Clinical trial NCT02157610
Conditions: Cervical Cancer Tobacco Use Smoking Cessation
Keywords: Cervical Cancer Cervical Cancer Survivors Smoking Cessation Motivation And Problem-Solving MAPS Saliva test Self help materials Pamphlets Texas Quitline Nicotine patch Questionnaires Surveys Telephone counseling sessions
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2015-01-01; Completion date: 2021-08-01
Enrollment: 202 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this research study is to compare a program called Motivation And Problem-Solving (MAPS) to the standard treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking.

Detailed description:
Study Groups:

If you agree to take part in this study, you will be randomly assigned to 1 of 2 possible study groups. Randomization means that you are put in a group by chance, like the flip of a coin. A computer program will make this random assignment.

* If you are in Group 1, you will receive free self-help materials, and a referral to the Quitline.
* If you are in Group 2, you will receive free self-help materials, a referral to the Quitline, and 6 telephone counseling sessions over the next year. The Quitline provides free quit smoking services to eligible callers.

No matter which group you are in, you will also receive a 12-week supply of nicotine replacement therapy. The strength of the nicotine patches and lozenges you receive will depend on how much you smoke each day. You should use the nicotine patch as directed by the package instructions.

Unused and used patches have enough nicotine to poison children and pets. Be sure to fold the sticky ends together when you are done using the patch. In case of accidental overdose, call your doctor or a poison control center right away.

Even if you do not wish to use the nicotine patch, you will still be allowed to take part in the study.

Study Questionnaires:

You will be asked to complete questionnaires over the phone 5 times:

* Baseline
* Month 3
* Month 6
* Month 12
* Month 18

You will be asked about your feelings, moods, cervical cancer or dysplasia diagnosis, and smoking status. These calls should take about 45 minutes each time to complete.

Saliva Testing:

At Months 3, 6, 12 and 18, you may also be asked to provide a saliva sample to test for cotinine to confirm your smoking status. Cotinine is a chemical released in your body when it breaks down nicotine. You will receive a kit in the mail with supplies for testing. The research staff will call you to make sure that you received the kit and to discuss the instructions with you. If you have any questions about how to use the kit, you may contact the study staff during the study.

To collect the saliva, you will put a small piece of cotton in your mouth for a few minutes. You will be asked to mail the saliva sample back to the research staff, using a prepaid return envelope. You may be contacted by mail, telephone, and/or email during the study to be given reminders to send back the kit.

Telephone Counseling:

If you are in Group 2, you will have 6 telephone counseling sessions that may last up to 30 minutes each. These calls will occur over a 12-month period at times that are convenient for you. During the calls, you will be asked about how motivated you are to quit smoking, what barriers to quitting you may have, and factors that may be related to your smoking such as stress and family issues.

These sessions will be digitally recorded. The recordings will be used to help the researchers make sure that the counselors are following the correct procedures and to help the investigators better understand or improve the counseling.

Length of the Study:

Your participation in the study will end when you complete the final questionnaire call at Month 18.

If you wish to leave the study early, you should tell the study staff that you want to stop taking part in this research study. Once you tell the study staff that you want to stop participating, you will not receive follow-up questionnaire phone calls.

This is an investigational study. The nicotine patch used in this study is FDA approved and commercially available.

Up to 455 participants overall will take part in this research study.

In-Depth Interviews:

If you agree to take part in this study, you be asked to complete a questionnaire and will participate in an in-depth interview.

Demographic and Smoking History Questionnaire:

At the time of your visit you will be asked to complete a questionnaire in efforts to collect demographic and smoking history information. You may refuse to answer any question that makes you feel uncomfortable. The questionnaire may take up to 10 minutes to complete.

In-depth Interview:

You will be asked to discuss various parts of a new program designed to help women with cervical cancer quit smoking. You will be asked your thoughts on how important you think the program is, your feelings about it, and if you like it. The interview is designed to be done in a non-threatening, non-judgemental, and supportive way.

The interview should last about 2 hours.

In-depth interviews will be audio recorded and transcribed (written down).

Your participation in this study will be over when you complete the interview.

This is an investigational study.

Up to 30 women will take part in the interviews.

Up to 350 participants overall will take part in this research study. All will be enrolled at the Stephenson Cancer Center.

Arms: arm 1: Participants receive free self-help materials mailed at baseline, 6, and 12 months. Participants receive a referral to the Oklahoma Quitline. Participants receive a 12-week supply of the nicotine patch and lozenge. Nicotine patch regime based on participant's self-reported smoking rate. REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months. Saliva test performed at 3, 6, 12, and 18 months. arm 2: Participants receive free self-help materials mailed at baseline, 6, and 12 months. Participants receive a referral to the Oklahoma Quitline.Participants receive a 12-week supply of the nicotine patch and lozenge. Nicotine patch regime based on participant's self-reported smoking rate. REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months. Saliva test performed at 3, 6, 12, and 18 months. 6 telephone counseling sessions performed over 12 months. Sessions performed at baseline, 3, 6, 12, and 18 months. Sessions digitally recorded.
Interventions: intervention 1: Self-Help Materials intervention 2: Nicotine Patch intervention 3: REDCap intervention 4: Saliva Test intervention 5: Telephone Counseling Sessions intervention 6: Nicotine lozenge
Intervention descriptions: intervention 1: Participants receive free self-help materials mailed at baseline, 6, and 12 months. and a referral to the Oklahoma Quitline. intervention 2: Participants receive a 12-week supply of nicotine patch. Nicotine patch regime based on participant's self-reported smoking rate. Participants who smoke \>10 cigarettes/day receive 8 weeks of 21 mg, 2 week of 14 mg, and 2 week of 7 mg patches. Those who smoke \<10 cigarettes/day receive 8 weeks of 14 mg and 4 weeks of 7 mg patches. intervention 3: REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months. intervention 4: Saliva test performed at 3, 6, 12, and 18 months. intervention 5: 6 telephone counseling sessions performed over 12 months. Sessions performed at baseline, 3, 6, 12, and 18 months. Sessions digitally recorded. intervention 6: Participants receive a 12-week supply of nicotine lozenges. All participants receive 12 weeks of 2mg lozenges.

Protocol documents:
Prot_SAP_001.pdf: 
 
 
Smoking Cessation for Cervical Cancer Survivors (Project SUCCESS) 
 
NCT02157610 
 
 
Version 6 
January 15, 2021 


Page 1 
 
 
 
 
TITLE: 
Smoking Cessation for Cervical Cancer Survivors (Project SUCCESS) 
 
