephone contact to this condition. This telephone contact will be timed to occur 
when the participant is due to receive the first Stop Smoking for Good booklet. The aim of this 10-minute 
call will be to build rapport and to provide a personal connection to garner trust and credibility in the 
intervention.  During the call, we will briefly present the rationale for the intervention and offer suggestions 
for intended use of the intervention materials.  If effective, this intervention could blend seamlessly into 
existing telephone Quitline services. 
D3.3.2 Usual Care (UC). This condition will comprise a single, high-quality booklet that 
is currently in wide-dissemination and was developed by the National Cancer Institute: Viva de forma más 

14 
 
saludable para usted y su familia, deje de fumar hoy mismo (Live Healthier for You and Your Family, Quit 
Smoking Today; NCI, 2011). This is a comprehensive 40 page Spanish- language booklet with high quality 
content and visual presentation. We chose to use credible usual care as a comparison condition rather than 
a no-treatment control for two reasons. First, when using a reactive recruitment strategy that publicizes an 
offer of cessation assistance, we believe that there is an ethical obligation to provide at least high quality 
usual care to all participants. Second, it is simply more meaningful to evaluate a novel self-help intervention 
(our Stop Smoking for Good booklets) against an existing credible intervention. To have any public health 
significance, the new intervention must demonstrate greater efficacy than an existing,  less intensive 
intervention.  In summary, the UC control condition enhances the external validity of the study by 
providing a comparison to an existing, credible intervention that a smoker could receive in a medical 
setting or elsewhere. 
 
 
D3.4. Assessments 
As Table 2 indicates, assessments will occur at baseline and at 6-month intervals thereafter, 
through 24 months.  Assessments will be conducted as we have before (Brandon et al., 2000, 2004), via 
the mail, with an internet option.  A tension inherent in clinical trials, particularly trials of minimal 
interventions for behavior change, involves balancing the value of assessment against the risk of reactance 
effects. This is a concern in the current study because we posit that contact contributes to treatment 
effects.  Moreover, assessment of specific domains may influence those very domains.  For example, 
assessment of coping skill usage is itself a reminder to use coping skills.  Finally, participants who enroll in 
studies of minimal interventions often will reject the burden of a heavy assessment load, increasing attrition 
and reducing generalizability.  Therefore, in our self-help studies, we aim to keep both the frequency and 
magnitude of assessments to the minimum required to meet the specific aims.  Compared to our traditional 
treatment studies, we must be more selective in choosing instruments to administer in our self-help studies, 
and we limit assessments to 6-month intervals. 
All assessments will be conducted in Spanish. When existing Spanish-language versions are 
unavailable, they will be created by a certified translator, with verification via back- translation, and then 
provided to a small sample (N = 6) of representative men and women from Hispanic/Latino subgroups for 
key informant cognitive interviews to ensure that the instruments are “grounded” in accord with the 
capabilities of our population of interest (Jones et al., 2001). When Spanish-language versions of proposed 
measures exist, but they had not been developed and validated with diverse Hispanic/Latino populations, 
we will engage in a similar process to verify that the Spanish is understandable to individuals from different 
countries of origin. 
D3.4.1. Assessment Instruments. 
Initial Telephone Contact. When smokers call the toll-free phone number in response to recruitment 
efforts, the Spanish-speaking telephone operator will collect basic demographic information, a brief smoking 
history, and screen for the inclusion criteria. 
Baseline Assessment.  Smokers who meet inclusion criteria and provide initial verbal consent over 
the telephone will be sent a bound set of baseline Spanish-language questionnaires. The following 
questionnaires will be included:  (1) a demographic (age, sex, socioeconomic status [measured by 
education, household income, number of members in household and debt level (Chiang & Borrelli, 2014)] 
country of origin, generational status, years living in the US, etc.) and smoking history questionnaire, 
including electronic cigarette use and quitting aids use.  The Spanish-validated Fagerström Test for Nicotine 
Dependence (Becoña & Vazquez, 1998) will be administered. The FTND is the standard, validated, 
instrument to assess nicotine dependence. (2) an 11-point measure of readiness to quit, the Contemplation 
Ladder (Biener & Abrams, 1991). (3) the Stages of Change Algorithm (SOC) translated in Spanish (Becoña 
& Lorenzo, 2004).  Although this algorithm lacks some of the psychometric advantages of the Contemplation 
Ladder and it produces a different distribution of quitting motivation (Nath et al., 2002), it is widely used, and 
its inclusion allows for comparisons with other published studies. We will also administer the brief measure 
of abstinence-related motivational engagement (Simmons et al., 2010) and two other motivation- related 
constructs: a situation-specific abstinence self-efficacy scale (Velicer et al., 1990); and a measure of 
smoking expectancies that has been validated among Spanish-speaking Latino smokers, the Smoking 
Consequences Questionnaire-Spanish (SCQ-Spanish; Irvin Vidrine et al., 2009; Reig-Ferrer & Cepeda-

