Clinical trial NCT05095779
Conditions: Cigarette Smoking Nicotine Dependence
Keywords: Persistent Poverty Smoking Cessation Financial Incentives Contingency Management Tobacco Helpline Tobacco Quitline Socioeconomic Status
Sponsor: University of Oklahoma
Start date: 2022-03-09; Completion date: 2023-08-11
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The proposed pilot project is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the completion of smoking cessation counseling and self-reported abstinence at follow-up among Oklahoma Tobacco Helpline (OTH) callers living in persistent poverty counties (PPCs). The study will enroll at least 160 adults who reside in any of the 16 persistent poverty counties in Oklahoma, who are seeking smoking cessation treatment through the OTH.

Detailed description:
The proposed randomized controlled trial will enroll adults who are seeking smoking cessation treatment through the OTH and who reside in any of the 16 PPCs in Oklahoma. Participants will be randomly assigned to OTH (coaching calls + nicotine replacement therapy) or OTH plus escalating financial incentives (OTH+FI) for completing up to 5 counseling calls over 8 weeks. Feasibility outcomes for the incentives-based intervention will focus on counseling call completions, follow-up assessment completion, smoking cessation, and incentive costs. Potential effectiveness will be evaluated based on comparisons of counseling call completions over the first 8 weeks post-enrollment and rates of self-reported smoking abstinence through 12 weeks post-enrollment (4 weeks after incentives have ended) in OTH+FI relative to OTH alone.

Arms: arm 1: Participants randomized to OTH will be offered coaching calls and nicotine replacement therapy. arm 2: Participants will receive standard OTH care (coaching calls + nicotine replacement therapy) and escalating financial incentives for completing up to 5 coaching calls.
Interventions: intervention 1: Coaching calls intervention 2: Nicotine replacement therapy intervention 3: Financial Incentives
Intervention descriptions: intervention 1: OTH coaching calls intervention 2: 8 weeks of nicotine replacement therapy intervention 3: Escalating financial incentives for completing up to 5 coaching calls

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
Study Title: Monetary Incentives to Promote Engagement with the Oklahoma Tobacco 
Helpline in Counties Experiencing Persistent Poverty 
NCT Number: NCT05095779 
Protocol Approval Date: April 17, 2023 


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RESEARCH PROTOCOL 
Title of Project:
Monetary Incentives to Promote Engagement with the Oklahoma Tobacco 
Helpline in Counties Experiencing Persistent Poverty
Principal Investigator:
Darla Kendzor, Ph.D., Department of Family and Preventive Medicine
Jon Hart, Ph.D., Department of Pediatrics
Co-Investigators:
Mark Doescher, MD, Department of Family and Preventive Medicine
Summer Frank-Pearce, Ph.D., Department of Biostatistics and 
Epidemiology
Abstract
Nearly 20% of all cancers and more than 80% of lung cancers in the U.S. are attributable to smoking.1 
Research has highlighted elevated cancer mortality rates in U.S. counties experiencing persistent poverty 
(≥20% living in poverty for the past 30 years ).2 In Oklahoma, 16 counties meet the persistent poverty 
criteria.2 Within these counties, smoking prevalence ranges from 19% to 32%, which is higher than the 
national smoking prevalence rate of 14%.3 Smoking may be a primary contributor to elevated cancer 
mortality rates in these counties. Incentivizing treatment engagement and smoking abstinence is a 
promising approach for reducing smoking rates and tobacco-related cancers. The proposed pilot project 
is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the 
completion of smoking cessation counseling among Oklahoma Tobacco Helpline (OTH) callers living in 
persistent poverty counties (PPCs). The study will enroll 250 adults who reside in any of the 16 
persistent poverty counties in Oklahoma, who are seeking smoking cessation treatment through the 
OTH. Participants will be randomly assigned to OTH care or OTH plus escalating incentives (OTH+I) 
for completing up to 5 counseling calls over 8 weeks.Feasibility outcomes for the incentives-based 
intervention will focus on counseling call completion, follow-up assessment completion, , and 
perceptions of the intervention. Potential effectiveness will be evaluated by comparing self-reported 
abstinence rates at 12 weeks post-enrollment in OTH+I relative to OTH alone. 
A. Specific Aims
Aim 1. To evaluate the feasibility of offering financial incentives for tobacco helpline counseling call 
completions and smoking abstinence among OTH callers who reside in Oklahoma PPCs.  