 
Principal Investigator: 
Jennifer Irvin Vidrine, PhD 
 
 
Protocol Version #6 Date: 
01/15/2021 


Page 2 
 
SPECIFIC AIMS 
Strikingly high rates of tobacco smoking have been documented among cervical cancer survivors. Recent 
national data indicate that between 44% and 48% of cervical cancer survivors are current smokers.1-3 The 
prevalence of smoking among cervical cancer survivors is over five times as high as that among lymphoma 
and prostate cancer survivors, and over 2.5 to 3 times as high as that among survivors of all types of cancer 
combined.3,4 Furthermore, while overall smoking rates have declined substantially among cancer survivors and 
among the general population of smokers, the prevalence of smoking among gynecologic cancer survivors – 
particularly cervical cancer survivors – has remained extraordinarily high.1,5 This is a critically important 
survivorship and public health issue given that smoking is a significant risk factor for cervical cancer 6 and 
continuing to smoke after a cancer diagnosis is associated with an increased risk of cancer recurrence, second 
primary cancers,7 and the development and progression of other smoking-related morbidities such as 
cardiovascular and respiratory diseases.8-11 Compared to survivors of other types of cancer, cervical cancer 
survivors have a significantly higher risk of developing any subsequent malignancy.12-14 Thus, it has been 
recommended that cervical cancer survivors be provided with a survivorship care plan that addresses the 
dangers of continued tobacco use and the risk of subsequent malignancy that persists throughout the 
survivor’s lifetime.12 A crucial part of this survivorship plan should involve the delivery of smoking cessation 
treatment designed to address the specific needs of these women.15 The vast majority of cancer survivors 
report a desire to quit smoking, and most are interested in cessation treatment programs.16,17 Unfortunately, 
cessation counseling is rarely delivered by healthcare providers. Only two-thirds of patients smoking at the 
time of a cancer diagnosis are advised to quit by healthcare providers,17 and very little research has focused 
on the development and evaluation of smoking cessation interventions for cancer survivors. Thus, there is a 
critical need to evaluate the efficacy of smoking cessation treatments among survivors of cervical cancer. The 
proposed study will be the first to target and address the specific treatment needs of this vulnerable and 
underserved population. 
This study will evaluate the efficacy and cost-effectiveness of a theoretically- and empirically-based 
“Motivation And Problem-Solving” (MAPS) approach to promoting and facilitating smoking cessation among 
cervical cancer and high grade cervical dysplasia survivors. Participants (N=300) will be recruited through the 
Stephenson Cancer Center or OU Physicians at the University of Oklahoma Health Sciences Center, via the 
ClinicalTrials.gov website, by responding to recruitment flyers and internet advertisements (e.g., flyers in 
clinics, Facebook), and through referrals from healthcare providers. Participants will be randomly assigned to 
one of two treatment groups: 1) Standard Treatment [ST] or 2) “Motivation And Problem-Solving” (MAPS) ST 
will consist of a mailed packet of materials including a letter referring smokers to the Oklahoma Tobacco 
Helpline, Florida Quitline or to the national quitline number (1-800-QUIT-NOW) for participants residing in other 
states, free nicotine replacement therapy when ready to quit, and standard self-help materials. ST will be 
mailed a total of 3 times to participants with completed assessments (Baseline, 6 and 12 months). MAPS will 
consist of ST plus up to 6 proactive telephone counseling sessions delivered over a 12-month period. 
Telephone assessments across all treatment conditions will be administered at baseline and 3, 6, 12 and 18 
months after baseline. The primary outcome is abstinence from tobacco at 18 months and the secondary 
outcomes are abstinence at other assessments, as well as quit attempts, cigarettes per day, use of the quitline 
across all post-baseline assessments, and cost-effectiveness. 
MAPS is a holistic, dynamic approach to facilitating behavior change that utilizes a combined motivational 
enhancement and social cognitive approach based on motivational interviewing (MI)18,19 and social cognitive 
theory.20-22 MAPS is designed for all individuals regardless of their readiness to change, and specifically targets 
motivation and intrinsic motives for change, social cognitive constructs (e.g., agency/self-efficacy), and other 
factors of key relevance to cervical cancer survivors (e.g., stressors, anxiety, depression, family conflicts, 
finances, fear of cancer recurrence). Because MAPS revolves around a Wellness Program that addresses 
numerous barriers and concerns that are prevalent among cervical cancer survivors, we believe it is 
particularly appropriate for treating this population. Furthermore, the delivery of this intervention via telephone 
offers a less resource intensive modality while also minimizing participant burden. 
 
The specific aims are to: 
1. Compare the efficacy of a MAPS approach to promoting and facilitating smoking cessation to ST 
among cervical cancer survivors. 
2. Assess the effects of MAPS on hypothesized treatment mechanisms (motivation, agency, and 
stress/negative affect) and the role of those mechanisms in mediating MAPS effects on abstinence. 
3. Compare the cost-effectiveness of MAPS and ST. 


Page 3 
 
SIGNIFICANCE 
 
Despite public health efforts that have had a dramatic influence on reducing the prevalence of smoking, 
smoking remains the leading cause of preventable morbidity and mortality in the United States.23 In addition to 
causing chronic bronchitis, emphysema, heart disease and cerebrovascular diseases, smoking is linked with 
increased risk of at least 15 different cancers and, in the presence of HPV, is a primary risk factor for cervical 
cancer.6,24-27 Since the Pap test became widely integrated into clinical practice in the 1950s and 1960s, cervical 
cancer has been preventable, and incidence rates have dramatically declined.28 Despite this decline, in the 
United States, approximately 250,000 women are survivors of cervical cancer, over 12,000 new cases of 
invasive cervical cancer are diagnosed each year, and approximately 4,200 women die from the disease each 
year.28,29 Cervical cancer predominantly affects younger women with a median age at diagnosis of 49 years.29 
Furthermore, there are profound racial/ethnic and socioeconomic disparities in the incidence and mortality of 
the disease.30 Compared to white women, the incidence of cervical cancer is 39% higher among African 
American women31 and 80% higher among Latina women.32 In addition, African American and Latina women 
are significantly more likely to die from cervical cancer.31,32 Smoking prevalence is lower among African 
American (15.5%) and Latina (8.6%) women compared to non-Latina White women (18.8%).33 However, 
women that are members of these racial/ethnic minority groups as well as women with low socioeconomic 
status are known to suffer disproportionately from the health consequences of smoking,34-36 and existing 
evidence suggests that these individuals may have greater difficulty quitting smoking.37 38 39 Moreover, 
disparities in tobacco use by SES have increased over the last several decades despite widespread availability 
of free, effective cessation treatment. Taken together, women with low socioeconomic status and women who 
are members of racial/ethnic minority groups suffer tremendous disparities with regard to cervical cancer 
related morbidity and mortality and the health consequences of smoking. Therefore, women who are current 
smokers and have a history of cervical cancer represent a particularly vulnerable subgroup at substantially 
elevated risk. 
Recent national data indicate that a strikingly high proportion of cervical cancer survivors – between 44% 
and 48% – are current smokers.1-3 This prevalence rate is extraordinarily high compared to the prevalence of 
smoking among other groups of cancer survivors. Specifically, it is over five times as high as that among 
lymphoma and prostate cancer survivors, and over 2.5 to 3 times as high as that among survivors of all types 
of cancer combined.3,4 Continuing to smoke after a cancer diagnosis is associated with an increased risk of 
cancer recurrence, second primary cancers, and the development and progression of other smoking-related 
morbidities such as cardiovascular and respiratory diseases.9 Furthermore, cervical cancer survivors have an 
increased risk for other subsequent tobacco-related cancers when compared with individuals who have never 
been diagnosed with cancer and survivors of other cancer types of cancer.15 Therefore, there is a crucial need 
to provide these women with evidence-based smoking cessation treatment that has been designed to facilitate 
long-term cessation and prevent relapse while addressing survivorship issues related to cervical cancer. 
 
Smoking Cessation Interventions among Cancer Survivors. The vast majority of cancer survivors who 
smoke report a desire to quit, and most are interested in cessation treatment.16,17,40 Unfortunately, counseling 
about cessation is rarely delivered by healthcare providers. Only two-thirds of patients smoking at the time of 
a cancer diagnosis are advised to quit by healthcare providers,17 and very little research has focused on the 
development and evaluation of smoking cessation interventions for individuals diagnosed with cancer. To 
date, fewer than 15 randomized clinical smoking cessation trials have been conducted with cancer patients.41 
With only a few exceptions, these studies have had small sample sizes (<30), measured only short-term 
smoking status, and most importantly, found no significant treatment effects.42-47 Larger studies have also 
generally failed to find significant treatment effects.48-51 Typically, interventions have focused on advice to 
quit, nicotine replacement therapy, written materials, and short intervention periods. Even fewer trials have 
addressed cessation among cancer survivors following the acute treatment phase, and no studies that we 
know of have specifically targeted women who have been diagnosed with cervical cancer.52 Thus, there is a 
critical need to evaluate the efficacy of cessation treatments to promote long term abstinence and prevent 
relapse within this population. 
 