15 
 
Benito, 2007).  Four subscales will be administered (negative affect reduction, craving/addiction, health 
risks, negative physical feelings). The Short Acculturation Scale for Hispanics (SASH; Marin et al., 1987) 
will be administered to assess level of acculturation. The SASH has demonstrated high reliability across 
Hispanic/Latino subgroups (Kaplan et al., 2014).  In addition, we will assess level of familism using the 
Attitudinal Familism Scale (Steidel & Contreras, 2013). Finally we will administer the trait version of the 
Spanish Positive and Negative Affect Schedule (SPANAS; Joiner et al., 1997; from Watson et al., 1988), 
which has been validated in younger and older populations (Buz et al., 2015; Ortuño-Sierra et al., 2015).  
These measures of demographics, motivation, mood, acculturation, and familism will be tested as potential 
moderator variables (Secondary Aim). 
Follow-Up Assessments.  Participants will be sent follow-up assessment packets (by mail or e-mail 
link, as per their preference) at six-month intervals through 24 months, as indicated in Table 2. This follow-
up duration provides for an assessment of smoking outcomes 6 months beyond the final mailing of the SS-
SP intervention materials. These brief assessments are intended to minimize participant burden and 
consequent attrition and will include a questionnaire assessing tobacco use since the previous contact, as 
well as any pharmacotherapy or other smoking cessation assistance. We also will assess participants' use 
and evaluation of the self-help materials, using the eight-item Client Satisfaction Questionnaire developed 
in Spanish (Roberts et al.,1984) plus additional items to distinguish the benefits of the content and the 
repeated contact.  To assess the impact of the smoking cessation intervention on health outcomes, we will 
use the Spanish version of the SF-12 health survey (Vilagut et al., 2008; Ware et al., 1995), which will be 
included in the 18 month and 24 month follow-up assessments. We will also administer the trait version of 
the SPANAS  at 18 month and 24 month follow-up. Research staff will attempt to contact participants to 
complete any missing data on the completed baseline and follow-up assessments. To biochemically 
confirm self-reported abstinence, we will travel to participants residing within 75 miles of our laboratory to 
collect breath and saliva samples.  At the 12 and 24 month assessments, an alveolar carbon monoxide 
(CO) sample will be collected, using a cut-off of 4 ppm (Cropsey et al., 2014). (see D3.6.) Due to higher 
than expected disconfirmation rates at the 12 month follow-up, we have elected to add an additional 
marker of smoking abstinence.  Cotinine measurements, collected via saliva, provides an approximation of 
nicotine over a more extended period of time and is less influenced by environmental exposures and other 
forms of smoking (i.e., marijuana smoking). At the 24 month assessment, in addition to the breath sample, 
a saliva sample will be collected, using a cut-off of 10ng/ml (Benowitz et al.,2002). To collect biosamples, a 
researcher will make an appointment to visit the participant at home, work, or other location for a face-to-
face interview. Participants will be compensated $20 for completing the interview and providing a breath 
and saliva samples.  Participants will also be provided with the option of coming to the lab to complete the 
face-to-face interview, and if they elect to do so, they will receive an additional $20. During the interview, 
the researcher will obtain consent to collect the breath sample. The breath sample will be collected with a 
portable CO monitor (Micro CO™ by Micro Direct, Inc.), and the saliva sample will be collected in a 2ml 
tube for immediate cotinine analysis using the NicAlert™ dipstick by Nymox. 
 
