Pilot Trial of a Smartphone Smoking Cessation Application Intervention for Cancer Patients (Quit2Heal Study)
Phase: NA
Conditions: Cancer, Smoking
Sponsor: Fred Hutchinson Cancer Center

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Study Protocol and Statistical Analysis Plan 
ClinicalTrials.gov Cover Page 
 
 
 
 
 
Title: Pilot Randomized Trial of a Smartphone Smoking Cessation 
Intervention for Cancer Patients (Quit2Heal Study) 
 
 
 
NCT: NCT03600038 
 
 
 
Document Date: 10/25/2019 
 
 
 

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Title: Pilot Randomized Trial of a Smartphone Smoking Cessation Intervention for 
Cancer Patients (Quit2Heal Study) 
 
Date: 10/25/2019 
 
INVESTIGATORS & KEY STAFF 
 
Jonathan B. Bricker, Ph.D. (PI, Fred Hutch) 
Jamie Ostroff, Ph.D. (Co-I, Memorial Sloan Kettering) 
Jaimee L. Heffner, Ph.D. (Co-I, Fred Hutch) 
Brie Sullivan (Project Manager, Fred Hutch) 
Kristin Mull (Statistical Research Associate, Fred Hutch) 
Noreen Watson (NIDA Post-Doctoral Fellow, Fred Hutch) 
 
FUNDING 
CVS Health Foundation 
 
PROJECT SUMMARY/ABSTRACT (DESCRIPTION) 
2 
SIGNIFICANCE & SPECIFIC AIMS 
 
2 
RESEARCH STRATEGY 
3 
  Research Plan and Methods for RCT 
3 
  Approach 
4 
  Measures and Statistical Analysis Plan 
6 
PROTECTION OF HUMAN SUBJECTS 
7 
  Protection Against Risk 
8 
  Inclusion of Women and Minorities 
10 
  Inclusion of Children 
11 
  Data and Safety Monitoring Plan 
11 
REFERENCES 
14 

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PROJECT SUMMARY/ABSTRACT (DESCRIPTION) 
 
Cigarette smoking has harmful effects on cancer patients’ treatment and prognosis, but 
there are enormous systemic barriers to delivering smoking cessation interventions to 
cancer patients, including lack of reimbursement methods, lack of provider training and 
time, and lack of systems for universal assessment, referral, and integration of 
cessation service into routine cancer care. One solution for addressing these barriers is 
to give patients immediate and low-cost access to smoking cessation treatment via a 
smartphone application.   
 
A smoking cessation smartphone application (app) specifically designed for cancer 
patients who smoke will address the problems of lack of provider training for smoking 
cessation, lack of funding and insurance reimbursement to adequately build and sustain 
an in-person smoking cessation team, and lack of immediate access to treatment. In-
person behavioral treatment for cancer patients who smoke is effective, so the Tobacco 
and Health Behavior Science Research Group has incorporated that treatment in 
designing a cancer-patient version of the existing iCanQuit smoking cessation app for 
general population smokers. iCanQuit is the result of four years of clinical and user-
centered design research, design, and development work totaling over $700,000. It is 
the first and only app for smoking cessation to be tested in randomized clinical trial and 
is supported by more research overall than any of the other 500 English language 
smoking cessation apps now available.  iCanQuit offered the ideal infrastructure for the 
development of a smoking cessation app designed for cancer patients, named 
Quit2Heal. 
 
Quit2Heal is engaging and tailored to the specific needs of the cancer patient, which 
include high prevalence of comorbid mental disorders, distress from cancer diagnosis, 
and lack of awareness of smoking’s effects on treatments and outcomes. The Quit2Heal 
app can be integrated into routine cancer care, and it offers the potential to reach 
millions of cancer patients worldwide who smoke, something an in-person treatment is 
unlikely to be ever be able to offer on the same scale and certainly not at the same cost.   
 
