Mindfulness-Based Ecological Momentary Intervention For Smoking Cessation Among Cancer Survivors
Phase: PHASE1
Conditions: Any Cancer Type
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

 PI: YANG  
 
TITLE:  Mindfulness-based ecological momentary intervention for smoking 
cessation among cancer survivors 
 
Coordinating Center: 
H. Lee Moffitt Cancer Center 
 
Principal Investigator: 
Min-Jeong Yang, PhD 
 
Moffitt Cancer Center 
 
12902 Magnolia Drive, MFC-TRIP 
Tampa, Fl 33612 
 
Phone: 813-745-1719 
Fax: NA 
Email: min-jeong.yang@moffitt.org 
 
Co-Investigators: 
Christine Vinci, PhD 
 
Vani Simmons, PhD 
 
Steven Sutton, PhD 
 
Smitha Pabbathi, MD 
 
Lee Ritterband, PhD (external) 
 
 
 
Protocol Version #7 Date: 05/02/2024 
 
 
 
Protocol Type: 
_x__ external grant  

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TABLE OF CONTENTS 
 
 
Page 
1. SPECIFIC AIMS  ...................................................................................................... B3 
 
2. BACKGROUND  AND SIGNIFICANCE .................................................................. B4 
 
3. PARTICIPANT SELECTION ................................................................................... B6 
 
4. STUDY DESIGN AND METHODS .......................................................................... B7 
 
5. STUDY CALENDAR ............................................................................................. B11 
 
6. REGULATORY AND REPORTING REQUIREMENTS ......................................... B11 
 
7. STATISTICAL CONSIDERATIONS ...................................................................... B11 
 
 
REFERENCES ........................................................................................................... B13 
 

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1. SPECIFIC AIMS 
Continued tobacco use among cancer survivors (hereafter called survivors) is a cause of second 
primary cancers and high mortality.1,2 Despite greater acute health risks from resuming smoking for 
individuals with cancer, smoking prevalence among survivors is higher than, or comparable to, those 
without a cancer history.3 Importantly, regardless of the high quit rate at cancer diagnosis,4 more than 
half of survivors who attempt to quit resume smoking within a few months.5 Notably, existing smoking 
cessation trials for survivors have not demonstrated consistent results.6 Such results might be due to 
a lack of understanding in the dynamic relation between cancer-specific (e.g., fatigue, pain, fear of 
cancer recurrence) and general smoking processes (e.g., negative affect) contributing to smoking 
relapse in real-time.4 Given the prominent role of distress as a predictor of smoking relapse7,8 and 
chronic distress among survivors,9 it may be more challenging to reduce the effect of distress on 
smoking in this population vs the general population. Importantly, the synergistic effect of cancer-
specific and general smoking vulnerabilities are linked to a higher likelihood of relapse.5,10-12 Given 
the projected 31.4% increase in the number of survivors by 2030,9 there is an urgent need to develop 
targeted, accessible, and scalable smoking cessation interventions for survivors to improve quality of 
life and decrease mortality.  
Mindfulness-based interventions (MBIs) have great potential to enhance tobacco abstinence. 
MBIs have demonstrated efficacy among general smokers for craving and relapse.13 The primary 
mechanism of MBIs is the weakening of the association of distress and smoking through enhanced 
self-regulatory processes.14 Although promising, there has been only 1 single-arm, feasibility study 
examining an MBI for smoking cessation among survivors, which consisted of 8 weekly 2-hour in-
person group sessions.15 This time-intensive and in-person format of traditional MBIs has been 
identified as a barrier to access.15,16 It also fails to leverage treatment delivery in the real world where 
efforts to quit smoking take place. Using a mobile health (mHealth) approach may address both 
issues. However, little effort has been made to integrate the core therapeutic elements of MBIs with 
mHealth, which could constrain the processes of acceptance and awareness.17 Thus, an mHealth 
MBI for smoking cessation tailored for survivors, with an emphasis on the strategic delivery of 
practices and implementation of core therapeutic ingredients would enhance accessibility, target key 
mechanisms, lessen patient burden, and reduce cancer-specific cessation barriers for patients (e.g., 
shame, guilt). Further, including psychometrically sound measures to assess momentary changes of 
relapse vulnerabilities in real-time would aid in testing the efficacy of an mHealth MBI. The overall 
objective of this application is to develop a mindfulness-based ecological momentary intervention 
(mindEMI) for smoking cessation for survivors.  
Aim 1. To develop a mindfulness-based EMI (mindEMI) targeting cancer-specific smoking 
vulnerabilities through an iterative multi-step process. Three phases are planned: (1) In-depth 
qualitative interviews with 15 survivors on their perception of existing mHealth MBI approaches and 
feedback on the utility and acceptability of key MBI practices (e.g., breathing meditation, brief 
mindfulness strategies); (2) Create an initial draft of the intervention 
Aim 2. To pilot test the mindEMI among cancer survivors. We will obtain feedback from 
another 10 survivors who will pilot the prototype of mindEMI that will deliver the MBI in real-time at 
both random moments and when high levels of smoking vulnerability are self-reported via EMA. The 
primary outcomes will be participants’ open-ended feedback along with perceived utility and likability 
of the mindEMI and retention through the end of treatment.  
This novel cessation intervention and demonstration of key feasibility and acceptability 
benchmarks, combined with the focused training plan, will lead to a future R01 trial of mindEMI for 
smoking cessation tailored for survivors. Ultimately, the intervention will dismantle cancer-specific and 
general risk factors of smoking relapse, with high accessibility, scalability, and the ability to intervene 
in real-time, thus increasing effect.  
 