Hypothesis: The feasibility of the incentives intervention will be evaluated based on several metrics 
including counseling call completion rates (≥3 completed), follow-up assessment completion rates 
(≥75%), smoking cessation rates at the 12-week follow-up (≥25% biochemically-verified 7-day point 
prevalence abstinence), incentive costs, and positive perceptions of the intervention.
Aim 2. To evaluate the potential efficacy of OTH+I relative to OTH alone. 
Hypothesis: Individuals randomly assigned to the OTH+I will complete more counseling calls and 
achieve higher rates of biochemically-verified abstinence at the 12-week follow-up than those assigned 
to OTH alone.
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The current study will generate preliminary data for a full-scale research proposal to evaluate the impact 
of offering a financial incentives program for OTH callers with the goals of increasing smoking 
cessation treatment uptake and cessation rates in PPCs, and reducing tobacco-related cancer incidence 
and mortality. 
Note, the original study protocol planned to gather biochemically-verified abstinence using carbon 
monoxide breath samples. Due to a technical difficulty, breath samples will not be gathered from 
participants and study staff will gather self-reported smoking status. Upon data analysis, the research 
team will take the above specified aims to evaluate the feasibility of and need of gathering 
biochemically-verified abstinence in such interventions. 
B.
Background and Significance
Smoking prevalence rates are disproportionately high among adults of low SES,4 and socioeconomic 
disadvantage is associated with a reduced likelihood of smoking cessation.5-10 The incidence of lung 
cancer, a disease primarily caused by smoking, is far greater among those with less education and those 
living in poverty relative to their higher socioeconomic status (SES) counterparts.11,12 Although 
individuals of lower SES are just as likely to initiate quit attempts, they are less likely to succeed.13 
Likewise, smoking cessation interventions for low-SES adults have produced very low abstinence rates 
at follow-up.14-17 Treatment approaches are needed to target socioeconomically disadvantaged people 
specifically and to reduce barriers to smoking cessation.
Contingency Management (CM). CM, or the tangible reinforcement of abstinence and other related 
outcomes (e.g., via financial incentives), is highly effective for promoting drug and alcohol abstinence 
among individuals with substance use disorders (see reviews 18-20). CM interventions are based on 
behavioral principles and operant conditioning.21,22 Specifically, outcomes associated with desired 
consequences (i.e., positive reinforcement) are more likely to recur. A recent meta-analysis concluded 
that there is strong evidence that offering financial incentives for smoking abstinence is an effective 
smoking cessation treatment that maintains its effect well beyond the discontinuation of incentives.23The 
findings of other two meta-analyses have indicated that financial incentives are associated with greater 
odds of behavior change for a variety of behaviors, particularly among low-SES individuals,24, 25and 
incentives may be particularly appealing in this group.26,27 Notably, Mundt et al.28 demonstrated that 
incentivizing both helpline counseling calls and biochemically-verified smoking cessation among 
Medicaid recipients improved biochemically-verified cessation rates after six months relative to a non-
incentivized control group, and that the cost-effectiveness of the intervention compared favorably with 
other treatments. Dr. Kendzor (program leader) has demonstrated evidence of the efficacy of a low-cost 
incentives-based intervention relative to standard care (SC; counseling and pharmacotherapy) among 
homeless shelter residents29 and safety net hospital patients.30 Preliminary findings from Dr. Kendzor’s 
ongoing randomized trial of a an incentives-based intervention for socioeconomically disadvantaged 
adults are extremely promising with 13% (SC) vs. 35% (SC + Incentives) biochemically-verified as 
abstinent at 12 weeks post-quit-date (N=235; R01CA197314).
Need for Cancer Control Program in PPCs. PPCs include counties where ≥20% of the population has 
been living in poverty for the past 30 years.2 PPCs have cancer mortality rates that are significantly 
higher than counties experiencing current, but not persistent, poverty and those that are neither 
experiencing current nor persistent poverty.2 This pattern of elevated cancer mortality is also observed 
for specific types of cancer, including lung/bronchus and others. Notably, PPCs are concentrated in 
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several rural areas of the U.S., including the southwest and great plains, in counties that overlap with 
tribal lands and that also have large non-White populations.31 
Persistent Poverty in Oklahoma. There are sixteen counties in Oklahoma that meet the criteria for 
persistent poverty (see Table 1).2 Rural-Urban Continuum Codes (RUCCs) are used to classify counties 
from 1 (most urban) to 9 (least urban), with codes 1-3 indicating metro areas and codes 4-9 indicating 
non-metro areas. The PPCs in Oklahoma have RUCCs between 2 and 9, and residents of PPCs in 
Oklahoma represent about 9.4% of the total population of the state (i.e., 371,206 people live in PPCs). 