SIGNIFICANCE & SPECIFIC AIMS 
Cigarette smoking can impact metabolism of chemotherapy and targeted therapy, 
increase risk of radiation therapy complications, increase rates of postoperative 
complication and mortality, increase risk of recurrence, and decrease rates of survival.  
Despite these effects, 64% of cancer patients who smoke pre-diagnosis will continue to 
smoke post-diagnosis [1].  Providing smoking cessation programs to help cancer 
patients quit smoking meets an important healthcare need and fills a necessary gap in 
oncology treatment. National Comprehensive Cancer Network guidelines for treating 
smoking cessation provide no guidance for the tailoring of cessation interventions for 
cancer patients (NCCN.org). A major barrier to provide smoking cessation support to 
cancer patients are a lack of appropriate resources, lack of provider training and their 
time to offer cessation treatments [2]. To address these gaps and limitations, we 
developed the first smartphone app for smoking cessation specifically tailored to cancer 
patients. The app is called Quit2Heal.  

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Specific Aim. This pilot project provides a timely opportunity to pursue one key aim: 
conduct a pilot trial comparing the Quit2Heal application for cancer patient smokers to 
the NCI Smokefree.gov Quit Guide application for general population smokers.  
 
Our primary aims are to: (1) assess the feasibility of the recruitment methods (e.g., 
cancer treatment center vs Facebook ads), (2) assess participants’ engagement with 
and receptivity to the Quit2Heal app, (3) assess usability of the Quit2Heal app, and (4) 
show the Quit2Heal app’s cessation progress and outcomes compared to NCI Quit 
Guide in short-term (2 month) follow-up. 
 
 
RESEARCH STRATEGY 
 
Research Plan and Methods for RCT  
 
Timeline. Over the course of 18 months, we will recruit, enroll, and randomize 
participants, conduct a 2-month post-randomization survey data collection, data entry, 
and quality control, and analysis. 
 
Table 1. Schedule of key activities. 
 
 
 
 
 
Quarter 
Spring Summer Fall Winter Spring Summer Fall 
1. Recruitment  
X 
X 
X 
X 
X 
 
 
2. Interventions  
X 
X 
X 
X 
X 
 
 
3. Outcome Surveys  
 
X 
X 
X 
X 
X 
 
4. Data Entry & QC 
 
 
X 
X 
X 
X 
X 
5. Analysis 
 
 
 
 
 
X 
X 
  
Randomized trial experimental design. We will conduct a two-arm randomized 
controlled trial that compares application-based ACT to an application-based smoking 
cessation intervention following US Clinical Practice Guidelines (Smokefree.gov). To 
balance baseline variables between the two conditions, following enrollment we will 
randomize participants.  
 
Figure 1. Experimental Design 
 
 
                                                  Screen, Consent & Baseline Survey 
 
 
 
 
 
 
 
 
 
 
Randomized (n=60) 
NCI Quit Guide (n=30) 
2 Month Survey 
2 Month Survey 
FH Quit2Heal (n=30) 

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APPROACH 
We will conduct a randomized effectiveness trial comparing our ACT smoking cessation 
application Quit2Heal to the NCI’s Quit Guide application. Specifics on our pilot trial, 
research team, and research strategy are the following: 
 
Eligibility Criteria: (1) age 18 or older, (2) diagnosed with cancer in the past 12 
months, or currently receiving or planning in the next 3 months to receive cancer 
treatment, (3) has smoked a cigarette (even a puff) in the past 30 days, (4) interested in 
learning skills to quit smoking, (5) willing to be randomly assigned to either smartphone 
application, (6) resides in US, (7) has at least daily access to their own smartphone, (8) 
knows how to login and download a smartphone application from the Apple app store or 
Android Play app store, (9) willing and able to read in English, (10) not currently using 
cessation medications or enrolled in other smoking cessation programs, and (11) has 
never used the NCI’s Quit Guide smartphone application. To increase follow-up 
retention, eligiblity criteria also include: (12) willing to complete one follow-up survey, 
(13) provide email, phone, and mailing address. Participants not eligible for or interested 
in randomization will be given the given the smokefree.gov website, the 800-QUIT-NOW 
phone number to reach their state’s quitline, and the NCI’s Quit Guide smartphone 
application.  
 