Participant Payment and Retention Procedures. We have developed a series of steps to minimize 
attrition in our prior longitudinal self-help studies (Brandon et al., 2000, 2004).  As an incentive, we will pay 
participants a $20 gift card for completing each assessment packet, and also send participants a pre-
selected gift (e.g., stylus pen, nail file, etc.) valued at approximately $1 if they return the forms within one 
week.  In addition, participants will be told that they will receive a bonus payment of a $50 gift card if they 
complete all 5 assessments.  Questionnaires will also be constructed in a manner to maximize participation 
(Dillman, 1991). Other procedures to reduce attrition include reminder phone calls, emails, text messages, 
and letters. We will also ask participants at baseline to supply the name and telephone number of a 
relative or significant other we can call if we lose contact with the participant. This will aid in reaching 
participants who move or change phone numbers.  
If participants are unable to be reached using the retention procedures described above, additional 
methods of contact will be attempted: 
1. 
Internet databases: If mail has been returned to us, indicating that we have a wrong address 
or the participant has moved, several free and paid services will be used to locate participants. Websites 
will include whitepages.com, smartpages.com, and Yahoo! People (people.yahoo.com). These services will 
allow us to search for individuals by name, address, and phone number. We will be able to verify whether or 

16 
 
not participants are in the armed forces, incarcerated, or have passed away by using Military.com and state 
websites like Florida.gov. 
2. 
Facebook: If all avenues of contact have been exhausted, we will utilize the social media 
platform ‘Facebook’ in an attempt to contact participants. 
 
Facebook Protocol   
A Facebook account will be opened under the study name ‘Libre del Cigarrillo.’ The profile will 
contain the study and Moffitt Cancer Center logo, along with a paragraph briefly describing the study. 
Facebook searches will be initiated using the participant’s first and last names. If the first and last names 
result in a match, we will attempt to further verify we have identified the correct individual by confirming 
‘current city’, ‘age’, or ‘email address’. When we are confident that we have identified the right individual, we 
will use the internal messaging system of the Facebook platform. An initial message will be sent to the 
individual asking if they are participating in Libre del Cigarrillo. The message will emphasize that we have 
exhausted all other means of contact, provide our telephone number and email address, and request that 
the individual contact us or reply via the internal messaging system regarding their willingness to update 
their contact information and continue their participation in the study. The message will apologize in 
advance for possibly contacting the wrong individual. If this was the case, we will additionally request that 
they simply reply with this respect to ensure they are not to be contacted in the future. If the user does not 
reply, another message will be sent 14 days later. 
D3.4.2. Outcome Variables.  At each assessment point we will calculate 7-day point- prevalence 
abstinence rates.  Point-prevalence measures are best for capturing the dynamic nature of cessation, 
maintenance, and relapse. Continuous abstinence is not feasible because quit dates will be highly 
variable across participants, and also because one goal of the intervention is to encourage lapsers to quit 
again (recycle). We need our outcome measures to reflect these changes in smoking status over time. 
We will also compare groups on continuous measures such as current smoking rate (cigarettes/day), 
months of smoking during the follow- up period, length of current abstinence period, and latency from quit 
date to relapse.  Data will be analyzed following multiple imputation (see below).  Finally, we will calculate 
the cost per participant of each intervention, and then incremental cost-effectiveness ratios, using Usual 
Care as the reference, to determine the cost per quitter. These statistics will facilitate economic 
comparisons with other cessation interventions. 
 
D3.5.  Study Timeline 
 
Month 
Activity 
1 – 3 
Hire and train staff; build database program; work with CAB and CAP to develop targeted 
recruitment plan and create advertising copy; translate assessment instruments; print 
intervention materials. 
 
4 – 23 
Accrue sample and begin distribution of interventions and follow-up assessments. 
24 – 53 
Continue Follow-up Assessments and prepare mid-term reports. 
54 – 60 
Complete final data analysis and prepare reports. 
 
 
D3.6. Design Considerations 
In this section we briefly address our rationale for a few important study-design decisions. 
Should biochemical verification be employed? The decision regarding inclusion of biochemical 
verification (e.g., saliva, serum, or urine cotinine; breath carbon monoxide) of self- reported smoking status 
is complex (Benowitz et al., 2002). Considering the low-intensity nature of the intervention, that 
assessments will be done by mail/internet, and there should be little differential in social-desirability 
demand across conditions, we concluded, consistent with Benowitz et al. (2002) and Velicer et al. (1992) 
that bio-verification of the full sample is not warranted. Moreover, the cost of bioverification for a study of 
this size and geographic distribution would be prohibitive.  In two prior studies, we conducted unannounced 
CO tests of 64 participants who self-reported abstinence at follow-up and who resided within 50-75 miles of 
our laboratory. Findings were consistent with self-reports for all but one participant. We will use this same 

17 
 
strategy to collect CO and saliva from a sample of participants residing within 75 miles at the 12 and 24 
month follow-up points.  In the unlikely possibility that we find nontrivial disconfirmation rates, we will use 
the data to adjust our outcome estimates.  
 
