Quit & Fit 2.0: Feasibility and Usability Testing
Phase: NA
Conditions: Smoking Cessation
Sponsor: Hackensack Meridian Health

CLINICAL STUDY PROTOCOL
Quit & Fit 2.0: Feasibility and Usability Testing
Protocol Version
05.02.2023

Study Number: Pro2022-0894
05.02.2023
Study Personnel
Principal Investigator/Department:
Lisa Carter-Bawa, PhD, APRN, ANP-C, FAAN
Director, Cancer Prevention Precision Control Institute @ the Center for Discovery & Innovation
Lisa.CarterBawa@hmh-cdi.org
Sub-I(s): N/A
Statistical support: N/A
Protocol Development support (if applicable): N/A
Name and information of sponsor: Hackensack Meridian Health
Research Locations (all non-HMH locations):
Georgetown Lombardi Comprehensive Cancer Center, Washington, D.C.
Abbreviations
Abbreviation
Explanation
NCCN
National Comprehensive Cancer Network
NRT
Nicotine Replacement Therapy
Revision History
Revision #
Version Date
Summary of Changes
Consent Change?
1
05.02.2023
Summary
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Study Number: Pro2022-0894
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Study Title
Quit & Fit 2.0: Feasibility and Usability Testing
Study Design
Pilot randomized controlled trial to compare tobacco
cessation rates of two arms: a 6-week culturally
tailored tobacco cessation intervention versus a
6-week personalized culturally-tailored tobacco
cessation intervention among African American
women (N=20).
Primary Objective
Examine feasibility, acceptability and satisfaction of a
6-week community-based tobacco treatment
intervention.
Secondary Objective(s)
Examine self-reported stage of change for tobacco
cessation.
Research Intervention(s)
community-based tobacco treatment intervention
Study Population
African American women who currently smoke
tobacco in Washington, D.C. and New Jersey
(Lombardi-Hackensack consortium)
Sample Size
N=20
Study Duration for individual participants
6 weeks
1 – Introduction
Despite lower overall smoking rates, African American women have comparable lung cancer
rates to higher rate smoking groups. Smoking is the leading cause of preventable morbidity
and mortality in African American women. Disparities exist in disease and death from
smoking-related diseases regardless of gender. Because African American women carry a
disproportionate tobacco-related disease burden, research that focuses on intervening in
tobacco treatment among African American women is critical.
Tobacco treatment is the single most important preventive health behavior African American women
can engage in to significantly reduce their chances of morbidity and premature mortality related to
smoking-related illnesses. Although more African American men smoke compared to African
American women, data show that African American women may be less successful at quitting than
men. Interventions are most effective when they are paired with other lifestyle behavior
interventions. Specifically, exercise has been used successfully as an adjunct to tobacco treatment
interventions because exercise has the potential to reduce cigarette cravings, withdrawal symptoms
and weight gain, all of which are barriers to tobacco treatment among women. Therefore, an
intensive tobacco treatment program paired with a fitness component is a promising intervention to
promote smoking abstinence in women who have difficultly quitting. Further, culturally tailored
comprehensive interventions that address tobacco treatment among African American women are
needed if we are to address the current disparities that exist in disease and death from
smoking-related diseases among African American women.
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2 – Background
2.1. Background/literature review (make sure you provide references)
Tobacco use remains the single most preventable cause of disease and death in the United
States.1-2 Smoking creates well-known risks for conditions such as cancer, stroke, and heart disease.
