Take a Break (TAB): mHealth-assisted Skills Building Challenge for Unmotivated Smokers
Phase: NA
Conditions: Smoking Cessation
Sponsor: University of Massachusetts, Worcester

INVESTIGATOR STUDY PLAN – Take a Break (H00007427) 
 
 
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1) Title 
Take a Break (TAB): mHealth-assisted skills building challenge for unmotivated smokers  
 
2) IRB Review History 
N/A 
 
3) 
Objectives 
Take a Break (TAB) is a randomized trial designed to evaluate Nicotine Replacement Therapy (NRT)-
sampling and a mHealth suite of apps. TAB is a time-limited self-efficacy and skills building experience 
for Motivation Phase smokers. TAB is designed to create a timeline within which motivation smokers will 
be encouraged to try a brief period of abstinence. Smokers in this Motivation Phase are relatively 
untapped in research available information. This project offers these smokers point-of-need technology 
support in the many components of the intervention. 
Our Specific Aims are 
• AIM 1: Refine the Take a Break mHealth tool and implementation program. 
• AIM 2: Conduct a randomized trial of the effectiveness of Take a Break. 
• AIM 3: Follow participants in the AIM 2 randomized clinical trial for 6 months to evaluate time to 
quit attempts, number of quit attempts, and 6-month biochemically verified point prevalent cessation. 
The Take a Break intervention is designed to increase self-efficacy and support new skills for Motivation 
Phase smokers. We hypothesize that, compared with the NRT-only group, the Take a Break group will 
have a greater number of days abstinent during the ‘break’ period, a greater increase in self-efficacy at the 
end of the ‘break’ period, a lower time to first quit attempt, and a higher rate of quit at 6 months. This 
research study will also provide valuable insight into this population of smokers and increase our 
understanding of which tools may be effective in helping them quit smoking. 
4) Background 
Smoking is the leading preventable cause of mortality in the United States.1 The use of pharmacological 
cessation aids combined with behavioral counseling doubles the chances of successfully achieving long-
term cessation.2 However, the majority (70-90%) of smokers are not actively quitting at any given time.3 
In smoking cessation research, the majority of evidence applies to the minority of smokers, those actively 
quitting. This known gap is significant because the majority of smokers–those who are not ready to quit 
smoking, also described as smokers in the “Motivation Phase” of the Phased Framework of Smoking 
Cessation, historically, have not been the focus of cessation interventions. In the Phased Framework of 
smoking cessation interventions,4 smokers can be considered in several phases (Figure 1). In Take a 
Break, we are focused on Motivation Phase smokers.4,5 Although some smokers are not willing to quit, 
many of these smokers are thinking of quitting in the future, but may need additional support and 
motivational interventions.  
Engaging those not ready to 
quit in treatment is 
challenging. However, prior 
interventions have been 
successful in engaging up to 

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Revised: November 11, 2021 
half of smokers who refuse cessation treatment in a brief, non-cessation experience.3,6 Precessation NRT 
can increase subsequent quit rates. In a meta-analysis, nicotine therapy (NRT) was estimated to double 
six-month cessation in Motivation Phase smokers.7 Effectiveness data from these studies8-10 demonstrates 
the potential of NRT-sampling in these smokers. 
 
As noted in a recent review,5 “One opportunity in the Motivation Phase is that there is time for smokers to 
learn and practice skills before undergoing cessation-related withdrawal.” In Motivation Phase 
interventions, the goal has been to increase a smoker’s confidence and skills related to smoking cessation. 
Motivation Phase smokers are asked to reflect upon smoking, briefly practice behaviors used during 
quitting, and develop new skills for managing smoking urges. Conceptually, these goals and strategies are 
related to core constructs from the Social Cognitive Theory including self-efficacy.11 Self-efficacy has 
been defined as the perceived capacity to perform a behavior.12,13 Self-efficacy can influence outcome 
expectations. Our game is designed to enhance self-efficacy in the context of brief abstinence, and 
subsequently in quit attempts. Self-efficacy can influence other factors including outcome expectations 
that influence goalsetting.14 In Take a Break, we will encourage participants to set goals for the brief 
abstinence Marathon, and at the end of the Marathon give them the option of goal setting for a quit 
attempt.  
 
5) Inclusion and Exclusion Criteria 
For all Aims, we will include individuals 18 years and older who are identified as current smokers who are 
not preparing to quit, and are active in care within the UMMHC system, Northwell Health, VA Central 
Western MA (VACWM) and Reliant Medical Group (RMG). Active in care is defined as having at least 
two clinical visits in the past year. If an eligible participant does not already have a smart phone, one will 
be provided to them, free of charge, for the duration of their participation in the study. 
• Exclusion Criteria: Those unwilling to sample nicotine lozenges or participate in the intervention will 
be excluded. All patients already on NRT will be excluded. All participants who have a FDA 
contraindication or cautions for nicotine lozenge use (pregnancy, breastfeeding, recent cardiovascular 
distress, or phenylketonuria) will be excluded. We have chosen to exclude patients with a diagnosis of 
depression, due to confounding factors. 
Adults unable to consent, individuals who are not yet adults (infants, children, teenagers), and 
prisoners will be excluded from this study. The Food and Drug Administration (FDA) advises caution 
for nicotine lozenge use among women who are pregnant. Thus, women who are pregnant at the time 
of baseline will be excluded from the study. Those who are already participating in another smoking 
cessation study at the time of screening will also be excluded from the study.  
 
6) Study-Wide Number of Subjects 
There are three phases of human subjects’ involvement in the study.  The total number of subjects for all 
phases is 550 smokers for all recruitment sites. 
 
7) Study-Wide Recruitment Methods 
There are three phases of human subjects’ involvement in the study. In Aim 1, we will refine the 
integration of the “Take a Break” mHealth tools with 50 smokers; up to 20 smokers will participate in 
Think Aloud Usability testing and 30 in mini pilots. In Aim 2, we will recruit 500 (approximately 250 

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from UMMS, 100 from Northwell Health, 75 from VACWM and 125 from RMG) smokers to conduct a 
randomized trial of the effectiveness of Take a Break. In Aim 3, we will follow participants in the Aim 2 
randomized trial for 6 months to evaluate cessation events. 
For both Aim 1 and Aim 2, we will recruit UMMHC patients who smoke, have had at least two primary 
care visits in the preceding 12 month, and are in the Motivation Phase. For Aim 2, we will also recruit 
from Northwell Health, VACWM and RMG.  We will not include Aim 1 smokers in Aim 2 recruitment. 
Please note that as of June 2019, Northwell Health is no longer actively recruiting study participants. 
Aim 1-Refining the Take a Break system:  
This will be conducted in two steps: 1) Think Aloud Usability sessions,15,16 and 2) Mini pilots. The Think 
Aloud usability sessions will be conducted in multiple phases at the UMMS Technology Usability lab, 
each with 4±1 subjects. These subjects will not be included in the mini pilots. The mini pilots will each 
include up to 10 smokers who will have access to the system for 3 weeks (training + Take a Break 
Marathon). The first mini-pilot will split the 3-weeks up into 2 segments. This first segment will consist of 
all study procedures from the screening through the TTS consultation after Week 1. The second segment 
will consist of the 2-week marathon and the 3-week follow-up survey. The subsequent mini pilots will test 
the entire process from start to finish. Throughout and at the end of  each mini-pilot, we will conduct 
qualitative assessments (see mini-pilot assessment question guide). Table 1 indicates the number of 
participants recruited for each aim. Aim 1 participants will be recruited from a cohort of former research 
participants. These participants previously indicated they would be interested in participating in future 
research studies and consented to be contacted.  Pilot participants will also be referred to us by our TTS 
consultant.  
Aim 2 and Aim 3- Take a Break intervention and 6 month Follow-Up: Aim 2 and Aim 3 study data 
collection will involve the recruitment of 500 smokers. Smokers will be recruited from UMMHC, 
Northwell Health, VACWM, and RMG. Please note that as of  June 2019, Northwell Health is no longer 
actively recruiting study participants. 
Recruitment Data Access: 
• UMMS recruitment data access: We will use the UMMS EHR to identify smokers. We will seek a 
HIPAA waiver from the UMass IRB for data access in order to identify potential participants. Once 
identified, patient data will then be stored in the UMMS regulated environment. At UMMS  we will 
identify patients who smoke and have had at least two primary care visits in the preceding 12 months.  
•  
• VACWM recruitment data access: Research staff at VACWM will handle all VACWM patient data 
during recruitment. They will seek a HIPAA waiver from their IRB for data access in order to generate 
list of potential participants.  
• RMG recruitment data access: Research Staff at RMG will handle all RMG patient data during 
recruitment. RMG staff will seek a HIPAA waiver from the UMMS IRB for data access in order to 
identify potential participants.  
 
 
Table 1: Pilot Study and RCT Participants 
Research Method 
Participants 
Duration 
Number 
Consent 

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UMass Recruitment Strategy:  
Opt-out mailing strategy: We will use an “opt-out” recruiting strategy for Aim 2. Smokers will be sent 
an initial communication that outlines the purpose of the study and informed consent (see InviteLetter-UMMS-TAB). 
A self-addressed, stamped “opt-out” postcard (see OPTOUT-UMMS-TAB) will be included with the initial 
communication; if the patient does not wish to participate, they can mail the “opt-out” postcard in order to 
be removed from all contact lists for the current study. Potential participants who do not “opt-out” within 
two weeks will be phoned to determine their interest in the study. As in our prior IRB-approved work, 
letters describing the study and stating that the patient may receive a phone call regarding the study will be 
sent to each patient. 
Referral Recruitment Strategy: We will also recruit study participants that are referred to us by 
UMMHC clinical partners. To execute the referral we will use an eRefer portal developed by the UMass 
Center for Clinical and Translational Science Informatics Core. The eRefer portal is a recruitment tool that 
allows potential research subjects to verbally agree to provide their email and/or cell phone number and be 
sent only one  email and/or text message with information about a research opportunity they are interested 
in. The message sent to prospective subjects interested in the study only contains IRB approved language 
(see TAB Invitation Letter) with slight edits tailored to the mode of delivery (email/text instead of 
mailing). Clinical partners, the ‘Referrer’ in the eRefer portal (see eReferPortal.Home), enter his/her email 
address on the eRefer home page, select the ‘Take a Break’ study from the project list and enter the 
potential participant’s email address and/or cell phone number as preferred by the patient. By providing 
their email address or cell phone number, the patients verbally agree to be sent the study invitation 
messages and contacted for recruitment. After the referral has been executed, the eRefer portal provides 
study staff with the subject’s contact information, allowing study staff to contact the subjects. The subjects 
also receive contact information of the study staff, allowing them to proactively contact the study staff. 
Data collected in the eRefer portal will be stored in a regulated environment until completion of the 
project or upon the request of the potential participant. The regulated environment provides applications to 
a secure network for collecting and storing confidential data.  The regulated environment has been 
securely configured to allow application access via the secure socket layer (HTTPS) protocol.  The 
regulated environment is secured using hardware and software firewalls, along with access restrictions to 
provide the needed security protocols for the regulatory and Federal standards required.  Access is 
restricted through a Virtual Private Network, a secure RSA token, and only restricted personnel are 
allowed access to the regulated environment. Our software program will use a secure Application 
Programmable Interface to send and receive the text messages. These text messages will be sent from toll-
free number  (18442764493) 
Participant Peer-Referral Strategy:  After participant completion of the 6 month visit, study 
staff will ask participants if they would like to give study information (See: Peer-Referral 
Invitation Letter) to friends and family members who might be interested in participating. If 
Think Aloud 
Usability (Aim 1) 
Smokers from UMMHC 
Clinics  and Inpatient 
1  hour 
20 
Written 
Mini Pilot (Aim 1) 
Smokers from  UMMHC 
Clinics  and Inpatient 
3 weeks 
30 
Written 
Take a Break 
Intervention (Aim 2) 
Smokers from  UMMHC, 
Northwell Health,  
VACWM, RMG 
3 week 
intervention 
500 
Written 
Follow-Up (Aim 3) 
Smokers from  UMMHC, 
Northwell Health, 
VACWM, RMG 
6 months 
500 
Written 

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interested in the study, friends and family can contact the study staff directly with the information 
provided.   
  