Thus, cancer prevention and control programs targeting PPCs in Oklahoma must reach individuals who 
live in the least urbanized areas of the state (and country). Another unique characteristic of Oklahoma 
PPCs is the significant overlap with tribal lands.33 Oklahoma PPCs have an overall population that is 
about 32% non-white, including 19%American Indian/Alaska Native [AI/AN]) residents.34 The 
proportion of AI/AN within each Oklahoma PPC is sizable, with all but four  counties reporting AI/AN 
populations of 16.1% to 46.1%, compared with the AI/AN population in the state overall of 9.4%.34 See 
Table 1. 
Cancer Incidence and Mortality. In 2018, cancer incidence in Oklahoma PPCs was exceptionally high at 
618.8 cancers per 100,000 people,37 compared to cancer incidence rates of 450.5 nationally38 and 572.6 
statewide.37 Thus, the Oklahoma PPC cancer incidence rate is 37% and 8% higher than national and 
statewide incidence rates, respectively. Likewise, the cancer mortality rate in Oklahoma PPCs is 255.4 
per 100,000 people,37 compared with cancer mortality rates of 149.0 nationally37 and 213.6 in Oklahoma 
overall.37 That is, cancer mortality in Oklahoma PPCs is 71%and 20%higher than the national and 
state cancer mortality rates, respectively. Finally, the PPC incidence and mortality rates for respiratory 
cancers specifically, are 104.3 and71.3, respectively37, relative to rates 50.8 and 34.8 nationally (105%  
Table 1. Characteristics of Persistent Poverty Counties in Oklahoma.
PPC3,4
Tribal 
Land
Population 
(2019)34
American 
Indian/Alaska 
Native, % (2019)35 
RUCC34
Smoking, % 
(2018)36*
Cancer Incidence, 
(age adjusted, per 
100k; 2018)37**
Cancer Mortality,  
(age-adjusted, per 
100k; 2018)37 ***
Tobacco 
Helpline 
Enrolled
(past year)
Adair
Cherokee
22,194
46.1
6
32
566.1
203.8
211
Caddo
Kiowa-
Comanche
-Apache
28,762
25.5
6
25
714.4
293.3
136
Cherokee
Cherokee
48,657
36.4
6
27
585.5
254.8
262
Choctaw
Choctaw
14,672
18.5
7
29
770.4
245.4
81
Greer
Choctaw
5,861
4.0
7
19
463.8
206.2
38
Harmon
N/A
2,653
3.2
9
21
750.8
375.4
8
Haskell
Muscogee 
(Creek)
12,687
17.7
6
21
797.3
276.3
68
Hughes
Choctaw-
Creek
13,279
20.4
7
28
404.9
225.0
78
Johnston
Chickasaw
11,085
16.1
9
26
685.0
210.1
63
McCurtain
Choctaw
32,832
17.1
7
27
626.9
275.2
267
Okfuskee
Creek
11,993
22.0
6
29
611.7
314.1
78
Payne
Pawnee- 
Sac and 
Fox- Iowa
81,784
5.4
4
19
443.7
154.8
301
Pushmataha
Choctaw
11,096
19.3
9
27
662.0
250.5
63
Seminole
Seminole
24,832
20.1
7
21
467.9
272.6
162
Sequoyah
Cherokee
41,569
22.5
2
25
806.2
269.6
207
Tillman
Kiowa-
Comanche
-Apache
7,250
5.1
6
24
544.4
258.6
29
OVERALL
-
371,206
18.9 (median)
2-9 
25.5 
(median)
618.8
255.4
2,052
*The national smoking prevalence rate was 14.0% in 2018.4   **The national age-adjusted cancer incidence rate was 450.5 per 100k (2014-2018).38 
***The national age-adjusted cancer mortality rate was 155.5 per 100k (2014-2018).38 
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and 105%  higher in PPCs, respectively)38 and 84.5 and 59.3 statewide (23% and 20%higher in PPCs, 
respectively).37 These extreme disparities in cancer incidence and mortality in Oklahoma require 
immediate and focused attention.