Blacks are 13% more likely to die from all types of cancer than Whites, adjusting for age.3 Even when
controlling for differences in socioeconomic status and age, Blacks have higher all-cancer mortality
across all but the highest socioeconomic decile, as compared to Whites.4 For lung cancer, Blacks have
2 to 3 times more risk than do any other ethnic group.5
Blacks face a significantly higher disease burden as a result of modifiable health behaviors as
compared to their White counterparts. They have a higher incidence of mortality attributed to
coronary heart disease, stroke, heart failure, and high blood pressure as compared to non-Hispanic
Whites.6 The prevalence of high blood pressure (a major risk factor for coronary heart disease,
stroke, heart failure, and kidney disease) is 40% higher among Blacks than in Whites, with even
greater disparities seen between women.7 Blacks are also more likely to consume fewer servings of
fruits and vegetables8 and have lower rates of physical activity,9-10 which are all modifiable risk factors
for cancer and cardiovascular disease.11 Reports illustrate that Black adult females across all age
groups are more likely to be overweight or obese compared to White females, and also exhibit
greater disparities than between Black and White men.6 Consequently, Black women are in
particular need of effective targeted interventions.7 Given the prevalence of smoking among women
in the U.S., evidence-based tobacco treatment programs need to be translated from the research
setting into community settings that are accessible to the large population of women who smoke.12
Women, in general, are four times more likely than men to report fear of weight gain as a reason for
smoking cessation relapse13 and they gain significantly more weight than men who smoke following
tobacco treatment.14 Black women are more likely to be satisfied with their body shape compared to
White women; however, they report less tolerance for post-cessation weight gain and are less likely
to exercise as a means of weight control.15
There is emerging evidence that positive changes in one’s health behavior may be accompanied by
other constructive health behavior changes. Berg et al. determined that among 539 Blacks who
smoked lightly, those who reduced or quit using tobacco were more likely to walk for exercise at
follow-up, after controlling for baseline walking status.16 Regular physical activity may be an effective
means of not only promoting one’s health directly but it has been associated with improved smoking
cessation rates and improved mood. A recent review of 15 clinical trials demonstrated that exercise
interventions combined with tobacco treatment can provide additional benefit compared to
interventions that do not incorporate exercise.17 Commit to Quit is a smoking cessation
intervention18-22 that has shown women who received cognitive-behavioral treatment (CBT)
combined with an exercise intervention achieved significantly higher levels of continuous abstinence
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Study Number: Pro2022-0894
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relative to CBT plus a contact control condition.20 However, Commit to Quit was validated over a
decade ago22 and advances in tobacco treatment in general have shown the importance of combined
treatment and inclusion of nicotine replacement therapy (NRT) in cessation programs.22
Although pilot work has attempted to translate Commit to Quit into a community setting,23 the
studies were primarily conducted among White women and little work has been done to examine
the efficacy of the approach in diverse samples. Previous research has highlighted the importance of
cultural relevance in health risk communications, including tobacco interventions. Webb et al24
demonstrated that that the culturally tailored tobacco treatment messaging produced greater
culturally specific risk perceptions, readiness to quit smoking, and smoking-related knowledge.24
Findings support the roles of message content and culturally specific framing in the efficacy of brief
written interventions for tobacco treatment in this population.
When individuals quit smoking, they tend to gain weight. Potential weight gain is a significant
barrier to tobacco treatment; weight maintenance strategies should be included in early tobacco
treatment support.25 Further, tobacco treatment is associated with hyperphagia and weight gain in
over 70% of those individuals who attempt to quit smoking. Nicotine, which is the known main
addictive component of tobacco, has anorexigenic properties and promotes body weight
reductions.26-29 Thus, the idea of weight gain has acted as an incentive for the continued smoking
habits and the effects of nicotine on energy homeostasis demonstrates that smoking leads to
negative energy balance.
Phone-based Interventions have the potential to drive behavior change. Health professionals use
cell phones to monitor chronic diseases, improve medication adherence,30 and to help individuals
who smoke to quit.31 Telephone quit lines enhance cessation rates by over 50%.31 A recent cell phone
cessation intervention in a low income, largely Black urban HIV clinic sample indicated that patients
who received 8 phone sessions were significantly more likely at 3 months follow-up to be abstinent.32
A recent review concluded that text message interventions are efficacious for tobacco treatment.30
Recent trials are emerging that suggest mobile phones are a feasible delivery method to promote
energy balance.33 For example, a randomized trial with 337 urban Blacks received 8 months of either
weekly automated, tailored, interactive phone calls, or standard care education.33 The phone calls
were arranged in three modules addressing hypertension medication adherence, physical activity,
and diet. The intervention was associated with improvements in a measure of overall diet quality and
in energy expenditure. The study suggests that diet and energy balance messages delivered by phone
have promise given their convenience, scalability, and ability to deliver tailored messages for urban
Blacks. Cell phones have a high penetration among underserved minority populations, and
researchers have explored the use of cellular phones as a disparity-reducing advancement.6 Black
and Hispanic groups have become the largest per capita users of basic cell phone functions.6 In 2014,
90% of African Americans reported cellphone ownership and 81% of all cellphone users reported
sending and receiving text messages.34 Cellular phones do not present the digital divide -- the
perceived gap between those who have access to the latest information technologies and those who
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Study Number: Pro2022-0894
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do not.6
Impact. To date, researchers have focused on tobacco treatment interventions individually as
opposed to combining positive changes in one health behavior as synergistic for another constructive
health behavior change. This application challenges the current status quo by transforming tobacco
treatment in the community among Black women to address not only tobacco treatment but to
proactively address the fear of weight gain with cessation using a culturally framed, targeted
approach. Ultimately, using a novel community-based tobacco treatment and exercise intervention
to target community-based Black women is innovative and has the potential to engage women with
individualized content that is personally relevant to foster engagement in improving their health.
