Smartphone Application Versus Group Mindfulness-based Smoking Cessation Intervention for Cancer Patients and Survivors: Reach Versus Effectiveness
Phase: PHASE4
Conditions: Tobacco Smoking
Sponsor: University of Miami

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 1 of 24
Revised: February 2, 2022
1)
Protocol Title
Smartphone Application versus Group Mindfulness-based Smoking 
Cessation Intervention for Cancer Patients and Survivors: Reach versus 
Effectiveness
2)
Objectives*
Smoking is a major public health problem among cancer patients and survivors in 
the US. Their access to clinical-based cessation treatment is limited, and current 
evidence-based interventions fail to meet their needs. Our proposed study aims to 
tackle two major barriers to smoking cessation in cancer patients and survivors, 
by: 
1) Increasing their access to treatment through the use of smartphone technologies 
to deliver the intervention, and
2) Addressing their high level of depression by using MT for smoking cessation. 
Findings will inform a larger study of the effectiveness of cessation approaches 
with great potential for translation and dissemination to cancer patients and 
survivors who smoke throughout the US. 
3)
Background*
A. Cigarette Smoking among Cancer Survivors. 
Cancer patients and survivors are a rapidly growing population and an 
important target for tobacco treatment interventions. Smoking cessation is 
essential after cancer diagnosis to improve clinical outcomes and lower the 
risk of treatment complications1.  In 2016, it was estimated that there were 
15.5 million cancer survivors, with 98% of these individuals receiving a 
cancer diagnosis as an adult.1,2 Approximately, 18.7% of cancer survivors 
continue to smoke after cancer diagnosis.3  Continued smoking after cancer 
diagnosis can lead to the development of potential treatment interactions, 
secondary cancers, and comorbid conditions. In contrast, there are numerous 
benefits to smoking cessation, even after a cancer diagnosis, including a 
greater response to treatment protocols and reduced risk of mortality.6-8 
Therefore, given the large population of smoking cancer patients and 
survivors and the importance of smoking cessation in this population, 
improving smoking cessation among this population is a high priority. 
B. Challenges for Cessation Efforts in Cancer Survivors. 
There have been only few randomized controlled trials of smoking cessation 
interventions for adult cancer survivors. Most of these interventions were 
tested in small studies, focused within the health care setting,9,10 and did not 
demonstrate a desirable effect.10-12 In addition, several reviews concluded that 
current standard tobacco cessation interventions are not specific for cancer 
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 2 of 24
Revised: February 2, 2022
survivors and have not demonstrated the same efficacy compared to the 
general adult population.10,13 In particular, one of the major logistical 
problems with smoking cessation efforts in cancer survivors is that of 
geographic diversity. While cancer survivorship is common and growing, the 
number of cancer survivors, for example, in any given medical practice, is 
likely to be very low. Moreover, a meta-analysis review concludes that 
depression in cancer survivors is roughly twice as common as in healthy 
controls during the first 2 years after cancer diagnosis, while risk of anxiety 
disorders persist for up to 10 years or more.14 Younger and middle-aged long-
term survivors of hematologic cancers were at highest relative and absolute 
risk to be psychologically impaired.15 Continued smoking among survivors 
were significantly associated with having feeling of hopelessness, sadness, 
and anxiety most of the time, moderate to severe stress, symptoms of 
depression, and lower reported physical and emotional well-being in multiple 
studies.16-18 Therefore, it is crucial to identified innovative smoking cessation 
interventions that are easily accessible and responsive to the special needs of 
cancer survivors.
C. How to Address the Unique Psychosocial Profile of Cancer 
Survivors? 
Depression and craving are two major predictors of smoking relapse. 
Depression and anxiety among cancer patients and survivors are higher than 
that in the general population. Smoking cessation on the other hand is a major 
life stressor and is strongly linked with psychological stress, depression, and 
negative and positive affect that can lead to relapse.19,20 One promising 
strategy for smoking cessation in cancer patients and survivors is Mindfulness 
Training (MT). MT proved to be effective in reducing both self-report and 
objective indices of negative affect and psychological stress.21,22 MT also can 
help smokers control craving by being less emotionally reactive and less 
prone to relapse related to avoidance of distressing symptoms.23 MT has been 
operationalized into two components: 1) maintaining attention on immediate 
experience, and 2) maintaining an attitude of acceptance toward that 
experience, which can improve individuals’ ability to avoid absorption in 
maladaptive mental patterns, behaviors, and emotional reactions that lead to 
depression.24,25 MT was feasible and effective in cancer survivors at 
improving psychological symptoms of anxiety and stress, quality of life, 
emotional well-being, and immunological status. Yet, MT for smoking 
cessation in this population and current cancer patients has not been 
implemented or tested. 
D. How to Increase Access to Treatment? 
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 3 of 24
Revised: February 2, 2022
An increasing body of evidence indicates that technology-based interventions 
may be well received by cancer patients and survivors and hold promise for 
health promotion initiatives.26-29 Smartphone-based applications (Apps) has 
emerged as an important tool for health-related behavioral interventions. Two 
systematic reviews conclude that smartphone-based smoking cessation apps 
are effective and significantly increase access to treatment.30,31 Smartphone 
apps provide a promising medium to deliver an intervention due to the 
propensity for widespread dissemination, their availability, relatively low cost, 
and ease of use. Compared to in-person treatment, this approach can be 
standardized, reduce stigma associated with seeking treatment, allow the use 
of multiple methods to deliver the intervention (e.g., video, audio), facilitate 
the integration of the treatment into user’s daily life, help tracking user’s 
progress 24/7, and simultaneously boosting user’s engagement, a strong 
predictor of smoking cessation.32-35 In the US, smartphones’ ownership is 
projected to reach at least 90% by 2020.36 
Recently, our Consultant Dr. Brewer developed an evidence-based 
mindfulness smoking cessation app “Craving-to-Quit” adapted from an in-
person (group) MT relapse prevention smoking cessation intervention that 
proved to be effective in the general population.37-40 In Brewer et al., although 
the control group was an active treatment (has the same intensity -- 8 
counselling sessions but used different strategies of behavioral counseling for 
smoking cessation), smoking abstinence rate at the end of treatment was very 
promising in the in-person (group) mindfulness intervention (36% vs. 15% in 
the control group).37 Building on his work, and using a sequential explanatory 
design mixed-method approach of quantitative and qualitative research, we 
propose to: 1) test in a pilot 3-arm randomized clinical trial (RCT) among 
cancer patients and survivors’ smokers the feasibility, acceptability, and 
potential efficacy of the “Craving-to-Quit” app versus group MT smoking 
cessation intervention (the original intervention of the craving-to-quit), and 
usual care; and 2) fine-tune the intervention based on feedback from 
participants for further testing in Phase II large-scale RCT. The pilot clinical 
trial will provide quantitative data about the feasibility, acceptability, and 
potential efficacy of mindfulness-based smoking cessation among cancer 
patients and survivors, while interviews with members of that group later will 
offer insights to further improve the intervention. This study will establish 
preliminary evidence on the feasibility and potential efficacy of mindfulness-
based smoking cessation among cancer survivors using two delivery 
modalities, the smartphone app and group MT compared to usual care. Using 
the app to deliver the MT smoking cessation intervention holds an immense 
promise to maximize the reach of the intervention to entire cancer population, 
while delivering the intervention in-person (in groups) promises to maximize 
the effectiveness of the intervention. 
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 4 of 24
Revised: February 2, 2022
E. Innovation
In addition to targeting a vulnerable population at high risk of tobacco-related 
health disparities, the originality of this project stems from utilizing 
smartphone app, a novel, low-cost and highly scalable delivery method, to 
deliver mindfulness training merges a new treatment for smoking cessation in 
cancer patients and survivors. Mobile MT can potentially improve efficacy by 
bringing MT into real-world contexts, allow an intervention to be delivered in 
multiple methods (e.g., video, audio), and help tracking progress 
consistently.23 MT helps smokers in reducing depression and gaining greater 
sense of control over craving by being less emotionally reactive and less prone 
to relapse-related distress,23 two major predictors of smoking relapse.37,39,41 In 
addition, the RCT design will allow a direct comparison between the 
feasibility, acceptability, and potential efficacy for two delivery modalities for 
MT (group vs. smartphone app), compare to usual care.
4)
Inclusion and Exclusion Criteria*
A. Inclusion Criteria
To be eligible participants should:

Be 18 years and older 

Cancer survivors (based on the NCI definition — “a person is 
considered to be a survivor from the time of diagnosis until the end 
of life” National Cancer Institute Dictionary of Cancer Terms, 
2014)52

Cancer patients currently in active treatment

Have smoked ≥ 5 cigarettes/day in the past year

Be interested in making a quit attempt in the next 30 days

Own a smartphone (apple/android)

Read/speak English 

Able to consent

Have no plans to move in the next 3 months

Are not pregnant or planning to be pregnant in the following 3 
months
Any histologic subtype of cancer is qualified for entry into this study.
B. Exclusion Criteria
Participants would be excluded if they:
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 5 of 24
Revised: February 2, 2022

Have contraindication to NRT (past month myocardial infarction, 
history of serious arrhythmias/or unstable angina pectoris, 
dermatological disorder) 

 Are currently being treated for a psychiatric condition.

Are currently being treated for smoking cessation, alcoholism, or 
illicit drug use

Are adults unable to consent

Are individuals who are not yet adults

Are pregnant women

Are prisoners
5)
Procedures Involved*
The National Center for Complementary and Integrative Health (NCCIH) 
conceptual framework for clinical research in the mind and body will guide the pilot 
testing of the intervention.50 This project will address the first 3 questions in the 
framework: 1) is the intervention feasible and acceptable? 2) is the intervention 
beneficial? and 3) can the intervention be optimized for future studies? To answer 
these questions, we will: (1) conduct 3-arm pilot RCT among cancer patients and 
survivors smokers to test the feasibility, acceptability, and potential efficacy of (1) 
the Craving-to-Quit app vs. (2) group MT, and (3) Usual Care (UC) intervention 
(control group), and (2) conduct post-intervention interviews with participants to 
refine the two interventions.
Study Timeline
During the first 2 months, we will focus on training staff, preparing study protocol 
and instruments, preparing the data entry program, and ensuring IRB approval 
and creating list of potential participants from the cancer registry. Aim 1 (RCT) 
will take place during the following 9 months. We will recruit 10-12 participants 
per month during the first 5 months. Follow-ups and the process evaluation 
The National Center for Complementary and Integrative Health (NCCIH) 
conceptual framework for clinical research in the mind and body.
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 6 of 24
Revised: February 2, 2022
interviews (Aim 2) will be completed in the following 3 months. Final analysis 
and reporting of study results will be conducted in the final 2 months.
Mon 
1
Mon 2
Mon 
3
Mon 4
Mon 5
Mon 6
Mon 
7
Mon 8
Mon 9
Mon 10
Mon 11
Mon12
Training staff
Preparing study 
protocol 
Ensuring IRB 
approval
Recruiting for the pilot RCT (10-12 
participants per month)
Completing the 3-month 
follow-ups 
Conducting the process 
evaluation interviews
Analyzing data
Reporting of study 
results
A. Aim (1). Conduct a 3-arm Pilot Randomized Controlled Trial (RCT)
Design 
We propose a three-arm pilot RCT among cancer patients and survivors smokers 
(n=30 total; 10/arm) designed to evaluate the feasibility, acceptability, and 
potential efficacy of: (1) the Craving-to-Quit vs. (2) group MT for smoking 
cessation, and (3) Usual Care (UC) intervention (control group). Participants in 
the three study arms will receive 6 weeks supplies of Nicotine Replacement 
Treatment (NRT). In addition to matching NRT between groups, this design 
allows us to compare the effectiveness of MT smoking cessation intervention 
delivered by Craving-to-Quit app vs. group MT; and whether each of the MT 
interventions improve cessation over the UC. Participants are randomly assigned 
to blocks of 6, based on gender stratification to one of the treatment arms in a 
1:1:1 ratio using a computer-based random number generating.  Given the pilot 
nature of the study, participants will be randomized in sequence for the app, the 
in-person, and then the UC group with the goal to reach 10 participants in each 
group. All participants will receive a follow-up assessment at the end of treatment 
and 3-months after quit date. Dr. Asfar, who has years of experience in training 
and supervising cessation trials,45,47,48,51 will direct and oversea the trial and will 
be responsible for the training of two Research Assistants (RAs) in recruitment 
and conduct of the cessation trial (e.g., human subjects protection, cessation 
pharmacotherapy, the study’s protocol). The team will meet weekly with Dr. 
Asfar for supervision, and case review. Participants will receive a $50 incentive 
($15 at the baseline assessment, $15 after their quit date, and $20 at the 3-month 
follow up). All study procedures will be conducted remotely via Zoom . We will 
use REDCap to collect our data. No data are collected from the medical record.
All participants will attend an orientation session, which will be conducted via 
Zoom. Informational materials will be sent to participants via email or mail, and 
NRT will mailed.
Interventions
1. Usual Care (UC)/control: Participants in this group will receive a brief advice 
to quit smoking, 6-week supplies of NRT, and self-help materials to quit smoking.
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 7 of 24
Revised: February 2, 2022
2. Craving-to-Quit app for smoking cessation intervention: This intervention is 
based on the theory of mindfulness-based cognitive therapy (MBCT) for relapse 
prevention. The MBCT uses cognitive behavioral therapy methods in 
collaboration with MT techniques. Cognitive methods focuses on the 
development of personal coping strategies that target solving problems and 
changing unhelpful patterns in cognitions (e.g. thoughts, beliefs), behaviors, and 
emotional regulation. MT focus on becoming aware of all incoming thoughts and 
feelings and accepting them, but not attaching or reacting to them. This process is 
known as "Decentering" and aids in disengaging from self-criticism and 
rumination that can arise when reacting to negative thinking patterns. Participants 
in this group will receive one orientation session, 6-week supplies of NRT, the 
“Craving-to-Quit” app, and two brief follow-up phone calls. 
a.
Orientation session: This session will occur 21 days before quit date. It will 
be moderated by a certified instructor in MT, and will last approximately 90 min. 
During the session, a research associate will explain the purpose, format, and 
procedures of the study, and will go through the written informed consent and 
have the participant complete the baseline assessment. Participants will then 
watch a video that explains the specifics of their respective arm’s study activities.
Then, participants will be instructed to download on their phone the “Craving-to-
Quit” app and will receive a 60-minute tutorial explaining the app content and 
features to troubleshoot any issues, followed by training on how to use the app 
and to practice MT techniques introduced in the app. Participants will be 
instructed to start using the app in the next day, and set a quit date within the next 
2 weeks. Participants will receive 6 weeks of NRT, and will be instructed to start 
using the NRT at the quit date. 
b. The Craving-to-Quit app: The app is comprised of 22 modules for 22 days, 5–
15 minutes each, designed to teach MT using audio, video, and animation. 
Participants have access to only one new module per day, and subsequent days are 
locked to prevent skipping ahead (pls. see LOS from Ms. Roman from 
MindSciences). The app teaches three basic formal MT techniques including 
Body Scan (bringing awareness to different parts of the body to foster awareness 
of body sensations that constitute cravings and affective states), Loving-Kindness 
(repeating phrases such as "may X be happy” to foster acceptance of oneself and 
others), Breath Awareness (paying attention to the breath wherever one feels it 
most strongly in the body to help retrain the mind away from habitually engaging 
in self-related thinking toward a more present-centered awareness), and one 
informal MT RAIN (Recognize, Accept, Investigate, and Note what cravings feel 
like as they arise/pass away). In RAIN, participants are asked to identify their 
smoking trigger, rate their craving, and choose between using RAIN to ride out 
their craving, or completing an audio-guided exercise to ‘smoke mindfully’ by 
paying attention to the moment-to-moment experience and bodily sensations of 