VACWM Recruitment Strategy:  
Opt-out Recruitment Strategy: Veterans will be sent an initial mailed communication that outlines the 
purpose of the study and informed consent. If the patient does not wish to participate, they will be 
instructed to call the VACWM research line and leave a voicemail indicating that they wish to be removed 
from all contact lists for the current study. Potential participants who do not “opt-out” within two weeks 
will be phoned to determine their interest in the study. At first telephone contact, study staff will conduct a 
short telephone screen based on inclusion and exclusion criteria to determine eligibility. Eligible and 
interested Veterans will then be scheduled for a consent visit, to review the consent documents and, if 
interested, agree to participate. Once the participant has consented to participate and signed the 
appropriate documents, an enrollment visit will be scheduled where Veterans will complete study 
documents and receive NRT. 
 
RMG Recruitment Strategy:  
In-person Recruitment Strategy: RMG will implement in-person screening at the time of visit. RMG 
will utilize the Epic Electronic Health Record (EHR) currently in production at practice sites to identify 
eligible subjects and obtain participation interest in real-time. Through this process, patients are screened 
for tobacco use by a Medical Assistant (MA) at the start of their visit. When patients report positive 
tobacco use, this information is flagged within the EHR and alerts the MA to inquire whether the patient 
might be interested in participating in the study. The EHR alert is a smart alert that only appears once if 
the patient is an active smoker age 19 and older who isn’t pregnant, has English listed as their primary 
language, and hasn’t been asked to participate in the study before. MA’s will be trained on the objectives 
of the study, the inclusions/exclusion criteria, and the study activities and commitments of participants. 
The MA enters the response into Epic. Each morning the RMG Research Department will query Epic’s 
Clarity Database to identify patients that expressed an interest in the study. This list of interested patients 
will then be forwarded to the RMG TAB study staff in order to identify eligible patients. Identified 
patients will be contacted by telephone within 48 hours of office visit by RMG study staff for screening  
of study inclusion criteria. During the screening call, the study staff member/recruiter will review the 
purpose of the study, answer any questions, assess for competency to provide verbal consent and assess 
study inclusion and exclusion criteria. Patients who screen-in and provide verbal consent will schedule an 
in-person appointment with RMG study staff to provide informed consent and be enrolled in the study. A 
total of three phone calls will be made over the course of 3 weeks from the initial contact. On the third 
call, study staff will leave a short voicemail message asking potential participants to call the RMG 
Research Department. If patients are not reached during these initial phone calls, an invitation letter (see 
RMG invitation letter) will also be sent asking potential participants to call the RMG study staff if still 
interested. 
 
8) Study Timelines* 
Refining the TAB suite of apps will commence in year one of the study. Participant recruitment will begin 
at the end of year one and will continue until the beginning of year four.   

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• Aim 1: Recruitment will begin at the end of year one for Aim 1 and will end at the beginning of year 
2. Duration of participation in the Think Aloud usability component of Aim 1 will be one hour.  
Duration of participation in the Mini Pilot portion of Aim 1 will be three weeks. 
• Aim 2 and Aim 3: Recruitment will begin at the beginning of year two and will end at the beginning of 
year 4.  
Duration of 
participation in 
the RCT through 
follow-up will 
be six months. 
The duration of 
the study in its 
entirety is 5 
years. Milestones of the study are outlined in Figure 2. 
9) Study Endpoints 
Study endpoints are the conclusion of the three-week marathon and the six-month follow-up. Although 
unlikely, a safety endpoint is the development of a FDA contraindication to NRT after enrolling in the 
study. The NRT-sampling component of the study will be discontinued if a FDA contraindication 
develops. Participation with the TAB app will not be discontinued if a FDA contraindication develops. 
10) Procedures Involved 
Aim 1: Usability Testing: While the smokers are reviewing the content and interacting with the program, 
we will use “Think Aloud” protocols, where participants will be asked to vocalize thoughts, feelings, and 
opinions. Think Aloud informs us how the user approaches the interface and what they are thinking about 
when utilizing the interface. We will develop prompts to guide the user if needed. We will conduct Think 
Aloud in two phases, which will allow us to capture the majority of usability issues. Each session will last 
approximately one hour. 
 
We will conduct each usability testing phase with 4±1 users. Think Aloud sessions will be conducted in 
the UMass Division of Health Informatics mobile usability lab using Morae software. Morae allows for 
recordings of the subject being tested, including recording clicks, keystrokes, and other events. The results 
of the Morae Interviews will be transcribed and de-identified. The transcribed interviews will be reviewed 
by two independent reviewers to inform the finalization of the graphics and interface prior to the mini-
pilot.  For information about Morae Software, please refer to the attached user guide (Guide for Software 
Usability Testing with Morae). 
Aim 1: Mini Pilot: Each mini pilot will include 10 smokers who will have access to the system for 3 
weeks (training + Take a Break Marathon). The first Mini Pilot will test the training and the marathon in 2 
different segments while the second Mini Pilot will test the full 3 weeks continuously in one segment. The 
Mini Pilot will follow the same procedures as outlined in Aims 2 & 3, but without the 6-month follow-up 
and longitudinal access to the apps.  Thus, the participants in the mini pilot will only have 2 in-person 
sessions per Mini-Pilot segment as opposed to the 3 in-person sessions described in Aim 2+3. Participants 
in the mini-pilot will be recruited from UMMHC only.  

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Aim 2 + 3: Components of Take a Break include a brief 3-week experience during which smokers are 
provided NRT, given the game, encouraged to try a brief period of abstinence, rewarded with recognition 
points for participation, and allowed continued access to the technology. The game includes Challenge 
Questions to assess smoking behavior and cravings and provide immediate feedback, and a suite of tools 
available at the point of need to help develop coping skills. 
Randomization: Our statistician will generate a randomization table; the randomization sequence will be 
conducted in 2 random blocks of different lengths (4, 8) to assure balance between the groups. In Take a 
Break, the mHealth system will “randomize itself.” At the end of the initial assessment our research 
assistant will access the Take a Break mHealth system on a computer  for all participants (both the 
experiment intervention and comparison groups). When first opened, the research assistant will enter the 
participant ID and participant mobile phone number from the baseline assessment survey. The Take a 
Break mHealth system will then look up allocation within the table, and change based on the allocation 
assignment. 
• The Intervention: Take a Break as an augmentation to NRT-sampling in Motivation Phase. Take a 
Break is an intervention in which smokers are encouraged to engage in smoking abstinence. As 
depicted in Figure 3, the main element, the “Break,” is a two-week challenge where smokers report 
days they are smoke-free. The Break is preceded by a 1-week training challenge where Challenge 
Quizzes (ecological momentary assessments) collect information to guide the smokers during the 
Break. At baseline, all smokers will be provided NRT lozenges for sampling. At weeks 1 and 3 of 
the “Marathon”, our Tobacco Treatment Specialist will call all smokers, assess their experiences 
and collect data.  
• The Comparison Group: For 
the comparison group, 
implementation will be 
balanced in all variables except 
the Take a Break Intervention. 
We will balance the two 
groups further by having the 
comparison (NRT-Sampling 
group) complete mHealth 
assessments (without feedback 
or goal-setting) as an attention 
control (Table 2).   
Participants in the intervention will receive the full tool suite. Participants randomized to the comparison 
group will only have access to a mHealth assessment tool similar to the “Challenge Quizzes” but without 
feedback. 
Take a Break Mobile Health Intervention Features: The core technology to support Take a Break is a suite 
of mHealth motivational tools and mini-games.  
• Recognition (Points and Rewards): For each of the “mini-games” below, participants have the 
potential of earning points. In Take a Break, a goal is to have days of smoking abstinence within the 
two-week period. However, we want to incentivize all participation in self-reported achievement 

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regardless of abstinence. In addition, all participants will get base points for participating in the 
Training challenge. Thus, it will not be possible to “lose” the Break. Based on their level of 
participation all study participants will receive CVS gift cards totaling either $5, $10 or $15.Study 
participants at RMG will receive checks (mail after each visit) in the same amount as the CVS gift 
cards. The lowest 25% of participants will receive $5, the middle 50% will receive $10 and the top 
25% will receive $15 gift cards.  
• Take A Break Peer Community: Intervention smokers will be able to support each other in a private 
online community. Peer-to-peer communication can enable information exchange, provision of social 
support (e.g. emotional and instrumental) and establishment of group norms.17 Online communities 
also improve engagement with other intervention functions. Those currently in a Marathon will be 
allowed to share their progress (and points) with other smokers in the 2-week Marathon. Those who 
have completed the Marathon will be able to see the status of others progressing. We will also 
regularly post topics designed to encourage participation in the community. Our group has prior 
experience developing online communities. In our prior RCT (1R01CA129091-01), smokers 
participating in a web-assisted tobacco intervention were provided an opportunity to participate in an 
online community. Community participants were more likely to take advantage of other intervention 
functions. Community participants were also more likely to quit smoking (24 to 28%). 
• Coping mini-games: We have multiple options for  coping mini-games to include in Take a Break.  
o Distraction Apps:  To distract smokers from 
cravings and prevent relapse, we developed 
and evaluated the smartphone game “Crave 
Out!” a multi-level pattern memory challenge 
(Figure 4).18,19 We conducted a pilot study 
recruiting smokers from outpatient and 
inpatient settings (n=30), and we 
demonstrated that Crave Out could 
potentially reduce cravings. In addition to 
Crave-Out, we have identified 3 free apps 
that can also be used for distraction from 
smoking cravings. They are:  
o WordScapes: This game combines the best of word searching and crosswords for tremendous brain 
challenging fun. Within each crossword puzzle, the participant will drag their finger to create a 
word that they see using the circular series of letters. The number of letters in the circle depends on 
their  respective level (the higher the level , the more letters). Depending on the number  of the 
words , the participant will be rewarded with various points based off of the completed level.  
o Piano Tiles: The objective of this game is to press all of the black tiles on the screen without 
hitting any white tiles. The participant will try to do it as quickly as possible until they make it to 
the finish line. 
o Flow Free: The participant will use their finger to drag to connect matching colors with a pipe to 
create a flow. The goal is to pair all of the colors and cover the entire board with pipe to solve each 
puzzle. 
o Relaxation Apps: Relaxation is recommended as a behavioral tool in the current Treating Tobacco 
Use and Dependence guidelines.20 In preparation for this application, we conducted a heuristic 

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review of popular relaxation or meditation Apps currently available on iTunes. We found ten Apps 
relevant to our review. The most popular used a combination of guided deep breathing and sounds 
to induce relaxation. Relaxation through deep breathing has been used in smoking cessation,21 and 
we will use these popular and evidence-supported principles. We have identified 3 free apps that 
can be used to help relax during a smoking craving. They are:  
o Take a Break: This app is designed to walk the participant through a guided breathing exercise to 
help with relaxation.  
o Calm: This app can help the participant relax their whole body through a series of auditory guided 
breathing and relaxation exercises. 
o Breathe2Relax: For this app, the participant can watch and participate in a series of demonstrations 
to help them relax. These include: diaphragmatic breathing, learning about stress, and engaging in 
reading, writing, and practicing different types of relaxation. 
 