References
1. Ries LAG, Melbert D, Krapcho M. SEER cancer statistics review, 1975-2005. 2008.
2. American Cancer Society. Cancer facts and figures for African Americans: 2022.
3. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;62(1):10-29.
4. Singh GK, Williams SD, Siahpush M, Mulhollen A. Socioeconomic, rural-urban, and racial
inequalities in US cancer mortality: Part I-all cancers and lung cancer and part II-colorectal, prostate,
breast, and cervical cancers. J Cancer Epidemiol. 2011;2011:107497.
5. Haiman CA, Stram DO, Wilkens LR, et al. Ethnic and racial differences in the smoking-related risk of
lung cancer. N Engl J Med. 2006;354(4):333-342.
6. Wang Y, Beydoun MA. The obesity epidemic in the united states--gender, age, socioeconomic,
racial/ethnic, and geographic characteristics: A systematic review and meta-regression analysis.
Epidemiol Rev. 2007;29:6-28.
7. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics--2012 update: A report
from the american heart association. Circulation. 2012;125(1):e2-e220.
8. Dubowitz T, Heron M, Bird CE, et al. Neighborhood socioeconomic status and fruit and vegetable
intake among whites, blacks, and mexican americans in the united states. Am J Clin Nutr.
2008;87(6):1883-1891.
9. U.S. physical activity statistics: 2007 state demographic data comparison. 2008.
10. Marshall SJ, Jones DA, Ainsworth BE, Reis JP, Levy SS, Macera CA. Race/ethnicity, social class, and
leisure-time physical inactivity. Med Sci Sports Exerc. 2007;39(1):44-51.
11. Bassuk SS, Manson JE. Physical activity and cardiovascular disease prevention in women: A review
of the epidemiologic evidence. Nutr Metab Cardiovasc Dis. 2010;20(6):467-473.
12. Glasgow RE, Lichtenstein E, Marcus AC. Why don't we see more translation of health promotion
research to practice? rethinking the efficacy-to-effectiveness transition. Am J Public Health.
2003;93(8):1261-1267.
13. Swan GE, Ward MM, Carmelli D, Jack LM. Differential rates of relapse in subgroups of male and
female smokers. J Clin Epidemiol. 1993;46(9):1041-1053.
14. Pirie PL, Murray DM, Luepker RV. Gender differences in cigarette smoking and quitting in a cohort
of young adults. Am J Public Health. 1991;81(3):324-327.
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15. Pomerleau CS, Zucker AN, Namenek Brouwer RJ, Pomerleau OF, Stewart AJ. Race differences in
weight concerns among women smokers: Results from two independent samples. Addict Behav.
2001;26(5):651-663.
16. Berg CJ, Thomas JL, An LC, et al. Change in smoking, diet, and walking for exercise in blacks.
Health Educ Behav. 2012;39(2):191-197.
17. Ussher MH, Taylor AH, Faulkner GE. Exercise interventions for smoking cessation. Cochrane
Database Syst Rev. 2014;8:CD002295.
18. Marcus BH, Albrecht AE, Niaura RS, Abrams DB, Thompson PD. Usefulness of physical exercise for
maintaining smoking cessation in women. Am J Cardiol. 1991;68(4):406-407.
19. Marcus BH, King TK, Albrecht AE, Parisi AF, Abrams DB. Rationale, design, and baseline data for
commit to quit: An exercise efficacy trial for smoking cessation among women. Prev Med.