Should pharmacotherapy use be an exclusion criterion? Excluding smokers who report using 
any pharmacotherapy would allow for a “cleaner” test of the self-help interventions per se. However, we 
ultimately decided against this exclusion criterion for the following reasons: 
(1) It would reduce the ecological validity of the study, because pharmacotherapy is readily available to 
smokers and is likely to be used by many smokers in the population to which we wish to generalize; in 
fact, the Stop Smoking for Good booklets and supportive pamphlets themselves discuss pharmacotherapy 
options. (2) It would cause us to reject or drop a significant proportion of participants, necessitating a much 
larger initial sample size and a study of longer duration. Instead, we will assess pharmacotherapy use (as 
well as electronic nicotine delivery systems [i.e., e-cigarettes]) at each assessment and we will examine 
their contribution statistically. 
C.7.1. Should materials be distributed only via the Internet or mobile modality? We propose 
to give participants an option to receive intervention materials electronically (via emailed link) in addition to 
printed “hard copies” delivered by the US Postal Service.  Internet- only distribution would have the 
advantage of reduced cost and easier eventual dissemination (c.f.,Marcus et al., 2007).  However, there 
are also advantages of tangible, printed intervention materials (Curry et al., 2003), and this was the 
modality that showed substantial efficacy in our prior studies, including the English-language version of the 
proposed intervention.  A written intervention is also particularly useful for low-income individuals who may 
experience barriers to access of technological modalities.  Rather than introducing additional variation, we 
feel that priority should be given to testing the booklets in their present form. Nevertheless, we will track 
use of the Internet option and include it as an exploratory moderator variable in analyses. We will collect 
metadata regarding use of the internet-based documents, namely how many times the link was accessed, 
and whether the electronic booklet(s) were downloaded, which will allow us to document their use and 
acceptability. We will also collect evaluations and preferences regarding internet distribution at follow-up 
to test as potential moderators or mediators of treatment effects. This information should assist us in 
deciding whether to transition fully to internet-based or mobile content (i.e., smart-phone/tablet apps) 
distribution in the future. 
 
D3.7. Data Management and Analysis 
D3.7.1. Data Management.  Participant recruitment and contact information will be input through 
screens created by the Data Systems Team within Moffitt's Research Computing Support Group 
(Research IT) and will be subject to computerized range and consistency checks. The data will then 
populate an Access database, which will also be created and maintained by Research IT. This process will 
be supervised jointly by the PI and Study Data Manager/Biostatistician.  Paper-and-pencils surveys will be 
entered into database files with computerized range and consistency checks. Online surveys will have 
range checks built into the survey items, as appropriate. The survey databases will be converted on a 
monthly basis to an analysis database. This analysis database and SAS version 9.4 (SAS Institute, Cary, 
NC) will be used by the statistician who will provide the PIs with reports and summaries on a regular basis 
and perform the final analyses. 
D3.7.2. Sample Size and Study Power Analysis. The primary statistical analyses will assess the efficacy 
of the full intervention (SS-SP) in producing smoking cessation compared to Usual Care (UC) in two ways: 
(1) across all 4 follow-ups using generalized estimating equations (GEE), and (2) at the 24-month follow-up 
using logistic regression. The estimated 7-day point prevalence abstinence rates for this study were based 
on the cessation study (C1.2.3, Table 1) with an adjustment of 0.625 standard error units to decrease group 
differences. For the four follow-ups, the estimated abstinent rates are 12.3%, 15.2%, 19.1%, & 19.8% in the 
UC condition and 15.2%, 23.0%, 26.9%, & 28.8% in the SS-SP condition. Power was targeted to be > .80 
with alpha=.05 and a 2-sided test. Using GEESIZE version 3.1 (Rochon, 1998; Dahmen 2004) with an AR(1) 
working correlation structure and coefficient of 0.7, sample size was estimated at 322/group for the GEE 
analyses. For the logistic regression at 24 months, sample size was estimated at 365/group. All analyses will 
be completed following multiple imputation to manage missing data (below). Therefore, no adjustments of 

18 
 
enrollment size will be needed to account for attrition. The final sample size for analyses was rounded up to 
370 per group. An additional 500 participants will be recruited from the state of Florida. 
We initially planned to enroll 1240 individuals, 740 nationally and 500 in Florida. However, due to 
higher-than-expected attrition, we are increasing our overall sample size to 1400 individuals, 850 nationally 
and 550 in Florida. 
 