smoking. The app also includes other features such as social support (quit friend 
sign-ups, the tip of the week), activity feed (to track interaction with the app), and 
my morning stats (to track smoking). 
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 8 of 24
Revised: February 2, 2022
c.
Two brief follow-up phone calls. The first phone call will occur one day 
before the quit date to remind participants about their quit date and provide 
support. The second will occur at the end of treatment (around day 60 after quit 
date) to review progress, provide support, and schedule the 3-month follow-up 
visit. Each phone call will last approximately 15 minutes. 
3. The group MT smoking cessation intervention: 
Participants in this group will receive twice weekly group sessions (eight total 
during 4 weeks) that were manualized and delivered by instructors experienced in 
MT (a single therapist with >4 years of training in MT). The intervention includes 
components that are well-matched with Craving-to-Quit. The overarching theme 
of momentary awareness and acceptance of cravings and affect (e.g., stress, 
anxiety etc.) will be introduced and reinforced in complementary ways throughout 
the training. Each session will last 45-60 minutes.
a.
Session (1): Will introduce participants to the concept of how smoking can 
become a habituated behavior triggered by an environmental, physical, or mental 
stimulus through associative learning. It also will explore how cravings feel in the 
body and how MT can help individuals become more aware of these processes. 
b. Session (2): Will examine how thoughts, emotions and body sensations 
become triggers for craving and smoking, and introduce a technique to 
‘mindfully’ work with cravings (Recognize, Accept, Investigate and Note what 
cravings feel like as they arise; acronym: RAIN). 
c.
Session (3): Will introduce how difficult emotions perpetuate smoking as well 
as a standard meditation technique called loving-kindness as a way to work with 
them. Loving-kindness is practiced through directed well wishing, typically by 
repetition of phrases such as ‘may X be happy.’ 
d. Session (4) (quit date): Will teach participants how cravings thwart long-term 
goals, and reinforce mindfulness techniques as a way to help individuals 
disengage from habitual responding and realign with their goals. 
e.
Session (5): Will introduce participants to mindfulness practice in everyday 
life, including “awareness of breath” meditation and mindful walking (“four 
modes of walking”, during which individuals practice systematically noting 
objects that they see, and then objects that they hear, then objects that they smell, 
and then tactile objects such as the pressure of their feet on the ground). 
f.
Session (6): Will explore the automaticity of thought, and how thoughts can 
lead to habitual behaviors. 
g. Session (7): Will reinforce the concept of acceptance and its role in changing 
habits. It will also explore how both mental and physical actions can “plant seeds” 
for future actions and habits. 
h.
Session (8): Will summarize the course tools and explore ways of maintaining 
these in the future. Home practice will be suggested after each session as a 
combination of formal MT meditations (the “body scan” which teaches 
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 9 of 24
Revised: February 2, 2022
individuals to systematically pay attention to different parts of their bodies as a 
way to reduce habitual mind-wandering and strengthen their attentional 
capacities, loving-kindness, and awareness of breath, which through focused 
attention on the breath also is intended to help individuals retrain their minds from 
habitually engaging in self-related pre-occupations -such as thinking about the 
past or future, or reacting to stressful stimuli- to more present moment 
awareness), and informal practices (four modes of walking, mindfulness of daily 
activities, mindfulness of smoking, RAIN). Each participant receives a meditation 
practice CD.
Retention, Follow-up, and Quality Assurance 
Extensive retention measures will be taken (e.g., collect contact information for 
close friends and family members, distribute newsletters). All participants will 
receive a follow-up assessment at 3 months after quit date to assess their smoking 
status and adherence to ART as well as get information about concomitant 
smoking and NRT use, use of additional NRT or cessation drugs (e.g., 
bupropion), and use of other tobacco methods.  Breath CO will be collected at the 
3-month follow-up points for participants who report abstinence. The breath 
sample will be collected with a portable CO monitor (coVita iCO™ 
Smokerlyzers®)). Cut-off of 6 ppm for CO will be used to determine abstinence 
(Benowitz et al 2002).
Outcome measures
1. Baseline Assessment: 
Demographics and cancer history: Age, race/ethnicity, relationship status, 
education, employment, income, time since cancer diagnosis, and cancer type and 
treatment (from medical chart), time since ending cancer treatment (if out of 
active treatment).
Smoking: Smoking history, past quit attempt, motivation to quit, confidence in 
quitting, Fagerström test for nicotine dependence,63 12-item smoking self-efficacy 
to resist urge to smoke,64 and 15-item Minnesota nicotine withdrawal scale (i.e., 
craving, irritability, anxiety, depression).65
Mindfulness skills: The five facet MT questionnaire that measures MT skills 
related to observing, describing, acting with awareness, non-judging of inner 
experience, and non-reactivity to inner experience.66 
Others: Use of technology, The 20-item Centers for the Epidemiologic Study of 
Depression (CES-D) scale,67 social support,68 quality of life,69 and alcohol and 
substance use (ASSIST).70
2. Three-month Follow-up Assessment: 
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 10 of 24
Revised: February 2, 2022
The follow up assessment will occur at 3 months (+30 days) after quit date. 
The visit will last approximately 45 minutes. 
All baseline assessment will be re-administered except demographics.
Usability: In the app group, measures of usability will be measured by: 1) The 
absolute number of times logged into the apps will be calculated for each user to 
obtain the mean number of using each app, 2) self-reported number of completed 
days for the app. And 3) level of comfort with the app “I am comfortable using 
the app.” In the group MT arm, we will collect information on number of sessions 
that was attended.
Acceptability: The acceptability will be assessed by 3 items “How satisfied 
were you with the intervention?”, “How likely are you to recommend this 
intervention to a friend?” and “How useful was the intervention?” Participants in 
Arms 2 will also complete The System Usability Scale (SUS) at call 1 & 2 and the 
3-month follow-up to evaluate the overall usability of and satisfaction with the 
app (John Brooke, 1986).
Feasibility: We will monitor rates of recruitment and effort required (e.g. number 
of staff hours) as well as the number of screenings conducted, proportion eligible, 
and proportion who agree to enroll. Feasibility of recruitment will be 
operationalized as an enrollment rate of 70% or higher (an established standard in 
the RCT literature). We will also record number of rescheduled, cancelled, and 
missed assessment visits as well as received visits/calls in each treatment arm to 
inform estimation of staffing needs and retention protocols for a planned efficacy 
RCT. Other outcomes are rate of attrition (not having a final visit at the end of 
treatment), rates of several categories of attrition (mortality, withdrawal from the 
study, transfer to non-study clinics, loss to follow-up without identifiable cause), 
and response rates to questionnaires (operationalized as 70% or higher), 
adherence/compliance rates (operationalized as completing at least 70% of the 
app’s module in arm 2 & 3), and time needed to collect and analyze data. As an 
evaluation of the feasibility of the app-based intervention, we will call participants 
in Arms 2 & 3 weekly during the 3-month trial to ask a brief set of questions 
about their mindfulness practice and use and opinions of the app.
Smoking Cessation:  Main smoking cessation outcome is 7-day point-
prevalence abstinence (defined as self-report of not smoking in the past 7-days; 
not even a puff) confirmed by expired carbon monoxide (CO) level of < 10 ng/ml 
at the 3-month follow up. Secondary outcome is the reduction in number of 
cigarettes smoked per day.71,72 Relapse is defined as smoking at least once/week 
on two consecutive weeks.73 