 

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2. BACKGROUND AND SIGNIFICANCE 
 
2.1. Cancer and Smoking 
Continued smoking after a diagnosis of cancer is linked to an increased risk of lowered 
effectiveness of cancer treatment, cancer-related mortality, developing a secondary primary cancer, 
worse quality of life,18,19  and increased cancer treatment costs ($3.4 billion/year).20 Despite greater 
acute health risks of resuming smoking, higher smoking prevalence is observed among cancer 
survivors (“survivors”) than those without a cancer history.3,21 Among those who make a quit attempt 
after cancer diagnosis (e.g., 31.4%),5 the relapse rate of over 50% is alarming.4,5 As such, promoting 
smoking cessation is recognized as an essential part of cancer care.22,23 However, the efficacy of 
smoking cessation interventions and strategies that are effective for general smokers has been 
minimal for survivors.6,24 This is likely due to a critical gap in the literature: Lack of understanding in 
real-time dynamic relations between cancer-specific (e.g., pain) and general smoking vulnerabilities 
(e.g., negative affect), which might synergistically increase the likelihood of smoking relapse.5,10-12 
Given the impact of chronic distress in relapse,7,8 survivors may face a particular challenge with 
cessation. With the projected 31.4% increase in the number of survivors (i.e., 22.1 million) by 2030,9 
there is an urgent need to develop targeted and scalable smoking cessation interventions for 
survivors with an emphasis on the interrelations between cancer-specific and general smoking 
vulnerabilities to improve mortality and quality of life. 
 
2.2. Mindfulness and Smoking 
Mindfulness-based interventions (MBIs) that cultivate awareness and acceptance of momentary 
experience25,26 are a promising approach to tobacco abstinence among survivors. From a theoretical 
perspective (e.g., Monitor and Acceptance Theory),27-30 MBIs are particularly efficacious for those in 
high stress situations, as MBIs can weaken the association between triggers (e.g., distress) and 
learned behaviors such as substance use, thereby reducing reactivity to triggers. This process occurs 
through purposefully paying attention, in a non-judgmental way, to the automatic cycle of triggers and 
present-moment experience. Among general smokers (i.e., non-cancer survivors), empirical evidence 
supports this theoretical framework by demonstrating a weakened association of craving and 
smoking31 through enhanced self-regulatory processes14 and decreased neural response to 
cigarettes32 and emotional cues,33 leading to successful quitting.34,35 Notably, MBIs have 
demonstrated efficacy in enhancing smoking outcomes among general smokers for craving, 
relapse,13,34-36 and abstinence.34,35,37,38 Nonetheless, MBIs for smoking cessation among survivors 
have been limited to 1 small-scale feasibility study conducted via in-person group treatment.15 
There are at least 3 reasons why MBIs hold promise for survivors who continue to smoke. First, 
MBIs improve cancer-related psychological difficulties, implicating their potential in smoking cessation 
for survivors. Meta-analyses have shown that MBIs improve pain, fatigue, quality of life, fear of cancer 
recurrence, and sleep disturbance.39-41 Further, in general population, mindfulness is positively 
associated with motivation to engage in behaviors because of genuine interest.42 Thus, MBIs may aid 
in managing cancer-related psychological difficulties that may interact with general smoking 
vulnerabilities, thereby facilitating quitting through enhanced motivation to sustain cessation efforts.34 
Second, MBIs may facilitate extinction of learned smoking behaviors (e.g., craving = grabbing a 
cigarette) by purposefully paying attention to the “autopilot” process of smoking (i.e., awareness), 
cultivating the ability to stay with craving and stress (i.e., acceptance), and enhancing self-regulatory 
processes, thereby attenuating the likelihood of smoking relapse.14,43 Survivors are more likely to face 
challenges in cessation because of the synergistic effects of cancer-specific and general smoking 
vulnerabilities, as indicated by a higher rate of continued smoking among those with a tobacco-
related cancer (vs other cancers)21 and higher smoking prevalence compared to those without a 
cancer history.21,44 Third, MBIs may alleviate cancer-specific cessation barriers such as guilt, 
shame4,5,10 among survivors. Contrary to other tobacco cessation approaches (e.g., cognitive 

