Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors in Laos
Phase: PHASE2
Conditions: Cigarette Smoking
Sponsor: University of Oklahoma

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RESEARCH PROTOCOL 
(Last updated: December 15, 2021)
Title of Project: Mobile Health Technology for Personalized Tobacco Cessation Support 
among Cancer Survivors in Laos 
Short title: SurvLaos
Principal Investigator:
Thanh Cong Bui; MD, DrPH
Stephenson Cancer Center, TSET Health Promotion Research 
Center
Co-Investigators:
1. Michael Businelle, PhD
Stephenson Cancer Center, TSET Health Promotion Research 
Center
2. Summer Frank-Pearce, PhD
Stephenson Cancer Center, TSET Health Promotion Research 
Center
  
Abstract
In Lao People's Democratic Republic (Lao PDR), tobacco smoking prevalence among 
cancer patients is high: 60% in men and 15% in women. Evidence from developed 
countries suggests that smoking cessation offers considerable benefits for cancer 
survivors, including improving cancer treatment outcomes, reducing recurrence rates, 
reducing second primary tumor development, and reducing overall cancer mortality 
rates. Despite, no tobacco treatment programs are available in major (public) 
hospitals in Lao PDR, including in cancer hospitals/institutions. The parent project 
(1R21CA253600-01, OUHSC IRB#: 12189) aims to adapt and evaluate the efficacy of 
our theoretically and empirically based mobile health (mHealth) technology to help Lao 
general patients quit smoking cigarettes. This mHealth automated treatment (AT) 
approach includes a fully automated, interactive, personalized, smartphone-based 
intervention for behavioral treatment, delivered through our Insight platform. In year 1 of 
the parent project, we have been adapting our intervention content to the sociocultural 
context, language, and communication styles of Laotians. The purpose of this 
supplementary project is to expand our mHealth-based AT to address the pressing 
need for smoking cessation among cancer survivors and their caregivers in Lao 
PDR. In this project, we will adapt our intervention and materials to make them 
comprehensible and relevant to these target populations. Next, we will conduct a pilot 
randomized controlled trial (RCT, N=80) to evaluate the preliminary efficacy of the 
intervention. Cancer survivors (n=40) and caregivers (n=40) of both sexes who smoke 
will be recruited at Setthathirath Hospital and Lao National Cancer Center. Similar to the 
parent project’s design, participants will be randomized to 1 of 2 treatment groups: 
standard care (SC) or AT (20 cancer survivors and 20 caregivers in each group). SC 
consists of brief advice to quit smoking, self-help written materials, and a 2-week supply 
of NRT (transdermal patches). AT consists of all SC components plus our fully-
automated interactive smartphone-based treatment program, personalized and tailored 
to cancer survivors or caregivers. The primary RCT outcome is biochemically 
confirmed self-reported 7-day point prevalence abstinence at 3 months post-study 
enrollment. The specific aims are: 1) to evaluate the feasibility of AT in cancer survivors 
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and caregivers, and 2) to evaluate the preliminary efficacy of AT in each cancer 
survivor/caregiver subgroup.
Protection of Human Subjects:
The study protocol and all related research materials (e.g., informed consent forms and 
assessments) will be reviewed and approved by the Institutional Review Boards (IRBs) of the 
Ministry of Health - Lao National Ethics Committee for Health Research (NECHR) IRB #1 
(IRB00006227) and of The University of Oklahoma Health Sciences Center (OUHSC). Our 
collaborative hospitals—Setthathirath Hospital and Lao National Cancer Center—are under 
supervision/management of the Ministry of Health of Lao PDR and have assurances relying 
upon the NECHR IRB#.
A. SPECIFIC AIMS
The specific aims are to:
-
Aim 1: Evaluate the feasibility of AT in cancer survivors and caregivers. Hypothesis 
(H1): ≥75% of AT content will be viewed/opened as indicated by digital date/time stamp 
in Insight.
-
Aim 2: Evaluate the preliminary efficacy of AT in each cancer survivor/caregiver 
subgroup. Hypothesis (H2): At the 12-week follow-up, 7-day point prevalence abstinence 
will be higher in the AT (vs. SC) group.
-
Aim 3 (capacity building): Advance mHealth research capacity in Lao PDR and sustain 
the US-Lao PDR research network by supporting Lao investigators through in-person 
workshops, in-service trainings, online trainings, manuscript preparation, and future 
mHealth research collaboration and grant applications.
B1. BACKGROUND AND SIGNIFICANCE
Globally, tobacco causes approximately 6 million deaths each year, of which 80% occur in 
low- and middle-income countries (LMICs).1,2 Tobacco use is the most important modifiable risk 
factor for cancer prevention and is a leading preventable cause of death1; smoking prevention 
and cessation are the most impactful and cost-effective interventions among the many 
recommended evidence-based preventive health services.3 Despite the need, cessation 
treatments in LMICs are often unavailable or unaffordable for most people.1
Of 7 million citizens in Lao PDR, 51% of men and 7% of women smoke tobacco.4,5 Although 
several tobacco control efforts have been implemented in Lao PDR (e.g., taxing tobacco 
products, expanding smoke-free environments, requiring health warnings on cigarette 
packaging, and comprehensive bans of tobacco advertising), no national tobacco treatment 
programs are available;4,6 we confirmed this in recent discussions with leaders of the National 
Tobacco Control Committee (NTCC) of Lao PDR. NTCC also described a pilot quitline with 
telephone counseling at the national Mahosot Hospital. However, funding limitations restrict 
NTCC’s ability to train more counselors and retain them for a nationwide implementation. Thus, 
there is a pressing need for evidence-based and highly scalable tobacco cessation 
treatment in Lao PDR to prevent smoking-related morbidity and mortality. Our project will 
address this unmet need.