Smoking. Nearly 20% of all cancers and more than 80% of lung cancers in the U.S. are attributable to 
cigarette smoking.1 Thus, smoking cessation is key to reducing cancer incidence and mortality. 
Although smoking rates in the U.S. have declined to 14.0%,3 smoking prevalence remains far higher 
among Oklahoma adults overall (20%),36 AI/ANs (29.3%), and those earning <$35,000 per year (27%).3 
Among those who reside in Oklahoma PPCs specifically, the smoking rates are exceptionally high, 
ranging from 19% (Greer and Payne county) to 32% (Adair county), with a median smoking rate of 
25.5%.36 In order to reduce cancer incidence and mortality in PPCs, it is imperative that individuals who 
reside in these areas have accessible and effective smoking cessation interventions available to them. 
Because smoking is a leading cause of cancer, this proposal will focus on addressing high rates of 
smoking in Oklahoma PPCs. Specifically, this proposal will evaluate the feasibility and efficacy of a 
high impact incentives-based treatment delivered via the OTH that includes telephone counseling and 
nicotine replacement therapy (NRT), with the addition of small monetary incentives for completing 
counseling calls and demonstrating biochemically-confirmed abstinence at follow-up.  
C.
Preliminary Studies/Progress Report  
The current proposal involves a partnership between Dr. Darla Kendzor, an investigator with a research 
focus on tobacco cessation intervention in socioeconomically disadvantaged adults, and Dr. Jon Hart, 
the Director of the OTH which serves the entire state, including the 16 Oklahoma counties experiencing 
persistent poverty. 
Darla Kendzor, Ph.D. (Program Leader) is an Associate Professor in the Department of Family and 
Preventive Medicine at the University of Oklahoma Health Sciences Center (OUHSC), Co-Director of 
the TSET Health Promotion Research Center (HPRC),39 and Co-Leader of the Cancer Prevention and 
Control Program at the NCI-Designated Stephenson Cancer Center (SCC).40 Dr. Kendzor has two 
ongoing NCI-funded randomized controlled trials focused on evaluating incentives-based tobacco 
cessation interventions for socioeconomically disadvantaged adults (R01CA197314, R01CA251451). 
She has published extensively on tobacco use and cessation in socioeconomically disadvantaged and 
vulnerable populations (e.g.,17, 29-30, 41-45). 
Jon Hart, Ph.D. (Program Co-Leader) is an Assistant Professor in the OUHSC Department of Pediatrics 
and Director of the OTH. Dr. Hart is an affiliate of the HPRC, and he offices at the HPRC in order to 
facilitate communication and collaboration between the HPRC and the OTH. Dr. Hart oversees the state 
helpline contract with Optum, which is the OTH operator. 
Mark Doescher, MD (Co-investigator) is a Professor in the Department of Family and Preventive 
Medicine, and Associate Director of Community Outreach and Engagement at the NCI-Designated 
SCC. Dr. Doescher is an affiliate of the TSET HPRC, and he offices at the HPRC to facilitate 
communication and collaboration. Dr. Doescher’s research focuses on rural and tribal health, including 
tobacco use (e.g.,46-50). He will assist with rural and tribal outreach and recruitment efforts.
Summer Frank-Pearce, Ph.D. (Co-Investigator) is an Assistant Professor in the OUHSC College of 
Public Health, within the Department of Biostatistics and Epidemiology and a member of the TSET 
HPRC. She has a history of tobacco-focused and other collaborations with Dr. Kendzor (Program 
Leader).43, 51-55 She will provide biostatistics support for the study.  
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D.
Research Design and Methods (What, When, How, Where)
Study Overview. The proposed randomized controlled trial will enroll 250 adults who are seeking 
smoking cessation treatment through the OTH and who reside in any of the 16 PPCs in Oklahoma. 
Participants will be randomly assigned to OTH or OTH plus escalating incentives (OTH+I) for 
completing up to 5 counseling calls over 8 weeks. Feasibility outcomes for the incentives-based 
intervention will focus on counseling call completion, follow-up assessment completion, smoking 
cessation, incentive costs, and perceptions of the intervention. Potential effectiveness will be evaluated 
based on comparisons of counseling call completions at 12 weeks post-enrollment (4 weeks after 
incentives have ended) in OTH+I relative to OTH alone.
Randomization Plan. Randomization will be stratified by sex (male vs. female), race/ethnicity (White 
vs. non-White), and cigarettes smoked per day (≤10 vs. >10).