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behavior therapy), MBIs put less emphasis on psychoeducation and skill-building and more on an 
individual’s experiential learning. Although MBIs provide psychoeducational content, the focus is to 
cultivate resiliency to distress45 through an inquiry-based learning process (i.e., explicit exploration of 
one’s experience during mindfulness practices). Such process can aid in the reduction of guilt and 
shame by shifting in perspective (i.e., decentering) and taking a more objective perspective toward a 
given situation.46  
 
2.3. mHealth and Smoking 
Smoking cessation interventions delivered via smartphone applications (apps) have flourished 
over the last 5 years47-53 and their feasibility and acceptability have been supported with high 
retention and abstinence rates among general smokers.48,50,52 A noted advantage of mHealth is the 
ability to deliver intervention content when it is most needed, such as the moment of vulnerability that 
precipitates lapse/relapse of smoking.54 As revealed by ecological momentary assessment (EMA) 
studies among daily smokers, momentary risk factors of relapse include negative affect (NA),55 
urge,55 positive affect (PA),56 stress,57 and the varying real-time dynamic relations of risk factors in the 
course of cessation efforts,58 consistent with the Dynamic Model of Relapse in substance use.59 
Though data are limited, such momentary risk factors are highly likely to be amplified by cancer-
specific smoking vulnerabilities among survivors. Thus, if the intervention is delivered in the presence 
of momentary vulnerability (i.e., ecological momentary intervention [EMI]), the smoking abstinence 
would be facilitated. Figure 1 summarizes our conceptual framework that is informed by several 
theoretical models described above.27-29,59 Indeed, preliminary results from EMIs49,50 support this 
approach. 
To date, there has been 1 full-scale 
randomized controlled trial (RCT) of an 
mHealth MBI for smoking cessation among 
general smokers,47 in which a smartphone app 
provided 22 modules of an MBI in various 
forms (e.g., audio, video) for 22 consecutive 
days.60 Notably, the association between 
craving and smoking was significantly weakened in the MBI arm (vs inactive control) and cue 
reactivity decreased at the neuronal level, which was associated with reduced daily cigarette use.32 
These promising results suggest that an MBI delivered via app is not only feasible but may also alter 
the strength of the association between craving and smoking at both behavioral and neuronal levels. 
However, biochemically verified abstinence at follow-up was not different between conditions, 
potentially because of a non-intended treatment component in the control condition (e.g., self-
monitoring).47 This app is currently being tested among young adult survivors,61 although it has not 
been tailored for survivors and does not incorporate EMI design or inquiry exercises,47,60 a key 
therapeutic component of MBIs that facilitates the learning process of acceptance and awareness.17 
Given the more frequent mindfulness practice, the better cessation outcomes,37 MBIs could be 
maximized by promoting the practice of mindfulness both briefly and regularly in the context of 
cessation in real-life, and when the vulnerable moment is captured by psychometrically sound items 
via EMA. 
To the best of our knowledge, there are no mindfulness-based EMIs (mindEMIs) for smoking 
cessation specifically developed for survivors. Only 1 study has examined the feasibility of an MBI 
delivered in-person for smoking cessation among survivors.15 However, its time-intensiveness 
(weekly 2-hour in-person group sessions for 8 weeks) is not only a potential barrier to 
accessibility,15,16 but it also does not leverage treatment delivery in the real-world context where 
quitting takes place. Given the promising efficacy of MBIs using technology in improving quality of life 
in the general cancer population,39 a mindEMI for smoking cessation tailored for survivors, with an 

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emphasis on both practice and inquiry-based learning processes, would not only enhance 
accessibility and target key smoking mechanisms, but also reduce patient burden.22 
 