Potential of mHealth interventions. The World Health Organization (WHO) acknowledges 
that mHealth could transform the face of health service delivery across the globe, including in 
least-developed countries (LDCs).7 Data from the International Telecommunication Union, which 
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is the United Nation’s official source for global information technology statistics, show that 
mobile-cellular subscriptions now make up >98% of voice subscriptions in LDCs.8 Active mobile-
broadband subscriptions grew extremely rapidly from 4% in 2007 to 56% in 2017, without signs 
of faltering.8 Mobile-phone prices in LDCs, including Lao PDR, decreased from 29% of gross 
national income per capita in 2010 to 14% by the end of 2014, resulting in increased ownership 
rates.9 Worldwide, the Asia and Pacific regions have the lowest average prices of mobile 
phones and cellular service and the most aggressive competition in prepaid mobile-cellular 
service.9 In some LDCs in the region, including Lao PDR, prepaid handset-based mobile-
broadband prices are less than 5% of gross national income per capita, making them 
outstanding examples for affordable mobile-broadband services in LDCs. In Lao PDR, there are 
4 major mobile operators, 2 of which launched LTE in 2015.10  In recent years, mobile-cellular 
subscription rates in Lao PDR ranged from 56%–68%;9-11 half of these included mobile-
broadband subscriptions.8 Although these subscription rates are moderate compared with the 
regional average, the most recent data indicate that Lao PDR was in the top 5 countries globally 
for increased mobile-broadband subscriptions from 2016–2017,8 suggesting substantial 
growth in mobile-broadband coverage and usage in the near future. Most smartphones 
(80%) in Lao PDR are Android-based (predominantly Samsung and Huawei)12 and can function 
in Lao script. In summary, smartphone ownership is clearly increasing in Lao PDR, 
providing an ideal yet largely untapped mechanism to deliver smoking cessation 
treatment. 
A small but growing body of research indicates that mHealth interventions are feasible in 
Lao PDR. For example, the Lao PDR Ministry of Health (MOH) supported the use of the Safe 
Delivery mobile app to provide midwives with direct and instant access to evidence-based and 
up-to-date clinical guidelines on basic emergency obstetric and neonatal care, making childbirth 
safer, especially in the most remote areas.13 Short message service (SMS) is also used in a 
real-time reporting system for vaccine administration and monitoring.14,15 The MOH’s 
receptiveness and support of mHealth solutions increase the potential for sustainability and 
widespread adoption of our proposed mHealth intervention approach. 
The effectiveness of smoking cessation interventions using text messaging, traditionally 
delivered via SMS, is shown in both randomized controlled trials (RCT) and a recent Cochrane 
review.16,17 A thorough economic analysis demonstrated that a mobile phone text messaging 
intervention for smoking cessation is cost-effective.18 Indeed, mobile phone-delivered text 
messaging has been identified as one of the most affordable interventions19 and has been 
endorsed and used by several international organizations, including the WHO, in their global 
tobacco control efforts.20,21 Development and evaluation of advanced smartphone-delivered 
interventions are ongoing. Leading app stores house >170 English-language apps designed to 
facilitate smoking cessation; however, only 6 of these are scientifically grounded, and only 3 of 
these have demonstrated a positive impact on abstinence compared to a control condition in 
pilot RCTs.22 While the evidence base for these next generation interventions has not yet been 
established, many agencies such as the US National Cancer Institute have made scientifically-
supported apps available for public use.23 
This supplementary project is relevant and responsive to the NOSI NOT-CA-21-058 
because it focuses on stimulating global cancer survivorship research using mHealth in Lao 
PDR–a LMIC as defined by the World Bank. Specifically, this study will evaluate the feasibility of 
a care/intervention delivery model beyond healthcare settings (i.e., mHealth approach) for 
cancer survivors (6,000 new cancer cases each year, the most common types: liver, breast, 
lung, and cervical-uterine) and caregivers. The study will adapt an evidence-based survivorship 
care service (i.e., smartphone-based smoking cessation treatment) in the United States (US) to 
serve these populations. This application is built on and leverages our existing relationships with 
stakeholders at national institutions in Lao PDR, including Setthathirath Hospital (SH), Lao 
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National Cancer Center (LNCC), National Tobacco Control Committee (NTCC), and the Ministry 
of Health (MOH). Results from this pilot project will be critical for developing our future R01 
application and will contribute significantly to reducing tobacco-related complications in 
cancer treatments, co-morbidities, cancer recurrence, and mortality rates in cancer 
survivors.
B2. INNOVATION
This is the first effort to provide a theoretically and empirically based smoking cessation 
treatment in cancer care in Lao PDR. Our mHealth Technology Shared Resource (Director: Dr. 
Businelle, co-investigator [co-I]) has developed the novel HIPAA-compliant Insight mHealth 
platform, which enables ecological momentary assessments (EMA) or just-in-time adaptive 
intervention (JITAI) for various health behaviors or issues. The use of Insight to manage and 
deliver AT is innovative in several aspects. Insight allows our AT to function autonomously 
and minimizes human involvement, making the approach affordable for large-scale 
implementation in LMICs. Unlike the traditional short message service (SMS) approach that 
requires an active cellular network connection, our Insight app will automatically deliver all 
prescheduled interventions and assessments, with or without an active connection, thus 
ensuring timely and reliable treatment delivery. Most importantly, Insight enables complex built-
in algorithms and branching logic, allowing us to create and deliver dynamically and 
individually tailored treatment content, using near real-time EMA data. Finally, using the 
friendly, intuitive Insight platform’s interface, Lao researchers can directly manage AT whenever 
and however they wish without knowledge of programming languages. Thus, in the 
subsequent implementation phase of AT or in future cancer survivorship research projects, Lao 
researchers can modify the JITAI content to target other behavioral, physical, and 
psychosocial survivorship outcomes (e.g., monitoring cancer treatment compliance, fatigue, 
and complications; providing timely personalized screening recommendations to detect 
recurrence early; or improving retention in care). 