ACT intervention. The overriding goals of the ACT intervention are to (1) develop 
acceptance-related skills for dealing with internal smoking cues while (2) enhancing an 
enduring commitment to quit smoking [3]. Participants are encouraged to make 
behavioral choices on the basis of commitment to goals linked to life values, and not on 
the basis of seeking to modify or alleviate certain sensations, emotions, and thoughts. 
To achieve these goals, the intervention will focus on ACT’s core interdependent 
processes: acceptance and commitment. In ACT for smoking cessation, acceptance 
refers to allowing one’s self to have, without defense, the sensations, emotions, and 
thoughts that cue smoking [3-4, 5-6]. The process of commitment in ACT means 
committing to taking actions to quit smoking even in the presence of sensations, 
emotions, and thoughts that cue smoking.  
 
Comparison app.  To address the question of whether Quit2Heal is more efficacious 
than an app following USCPG, we chose QuitGuide as the ideal comparison 
intervention for four key reasons. First, it is one of the few apps (of the 400 available) 
that follow the USCPG [7].  Second, its content and structure are directly based on 
Smokefree.gov, the most accessed cessation website in the world. Third, QuitGuide’s 
content is non-proprietary and free to the public, thereby providing maximal 
transparency, accessibility, and replicability. Finally, because of our pilot RCT and 
iCanQuit RCT, QuitGuide is now the only app following USCPG with adult quit rate 
estimates that are based on a clinical trial [8].   
 
Recruitment. Our goal is to have 600 participants screen eligible to randomize 60 study 
participants. To recruit nationally, we will work with Fred Hutch Communications and 
Marketing to develop a study media kit that includes a recruitment website, press 

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releases, and flyers with links to our recruitment website. Depending on the recruitment 
venue, relevant portions of our media kit will be distributed to Internet media (e.g., 
online sites and blogs), newspapers, radio stations, television stations, hospitals and 
community clinics, trade groups, quitlines, cessation websites, and Facebook Ads. We 
will also recruit through the National Cancer Institute Contact Center (NCICC, also 
known as NCI's Cancer Information Service), Memorial Sloan Kettering (MSK), and the 
Seattle Cancer Care Alliance (SCCA) and SCCA affiliate network sites. At NCICC, the 
trained information specialists will describe the study to potential participants (who call 
and disclose that they are cancer patients who smoke and would like to quit), using our 
call script, and will direct them to the recruitment website if they are interested in 
participating. At MSK and the SCCA clinic and affiliate network sites, fliers, brochures, 
and TV screen ticker-tape messages can be used to advertise the study, and site 
research personnel and/or healthcare providers can describe it to eligible participants. 
Additionally, Donna Manders who runs the cessation program at SCCA SLU will offer 
the study as an option to eligible patients who have declined participating in her 
cessation program. Donna and other MSK or SCCA or affiliate network staff will only 
describe the study and direct patients to the study recruitment website; they will not be 
involved in the study consent or intervention, which will all take place on the study 
website and app. We expect to recruit approximately 25% of participants through the 
NCICC, MSK, SCCA sites and SCCA affiliate network sites. 
 
Enrollment. We will use the identical enrollment method proven successful in our 
iCanQuit ACT smartphone RCT. Specifically, for participants who screen eligible on the 
recruitment website and provide their email address, we will instantly send them an 
email (and two reminders over a 14-day period) inviting them to complete a secured 
online survey to provide informed consent and complete the baseline assessment. 
Those not consenting and completing the online enrollment process within 14 days will 
be sent an email notifying them that they were not enrolled and provide both the 
smokefree.gov website and the 800-QUIT-NOW phone number to reach their state’s 
quitline. Those randomized will be emailed a secured link to download their app (either 
Quit2Heal or QuitGuide). All participants will be emailed identical once weekly 
reminders to use their assigned intervention.  
 