2.4. Innovation 
This study is highly innovative in several ways. First, this work will be among the first to integrate 
mHealth and MBIs for smoking cessation for survivors by retaining crucial theoretical and empirical 
components of MBIs (i.e., inquiry,17 acceptance and awareness,25,26 and formal meditation26). In 
particular, this work will address a significant gap in the literature: (1) Developing MBIs targeting 
cancer-specific smoking vulnerabilities integrating extant theories27-29,59 and evidence from general 
smokers;55-58 and (2) leveraging unique windows of opportunity for intervention delivery (i.e., EMI)54 in 
real time among survivors. Second, this work will be a novel mHealth MBI that integrates survivors’ 
direct input in its development through qualitative interviews and an iterative process. Given the 
limited evidence on the efficacy of extant cessation strategies among survivors,6 the intervention 
design will be informed by survivors who will assess the utility of brief mindfulness strategies and 
formal mindfulness meditations. Thus, the proposed intervention is not only theoretically driven but 
also user-centered. Third, mindEMI would potentially maximize MBI efficacy for smoking cessation 
through the regular and momentary practice of mindfulness at key vulnerable moments in the real-
world context, as evidenced by positive cessation outcomes through frequent mindfulness practice47 
and timely delivery of the intervention.49,50 Fourth, as compared to the intensiveness of traditional in-
person MBIs, our proposed mHealth approach has high potential for scalability and cost-
effectiveness, thereby reducing cessation barriers for survivors.4,5,10 Fifth, EMA will be used to assess 
real-time data that capture both cancer-specific and general risk factors of smoking relapse to 
intervene, using psychometrically sound measures. To the best of our knowledge, EMA has not been 
widely used to examine smoking behaviors among survivors,62 although EMA has been used to 
assess other health behaviors, such as sleep among individuals with a cancer diagnosis.63 Further, 
few EMA studies have tested the reliability of EMA scales used.55,64 Our study will provide a more 
accurate reflection of the dynamic relation between cancer-specific and general smoking 
vulnerabilities, informing future interventions for survivors. 
 
 
3. PARTICIPANT SELECTION 
 
3.1. Aim 1: Development 
3.1.1. Participants 
Interested participants will be screened over the phone and eligible participants will be scheduled 
for their interview. Inclusion criteria will include: (1) ≥18 years old; (2) having smoked at least one 
cigarette (even one or two puffs) within the past 30 days; (3) having been diagnosed with cancer; (4) 
valid home address and functioning phone number; (5) being able to read, write, and speak English; 
and (6) having a smartphone. Smartphone ownership is not expected to be a barrier to recruitment 
given that 85% of Americans and 76% of low-income individuals own a smartphone.65 Exclusion 
criteria will include (1) being enrolled in a smoking cessation program.  
 
3.1.2. Recruitment 
Aim 1 will involve original data collection, conducted either in-person or remotely. Qualitative and 
quantitative data will be collected from cancer survivors to inform the development of mindEMI. 
Survivors who are current smokers will be recruited in 2 ways. First, using electronic medical records 
at Moffitt, a trigger that is configured in the electronic system will notify our study team weekly of 
patients who are classified as current smokers, and study staff will contact potential participants. This 
recruitment strategy has been successfully implemented by co-primary mentor, Dr. Simmons’s 
research team66,67 (recruiting 4.6 cancer patients per month, who were interested in quitting but have 

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not completely quit, similar to the current proposal’s sample characteristic).12 She successfully 
recruited 7 and 12 cancer patients per month in her R0312 and R01,68 respectively and recruited one 
of the largest samples of this population in the literature to date (N = 412). Second, Dr. Pabbathi’s 
team at the Cancer Survivorship Clinic at Moffitt will connect potentially eligible participants with the 
study team, and the study team will contact them. 
 
3.2. Aim 2: Usability Testing 
3.2.1. Participants and Recruitment 
Aim 2 will recruit 10 survivors, independent from Aim 1, to pilot the prototype mindEMI. 
Recommended sample size in usability studies is at least N=10 to capture 94.7% of potential usability 
problems, which guided the current sample size,69 accounting for 30% drop out with a desired final 
sample size of 10 (will recruit N=13). Recruitment and eligibility will mimic Aim 1, with the addition of a 
few eligibility criteria. Additional inclusion criteria: (1) Willing to give quitting a try as part of the study; 
(2) Having a smartphone that allows installation of the app; and (3) Willingness to download and use 
the app daily. Additional exclusion criteria: (1) current use of smoking cessation medications (e.g., 
patch, gum, lozenge, nasal spray, inhaler, or any other nicotine replacement products or medications 
such as Chantix, Zyban, or Wellbutrin with the intent to quit smoking); (2) evidence of current 
psychosis; and (3) current/planning pregnancy or lactation. During the phone screen, we will ask 
participants to consult their physicians before nicotine patch use, if they endorse medical conditions 
(e.g., recent heart attack, heart disease, angina, high blood pressure not controlled by medications, 
stomach ulcer, diabetes type 1).70 
  
3.3. Inclusion of Women and Minorities 
 
Both men and women and members of all races and ethnic groups are eligible for this trial.   
 