C1. RESEARCH TEAM
A uniquely qualified multidisciplinary research team has been assembled for this project. Dr. 
Bui (PI) has extensive experience conducting health promotion research in international settings 
and in mixed-methods studies.5,24-30 Other US co-investigators (co-I) bring valuable expertise in 
mHealth tobacco cessation for low-income and other underserved populations (Dr. D. Vidrine, 
Dr. Businelle),31-36 tobacco health risk communication (Dr. J. Vidrine),37-40 mHealth methodology 
(Dr. Businelle),41-44 and biostatistics (Dr. Frank-Pearce).42,43,45,46 Dr. Xangsayarath is the Director 
of the National Center for Laboratory and Epidemiology (NCLE), a core unit of the Lao MOH 
that is responsible for a wide range of public health issues, including tuberculosis and other 
respiratory infections control. Dr. Xangsayarath was the PI of the National Adult Tobacco 
Survey (NATS) and has unique expertise regarding tobacco use in Lao PDR. Dr. 
Phandouangsy is the Deputy Head of the Secretariat of NTCC – an official inter-ministerial 
governmental authority responsible for tobacco control in Lao PDR, led by MOH. In this position, 
she provides technical support and oversight to several national tobacco control programs, 
including all 4 WHO-funded Global Youth Tobacco Surveys since 2003. Dr. Bui has worked with 
Drs. Xangsayarath and Phandouangsy since June 2017 to analyze the NATS data and prepare 
manuscripts.5 Drs. Vangnakhone is the Director of the Setthathirath Hospital. Dr. Arounlangsy is 
the Director of LNCC.
C2. PRELIMINARY STUDIES 
Most relevant to this proposal is our most recent pilot work (with qualitative and quantitative 
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components) at an HIV clinic in Phnom Penh, Cambodia.30,47 We linguistically and culturally 
adapted the intervention for Cambodian smokers, and then conducted a pilot RCT comparing 
SC (n=25) to AT (n=25) delivered by our Insight™ platform. Of all scheduled notifications and 
weekly assessments during the 2-month treatment period, 75% were delivered properly (i.e., the 
phones were properly charged, turned on, and not lost). Of all delivered messages and 
assessments, 81% were opened, as indicated by the digital date/time stamp. Retention through 
the end of the 2-month treatment period, as indicated by returning to the clinic for biochemical 
confirmation of smoking status (expired CO) was very promising – 100% in the AT group and 
92% in the SC group. The biochemically verified 7-day point prevalence abstinence rate at 
2 months was 40% in the AT group and 8% in the SC group (RR=5.0; 95% CI: 1.2–20.5). 
The AT group also scored significantly better (p=0.001) on knowledge items about smoking-
related health risks and had a greater, but nonsignificant, change in cessation self-efficacy. 
Most participants agreed that the AT program was helpful in supporting smoking cessation 
(92%) and would recommend it to other smokers (88%). These data demonstrate the 
acceptability, feasibility, reliability, simplicity, and preliminary efficacy of our AT 
technology in LMICs. This success suggests that AT may be appropriate and efficacious in 
Lao PDR, a culture comparable to Cambodia.
D. RESEARCH DESIGN AND METHODS
Stage 1: Further adapt the AT intervention 
Before conducting the RCT, we will use a multi-step process to adapt our already developed 
AT intervention for use by the target populations (i.e., cancer survivors and caregivers). These 
iterative steps include modifying content, user testing and eliciting feedback, and refining. 
Specifically, we will review all communication messages in the current AT program and modify 
them to ensure that they are applicable to cancer survivors and caregivers and to both sexes. 
Then, we will evaluate the AT content applicability, comprehensibility, and linguistic simplicity 
and clarity with ~10 cancer survivors or caregivers. We will ensure that approximately half of 
these testing users are women and that the whole testing sample is demographically diverse. 
Using input and feedback from these testing users, we will revise the AT further if needed. 
These series of tests and user-feedback sessions to refine the content further and to debug the 
system will go through an iterative process as needed. AT content taps on theoretical constructs 
of the Phase-Based Model (PBM)–a theoretical framework specific to smoking cessation used 
in our JITAI.48,49 
Stage 2: The pilot RCT
Participant recruitment. We will conduct a pilot RCT (N=80) to evaluate the preliminary 
efficacy of the intervention (Figure). Cancer survivors (n=40) or caregivers (n=40) of both sexes 
who smoke will be recruited from SH and LNCC in Vientiane (the capital of Lao PDR). At SH, 
the Department of Oncology and Department of Breast and Gynecologic Cancer serve >200 
cancer patients each year. LNCC serves >400 new patients with various types of cancer each 
year.50 Research staff will review medical records of cancer patients receiving care at the 2 
hospitals in the past 2 years, screen for their smoking status documented in the records, and 
contact those who smoked for further screening. To recruit caregivers, research staff will contact 
random cancer patients who did not smoke and ask if they have a caregiver and if the 
caregiver smokes. Given the pilot nature of this study, we propose to recruit independent groups 
of cancer survivors and caregivers who smoke, i.e., no dyads of smokers, to avoid potential 
interpersonal interactions. 
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Inclusion criteria. The pilot RCT will include those who are 1) aged ≥18 years; 2) self-
reported current combustible cigarette smokers (smoked at least 100 cigarettes in lifetime and 
currently smoke ≥1 cigarette/day); 3) willing to set a quit date within 2 weeks of study 
enrollment; 4) able to provide written informed consent to participate; and 5) able to read Lao 
(score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine—Short Form51). Exclusion 
criteria are 1) history of a medical condition that 
precludes use of NRT; 2) ineligibility to 
participate based on medical or psychiatric 
conditions diagnosed by a physician/clinician; 
and 3) enrollment in another cessation program 
or current use of other cessation medications. 