Two-month post randomization follow-up survey. At baseline, we will collect email, 
phone, and mailing address information as well as optional contact information on at 
least 2 collateral contacts. At 2 months post randomization, participants will be sent an 
email with an invitation to complete the 2-month follow-up survey. An additional two 
reminders will be sent within 9 days. A phone survey will be conducted for those not 
responding by the 12th day. There will be 12 attempts made over 12 days. Lastly, a 
reminder letter will be sent that will include a $2 bill pre-incentive to encourage 
participation. We will send reminder letters at each follow-up for those non-responders 
using an “Address Service Requested” envelope, for automatic forwarding to new 
mailing addresses. Each survey and Internet tracking will also collect address 
information. A final postcard with just two questions will be mailed out if follow-up rates 
are below 70%. All respondents will be mailed $25 after completing the survey, with a $10 
bonus if they complete the survey online within 24 hours.  

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MEASURES AND STATISTICAL ANALYSIS PLAN 
 
Table 2. Participant surveys and time points when they will be administered.  (All 
participants) 
 
Measure 
Screening 
Baseline 
2-month 
Purpose 
Eligibility & Enrollment 
(24 items) 
x 
  
  
Eligibility, Enrollment, & Stratification 
Demographics (24 items) 
  
x 
  
Stratification & Exploratory 
Nicotine Dependence (6 items) 
  
x 
x 
Stratification & Aim 1 
Smoking/Tobacco 
History (2 items) 
  
x 
  
Aim 1, Aim 4, and Exploratory 
Tobacco Use (9 items) 
  
x 
x 
Aim 4 
Alcohol Use (4 items) 
  
x 
x 
Aim 4 
PTSD Symptoms 
(6 items) 
  
x 
x 
Aim 4 
Post Traumatic Growth 
Inventory (21 items) 
 
x 
x 
Aim 4 
Generalized Anxiety Symptoms 
(7 items) 
  
x 
x 
Aim 4 
Social Anxiety Symptoms  
(3 items) 
  
x 
x 
Aim 4 
Depression Symptoms  
(10 items) 
  
x 
x 
Aim 4 
Distress Tolerance (6 items) 
  
x 
x 
Aim 4 
Values (10 items) 
  
x 
x 
Aim 4 
Internalized Shame Symptoms 
(5 items) 
 
x 
x 
Aim 4 
Self-Compassion 
(10 items) 
 
x 
x 
Aim 4 
Smoking and Cancer Outcome 
Expectancies (4 items) 
 
x 
x 
Aim 4 
Quitting Self-Efficacy 
(1 item) 
  
x 
  
Aim 4 and Exploratory 
Internalized and Perceived 
Stigma Items (9 items) 
 
x 
x 
Aim 4 
Mobile Device Use (6 items) 
  
x 
  
Eligibility and Aim 1 
Receptivity/utilization (14 items) 
  
  
x 
Aim 2 and Aim 3 
Cessation & Extra Aids (5 items) 
  
  
x 
Aim 1, Aim 3, and Exploratory 
Willingness to discuss (1 item) 
  
  
 X 
Follow-up 
Acceptance of cues (18 items) 
  
x 
x 
Aim 4 & Exploratory 
 
Analyses. Our aims examining feasibility, engagement, usability, and cessation are all 
exploratory.   Analyses based on follow-up survey items will be limited to participants 
who complete the 2-month follow-up survey.  All other analyses will include all 
randomized participants.  

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Feasibility of recruitment methods. We will assess the number and proportion of study 
participants recruited directly by the cancer treatment center and through Facebook 
ads.  A table with N (%) by treatment arm will be provided. 
 