Cervical Cancer Survivorship. The incidence and mortality of cervical cancer has declined substantially 


Page 4 
 
in the United States over the last four to five decades, and these declines are largely attributable to 
improvements in screening, early detection, and treatment.28 Because cervical cancer generally affects 
younger women, women who are successfully treated can expect to live 25 to 30 years after treatment.29 
Therefore, post-diagnosis health behaviors of cancer survivors have begun to receive significant research 
attention. Such attention has been largely directed toward targets for tertiary prevention including smoking, 
alcohol use, physical activity, diet, and cancer screening as each of these behaviors may contribute 
substantially to poor outcomes related to cancer treatment sequelae.5 As described above, no previous 
studies that we know of have specifically targeted survivors of cervical cancer. Multiple studies have 
documented that cervical cancer survivors suffer generally moderate to poor health related quality of life.53 
Longstanding psychosocial sequelae associated with the disease including anxiety, depression, stress 
related to family responsibilities, relationship issues, and difficulty with sexual functioning have also been well 
documented.53-57 Moreover, cervical cancer survivors with lower socioeconomic status and limited social 
support are at even greater risk for poor outcomes.53,58,59 Because MAPS is built around a Wellness Program, 
addresses life events, stressors, and other concerns of each individual (e.g., anxiety, depression, stress, fear 
of cancer recurrence, family conflicts, financial concerns, relationship and sexual issues) it is especially well- 
suited to address concerns of particular relevance to cervical cancer survivors. Furthermore, the delivery of 
the MAPS intervention and the collection of theoretical mechanisms data via telephone will offer a more cost 
effective and less burdensome approach. 
 
MAPS Overview and Rationale. MAPS is a holistic, dynamic framework for behavior change that 
integrates treatment elements from both motivational interviewing (MI)18,19,60 and social cognitive theory.20,21,61 
MAPS is structured around a Wellness Program that addresses a wide array of concerns and barriers to 
change, similar to patient navigation programs.62 The overarching theoretical rationale for MAPS is the social 
cognitive model of behavior change.21,63,64 Social cognitive theory posits that “High levels of both motivation 
and self-efficacy are important ingredients … an individual may fail to engage in a specific behavior despite 
high levels of self-efficacy if the motivation for performance is low or absent.”65 Similarly, Miller et al.66 note that 
“the key element for lasting change is a motivational shift that instigates a decision and commitment to change. 
In the absence of such a shift, skill training is premature." That is, theory posits that effective smoking 
cessation treatments require both enhancing the motivation to achieve and maintain change, as well as 
developing the self-efficacy and skills necessary to do so. Nevertheless, current interventions often focus 
largely on either motivation or problem-solving/skills training despite the strong theoretical and empirical bases 
for focusing on both. When motivation is addressed, the focus is typically on motivating individuals to initiate a 
quit attempt, with little to no focus on the motivation to maintain change.20,67 
In contrast to previous approaches, MAPS utilizes an innovative combination of motivational enhancement 
and social cognitive treatment techniques, is designed for all individuals regardless of their readiness to 
change, and specifically targets motivation, agency/self-efficacy, and stress/negative affect. Although stage- 
based conceptualizations of behavior change also emphasize both motivation and skills training, motivational 
shifts are conceptualized as relatively stable changes in “stage.”68 In contrast, MAPS is unique in that it 
conceptualizes motivation as a fluid construct that can fluctuate on a moment-to-moment basis depending on 
context. Counselors carefully assess and attend to changes in motivation so that treatment strategies are 
appropriately matched to motivation in the moment. MAPS is built around a Wellness Program that in addition 
to focusing on smoking cessation and relapse prevention, also addresses life events, stressors, and other 
concerns of each individual (e.g., anxiety, depression, stress, fear of cancer recurrence, family conflicts, 
financial concerns, relationship and sexual issues, etc.). By addressing the larger context in which smoking 
cessation occurs, not only are many of the barriers to success addressed, but we believe that adherence is 
increased because individuals perceive that the counselors care about them as whole people, and are not 
solely interested in their smoking behavior. Most importantly, our previous research has supported the efficacy 
of MAPS for motivating quit attempts, increasing cessation, and preventing relapse.69-71 
 
Major Hypothesized Mechanisms. Both research and theory identify motivation, agency, and 
stress/negative affect as critical mechanisms underlying behavior change.72-75 As such, MAPS specifically 
targets these mechanisms and they are hypothesized to underlie MAPS effects on behavior change. 


Page 5 
 
 
 
Motivation. Motivation prospectively predicts both the decision to make a quit attempt and the likelihood of 
cessation.68,76 Further, motivation can change rapidly,77-80 consistent with a recent model positing that 
motivation is dynamic and characterized by frequent fluctuations.80 Motivation for the maintenance of change 
has received much less attention, although the extant empirical data indicate that motivational deficits are 
important in determining the maintenance of abstinence - 24% of all relapse episodes are characterized by a 
distinct lack of motivation to maintain abstinence81 and a decline in motivation over time prospectively predicts 
relapse.82 In addition, the specific motives underlying cessation are important.83 Intrinsic motives predict 
abstinence whereas extrinsic motives do not, and only intrinsic motives are associated with long-term 
abstinence.84,85 In sum, the data indicate that: motivation influences the initiation of a quit attempt, cessation, 
and the maintenance of abstinence; type of motives influence long-term success; and, motivation can fluctuate 
rapidly. Therefore, MAPS utilizes an approach with a specific emphasis on motivation and on appropriate 
therapeutic responses to common rapid fluctuations in motivation that occur throughout the change process. 
Agency. Agency reflects the ability to intentionally affect one’s behavior or life situation.86 Self-efficacy is a 
form of agency that is context and behavior dependent (i.e., varies based on the behavior and situational 
demands). Self-efficacy has predicted cessation outcomes in numerous studies.87-89 Therefore, based on both 
data and social cognitive theory,21 MAPS targets agency as a key mechanism with particular relevance to 
cervical cancer survivors. MAPS is hypothesized to influence agency via the removal of barriers to quitting and 
maintaining abstinence, standard problem-solving and coping skills training, and increased motivation.21,90-92 
Stress/Negative Affect. Stress and negative affect, measured in many different ways, predict cessation 
outcomes. Affective predictors include affective responses to smoking-related acute events, individual 
differences in affective vulnerability, depressive symptoms, and the magnitude and trajectory of stress/negative 
affect over time. 19,81,87,93-97 In addition to the stress/negative affect engendered by cessation, life stressors such 
as those experienced by cervical cancer survivors, have been shown to have adverse effects over time on 
motivation, self-efficacy, and abstinence. 98,99 Further, social cognitive theory posits that weak motivation for 
abstinence can increase stress/negative affect, particularly during high-risk situations.21 Thus, MAPS is 
hypothesized to reduce stress/negative affect via its impact on decreasing ambivalence and increasing 
motivation, through the application of coping skills training and problem-solving, and through utilization of a 
holistic approach in which other life concerns and stressors are addressed. 
 