1997;26(4):586-597.
20. Marcus BH, Albrecht AE, King TK, et al. The efficacy of exercise as an aid for smoking cessation in
women: A randomized controlled trial. Arch Intern Med. 1999;159(11):1229-1234.
21. Marcus BH, Albrecht AE, Niaura RS, et al. Exercise enhances the maintenance of smoking
cessation in women. Addict Behav. 1995;20(1):87-92. doi: 0306460394000484 [pii].
22. Marcus BH, Lewis BA, King TK, et al. Rationale, design, and baseline data for commit to quit II: An
evaluation of the efficacy of moderate-intensity physical activity as an aid to smoking cessation in
women. Prev Med. 2003;36(4):479-492.
23. Whiteley JA, Napolitano MA, Lewis BA, et al. Commit to quit in the YMCAs: Translating an
evidence-based quit smoking program for women into a community setting. Nicotine Tob Res.
2007;9(11):1227-1235.
24. Webb MS, Baker EA, Rodriguez de Ybarra D. Effects of culturally specific cessation messages on
theoretical antecedents of behavior among low-income african american smokers. Psychol Addict
Behav. 2010;24(2):333-341.
25. Travier N, Agudo A, May AM, et al. Longitudinal changes in weight in relation to smoking
cessation in participants of the EPIC-PANACEA study. Prev Med. 2012;54(3-4):183-192.
26. Filozof C, Fernandez Pinilla MC, Fernandez-Cruz A. Smoking cessation and weight gain. Obes Rev.
2004;5(2):95-103.
27. Grunberg NE. A neurobiological basis for nicotine withdrawal. Proc Natl Acad Sci U S A.
2007;104(46):17901-17902.
28. Mineur YS, Abizaid A, Rao Y, et al. Nicotine decreases food intake through activation of POMC
neurons. Science. 2011;332(6035):1330-1332.
29. Seeley RJ, Sandoval DA. Neuroscience: Weight loss through smoking. Nature.
2011;475(7355):176-177.
30. Whittaker R, McRobbie H, Bullen C, Borland R, Rodgers A, Gu Y. Mobile phone-based
interventions for smoking cessation. Cochrane Database Syst Rev. 2012;11:CD006611.
31. Stead LF, Perera R, Lancaster T. Telephone counselling for smoking cessation. Cochrane Database
Syst Rev. 2006;(3)(3):CD002850.
32. Mottillo S, Filion KB, Belisle P, et al. Behavioural interventions for smoking cessation: A
meta-analysis of randomized controlled trials. Eur Heart J. 2009;30(6):718-730.
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33. Migneault JP, Dedier JJ, Wright JA, et al. A culturally adapted telecommunication system to
improve physical activity, diet quality, and medication adherence among hypertensive
african-americans: A randomized controlled trial. Ann Behav Med. 2012;43(1):62-73.
34. Mobile technology fact sheet.
http://www.pewinternet.org/fact-sheets/mobile-technology-fact-sheet/. Updated January 2014.
3 – Rationale, Objectives and Hypothesis
3.1. Study Rationale/Problem Statement/Research question or Study significance
The rationale of the overarching study that this pilot feasibility and usability study will support is to
compare the effectiveness of a 6-week community-based tobacco treatment and exercise
intervention – Quit & Fit to the control (tobacco treatment intervention) targeted to African
American women on tobacco cessation rates via 7-day cotinine confirmed point-prevalence
abstinence (primary outcome) and secondary outcomes (caloric intake, weight changes, health
beliefs).
For this study, the rationale is to pilot the feasibility, acceptability and satisfaction of the study
procedures of a shortened intervention protocol that compares a culturally-tailored tobacco
treatment intervention to a preference driven culturally-tailored tobacco treatment intervention.
3.2. Hypothesis (if applicable)
1)
Participants will report the 6-week tobacco treatment intervention is
acceptable and they are satisfied with the intervention.
2)
Participants who complete the preference driven culturally-tailored
tobacco treatment intervention will have higher rates of tobacco
abstinence compared to participants in the control arm.
3.3. Primary Objective
Aim 1. Examine the feasibility, acceptability and satisfaction (primary outcome) of a 6-week
community-based culturally-tailored tobacco treatment intervention to a preference driven
culturally-tailored tobacco treatment intervention targeted to African American women.