With these criteria in our Cambodian pilot study, 
we recruited 2–5 participants per day; thus, we 
expect a similarly high consent rate and 
feasibility for this study.
Baseline assessment. Enrolled participants 
will complete a 45-minute baseline self- or 
assisted interview, managed and delivered by 
REDCap.52,53 Participants will be randomly 
assigned to SC or AT by the REDCap 
randomization module (simple, 1:1). 
Smartphones will be loaned to participants as 
needed. All participants will complete a brief 
training session on smartphone use and the 
Insight app. The Insight app also includes a help 
button for instructions on how to use each 
feature, which participants can review at any 
time.
Treatment groups. SC consists of brief 
advice to quit smoking delivered by research staff, self-help written materials (the WHO’s “A 
guide for tobacco users to quit”54 that we have translated to and validated in Lao), and a 2-week 
supply of NRT (transdermal patches). AT consists of all SC components plus a fully automated 
smartphone-based JITAI that involves proactive, interactive, and personalized messages, 
images, or videos in Lao. Adapted from the parent study and based on the PBM, AT content is 
designed to increase motivation, self-efficacy, and use of coping skills and reduce nicotine 
withdrawal symptoms and stress. AT will begin immediately after enrollment and continue for 12 
weeks (about 2 messages/images/videos per day, delivered at participants’ preferred time). Quit 
date is set at day 14 post-enrollment for AT and SC participants. JITAI content for AT 
participants each week will be personalized and tailored to each participant’s baseline 
information (e.g., sex, cancer types, caregiver status, and current health conditions), current 
PBM phase,48 and responses to the brief weekly EMAs that drive AT (see Measures). Our 
AT only targets cigarette smoking because it is the most common type of tobacco used by Lao 
smokers (95%).55
Measures (Table). Primary assessments will be conducted at baseline and at the 12-
week follow-up, which collect 3 types of data: self-reported data collected by REDCap, expired 
air carbon monoxide (assessed with Vitalograph BreathCO) to verify smoking status 
biochemically, and medical record data (for AT personalization). Most of these measures are 
similar to the parent study and have been translated into Lao. Participants will be compensated 
US$15 after completing each of the two primary assessments.
Participants in both groups will be asked to complete brief weekly assessments (EMAs) 
Figure: Study schema
Lao cancer survivors (n=40) and caregivers (n=40)
Baseline assessment
Randomization (n=40 in each arm)
Automated Treatment (AT)
• Brief advice to quit
• Nicotine patches
• Self-help materials
• Interactive personalized 
treatment via Insight app
• Weekly smoking-related 
assessments to drive AT 
Standard Care (SC):
• Brief advice to quit
• Nicotine patches
• Self-help materials
• Weekly diet 
assessments
Self-reported weekly smoking status 
12-week follow-up, pilot trial ends
Qualitative data from in-app self-initiated assessment 
and open-ended questions at the end of RCT
Not abstinent: Reasons 
for not quitting, barriers, 
and what would help
Abstinent: Reasons 
for quitting, barriers, 
and how to overcome 
Mixed 
methods data
integration
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via Insight app. AT participants will receive 6 PBM-based smoking-related questions (Table) that 
drive JITAI. To balance the effects of these weekly contacts between the RCT groups, we will 
ask SC participants to complete a weekly 6-item diet EMA. All participants will be provided a 
prepaid 3-month unlimited data plan. The primary outcome is biochemically confirmed (CO 
level <6 ppm) self-reported 7-day point prevalence abstinence.56 
Data analysis. 
Descriptive statistics will be 
used to assess feasibility of 
AT. Regarding preliminary 
efficacy of AT, we will use 
log-binomial regression with 
an intent-to-treat approach 
(i.e., missing=smoking) to 
compare the effect of the 
treatment on the dichotomous 
abstinence outcome at 12 
weeks post-enrollment, 
controlling for selected 
covariates such as sex, 
education level, and/or 
baseline stress level. 
Secondary outcomes will be 
examined using appropriate 
linear and generalized linear 
mixed models with log-
binomial and linear 
regression for binary and 
continuous variables, 
respectively. Given the 
preliminary nature of the RCT, we do not expect to have sufficient power for full hypothesis 
testing. However, from our previous work, we anticipate that the abstinence at the 12-week 
follow-up will be 8% in the SC group. With 40 participants in each group, we will have 80% 
power to detect a difference as small as 20% in smoking abstinence rates between groups 
(α=0.05, one-tailed, unadjusted). 
Mixed methods data analysis. 
At the 3-month follow up assessment, we will use additional open-ended questions at the 
end of the assessment to explore why and how the participants did or did not successfully quit 
smoking and stay abstinent. Specifically, for participants who were biochemically confirmed 
abstinent, the questions will focus on what motivated them to quit and how they overcame 
challenges or barriers to stay abstinent. For participants who were not abstinent, the questions 
will focus on why they did not or could not quit, what they underwent, what challenges or 
barriers they had, and what would help them quit in the future. 