APPROACH 
 
Project Design and Procedures. Participants will be women with a diagnosis of cervical cancer or high 
grade cervical dysplasia who report smoking any cigarettes within the past 30 days, recruited through the 
Stephenson Cancer Center or OU Physicians at the University of Oklahoma Health Sciences Center, via the 
ClinicalTrials.gov website, by responding to recruitment flyers and internet advertisements (e.g., flyers in 
clinics, Facebook), and through referrals from healthcare providers. Participants will be followed for a period of 
18 months, and randomly assigned to one of two groups: 1) Standard Treatment [ST], or 2) Motivation and 
Problem Solving [MAPS]. ST will consist of a mailed packet of materials including a letter referring smokers to 
the Oklahoma Tobacco Helpline, Florida Quitline or to the national quitline number (1-800-QUIT-NOW) for 
participants residing in other states, free nicotine replacement therapy when they are ready to quit, and 
standard self-help materials. ST will be mailed a total of 3 times to participants with completed assessments 
(at Baseline, 6 and 12 months). MAPS will consist of ST plus up to 6 proactive phone counseling sessions 
delivered over a 12-month period. The timing of counseling sessions in MAPS is flexible and determined 
jointly by the participant and the counselor. 
 


Page 6 
 
Assessment calls will occur at Baseline and at 3, 6, 12, and 18 months after Baseline. The primary outcomes 
are abstinence from tobacco at the 18-month follow-up and abstinence across all follow-ups. Secondary 
outcomes are smoking quit attempts, cigarettes per day, use of the quitline, and cost-effectiveness. 
Participants will be scheduled to complete a baseline assessment call within one week. Following the baseline 
assessment, participants will be randomly assigned to ST or MAPS. Participants will schedule their first 
counseling call at that time (see Table 1). 
 
Recruitment. Participants will be women with a diagnosis of cervical cancer or high grade cervical 
dysplasia who report smoking any cigarettes within the past 30 days, recruited through the Stephenson Cancer 
Center or OU Physicians at the University of Oklahoma Health Sciences Center, via the ClinicalTrials.gov 
website, by responding to recruitment flyers and internet advertisements (e.g., flyers in clinics, Facebook), and 
through referrals from healthcare providers. 
 
Participant Eligibility. Inclusion criteria: > 18; current smoker with a history of at least 100 lifetime 
cigarettes and a self-report of smoking within the last 30 days; history of cervical cancer or high grade cervical 
dysplasia (we have defined survivorship as beginning at the time of cancer diagnosis, consistent with the NCI 
definition); has a working cell phone; valid home address; speaks English, Spanish or both languages. 
Exclusion criteria: current use of tobacco cessation medications; self-report of being pregnant or lactating; or, 
another household member enrolled in the study; or contraindication of nicotine patch use unless under the 
supervision of a physician as advised by project staff. 
 
Table 1. Schedule of Study Procedures and Assessments 
Screening Baseline 
Month 3 
Month 6 
Month 12 
Month 18 
Inclusion/Exclusion Criteria 
X 
X 
Compensation 
$60 
$60 
$60 
$60 
$60 
TREATMENT PROCEDURES 
Standard Treatment (ST) 
Delivered at Baseline, and Months 6 and 12 
Motivation And Problem Solving (MAPS) 
ST plus up to 6 MAPS Counseling Calls delivered over 12 months 
DEMOGRAPHICS, MENTAL HEALTH 
Demographics and Smoking History 
X 
Cancer stage at diagnosis, time since diagnosis, current stage, treatment 
status 
X 
Subjective Social Status 
X 
X 
X 
X 
X 
Fear of Cancer Recurrence Inventory (FCRI) 
X 
X 
X 
X 
X 
X 
MOTIVATION 
Contemplation Ladder 
X 
X 
X 
X 
X 
Reasons for Quitting (Intrinsic and Extrinsic Motivation) 
X 
X 
X 
X 
X 
Motivation 
X 
X 
X 
X 
X 
AGENCY: SENSE OF CONTROL, SELF-EFFICACY, COPING BEHAVIOR 
Sense of Control 
X 
X 
X 
X 
X 
Self-Efficacy Scale 
X 
X 
X 
X 
X 
Coping Inventory 
X 
X 
X 
X 
X 
STRESS, NEGATIVE AFFECT 
Perceived Stress Scale (PSS) 
X 
X 
X 
X 
X 
Positive and Negative Affect Scale (PANAS) 
X 
X 
X 
X 
X 
Depression (CES-D) 
X 
X 
X 
X 
X 
SMOKING-RELATED MEASURES 
Heaviness of Smoking Index (HSI) 
X 
X 
X 
X 
X 
Wisconsin Smoking Withdrawal Scale (WSWS) 
X 
X 
X 
X 
X 
Wisconsin Inventory of Smoking Dependence Motives (WISDM-37) 
X 
X 
X 
X 
X 
SMOKING STATUS, BIOCHEMICAL VERIFICATION, QUITLINE USE 
Smoking Status (SRNT) 
X 
X 
X 
X 
X 
X 
Use of the Quitline Cessation Services (including Pharmacotherapy) 
X 
X 
X 
X 
X 
Cotinine (only among participants reporting abstinence) 
X 
X 
X 
X 
PATIENT REPORTED OUTCOMES 


Page 7 
 
Functional Assessment of Cancer Therapy – Cervix Cancer (FACT-Cx) 
X 
X 
X 
X 
X 
X 
EQ-5D (for health utilities) 
X 
X 
X 
X 
X 
 
Screening and Informed Consent Procedures. After being screened in-clinic or completing a secure 
online screener via REDCap, potential participants will be contacted by research staff at Moffitt Cancer Center 
or Stephenson Cancer Center. All eligible individuals will be invited to participate. A detailed description of the 
study will be provided and informed consent will be obtained. For those who agree to enroll in the study, 
research staff will obtain informed consent either in-person or over the phone. When participants are 
consented over the phone, research staff will read the informed consent document to participants and will 
document in our database that verbal informed consent has been obtained. A copy of the informed consent 
document and project materials will be provided to participants either in-person or by mail. All informed consent 
materials will be available in both English and Spanish. Women who decline or are ineligible will be given self- 
help materials and a referral to other cessation programs if they so desire. 
 
Baseline Assessment and Randomization. Eligible women who choose to participate will complete 
telephone-administered questionnaires where data are entered directly into a database. The system includes 
online error checking and is used in all of our ongoing research projects. After completing the assessment, 
participants will be randomly assigned to ST or MAPS using a form of adaptive randomization called 
minimization.100,101 Compared to techniques such as stratification, minimization results in better group balance 
with respect to participant characteristics. Minimization also provides for balanced treatment groups throughout 
the randomization process. Thus, for trials like this one that have extended accrual periods, the treatment 
groups remain balanced with respect to participant characteristics that may be related to time of accrual. In this 
study, we will randomize based on race/ethnicity, age, education, cigarettes/day, cervical cancer or dysplasia 
stage, cervical cancer or dysplasia treatment status, and time since diagnosis. After completing the 
assessment and randomization procedures, the 3-month follow-up assessment will be scheduled, and MAPS 
participants will schedule their first counseling call. 
 
Financial Compensation and Retention Procedures. Participants will receive financial remuneration after 
completing each assessment call to compensate for the time and inconvenience associated with participation 
($60 for each of the 5 assessment calls and up to a total of $300). The inclusion of compensation makes study 
participation more feasible and acceptable, which increases the representativeness of the sample and 
generalizability of the results. Compensation also increases follow-up rates, which reduces biases, and we 
have consistently achieved follow-up rates of approximately 80% even among very low-SES and 
racially/ethnically diverse smokers.69,102 Other procedures to reduce attrition include: 1) mailing postcard 
reminders and calling to remind participants of upcoming assessment calls; 2) maintaining communication with 
participants throughout the study period via mailing birthday cards, holiday cards, etc. (each mailing includes a 
stamped address update postcard with the study return address); 3) Having a staff member available at all 
times during business hours as well as evenings and weekends to conduct assessment calls; 4) requiring that 
in addition to a functional phone number (necessary for counseling calls), participants must have a home 
address so that they can be contacted by mail if necessary; and 5) obtaining names, addresses, and phone 
numbers of up to three collaterals (i.e., relatives/friends) who can provide information on participants’ 
whereabouts during the study (permission to contact the collaterals will be obtained from participants). 
In addition to being compensated for the time associated with completing assessments, all participants will be 
compensated up to a total of $150 for completing the assessments, up to a total of $150 for costs incurred as a 
result for the use of study-related cell phone minutes, and up to a total of $120 for returning the cotinine tests. 
Compensation for completing assessments will be provided at baseline, 3, 6, 12, and 18 months from baseline 
(5 times points x $30 = $150). Compensation for study-related cell phone use will be provided at baseline, 3, 6, 
12, and 18 months from baseline (5 time points x $30 = $150). Compensation for returning the cotinine tests 
will be provided at 3, 6, 12, and 18 months (4 time points x $30 = $120). 
 