Engagement and receptivity to the Quit2Heal app.  We will assess the number of times 
participants log into their assigned apps and total time spent on the apps based on data 
automatically logged on the secure server.  Receptivity to the apps will be assessed by 
two items on the 2-month follow-up survey.  One asks participants to rate the overall 
usefulness of their assigned Quit2Heal app for quitting smoking.  Ratings will be 
dichotomized as “somewhat”, “mostly”, or “very” useful vs. lower ratings.  The second 
item allows participants to provide comments or suggestions that will allow us to 
qualitatively assess receptivity to the app and aid in future development of the app.  
Tables with N (%) or Mean (SD) by treatment arm will be provided. 
 
Usability of the Quit2Heal app.  We will compare the two arms on items measuring the 
usability of the assigned program using descriptives. If participants indicate that they are 
willing to discuss their experience in the study, we will contact them to inquire about 
their user experience with the app.  Responses will be used to qualitatively assess ease 
of use, appeal of the app design, and suggestions users may have for improvements. 
 
Cessation outcomes and cessation progress at 2-month follow-up.  We will report the 
30-day point prevalence quit rate at 2-months post randomization, as well as secondary 
cessation outcomes 7-day and 24-hour point prevalence abstinence.  We will provide 
both complete case and missing=smoking results for each study arm.  Quit2Heal vs. 
NCI Quit Guide cessation rates will be compared using logistic regression, adjusting for 
the three factors used in stratified randomization: Heaviness of Smoking Index, 
Commitment to Quitting Smoking Score, and recruitment method. 
 
Cessation progress outcomes will include number of 24-hour quit attempts, change in 
number of cigarettes smoked per day since randomization, nicotine dependence level, 
acceptance of cravings to smoke, commitment to quitting, and use of nicotine 
replacement therapy or medications to aid quitting.  Tables with N (%) or mean (SD) by 
treatment arm and p-values obtained from logistic regression, linear regression, or 
negative binomial regression models adjusted for randomization factors will be 
provided. 
 
 
PROTECTION OF HUMAN SUBJECTS  
 
Risks to the Subjects 
 
Human subjects’ involvement and characteristics. We will conduct a two-arm 
randomized controlled trial that compares the Quit2Heal cancer-patient specialized 
application-based ACT to an application-based smoking cessation intervention following 
US Clinical Practice Guidelines (Smokefree.gov). To balance baseline variables 

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between the two conditions, following enrollment we will randomize with stratification 
according to these known predictors of smoking cessation: nicotine dependence 
(Heaviness Smoking Index cut off score of 4 [9]), motivation to quit (Commitment to 
Quitting Scale cutoff score of 4 [10], and recruitment method (clinic vs. social media). 
The hypothesized moderators will be measured at baseline. The hypothesized 
mediators will be assessed at both baseline and two months post randomization, while 
cessation and progress outcomes will be measured at 2 months post randomization.  
 
Potential Risks 
 
Main risks. The main risk to participation in this study is a small risk of breach of 
confidentiality. A breach could possibly occur if, for example, an unauthorized person 
accesses the study’s database records and/or hard copy records, telephone enrollment 
or survey conversations are accidentally overheard by someone who does not know the 
participant smokes or is taking part in a smoking cessation study. Also, some 
participants might feel emotional upset during their assigned intervention or 
embarrassment when talking about their smoking during the telephone survey. Finally, 
some smokers making quit attempts may experience some short-term discomfort 
associated with nicotine withdrawal.  
 
PROTECTION AGAINST RISK 
 
All research activities will be reviewed and approved by the IRB at Fred Hutch to ensure 
that participants are adequately protected against risk. The research aims and activities, 
as well as risks and benefits, will be explained in detail to all potential participants prior 
to obtaining informed consent. Steps to protect against risk are described below: 
 