D3.7.3. Data Analysis Overview.  Analyses will be conducted with SAS version 9.4 and Mplus 
Version 7 (Muthén & Muthén, 2008).  Frequency distributions and contingency table analyses will be used 
as a point of departure for more advanced analyses. Group differences in baseline measures will be 
assessed and any variable that exhibits a significant group difference will be incorporated into the primary 
analyses. 
To manage missing data, multiple imputation under the Missing at Random assumption will be 
applied using a Markov Chain Monte Carlo method (Schafer, 1997) via PROC MI in SAS, given the expected 
large number of non-monotonic missing data patterns and the expected large number of auxiliary variables 
(e.g., baseline measures that predict smoking status at follow-up) to be determined by preliminary analyses. 
A post hoc approach (Rubin, 1987) will address the influence of Missing Not at Random (MNAR) on smoking 
status (i.e., missing is due to smoking). Sensitivity analyses will be performed by comparing results from 
different multiple imputation data sets that were generated using different levels of MNAR influence. 
D3.7.4. Analytic Plan for Addressing Specific Aims. All analyses will be performed on complete 
data sets following multiple imputation using all 1400 participants. 
Specific Aims 1 . All analyses will be performed on complete data sets following multiple imputation. 
Generalized estimating equations (GEE) will be used to fit population-averaged models of the longitudinally 
measured 7-day point prevalence, with the main covariates of intervention condition (UC vs. SS-SP), time 
(months from baseline), and the interaction of condition and time. The GEE analysis will allow for 
assessment of changes in abstinent rates over time and group differences in changes. Logistic regression 
will be used to assess condition differences at the 24-month (final) follow-up, which is 6 months after the SS-
SP intervention. In both the GEE models and logistic regression, potential confounding variables (e.g., group 
differences on demographic variable) that appear despite randomization will be included. 
Secondary Aim. The secondary aim is to assess prospective moderators of the expected intervention 
effect (e.g., gender, SES, quitting motivation, nicotine dependence, country of origin, acculturation, trait 
affect, self-efficacy). Each moderator will be assessed individually within a logistic regression for the 24-
month assessment and within a GEE model by adding the moderator and the interaction term for the 
moderator and condition. The GEE models will also include interaction terms for the moderator with time and 
with the time x condition interaction. 
Significant interaction terms in a GEE model will be further explored using time-specific analyses. 
Significant interaction terms for the logistic regression at 24 months will be explored by assessing condition 
differences for each level of categorical moderators. 
D8.  Public Health Impact 
The proposed research will test the efficacy a culturally-appropriate, Spanish-language version of a 
previously validated self-help intervention for tobacco dependence—the leading preventable cause of death 
and disability.  If demonstrated efficacious, this research will  improve the availability and delivery of smoking 
cessation assistance to a large underserved population of Spanish-speaking individuals throughout the 
country. This study responds to Healthy People 2020 goal TU-5.2 (Increase recent smoking cessation 
success by adult smokers using evidence-based strategies; USDHHS, 2014) and corresponds to the HHS 
Action Plan to Reduce Racial and Ethnic Health Disparities (USDHHS, 2011) Strategy IV.B (Conduct and 
support research to inform disparities reduction initiatives) and Action III.A.4 (Reduce tobacco- related 
disparities through targeted evidence-based interventions in locations serving racial and ethnic minority 
populations).  Moreover, the intervention corresponds to the National Standards for Culturally and 
Linguistically Appropriate Services in Health and Health Care (USDHHS, 2013). The intervention is expected 
to be efficacious, cost-effective, and easily disseminated. 
As such, it would be attractive to both public and private stakeholders and health care services. By 
expanding the reach of evidence-based treatments for tobacco dependence, this line of research contributes 
to reducing the health and economic burden of tobacco at the individual and societal levels. 

19 
 
Protection of Human Subjects 
 
 
 
 
 
1.RISKS TO HUMAN SUBJECTS 
 
 
 
a. Human Subjects Involvement, Characteristics, Design 
 
 
 
 
 
Participants (N = 1400) will be randomized to one of two smoking cessation interventions, with 700 
participants randomized to each condition. The Stop Smoking for Good intervention in Spanish condition is 
comprised of a series of 10 booklets distributed over 18 months, plus additional monthly contacts via 
supportive pamphlets. The Usual Care condition will comprise a single, Spanish-language, smoking 
cessation booklet developed by the National Cancer Institute (NCI). All participants will complete five 
assessments comprised of self-report questionnaires: a baseline assessment and four follow-up 
assessments occurring at six-month intervals, through 24 months. Participants will be paid a $20 gift card 
for completing each assessment and a bonus payment of a $50 gift card if they complete all 5 assessments.  
 