TREATMENT PLAN 
 
Nicotine Replacement. All participants are eligible to receive a 12-week supply of nicotine patches and 


Page 8 
 
lozenges. Participants will receive educational materials describing potential side effects; proper use of the 
patch and an illustration demonstrating the proper placement of the patch on the body. The nicotine patch and 
lozenge regimen will be based on the participant’s self-reported smoking rate and will not be validated once 
assigned. At the time of enrollment, a research staff member will determine the proper dose. Participants who 
smoke >10 cigarettes/day will receive 8 weeks of 21 mg. patches, 2 weeks of 14 mg. patches, 2 weeks of 7 
mg. patches, and 12 weeks of 2 mg. lozenges. Those who smoke <10 cigarettes/day will receive 8 weeks of 
14 mg. patches, 4 weeks of 7 mg patches, and 12 weeks of 2 mg. lozenges. 
Standard Treatment (ST). ST will consist of 1) a mailed packet of materials including a letter referring 
smokers to the quitline, 2) free nicotine replacement therapy when they are ready to quit, and 3) standard self- 
help materials. ST will be delivered a total of 3 times to participants with completed assessments (at Baseline, 
6 and 12 months). 
MAPS. MAPS will consist of ST plus up to 6 proactive telephone counseling sessions over a 12-month 
period. Each call will last approximately 30 minutes. Calls are scheduled based on participants’ needs in 
negotiation with the counselor. For example, call timing can be negotiated to be clustered around the timing of 
a specific quit attempt. This is consistent with many interventions that load treatment during the period when 
relapse risk is highest.103 Similarly, a woman not motivated to quit might negotiate the next call to occur many 
months later, or to occur sooner if specific barriers are noted that the individual wishes to address (e.g., stress, 
social support, family problems). Similarly, individuals struggling with maintaining abstinence may have several 
calls in a shorter period of time to get them through the problematic period, while others need less frequent 
help. 
 
Counselor Qualifications and Training. We have adopted the therapist selection criteria employed in 
major clinical trials of MI-based approaches: 1) master’s degree in counseling, psychology or social work, and 
2) 2+ years of clinical experience.66 This, along with our training and ongoing monitoring, will ensure that the 
delivered treatments are of the highest quality. Drs. Wetter and Vidrine are clinical psychologists with extensive 
experience in MAPS. Dr. Vidrine will conduct the counselor training and supervision. Counselors will receive 
20 hours of MAPS training initially. Training will continue until the counselor reaches performance criteria for 
competence and adherence to the protocol. Counselors will also participate in 1-2 hour “booster” training 
sessions every 2 months. Dr. de Dios will supervise all Spanish language cases and bilingual therapists. 
 
Treatment Fidelity and Monitoring of the Trial. To monitor deviation or drift from the protocol, all 
counseling calls will be digitally recorded and encrypted. A random sample of 10% of calls will be coded to 
ensure adequate competence and protocol adherence. A counselor who falls below performance criteria will 
receive additional training. The Motivational Interviewing Treatment Integrity Manual (MITI, 2nd edition)104 has 
empirically validated reliability and validity and is used to code sessions and ensure treatment fidelity. The MITI 
works well for ensuring that counselors are following the protocol and utilizing the general MI spirit. In addition, 
the MITI is modified slightly to include coding of discussions around social cognitive/problem solving strategies 
and transitions between motivational enhancement and problem-solving. To monitor implementation, we will 
review weekly monitoring reports to track call completion and follow up rates. Dr. de Dios will be responsible 
for the fidelity monitoring of the Spanish language cases through the same process outlined above. 
 
ASSESSMENTS 
 
Assessments. Research Electronic Data Capture (REDCap) will be used to administer all questionnaires 
over the phone, in person, and/or via a web-based link when convenient for the participant. REDCap is a 
secure, web-based application designed to support data capture and utilizes a computer-administered self- 
interview format. This system is used in all of our current research and is designed to comply with all HIPAA 
regulations. Having research staff read the questionnaire items to participants will help overcome problems 
related to low literacy levels. Finally, we will attempt to reduce the inconvenience associated with completing 
assessments by providing financial compensation for participants’ time. In sum, the battery of instruments 
comprehensively assesses our hypothesized mechanisms and associated variables of interest. A copy of each 
assessment instrument is included in the Appendix and all measures are listed in the Procedures Table (Table 
1). 
 
Smoking Abstinence. Abstinence assessments are based on recommendations from the Society for 
Research on Nicotine and Tobacco (SRNT).105 We will report both prolonged and point-prevalence abstinence 


Page 9 
 
at all follow-up assessment points. Prolonged abstinence refers to abstinence beginning with the initiation of 
treatment and including a grace period. The prolonged abstinence measure utilizes SRNT’s recommendation 
for determining relapse (i.e., 7 consecutive days of smoking or smoking in each of 2 consecutive weeks). We 
will also evaluate two point-prevalence abstinence measures: 1) no smoking during the previous 7 days, and 2) 
no smoking during the previous 30 days. For all abstinence measures, we will analyze both completers only, 
and intent to treat in which smokers lost to follow-up are considered smoking. Abstinence at all follow-ups will 
be biochemically verified using a saliva cotinine level of <20 ng/ml. 
 
Participants who self-report abstinence will be mailed a prepaid envelope, instructions for providing the 
cotinine sample, and a saliva cotinine kit. Research staff will contact participants by phone to ensure the arrival 
of packet, review the contents of the packet, and answer any questions participants may have about collecting 
a saliva specimen. Although cotinine cannot comprehensively validate the various abstinence definitions and 
timeframes, the most comprehensive review on biochemical validation concluded that misreporting is typically 
very low (~2%), and that adjustment for misreporting almost never influences analyses regarding relative 
treatment efficacy.106 As such, our biochemical validation procedures are well justified both scientifically and 
practically. 
 
PSYCHOLOGICAL DISTRESS ASSESSMENT AND MANAGEMENT PLAN 
 
If a participant: 1) states that she is thinking about harming herself or others, or 2) uses actions or words to 
lead us to believe that she may be in eminent danger or in danger of harming another person, research staff 
will execute our standard crisis procedures. These procedures are described in detail in Appendix H. Once the 
plan is executed, a trained counselor will assess the participant using the “Crisis Assessment” (Appendix I). 
Participants will also be encouraged to follow ups with a mental health professional of their choice. Our team 
will have extensive interactions with participants throughout the course of the study. Therefore, our plan is 
appropriate for our target population. 
 
STATISTICAL CONSIDERATIONS 
 
Data Analysis Approach. The primary outcome is abstinence from smoking at the 18-month assessment. 
To test the treatment effect at 18 months, we will conduct logistic regression analysis with abstinence as the 
outcome variable, and treatment (a two-level categorical variable) as the predictor, adjusting for covariates, 
specifically, factors used in the minimization procedures (race/ethnicity, language, age, education, income, 
cigarettes/day, cervical cancer stage, and time since diagnosis). Interactions between treatment and specific 
covariates of interest may be included and tested for exploratory purposes. 
 