• “Smoker 2 Smoker” Motivational Messages: Our team has developed and evaluated a computer-
tailored motivational messaging system. Messages were evaluated within the context of a web-assisted 
tobacco intervention (R21-CA089011, 1R01CA129091-01).22-26 Expert-written messages were 
developed through a group review, and were guided by current guidelines2 and Social Cognitive 
Theory.27 Smoker-written messages were written by current smokers responding to scenarios that 
varied on readiness to quit smoking. We have demonstrated that the messages increased engagement 
in the online smoking intervention and increased six-month smoking cessation outcomes. As with the 
other mini-games, smokers will receive points for viewing the messages. Smokers can also receive 
bonus points by writing their own messages. 
• Challenge Quizzes: These brief games will consist of 1 to 3 questions with multiple-choice answers. 
The purpose of the Quizzes is two-fold: 1) to impart tailored feedback (brief educational messages 
designed to change perceptions about smoking cessation); and 2) to assess situational characteristics, 
abstinence behaviors, and cravings. Smokers will have up to 3 Quizzes per day. Players will receive 
increasing points for the number of consecutive reports, regardless of abstinence or lack of abstinence.  
Take a Break 3-week Marathon & Longitudinal Access: 
• Week 1 TRAINING Challenge: The purpose of the Training Challenge is to collect information about 
smokers’ daily 
life experiences. 
Smokers may 
think about 
challenges they 
may encounter 
when they 
“Break” with 
smoking. Players 
will earn points 
by completing 
Challenge 
Quizzes. In addition to providing data, the use of the Challenge Quizzes will provide smokers 
experience with interacting with the game so they will be better prepared to “Take a Break.” At the 

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completion of the Training Challenge, players will be asked to set a goal for number of days abstinent 
during the Break challenge.  
• Week 2-3 The BREAK NRT-sampling experience and mHealth tools: The Break is a two-week 
experience. During the Break, smokers are encouraged to initiate abstinence from smoking and 
maintain abstinence for as long as possible. Consistent with a motivational intervention, smokers will 
not be forced to initiate abstinence on the first day of their assigned Break period, but will earn points 
for each day they reply to the ecological momentary assessment through our two-way texting system. 
During the Break, smokers will be supported by our evidence-based and effectiveness-tested mobile 
health tools in the Game. At the end of the Break, players will meet once more with our study staff. 
All Intervention participants will receive gold, silver, or bronze level awards for participation and will 
be asked if they would like to set a quit date. Current smoking will be determined through self-report 
and verification with a carbon monoxide breath monitor. Smoking cessation verification will be 
performed at the study site they were recruited at during the participant’s last in-person session. 
Take a Break Game Longitudinal Access: After the immediate skills-building experience, smokers in the 
intervention group will have access to the game during the 6-month follow-up period. This access includes 
motivational text messages sent from a toll-free number (18442764493) , distraction and relaxation apps, and 
access to the study TTS. Thus, once they are ready for a future quit attempt, these intervention tools will be 
available to them. Smokers who have already completed a Take a Break experience may then choose to join 
new challenges, trying additional abstinence periods. Thus, the initial 3-week experience period serves as an 
intervention itself, and as a practice use of the game so that the smoker will be better prepared for the next quit 
attempt. NRT will not be provided by investigators after the first 3-week experience. Upon completion of study 
participation after the 6-month follow-up visit, participants (both Intervention and Control) will be asked if they 
are interested in participating in future research activities. Interested participants will be asked to sign an 
authorization to contact form (See TAB.authorization_to_contact.7.19.17).To increase engagement with 
intervention tools after the 3-week follow-up, we will send an additional texting assessment to intervention 
participants. These smokers will be asked to rate their current mood using the question, “How would you rate 
your mood right now?” Participants will be prompted to reply based on the response options “1= good, 2=ok, or 
3= bad”. We will ask this question for a period of 5 weeks, twice a week for a total of 10 assessments. 
Following this assessment, study participants will be randomly asked whether they would like to speak to the 
TTS or reminded to utilize the distraction or relaxation mobile apps previously downloaded.  
• For study participants unable to come in person to complete the 6- month follow-up visit, we will mail 
a letter [see “Request to complete_TAB_6mo_fuvisit"] asking them to complete the 6 month follow up 
survey and mail back in the included pre-postage envelope.   
 
NRT-Sampling (provided to both intervention and comparison groups):  
During the initial recruitment session, we will provide smokers’ 1 box (81 Nicorette4-mg mint) of nicotine 
lozenges  purchased over the counter from a commercial vendor. Participants can choose to use or not to 
use the NRT.  It will be provided to participants, but use of it is optional.  (See Section #32 for details on 
dispensing procedures.)  
Quality Improvement Interviews: The researchers would like to interview UMass Memorial nurses and 
hospital leadership to better understand the current initiatives related to tobacco cessation in the hospital 
setting and how a quality improvement mobile health tool for tobacco cessation could enhance care for 
current tobacco users staying at the hospital. The purpose of interviewing hospital leadership is to gather 
insight into current tobacco cessation initiatives and their insight into whether this tobacco cessation tool 
could improve the quality of care given to tobacco users admitted to the hospital. We will interview 10 

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people in hospital leadership at UMass Memorial. The purpose of interviewing nurses would be to 
understand more fully the work they currently perform on their hospital floor, how they identify tobacco 
users on admission, the actions taken to assist tobacco users during their hospital stay and their insight as 
to whether this tobacco cessation tool would benefit tobacco users in the hospital. We will interview 20 
nurses at UMass Memorial. 
Participants will be interviewed for approximately 45 minutes and will be audio-recorded. The interviewer 
will remind participants that the interview is being audio-recorded and as a measure to protect your 
confidentiality, they will be asked not to mention their full name once the interview recording starts. 
Participants will give verbal consent and will be given a Fact Sheet for their records. They will be 
reminded that the data will be protected and should data be lost or stolen, it poses minimal risk to 
participants. The recorder will be stored in a locked drawer, the data will be protected in the password-
protected PI’s UMass Medical QHS department folder, and the data will be destroyed at the end of the 
study. The participants will be compensated for their time with a $50 Amazon gift card. Funds from a 
training grant funded by NCI for post-doctoral fellows in Cancer Research are being utilized for the 
incentives of the Quality Improvement Interviews. As part of the training grant’s budget, each fellow is 
awarded funding to conduct their own research. The research & human subjects portion of the grant are 
not provided in section 7.0 because the grant does not provide the specifics of the research activities.  
Below are timelines of the events for each study aim.  Described in the timeline are the events that will 
occur at each of these study points. 
 
Take a Break Study Timeline by Study Aim (1) 

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Take a Break Study Timeline by Study Aim (2 &3) 

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11) Data and Specimen Banking 
Data collection for this project includes web-based, telephone, and in-person methods for Aims 1, 2, and 
3. (Table 3). All primary study data collected will be centralized and stored within the UMMS Regulated 
Environment. Paper copies of consent forms and data collection tools (baseline and follow-up surveys) 
will remain at the study-specific sites in a locked cabinet. Only CITI trained study staff will be able to 
access to primary study data. Data files cannot be transferred electronically outside of the regulated 
environment. 
Aim 1: Usability think-aloud interviews. We will conduct usability interviews using the Morae software 
and laptops with full data encryption. The Morae recording will be transferred to a server in the UMMS IS 
regulated environment and removed from the laptops.  
Aim 1 + 2: Mini Pilot + RCT.  Surveys conducted on the telephone and in-person (see Table 3 for specific 
surveys) will be recorded within REDCap at the time of completion. TAB activity will be collected by 
UMMS web-based servers and stored within the UMMS IS regulated environment.  
Aim 3: Follow-Up. Surveys 
conducted during follow-up 
will be stored in the same 
manner as in Aim 1 and 2.  
Biochemically verified 
smoking cessation results 
will be stored in REDCap. 
Biochemically verified 
smoking cessation tests will 
only be conducted with 
participants that used the 
optional NRT. 
Quality Improvement 
Interviews: Participant 
interviews will be audio-
recorded. The interviewer 
will remind participants that 
the interview is being audio-
recorded and as a measure to 
protect their confidentiality, 
they will be told not to 
mention their full name once 
the interview recording 
starts. They will be reminded 
that the data will be 
protected. In the unlikely 
event that the data is lost or 
Table 3: Data Collected and Source 
Variable 
Source 
Stage of Collection 
 