 
The subject population for the study will be comprised of male and female adult smokers recruited from the 
community and throughout the country via a variety of advertising methods. 
 
 
 
 
Inclusion criteria will include: 1)18+ years of age; 2) monolingual Spanish-speaking, or bilingual Spanish-
English and prefer educational health materials in Spanish; 3) have been smoking at least 5 cigarettes per 
week over the past year; and 4) not currently enrolled in a face-to-face smoking cessation program. Initial 
screening will be conducted via telephone. Inclusion criteria will be confirmed with data provided in the baseline 
assessment. Participants who do not meet criteria based on baseline assessment will be withdrawn. We will 
assess whether participants use any other smoking cessation services (e.g., state quitline, websites) or 
pharmacotherapy so that we can examine their impacts statistically, but we will not exclude smokers who 
utilize these widely available smoking cessation tools. To minimize treatment contamination, study 
participation will be limited to only one participant from each household address. 
 
 
b. Sources of Research Material (to be used for research purposes only) 
 
 
Questionnaires measuring sociodemographic characteristics, smoking history, current smoking status, 
motivation to quit smoking, acculturation, and evaluation of the program. Confidentiality will be maintained by 
using participant ID numbers on questionnaires, rather than names. All assessment instruments will be in 

20 
 
Spanish. Breath and saliva samples to be analyzed for carbon monoxide and nicotine from a subsample (i.e., 
participants residing within 75 miles of the laboratory) of participants at follow-up. 
 
 
c.  Potential Risks 
 
 
Risks are judged to be extremely minimal. The interventions are minimal, self-help approaches, and the 
assessment is all self-report. The only potential risk involves confidentiality and loss of privacy related to the 
information provided during telephone screening and written assessments. 
 
 
 
 
 
 
2.ADEQUECY OF PROTECTION AGAINST RISKS 
 
 
 
a. Recruitment and Informed Consent 
 
 
 
These studies do not involve any deception.  Participants will be recruited from the community and 
throughout the country through multimedia advertisements (Spanish newspapers, radio, cable TV, social 
media, public transportation signage) and community partnerships. 
 
 
Eligibility Screening: 
 
 
 
When smokers call the toll-free phone number in response to the advertisements or other recruitment 
efforts, the telephone operator will collect basic demographic information, a brief smoking history, and 
screen for the inclusion criteria. All conversations will occur in Spanish. Eligible participants will be sent a 
baseline questionnaire. The baseline questionnaire will include an introductory cover letter that contains a 
written explanation of the study and includes all the required elements of the informed consent.  All written 
materials will be in Spanish. 
 
 
Description of Informed Consent Process: 
 
All participants will have the study explained to them in full by a member of the research team including an 
explanation of risks and benefits and confidentiality of the collected information, including that data will be 
shared with investigators and the Moffitt Cancer Center. They will be informed about all of the procedures 
involved in the study as well as participation duration and compensation. Participants will be informed that 
they can freely withdraw from the study at any time without penalty. All potential participants will be given an 
opportunity to ask questions prior to providing consent. All conversations will occur in Spanish. 

21 
 
 
 
 
 
Data collection will be conducted entirely via telephone, mail, and/or internet, and recruitment will occur 
throughout the country, thus we will request a waiver of written informed consent documentation (based on 
practicality and minimal risk), which has been granted by the IRB for the previous self-help intervention 
studies. Initial verbal consent will be obtained over the telephone after the telephone operator describes the 
study, explains that participation is voluntary, and that there is no penalty for non-completion of the study 
(i.e., for not returning questionnaires). In addition, operators will describe compensation, risks and benefits to 
participation, and confidentiality of the collected information. Callers will be given the opportunity to ask any 
questions prior to giving their verbal informed decision. In addition, the baseline questionnaire will include an 
introductory cover letter that contains a written explanation of the study and includes all the required 
elements of informed consent. The letter will explain that returning the completed baseline questionnaire will 
be considered their provision of informed consent. Return of the baseline questionnaire by participants will 
signify agreement to participate and formal enrollment into the clinical trial. All conversations and documents 
will be in Spanish. 
 
 
b. Protections Against Risk 
 
 
 