Because the primary and secondary outcomes and mechanisms include repeated measurements that are 
correlated within subjects, our data analytic approach will also utilize generalized linear mixed model 
regression (GLMM)107,108 to analyze the effects of MAPS across the 3, 6, 12, and 18 month timepoints. For 
abstinence, we will assume a logit link and binomial variance function for the GLMM, and parameterize them 
with blocking on individual nested within treatment conditions. Treatment and time will be included, as well as 
their interaction, with adjustment for relevant covariates. The effects of interactions between treatment and 
specific covariates will also be examined. Similarly analyses will also be conducted to assess the MAPS effects 
on quit attempt and use of the quitline (both binary). To assess MAPS effects on continuous measures such as 
cigarettes per day and mechanisms, the GLMM analysis will be replaced by linear mixed model (LMM) 
analysis (i.e., a special case of the GLMM). Similarly, the logistic regression analysis for the 18-month 
assessment will be replaced by multiple linear regression. Normalizing transformations for continuous 
measures (such as cigarettes per day) will be applied as appropriate. Alternatively, Poisson GLMM or Poisson 
regression could be used to analyze the effect of MAPS on cigarettes per day. In addition to examining the 
effects of treatment on primary and secondary outcomes and mechanisms, we will also assess the mediation 
(indirect) effects of treatment on abstinence through the mechanisms (motivation, agency, stress/negative 
affect) using single and/or multiple mediator models.109 With the primary outcome being abstinence at the 18- 
month assessment, potential mediators will be mechanisms measured at the previous time points (i.e., 3, 6, 
and 12 months), one at a time. A recommended approach to estimating and/or testing for the indirect effects 
for a binary outcome variable is via coefficient standardization in the b path (e.g., logistic regression), as 
appropriate, and bootstrapping.109-111 Appropriate covariates including mediators measured as baseline will be 


Page 10 
 
adjusted for in the a and b-path analyses. Mediators in the final mediator model will be selected using a 
backward selection approach.112 We will also compute and compare proportions of mediated effects along with 
their standard errors across the single and multiple mediator models, as well as across time points where the 
mediators are measured.113 A larger proportion of the mediated effect in general suggests a larger mediation 
effect. Additional mediation analysis for repeated measures abstinence analyses will be conducted using a 
similar approach with both a and b paths involving repeated measures analysis, as applicable.113 
 
Missing Data and Dropouts. It is anticipated that some individuals will drop out or be lost to follow-up, as 
is typical in smoking cessation treatment studies. Our primary analysis for examining abstinence at 18 months 
will utilize an intent-to-treat approach by coding missing abstinence data as smoking. However, we will also 
conduct sensitivity analyses by examining alternative approaches for handling missing data, including multiple 
imputation (under a missing at random assumption),114,115 and selection models (under an assumption of non- 
ignorable missingness, or missing not at random).114,116-118 In the multiple imputation approach, we will conduct 
analyses to examine whether participants who drop out of the study differ from those who do not, and include 
those covariates in our multiple imputation models, to mitigate the potential impact of non-ignorable 
missingness. Regardless of the approach used to handle missing data, it is unlikely that serious biases in 
estimation or considerable loss of efficiency in inference will result when the proportion of missing data low 
(e.g., not more than 10%; even more so when the missing data proportions are similar in MAPS and ST). 
Overall, robust results based on both the primary and sensitivity analyses will strengthen our study findings. 
 
Power. Our power analysis is based primarily on the comparison of 18-month abstinence rates between 
MAPS and ST. Because an intent-to-treat approach will be used, power is calculated based on the full sample 
without attrition (N=300; 150 per group), given that individuals lost to follow-up will be treated as smoking). All 
power analyses assume a significance level of 0.05 and a two-sided test. Based on the Guideline,20 we 
estimated that abstinence for ST would be approximately 10%. Using a chi-square test to examine the effect of 
treatment on abstinence at 18 months, a sample size of 300 (150 per group) will provide 80% power to detect 
an overall treatment effect that corresponds to abstinence rates of 10% and 21.9% in ST and MAPS 
respectively. Relative to examining abstinence over time, these calculations represent the worst case scenario. 
Table 2 presents detectable differences across a range of possible abstinence rates. Analyses conducted 
using GLMM will have greater power to detect the same average differences across time. 
 
Table 2. Detectable differences in binary smoking outcomes with 80% power (abstinence, quit attempt) 
ST (n=150) 
MAPS (n=150) 
5.0% 
14.60% 
10.0% 
21.90% 
20.0% 
34.40% 
30.0% 
45.70% 
40.0% 
56.20% 
 
Although the proposed mediation analyses for aim 2 are theoretically-grounded and hypothesis-driven (see 
Figure 1), they are quasi-exploratory in nature, and the sample size for this study was based on power to 
detect a significant difference for Aim 1. Nonetheless, power for the mediation analyses (Aim 2) has been 
calculated as follows. For the mechanism analyses (Aim 2), power is based on a conservative 25% attrition 
rate (N= 300; 112 per group). Because the mechanism variables are continuous, a sample size of 300 (112 per 
group at 18 months) will provide 80% power to detect an effect size of 0.376 standard deviation (SD) unit 
(difference in means between the ST and MAPS divided by common SD), using a two group t-test with a 0.05 
two-sided significance level. Because we have excellent power to detect treatment effects on the primary 
outcome and mechanisms, as well as the effects of mechanisms on abstinence (with power generally greater 
using continuous predictors than binary predictors such as treatment group), we expect to have good power to 
detect mediation effects. We note, however, that the power calculated for analyses in Aim 2 should be 
considered in the context of inflated type 1 error due to multiple analyses and hypothesis tests (including the 
mediation analyses) being performed for this aim. We feel that this inflated type 1 error is acceptable given the 
quasi-exploratory nature of this aim. Nevertheless, future studies focusing on testing specified mediational 
models should be sufficiently powered using approaches of Fritz and MacKinnon119 or Thoemmes et al.120, as 
appropriate. 
 
 
 