EHR 
Registry
Baseline 
App Metrics 
Follow Up 
Screening 
Baseline 
Intervention 
Follow Up 
Demographics (age, gender, race) 
Y 
Y 
N 
N 
Y 
Y 
N 
N 
Level of Addiction (FTND) 
N 
Y 
N 
N 
N 
Y 
N 
N 
Past Quit History 
Y 
Y 
N 
N 
N 
Y 
N 
N 
Readiness to Quit 
N 
Y 
N 
Y 
Y 
Y 
N 
N 
SES/Housing Stability 
N 
Y 
N 
N 
N 
Y 
N 
N 
Depression (CES-D) 
N 
N 
N 
N 
Y 
N 
N 
N 
Alternative Tobacco Use & e-cig 
N 
Y 
N 
Y 
N 
Y 
N 
Y 
NRT Use 
Y 
Y 
N 
Y 
Y 
Y 
N 
Y 
Alcohol/Illicit Drug Use 
N 
Y 
N 
Y 
N 
Y 
N 
Y 
Smoking in Household 
N 
Y 
N 
N 
N 
Y 
N 
N 
Cessation Treatment Beliefs 
N 
Y 
N 
Y 
N 
Y 
N 
Y 
Health Behaviors (exercise, sleep diet) 
N 
Y 
N 
Y 
N 
Y 
N 
Y 
Health Literacy 
N 
Y 
N 
N 
N 
Y 
N 
N 
Medical Comorbidities (SCQ) 
Y 
Y 
N 
N 
Y 
Y 
N 
N 
Perceived Stress 
N 
Y 
N 
Y 
N 
Y 
Y 
Y 
Provider Behavior 
N 
Y 
N 
N 
N 
Y 
N 
N 
Religion 
N 
Y 
N 
N 
N 
Y 
N 
N 
Self-efficacy (SEQ-12) 
N 
Y 
N 
Y 
N 
Y 
N 
Y 
Smoking Urges (QSU) 
N 
N 
Y 
Y 
N 
N 
Y 
Y 
Social Support/Family (mMOS-SS) 
N 
Y 
N 
N 
N 
Y 
N 
N 
Technology Literacy 
N 
Y 
N 
N 
N 
Y 
N 
N 
Triggers 
N 
Y 
N 
N 
N 
Y 
N 
N 
Challenge Quiz Completion 
N 
N 
Y 
N 
N 
N 
Y 
N 
Days Abstinent 
N 
N 
Y 
N 
N 
N 
Y 
N 
Smoking Cessation*  
(biochemically verified a 3wk, 6 months) 
N 
N 
N 
Y 
N 
N 
N 
Y 
Time to First Quit Attempt 
N 
N 
N 
Y 
N 
N 
N 
Y 
Use of Apps/Mini-Games 
N 
N 
Y 
Y 
N 
N 
Y 
Y 

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Revised: November 11, 2021 
stolen, there is minimal risk to participants. The recorder will be stored in a locked drawer in a locked 
office.  Upon transcription of the interviews, the data will be stored within the UMMS Regulated 
Environment and saved within a password-protected folder created for this aim of the study.  The list of 
participants will be stored separately from the transcribed interviews. 
Data will not be released to other researchers. Data will be stored for 6 years.   
 
12) Data Management 
Data Analysis Plan: In Take a Break, we are interested in both the immediate and long-term effects. 
Measuring immediate and long-term effects allows us to demonstrate the pathways (brief abstinence, and 
enhanced self-efficacy) by which long-term quit attempts and cessation result.4 Compared with the NRT-
only comparison, the Take a Break intervention group will have:  
• Hypothesis 1: (Aim 2) Greater mean number of days abstinent during the immediate Marathon Days 
Abstinent: We will measure the difference in the number of days abstinent reported by mHealth 
assessment. The abstinence interval is 2 weeks, and an abstinence assessment will occur daily. Thus, 
days abstinent can vary from N to 14 days.  
• Hypothesis 2: (Aim 2) Greater increase in self-efficacy at the end of the 3-week experience: Change in 
Self-Efficacy is defined as the difference in reported self-efficacy (SEQ-12)28 comparing baseline and 
follow-up at the end of the 3 week experience for intervention and NRT-only comparison patients.  
• Hypothesis 3: (Aim 3) Lower time to first quit attempt (1-survival in longitudinal analysis) Time to 
first quit attempt (mean survival) – Primary Outcome: Quit attempts and cessation will be assessed at 
follow-up surveys at 3 wks and 6 months. Quit attempts will be assessed using the Timeline follow 
back method, which uses a calendar to reconstruct smoking behaviors.29  
• Hypothesis 4: (Aim 3) Higher rate of point prevalent cessation measured at 6 months Six-month point 
prevalent smoking cessation: Smoking cessation trialists have recommended assessment of smoking 
cessation in randomized trials of motivational interventions of point prevalence cessation.30,31 The 
Take a Break trial is defined as a test of treatment to motivation cessation (also termed cessation 
induction). As Hughes and colleagues for the Society for Research in Nicotine and Tobacco 
Workgroup on Measurement note, point prevalence cessation is often the best measure for motivation 
phase trials.31 
Statistical Analyses: To preserve the power of randomization, all primary analyses will be on an intent-to-
treat basis. However, secondary analyses will explore dose-response effects among those with variable 
levels of adherence to the intervention, as ascertained by survey. All analyses will be two-sided and alpha 
error will be set at 0.05. We will begin the statistical analysis by examining univariate statistics (means, 
medians, standard deviations and 95% confidence intervals) and distributions. We will examine the 
balance of participant characteristics by study groups and account for any imbalances in our multivariable 
analysis. As appropriate, group differences will be tested using chi-square tests of independence 
(categorical variables), Z-test or t-test (continuous variables) or the equivalent non-parametric tests 
depending on the distribution of the variables. In accordance with best practice, differences in baseline 
characteristics of the intervention and comparison groups will be established based on standardized 
differences, rather than on tests of statistical significance.32,33  

I N V E S TI G A T O R S T U D Y P L A N – T a ke a Bre a k ( H 0 0 0 0 7 4 2 7) 
 
 
Pa ge 1 5 of 3 3  
Re vis e d: N o ve m ber 1 1, 2 0 2 1  
•  H y p ot hesis 1: T he mea n n u m ber of da ys a bsti ne nt will be greater i n t he i nter ve nti o n t ha n i n t he 
c o ntr ol. B ot h gr o u ps will be o bser ve d f or (t =) 1 4 d a ys. If w e ass u me X 1 t o be t he n u m ber of d a ys 
a bsti ne nt i n t he i nter ve nti o n gr o u p a n d X 2 t o be t h e n u m ber of d a ys a bsti ne nt i n t he c o ntr ol gr o u p, 
t he n X 1 ~ P oiss o n(t λ 1) a n d X 2 ~ P oiss o n(t λ 2) w here λ 1 a n d λ 2 are mea n d a ys of a bsti ne nce i n t he t w o 
gr o u ps. O ur n ull h y p ot hesis is t hat t hese t w o rates are si milar. I n or d er t o test t his h y p ot hesis, we will 
first c o m p ute t he n u m ber of da ys a bsti ne nt f or eac h i n di vi d ual o ver t he 1 4 da ys of t he “ Br ea k” p orti o n 
of t he Marat h o n a n d o btai n t he mea n n u m ber of d a ys a bsti ne nt wit hi n eac h gr o u p. We will use t he Z-
test t o test w het her differ e nce i n t he mea n da ys of a bsti ne nce bet w ee n t he gr o u ps is statisticall y 
si g nifica nt. If we fi n d si g nifica nt differe nces i n t he distri b uti o n of t he c haracteristics of s u bjects i n t he 
t w o gr o u ps, t he n we will i ncl u de t he m as c o variates i n a m ulti varia ble P oiss o n re gressi o n m o del wit h 
t he n u m ber of da ys a bsti ne nt as o ur mai n o utc o m e a n d gr o u p as t h e mai n i n de pe n de nt varia ble. 
•  H y p ot hesis 2 : T he self-efficac y ( S E Q- 1 2) sc ores will be hi g her i n Ta ke a Brea k gr o u p t ha n i n t he 
c o ntr ol. T he S E Q- 1 2 is a 1 2-ite m q uesti o n naire wit h 6 q uesti o ns u n der eac h d o mai n. T w o c o m p osite 
sc ores are c o m p ute d f or eac h of t h ese d o mai ns b y a d di n g t he i n di vi d ual ite ms. T hese data will be 
c ollecte d at bas eli ne a n d at t he f oll o w - u p. T he ai m is t o assess t he effect of i nter ve nti o n o ver t he 
i m me diate peri o d, i.e., d o t he sc ores i m pr o ve fr o m baseli ne t o t he e n d of t he Marat h o n m ore f or t h e 
i nter ve nti o n gr o u p t ha n t he c o ntr ol gr o u p. We will c o m p ute t he sc ores at baseli ne a n d 3 w ee ks f or 
eac h p atie nt i n t he t w o gr o u ps. We will e val uate w het her t he i nter v e nti o n differe nces c ha n g e o ver ti me 
(i.e., is t here a i nter ve nti o n a n d ti me i nteracti o n?). T o a d dress t his q uesti o n, we will use a ra n d o m-
effects m o del of t he f or m: yijt = α + γi + βj + δt + ( β δ)it + uij + eijt w here, yijt is res p o nse at ti me t f or 
t he j-t h s u bject i n t he i-t h gr o u p, α is t he i nterce pt, γj is t he vect or of effects ass ociate d wit h c o v ariat es, 
βi is t he mai n effect f or t he  i nter ve nti o n gr o u p, δt is t he mai n effect f or ti me, ( β δ)it is t he effect f or t he 
i nteracti o n bet wee n i nter ve nti o n gr o u p a n d ti me, uij is t he ra n d o m effect c orres p o n di n g t o t he j-t h 
s u bject i n t he i-t h gr o u p ( ass u me d t o be N( N, ߪ௨ ଶ)), a n d eijt is t he ter m acc o u nti n g f or sa m pli n g 
varia bilit y (ass u me d t o b e N( N,   �ߪଶ)). T h e c o effi cie nt ( β δ) it is t he esti mate of t he i nteracti o n ter m 
w hic h, if si g nifica nt, i n dicates t hat t he i nter v e nti o n effect varies si g nifica ntl y wit h ti me. We will first 
ge nerat e t he varia nce -c o varia nce matri x t o deter mi ne t he a p pr o priat e c o v aria nce str uct ure. We a gai n 
perf or m m o del dia g n osti cs t o assess fit.  
•  H y p ot hesis 3 ( Pri mar y H y p ot hesis) : Ti me t o first q uit atte m pt will be less i n t he i nter ve nti o n gr o u p 
t ha n i n t he c o ntr ol gr o u p o ver t he peri o d of t he st u d y. O ur o utc o me of i nterest here is t he s ur vi val ti me 
(i n o ur case ti me t o q uit), a n d we w a nt t o c o m pare t he s ur vi val ti me i n t he t w o gr o u ps or assess t he 
relati o ns hi p of gr o u p stat us t o s ur vi val ti me. We will o btai n t he s ur vi val c ur ves f or t he t w o gr o u ps a n d 
pl ot t he Ka pla n- Meier c ur ves. We will use t he l o g-ra n k test t o test t he h y p ot hesis of n o differe nce 
bet wee n t he t w o gr o u ps. T his test ass u mes i n de pe n de nce i n t he o bser vati o ns a n d i n de pe n de n ce 
bet wee n t he ce ns ori n g a n d s ur vi val distri b uti o ns. We will als o c o nstr uct C o x- pr o p orti o nal Hazar ds 
re gressi o n m o dels t o assess t he ass ociati o n bet wee n gr o u p a n d atte m pt t o q uit s m o ki n g. T his is a se mi-
para metri c m o del w hic h d oes n ot ass u me a n y distri b uti o n f or t he baseli ne hazar d a n d is defi ne d as: 
h(t; x 1, x 2,. . ., x k) = λ N (t) e x p( λ 1 x 1 + λ 2 x 2 + … + λ k x k) w here, λ o(t) is t he baseli ne hazar d at ti me t 
a n d x 1, x 2, . . . , x k ar e k i n de pe n de nt c o v ariates. N o ass u m pti o ns are ma de re gar di n g t he bas eli ne 
hazar d f u ncti o n. Let X 1 de n ote gr o u p stat us ( 1 =i nter ve nti o n; N =c o ntr ol). T he n e x p( λ 1) is t he hazar d 
rati o f or t he su bjects i n t he i nter ve nti o n gr o u p vers us t h ose i n t he c o ntr ol gr o u p a n d i n dicates t he rati o 