Potential risks involve confidentiality and loss of privacy because participants may provide personal 
information about themselves on questionnaires. To minimize potential risks all research assistants will 
receive training in research ethics. Confidentiality will be maintained by using participant ID numbers on 
data, rather than participants' names. Participant data will be kept separate from the identifying information. 
Demographic information with identifying information will be kept in a locked file cabinet separate from study 
data with ID numbers. 
Participant data will be available only to research staff. Data will be kept in locked filing cabinets in locked 
laboratory rooms. Electronic data will be stored in a password-protected database. All results from the study 
will be published in aggregate form, and individual identifying information will not be reported. All participants 
will be fully informed that participation is voluntary and they may withdraw from the study at any time without 
penalty. 
 
 
3.POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO HUMAN SUBJECTS AND OTHERS 
 
 
 
The potential risks are judged to be very minor. The main benefit to participants is that it may increase the 
odds of them quitting smoking and remaining abstinent. In addition, they are participating in research that 
may lead to the future dissemination of interventions to help Spanish-speaking smokers to stop smoking. 
 
4.IMPORTANCE OF KNOWLEDGE TO BE GAINED 
 
 
 

22 
 
The goal of the proposed research is to increase the reach of smoking cessation treatment to Hispanics, the 
largest and fastest growing minority population in the US. Currently, few cessation interventions exist 
specifically for Spanish-speaking smokers. The proposed research study has the potential to yield a cost-
effective smoking cessation intervention designed specifically for Spanish speaking smokers. If the Spanish-
language intervention is efficacious, it has potential to have significant public health impact with respect to 
reducing smoking rates and smoking related illness and mortality among a large underserved minority 
population in the US. 
 
 
 
5.DATA SAFETY AND MONITORING PLAN 
 
 
 
Overview 
 
 
 
This is an extremely minimal risk study.  Nevertheless, the principal investigators, Drs. Brandon and 
Simmons, will implement a DSMP to ensure that the expected risk/benefit ratio is maintained throughout the 
study and that the confidentiality and accuracy of the data are preserved. All members of the study team will 
receive formal training in research ethics and HIPAA procedures through the University of South Florida 
IRB, as well as study-specific training provided during research team meetings. The study team will meet 
weekly to discuss study progress, including participant recruitment and retention, data management, any 
participant complaints, and confidentiality issues. In addition, study progress will be tracked by Moffitt 
Cancer Center’s Protocol Review and Monitoring Committee (PRMC). The probability of an adverse event 
occurring in this study is extremely low, given the nature of the study. However, as per IRB policy, any 
serious or unexpected adverse events will be reported promptly (within 2- 5 business days, depending on 
the nature of the event) to the IRB and the PRMC. A summary of the adverse events that occurred during 
the previous year will be included in the annual progress report to NIH. 
 
 
Description of the Protocol 
 
 
 
We propose a two-arm randomized design.  Participants (N =1400) will be randomized to one of two 
smoking cessation interventions. The Stop Smoking for Good intervention in Spanish (SS- SP) condition is 
comprised of a series of 10 booklets distributed over 18 months, plus additional monthly contacts via 
supportive pamphlets. The Usual Care (UC) condition will comprise a single, Spanish-language, smoking 
cessation booklet developed by the National Cancer Institute (NCI).  Specific Aim 1 will test the efficacy of a 
Spanish-language extended self-help intervention compared to usual care. As a secondary aim, we will 
evaluate moderator variables that may aid in refining and targeting of the intervention to maximize impact. 
 
Primary and Secondary Outcome Measures 
 
At each assessment point we will calculate 7-day point-prevalence abstinence rates. Point- prevalence 
measures are best for capturing the dynamic nature of cessation, maintenance, and relapse.  Continuous 
abstinence is not feasible because quit dates will be highly variable across participants, and also because 
one goal of the intervention is to encourage lapsers to quit again (recycle). We need our outcome measures 

23 
 
to reflect these changes in smoking status over time. We will also compare groups on continuous measures 
such as current smoking rate (cigarettes/day), months of smoking during the follow-up period, length of 
current abstinence period, and latency from quit date to relapse. Finally, we will calculate the cost per 
participant of each intervention, and then incremental cost-effectiveness ratios, using Usual Care as the 
reference, to determine the cost per quitter. These statistics will facilitate economic comparisons with other 
cessation interventions. 
 