Page 11 
 
Cost Effectiveness 
Methods overview. Cost-effectiveness analyses (CEA) will compare the two interventions: ST and MAPS. 
The conventional CEA summarizes study findings in terms of the incremental cost-effectiveness ratio 
(ICER).121,122 The ICER, calculated as the difference in mean costs between the new and standard treatment 
divided by the difference in mean effectiveness between the new and standard treatment, estimates the 
additional resource consumption needed to achieve an increase in an additional unit of effectiveness. The 
ICER is then compared with a commonly cited or published threshold value associated with an intervention 
already found to be cost-effective to determine whether a new intervention is cost-effective. 
The net benefit approach, introduced more recently, 123,124, transforms the ICER into the net benefit, defined 
as NB(λ)= λ• ∆E – ∆C, where λ represents a societal willingness-to-pay (WTP), ∆C represents the incremental 
costs; and ∆E represents the incremental effectiveness. We will report the CEA results both in terms of the 
conventional ICER and the CE acceptability curve,123,125 the latter informs decision makers of the probability 
that the new intervention is more cost-effective than the standard treatment at various levels of societal WTP. 
The net benefit approach has been incorporated into a regression framework to allow for covariate adjustments 
and examination of interaction effects in CEA.126 Shih and colleagues further extended this net benefit 
regression framework to a Bayesian regression framework to allow the inclusion of prior knowledge and more 
flexible inferences.127,128 This regression-based approach is relevant to our study as there may be moderating 
factors such as individual characteristics that affect the cost-effectiveness of interventions. 
Measures of costs and collection of cost data. For each of the two intervention arms, the costs associated 
with implementing the intervention will come from three sources: study personnel, production of materials, and 
materials to participants. Project staff will keep logs of time spent on each of the tasks related to implementing 
the intervention, net of additional time that may be spent to satisfy the research and evaluation components of 
the project. Costs of developing training materials and information systems will apply to each intervention arm, 
whereas costs associated with training counselors will apply only to MAPS. Any hardware costs necessary for 
implementing the intervention will be tracked through invoices. Material costs will be obtained from invoices 
maintained by project staff from vendors delivering intervention materials. All intervention-related costs will be 
expressed in local market terms for personnel, office space, furnishings, and equipment. The cost model will 
include all personnel, hardware, and material costs necessary to implement the interventions. Even if the 
research team uses existing resources at Moffitt Cancer Center, Stephenson Cancer Center, or the quitlines 
without charge (e.g., office space, phones, computers), we will estimate all of the expenses necessary for 
implementing MAPS since these expenses would be required for the implementation of population-based 
tobacco control programs. We will not include other health care costs. This decision was based on the existing 
evidence regarding the heath care cost consequences associated with smoking and cessation and the 
expectation of how this evidence impacts the difference in costs among different intervention arms. Although 
smokers incur greater health care costs than non-smokers,129-133 it has been shown that cost savings related to 
improvement in health from cessation may be balanced out by future cost increases due to greater longevity.134 
In addition, former smokers incur greater short-term health care utilization and costs than continuing 
smokers.132,135 That increase in cost however, is likely linked to a health event that precedes and motivates the 
successful quit attempt. That is, higher health care costs are concurrent with but not caused by smoking 
cessation. 
Measures of Effectiveness. Two commonly used effectiveness measures in studies comparing the cost- 
effectiveness of cessation interventions are number of quitters and years of life saved (YOLS).136 To facilitate 
comparing ICER estimated from our CEA with that from other published studies, we will include both 
measures. The number of quitters in each treatment arm will be retrieved from the primary abstinence endpoint 
at month 18. We will extrapolate from abstinence to YOLS using a published algorithm that models YOLS per 
quitter for persons in various age-specific subgroups.137 In addition, to assist decision making in selecting 
among interventions targeted at different conditions that compete for limited budgets, we also included quality- 
adjusted life year (QALY) as an additional effectiveness measure, and calculate QALY from the health utilities 
obtained from the EQ-5D. This algorithm was favored over other published methods of extrapolation because it 
was built from a model with good face validity and has been adopted in many related CE studies.136 
Analysis. We will compare the cost-effectiveness of the interventions in three time frames: short-term, mid- 
term and long-term. The short-term and mid-term CEA will use "number of quitters" as the effectiveness 
measure and assess cost-effectiveness based on information collected at Months 3 and 6 (short-term), Month 
12 (mid-term), and month 18 (long-term), respectively. The long-term analysis will extrapolate the intervention 
effect to lifetime and use YOLS and QALY as the effectiveness measure. A 3% discount rate will be applied to 
costs and outcomes accrued in the second year and forward. First, we will work with the lead biostatistician of 


Page 12 
 
this study (Dr. Li) to address the issue of missing data using analytical approaches such as multiple imputation 
or selection models (details see above) and obtain imputed values for individual with missing value in cost 
and/or effectiveness variable. Next, we will perform deterministic CEA based on ICER. We will then apply the 
Bayesian approach to construct the CE acceptability curve and conduct probabilistic sensitivity analysis 
(PSA).138,139 The PSA assigns distributions for each of the key parameters to characterize uncertainties in each 
parameter, propagates all parameter uncertainties through the model simultaneously using simulation 
methods, and generates an empirical distribution for either the ICER or the net benefit;140,141 it has been 
incorporated in more recent CEA Guidelines.142 We will conduct the Bayesian analysis using WinBUGS, with 
costs modeled as a gamma or lognormal distribution and abstinence from tobacco or as a binomial distribution. 
Finally, we will apply the regression-based cost-effectiveness analysis. Individual-level net benefit will be 
regressed on covariates, plus a binary variable indicating the ST vs. MAPS arm. Using the "ST" arm as the 
reference group, the regression coefficients associated with the treatment binary variable will provide 
information on the cost-effectiveness of the MAPS intervention compared to ST. The regression model will be 
analyzed in two ways: 1) GLMM to examine how cost-effectiveness varies over time, and 2) Bayesian 
regression to systematically update information gathered at each time point. 
 
Table 3. Project Phases and Timeline 
Phase 1: 1 Year 
Refinement of Treatment Manuals, Counselor Training, Data Management and Tracking Systems, Focus Groups, Pilot Testing 
Phase 2: 3.5 Years 
Enroll 300 participants, Implement Procedures (Recruitment, Screening, Randomization, Treatment Delivery, Assessment, etc.) 
Phase 3: 0.5 Years 
Complete Data Analysis and Prepare Manuscripts for Publication 


Page 13 
 
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ICF_000.pdf: 
Smoking Cessation for Cervical Cancer 
Survivors (Project SUCCESS) 
 
NCT02157610 
 
ICF Version 2 Dated 9/05/2019 


MCC #: 20134 
 
 
 
 
 
 
 
Version 2 version date: 09/05/2019 
Advarra IRB Approved Version 5 Sep 2019  
Page 1 of 10 
 
 
 
 
 
CONSENT TO TAKE PART IN A CLINICAL RESEARCH STUDY 
AND 
AUTHORIZATION TO DISCLOSE HEALTH INFORMATION 
Study Title:
  
“Smoking Cessation for Cervical Cancer Survivors in a Safety 
Net Healthcare System (Project SUCCESS)” 
 
Protocol Number:
 
Sponsor: 
MCC 20134
 
Moffitt Cancer Center 
 
Principal Investigator:
(Study Investigator) 
 
Jennifer Vidrine, PhD
 
Telephone:
(24 hour number) 
813-745-1751
800-456-3434 
 
Address:
Moffitt Cancer Center Prevention Research, Fowler Campus
4117 E Fowler Ave. 
Tampa, FL    33617 
 
 
You are being asked to take part in a research study.  The information in this document should 
help you to decide if you would like to participate. 
 
The purpose of the study is to compare a program called Motivation and Problem Solving 
(MAPS) to the standard approach to helping patients with a history of cervical cancer or cervical 
dysplasia to quit smoking.   
 
The study design will randomly place you in to 1 of 2 possible study groups. Your group will be 
chosen by chance, like the flip of a coin.  
 
Group 1 will receive: 
       • Free self-help materials 
       • A referral to the Tobacco Free Florida (or your state’s tobacco helpline) 
       • 12-week supply of nicotine replacement therapy (the patch and lozenges) 
 
Group 2 will receive: 
       • Free self-help materials 
       • A referral to Tobacco Free Florida (or your state’s tobacco helpline) 
       • 12-week supply of nicotine replacement therapy (the patch and lozenges) 
       • 6 telephone counseling sessions over the next year 
 


MCC #: 20134 
 
 
 
 
Version 2 version date: 09/05/2019 
Advarra IRB Approved Version 5 Sep 2019 
   Page 2 of 10 
 
 
The Florida Tobacco Helpline, Tobacco Free Florida (1-877-U-CAN-NOW (1-877-822-6669)) is 
a service that provides free quit smoking services to eligible callers.  
You will also be asked to complete questionnaires over the phone, in person, or via a web-
based link. You will be asked to complete a questionnaire 5 times. These questionnaires should 
take about 45 minutes each time to complete. You may also be asked to provide saliva 
samples. 
 
You are being asked to take part because you are a current cigarette smoker with a history of 
cervical cancer or cervical dysplasia. 
 