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of instantaneous probability of an event in the two groups. A positive hazard ratio implies that the 
intervention group will have a shorter time to quit than the control group. We will express the risk 
estimates as hazards ratios, 95% confidence intervals, and p-values. As with the previous aims we will 
also assess model fit.  
• Hypothesis 4: Point prevalent cessation measured at 6 months will be greater in the Take a Break 
intervention than in the control group. The main dependent variable is patient tobacco cessation rate. 
The primary independent variable is assignment to intervention or control group. We have designed a 
patient-level analysis around point prevalence cessation based on the following question “Do you 
currently smoke cigarettes (smoked even 1 puff in the last 7 days)?” We will use a two-sided chi-
square test for equality of proportions to test whether the quit rates differ between the groups. If we 
need to adjust for any covariates, we will include them in a multivariable logistic regression model 
with smoking cessation as the outcome and group status as the main independent variable. Using 
mediation analysis, we will examine the potential mechanisms through which we anticipate the 
intervention may produce a beneficial effect.34 
Power Analysis: We will make every effort to maximize participant retention in the study. For our short-
term evaluation, we do not expect high rates of attrition; however, we approximate that there will be about 
15-20% attrition based on previous studies. Thus, although we plan to randomize 500, our power 
calculations for outcomes are based on 400 completing follow-up. We will monitor recruitment and 
retention, and inflate our sample as needed to achieve the resulting sample of 400 completing 6-months. 
We will estimate potential bias due to dropouts in our study and perform a series of sensitivity analyses to 
understand the extent of this bias. We will assess the extent of missing data by treatment group for each 
time point. Power calculations are based primarily on the two primary hypotheses (H1 and H3) and were 
conducted in the statistical software PASS.35 Again, power calculations are based on 400 subjects with 
complete data (even though we plan to randomize 500).  
• Hypothesis 1: We are interested in testing whether the mean number of days in the intervention group 
is higher than that in the control group after 14 days. Assuming 2NN subjects in each group observed 
over 14 days, we have 8N% power to detect a difference in mean number of days abstinent 
(Hypothesis 1) as small as 0.08. In the prior practice quit attempt study, 80% of participants reported 
one quit attempt during a six-week interval, thus we have assumed a base rate of 1 day abstinent in the 
comparison group. This is based on a one-sided test to test the ratio of two Poisson means and assumes 
a significance level of 0.025.  
• Hypothesis 2: We assumed the mean SEQ-12 to be 38.6 in the control group as reported by Wangberg 
et al and a standard deviation of 3 (inferred from their paper but not reported by them). A sample of 
size 200 in each group will achieve 80% power to detect a difference of 0.8 between the group means. 
This was based on a two-sided two-sample t-test and a significance level of 0.05.  
• Hypothesis 3: We have used power calculations for survival analyses. Our outcome of interest is time 
to event (first quit attempt). A sample of size 200 in each group will have 80% power to detect a 
hazard ratio of 1.88 when the proportion quitting in the control group is 0.30 and that in the 
intervention group is 0.49. This calculation was based on the log-rank test and assumes that we only 
conduct one sequential test using the O’Brien-Fleming spending function to determine the test 
boundaries, that the survival times are exponential and a two-sided significance of 0.05. If we 
conducted 3 sequential tests, the detectable hazard ratio is 1.89. 

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• Hypothesis 4: We assumed a control cessation rate of 15%, 48 a two-sided significance level of 0.05. 
A sample size of 200 in each group will achieve 80% power to detect a difference of 11% (quit rate in 
the intervention=26%) in quit rates between the two groups. This is based on a Z-test with pooled 
variance. 
Data Security: We will handle data differently for UMMS, Northwell Health, VACWM and RMG smokers, 
per each institution’s protocol. UMMS and RMG are covered under the same UMMS IRB docket while 
Northwell Health and VACWM have protocols independently reviewed by their own IRB. Table 4 
summarizes data collection. There will be no transfer of patient data between study sites and UMMS prior 
to recruitment into study. Screening data collected for recruitment will be password protected and stored 
behind each study site’s firewall. Patient contact information provided through the eRefer portal will be 
encrypted at rest and during transit using Secure Sockets Layer (SSL) standard security protocol. Each 
study site will have access to only its own identifiable patient data with the exception of UMMS study staff 
which will have access to all participant identifiable data. Once smokers are enrolled in the study, their 
intervention data will be stored on UMass servers. This will be done by entering the data directly into the 
UMMS REDCap database by study staff at each study site.  This data will be stored in the regulated 
database servers and accessible through a secure form and a password-protected connection.  
 
Table 4: Data Collection Source and Storage 
Source 
Collected From 
Personal Identifiers 
Collected By 
Data Storage 
Aim 1 
Think Aloud 
Usability 
 
Smokers participating in 
the usability sessions at 
UMMS Technology 
usability lab 
Yes (identifiers are 
collected and 
stored in encrypted 
form) 
 
UMMS database server in the 
regulated environment 
UMMS IS 
regulated 
environment 
 
Mini pilot 
 
Mini Pilot will match 
Aim 2 data collection 
plus an additional 
qualitative interview 
Yes (identifiers are 
collected and 
stored in encrypted 
form) 
See Aim 2 procedures. Qualitative 
interviews are directly entered 
into the regulated environment 
through a secure REDCap form 
UMMS IS 
regulated 
environment 
Aim 2 Recruitment 
Recruitment – 
UMMS 
Smoker data will be 
collected from UMMS 
EHR and the eRefer 
portal  
Yes (identifiers are 
collected and 
stored in encrypted 
form) 
All data extracted from EHR will 
be stored in the regulated 
environment. Data collected from 
eRefer portal will be encrypted.  
UMMS IS 
regulated 
environment 
Recruitment – 
Northwell   
Smoker data will be 
collected from Northwell 
EHR  
Yes (identifiers are 
collected and 
stored in encrypted 
form) 
All data extracted from EHR will 
be stored in the regulated 
environment  
Northwell IS 
regulated 
environment  
Recruitment –
VACWM 
Smoker data will be 
collected from VA EHR 
Yes (identifiers are 
collected and 
stored in encrypted 
form) 
All data extracted from EHR will 
be stored in the regulated 
environment  
 VACWM IS  
regulated 
environment 
Recruitment – RMG 
Smoker data will be 
collected from RMG  
EHR 
Yes (identifiers are 
collected and 
stored in encrypted 
form) 
All data extracted from EHR will 
be stored in the regulated 
environment  
RMG IS regulated 
environment  
Aims 2 and 3 Intervention 
Baseline and 1-week 
In-person (baseline) and 
the phone 
Yes (identifiers are 
collected and 
stored in encrypted 
form) 
Will be directly entered into the 
UMMS database server in the 
regulated environment 
UMMS IS 
regulated 
environment 

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Revised: November 11, 2021 
1-week TTS Call  
Telephone 
Yes (identifiers are 
collected and 
stored in encrypted 
form) 
Will be directly entered into the 
UMMS database server in the 
regulated environment 
UMMS IS 
regulated 
environment 
 
 
 
 
 
System use (3 weeks 
intervention) 
Smokers responses to 
text messages from 
system 
Yes (identifiers are 
collected and 
stored in encrypted 
form) 
UMMS database server in the 
regulated environment 
UMMS IS 
regulated 
environment 
Follow-Up at 3 
week and 6 months 
In-person and Telephone 
Yes (identifiers are 
collected and 
stored in encrypted 
form) 
Will be directly entered into the 
UMMS database server in the 
regulated environment via 
REDCap 
UMMS IS 
regulated 
environment 
 
Data Security at Northwell Health: The Department of Research Information Systems at Northwell 
Health provides resources and support needed in a research environment, and includes IT Security for the 
research enterprise at Northwell Health. The IT Security team provides many services to help 
the Northwell Health research community protect electronic protected health information, or ePHI, 
including vetting nonstandard systems (hardware & computing resources) and nonstandard applications 
and software to ensure security and compliance, granting temporary access to an electronic medical record 
for research monitors and auditors. EMR access is controlled with unique user IDs, password protection, 
levels of access based on research needs, termination of access, and automatic logoff after inactivity. 
Workstations are secured and protected from public view, and data is maintained and backed up on a 
secure health-system server. IT Security also provides tools for secure data storage and archiving, such as 
dedicated PHI drives, and encryption of portable devices like external hard drives and USB drives. All 
paper forms that contain identifying information will be kept double locked (ie. lockable cabinet, in a 
locked room) to maintain their security. These paper forms will remain at the study site throughout the 
duration of the study. All study data forms will only contain participants' unique study identification 
number, using reference system maintained by the PI and study research staff. All electronic study data 
will be kept in password protected files on secured network servers. Only IRB approved study personnel 
will have access to the data.  
Usage data will be temporarily stored on the mHealth system until it can be transferred to the UMMS IS 
regulated database servers upon network access. To prevent access to this data, all security precautions 
will be taken. This data will be encrypted using industry standard encryption algorithms. We will support 
remote-wipe capabilities in case a phone is stolen.  
Data Security at VACWM: Each participant will be assigned a subject number upon entry into the study 
by the secure mHealth system at UMMS, and all measures/records will be tracked using only this number. 
The subject number will not be based on any information that could be used to identify the Veteran. A 
master list matching personal information with research codes will be kept separate from all personal 
information in a separate folder on a secure VA network drive and a secure UMMS server. Data collected 
through telephone and in-person questionnaire and study instrument data collection will be collected via 
hard copy and will be promptly entered into REDCap, which is hosted in a regulated environment stored 
in regulated, secure UMMS database servers. At screening, personal identifiers (name, address, phone 
number, and e-mail address) will also be promptly entered into REDCap, separate from survey data, and 
maintained on secure VA servers. All data collected in the project will also be stored in a regulated 