 
4. STUDY DESIGN AND METHODS 
 
4.1. Aim 1 
4.1.1. Aim 1: Design 
 
Qualitative data will be collected to inform the development of the mindEMI among survivors, 
followed by configuring the smartphone app with key MBI practices. 
 
4.1.2. Aim 1: Procedure and Data Collection 
Survivors (N=15) will complete a single individual in-depth qualitative interview with a brief survey 
which will last about 1 hour. The thematic analysis literature recommends the sample size of 6 to 
16.71,72 Thus, we will recruit 15-20 participants for analyses. The proposed procedures are based on 
recommendations in the literature and Dr. Simmons’s prior qualitative work.72,73 Following the phone 
screen, eligible participants will provide verbal informed consent and will be scheduled for the phone, 
zoom, or in-person interview per participant’s preference. During the interview, the following topics 
will be addressed: (1) Several key formal mindfulness meditations (e.g., breathing) of various lengths 
(5-15 minutes) adopted from  Mindfulness-Based Cancer Recovery,74 Mindfulness-Based Relapse 
Prevention,75 and Dr. Vinci’s studies76-78 will be briefly introduced. Participants will be guided through 
1 to 2 meditations, before giving feedback. Participants’ perceived utility and acceptability of the 
meditations will be assessed via a brief scale developed for Time2Quit77 (benchmark: ≥75% reporting 
useful).79 (2) Brief mindfulness strategies (content areas: fear of cancer recurrence, pain, fatigue, and 
self-compassion; each takes 1 to 3 minutes to complete) will be presented. Participants will practice 
several strategies, after which overall feedback and comprehensibility of the strategy will be obtained. 
(3) The mHealth component will be introduced. Preferred frequency and timing of the practice and 
delivery of MBIs, means of delivery (prompted vs user-initiated), and inclusion of MBIs addressing 

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cancer-relevant distress will be assessed. (4) Given the perceived need and importance of human 
support in the mHealth smoking cessation literature,80-82 feedback on preferences for counseling, 
including modality (in-person vs phone), and timing will be obtained. Participants will be compensated 
$20 for completing the interview. Participants can also receive a bonus of $5 for each online survey 
completed within 24 hours of being sent the link. Interviews will be audio-recorded and transcribed for 
content analysis. Using an inductive thematic saturation approach,71 interviews will continue until 
saturation is met, when no more new information (i.e., the number of new themes) is obtained. 
Following the interviews, the prototype of mindEMI will be fully developed and pilot tested in an 
independent sample of survivors who currently smoke.  
 
4.1.3. Aim 1: Measures 
 
Participants’ demographics and perceived utility and acceptability of the meditations and 
mindfulness strategies will be assessed via a brief scale developed for Dr. Vinci’s prior study on a 6-
point Likert scale.77 (benchmark: ≥75% reporting useful).79 Semi-structured interview will ask for the 
participants’ feedback and suggestions on the planned intervention (See the interview guide for 
specific questions). 
 
In a brief survey, we will use both an established questionnaire as well as questions adapted from 
previous studies. Participants will complete a survey of demographics (e.g., ethnicity, race, sex, 
sexual orientation, gender identity, marital status, education, employment status, income), smoking 
history as assessed by Cancer Patient Tobacco Use Questionnaire (C-TUQ),83 nicotine dependence 
using Heaviness of Smoking Index,84 The Contemplation Ladder,85 previous experience with 
contemplative practice and perceived usability of mindfulness as assessed by the items developed for 
Dr. Vinci’s Time2Quit study,86 and perceived usability scale of the Technology Acceptance Model 
measure.87 
 
Additionally, clinical characteristics (e.g., cancer type, date diagnosed with recent cancer) will be 
assessed by chart abstraction. 
 
4.1.4. Aim 1: Intervention 
 
NA 
 
4.1.5. Aim 1: Adverse Reactions 
 
Minimal risks are anticipated for this study. Research staff will report any potential AEs 
immediately to the PI. The PI will report AEs to the IRB within five business days using the required 
reporting format. Any SAEs (using the FDA definition of SAEs) will be reported within two days to the 
IRB and NIH using the required reporting format. Given the relatively minimal risk nature of the 
proposed research, this is considered a highly remote possibility. Any IRB actions in relation to this 
protocol will also be reported to NIH. 
 