At the end of the intervention and 3-months after the intervention, all 3 groups 
will be asked to complete a survey with similar items to the baseline survey.
Breath CO will be will be collected at the 3-month follow-up points for 
participants who report abstinence. The breath sample will be collected with a 
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 11 of 24
Revised: February 2, 2022
portable CO monitor (Micro CO™ by Micro Direct, Inc.). Cut-off of <6 ppm for 
CO will be used to determine abstinence (Benowitz et al 2002). These portable 
CO monitors will be mailed to participants for data collection.
B.
Aim (2). Conduct a Post-intervention Evaluation
A semi-structured post-intervention evaluation interviews will be conducted with 
randomly selected participants from the Craving-to-Quit app and group MT 
groups (n=30; 10/group) to further inform our assessment of acceptability and 
perceived helpfulness of interventions, and identifying key areas for refining the 
intervention protocols (e.g., improving access, content, usability). 
This interview will be scheduled during or after the 3-month follow-up over the 
phone. It will take approximately 30-45 minutes to complete. Participants will 
receive $25 for participating. 
6)
Data and Specimen Banking*
There will be no banking or storage of data or specimens. 
7)
Data Management*
The primary focus of the proposed formative clinical research will be to 
examine the feasibility and acceptability of Craving-to-Quit app and group 
MT for smoking cessation to inform a larger planned Phase II efficacy 
RCT to be considered as a R01 grant application. Although we will 
conduct intent-to-treat analyses of our combined intervention on primary 
and secondary outcomes using data from the proposed pilot RCT, this is 
only to explore the potential for a treatment effect. There is increasing 
recognition that the effect size estimates from pilot RCTs should be 
interpreted with caution because they lack sufficient precision for 
establishing efficacy or informing subsequent power analyses.74 
Therefore, we plan to recruit 30 participants (10/arm with equal gender 
distribution) to estimate the study parameters.75 Expecting an overall  20% 
attrition rate, this will leave us with a sample of 48 participants.48,76 
However, we are planning to recruit more participant to substitute those 
who withdraw from the trial until we reach our target sample (n=30).
The analysis of the feasibility and acceptability outcomes will be mainly 
descriptive. We will use Chi-square tests and one-way ANOVA to 
compare between-group differences in baseline characteristics, indices of 
treatment implementation, adherence, retention, and treatment perceptions. 
Attrition analyses will compare respondents who complete all 
measurements to those who do not based on baseline characteristics. 
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 12 of 24
Revised: February 2, 2022
Direct maximum likelihood estimation and multiple imputation will be 
used to address incomplete data. For potential effect of treatment, we 
hypothesis that both active treatment arms (Craving-to-Quit; group MT) 
will achieve better smoking abstinence rates than the UC. Chi-square tests 
will be used to compare main outcomes (cessation) between the three arms 
at 3-month follow up. Univariate and multivariable logistic regression 
models will be used to explore baseline predictors of 3-month smoking 
cessation and adherence to ART outcomes, and the usability, acceptability, 
and feasibility of the intervention. Cross-tabulations for ordinal variables 
and mean and corresponding 95% confidence intervals for continuous 
variables will be used to explore secondary outcomes including 
improvement in depression, smoking self-efficacy, craving, quality of life, 
and mindfulness skills. Although we are unpowered to detect differences 
by gender, we will consider exploring the gender effect on our main 
outcomes in our analysis. Data management for preparing data for 
statistical analysis and statistical analysis will be performed with SAS or R 
statistical software.
A semi-structured post-intervention evaluation interviews will be 
conducted with randomly selected participants from the Craving-to-Quit 
app and group MT groups (n=30; 10/group) to further inform our 
assessment of acceptability and perceived helpfulness of interventions, 
and identifying key areas for refining the intervention protocols (e.g., 
improving access, content, usability). 
Qualitative analyses will identify emergent themes related to acceptability 
and specific targets for refinement of content and delivery. Interviews will 
be audio-recorded, transcribed verbatim, and transferred to dedoose, a 
secured platform, (https://www.dedoose.com/). This program is designed 
for the storage, coding, retrieval, and analysis of qualitative data. Two 
complementary coding schemes will be used: 1) descriptive, which uses 
words or short phrases to summarize passages of data and 2) in dedoose, 
in which actual language from participants is used to name concepts and 
themes. Extensive analytic memos will be written after each interview is 
conducted, coded, and throughout the analysis process to reflect on code 
choices, emergent themes and patterns, and conceptual models. Finally, 
the data will be themed, in which the final sets of codes and their 
meanings will be transformed into longer and more descriptive themes to 
organize recurrent meanings and patterns. Themes and definitions will be 
compared across interviews to ensure consistency and reliability.  
Statistical analyses will be done using SPSS, V21, 
(https://www.ibm.com/analytics/spss-statistics-software). 
All study data will be entered and captured by REDCap (http://project-
redcap.org/) and Velos (velos.med.miami.edu) which provides secure data capture 
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 13 of 24
Revised: February 2, 2022
for clinical and non–clinical research studies. All data will be stored in the office 
of the PI located at 1120NW 14ths St, Room 915, Miami, FL 33136. 
The University desktops require secure login credentials accessible only to the 
research team and the hard drive on the desktops have secure encryption 
technology to prevent identification. The computer is located in the research 
office accessible only to the research team by entering the office with University 
ID.
8)
Risks to Subjects*
The risks to subjects, immediate and long range, are considered minimal. Study 
participants will be asked to complete questionnaires before and after receiving 
advice to quit smoking, either self-help materials to quit or a behavioral 
intervention, as well as nicotine replacement for smoking cessation. It is possible 
that subjects might become psychologically distressed while completing the 
questionnaires or be dissatisfied with the self-help information or intervention. 
They will be provided with transdermal nicotine patches that are available over-
the-counter. Participants will be required to indicate whether they have any health 
conditions that may negatively interact with the patches. 
To minimize the risk of psychological distress due to questionnaire completion, 
the measures do not contain private or potentially embarrassing items, and will 
take about 30-45 minutes for completion time per assessment. To minimize the 
risk of dissatisfaction with the intervention, we will use an established 
intervention that has high efficacy. To minimize risks associated with the nicotine 
patches, subjects will be provided with thorough education of the indications for 
the nicotine patch, possible side effects, and known health conditions that 
preclude patch use. The patches are available over the counter; thus, they do not 
pose a significant health risk to most people. They contain minimal amounts of 
nicotine (which are much less than they get from smoking), and are absent the 
remaining 7,000 toxins contained in cigarettes. In addition, we will refer patients 
with a questionable medical history to their physician or to Jackson Memorial 
Hospital for consultation.    
Though we regard the risks of participating in this study as low, we will take 
every measure to ensure that every recruiter, interviewer or project personnel, is 
trained to handle situations sensitively and with empathy. All research staff are 
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 14 of 24
Revised: February 2, 2022
required to complete site mandated training on the Protection of Human Research 
Participants. 
9)
Potential Benefits to Subjects*
Individual subjects can potentially benefit from participating in the study because 
they may be exposed to one of three established evidence-based smoking 
cessation treatments plus transdermal nicotine patch therapy. Thus, all 
participants will have the opportunity to make a quit attempt and the possibility of 
long-term smoking cessation. This is associated with a number of additional 
benefits including improved health, economic savings, the confidence and 
happiness associated with becoming an ex-smoker, and reducing their stress as a 
result to practicing mindfulness.
10) Vulnerable Populations*
This research study does not include vulnerable populations.
11) Setting
The primary study site is the University of Miami Miller School of Medicine 
Campus. Recruitment will mostly take place at Sylvester Comprehensive Cancer 
Center clinics. The consent process, participant assessments, and group meetings 
will take place via Zoom. 
12) Resources Available
This project is a collaborative effort between investigators at University of Miami 
(Asfar, Lee, Koru-Sengul, Antoni) and a consultant from Brown University 
(Brewer) (Pls. see attached biosketches). Our team of multi-disciplinary experts in 
smoking cessation, MT, and clinical trial management and analysis is a pioneer in 
developing and testing novel smoking cessation interventions among vulnerable 
populations (e.g., minorities, childhood cancer survivors, and construction 
workers). Drs. Asfar, Lee, and Koru-Sengul have long-term collaboration on 
several epidemiological studies and community-based cessation trials.42-44 Dr. Asfar 
(PI) is a Research Assistant Professor in the Department of Public Health Sciences 
at the University of Miami (UM). She has more than 10 years of experience in 
tobacco research. She had led several clinical- and community-based smoking 
cessation trials using RCT design.45-48 Dr. Lee (Co-I) has been involved in tobacco 
research for over 20 years. Recently, he has been evaluating mindfulness-based 
interventions targeting high-stress occupational groups. Dr. Antoni is a Professor of 
psychology and psychiatry and behavioral sciences.  He is also a behavioral 
intervention theme leader, and cancer control member at the SCCC. Drs Lee and 
Antoni will assist Dr. Asfar in the development and testing of the proposed 
intervention. Dr. Koru-Sengul (Co-I), has been involved for more than 10 years in 
the design and analysis of clinical trials. She will oversee the data management and 