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environment in the data center maintained by the UMMS Information Services department. The UMMS 
regulated environment provides applications on a secure network for confidential data. The regulated 
environment has been securely configured to allow application access via the secure socket layer (HTTPS) 
protocol. The setup of regulated environment provides the needed security protocols for the regulatory and 
Federal standards required. Access is restricted through a Virtual Private Network and a secure RSA token 
and only restricted personnel are allowed access to the regulated environment. The Regulated environment 
is secured using hardware and software firewalls, along with access restrictions to enforce governmental 
policies requiring to enforcement. 
 Paper copies of all documents will be stored in a locked office within a locked cabinet in Worcester 
Plantation Street, Biotech 4, Room 3432. Personal identifiers (name, phone number, address, & e-mail) 
will be obtained at study screening to contact Veterans. This information will be entered directly into a 
Microsoft Excel file on a secure server behind the VA firewall as well as into REDCap at the time of 
screening, and kept separate throughout the study from the participants’ other information (e.g., their self-
report measures/clinical interviews) which will only be identified by their participant number. The hard 
copy data will be kept in locked drawers in Worcester Plantation Street, Biotech 4, Room 3432, which 
will be in a locked, secure office within the VA. Any electronic data not entered into REDCap (study 
regulatory documents, and tracking spreadsheets) will also be kept on a secure VA Research drive 
network. 
13) Provisions to Monitor the Data to Ensure the Safety of Subjects 
All data will be stored in a HIPAA compliant regulated environment and access will be only through a 
secure VPN network. All smokers’ related identifiers are encrypted in the database. The biostatistician of 
the Quantitative Methods Core will organize data security and archiving.  
In no way will individual participant data be released to the public or cited in a publication. We have 
substantial experience with successfully implementing these methods. 
To ensure the safety of subject, the telephone screening script refers patients who screen ineligible due to 
possible depression to contact their primary care provider if they need to talk about how they are feeling.  
Data and Safety Monitory Board: This trial is not a Phase III study of a pharmaceutical treatment, but as 
we will be including NRT and our behavioral intervention, we will establish a Data and Safety Monitory 
Board (DSMB). The DSMB will review protocols and consent documents for this trial, monitor safety 
issues throughout the study and the quality of the accumulating data, provide guidance on interim analyses 
and stopping rules. They will also serve as a liaison among the study investigators, the University of 
Massachusetts Medical School’s Office of Human Research Protections (IRB), and the National Institute 
of Health (NIH). The DSMB will be comprised of persons with no direct involvement in the study or 
conflict of interest with the research team conducting the randomized trial. The DSMB will include 
individuals with expertise in: 1. Clinical research in Tobacco; 2. Health Informatics and/or Information 
Technology intervention research; and 3. Biostatistical experience. Once patient recruitment for the trial 
has begun, the DSMB will meet two times per year or more frequently as determined by the DSMB 
members. The Board and the PI will decide upon the format of the meetings. The PI may present 

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information about the study to the Board, but the PI will not be present for the DSMB’s discussion or 
voting. Additional telephone conferences will be held if doing so is recommended by the DSMB. 
 
14) Withdrawal of Subjects 
We do not anticipate withdrawing any participants without them being informed. If study staff are notified 
of a contraindication to NRT use, the participant will be notified and advised to discontinue NRT use. If 
this event occurs, the event will be documented by the study staff member and will report it to the PI the 
same day. Participants who develop a contraindication to NRT after being enrolled in the study, will not 
be removed from the study, as use of NRT is not mandatory, but is available, to the study protocol. 
Participants can opt out of the evaluation at any time, and data collection will stop for those participants.  
 
15) Risks to Subjects 
The risks of the study are not high. Risks to participants relate mostly to misinterpretation of what is 
research and what is loss of confidentiality. The major risk is the accidental disclosure of information; 
however as noted, every precaution will be taken to prevent this and the study team has an excellent track 
record of protection of confidential data. The data will be stored in a HIPAA-compliant regulated 
environment and access will be only through a secure VPN network. All smokers’ related identifiers are 
encrypted in the database.  
Participants will be provided with NRT at the same dose available over-the-counter, to be used if the 
participant desires. Nicotine lozenges will be used because they are available over-the-counter, they can 
be used as needed, and many smokers find them more palatable. As this treatment has less nicotine than 
cigarettes, it is in general a risk reduction from active smoking. Please refer to the Product Information 
(see Attachment-Nicorette Lozenges Product Information) for potential risks of Nicorette Lozenges. As 
we review our list of smokers for proactive recruitment with their physicians, we will exclude any patients 
who their provider deems is a risk for NRT. All participants who have a Food and Drug Administration 
contraindication to nicotine lozenge at baseline will be excluded. We will monitor participants for 
development of contraindications during the study period. If one develops, we will advise the participant 
to discontinue NRT use and to discuss it with their doctor. Participants who develop a contraindication 
will not necessarily be removed from the study in its entirety, just the NRT-sampling aspect. 
Participants may feel embarrassed, uncomfortable, or discouraged as a result of the study (for example, if 
they have difficulty maintaining short-term abstinence, if they have difficulty understanding how to use 
the app, etc.). All feelings will be addressed with sensitivity, compassion, and empathy by the study staff. 
As with all other aspects of the study, any feelings or emotions discussed with study staff will be kept 
confidential. 

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16) Potential Benefits to Subjects 
The major benefit to smokers is the additional resources to encourage smoking cessation and the potential 
for supporting cessation attempts and maintenance and the resulting health benefits.  
 
17) Vulnerable Populations 
This study does not involve individuals who are vulnerable to coercion or undue influence, such as 
cognitively impaired adults, persons who have not attained the legal age for consent to treatments or 
procedures, pregnant women or neonates of uncertain viability or non-viable neonates. 
UMMS employees will be recruited for the Quality Improvement Interviews.  The researchers will work 
with the nursing supervisors to see if staff nurse interview times and locations, generally, could be 
incorporated into the normal workflow. This will ensure there is a private space for an interview and that 
the study will not interfere with normal operations. If the supervisor believes interviewing during working 
hours is feasible with adequate coverage, then this will be an option for staff. Otherwise, all interviews 
will be performed outside of working hours and supervisors will not be aware of which staff member does 
or does not participate.  
The supervisor will introduce the study to their staff and interested staff will then contact the researchers. 
If the interview is performed outside of regularly scheduled work hours, this information will not be 
shared, but the participant may share their participation if they wish. If staff elect for an interview during 
working hours, permission of their supervisor may need to be sought. This will be communicated to the 
staff member by the researchers during recruitment. 
 
The following safeguards have been established to protect the rights and welfare of this population: 
• Researchers will not inform supervisors of nurses’ participation status. 
• Under no circumstances will participation records be available to supervisors. 
• Individuals involved in research processes (recruitment, consent, & interviewing) will not be 
involved in the employee evaluations and assessments. 
• Participation in this study will have not have any effect on grades, employment records and/or 
performance reviews. 
18) Multi-Site Research 
This is a multi-site research study. Recruitment will take place at UMMHC, Northwell Health, VACWM 
and RMG. Please note that as of  June 2019, Northwell Health is no longer actively recruiting study 
participants. To ensure consistency among all research sites, all recruitment documents will be created by 
UMMS staff. All sites will have the most current version of the protocol, consent documents, and HIPAA 
authorization. All required approvals will be obtained at each site. If necessary, all modifications will be 
communicated to staff at each site  and approved before the modification is implemented. Each site will 
safeguard data as required by local information security policies. All study staff at each recruitment 
location will conduct the study according to protocol. Any SAEs will be reported within one day of 
occurrence to the UMMS PI and project coordinator. All non-compliance or deviations from the study 
protocol will be reported to the UMMS PI and project coordinator who will report it to the appropriate 
authority.  

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There will be bi-weekly telephone meetings involving study staff from all recruitment locations. Core 
study staff (PIs and Directors/Coordinators) of all locations will meet weekly. Meeting minutes will be 
emailed to study staff and stored in a location all study staff can access. 
19) Community-Based Participatory Research* 
N/A 
20) Sharing of Results with Subjects* 
Currently, there are no plans to share results with subjects. 
21) Setting 
The Take a Break research study will be conducted at the UMass Memorial Health Care, led by research 
staff  within the Quantitative Health Sciences (QHS) Department, and external sites including Northwell 
Health, VACWM and RMG. Please note that as of June 2019, Northwell Health is no longer actively 
recruiting study participants. All sites will follow the protocol as specified in this ISP. Additionally, 
Northwell Health and VACWM have ISPs which mirror this ISP and are approved by their own IRBs. 
UMMS study staff may provide assistance in recruitment at external study sites after receiving required 
approval at each site.   
UMMS Division of Health Informatics and Implementation Sciences (HIIS):  
Within QHS, HIIS houses the Biomedical Research Informatics Development Group (BRIDG), and the 
Technology Usability lab.  
o UMMS Biomedical Research Informatics Development Group (BRIDG): The BRIDG (Rajani 
Sadasivam, PhD, Director) provides informatics consultation and application development 
support for UMMS researchers. The BRIDG has expertise in the development and evaluation 
of provider and patient facing e-health technologies. The BRIDG also closely works with the 
Quantitative Methods Core for data management. The BRIDG will be responsible for the 
refinement of the Take a Break apps. 
o Technology Usability Lab (Rajani Sadasivam, PhD, Director): The lab is a state-of-the-art 
facility designed to support multiple types of usability studies which utilize video and audio 
recordings. The two-room suite is designed to accommodate focus groups, as well as individual 
and multi-user evaluation sessions. The lab has a testing room and an adjacent observation 
room with capacity for 5 observers. The two rooms are separated by a one-way mirror to allow 
study personnel to observe the test sessions. The testing room is equipped with 6 computers 
that have the Morae usability “Recorder” software configured on them. The Morae “Recorder” 
allows for live capture of subject being tested including recording of clicks, keystrokes, and 
other events. Each of these computers can be observed using two computers in the observation 
room that have the Morae “observer” software installed on them. The lab offers a wide range 
of viewing angles and auxiliary macro cameras for ultimate flexibility in product testing, for 
both software and physical devices. The lab also supports recording of other types of user 
testing (focus groups, interviews, exergaming etc.) through five high definition cameras 
installed on the four sides and the center wall of the room. The video and audio of all of these 
cameras are securely captured using state-of-the-art video and audio recording equipment. In 

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addition, the usability lab also has a 5N inch LCD television through which training sessions 
and demonstrations can be conducted.  All usability testing will take place in the Usability Lab. 
o The research project offices where the study will be conducted are on the University’s computer 
network which has extensive mainframe and microcomputer facilities and capacities. Each of these is 
equipped with a high-speed personal computer using shared storage on the UMMS network where it is 
backed up daily. Faculty offices and conference rooms within the division located on the 8th floor of 
the Albert Sherman Center will be used for sessions with the tobacco treatment specialist and for 
conducting smoking cessation verification. 
Northwell Health:  
Northwell Health is the largest clinically integrated healthcare network in New York State and the third 
largest non-secular health care system in the United States. Northwell Health consists of 21 owned and 
affiliated hospitals and employs 2,700 physicians and 15,000 nurses serving a catchment population of 8 
million people. There are 450 ambulatory and physician practices with more than 5,000 support staff. The 
research infrastructure for Northwell Health is the Feinstein Institute for Medical Research. The Feinstein 
Institute for Medical Research is located on the campus of North Shore University Hospital but clinical 
research extends throughout the Health System. The Feinstein supports two centralized health system 
IRBs and a Grants Management Office for pre- and post-award services. These facilities and services are 
available to all faculty of the health system. 
Patient recruitment will be conducted in ambulatory primary care practices under the Division of 
General Internal Medicine. The Division of General Internal Medicine is composed of a large, dynamic, 
and diverse group of clinicians, educators, and researchers who provide comprehensive primary care 
services. The Division also provides preventive care with a particular emphasis on managing chronic 
conditions such as hypertension, diabetes, and cardiovascular disease. There is also an emphasis on 
continuity of care, preventive medicine, and patient education. The Division has implemented several 
disease management interventions for depression, addictions, and medication adherence.  
The Division’s largest practice in Great Neck, NY includes both a faculty and resident practice with 
approximately 32,000 visits per year. Patients from a variety of socioeconomic and ethnic backgrounds 
are cared for by 16 faculty providers and 72 internal medicine residents. In addition to medical staff the 
practice includes a clinical psychologist, 2 nurse practitioners, 2 social workers, a certified diabetes 
educator, a clinical pharmacist, and a nutritionist. Medical assistants, nurses, and administrative staff 
support clinical staff members. 
 