Protection against breach of confidentiality. Our research group uses the following 
confidentiality procedures: All data records are stored in secured servers or in locked 
file cabinets inside locked (limited access) rooms in our secured building. Completed 
paper surveys have no identifying information other than the participant’s unique Study 
ID number. Access to paper and electronic study data and records, and to the link 
between participant names and Study ID numbers, is restricted to a limited number of 
need-to-know study personnel, and data may not be taken off the premises for any 
purpose. Users have no access to project computers unless they have a domain 
(network) account. All users must change passwords every 120 days. The electronic 
database resides on a server that is in a locked cabinet in a locked server room, with 
strictly limited, key-card access. The server also lies behind the Center’s firewall, which 
permits no access to the server at all from outside the Center, except through the 
database server port using a secure, encrypted channel.  The research group places 
additional restrictions, through DBMS software, on which data items users may view 
and the kinds of activities they are permitted. These permissions are based strictly on 
each staff member’s need to see and use the data. No staff member will be able to 
access the data by default. The Project web server also resides in the same secure 
room as the database server, and is similarly protected by firewalls, with no user access 
except through the web server software. The database administrators maintain a 

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rigorous system of daily full tape backups of the database and web servers. The 
backups include sets of tapes stored at a secure distant site. 
 
Study participants will be recruited using a publicly accessible web site running on the 
Apache web server on a Linux operating system. The public web server is segregated 
from the rest of the Fred Hutch network within a DMZ (demilitarized zone). After 
indicating interest in the study, participants will complete online surveys via the secure 
sockets layer protocol (SSL). Employment of the SSL protocol will prevent anyone from 
intercepting data passed between the end user’s web browser and the web server. 
Once randomized, each treatment group will have access to their assigned smartphone 
application protected upon successful download. All connections to the enrollment 
website will be made using the secure sockets layer (SSL). 
 
Surveys are implemented using a secure, metadata-driven system designed and tested 
by our software development team, which has been in use for the past five years for 
other research studies in which participants enter information about themselves.  
Surveys are hosted on a Web site running on the Apacheweb server on a Linux 
operating system. The public web server is segregated from the rest of the Fred Hutch 
network within a DMZ (demilitarized zone). Study participants who complete these 
online surveys will only have access to data that they have entered on in-process 
surveys.  Participants may access partially completed surveys via a participant-specific 
link provided by email and entry of the participant’s birthdate.  Once surveys are 
complete, the data are inaccessible from the web site.  Participants and others will be 
prevented from accessing any other data on the Web server by a number of operating 
system, web server, and application controls. Users will connect to the web site to 
complete the surveys using the secure sockets layer protocol (SSL). Employment of the 
SSL protocol will prevent anyone from intercepting data passed between the end user’s 
web browser and the web server. 
 
Protection against emotional upset or embarrassment. If participants feel 
uncomfortable answering research questions or participating in their assigned 
intervention they will be able to skip any assessment items that they are not comfortable 
answering. Participation during the intervention will also be voluntary. Participants may 
choose not to participate in any components of their assigned intervention which make 
them feel uncomfortable. All participants will have the option of contacting via email the 
PI, Dr. Bricker, a Licensed Clinical Psychologist with the experience and expertise to 
responding effectively to potential adverse emotional reactions. He will plan to respond 
within 24 hours. If a referral to treatment is needed, he is acquainted with appropriate 
referral facilities and processes of identifying treatment available throughout the United 
States.  
 
Protection against discomfort of nicotine withdrawal. Participants who quit smoking 
may experience some discomfort associated nicotine withdrawal. Participants will also 
be fully informed of the symptoms of nicotine withdrawal during the informed consent 
process. Interventions in both treatment groups provide strategies designed to cope 
more effectively with symptoms of nicotine withdrawal. Finally, participants in both 

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treatment groups will be given information on pharmacotherapy for smoking cessation 
(e.g., nicotine patch) and how to obtain these medications.  
 
Reporting Breaches and Complaints. Taken together, these measures will minimize 
risks to study participants. However, should a breach/complaint occur, or if a participant 
is not pleased with any of the surveys, or with the study’s procedures, the study’s 
scientific staff will attempt to address the concerns; if unsuccessful, the 
breach/complaint will be reported to the IRB office, and the participant will be referred to 
Karen Hansen, Fred Hutch IRO Director.  
 