 
4.2. Aim 2. 
4.2.1. Aim 2: Design 
 
Pilot the prototype of the mindEMI in an independent sample of survivors and obtain feedback to 
inform the final version of the mindEMI. 
 
4.2.2. Aim 2: Procedure and Data Collection 
 
Aim 2 will be conducted remotely. Importantly, the mindEMI content will comprise brief 
mindfulness strategies and meditations selected and/or modified per survivors’ feedback from Aim 1 
and EMA items will assess both cancer-specific and general smoking relapse vulnerabilities by 
including psychometrically sound items including cancer-specific items.88-91 Thus, the prototype will 
be adapted specifically to survivors. 

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Study participation will last 4 weeks, with 2 assessments and 3 brief counseling sessions (Figure 
2). Participants will be enrolled in the study once they have completed the baseline survey. Treatment 
will entail brief cessation counseling over the telephone or Zoom conferencing tool per participants’ 
preferences, provision of written cessation materials (i.e., NCI’s Clearing The Air booklet),92 and 
nicotine replacement therapy (NRT) in the form of nicotine patch and its instructions (e.g., suggested 
areas of body to put on) sent via mail; and brief mindfulness strategies/meditations delivered one-week 
pre-quit and 2 weeks post-quit. The mailout will also include instructions on how to use the app, and 
details about the study timeline. Meditations will continue 3 weeks post-quit.  
Following the phone screen, eligible 
individuals will provide verbal informed consent 
and will be scheduled for the 1st counseling 
session. Baseline measures will be sent via 
REDCap to be completed online prior to the 1st 
session, during which participants will be 
oriented to the app for mindEMI and EMAs. 
The quit date (QD) will be scheduled for within 
about one week after the 1st session.  
The 2nd session will occur around the QD 
and 
the 
3rd 
session 
will 
take 
place 
approximately at the end of treatment (i.e., 
mindEMI; QD+2W).  
During the week following the 3rd session (QD+3W), the end of treatment measures will be sent via 
REDCap and a brief phone interview will be conducted to collect feedback on mindEMI. Interviews will 
be audio-recorded and transcribed for content analysis. Smoking status will be measured using 7-day 
point prevalence of abstinence ([PPA]; no self-reported smoking in prior 7 days). The counseling 
sessions will be scheduled at/around the appointment that coincides with our timeline, remaining 
flexible if there may be medically related changes in schedules (e.g., unanticipated complications) or 
unanticipated conflicts. EMAs will be completed over 4 weeks. Participants will be compensated $30 
and $60 for completion of baseline and end of treatment assessments (including a brief phone 
interview), respectively. Those who complete a brief phone interview at the end of treatment will be 
compensated an additional $30. Participants can also receive bonus compensation for each online 
survey completed within 24 hours of being sent the link ($5 at both baseline and the end of treatment).  
 
Concerted efforts to keep retention high will include phone calls if incomplete EMAs are observed 
for more than 2 consecutive days, obtaining a functioning phone number, home address, and the 
name and phone number of 2 collaterals who can provide contact information if the participant is 
unreachable, and providing compensation for completing assessments, including increased 
compensation during later study periods.   
 
4.2.3. Aim 2: Measures 
 
Baseline and end of treatment. At baseline and end of treatment, the self-reported following will 
be measured: Demographics (baseline only), smartphone-related information (e.g., operating 
system), smoking history/status,83,93 nicotine dependence using 2-item Heaviness of Smoking 
Index,84,94 smoking-related cognitive and affective processes (e.g., withdrawal symptoms),85,95-97 team 
developed measure of previous experience with contemplative practice developed for Dr. Vinci’s 
Time2Quit study (used in Aim 1),86 mindfulness using Avoidance and Inflexibility Scale,98 Five Facet 
Mindfulness Questionnaires,99  Self-Compassion Scale,101 affect using Positive and Negative Affect 
Schedule,102 depression using Patient Health Questionnaire, anxiety using Generalized Anxiety 
Disorder-7,105 and cancer-relevant variables including pain, fatigue, and fear of cancer recurrence.106-
108 Chart abstracted cancer variables (e.g., cancer type) will allow us to describe the heterogeneity in 
our sample. At the end of treatment, additional items will be assessed: smoking status, nicotine patch 

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use, changes in smartphone and/or carrier, perceived utility and acceptability of the mindEMI using 
team-developed items that were used in our team’s previous studies (e.g., "How helpful were the 
mindful skills?”)86,109-111 as well as validated measures.87,112-114 During the end of treatment interview, 
open-ended questions on the mindEMI and feedback on the app and format of counseling (e.g., 
number of treatment sessions) will be assessed using the team developed items (e.g., "What did you 
like about using the app?”).  
 