Two research team members will perform qualitative data coding with the aid of the R-
QDA.77 Discrepancies will be discussed to achieve intercoder agreement. Codes and quotations 
will be arranged into focused themes (i.e., thematic content analysis) to develop the mixed 
methods data inventory.78 Next, we will examine quantitative (RCT) and qualitative data jointly, 
using the integration strategy of explaining with the intent to explore why participants could or 
could not quit and stay abstinent.78,79 Mixed methods linked data, results, and meta-inferences 
will be presented in visual joint displays,79 similar to our previous publication.80 
Identifiers might be removed and the de-identified information may be used for future 
Table. Trial Assessments 
Variable type
Measure
BL W* 12
Demographics; Health Literacy57
X
X#
Alcohol and Drug Use58,59
X
X
COVID-19–related issues,60 co-morbidities61,62
X
X
Descriptors/ 
potential 
moderators
Dependence – Heaviness of Smoking Index63
X
Feasibility/ 
Adherence to 
AT app
Numbers of messages/images/videos opened 
and completed; weekly assessments opened 
and completed; activity logs
Date/time 
stamps in 
Insight 
Wisconsin Smoking Withdrawal Scale64
X
X
Reasons for Quitting (Intrinsic, Extrinsic)65
X
X
Contemplation Ladder66,67
X
X
X
Kessler Psychological Distress Scale (K10)68
X
X#
X
Positive and Negative Affect Schedule69
X
X#
X
Phase-Based 
Model 
mechanisms
Self-Efficacy (related to smoking cessation)70 
X
X#
X
Cancer 
survivorship 
Fear of cancer recurrence (survivors only),71 
family support,72-74 and spiritual well-being75
X
X
Qualitative, 
open-ended 
assessment
An in-app participant-initiated assessment—
“Share with us anything on your mind”—with an
open text field to capture the participant’s 
thoughts, feelings, and behaviors 
Initiated 
anytime 
by 
participant
Smoking status in the past week76
X
X#
X
Primary 
outcome
Expired carbon monoxide at follow-up56,76
X
X
X
Secondary 
outcomes
E.g., number of quit attempts, days abstinent, 
and other tobacco product use76
X
X
Abbreviations: AT, automated treatment; BL, baseline; W, weekly; 12, 12-
week follow-up. *Delivered via Insight app; **Brief versions of the scales.
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research without additional informed consent from the subject.
E. CHART REVIEW
As described above, at the in-clinic assessments at baseline and at 3-month follow-up, the Lao 
research team will also collect data from participants’ medical records (in addition to interview 
data and expired air CO assessment). Medical records will be used to collect clinical 
information, such as comorbidities, recent/current diagnosed health conditions, and current use 
of medications for AT personalization. In Lao PDR, most of these medical records/data are in 
paper form; thus, the Lao research staff will review the records/forms and will enter data into the 
standardized sections/questions in REDCap Mobile app. The tablets that contain the REDCap 
app are password protected, encrypted, and can be remotely wiped if lost.
F. BIOSPECIMEN
This project does not collect biospecimen.
G. BANKING/REPOSITORY/DATABASE
This project does not bank or store data for future use in other projects.
H. INCLUSION/EXCLUSION CRITERIA
Inclusion criteria. The pilot RCT will include those who are 1) aged ≥18 years; 2) self-
reported current combustible cigarette smokers (smoked at least 100 cigarettes in lifetime and 
currently smoke ≥1 cigarette/day); 3) willing to set a quit date within 2 weeks of study 
enrollment; 4) able to provide written informed consent to participate; and 5) able to read Lao 
(score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine—Short Form51). 
Exclusion criteria are 1) history of a medical condition that precludes use of NRT; 2) 
ineligibility to participate based on medical or psychiatric conditions diagnosed by a 
physician/clinician; and 3) enrollment in another cessation program or current use of other 
cessation medications. With these criteria in our Cambodian pilot study, we recruited 2–5 
participants per day; thus, we expect a similarly high consent rate and feasibility for this study.
I. GENDER/MINORITY/PEDIATRIC INCLUSION FOR RESEARCH
I1. Inclusion of Women
We will recruit a pilot sample that mirrors the national smoking prevalence in men and 
women. Specifically, we will ensure that female smokers are represented in our sample in a 
manner that aligns with the smoking prevalence by sexes in the real-world. All participants, 
including men and women, will be encouraged to continue their participation in the study. 
I2. Inclusion of Minorities
An attempt to enroll all eligible participants will be made without regard to race/ethnicity. 
Because this project will take place in Lao PDR, we expect that all participants will be Asian. 
Among these, approximately 90% will be of Lao ethnicity, 5% will be of other ethnicities (e.g., 
Chinese, Vietnamese, Thailand), and 5% will be multi-ethnicity. As with all participants, the 
recruited minority participants will be encouraged to continue their participation in the study.
I3. Inclusion of Children
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We have excluded children under the age 18 from the proposed study. In Lao PDR, 18 
is the age of majority and, therefore, participants aged ≥ 18 years can consent. We excluded 
smokers under the age of 18 because the safety of nicotine replacement therapy (NRT) has not 
been determined for this population. The US Food and Drug Administration has not approved 
the use of NRT for smoking cessation for children and adolescents.
J. RECRUITMENT AND ENROLLMENT
Cancer survivors (n=40) or caregivers (n=40) of both sexes who smoke will be recruited 
from SH and LNCC in Vientiane (the capital of Lao PDR). At SH, the Department of Oncology 
and Department of Breast and Gynecologic Cancer serve >200 cancer patients each year. 
LNCC serves >400 new patients with various types of cancer each year.50 Research staff will 
review medical records of cancer patients receiving care at the 2 hospitals in the past 2 years, 
screen for their smoking status documented in the records, and contact those who smoked for 
further screening. To recruit caregivers, research staff will contact random cancer patients who 
did not smoke and ask if they have a caregiver and if the caregiver smokes. Given the pilot 
nature of this study, we propose to recruit independent groups of cancer survivors and 
caregivers who smoke, i.e., no dyads of smokers, to avoid potential interpersonal interactions. 
K. RISKS AND BENEFITS
K1. Potential Risks
The risks to participants are generally minimal and include breach of confidentiality, 
emotional distress (due to the nature of the assessment questions), and side effects associated 
with NRT patch use. 