Interventions. Eligible OTH callers will be randomly assigned to one of two treatment groups: OTH or 
OTH+I. OTH care will include up to 5 counseling calls with a Tobacco Treatment Specialist and eight 
weeks of NRT. Note that an additional 6 weeks supply of NRT will be provided beyond the 2-week 
supply typically offered by the OTH to ensure that all participants receive adequate pharmacotherapy. 
OTH+I will include all components of OTH care plus escalating incentives for completing up to 5 
counseling calls over 8 weeks (at least one week apart).Based on the incentive schedule used in our 
current (PI: Kendzor, R01CA197314) and past research,29,30 incentives will start at $20 for completing 
the first call, and will increase by $5 for each consecutive call completed until the 5th call is completed 
(i.e., up to $40 may be earned for completing the 5th call). The incentive will reset to $20 if a call is 
missed (i.e., not completed within 2 weeks of the prior call). OTH treatment group participants may 
receive up to $140 and OTH+I treatment group participants may receive up to $290. 
Contingency Management (CM). CM participants will receive counseling and nicotine replacement 
therapy (as described above). They will receive financial incentives for completing counseling calls.
Measurement of Abstinence. 
Participants enrolled prior to May 19, 2022 who self-report smoking abstinence at 8 weeks post 
enrollment will receive the abstinence payment of $50 as specified in the initial study application. 
Because breath samples will not be gathered as specified in the initial protocol, these participants may 
not receive the $20 breath sample payments. Participants who are enrolled after May 19, 2022 will 
follow the payment schedule as outlined above in the protocol (payments for questionnaires, incentive 
group will also receive payments for counseling calls), and the payments for breath samples will be 
removed. In total, the standard care group will be eligible for up to $140. In total, the standard care plus 
financial incentives group will be eligible for $290. 
 
Measures. Participants will be asked to complete a web-based Research Electronic Data Capture 
(REDCap)56,57 assessment upon enrollment to assess sociodemographic characteristics and tobacco use 
history, and again at 4-, 8- and 12-weeks post-enrollment to assess self-reported smoking status and 
perceptions of the intervention. Participants will be compensated $50 for the baseline assessment and 
$30 for each of the following assessments. The number of completed counseling sessions will be 
documented (data provided by Optum), as well as follow-up completion rates at 8- and 12- weeks post-
enrollment. Participants will be compensated via Greenphire reloadable study credit card. 
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Data Loss Prevention. Phones will be programmed to connect to our secure server 4 times daily to 
upload encrypted data, to overcome the potential loss of data if participants lose or change phones, 
which has rarely occurred in our previous research. This strategy will also allow the staff to monitor 
participant survey completion rates and call participants when this rate is low. Importantly, assessment 
data are password protected and encrypted. Thus, study data are only accessible by the research team. 
Data will be remotely deleted from lost phones and one replacement phone will be provided. 
Disclosure of Results to Participants. Study results will not be disclosed to participants. 
Future Use of Data. Identifiers might be removed and the de-identified information may be used for 
future research without additional informed consent from the subject.
E.
Chart Review
This protocol does not involve a chart review. However, please note that participants will be required to 
disclose some sociodemographic information and tobacco history to determine eligibility and to identify 
differences between eligible and ineligible participants including address, age, phone, sex, ethnicity, 
race, and ethnicity. All information will be stored in a REDCap database. 
F.
Biospecimens
No biospecimens will be collected as part of this protocol.
G.
Banking/Repository/Database
Questionnaire and expired carbon monoxide, will be collected and stored via REDCap and the 
INSIGHT mobile health platform. No biospecimens will be stored.
H.
Inclusion / Exclusion Criteria
Interested participants may be included in the study if they: 1) contact the OTH seeking smoking 
cessation treatment, 2) reside in any of the 16 PPCs in Oklahoma (Adair, Caddo, Cherokee, Choctaw, 
Greer, Harmon, Haskell, Hughes, Johnston, McCurtain, Okfuskee, Payne, Pushmataha, Seminole, 
Sequoyah, Tillman), 3) report smoking ≥ 5 cigarettes per day, 4) are ≥ 18 years of age, 5) are able to 
provide a copy/photo of their ID/driver’s license or other documentation of identity and residence (i.e., 
residence in a PPC must be established), 6) be able to read, speak, and understand English, and 7) have 
no contradictions for NRT. Participants will be excluded if they do not meet these inclusion criteria. 