 
App data. EMA measures will consist of self-reported items on state mindfulness using 3 items 
selected from extant validated measures,115-117  6 affect items,102,118 1 craving item (“I have an urge to 
smoke”), using a multiple-point Likert scale, and the number of cigarettes smoked and nicotine patch 
use (yes/no) as well as psychometrically sound cancer-specific items that include: 1 fatigue item (on a 
11-point Likert scale),107 1 pain item (on a 11-point Likert scale),106 and 1 item on fear of cancer 
recurrence (on a 4-point Likert scale).91,108,119,120 The EMAs can be completed in <2 minutes.   
 
4.2.4. Aim 2: Intervention 
App used for mindEMI. MetricWire app, by MetricWire (metricwire.com) will be used to deliver the 
mindEMI. This research-oriented app has been widely used for EMI and EMA studies. Notable 
strengths of the app include high flexibility in customization of EMA and EMI design and its potential for 
future scalability (i.e., operates on both Android and iOS).  
mindEMI Intervention Content and Logistics. Here we describe the components of the mindEMI. 
Formal mindfulness meditations (5-20 minutes) 
will be in the form of audio recordings in the app; 
a prompt to complete the meditations will be 
pushed 1 time/day at a time pre-determined by 
the participant (i.e., fixed). Meditations will be 
primarily adopted from feedback from survivors in 
Study 2a and existing literature.74,75 The ‘inquiry’ 
exercise to reflect on meditations will be 
completed 1 time/day, following meditations. 
Brief mindfulness strategies (1-3 minutes) modified in Aim 1 will be delivered in the form of text in 2 
ways: (a) when either high cancer-related stress, craving, or NA is indicated via EMA (i.e., prompted at 
high-risk), and (b) at random. This delivery approach aims to promote the cultivation of mindfulness 
specifically during high-risk situations, and also more generally when craving/distress may be low. We 
expect that the meditations will provide a foundation of mindfulness, whereas the strategies will promote 
the momentary application of mindfulness.  
Random EMAs will be pushed 4 times a day. A day will be blocked such that participants can receive 
up to 6 mindfulness strategies per day, up to 4 of which will be delivered when high risk is detected via 
EMA (Figure 3). Following prompted strategies at high-risk moments, a follow-up EMA comprised of 4 
items (i.e., craving, NA, timing, helpfulness) will be pushed. Both mindfulness strategies and 
meditations will be available on-demand in the app. The ‘inquiry’ exercise will also be completed when 
participants complete on-demand meditations. 
 
4.2.5. Aim 2: Adverse Reactions 
 
Minimal risks are anticipated for this study. Data including self-report and interview (psychological 
and medical) involve risk of breaches in confidentiality. Participants will always be given the option to 
refuse to answer any questions on the measures that may be distressing. For Aim 2, data will also be 
collected via smartphone. As such, there are always risks associated with privacy when collecting 
data in this format.  
 
Successful abstinence may cause irritability, anxiety, general distress, and difficulty concentrating. 
The nicotine patch that participants will wear beginning on the quit date in Aim 2 will be the 

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appropriate dose for their level of smoking, and the patch should aid in the management of 
withdrawal symptoms. The nicotine patch and smoking cessation counseling have been shown to be 
safe and effective for smokers attempting to quit (e.g., the patch is available over-the-counter). 
However, side effects to the patch may occur and include skin irritation/ rash, nausea, dizziness, dry 
mouth, diarrhea, nervousness, headache, vivid dreams or sleep disturbances, irritability, and irregular 
heartbeat.  
 
Risks will be protected against as described below. This study involves no investigational drugs or 
devices. 
Emergency procedures will be in place should any psychiatric emergency arise during the 
screening and/or treatment processes. Although this is likely to be very rare, all study personnel will 
be trained in these procedures. 
 
Potential side effects from the nicotine patch (Aim 2) will be monitored by study staff and the PI. 
Participants will be told of potential allergic reactions and side effects in response to the patch and 
nicotine side effects, and also told that they are free to remove the patch at any point in time. Should 
participants experience side effects, they will be advised to discontinue the patch, and also told to 
contact the PI and study staff. Given three phone counseling calls will be scheduled with participants, 
and that discussion of the patch will be conducted at these times, we do not anticipate any issues 
with monitoring patch side effects. Additionally, initial eligibility screening will exclude those with 
medical conditions that are contraindicated for the patch. Research staff will report any potential AEs 
immediately to the PI. The PI will report AEs to the IRB within five business days using the required 
reporting format. Any SAEs (using the FDA definition of SAEs) will be reported within two days to the 
IRB and NIH using the required reporting format. Given the relatively minimal risk nature of the 
proposed research, this is considered a highly remote possibility. Any IRB actions in relation to this 
protocol will also be reported to NIH. 
 