About 450 women will participate in this study overall. Of them, up to 30 women will participate 
in the in-depth interviews. Up to 20 women will participate in the pilot portion of the study. 
 
Your participation is voluntary, and you may stop the study at any time.  There will be no 
penalties or loss of benefits or opportunities if you do not participate or decide to stop once you 
start. Since this is not a treatment study, your alternative is to not participate. 
 
We do not know if you will receive any benefit from your participation. If you agree to take part in 
this study, there may or may not be direct medical benefit to you. Taking part in this study may 
help you control or quit smoking. We hope that the information learned from this study will 
benefit other patients with this condition in the future.  
 
The most common and most serious risks that may be related to taking part in this research 
include: 
       • Side effects from the nicotine patch or lozenges, such as increased heart and blood 
pressure  
       • Skin redness  
       • Symptoms of nicotine overdose like nausea, dizziness, weakness  
       • Vivid dreams or difficulty sleeping  
       • Allergic reactions such as difficulty breathing or rash  
       • Mouth, teeth, and jaw problems  
       • Indigestion 
       •   Sore throat 
 
Any new important information that is discovered during the study and which may influence your 
willingness to continue participation in the study will be provided to you. 
 
Even if we publish the findings from this study, we will keep your study information private and 
confidential.  Anyone with the authority to look at your records must keep them confidential.  
 
WHAT IS INVOLVED IN THE STUDY? 
No matter which group you are in, you will receive a 12-week supply of nicotine replacement 
therapy (the patch and lozenges). The strength of the nicotine patches and lozenges you 
receive will depend on how much you smoke each day. You should use the nicotine patch as 
directed by the package instructions. 
 


MCC #: 20134 
 
 
 
 
Version 2 version date: 09/05/2019 
Advarra IRB Approved Version 5 Sep 2019 
   Page 3 of 10 
 
 
Unused and used patches have enough nicotine to poison children and pets. Be sure to fold the 
sticky ends together when you are done using the patch. In case of accidental overdose, call 
your regular doctor or a poison control center right away. 
 
Even if you do not wish to use the nicotine patch, you will be allowed to take part in the study. 
 
Study Questionnaires: 
You will be asked to complete questionnaires over the phone, in person, or via a web-based 
link. You will be asked to complete these questionnaires 5 times. These will occur at the 
beginning of study and at months 3, 6, 12 and 18. You will be asked about your feelings, 
moods, cervical cancer or dysplasia diagnosis, and smoking status. These questionnaires 
should take about 45 minutes each time to complete. 
 
Saliva Testing: 
At months 3, 6, 12 and 18, you may also be asked to provide a saliva sample to test for cotinine. 
Cotinine is a chemical released in your body when it breaks down nicotine. This test is to 
confirm your smoking status. You will receive a kit in the mail with supplies for testing. The study 
staff will call you to make sure you received the kit and to discuss the instructions with you. If 
you have any questions about how to use the kit, you may contact the study staff during the 
study. 
 
To collect the saliva, you will put a small piece of cotton in your mouth for a few minutes. You 
will be asked to mail the saliva sample back to the study staff using a prepaid return envelope. 
During the study, you may be contacted by mail, telephone, and/or email to be reminded to 
send back the kit. 
 
Telephone Counseling (for Group 2 Only): 
If you are in Group 2, you will have 6 telephone counseling sessions. These sessions may last 
up to 30 minutes each. These calls will occur over a 12-month period at times that are 
convenient for you. During the calls, you will be asked about how motivated you are to quit 
smoking, what barriers to quitting you may have, and factors that may be related to your 
smoking such as stress and family issues. 
 
The telephone counseling sessions will be digitally recorded. Only the study investigators and 
study staff will be allowed to view or listen to the recordings. Your identity will be kept strictly 
confidential. Your study identification number will be stated by the counselor at the beginning of 
the taped session. The recordings are stored digitally, encrypted, and password protected. The 
telephone counseling recordings will be destroyed 10 years after results from the study are 
published. 
 
Other Information: 
You will also be asked to provide the names and contact information of family and/or friends. 
Study staff will contact these people if they have trouble reaching you. All study data, including 
informed consent recordings and telephone counseling session recordings, will be destroyed 10 
years after results of the study have been published. All data will be stored in a secured location 
on one of the departmental servers, which are backed up daily. Only certain members of the 
study staff or others designated by the study chair will have access to the study data. 
 
WHAT IS THE STATUS OF THE DRUGS INVOLVED IN THIS STUDY? 


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MCC #: 20134 
 
 
 
 
Version 2 version date: 09/05/2019 
Advarra IRB Approved Version 5 Sep 2019 
   Page 8 of 10 
 
 
The purpose for the uses and disclosures you are authorizing is to conduct the study explained 
to you during the informed consent and research authorization process. Also, the purpose is to 
ensure that the information relating to the study is available to all parties who may need it for 
research purposes. 
 
Your authorization to use your health information will never expire unless and until you 
expressly revoke it in writing to the study investigator listed on the first page of this form. 
 
Any data collected before your letter will continue to be used as necessary to preserve the 
integrity of the study. No additional information will be collected after you withdraw your 
authorization. 
 
You will receive a copy of this form. 
 
Certificate of Confidentiality 
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the 
National Institutes of Health.  With this Certificate, the study investigators may not disclose 
research information that may identify you in any Federal, State, or local civil, criminal, 
administrative, legislative, or other proceedings, unless you have consented for this use.  
Research information protected by this Certificate cannot be disclosed to anyone else who is 
not connected with the research unless: 
1) There is a law that requires disclosure (such as to report child abuse or communicable 
diseases but not for legal proceedings); 
2) You have consented to the disclosure, including for your medical treatment; or 
3) The research information is used for other scientific research, as allowed by federal 
regulations protecting research participants. 
 
Disclosure is required, however, for audit or program evaluation requested by the agency that is 
funding this project or for information that is required by the Food and Drug Administration 
(FDA). 
 
You should understand that a Confidentiality Certificate does not prevent you or a member of 
your family from voluntarily releasing information about yourself or your involvement in this 
research.  If you want your research information released to an insurer, medical care provider, 
or any other person not connected with the research, you must provide consent to allow the 
researchers to release it.  This means that you and your family must also actively protect your 
own privacy. 
 
Finally, you should understand that the study investigator is not prevented from taking steps, 
including reporting to authorities, to prevent serious harm to yourself or others. 
 
WHOM TO CONTACT ABOUT THIS STUDY 
 
During the study, if you have questions, concerns or complaints about the study, please contact 
the study investigator at the telephone number listed on the first page of this consent document. 
 
An institutional review board (IRB) is an independent committee established to help protect the 
rights of research participants.  If you have any questions about your rights as a research 
participant, and/or concerns or complaints regarding this research study, contact: 


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MCC #: 20134 
 
 
 
 
Version 2 version date: 09/05/2019 
Advarra IRB Approved Version 5 Sep 2019 
   Page 10 of 10 
 
 
STATEMENT OF CONSENT AND AUTHORIZATION 
I have read this form and its contents were explained to me.  I agree to be in this research study 
for the purposes listed above. I authorize the use and disclosure of my personal health 
information for the use of this study.  All of my questions were answered to my satisfaction.  I 
will receive a signed and dated copy of this form for my records. 
 
 
 
Printed Name of Participant 
 
 
 
 
 
 
 
 
 
Signature of Participant 
Date 
 
Time 
 
 
 
STATEMENT OF PERSON OBTAINING INFORMED CONSENT / RESEARCH 
AUTHORIZATION 
I attest that the participant named above had enough time to consider this information, had an 
opportunity to ask questions, and voluntarily agreed to be in this study. 
 
 
 
 
Printed Name of Person Explaining Consent 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Consent 
Date 
 
Time