Participants will not be terminated from the study. Note, participants who are currently enrolled in the 
Tobacco Treatment Research Program (IRB 6951) and other Health Promotion Research Center related 
studies may be excluded from enrolling in this study due to the possibility of conflicting medication 
dosages. Staff will verify enrollment via Redcap. Note, participants cannot enroll in the study after 
initial completion. 
Inclusion of Pregnant Women. The findings of a recent Cochrane review suggests that NRT may be an 
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effective smoking cessation treatment for pregnant women.36 There has been no evidence of serious 
adverse events associated with NRT among pregnant women,36 and NRT does not appear to impact birth 
outcomes.37 In contrast, continued smoking during pregnancy is associated with adverse outcomes 
including preterm delivery, small size for gestational age, and childhood overweight.38 The American 
College of Obstetricians and Gynecologists (ACOG) advises that NRT may be used with supervision, 
after a discussion with the patient about the risks of continued smoking and the possible risks of NRT.39 
Although we do not expect many individuals who are pregnant to participate in the study, they will not 
be excluded from participation. Following completion of informed consent and study enrollment, the 
following safeguards will be employed for pregnant women: 1) approval will be sought from the 
participant’s obstetrician/physician to offer NRT, 2) the participant’s personal physician will be notified 
when the patient has been provided with NRT, and 3) NRT side effects will be tracked and monitored 
using REDCap, by the Tobacco Treatment Specialists (counselors) and the Oklahoma Tobacco Research 
Center Staff. The staff physician will be automatically notified in real-time via encrypted email when 
moderate/severe side effects are endorsed, and the physician will then follow-up with the participant to 
obtain additional information and to provide guidance. At the discretion of the staff physician, the 
participant’s personal physician may also be notified of the side effects/symptoms. This process will 
allow the participant’s physician to offer guidance and follow-up to their patient regarding their use of 
NRT during the pregnancy at regular prenatal visits, and potential side effects/adverse events will also 
be tracked and addressed as part of the study.  Non-pregnant participants will be advised to refrain from 
becoming pregnant while participating in the study, and pregnancy status will be assessed during 
screening and again at 4 and 8 weeks post-quit. Physician approval for NRT will be sought in cases 
where a participant becomes pregnant.  
I.
Gender/Minority/Pediatric Inclusion for Research
The study has no inclusion/exclusion criteria based on gender or race/ethnicity. The current study 
focuses only on adults who are 18 years of age and older (no maximum age). Children <18 years of age 
will be connected with the appropriate alternative resources through the Oklahoma Tobacco helpline. 
Separate smoking cessation interventions designed for children are warranted and preferable as the 
smoking characteristics and cessation-related needs of children and adults are likely to be very different.
J.
Recruitment and Enrollment
Recruitment. Adults who meet the eligibility criteria as specified above in the inclusion/exclusion 
criteria will be recruited for the study. Participants who contact the OTH from eligible counties will be 
asked about their interest in participating in this study. If interested, individuals will be screened for 
eligibility at the time of contact and their information will be forwarded to study staff to reduce barriers 
to enrollment. Eligible and interested participants will consent via electronic signature using REDCap or 
by the use of a physical consent form. The OTH presently advertises to Oklahomans through a variety of 
modalities (e.g., television, social media). However, to increase awareness of the OTH social media and 
traditional advertising approaches including print and advertising will be employed as needed.
Retention. We will use several strategies that have been successful in our prior research efforts to retain 
participants in the study. Participants will be sent assessment reminder messages via phone, text, email, 
and mail. Study staff will closely follow the schedules of each participant, and attempt to contact 
participants who miss study assessments. Participants will be compensated separately for the completion 
of web-based assessments, and counseling completions. Participants may earn up to $290. 
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Informed Consent. Individuals will be provided with information about their treatment options and study 
by OTH staff. Staff will provide an oral overview of the consent form, and individuals will have the 
opportunity to have their questions answered. Participants will be advised that participation is voluntary, 
and made aware that other treatment options are available to them if they do not wish to participate. 
Written informed consent will be obtained by sending an electronic copy or by sending a physical copy 
to participants. Participants will review the consent form and sign electronically via REDCap or 
physically. Participants will be mailed or emailed a copy. Those who are not interested or eligible will 
be offered the standard OTH treatment offered to all adults, or they may be referred to smokefree.gov or 
the OUHSC Tobacco Treatment Research Program (TTRP).  