There are minimal potential risks to participants from the personal nature of the 
questions asked regarding health behaviors and health status. Answering the questions may 
cause participants to feel uncomfortable and/or upset. 
Problems associated with the use of nicotine patches include local skin irritation at the 
site of application, nausea (if the dose of the patch is too high or if high levels of smoking are 
continued while using the patch), and distressing dreams. Skin allergic reactions have been less 
commonly reported. Participants may experience unpleasant withdrawal symptoms following 
smoking cessation. These symptoms include anxiety, restlessness, anger, irritability, sadness, 
difficulty concentrating, change in appetite, weight gain, insomnia, and decreased heart rate. 
K2. Protection against Risks 
Protection against Confidentiality Breach: Confidentiality will be maintained for all data and 
contact information. To protect against the risk of a confidentiality breach, the following steps 
will be taken: 
-
REDCap will be used to collect and manage information for most procedures, including 
screening eligible participants, administering in-clinic assessments at baseline and 
follow-ups, and capturing participants’ information from medical records. REDCap is a 
secure web-based application designed to comply with all HIPAA regulations. Data will 
be collected by participants (e.g., self-interviews for baseline assessment) or by 
research staff (e.g., screening or reviewing medical records) on tablets using the 
REDCap Mobile App. Each participant will be given a unique identification number (UIN) 
in this study, and the UIN will be used in all data collection procedures that are managed 
by REDCap. The REDCap Mobile App employs encryption at-rest on the mobile device’s 
hard drive so that all important data and information stored on the device are properly 
protected from unauthorized or malicious users. All data are transmitted between the 
app and the OUHSC secure REDCap server using a secure, encrypted transmission 
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(SSL/HTTPS). REDCap has been used by several institutions in Lao. The tablets are 
password protected, encrypted, and can be remotely wiped if lost.
-
All data related to participants will be identified only by the UIN. A master list of 
participant UINs linked to participant names will be stored in locked file cabinets in 
locked study offices at SH or CH. Access to the master list will be limited to those with 
privileges. After completion of the study and data analysis, the identification file will be 
destroyed. 
-
Participants will not be identified in any public reports or documents. In qualitative 
component reports, if any, only participant initials or random initials will be used for 
quotations. In the trials, only aggregate data will be reported and released. At no time 
will individual names appear in any report, article, or manuscript related to the study.
-
To minimize risks related to participant information potentially being disclosed via the 
use of smartphones, the following features are designed to ensure the security of the 
assessment data: 
o
The data stored on the smartphone device is in a SQLite database in a sandbox 
environment, where read/write operations are only available through the 
programming application (i.e., no file or output is readable to end users). 
o
A 10-character password (only known to researchers) is required to authenticate 
the current user before data can be manually accessed on the smartphone. 
o
Encrypted smartphone data will be automatically sent to our OUHSC mHealth 
Shared Resource secure servers multiple times per day. 
o
The web browser application linking the investigator’s computer to the database 
uses HTTPS protocol (SSL certificate with encryption), which will guarantee the 
protection of data transferred from the web browser to the backend database.
o
The backend database is hosted by the OUHSC mHealth Shared Resource in a 
secure setup. 
o
Software will be downloaded onto each study phone so that phones can be 
remotely wiped if lost.
-
During the consent process, participants will be informed of the potential for 
psychological distress or discomfort associated with unintentional disclosure of personal 
information to non-study staff, and the nature of the questions to be asked will be made 
clear. 
-
Participants will be informed of the safeguards in place and encouraged to contact 
investigators at any time to discuss any confidentiality concerns that arise. 
Protection against Coercion: All recruitment contacts will emphasize the voluntary nature of 
participation. Consent materials will clearly state that participants recruited for the trial will be 
randomly assigned to 1 of 2 groups and that participation in the study may not be personally 
beneficial.  
Protection against Assessment-Related or Intervention-Related Discomfort: 
The potential for discomfort associated with being asked personal questions regarding sensitive 
topics will be minimized in the following ways:
-
Participants will be informed of the nature of questions to be asked and topics covered; 
participants can decline participation if such topic areas are known to be personally 
uncomfortable.
-
Only measures that have been validated or used in prior studies will be used or will be 
adapted for use in this study. None of the proposed instruments have been known to 
evoke serious emotional reactivity.
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-
The use of self-administration for the assessments on a tablet or phone may help 
participants feel more comfortable in answering sensitive questions. 
-
Participants can refuse to answer any questions that they do not wish to answer.
-
Participants who become distressed by answering questions will be given resources to 
access help. 
-
Participants will be reminded during the consent process that they may contact the 
research staff with any questions or concerns that arise during their participation.
-
Participants may choose to discontinue participation at any time. 
Those who experience a skin reaction from nicotine patch use will be instructed to move 
the site of the nicotine patch each day. Additionally, participants will be instructed to wait at least 
7 days before using the same site for patch placement. To minimize nausea, participants will be 
instructed not to smoke while using the patch. If smoking relapse occurs, the participant will be 
instructed to stop using the patch. Participants experiencing distressing dreams or other sleep 
interference will be instructed to remove the patch before bedtime. If a severe skin reaction 
develops, the participant will be instructed to discontinue patch use. Use of the patch should 
reduce the severity of withdrawal-related symptoms. Withdrawal symptoms are generally short-
lived and typically last no more than 2 weeks after smoking cessation. Patches will be 
dispensed under the supervision of a health care provider.
K3. Potential Benefits of the Proposed Research to Human Subjects and Others
Tobacco smoking is among the leading causes of morbidity and mortality in low- and 
middle-income countries. Smoking cessation treatment offers tremendous potential to prevent 
smoking-related morbidity and to reduce overall mortality in this population. The risks to 
participants are small, and the health benefits of quitting smoking at the individual level are 
appreciable and well documented. 
