Conditions: Smoking, Cigarette
Keywords: Smoking, Cancer, Treatment
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 90
Healthy volunteers: no

Brief summary:
Tobacco use among cancer survivors reduces the effectiveness of cancer treatments, increases the risk for additional primary cancers, and increases mortality. Implementation of tobacco treatment for cancer patients is challenging, but may be improved substantially with clinically-efficient and sustainable solutions to accurately identify tobacco users, direct them to evidence-based treatment, and provide demonstrable outcomes for stakeholders.

At UF Health Cancer Center (UFHCC), patient access and utilization of tobacco use treatment are sub optimal. Further, UFHCC has a largely rural catchment area with a high burden of tobacco-related disease and mortality. To address this research-to-practice gap using a mixed-methods approach to assess the relevant contextual factors at UFHCC and evaluate the feasibility of implementing a multi-level intervention to increase tobacco treatment utilization and improve health outcomes.

This study uses a mixed methods approach and will inform the design of a pragmatic clinical trial to improve the delivery of tobacco use treatment services to cancer patients. Guided by a conceptual model that emphasizes patient, provider, and organizational characteristics, the study team will identify factors that influence the implementation process at the UFHCC. The ultimate goal of the proposed research is to provide new knowledge to facilitate the widespread adoption, implementation, and dissemination and sustained utilization of evidence-based tobacco use treatments in cancer care settings.

Detailed description:
Study Design: This study uses a mixed methods approach and will inform the design of a pragmatic clinical trial to improve the delivery of tobacco use treatment services to cancer patients.

Study Setting: The pilot study will be conducted at the UF Health Medical Oncology and Ear, Nose \& Throat (ENT) clinics. Smoking is the leading cause of head and neck cancers, and almost one-third of patients continue to smoke after their head and neck cancer diagnosis, making this a priority population for intervention.

Population: UF Health cancer patients ≥18 yrs old who are current smokers and smartphone users; for mCBT, the investigators will also ensure CO breath sample \>5 parts per million (ppm). Patients with unstable medical or psychiatric illness or use disorder for illicit drugs will be excluded.

Procedures: The investigators will request Epic access to identify potential subjects and schedule recruitment during clinic hours. Research assistants (RAs) will be at the Medical Oncology and ENT clinics to meet with eligible patients during their visit. RAs will approach eligible patients at checkout after they are introduced by someone who has a clinical relationship with the patient. Following screening and brief counseling by the provider, RAs will offer eligible patients the 3 TUT options (i.e., AHEC, Quitline, or mCBT), obtain informed consent using REDCap (eConsent) or a paper consent (if desired by the patient), administer the Patient Exit Interview (PEI) in REDCap, and arrange a follow-up phone interview. Patients who choose AHEC/Quitline will be referred by a nurse using Epic. Those choosing mCBT will be trained on the use of Vidyo and the iCOTM Smokelyzer® by the RA, and follow-up will be arranged with a CTTS counselor.

Participants in mCBT will meet with a trained certified tobacco treatment counselor on Vidyo for 30 minutes, once a week, for 6 weeks. The counselor will cover topics that include addiction, withdrawal, dealing with triggers, overcoming cravings, and relapse prevention. At enrollment, investigators will offer mCBT participants-if interested-a 2-week supply of nicotine replacement therapy (NRT). The 2-week supply of NRT is consistent with what is offered to participants at AHEC and the Quitline. Participants who smoke less than 10 cigarettes per day will receive 14 mg of NRT, and those who smoke more than 10 cigarettes per day will receive 21 mg of NRT. Medical clearance from the provider will be obtained prior to NRT administration. At the end of the study (week 12), participants (all participants in mCBT and a random sample of patients referred to AHEC/Quitline) will complete the follow-up telephone interview. At the end of the study, participants (AHEC/Quitline \& mCBT) may also provide a saliva sample to test their cotinine level; this process will be remotely monitored via Vidyo for participants in mCBT and participants in AHEC/Quitline will be encouraged to contact study staff to answer any questions they may have. Evaluation tools also consist of Patient Exit Interviews and Telephone Survey to be administered among research participants.

Analysis Plan: All data collected will be entered in a REDCap database. The primary analysis will be the estimation of rates/means, with 95% CIs. To demonstrate the feasibility of the 3 implementation strategies, investigators will measure reach as the number of smokers visiting the 2 clinics who are referred to any TUT (i.e., AHEC/Quitline/mCBT) divided by the total number of smokers visiting the clinics. For each TUT, investigators will calculate enrollment as the total number of smokers who enroll in a given treatment divided by the total number of referred smokers; investigators will compare the rates of patients selecting into each of the 3 TUT programs. Investigators will assess TUT completion as the number of enrolled smokers who complete the program. Investigators will also evaluate acceptability using TAQ. As secondary outcomes, investigators will measure prolonged abstinence at week 12 and the change (baseline to week 12) in past-7-day point prevalence (all programs), as well as CO-verified abstinence at weeks 6 \&12 (mCBT only). CO levels will also be modeled across time (weeks 1, 6, 12) to assess for reductions over time via linear mixed models.