Potential Benefits of the Proposed Research to the Subjects and Others. 
Successfully assisting cancer patients who smoke to quit would have significant positive 
benefits to their health. Overall, participants assigned to either of the two interventions 
have the potential to benefit by quitting smoking and the potential short- and long-term 
health benefits of quitting on their cancer treatment and prognosis, and overall lifetime 
health.  
 
Importance of Knowledge to Be Gained. The proposed intervention shows exciting 
promise for improving cessation rates among cancer patients, who currently do not 
have standard cessation interventions as part of their treatment. If effective, the public 
health impact of this low-cost intervention is significant. Even if the intervention is not 
better than our standard care control, it suggests the new intervention should be 
disseminated as a reasonable alternative to other publicly available application-based 
interventions.  
 
INCLUSION OF WOMEN AND MINORITIES 
 
The population for this study will be 60 adult male and female cancer patients who 
currently smoke and want to quit, or have quit smoking within in the past 30 days. 
Recruitment and eligibility screening methods are designed to achieve a broad 
representation of adult smokers that is 50% female and 25% minority race/ethnicity. 
The expected gender and race/ethnic distribution of the trial participants is reported in 
the Targeted/Planned Enrollment Table. 
 
TARGETED/PLANNED ENROLLMENT TABLE 
Total Planned Enrollment: 
60 
TARGETED/PLANNED ENROLLMENT: Number of Subjects 
Ethnic Category 
Sex/Gender1 
Females 
Males 
Total 
Hispanic or Latino 
2 
2 
4 
Not Hispanic or Latino 
43 
13 
56 
Ethnic Category: Total of All Subjects * 
45 
15 
60 

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Racial Categories 
 
American Indian/Alaska Native 
1 
0 
1 
Asian 
0 
1 
1 
Native Hawaiian or Other Pacific Islander  
0 
0 
0 
Black or African American  
7 
4 
12 
White 
36 
9 
44 
More Than One Race 
1 
1 
2 
Racial Categories: Total of All Subjects * 
45 
15 
60 
* The “Ethnic Category: Total of All Subjects” must be equal to the “Racial Categories: Total of All Subjects.” 
INCLUSION OF CHILDREN 
 
This is a study of adult smoking cessation; participants will be aged 18 or older. The 
NIH definition of children includes young adults up to age 21. By the NIH definition, the 
only “child” participants in this study will be those aged 18-21, over the age of majority 
and fully capable of participating in informed consent. Therefore, no special protections 
are required for their inclusion in this research.  
 
Children under the age of 18 will be excluded on the basis of the following: 1) 
Both interventions used in this trial have not been designed for or tested with adolescent 
smokers; 2) Youth may respond differently to intervention than do adults.  As such, data 
collected from these individuals may not generalize to the larger adult population; 
and, 3) Our standardized assessment measures were validated in adult samples and 
are not applicable to children.   
 
DATA SAFETY AND MONITORING PLAN 
 
The DSMP includes plans for the following required elements: (1) monitoring the 
progress of trials and safety of participants, (2) assuring compliance with requirements 
regarding the reporting of adverse events, (3) assuring that any action resulting in 
temporary or permanent suspension of the trial is reported to the sponsor, and (4) 
ensuring data accuracy and protocol compliance. The trial’s DSMP will be carried out by 
the scientific/management team, including the Principal Investigator, at weekly 
meetings. 
 
Data Management. In addition to and in combination with meeting HIPAA regulations, 
data collected and managed will be securely handled to prevent unauthorized access or 
modification. All those in the study staff who have access to data on those screened 
and/or participating in the study will follow these procedures when handling the data: (1) 
education about the need for security and confidentiality, (2) signing a confidentiality 
agreement, (3) using passwords to control access to the electronic databases and 

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regular changing of passwords, (4) keeping paper versions of surveys and any other 
paper versions of screened/participating individuals’ data in a locked room, & (5) 
servers will be protected by firewalls, McAfee Virus Scan Enterprise anti-virus software, 
daily full tape backups stored in a locked room, and encryption via the https protocol. 
 