Aim 2. Compare the effectiveness of a 6-week community-based culturally-tailored tobacco
treatment intervention to a preference driven culturally-tailored tobacco treatment
intervention targeted to African American women on self-reported stage of change for
tobacco cessation (secondary outcome).
3.4. Primary Outcome Variable(s)
Feasibility, acceptability and satisfaction with the content of the educational content and the tobacco
treatment intervention.
4 - Study Design
4.1 General Design
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Study Number: Pro2022-0894
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The overall study design is a 6-week community-based tobacco treatment intervention to address
tobacco use in the African American female community. This pilot study is testing the feasibility,
acceptability and satisfaction of a 6-week community-based culturally-tailored tobacco treatment
intervention to a preference driven culturally-tailored tobacco treatment intervention targeted to
African American women in New Jersey with 20 African American women; 10 participants will
receive the culturally-tailored tobacco treatment intervention and 10 participants will complete the
one-item Control Preference Scale and receive preference driven culturally-tailored tobacco
treatment intervention based upon their control preference.
4.1.1 Study Duration (if applicable)
Total study duration = 6 months
4.1.2 Number of Study Sites
1 (HMH)
4.2 Study Population
African American women
4.2.1. Number of Participants
20
4.2.2. Eligibility Criteria
Inclusion Criteria:
●
Self-identify as an African American woman
●
Aged 18 years to 69 years
●
Currently smoke 5 cigarettes per day or more
●
Has smoked daily for the past one year
●
Able to provide informed consent
●
Generally good health as determined by medical history
Exclusion Criteria:
●
Currently pregnant
●
Diagnosis of cardiovascular disease
●
Diagnosis of lung disease
●
Diagnosis of mental illness
●
Adults unable to consent
●
Individuals who are not yet adults (infants, children, teenagers)
●
Prisoners
4.2.3. Vulnerable populations (if applicable). Vulnerable populations include children,
prisoners, cognitively impaired individuals, economically or educationally
disadvantaged individuals, employees, students. When vulnerable populations are
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Study Number: Pro2022-0894
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included, indicate what safeguards are in place to minimize coercion or undue
influence to participate.
n/a
4.2.4. Withdrawal criteria (as applicable)
n/a
4.3. Study procedures
We will recruit participants using informal recruitment through advertisements/media (e.g.
advertisements, neighborhood flyers) in New Jersey.
After a participant is consented and enrolled into the study, they will complete a baseline
survey, receive the home CO monitor and instructions on how to use, and be scheduled for
weekly telephone calls with a certified tobacco treatment specialist (CTTS). The
culturally-tailored tobacco intervention content by week via telephone call with the CTTS is
listed in the table below:
Table 1
Week
Tobacco Intervention Content
1
Reasons and Motivations for Quitting, Nicotine as an Addiction, Coping Response
Training, Tracking Your Triggers, Education about Nicotine Replacement Therapy
2
Benefits of Quitting; Reinforce Prior Education about NRT
3
Discussion about Creating a Buddy System for Cessation and Discussion with
Participant about Decreasing Daily Cigarette Use by an Additional 20% (total 40%)
(CTTS will assess current cigarettes per day and ask participant to decrease
cigarettes by 20% using Table 1)
4
Stress Management
5
Stress Management
6
Discussion about Environmental Influences, Stress Management, Life in your
neighborhood, Gaining freedom from smoking
This intervention will address practical and logistical barriers associated with engaging
patients. The intervention will integrate motivational interviewing and evidence-based
tobacco treatment (i.e., cessation counseling and nicotine replacement therapy medication).
Intervention Content
Culturally-tailored Tobacco Treatment Intervention (Arm 1) vs. Preference-Driven
Culturally-tailored Tobacco Treatment Intervention (Arm 2)
In addition to weekly cessation counseling by a CTTS for 6 weeks covering the
Tobacco Intervention Content outlined above in Table 1, participants will receive
weekly Content Newsletters emailed after their weekly cessation counseling session.
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Participants randomized to Arm 1 will receive the Culturally-tailored Content
Newsletters and participants randomized to Arm 2 will complete the one-item
Control Preference Scale and receive either an Active Content Newsletter or Passive
Content Newsletter. The Control Preference Scale question is:
In terms of making decisions about your health care with your provider, which ONE of the following
best describes how you would like to make these decisions?