K. Risks and Benefits
Potential Risks. Study data will not be de-identified, given that information such as names, study 
assessment dates, and contact information will be required for participant contact and data analysis. 
Participation in this study poses minimal risk to participants. However, one potential, although unlikely, 
risk to participants is loss of confidentiality. The severity of harm in the case of loss of confidentially may 
range from mild to severe depending upon the individual and the specific circumstances. Side effects from 
NRT (nicotine patches, gum, lozenges) are possible, though adverse experiences are usually mild in 
nature. Potential risks arising from use of nicotine patch therapy include nausea, erythema, and other 
dermatologic reactions.
Protections against Risk.
General Protections. Each participant will be assigned an identification number that will be utilized in 
place of names in all electronic and print data files. The file containing the links between participant 
names and identifiers will be kept in a separate password-protected file, which will be destroyed 12 
months after the completion of the study. All print information will be stored in a locked filing cabinet at 
the OUHSC. Electronic data will be maintained on the investigators/staff computers, and all computers 
will be password protected. Participants will complete questionnaires that can only be accessed with a 
password through the web-based REDCap program. Project staff will complete extensive training focused 
on each of the following topics: 1) project rationale and objectives, 2) the informed consent process, 3) 
general data collection procedures (e.g., computer data collection, privacy), and 4) measurement of CO 
and data. 
Nicotine Replacement Therapy. Adverse experiences associated with the nicotine replacement therapy are 
almost always mild in nature. Potential risks arising from use of nicotine patch therapy are mostly limited 
to nausea, erythema, and other dermatologic reactions. 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 NRT.
Potential Benefits. Potential benefits to patients include the provision of an evidenced-based treatment for 
tobacco cessation (counseling + NRT) to increase the chances of successful smoking cessation. In 
addition, the knowledge gained from this study may be utilized to improve our understanding of tobacco 
cessation treatments, especially among disparate populations. Such information may facilitate the 
development of more effective tobacco cessation interventions that may be utilized within cessation 
clinics and programs.
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Risks in Relation to Benefits. The possible risks of participation in this study are minimal and reasonable 
in relation to benefits. The health benefits gained from participation in a tobacco cessation intervention far 
outweighs the risks of continued tobacco use.
L. Multiple Sites
Data collection will occur remotely via telephone, and web- and smartphone-based surveys from the OTH 
and the OUHSC. 
M. Statistical Methods  
In our previous research, smoking abstinence rates were 14% vs. 33% for SC (counseling + 
pharmacotherapy) and SC plus incentives, respectively, at the 12 week post-quit-date follow-up in safety 
net hospital patients,14 and preliminary findings are similar at 12 weeks post-quit-date (13% vs. 35%, 
N=235) in our ongoing randomized controlled trial (PI: Kendzor; R01CA197314). Assuming a two-sided 
alpha of 0.05, a sample of 250 participants (80 per group) will offer 80% power to detect an 18% 
difference in cessation rates between OTH and OTH+I at the 12-week follow-up if we assume abstinence 
rates of 12% vs. 30%. This sample size would also offer 80% power to detect a small effect size of 
intervention group (OTH vs. OTH+I) on the number of counseling calls completed (0-5 calls possible).
Feasibility (Aim 1). The feasibility of offering treatment-related incentives via the OTH will be evaluated 
based on several metrics including the total number of counseling calls completed (0-5 possible), with the 
goal of achieving an average ≥3 completed counseling calls, and a follow-up rate of ≥75% based on 
follow-up rates in our previous30 and ongoing trial (PI: Kendzor; R01CA197314).  As in other CM 
studies,60,62,66,67,68 an intent-to-treat approach will be used in which participants who do not demonstrate 
biochemical verification of abstinence will be classified as smoking (i.e., no need to account for loss to 
follow-up). We will characterize intent-to-treat smoking cessation rates at the 12-week follow-up, with 
the goal of achieving ≥25% biochemically-verified 7-day point prevalence abstinence in the incentives 
group. Participant perceptions of the intervention will be characterized, as well as the costs associated 
with counseling- and abstinence-contingent incentives.