Data Accuracy. Data accuracy has two aspects in this trial: (1) accuracy of self-
reported data by trial participants, and (2) accuracy of data management. The trial has 
procedures for both, which will be reviewed annually by the Project Manager and 
approved by the Principal Investigator.  
 
Monitoring Data Quality and Integrity. Several procedures will be used to maintain 
data integrity. All databases will be stored in a centralized location at FHCRC on a 
secure server. Data will be backed up daily and access will be password protected and 
limited to persons working on the project. Persons will only have access to specific data 
required for their project tasks. Identifying information will be stored separately from the 
assessment data. Data will be audited on an ongoing basis to ensure confidentiality 
safeguards are being maintained and data integrity is being maintained. Data entry 
systems will be set-up to allow field checks, range checks for continuous variables, valid 
value checks for categorical variables, and checks for logical consistency of responses. 
Queries and data reports will be generated on a routine basis to monitor data quality. 
 
GUIDELINES FOR MONITORING AND REPORTING UNEXPECTED AND ADVERSE 
EVENTS 
 
 
Monitoring. Throughout the study, the Principal Investigator, Co-Investigator, and 
Project Manager will monitor participants for adverse events and protocol compliance. 
The study coordinator will complete monthly reports on participant progress and status, 
any adverse events, and any protocol deviations. Protocol adherence will be monitored 
by the Principal Investigator.  
 
Reporting. Study staff will be trained, and required, to report all unexpected and 
adverse events to the Principal Investigator. An on-line form will be available for this 
purpose. Adverse events beyond what would be expected in the course of smoking 
cessation will be reported to the FHCRC’s IRB in accordance with FHCRC policy.  
 
Definitions. In general, unexpected events (UEs) include any event, adverse or 
otherwise, that was not described as part of the study risks. For this trial, an example of 
an unexpected event that is not adverse is a participant who has become very unhappy 
with trial procedures. Adverse events (AEs) are any untoward occurrence with a trial 
participant whether or not it can be considered to be related to their smoking cessation. 
An example of an adverse event in this trial could include an increase in depressive 
symptoms. Serious adverse events (SAEs) include any AE that results in death, a real 
risk of dying, inpatient hospitalization, persistent or significant disability/incapacity, or 
AEs that require intervention to prevent permanent impairment or damage. In this trial, 
an example of a serious adverse event would be a suicide attempt.  

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UEs, AEs, and SAEs will be reported to the Principal Investigator as soon as staff 
members are aware of them. If there is any doubt as to whether an event qualifies as a 
UE, AE, or SAE, staff members will be trained and encouraged to err on the side of 
caution – and to bring the event to the Principal Investigator’s attention for review.  
 
Attribution. The Principal Investigator, in consultation with the Co-Investigator, will 
decide if a UE should be classified as an AE. If an event is classified as an AE, further 
attribution will be determined, as follows: 
• 
Related – AEs that are definitely, probably, or possibly related to the 
smoking cessation intervention. 
• 
Not Related – AEs that are doubtfully related or clearly not related to the 
smoking cessation intervention. 
 
Reporting. 
1. SAE’s: For AE’s meeting the criteria for an SAE, regardless of its attribution, a 
FHCRC SAE Report form will be completed. The SAE Report form will be faxed by 
the Principal Investigator to the IRO office at 206-667-6831 within 24 hours of the 
internal report. All available information will be submitted. Should additional 
information become available after the initial report, a revised report will be submitted 
within 15 days.  
2. AE’s that do not meet the criteria for SAE: For these events, the Principal 
investigator or the Study Coordinator will complete and submit an FHCRC Adverse 
Event Reporting form within seven (7) calendar days of learning of the events. 
3. UE’s that do not meet the criteria for AE’s: For these events, the Study 
Coordinator will complete and submit an FHCRC UE Reporting Form within seven 
(7) calendar days of learning of the events. 
 
A Data Safety Monitoring Board will not be required since this is a minimal risk 
application-based behavioral intervention.  
 
 

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