analysis of the RCT. Finally, Dr. Brewer (Consultant) has extensive experience in 
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 15 of 24
Revised: February 2, 2022
mindfulness-based smoking cessation interventions,23,49 and has developed the 
“Craving-to-Quit” app.37,38 He will serve as a Mindfulness domain expert on this 
project. All data will be kept at the University of Miami and there will be no data 
sharing with Brown University.
13) Prior Approvals
N/A
14) Recruitment Methods
Our target sample size is 30 cancer patients and survivors who smoke. The 
main source of recruitment will be UHealth’s Consent to Contact 
database. The Consent to Contact Initiative will provide a list of identified 
potential eligible participants who have consented to being contacted for 
research studies. Flyers will also be distributed at UM/SCCC clinics and 
various community-based clinics/organizations not directly affiliated with 
UM/SCCC, such as Jackson Health System (JHS). We will also recruit via 
advertisements on social media platforms.
We will be provided with a list of potential participants by the Consent to 
Contact Initiative. We will reach out to cancer patients and survivors who 
seem to meet criteria and have consented to be contacted for studies. We 
will be provided with a list of potential participants including their names, 
contact information, smoking status, and cancer history. Participants from 
the Consent to Contact list will be contacted by phone and invited to 
participate in the study. However, interested participants from JHS will 
contact our research staff first and then receive additional study 
information. Additionally, they may also scan the QR code included on 
the study flyer to complete the screening questions independently via 
REDCap. The staff will describe the study and screen potential 
participants to determine eligibility. Those who are not eligible, or decline 
to participate will still be encouraged to quit smoking and given a list of 
available resources. 
Those who are eligible and want to participate will be sent them an email 
with a link to complete connect to Zoom with the Research Associate and 
complete a REDCap eConsent informed consent and then the baseline 
survey. During the initial phone call they will be scheduled for an 
orientation session and Arm 3 group sessions, if applicable.
ResearchMatch.org will be utilized as a recruitment tool for this 
protocol.  ResearchMatch.org is a national electronic, web-based 
recruitment tool that was created through the Clinical & Translational 
Science Awards Consortium in 2009 and is maintained at Vanderbilt 
University as an IRB-approved data repository (Vanderbilt University 
IRB #090207).  
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 16 of 24
Revised: February 2, 2022
We will also collaborate with St. Jude who will assist in identifying 
eligible patients from their hospital. They will provide eligible patients 
with information about the study, our team’s contact info, and study flyer 
so patients can contact our research staff directly or scan the QR code 
included on the study flyer to complete the screening questions 
independently via REDCap. We will in turn provide St. Jude with a list of 
their patients who have been screened and enrolled so they can update 
their records. After UM IRB approval is granted, they will pursue IRB 
approval from their institution and will request a reliance agreement be set 
up with UM as the IRB of record.
Participants will receive up to a $50 incentive for their time and 
participation in the program: $15 after completing the baseline assessment, 
$15 after their quit date, and $20 at the 3-month follow up. Participants 
who complete the post-intervention evaluation interview will receive an 
additional $25 for participating. These payments will be made via an 
electronic gift card or cash transfer app.
Participants can expect to be in the study for 3 months. 
15) Local Number of Subjects
Our target sample size is 30 cancer patients and survivors who smoke.
16) Confidentiality
Multiple steps will be taken to guarantee confidentiality. All electronic surveys 
and forms will be entered and uploaded using Research Electronic Data Capture 
(REDCap). All REDCap data is securely hosted by the University of Miami’s IT 
Department. Research IT administers project creation, user account management, 
and movement of projects from development to production. Authentication is 
performed via CaneID Authentication Service (CAS), the same institution-wide 
system used for a variety of applications such as mum.  Other electronic data will 
be stored in password-protected files that only the PI and study staff will be able 
to access. Participants will be assigned an ID# in REDCap and a master key 
linking names and ID# will be kept in a separate location accessible only 
approved study personnel.
There are multiple levels of security once placed on the local network.  All study 
personnel will be certified to conduct human subjects’ research by the University 
of Miami Institutional Review Board. All data will be inspected for quality 
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 17 of 24
Revised: February 2, 2022
assurance prior to analysis. Prior to performing statistical analyses on quantitative 
data, the data will be checked, screened and verified.
In order to enhance privacy when conducting the sessions via Zoom, participants 
will be instructed not to share the meeting link with anyone; for the privacy of all 
participants to attend the session in a private setting without others in the 
background; to change their location if it other people come into the area; to not 
discuss anything shared in the session with others; and to not share any sensitive 
personal data during the session. Participants will be also placed in the Zoom 
waiting room and admitted only by the research staff.
Jackson Health System additional requirement
 This section is not applicable because the research is not collecting health information 
from JHS under a waiver of authorization (without obtaining a HIPAA authorization 
from the participant)
If health information, including Protected Health Information and/or Personally 
Identifiable Information are collected from JHS without a signed authorization from the 
subject (with a waiver of authorization from an IRB or Privacy Board), you must agree to 
the following:  
 JHS data, including Protected Health Information (PHI) and/or Personally 
Identifiable Information (PII), acquired from JHS for this research with a 
waiver of the requirement for an authorization under HIPAA shall only be 
stored on the secured JHS SharePoint environment made available by JHS. 
I and the Study Team members shall not copy or store the JHS sourced 
personally identifiable information (PII), including protected health 
information (PHI) data to any other system, including any systems 
maintained or provided by the University of Miami. I and the Study Team 
shall only copy or transfer JHS-sourced data that has been properly de-
identified in accordance with all requirements contained in the HIPAA 
Rules by removing all of the identifiers listed in the instructions for Section 
15 of this protocol.
If the data obtained for this research will be acquired from a retrospective “chart review” 
involving health information from JHS with a waiver of authorization (without obtaining 
an signed HIPAA authorization from the subject) then the data and the link and/or key to 
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 18 of 24
Revised: February 2, 2022
each subject’s identity shall only be maintained in the secure JHS SharePoint environment 
made available by JHS. 
17) Provisions to Protect the Privacy Interests of Subjects
The Sylvester Comprehensive Cancer Center Data and Safety Monitoring 
Committee (DSMC) will monitor the study according the Cancer Center’s data 
and safety monitoring plan. 
18) Consent Process
Participants will be consented using the REDCap eConsent function during a 
Zoom meeting with the Research Associate. Permission to audio record the 
consent process will be attained from all participants. All participants will also 
be offered a copy of the informed consent for their records. 
19) Process to Document Consent in Writing
Participants will sign an electronic consent form using REDCap eConsent for 
participation in this study. In the event that participants have difficulty 
completing the electronic consent in REDCap via Zoom, we will mail them a 
copy, have them sign while on Zoom, and ask them to mail it back to us. A copy 
of consent will be provided to participants. The consent will also include 
information regarding who they can call if they have any questions regarding 
their participation in the study. The consent process will be thorough to ensure 
that any questions participants may have will be fully considered and answered. 
The consent process will be documented via REDCap and an internal tracking 
database. 
20) Withdrawal of Subjects
Participation in study is voluntary. Participants can elect not to answer any 
specific question on the survey or interview and can elect not to participate in any 
procedures or all procedures of the study.
Stopping rules for the individual subject: For any reported adverse event, the PI 
must decide whether the event should be classified as serious or not. We use the 
standard UM Clinic IRB definition for Serious Adverse Events per FDA 
guidelines. The PI or co-investigator (Drs. Lee, and Antoni) will cooperate and 
provide assistance to any personal physician treating the participant for this 
adverse event in order to facilitate the clinical management of the patient. If the 
adverse event is thought to be related to study participation, the investigator may 
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 19 of 24
Revised: February 2, 2022
request the participant to undergo a physical examination, psychiatric evaluation, 
and/or laboratory testing whenever appropriate.
21) Waiver of Authorization for Use and Disclosure of Protected 
Health Information (HIPAA) 
 Yes.  Consent to contact process
Confirm that you will destroy the Protected Health Information (PHI) you and/or 
your Study Team acquire receive from JHS and/or UHealth at the earliest 
opportunity. 
☒    I confirm 
Confirm that the Protected Health Inform (PHI) you acquire from JHS and/or 
UHealth will not be re-used or disclosed to any other person or entity, except as 
required by law or for authorized oversight of the research study or for other research 
for which the use or disclosure of PHI is permissible.           
☒     I confirm  
Notwithstanding the preceding “I confirm” statements above, I agree that neither I nor 
any member of the study team listed on the IRB submission for this Protocol shall ever 
re-use or re-disclose any of the information acquired from Jackson Health System in any 
format, whether identifiable or de-identified, to any individual or entity without first 
obtaining written permission from Jackson Health System, even if such re-use or re-
disclosure is permissible by law (e.g., HIPAA).
  