To our knowledge, no theoretically based tobacco treatment program is available in 
national public hospitals in Lao PDR. It is also unknown whether mHealth-based smoking 
cessation approaches that have efficacy in developed countries would be effective in low- and 
middle-income countries. The results of this study will help Lao governmental health officials 
implement a potential affordable and sustainable approach for smoking cessation for Laotians 
that may lead to widespread adoption and also be applicable to other health issues. Thus, this 
research has the potential to transform healthcare delivery throughout the country.
L. MULTIPLE SITES
Not applicable.
M. STATISTICAL METHODS
Descriptive statistics will be used to assess feasibility of AT. Regarding preliminary 
efficacy of AT, we will use log-binomial regression with an intent-to-treat approach (i.e., 
missing=smoking) to compare the effect of the treatment on the dichotomous abstinence 
outcome at 12 weeks post-enrollment, controlling for selected covariates such as sex, education 
level, and/or baseline stress level. Secondary outcomes will be examined using appropriate 
linear and generalized linear mixed models with log-binomial and linear regression for binary 
and continuous variables, respectively. Given the preliminary nature of the RCT, we do not 
expect to have sufficient power for full hypothesis testing. However, from our previous work, we 
anticipate that the abstinence at the 12-week follow-up will be 8% in the SC group. With 40 
participants in each group, we will have 80% power to detect a difference as small as 20% in 
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smoking abstinence rates between groups (α=0.05, one-tailed, unadjusted). 
Mixed methods data analysis. At the 3-month follow up assessment, we will use additional 
open-ended questions at the end of the assessment to explore why and how the participants did 
or did not successfully quit smoking and stay abstinent. Specifically, for participants who were 
biochemically confirmed abstinent, the questions will focus on what motivated them to quit and 
how they overcame challenges or barriers to stay abstinent. For participants who were not 
abstinent, the questions will focus on why they did not or could not quit, what they underwent, 
what challenges or barriers they had, and what would help them quit in the future. 
Two research team members will perform qualitative data coding with the aid of the R-
QDA.77 Discrepancies will be discussed to achieve intercoder agreement. Codes and quotations 
will be arranged into focused themes (i.e., thematic content analysis) to develop the mixed 
methods data inventory.78 Next, we will examine quantitative (RCT) and qualitative data jointly, 
using the integration strategy of explaining with the intent to explore why participants could or 
could not quit and stay abstinent.78,79 Mixed methods linked data, results, and meta-inferences 
will be presented in visual joint displays,79 similar to our previous publication.80 
N. DATA AND SAFETY MONITORING PLAN
The PI (Dr. Bui) and site PI (Dr. Xangsayarath) will be responsible for all data monitoring 
and for compliance with all federal, OUHSC IRB, and Lao IRB policies and procedures 
regarding monitoring progress, safety, reporting of unanticipated problems or adverse events, 
and assuring that actions resulting in suspension of the study are reported.
Unanticipated problems
The PI will inform the OUHSC and Lao IRB within five (5) business days of discovering 
any unanticipated problems (both internal and external) involving risks to participants and 
others. 
Serious adverse events
A serious adverse event is defined as follows: death, a life-threatening adverse event, 
inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant 
disability/incapacity, a congenital anomaly/birth defect, or a medically significant event. Risks of 
participation will be continually monitored and appropriate measures implemented in cases of 
unforeseen adverse events. If a serious adverse event occurs, the PI will notify the IRB and the 
designated program person at the NCI in writing. These events will be reported regardless of 
whether they appear to be related to study procedures.
Given the non-invasive, minimal risk nature of the proposed research, we anticipate no 
serious adverse events related to the interventions or the study procedures. The types of 
adverse experiences that may occur, if any, will focus on the possible distress associated with 
self-interviews during data collection or on the use of nicotine patches. We have included 
procedures to minimize these risks (see section K above).
Adverse Experiences Associated with Self-Report
The trials will involve the use of assessments that could reveal sensitive information 
(e.g., mood disturbance, substance use). The instruments are not used to communicate 
psychiatric diagnosis to the participant and procedures are in place to protect participant 
confidentiality. Possible resolutions for this type of adverse experience include referring 
participants to their primary care physicians, and/or other physicians, and/or other mental health 
providers. Other procedures to minimize this type of adverse experience are described in the 
section K above.
Adverse Experiences Associated with the Nicotine Patch
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Adverse experiences associated with the nicotine patch are almost always of a mild 
nature. Potential risks arising from use of nicotine patch therapy are mostly limited to nausea, 
erythema, and other dermatologic reactions. Procedures to minimize this type of adverse 
experience are described in the section K above. The incidence of side effects with the patch is 
small and can be locally treated or reversed with discontinuation of the patch. The risk of 
nicotine toxicity is extremely low. Appropriate warnings about not smoking while using the patch 
will be issued each time patches are dispensed. Management of AE’s are done in accordance 
with standards of clinical practice and almost always are relieved by a reduction in dose, or 
although rarely necessary, discontinuation of patch use.
Adverse Experiences Associated with Nicotine Abstinence/Withdrawal
Participants may also experience nicotine abstinence/withdrawal effects. These effects 
may include irritability, difficulty concentrating, insomnia, anxiety, dysphoria, and increased 
hunger. None of these effects results in serious adverse events.
COVID-19 Risk Mitigation Plan 
The below actions will be implemented to mitigate the risk of COVID-19 transmission 
and acquisition:
-
In general, the Lao research team and US investigators in Lao PDR will follow COVID-
19 prevention plan/guidance of the Ministry of Health of Lao PDR.