VA Central Western MA:  
VACWM provides primary, specialty, and mental health care, including psychiatric, substance abuse 
and PTSD services, to a Veteran population in central and western Massachusetts of more than 120,000 
men and women. Care is provided at the Northampton VA Medical Center, which has 85 behavioral 
health beds, a 44-bed nursing home care unit, and a 16-bed substance abuse, compensated work therapy 
and transitional residence located off-campus. The healthcare system also oversees seven community-
based outpatient clinics (CBOCs) in Fitchburg, Greenfield, Pittsfield, Springfield, and 3 clinics in 
Worcester.  
VACWM is an increasingly dynamic and growing research program that focuses on developing and 
studying innovative methods to improve quality, efficiency and access of care to Veterans around the 

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country. As part of its commitment to increasing availability and study of Veterans’ healthcare, new 
clinics have been built for specialty services and research in Worcester, MA. This will be the primary 
recruitment site for this project at VACWM. The Worcester Plantation Clinic is located within a newly 
constructed UMass Medical School (UMMS) building and is located across the street from UMMS main 
campus. As a result, VACWM maintains strong academic affiliations for teaching and research with the 
University of Massachusetts Medical School in Worcester. Thus, VACWM is an intellectually rich 
environment with a wide range of expertise available to inform the successful completion of this project. 
 
Reliant Medical Group:  
The study will be conducted in the context of a large multi-specialty group practice (Reliant Medical 
Group) located in Central Massachusetts, which has proven to be an ideal setting for conducting a number 
of prior NIH and AHRQ-funded studies focused on improving medication safety and health outcomes, as 
well as falls in the elderly.   In addition, Reliant was a center for the Women’s Health Initiative, as well as 
a major Mammography Study.  
Reliant Medical Group employs 265 physicians and 80 mid-level providers, and provides care for over 
252,000 patients at 20 office locations across Central Massachusetts. The practice has used an EHR since 
2006 (Epic Systems Corporation). Epic’s EHR, EpicCare®, is ARRA certified by the Certification 
Commission for Health Information Technology (CCHIT). Recruitment and verbal consent will take place 
via telephone at Reliant Medical Group offices in Worcester, MA. The in-person intervention and consent 
process will take place at RMG Pulmonary Department located at Worcester Medical Center (123 
Summer Street), telephone visits will also take place with a Reliant Tobacco Treatment Specialist (whose 
main office is in Webster, MA).  Data collection/analysis will take place at Reliant Medical Group and 
UMass Medical School in Worcester, MA. 
 
22) Resources Available 
The Department of Quantitative Health Sciences’ (QHS) mission is: (a) to fulfill the quantitative health 
science needs of the academic medical center to become a leader in clinical and translational research; (b) 
to weave service to the academic medical center into discovery of new approaches to address the health 
care needs of the Nation; and (c) to train the next generation of scientists who will contribute to the health 
of populations and individuals and the transformation of health care through methodological innovation. 
The research team is part of the UMMS Division of Health Informatics and Implementation Sciences 
(HIIS). The research vision for the Division is to create new knowledge focusing on computational, 
cognitive, and socio-cultural aspects of health informatics. The Division of HIIS works closely with 
Northwell Health, VACWM and RMG systems. Consistent with the vision of the division, and driven by 
institutional needs, HIIS faculty have been recruited with expertise in clinical research informatics, 
consumer health informatics, human factors and human-computer interaction, clinical decision support, 
data mining and natural language processing. The Division houses nine faculty, program directors, and 
programmers. 
Core Investigative Team: 
• Principal Investigator: The PI is currently a Professor at the University of Massachusetts Medical 
School and Director of the Division of Health Informatics and Implementation Science. While still an 
active clinician at the Bedford VA, they devote their time at UMass to research and directing the 
research mission of the division. They also have secondary appointments in the UMass Division of 
Preventive Medicine. The PI has gained national recognition for their health informatics research with 

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a specific focus on patient informatics. They have been PI of two NIH-funded R01 tobacco control 
grants (R01DA017971 and R01CA129091). They have published articles on tobacco epidemiology, 
health services delivery, research methods, and intervention to reduce tobacco use. In concert with 
their other colleagues in primary care, the PI will review eligibility and enrollment of patients 
(including appropriateness of NRT). The PI will be responsible for the overall conduct of the study. 
• Co-Investigator: The Co-Investigator has over past 15 years of continuous extra-mural funding from 
the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Robert 
Wood Johnson Foundation.  They initially trained as a primary care physician and epidemiologist, and 
for the past ten years, has had a career focused on implementation science and health disparities 
research. They are the Vice Chair of QHS, and also directs the NIH-funded Center of Health Equity 
Intervention Research (CHEIR). Since we anticipate a high percentage of lower income and minority 
patients, the Co-Investigator was recruited to the team. They will lend their expertise to the project by 
being involved in the implementation planning of the study, and consultant on the analysis of study 
data. 
• Co-Investigator: The Co-Investigator is an Assistant Professor in the Division of Health Informatics, 
QHS.  They are also trained as a Tobacco Treatment Specialist. They are a recent awardee of a K07 
award entitled “Smoker for Smoker (S4S),” designed to train in cancer health behavior, health 
communication, intervention design, and analysis. The Take a Break project is in direct alignment with 
these goals, and their efforts will be concurrent.  Under the direction of the PI, they will advise on the 
refinement of the interactive mHealth tools, and assist in supervision of the programmer. They will 
also provide expertise in usability assessment.   
• Co-Investigator: The Co-Investigator has successfully implemented Electronic Health Records and has 
also worked to upgrade and maintain those systems. Their research focuses heavily on user workflows 
and strives to implement informatics solutions that maximize the efficiency of health care providers. 
They are an expert in retrieving data from outpatient clinical systems and turning into actionable data 
to improve quality of care. They will work to develop the recruitment protocols, and data extraction 
through the Allscripts EHR at UMass. The co-investigator has a primary appointment at the University 
of Alabama but remains an adjunct faculty member at UMMS. There is an IRB authorization 
agreement in place for the University of Alabama to defer to UMMS as the IRB of record. 
• Biostatistician: The Biostatistician is a senior faculty member of the Quantitative Methods Core, who 
will direct the statistical analyses for evaluating processes and outcomes.   
• Investigator:  This Investigator has extensive experience in tobacco dependence treatment in their role 
in oversight of the tobacco and smoke-free campus movement for both UMass Memorial Health Care 
and the University of Massachusetts Medical School. They will provide input in the implementation of 
the study intervention and assist with recruitment. They will work closely with the consultants in 
developing and implementing the in person and telephone contact with smokers.   
• Project Director: The PD will be responsible for overseeing the recruitment of patients to participate in 
the study, and conducting the planning visit with participant pre-break. They will work with the 
Research Assistants in other aspects of implementation of the study protocol, oversee distribution of 
incentives to participants, and will direct the research assistants in any other needed areas. 
• Project Coordinators: The Project Coordinators, under the direction of the project director, will 
participate in all phases of patient recruitment, patient telephone follow-up, and conduction of the 

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study and wrap up of the study but will specifically coordinate patient follow-up. They will work 
closely with project personnel to design and print materials required for the project.   
• Research Assistants: The Research Assistants will be responsible for preparing and assembling all 
materials for the study. They will prepare all IRB and human use protocol materials, ensuring annual 
renewal of IRB. They will assist in the production of study materials, assist with recruitment, 
participant visits, and conduct follow-up calls as needed.  
• Website Programmer: The Website Programmer, under the direction of the Co-Investigators, will be 
responsible for developing the elements of the interactive internet intervention including Active Server 
Pages and HTML coding, database design, login and security of the program and data, and 
development of the control program.   
• CONSULTANTS: 
o A trained TTS Consultant will work with the Investigator to recruit patients and conduct assessment 
at 1 week.  
o An additional consultant is Associate Professor in the Department of Psychiatry at the Medical 
University of South Carolina and will advise us on the implementation of the intervention process.  
• RMG Study Team 
o Site-PI: The RMG site PI will be responsible for conducting all research-related procedures 
at RMG and will participate in bi-weekly telephone meetings with UMMS study staff.  
o Project Coordinator: The project coordinator, under the direction of the Research Manager, 
will participate in all phases of patient recruitment, patient telephone follow-up, and 
conducting all study activities at RMG.  
o Research Manager: The research manager will be responsible for overseeing the day-to-day 
study activities and implementation of the study protocol and supervision of project 
coordinator.  
o Tobacco Treatment Specialist (TTS): The RMG TTS will be responsible for conducting the 
1-week telephone visit for all RMG participants.  
o Programmer/Analyst: The programmer/analyst will be responsible for generating the 
SMART alert in the EHR.   
• Northwell Health and VACWM site PI/PD: The Northwell Health and VACWM site PI’s will be 
responsible for conducting all research-related procedures at each corresponding site. They will 
oversee all elements of recruitment at each sites. To ensure that all persons assisting with the 
research are adequately informed about the protocol, the research procedures, and their duties and 
functions, all site PI’s and research team will participate in bi-weekly telephone meetings with 
UMMS study staff to provide any updates.  All -site PI/PD’s will also meet weekly with the UMMS 
PI (or their designee) and PD to discuss any issues or concerns with recruitment. Meeting minutes 

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will be drafted by a UMMS research assistant/coordinator and will be emailed to all study staff and 
stored in a location that all study staff can access.  
UMMS study personnel may assist performing research activities at Northwell Health, VACWM and 
RMG sites as approved by each study site. Northwell Health, VACWM and RMG study personnel will 
not perform research activities at UMMS.  
Smoking Cessation verification equipment (CO meters), Nicotine Replacement Therapy (NRT), and up to 
100 smart phones will be purchased throughout the study. 
 