•1
Make the final selection about which treatment I will receive.
•2
Make the final selection after seriously considering my provider’s opinion.
•3
Have my provider and I share responsibility for deciding what treatment is best.
•4
Have my provider make the final decision but consider my opinion.
•5
Leave all decisions regarding treatment to my provider. 
Individuals will be classified as follows:
1 or 2 = Active Control Preference
3 or 4 = Collaborative Control Preference
5 = Passive Control Preference
Participants will receive weekly cessation counseling by a CTTS for 6 weeks covering
the Tobacco Intervention Content outlined above in Table 1. Participants will receive
variations (active vs. passive control preference) of the weekly Content Newsletters
emailed after their weekly cessation counseling session:
#
Active Content Newsletter
Passive Content Newsletter
1
Addresses Race and Smoking, History of
Research Distrust, and Concerns about Nicotine
Replacement Therapy (NRT)
Concerns about Nicotine
Replacement Therapy (NRT)
2
Addresses Reasons and Motivations for
Quitting, Nicotine as an Addiction, Coping
Response Training, Tracking Your Triggers
Nicotine as an Addiction, Coping
Response Training, Tracking Your
Triggers
3
Addresses Benefits of Quitting, Stressors
Unique to African Americans, Discrimination &
Racism, Ways to Cope
Addresses Benefits of Quitting,
Ways to Cope
4
Addresses Mood and Depression Among
African Americans, Buddy System
Buddy System
5
Addresses Stress Management (same)
Addresses Stress Management
(same)
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6
Addresses Weight and African Americans,
Smoking and Weight Concerns, Minimizing
Weight Gain, Healthy Eating within a Soul Food
Diet including Recipes
Minimizing Weight Gain
During the Week 1 telephone call with the CTTS, the participant will be educated about
combination nicotine replacement therapy over-the-counter medication and the Nicotine
Replacement Therapy (NRT) patch kit + NRT lozenge kit will be mailed to the participant’s
home.
4.3.1. Study discontinuation (if applicable) n/a
4.3.2. Concomitant medication (if applicable) n/a
4.4. Risks and Benefits
4.4.1. Risks
As this study proposes tobacco cessation, risks to participants are deemed minimal. There is
a potential risk of loss of confidentiality but that is protected against by coding all data with
study IDs only, presenting results of statistical analyses only in aggregate form, and limiting
the use of the data to research staff who are IRB approved to participate in the research,
have been trained in methods of maintaining confidentiality, and have completed training in
the protection of human subjects and research integrity at regular intervals.
4.4.2. Benefits
Potential benefits are tobacco cessation for participants.
5 – Methods
5.1. Screening
This is a community-based feasibility and usability study. As such, recruitment procedures
will be community-based and described below.
5.2. Recruitment, enrollment, and retention (including screen failures as applicable)
We will recruit participants using informal recruitment through social networks and
community-based advertisements/media (advertisements, neighborhood flyers) in New
Jersey.
The weekly intervention calls with the CTTS will assist with retention in this 6-week study. In
addition, the weekly content newsletter will assist with retention secondary to actively
engaging participants during the course of the study.
5.3. Study intervention (including schedule of events and study visits)
The study intervention includes a combination of tobacco treatment counseling sessions
using motivational interviewing by certified tobacco treatment specialists, randomization to
either (a) culturally-tailored tobacco treatment intervention or (b) preference driven
culturally-tailored tobacco treatment intervention, home CO monitoring, and combination
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nicotine replacement therapy over-the-counter medication and the Nicotine Replacement
Therapy (NRT) patch kit + NRT lozenge kit.
After a participant is consented and enrolled into the study, they will complete a baseline
survey and be scheduled for weekly telephone calls with a certified tobacco treatment
specialist. After the baseline survey is completed, a personal home CO monitor will be
ordered for the patient and shipped directly to their home. Instructions on how to use will be
emailed to the participant and reviewed in the 1st weekly counseling session with the CTTS.