-
Body temperature check: Before in-person interviews, body temperature of research 
staff and participants will be measured using a portable non-contact infrared digital 
thermometer. Research staff’s body temperature will be measured once per day before 
the first interview. Persons with a temperature >38.5oC will not be allowed to participate 
in the interviews and will be advised to seek further health care.
-
Masking: All research staff and participants will be provided surgical-style masks and will 
be required to wear masks during in-person interviews.
-
Hand washing: Research staff and participants will be asked to wash their hands before 
and after the interviews. 
-
Wearing gloves: Research staff will be required to wear gloves when direct physical 
contact with research participants is needed, discard gloves after contact appropriately, 
and wash hands.
-
Social distancing: Research staff and participants will be required to maintain social 
distancing of 6-feet (2 meters) in all directions unless necessary to conduct intervention 
or measures. 
-
Disinfection: Research areas and tools, including rooms, tables, chairs, and tablets will 
be appropriately disinfected as recommended by the Ministry of Health of Lao PDR. 
Disinfecting will take place before the first participant, between participants, and after the 
last participant. Inexpensive supplies such as pens, small notebooks, or participants’ 
folders will be given to participants without reuse/recycling. 
-
The Directors of the participating hospitals and of the NCLE (i.e., site PI) will be informed 
if the research staff becomes aware of a team member or a participant who tests 
positive for COVID-19. 
-
As the nature of COVID-19 remains dynamic, the NCLE will regularly evaluate this 
COVID-19 prevention plan and revise the plan if necessary.
O. DATA SHARING
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The US and Lao investigators have equal rights to access to study data.
All qualitative data will be deidentified during the verbatim transcribing process and 
translation to English. Deidentified data will be transferred to the PI in encrypted files. 
Quantitative data collected by REDCap program will be transmitted between the 
REDCap app and the OUHSC secure REDCap server on a daily basis using a secure, 
encrypted transmission (SSL/HTTPS). REDCap has been used by several institutions in Lao. 
The tablets with REDCap mobile app are password protected, encrypted, and can be remotely 
wiped if lost.
Quantitative data collected by our Insight app on smartphones will be automatically 
encrypted and will be automatically sent to our OUHSC mHealth Shared Resource secure 
servers whenever there is active internet (4G) connection. The web browser application linking 
the investigator’s computer to the database uses HTTPS protocol (SSL certificate with 
encryption), which will guarantee the protection of data transferred from the web browser to the 
backend database. The backend database is hosted by the OUHSC mHealth Shared Resource 
in a secure setup.
Data storage, or data transfer if there is a request, will follow all OUHSC’s requirements 
for data security. In all components of the research project, participants will be assigned unique 
identification numbers, and this identification numbers will be used in all data transfer and data 
analysis. When data sharing is requested, de-identified data files will be transferred on a 
password-protected and encrypted drive and will be maintained on institutional servers with 
appropriate antivirus software. Final de-identified data files will be maintained by the PI at 
OUHSC, and all other copies of data files will be deleted after the publication of outcome 
papers.
P. CONFIDENTIALITY
Protection against Confidentiality Breach: Confidentiality will be maintained for all data and 
contact information. To protect against the risk of a confidentiality breach, the following steps 
will be taken: 
-
REDCap will be used to collect and manage information for most procedures, including 
screening eligible participants, administering in-clinic assessments at baseline and 
follow-ups, and capturing participants’ information from medical records. REDCap is a 
secure web-based application designed to comply with all HIPAA regulations. Data will 
be collected by participants (e.g., self-interviews for baseline assessment) or by 
research staff (e.g., screening or reviewing medical records) on tablets using the 
REDCap Mobile App. Each participant will be given a unique identification number (UIN) 
in this study, and the UIN will be used in all data collection procedures that are managed 
by REDCap. The REDCap Mobile App employs encryption at-rest on the mobile device’s 
hard drive so that all important data and information stored on the device are properly 
protected from unauthorized or malicious users. All data are transmitted between the 
app and the OUHSC secure REDCap server using a secure, encrypted transmission 
(SSL/HTTPS). REDCap has been used by several institutions in Lao. The tablets are 
password protected, encrypted, and can be remotely wiped if lost.
-
All data related to participants will be identified only by the UIN. A master list of 
participant UINs linked to participant names will be stored in locked file cabinets in 
locked study offices at SH or CH. Access to the master list will be limited to those with 
privileges. After completion of the study and data analysis, the identification file will be 
destroyed. 
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-
Participants will not be identified in any public reports or documents. In qualitative 
component reports, if any, only participant initials or random initials will be used for 
quotations. In the trials, only aggregate data will be reported and released. At no time 
will individual names appear in any report, article, or manuscript related to the study.
-
To minimize risks related to participant information potentially being disclosed via the 
use of smartphones, the following features are designed to ensure the security of the 
assessment data: 
o
The data stored on the smartphone device is in a SQLite database in a sandbox 
environment, where read/write operations are only available through the 
programming application (i.e., no file or output is readable to end users). 
o
A 10-character password (only known to researchers) is required to authenticate 
the current user before data can be manually accessed on the smartphone. 
o
Encrypted smartphone data will be automatically sent to our OUHSC mHealth 
Shared Resource secure servers multiple times per day. 
o
The web browser application linking the investigator’s computer to the database 
uses HTTPS protocol (SSL certificate with encryption), which will guarantee the 
protection of data transferred from the web browser to the backend database.
o
The backend database is hosted by the OUHSC mHealth Shared Resource in a 
secure setup. 
o
Software will be downloaded onto each study phone so that phones can be 
remotely wiped if lost.
-
During the consent process, participants will be informed of the potential for 
psychological distress or discomfort associated with unintentional disclosure of personal 
information to non-study staff, and the nature of the questions to be asked will be made 
clear. 
-
Participants will be informed of the safeguards in place and encouraged to contact 
investigators at any time to discuss any confidentiality concerns that arise. 
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