 
       4/1/2024
______________________________________________
PI Signature                                                               Date
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 20 of 24
Revised: February 2, 2022
References
1.
Siegel R, DeSantis C, Virgo K, et al. Cancer treatment and survivorship statistics, 
2012. CA: a cancer journal for clinicians. 2012;62(4):220-241.
2.
National Cancer Institute. Statistics. 2019; 
https://cancercontrol.cancer.gov/ocs/statistics/statistics.html.
3.
Mayer DK, Carlson J. Smoking patterns in cancer survivors. Nicotine & Tobacco 
Research. 2010;13(1):34-40.
4.
Harding M. Health-promotion behaviors and psychological distress in cancer 
survivors. Paper presented at: Oncology nursing forum2012.
5.
Asfar T, Dietz NA, Arheart KL, et al. Smoking behavior among adult childhood 
cancer survivors: what are we missing? Journal of Cancer Survivorship. 2015:1-
11.
6.
Browman GP, Wong G, Hodson I, et al. Influence of cigarette smoking on the 
efficacy of radiation therapy in head and neck cancer. New England Journal of 
Medicine. 1993;328(3):159-163.
7.
Parsons A, Daley A, Begh R, Aveyard P. Influence of smoking cessation after 
diagnosis of early stage lung cancer on prognosis: systematic review of 
observational studies with meta-analysis. Bmj. 2010;340:b5569.
8.
US Department of Health and Human Services, Centers for Disease Control and 
Prevention, National Center for Chronic Disease Prevention and Health 
Promotion, Office on Smoking and Health. The Health Consequences of 
Smoking—50 Years of Progress: A Report of the Surgeon General. 2014.
9.
de Moor JS, Elder K, Emmons KM. Smoking prevention and cessation 
interventions for cancer survivors. Paper presented at: Seminars in oncology 
nursing2008.
10.
Nayan S, Gupta MK, Strychowsky JE, Sommer DD. Smoking cessation 
interventions and cessation rates in the oncology population: an updated 
systematic review and meta-analysis. Otolaryngology--Head and Neck Surgery. 
2013;149(2):200-211.
11.
Klesges RC, Krukowski RA, Klosky JL, et al. Efficacy of a Tobacco Quitline 
among Adult Cancer Survivors. Preventive medicine. 2015.
12.
Klesges RC, Krukowski RA, Klosky JL, et al. Efficacy of a Tobacco Quitline 
Among Adult Survivors of Childhood Cancer. Nicotine Tob Res. 2014.
13.
Toll BA, Brandon TH, Gritz ER, Warren GW, Herbst RS. Assessing tobacco use 
by cancer patients and facilitating cessation: an American Association for Cancer 
Research policy statement. Clinical Cancer Research. 2013;19(8):1941-1948.
14.
Mitchell AJ, Ferguson DW, Gill J, Paul J, Symonds P. Depression and anxiety in 
long-term cancer survivors compared with spouses and healthy controls: a 
systematic review and meta-analysis. The lancet oncology. 2013;14(8):721-732.
15.
Kuba K, Esser P, Mehnert A, et al. Risk for depression and anxiety in long-term 
survivors of hematologic cancer. Health Psychology. 2019;38(3):187.
16.
Berg CJ, Thomas AN, Mertens AC, et al. Correlates of continued smoking versus 
cessation among survivors of smoking‐related cancers. Psycho‐Oncology. 
2013;22(4):799-806.
17.
Kim H, Kim M-H, Park Y-S, Shin JY, Song Y-M. Factors that predict persistent 
smoking of cancer survivors. Journal of Korean medical science. 2015;30(7):853-
859.
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 21 of 24
Revised: February 2, 2022
18.
Harding M. Health-promotion behaviors and psychological distress in cancer 
survivors. Oncol Nurs Forum. 2012;39(2):E132-140.
19.
Cinciripini PM, Wetter DW, Fouladi RT, et al. The effects of depressed mood on 
smoking cessation: Mediation by postcessation self-efficacy. Journal of 
consulting and clinical psychology. 2003;71(2):292.
20.
Borrelli B, Niaura R, Keuthen NJ, Goldstein MG. Development of major 
depressive disorder during smoking-cessation treatment. The Journal of clinical 
psychiatry. 1996.
21.
Davidson RJ, Kabat-Zinn J, Schumacher J, et al. Alterations in brain and immune 
function produced by mindfulness meditation. Psychosomatic medicine. 
2003;65(4):564-570.
22.
Baer RA. Mindfulness training as a clinical intervention: A conceptual and 
empirical review. Clinical psychology: Science and practice. 2003;10(2):125-143.
23.
Elwafi HM, Witkiewitz K, Mallik S, Thornhill IV TA, Brewer JA. Mindfulness 
training for smoking cessation: Moderation of the relationship between craving 
and cigarette use. Drug & Alcohol Dependence. 2013;130(1):222-229.
24.
Kabat-Zinn J. Wherever you go, there you are: Mindfulness meditation in 
everyday life. Hachette Books; 2009.
25.
Malinowski P. Neural mechanisms of attentional control in mindfulness 
meditation. Frontiers in neuroscience. 2013;7:8.
26.
Free C, Phillips G, Galli L, et al. The effectiveness of mobile-health technology-
based health behaviour change or disease management interventions for health 
care consumers: a systematic review. PLoS medicine. 2013;10(1):e1001362.
27.
Hong YA, Goldberg D, Ory MG, et al. Efficacy of a mobile-enabled Web app 
(iCanFit) in promoting physical activity among older cancer survivors: a pilot 
study. JMIR cancer. 2015;1(1).
28.
O’Reilly GA, Spruijt-Metz D. Current mHealth technologies for physical activity 
assessment and promotion. American journal of preventive medicine. 
2013;45(4):501-507.
29.
Bantum EOC, Albright CL, White KK, et al. Surviving and thriving with cancer 
using a Web-based health behavior change intervention: randomized controlled 
trial. Journal of medical Internet research. 2014;16(2).
30.
Haskins BL, Lesperance D, Gibbons P, Boudreaux ED. A systematic review of 
smartphone applications for smoking cessation. Translational behavioral 
medicine. 2017;7(2):292-299.
31.
Regmi K, Kassim N, Ahmad N, Tuah N. Effectiveness of mobile apps for smoking 
cessation: A review. Tob Prev Cessation. 2017;3:1-11.
32.
Shahab L, McEwen A. Online support for smoking cessation: a systematic review 
of the literature. Addiction. 2009;104(11):1792-1804.
33.
Bricker JB, Mull KE, Kientz JA, et al. Randomized, controlled pilot trial of a 
smartphone app for smoking cessation using acceptance and commitment 
therapy. Drug & Alcohol Dependence. 2014;143:87-94.
34.
Richardson A, Graham AL, Cobb N, et al. Engagement promotes abstinence in a 
web-based cessation intervention: cohort study. Journal of medical Internet 
research. 2013;15(1).
35.
Civljak M, Sheikh A, Stead LF, Car J. Internet-based interventions for smoking 