 
5. STUDY CALENDAR 
 
 
 
 
6. REGULATORY AND REPORTING REQUIREMENTS 
 
 
6.1. Institutional Review Board 
 
No subject is to be enrolled on this protocol until the Center’s Institution Review Board has 
approved it. 
 
6.2. Monitoring 
 
The Protocol Review & Monitoring Committee will monitor this study.   
 
6.3. Informed Consent 
 
The investigators and the research associated with the study are responsible for obtaining consent 
by the participants in a manner approved by the Institutional Review Board. 
 
1
2
3
4
5
6
7
8
9
10
11
12
1
2
3
4
5
6
7
8
9
10
11
12
Prepare interview materials, measures, and protocol for Aim 1
x
x
x
Aim 1: Recruit participants (N=10)
x
x
x
x
x
x
x
Aim 1: Data collection
x
x
x
x
x
x
x
Develop prototype smartphone app for mindEMI
x
x
x
Staff testing the mindEMI
x
x
Aim 2: Recruit participants (N=10)
x
x
x
x
x
x
Aim 2: Data collection
x
x
x
x
x
x
Finalize the full version of mindEMI
x
x
x
x
x
x
Year 1 (Month)
Year 2 (Month)
Activity

 PI: YANG  
B12 
6.4. Investigator Study Files 
 
Research records are the responsibility of the investigator. They will be available for review by the 
sponsors of the trial, health care personnel involved in this study, the IRB, and the SRC. 
 
6.5. Data Sharing 
 
As required by NIH rules, Dr. Yang and her mentoring team will make the data collected in the current 
project available to outside investigators. Specifically, de-identified data could be used for future 
research studies or distributed to another investigator for future research studies without additional 
informed consent. A data-sharing plan has been developed by Dr. Yang and her mentoring team to 
disseminate the research outcomes in a timely manner. Overall, shared data will be made available 
via mechanisms including NIH-designated Data Repositories (e.g., 
http://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html) or direct data transfer by Moffitt 
Research Information Technology (IT) following necessary approvals. The timing of data and 
resource sharing or public release will follow the corresponding guidelines as outlined in the 
corresponding NIH policy. 
7. STATISTICAL CONSIDERATIONS 
 
7.1. Sample Size/Accrual Rate 
Aim 1. Aim 1 will recruit 15-20 cancer survivors who smoke for analyses. We will use an inductive 
thematic saturation approach, whereby interviews will continue until saturation is met, when no more 
new information (i.e., the number of new themes) is obtained. The thematic analysis literature 
recommends the sample size of 6 to 16. Thus, our sample will be 15-20 participants for analyses. 
Accounting for a drop out rate of ~30%, we will consent 26 participants. Dr. Yang will lead the qualitative 
analysis while consulting with Dr. Simmons who has expertise in this area; resources available at Moffitt 
for qualitative analysis will also be used.  
Aim 2. Aim 2 will consist of 10 cancer survivors who smoke, independent from Aim 1, to pilot the 
prototype mindfulness-based ecological momentary intervention (mindEMI). Recommended sample 
size in usability studies is at least N=10 to capture 94.7% of potential usability problems, which guided 
the current sample size, accounting for 30% drop out with a desired final sample size of 10 (will recruit 
N=13).  
 
7.2. Data Analysis 
Aim 1. Two approaches of qualitative analysis will be used. First, the transcripts will be coded and 
key themes will be identified by 2 trained study staff. Texts will be analyzed for frequency (number of 
times the comment was mentioned), extensivity (number of participants making the comment), intensity 
(expressive strength of the comments), and specificity (degree of clear focus of the comment). A 
software, NVivo will be used to analyze the data. Coder agreement will be assessed using a Kappa 
statistic (≥.80). Second, based on the principles of saturation in qualitative research, details of 
narratives will also be a focus of analyses. Qualitative analytic strategies such as immersion-
crystallization will be implemented, in which the researcher reviews the data both intuitively and 
reflectively until the most relevant theme to the research questions arises. Descriptive analyses will be 
conducted on the data collected through survey and chart abstraction (M, SD, %). 
Aim 2. The primary outcomes will be participants’ open-ended feedback, and perceived utility and 
likability of the mindEMI based on the Aim 1 benchmarks and retention (≥75% through end of 
treatment). Dr. Yang will lead the qualitative thematic content analyses of the feedback and conduct 
descriptive analyses on usability measures (M, SD, %). 
 
   
 

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