 
Inclusion/exclusion Criteria 
 
 
 
1)18+ years of age; 2) monolingual Spanish-speaking, or bilingual Spanish-English and prefer educational 
health materials in Spanish; 3) have been smoking at least 5 cigarettes per week over the past year; and 4) 
not currently enrolled in a face-to-face smoking cessation program. We will assess whether participants use 
any other smoking cessation services (e.g., state quitline, websites) or pharmacotherapy so that we can 
examine their impacts statistically, but we will not exclude smokers who utilize these widely available 
smoking cessation tools. To minimize treatment contamination, study participation will be limited to only one 
participant from each household address. 
 
 
List of Participating Data Collection Centers 
 
Tobacco Research and Intervention Program at the H. Lee Moffitt Cancer Center and Research Institute, 
Tampa, Florida. 
 
 
Data Acquisition and Data Entry 
 
Participants will be randomized into the two arms (700 each) using balanced-permuted block, stratified by: 
sex, smoking rate (daily vs. non-daily smoking), and income (household income < 
$10,000) and data will be collected via (1) paper and pencil measures or (2) secure internet websites 
managed by Moffitt’s Survey Core. Data from paper and pencil measures will be input through screens 
created by the Data Systems Team within Moffitt's Research  Computing Support Group (Research IT) and 
will be subject to computerized range and consistency checks.  The data will then populate an Access 
database, which will also be created and maintained by Research IT. This process will be supervised 
jointly by the PI and Study Data Manager/Statistician. The database will be converted on a monthly basis 
to a SAS database (SAS Institute, Cary, NC). This database and SAS will be used by the statistician who 
will provide the PI with reports and summaries on a regular basis and perform  the final analyses. 
 
To ensure participant confidentiality, baseline and follow-up assessment data will not include any unique 
identifiers. 
 
 
 
 
Quality Assurance Plan 

24 
 
 
Validity checks of data values and ranges will be conducted upon data entry and again prior to analysis.  
Data entered by staff will be double-entered and compared for inconsistencies. 
Online surveys will have range checks built into the survey items, as appropriate. 
 
 
 
Reporting of AEs/SAEs 
 
This is an extremely minimal risk study and Adverse Events as a direct result of study participation are not 
anticipated. Nevertheless, the study PIs and Project Director will review Adverse Events. Adverse Events will 
be reported in accordance with the IRB and Sponsor requirements. Any serious, related adverse events 
(and unanticipated) will be reported within two days (48 hours) to the IRB and to the designated Project 
Officer at NCI using the required reporting formats.  Given the low-risk nature of the proposed research, this 
is considered an extremely remote possibility.  Any IRB actions in relation to this protocol will also be 
reported to NIH/NCI. We do not anticipate any circumstances that would necessitate early stopping of this 
minimal-risk study. 
 
 
Report of Changes or Amendments to the Protocol 
 
All changes to the protocols will be submitted and reviewed by the Moffitt Cancer Center Scientific Review 
Committee and the Institutional Review Board prior to implementation.  Major changes that affect the specific 
aims will reported to NCI for pre-approval.  Other significant changes will be reported to NCI via the annual 
reports. 
 
 
Trial Stopping Rules 
 
Given the nature of the intervention under study (i.e., informational booklets and pamphlets), we do not 
anticipate any circumstances that would call for premature stoppage of the trial. 
 
 
Conflict of Interest 
 
All key personnel comply with federal and institutional conflict of interest reporting requirements. 
 
 
 
Potential Risks and Benefits for Participants 
 
The potential risks are judged to be extremely minor. The main benefit is that participants may receive 
information to help them quit smoking and maintain abstinence.  In addition, they are 
participating in research that may lead to the future dissemination of interventions to help Spanish-
speaking smokers to stop smoking. 
 
 
 
 

25 
 
Collection and Reporting of AEs and SAEs Management of 
SAEs or other study risks See “Reporting of AEs/SAEs,” 
above. 
 
 
Plans for Interim Efficacy Analysis 
 
We do not plan interim efficacy analysis. 
 
 
 
Responsibility for Data and Safety Monitoring 
 
The study data manger/statistician will have primary responsibility for data monitoring, and the project director 
will have primary responsibility for safety monitoring. Both will report to the MPIs, who will have ultimate 
responsibility over both areas. 
 
 
Frequency of DSM Reviews 
 
DSM reviews will take place on an ongoing basis during the weekly project meetings. 
 
 
 
Content of DSM Report 
 
Any DSM-related issues will be included in the minutes of the weekly project meetings. 
 
 
 
DSM Board 
 
Not applicable 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

26 
 
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