The tobacco intervention content will be delivered by telephone by a CTTS weekly. The
weekly activities including plan to reduce total cigarette intake, and dosing chart for the
nicotine replacement (based upon the National Comprehensive Cancer Network’s
Evidence-Based Tobacco Treatment Guidelines (2022) is listed below by week:
Week
Tobacco Intervention Content
Nicotine Replacement Therapy
Orientation
(Baseline)
●
Overview of Study
●
Informed Consent
●
Baseline Surveys
Dosing Chart
>10cigarettes/day: Initially one 21mg patch
daily for 6 weeks; then one 14mg patch daily
for 2 weeks, then one 7mg patch daily for 2
weeks, then stop.
≤10cigarettes/day: initially one 14mg patch
daily for 6 weeks then one 7mg patch daily
for 2 weeks, then stop.
Session 1
●
Review Quit Plan
●
Baseline CO Level
Session 2
●
Behavior Target: Decrease # of Cigarettes
Daily by 20%
●
Start NRT: Nicotine Patch (see dosing
chart) + 2mg NRT lozenges prn
Session 3
●
Behavior Target: Decrease # of Cigarettes
Daily by additional 20% (total = 40%)
●
Continue NRT: Nicotine Patch (see dosing
chart) + 2mg NRT lozenges prn
Session 4
●
Behavior Target: Decrease # of Cigarettes
Daily by additional 20% (total = 60%)
●
Continue NRT: Nicotine Patch (see dosing
chart) + 2mg NRT lozenges prn
Session 5
●
Behavior Target: Decrease # of Cigarettes
Daily by additional 20% (total = 80%)
●
Continue NRT: Nicotine Patch (see dosing
chart) + 2mg NRT lozenges prn
Session 6
●
Behavior Target: Decrease # of Cigarettes
Daily by additional 20% (total = 100% =
QUIT)
●
Continue NRT: Nicotine Patch (see dosing
chart) + 2mg NRT lozenges prn
Final
Session
●
Assess how participant is doing. How many
cigarettes (if any) smoking per day. Answer
any questions including questions about
NRT tapering schedule
●
Assess NRT use, response, issues
●
Taper NRT per protocol
During the Week 1 telephone call with the CTTS, the participant will be educated about
combination nicotine replacement therapy over-the-counter medication and the Nicotine
Replacement Therapy (NRT) patch kit + NRT lozenge kit will be mailed to the participant’s
home.
The 6 tobacco treatment counseling sessions will use motivational interviewing by a CTTS to address
quitting motivations, benefits of tobacco treatment, overcoming nicotine dependence and practical
ways to handle triggers, nicotine withdrawal management, stress management, healthy eating and
activity, and relapse prevention.
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5.4. Assignment / randomization (if applicable) n/a
5.5. Section of instruments.
The primary outcome of this feasibility and usability pilot study is satisfaction with the processes of
the study. A Satisfaction and Usability Questionnaire will be used that assesses participant thoughts
and opinions about the intervention components, duration, outreach, and methods.
In addition, we will assess sociodemographic data including gender, race, marital status, education,
and employment status will be gathered along with data on health status, history of chronic disease,
and height and weight. Nicotine addiction will be measured by the Fagerström Questionnaire. Stage
of change for smoking will be assessed uses the processes of change, self-efficacy for behavior
change, and decisional balance (pros and cons of change). Biochemical Validation. Expired carbon
monoxide measures will be used to confirm smoking status. CO levels < 9 ppm will be used as the
cutoff.
Timing of Assessments
Baseline
Weekly
6 weeks post study
start
Sociodemographic & Health Status
Questionnaire
X
Fagerstrom Test for Nicotine Dependence
X
X
X
CO Monitor
X
X
X
Stage of Change for Tobacco Cessation
X
X
Usability
X
Acceptance & Satisfaction
X
5.6. Data management (data collection, source and storage)
Data at baseline and end of study (6 weeks post study start for each participant) will be collected by
phone. Self-report data will be gathered via a standardized interview using REDCap (Research
Electronic Data Capture). REDCap is a secure web-based application for building and managing online
surveys and databases. REDCap provides audit trails for tracking data manipulation and user activity
as well as export procedures for secure data downloads to common statistical packages.
5.7. Follow-up and end-of study (if applicable) n/a
5.8. Statistical Method
5.8.1. Sample size calculation and justification N/A (this is a feasibility and usability pilot
study with 20 participants)
5.8.2. Statistical Analysis Plan
This is a feasibility and usability pilot study; all analysis will be descriptive.