Potential Efficacy (Aim 2). Logistic regression analyses will be conducted to evaluate the influence of 
OTH vs. OTH+I on biochemically-confirmed 7-day point prevalence smoking abstinence (binary) at 12 
weeks (primary outcome) post-enrollment which is 4 weeks after incentives have ended. Linear 
regression analyses will be conducted to evaluate the influence of treatment group on the number of 
counseling calls completed.  However, if the number of counseling calls completed is not normally 
distributed, we will explore the use of other models such as Poisson, negative binomial, or zero-inflated 
models. Covariates in the analyses may include age, sex, race/ethnicity, nicotine dependence, insurance 
status, annual household income, and/or educational attainment.
Note, the original study protocol planned to gather biochemically-verified abstinence using carbon 
monoxide breath samples. Due to a technical difficulty, breath samples will not be gathered from 
participants and study staff will gather self-reported smoking status. Upon data analysis, the research 
team will take the above specified aims to evaluate the feasibility of and need of gathering 
biochemically-verified abstinence in such interventions. 
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N. Data and Safety Monitoring Plan
The Program Leaders (Kendzor, Hart) will be responsible for all data monitoring and for compliance with all 
federal and OUHSC IRB policies and procedures for monitoring progress, safety, reporting of unanticipated 
problems or adverse events, and assuring actions resulting in suspension of the study are reported.
Because this proposal reflects a pilot/feasibility study, a formal Data Safety and Monitoring Board 
(DSMB) is not required. The program leaders will be responsible for monitoring rates of enrollment, 
risks of participation, protocol adherence by the research team, safety and confidentiality of data 
collection, data entry, and statistical issues. Relevant unanticipated problems, adverse events, or 
participant concerns will be reviewed by the program leaders. The OUHSC IRB will be informed of any 
findings. All modifications to the protocol will be submitted for IRB approval. Changes to or errors in the 
protocol will be promptly disseminated to study personnel via e-mail, and retraining procedures will be 
implemented as needed. Appropriate modifications will be made in consultation with the designated 
program person at the National Institutes of Health if necessary. 
Unanticipated problems. For all protocols conducted at the OUHSC, the PI is required to submit to the 
IRB within five (5) university 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 study PI (Kendzor) will notify the IRB and the 
designated program person at the National Institutes of Health (if funded) 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. 
Adverse Experiences Associated with Nicotine Replacement Therapy. Individuals who report a medical 
condition that precludes the use of nicotine replacement therapy (NRT; e.g., recent heart attack, 
uncontrolled hypertension) will be excluded from the study. The incidence of side effects with NRT is 
low and can be locally treated or reversed with discontinuation of the patch. The risk of nicotine toxicity 
is extremely low. Management of adverse events 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 NRT 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.
Data Quality and Integrity. Because of the ongoing monitoring of the project, study investigators and 
staff will maintain quality assurance procedures for all data. The Insight™ platform, developed by the 
mHealth Shared Resource, will be used to collect all CO measurements. The Insight™ platform has two 
primary components: a web-based Content Management System (Insight-CMS) and an Insight-app (a 
shell in smartphones). Insight™ is a secure platform and is designed to comply with all HIPAA 
regulations. Data may also be collected via REDCap, which is a secure web database, and sent to 
OUHSC servers using the OUHSC secure file transfer system. The servers are password protected and 
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backed up regularly. The data and referral information will only be accessible to the study investigators 
and staff. 
Several procedures will be used to maintain the integrity of the data. All participants’ information or 
responses will be temporarily saved on password-protected, encrypted smartphones or tablets. When 
there is active connection, encrypted data will be automatically sent to our OUHSC mHealth Shared 
Resource secure servers multiple times per day. Access to all databases are limited to specific users at the 
discretion of the MPIs. Additional quality assurance procedures will include a data collection protocol 
documented in a protocol manual, and regular meetings among the investigators and project staff to 
review problems and solutions and discuss concerns. 
O.
Data Sharing
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. De-identified 
data files may also 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 (Kendzor) at OUHSC.
P.
Confidentiality 
The Insight™ platform, developed by the OUHSC/SCC mHealth Shared, will be used collect expired 
carbon monoxide at follow-up. The Insight™ platform has two primary components: a web-based 
Content Management System (Insight-CMS) and the Insight-app (a shell in smartphones). Insight™ is a 
secure platform and is designed to comply with all HIPAA regulations. Questionnaire data will be 
collected via REDCap, which is a secure web database, and sent to OUHSC servers using the OUHSC 
secure file transfer system. The servers are password protected and backed up regularly. The data and 
referral information will only be accessible to the study investigators and staff.
Q.
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