cessation. Cochrane Database Syst Rev. 2010;9(9).
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 22 of 24
Revised: February 2, 2022
36.
Pew Internet and American Life Project. Americans’ Views on Mobile Etiquette. 
Chapter 1: Always on Connectivity. : . 2015; 
http://www.pewinternet.org/2015/08/26/chapter-1-always-on-connectivity/.
37.
Brewer JA, Mallik S, Babuscio TA, et al. Mindfulness training for smoking 
cessation: results from a randomized controlled trial. Drug & Alcohol 
Dependence. 2011;119(1):72-80.
38.
Garrison KA, Pal P, Rojiani R, Dallery J, O’Malley SS, Brewer JA. A randomized 
controlled trial of smartphone-based mindfulness training for smoking cessation: 
a study protocol. BMC psychiatry. 2015;15(1):83.
39.
Brewer JA, Elwafi HM, Davis JH. Craving to quit: Psychological models and 
neurobiological mechanisms of mindfulness training as treatment for addictions. 
2014.
40.
Garrison KA, Pal P, O’Malley SS, et al. Craving to Quit: A Randomized 
Controlled Trial of Smartphone app-based Mindfulness Training for Smoking 
Cessation. Nicotine & Tobacco Research. 2018.
41.
Koszycki D, Benger M, Shlik J, Bradwejn J. Randomized trial of a meditation-
based stress reduction program and cognitive behavior therapy in generalized 
social anxiety disorder. Behaviour Research and Therapy. 2007;45(10):2518-
2526.
42.
Webb Hooper M, Antoni MH, Okuyemi K, Dietz NA, Resnicow K. Randomized 
controlled trial of group-based culturally specific cognitive behavioral therapy 
among African American smokers. Nicotine & Tobacco Research. 
2017;19(3):333-341.
43.
Webb MH, Asfar T, Unrod M, et al. Reasons for Exclusion from a Smoking 
Cessation Trial: An Analysis by Race/Ethnicity. Ethnicity & disease. 
2019;29(1):23-30.
44.
Asfar T, Arheart KL, Koru-Sengul T, et al. National estimates and correlates of 
secondhand smoke exposure in US cancer survivors. Journal of Cancer 
Survivorship. 2017:1-8.
45.
Asfar T, Klesges RC, Sanford SD, et al. Trial design: The St. Jude Children's 
Research Hospital Cancer Survivors Tobacco Quit Line study. Contemp Clin 
Trials. 2010;31(1):82-91.
46.
Asfar, Caban-Martinez AJ, McClure LA, et al. A cluster randomized pilot trial of a 
tailored worksite smoking cessation intervention targeting Hispanic/Latino 
construction workers: Intervention development and research design. 
Contemporary clinical trials. 2018, b;67:47-55.
47.
Asfar T, Weg MV, Maziak W, Hammal F, Eissenberg T, Ward KD. Outcomes and 
adherence in Syria's first smoking cessation trial. Am J Health Behav. 
2008;32(2):146-156.
48.
Ward KD, Asfar T, Al Ali R, et al. Randomized trial of the effectiveness of 
combined behavioral/pharmacological smoking cessation treatment in Syrian 
primary care clinics. Addiction. 2012:n/a-n/a.
49.
Mason AE, Jhaveri K, Cohn M, Brewer JA. Testing a mobile mindful eating 
intervention targeting craving-related eating: feasibility and proof of concept. 
Journal of behavioral medicine. 2018;41(2):160-173.
50.
The National Center for Complementary and Integrative Health. Framework for 
Developing and Testing Mind and Body Interventions. 2017; 
https://nccih.nih.gov/grants/mindbody/framework.
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 23 of 24
Revised: February 2, 2022
51.
Asfar T, Al Ali R, Rastam S, Maziak W, Ward KD. Behavioral Cessation 
Treatment of Waterpipe Smoking: The First Pilot Randomized Controlled Trial. 
Addictive Behaviors. 2014.
52.
NCI. NCI Dictionary of Cancer Terms. 2019; 
https://www.cancer.gov/publications/dictionaries/cancer-
terms/search?contains=false&q=survivor.
53.
Fiore MC, Jaén CR, Baker TB, et al., eds. Treating Tobacco Use and 
Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. 
Department of Health and Human Services 2008. Quality AfHRa, ed.
54.
Sipe WE, Eisendrath SJ. Mindfulness-based cognitive therapy: theory and 
practice. The Canadian Journal of Psychiatry. 2012;57(2):63-69.
55.
Beck JS. Cognitive behavior therapy: Basics and beyond. Guilford press; 2011.
56.
Hayes SC, Villatte M, Levin M, Hildebrandt M. Open, aware, and active: 
Contextual approaches as an emerging trend in the behavioral and cognitive 
therapies. Annual review of clinical psychology. 2011;7:141-168.
57.
Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain 
patients based on the practice of mindfulness meditation: Theoretical 
considerations and preliminary results. General hospital psychiatry. 1982;4(1):33-
47.
58.
Gunaratana H. Mindfulness in Plain English (Revised and Expanded ed.). 
Boston: Widom. 2002.
59.
Rebagliato M. Validation of self reported smoking. Journal of Epidemiology and 
Community Health. 2002;56(3):163-164.
60.
Centers for Disease Control and Prevention, National Center for Environmental 
Health. National report on human exposure to environmental chemicals. 
Atlanta2001.
61.
Asfar T, Caban-Martinez AJ, McClure LA, et al. A cluster randomized pilot trial of 
a tailored worksite smoking cessation intervention targeting Hispanic/Latino 
construction workers: Intervention development and research design. 
Contemporary clinical trials. 2018;67:47-55.
62.
Sechrest et al. Evaluation of treatment program. 1979.
63.
Heatherton TF, Kozlowski LT, Frecker RC, FAGERSTROM KO. The Fagerström 
test for nicotine dependence: a revision of the Fagerstrom Tolerance 
Questionnaire. Addiction. 1991;86(9):1119-1127.
64.
Etter JF, Bergman MM, Humair JP, Perneger TV. Development and validation of 
a scale measuring self‐efficacy of current and former smokers. Addiction. 
2000;95(6):901-913.
65.
Hughes JR. Effects of abstinence from tobacco: valid symptoms and time course. 
Nicotine & Tobacco Research. 2007;9(3):315-327.
66.
Baer RA, Smith GT, Allen KB. Assessment of mindfulness by self-report: The 
Kentucky Inventory of Mindfulness Skills. Assessment. 2004;11(3):191-206.
67.
Radloff LS. The CES-D scale: A self-report depression scale for research in the 
general population. Applied psychological measurement. 1977;1(3):385-401.
68.
Zimet GD, Dahlem NW, Zimet SG, Farley GK. The multidimensional scale of 
perceived social support. Journal of personality assessment. 1988;52(1):30-41.
69.
Stevanovic D. Quality of Life Enjoyment and Satisfaction Questionnaire–short 
form for quality of life assessments in clinical practice: A psychometric study. 
Journal of Psychiatric and Mental Health Nursing. 2011;18(8):744-750.
-       Study #: 20190328        Effective Date: 4/2/2024