6 - Trial Administration
6.1. Ethical Considerations - Institutional Review Board (IRB) Review
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The study will be conducted according to the International Conference on Harmonization (ICH), Good
Clinical Practice (GCP), the Declaration of Helsinki, Institutional Review Boards (IRB) and in
accordance with the U.S. Code of Federal Regulations on Protection of Human Rights (21 CFR 50).
6.2. Institutional Review Board (IRB) Review (list the IRB of record)
The final study (ICF, HIPAA form as applicable) and data collection tools will be approved by the
Institutional Review Board (IRB) at HMH. Approval will be received in writing before study initiation.
Any changes to the study design will be formally documented in amendments and be approved by
the IRB prior to implementation.
6.3. Confidentiality
A unique identifier (study ID number) will be assigned to each participant. The study ID number will
be included in the data collection tools and analysis software while the list with direct identifiers and
ID numbers will be stored separately in a HMH-password protected computer and locked office.
If results of the study are published, individual names or other identifying information will not be
used, and findings will be reported in aggregate data only.
6.4. Informed consent
Participants are invited via community-based recruitment flyers and
advertisements. Participants who contact the study office will be screened
by telephone for inclusion and exclusion criteria. During the telephone
screening, the study personnel will speak with the individual to determine
that they can give informed consent for themselves. At that time, the study
personnel will read through and discuss the informed consent with the
individual. Once they have finished discussing the informed consent, the
individual will be given an opportunity to ask any questions they may have.
The study personnel will stress that the individual can withdraw from the
study at any time with no penalty. The individual will then be asked to
provide verbal informed consent and enroll in the study, or to decline to
participate. If the individual provides verbal informed consent, a copy of the
consent form will either be emailed or mailed to their home for their
records.
6.5. Data Quality Assurance (if applicable)
Online processes and platform (REDCap) will be monitored by the study team to assess survey/data
collection issues and any unusual events. Modifications will be made as necessary and recorded to
ensure maintenance of protocol integrity. In addition, any problems identified will be discussed at
team meetings and corrected.
6.6. Study Records (retention etc.)
Records will be retained in accordance with regulatory and organizational requirements, but for no
less than six (6) years following the completion of the study. Disposal of records will be performed
according to regulations.
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6.7. Compensation for Research-Related Injury (if applicable)
N/A
6.8. Economic Burden to Subjects (if applicable)
N/A
6.9. Credentials, Training
All research personnel will be up to date with required CITI training.
6.10. Financing and Insurance (if applicable)
N/A
6.11. Publication Plan (if applicable)
N/A
7- Resources Available
7.1. Describe the resources available to conduct the research:
The Cancer Prevention Precision Control Institute is led by the applicant. The primary office
space for senior investigators, fellows, data managers and research support staff consists of
10,000 sq feet. Access to the research office, which houses study data, is limited to study
personnel and is kept locked at all times. The space is well equipped with individual offices,
cubicles, and several multipurpose rooms for conducting interviews and convening research
team meetings, journal clubs, and didactic seminars. Faculty all have office space, computer
workstations, locked filing cabinets, and onsite access to videoconference facilities.
Computer The PI and research team have designated computer workstations that are
networked to the various secure campus-wide hospital systems. CDI has a well-maintained
computing environment that includes frequent software updates, proper hardware
maintenance schedules, and 24/7/365 help desk and network administration support. CDI
has an institutional site license for many software programs including Microsoft Office Suite,
Adobe Acrobat, SAS, and SPSS. The computers are also equipped with the statistical program
R, and bibliographic manager software (EndNote). The CDI has its own web and database
servers based on Microsoft platform to streamline data collection and maintain data
integrities. The department also has full-time in-house software developers and project
managers to build and manage all the research IT related activities.
Administrative Support: The CDI and HMH provide full supportive services for all research
projects including a full time Sponsored Programs Manager to help investigators comply with
all relevant regulations and policies and managing grants. A financial analyst supports
financial needs in sponsored research, cost analysis, procurement, and budgeting. The
Research Department also has comprehensive administrative support for all researchers.
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Appendices
Appendix #
Name
1
Measures
2
Content Newsletters (Active)
3
Content Newsletters (Passive)
17