23) Prior Approvals 
Approvals from Northwell Health and VACWM IRB have been obtained prior to start of any research 
activities. RMG Research Department has granted approval for research to take place with UMMS IRB 
approval.  
24) Recruitment Methods 
See section 7: Study-Wide Recruitment Methods 
Compensation: The schedule of participant compensation is shown below.  All compensation will be 
received within 48 hours upon completion of the particular task (i.e. after in-person session, after 
telephone survey).  Compensation will be in the form of Amazon gift cards, in $25 and $50 denominations 
.Study participants at RMG will receive checks (mail to them after each visit) in the same amounts as 
Amazon gift cards.  
Table 5: Compensation Type for each Study Aim/Task 
Research Method 
Participants 
Duration 
Honoraria (All in the form of Amazon 
gift cards and checks) 
Aim 1 Usability 
Testing 
Smokers from UMass 
Clinics and Inpatient 
1 hour 
In-person visits $50 each; 1 in-
person visit  
 
Aim 1 Mini Pilot 
Smokers from UMass 
Clinics and Inpatient 
3 weeks 
Two in-person visits are $50 each; 
two phone contacts are $25 each – 
total  of $150 /participant 
Aim 2 Take a Break 
Intervention 
Smokers from UMMS, 
Northwell Health, 
VACWM and RMG  
3 weeks 
Three in-person visits are $50 
each; one phone contact is $25  – 
total  of $175 participant 
Aim 3 Follow-Up 
Smokers from UMMS, 
Northwell Health, 
VACWM and RMG  
6 months 
Quality 
Improvement 
Interviews 
UMMHC Nurses & 
hospital leadership 
45 minutes 
$50 per interview 

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25) Local Number of Subjects 
For Aim 1 usability testing, we will recruit up to 20 local subjects. For the Aim 1 mini pilot, we will 
recruit up to an additional 30 local participants. We will recruit up to 300 participants locally for the RCT 
(Aim 2 &3). 
 
26) Confidentiality  
We have stringent protection against breach of confidentiality using secured servers and locked office 
spaces for data entry at each site. The research team at each site will do periodic checks to ensure that 
participant confidentiality is protected at all stages of data management and analysis. At the start of the 
evaluation all project team members will be trained in practices that ensure participants’ confidentiality 
and privacy.  
Recordings collected during usability testing will be de-identified using subject ID numbers. No 
identifiable information, such as a full name or image of a subject’s face, will be collected by the 
recording. Identifiers will be collected separately and will be stored in an encrypted form. Recordings will 
be transcribed and de-identified. Recordings will be stored in a secured UMMS drive specified for the 
study within the UMMS IS regulated environment, where only UMMS study staff will have access to 
them. Recordings, and all other data collected in this study, will be retained and destroyed in accordance 
with SOP HRP-800. 
All data will be stored in a HIPAA compliant regulated environment and access will be only through a 
secure VPN network. All patient related identifiers are encrypted in the database. The investigators have 
substantial experience with implementing these methods successfully in their research. All data will 
remain confidential and only reported in aggregate. UMMS will have access to Northwell Health, 
VACWM and RMG recruitment data.  All data collected through the RCT will be stored in REDCap and 
our secure mHealth system. All in-person session (UMMS, Northwell Health, VACWM and RMG) data 
collection will be conducted using paper forms. Paper forms will be stored in a locked office within a 
locked cabinet at each study site. All data from paper forms will be entered into REDCap, which is hosted 
in our regulated environment and all data collected through it is stored in the UMMS regulated database 
servers. 
All subjects, for all study aims, will be assigned an ID number and a link between the ID number and 
identifiable information will be stored and secured in a different drive folder than any study data. 
For participants using their own personal smart phones, all security precautions will be taken to prevent 
access to app usage data. This data will be encrypted using industry standard encryption algorithms. 
Additionally, we will support remote-wipe capabilities in the event a phone is stolen or lost. 
All data for patients who were screened for participation but did not consent to participate in the study, 
will be destroyed once recruitment has been completed for Aim 2. 
 
27)  Provisions to Protect the Privacy Interests of Subjects (HIPAA) 
We have minimized data collection to only what is needed to answer our hypotheses. We have stringent 
protection against breach of confidentiality using secured servers and locked office spaces for data entry at 
UMMS. The research team will do periodic checks to ensure that participant confidentiality is protected at 

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all stages of data management and analysis. At the start of the evaluation all project team members will be 
trained in practices that ensure participants’ confidentiality and privacy.  
We are requesting a waiver of HIPAA authorization, (see HIPAAwaiver-TAB_21815). Recruitment cannot 
be undertaken using health information that has been de-identified. It is not feasible for the research team 
to obtain a signed Authorization for all PHI that we need to obtain for recruitment. Consent to participate 
in the usability testing, mini pilot, and RCT will be written. We will protect all patient information by 
keeping all data of enrolled participants on a secure  UMMS server, on a separate drive specified for the 
evaluation, behind  the UMMS firewall. All data files will be labeled with a participant code unrelated to 
any participant information. UMMS will maintain a master list of participants and linked codes, but these 
will be stored separately from the data and accessible only by select research staff. Each file will have a 
site level and participant level code.  
Additionally, we are requesting a HIPAA Authorization to use PHI for research purposes. Attached to the 
eIRB is a HIPAA Authorization form that will be presented at the time of consent. We will be using 
demographics and medical diagnosis within analysis. If a participant does not sign the authorization form, 
we will not use the PHI obtained for recruitment for research purposes. Therefore, we will not be using the 
PHI of anyone who is not a participant in the study and who did not sign an authorization form. We 
believe by using the PHI already obtained, we are reducing the burden on the participant by limiting the 
amount of data collection they are directly involved in.   
 
28) Compensation for Research-Related Injury 
This research does not involve more than minimal risks to participants. Consequently, no funds have been 
set aside for research-injury compensation.  
 
29) Economic Burden to Subjects 
We will provide smartphones and cellular access to smokers who do not have access to one. We will also 
compensate travel costs. 
 
30) Consent Process 
We will be obtaining consent for participation in this study in accordance with HRP-802. The process of 
informed consent will begin before the intervention is administered or any data (not including EHR data) 
is collected (see table 6 for type of consent). The study procedures will be explained prior to consent. 
Participants will be given the opportunity to ask any questions or for clarifications before consenting to 
participation. It will be explained that the healthcare they receive at UMMHC or Northwell Health or 
VACWM or RMG will not be affected by their decision to participate or to not participate in the study. 
Participants will then read the consent form and sign it (see Consent Form A1a, Consent Form A1b, 
Consent Form A1c, and Consent Form 2 & 3), if they choose to participate. Participants may opt out of 
the research study at any time. If necessary, all participants will be given additional information 
throughout the course of the study in order to maintain informed consent. 
 
Table 6: Consent  Type for each Study Aim 

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Research Method 
Participants 
Duration 
Number 
Consent 
Aim 1 Think Aloud Usability 
Smokers from UMass Clinics and Inpatient 
1 hour 
20 
Written  
Aim 1 Mini Pilot(s) 
Smokers from UMass Clinics and Inpatient 
3 weeks 
30 
Written 
Aim 2 Take a Break Intervention 
Smokers from UMMS,  Northwell Health, 
VACWM and RMG 
3 weeks 
500 
Written 
Aim 3 Follow-Up 
Smokers from UMMS,  Northwell Health 
VACWM and RMG  
6 months 
500 
Written  
QI interviews 
UMMHC Nurses & hospital leadership 
45 minutes 
30 
Verbal 
 
Individuals that are non-English speaking, not yet adults (infants, children, teenagers), cognitively 
impaired, or are unable to consent will be excluded from participating in the study. 
Waiver or Alteration of the Consent Process: We are requesting a waiver of HIPAA authorization (see 
UMass HIPAA Waiver Appendix) for recruitment purposes.  
For the quality improvement interviews, we will explain study procedures prior to obtaining verbal 
consent. Participants will be given the opportunity to ask any questions or for clarifications before 
verbally consenting to participation. Upon verbal consent, the participant will receive a Fact Sheet that 
summarizes the study for their records. 
 
31) Process to Document Consent in Writing 
Since all of our study aims will only include written consent (see Table 6), we will be following the 
guidelines to obtaining written consent outlines in SOP: Written Documentation of Consent (HRP-803).   
We will:  
• Verify that the consent form is in language understandable to the participant 
• Print the name of the following individuals on the consent document: 
o Subject/Representative 
o Person obtaining consent 
• Have the following individuals personally sign and date the consent document: 
o Subject/Representative 
o Person obtaining consent 
• Provide copies of the signed and dated consent document to the subject/representative 
We request a Waiver of Documentation of Consent for the quality improvement interviews. The 
interviews involve no more than Minimal Risk to the participants. The procedures in place to 
protect patient confidentially are described in sections 11, 26 and 27. The waiver will not 
adversely affect the rights and welfare of the subjects. Whenever appropriate, the participants will 
be provided with additional pertinent information after participation. In the unlikely event of this 
happening, we will contact UMMS IRB for guidance. This evaluation meets the following criteria 
for a waiver of written documentation of the consent process for the subsequent reasons: 
• The evaluation presents no more than Minimal Risk of harm to subjects.  
• The evaluation involves no procedures for which written consent is normally required outside 
the research context. 
 

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32) Drugs or Devices 
The NRT used in this study is not investigational, and therefore, does not have an IND. The NRT 
being used in this study is IND exempt since it meets the following criteria: 1) The drug is lawfully 
marketed in the United States; 2) The investigation does not involve a route, dosage level, or use in 
a patient population or other factor that significantly increases the risks (or decreases the 
acceptability of the risks) associated with the use of the drug product; 3) The investigation is not 
intended to be reported to FDA as a well-controlled study in support of a new indication for use 
nor intended to be used to support any other significant change in the labeling for the drug; and 4) 
The investigation is not intended to support a significant change in the advertising for the product.  
The lozenges will be stored according to the instructions on the box. They will be locked up inside the 
PI/PI-designee’s office. Only IRB-approved members of the research team, Tobacco Treatment 
Specialists or physicians will provide NRT to the participants.  Participants will be asked about any FDA 
contraindications at the time of dispersion.  For all sites, the lozenges will be purchased by UMMS from a 
commercial vendor and mailed to each site as required. For Northwell Health and RMG, the lozenges will 
be kept locked in the site-PI-designee’s office. For VACWM, the lozenges will be stored according to the 
instructions on the box and will be kept at the VACWM pharmacy. Only physicians listed as study staff 
will be able to prescribe NRT to the participants. Additionally, a copy of the participant’s informed 
consent form will be uploaded to the participant’s electronic medical record prior to dispensation of NRT. 
 
Participants can choose to use or not to use the NRT.  It will be provided to participants, but use of it is 
optional. A dispensation log will be kept at each site detailing the NRT that was provided to participants 
and the research staff member dispensing the lozenges. If participants use the NRT, they will be asked to 
participate in a smoking cessation verification test using a carbon monoxide (CO) monitor. At the 
conclusion of the project, unused NRT will be returned to study staff at UMMS for proper disposal if 
desired by participants. All returned NRT will be destroyed by the UMMS IDS pharmacy. 
 
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