Date: 4/1/2024
Protocol Version: 5
IRB Study Number: 20190328
NCT04038255
Page 24 of 24
Revised: February 2, 2022
70.
Humeniuk R, Ali R, Babor TF, et al. Validation of the alcohol, smoking and 
substance involvement screening test (ASSIST). Addiction. 2008;103(6):1039-
1047.
71.
Asfar T, Ebbert JO, Klesges RC, Relyea GE. Do smoking reduction interventions 
promote cessation in smokers not ready to quit? Addictive Behaviors. 
2011;36(7):764-768.
72.
Asfar T, Ebbert JO, Klesges RC, Klosky JL. Use of smoking reduction strategies 
among U.S. tobacco quitlines. Addictive Behaviors. 2012;37(4):583-586.
73.
Hughes JR, Hatsukami D. Signs and Symptoms of Tobacco Withdrawal. 
Archives of General Psychiatry. 1986;43(3):289-294.
74.
Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding 
the use of pilot studies to guide power calculations for study proposals. Archives 
of general psychiatry. 2006;63(5):484-489.
75.
Browne RH. On the use of a pilot sample for sample size determination. 
Statistics in Medicine. 1995;14(17):1933-1940.
76.
Klesges RC, Brown K, Pascale RW, Murphy M, Williams E, Cigrang JA. Factors 
associated with participation, attrition, and outcome in a smoking cessation 
program at the workplace. Health Psychol. 1988;7(6):575.
New References 
1) Matulewicz, Richard S., Scott Sherman, and Marc A. Bjurlin. "Smoking 
cessation and cancer survivorship." JAMA 324, no. 14 (2020): 1475-1475.
-       Study #: 20190328        Effective Date: 4/2/2024