Arms:
arm 1: Cognitive Behavior Therapy (CBT) will be provided by a certified tobacco treatment specialist (CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling. arm 2: The Area Health Education Center (AHEC) is a locally available tobacco cessation program aimed at strengthening the capacity of Florida's healthcare system to deliver effective evidence based tobacco use treatment, and prevention services throughout the state. The intervention is education on the health effects related to tobacco use, and benefits of quitting and what to expect when quitting. A tobacco cessation specialist of trained facilitator guides participants as they identify triggers and withdrawal symptoms, and discuss ways to cope with them. The program offers free nicotine replacement therapy, educational materials, goodies for their quit day and follow up support. arm 3: Quitline is a local program in the state where smokers can call a toll free number to talk to coach who can help them quit. There is also an option of online program if they prefer to engage in online help to quit tobacco use.

The intervention in this arm is counseling support by phone or online with an option of Nicotine replacement therapy. If participants prefer this option, our nurse will refer them to locally available quitline service using EPIC.

Interventions: intervention 1: Nicotine Replacement Therapy intervention 2: Referral to AHEC/Quitline
Intervention descriptions: intervention 1: Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform. intervention 2: Participants will be referred to local AHEC/Quitline for treatment

Protocol document:
Prot_SAP_001.pdf: 
Protocol 
 
Implementation Strategies to Improve Tobacco Treatment for UF Health Cancer Center Patients  
 
Principal Investigator  
 
Ramzi Salloum, PhD, Assistant Professor  
Department of Health Outcomes and Biomedical Informatics, College of Medicine 
Telephone: (352) 294-4997; E-mail: rsalloum@ufl.edu 
 
1. Background 
 
Smoking causes 30% of all cancers and 80% of mortality from head and neck and lung cancer.1,2 Upward 
of 25% of the 12 million cancer survivors in the US are smokers.3 Continued tobacco use among cancer 
survivors reduces the effectiveness of cancer treatments and is associated with increased overall and 
cancer-specific mortality, increased risk for recurrence and second primary cancers, and diminished quality 
of life after treatment.4–10 The routine assessment of tobacco use and the provision of tobacco use 
treatment (TUT) are recommended by all major professional and advocacy groups in oncology.11,12 Due to 
the competing demands of complex cancer care, however, cancer centers are challenged with 
implementing strategies that both assess tobacco use and link tobacco users with TUT services. Whereas 
assessment of tobacco use may be common in oncology settings, improved cessation outcomes will not be 
realized if patients are not offered counseling and TUT support.13 TUT for cancer patients may be improved 
substantially with solutions to accurately identify tobacco use, provide patient-centered treatment support, 
and minimize the burden on clinical staff.  
 
The purpose of this study is to investigate the feasibility of implementing multi-level strategies to improve 
the access and utilization of TUT for cancer patients. Our strategies includes 1) offering provider and 
clinical staff training on current best practices, 2) developing an audit and feedback process, and 3) offering 
patients the choice of a dedicated technology-based cognitive behavioral therapy (CBT) program in 
addition to existing evidence-based TUT programs (i.e., the Florida Quitline; and Area Health Education 
Center [AHEC]14).  The ultimate goal of this research is to provide new knowledge to facilitate the 
widespread adoption, implementation, and dissemination and sustained utilization of evidence-based 
tobacco use treatments in cancer care settings. 
 
This protocol focuses on the patient-level trial only (Strategy 3).   
 
A separate protocol was developed for the provider-level implementation strategies (Strategies 1 and 2; 
see IRB201800135).  
 
The full protocol was approved by the UF Health Cancer Center Scientific Review and Monitoring 
Committee (Protocol # OCR1729; 01/26/2018).  
 
2. Study Description 
 
There is evidence that cancer patients benefit from dedicated services to help them quit smoking.15 Our 
evidence-based mobile phone CBT (mCBT) intervention will capitalize on the convenience and growing 
ubiquity of smartphone technology to deliver CBT and verify abstinence.16  We will offer patients at two UF 
Health Cancer Center (UFHCC) clinics 3 TUT options (i.e., AHEC, Quitline, or mCBT). Assignment to TUT 
options will be based on patient preferences. Patients who choose AHEC/Quitline will be referred by a 
nurse using Epic. Those choosing mCBT will participate in a 12-week tobacco treatment program via their 
smartphone. Only participants with a smartphone or data plan will be eligible to participate in mCTB; the 
research assistant will confirm verbally at enrollment. Participants in mCBT will use Vidyo, a HIPAA-
compliant video-conferencing platform, on their smartphone to complete the treatment program. 
Participants will meet with a certified tobacco treatment specialist (CTTS) on Vidyo for 30 minutes, once a 
week, for 6 weeks.  The counselor will cover topics that include addiction, withdrawal, dealing with triggers, 
overcoming cravings, and relapse prevention. To verify abstinence, we will collect breath carbon monoxide 
(CO) samples during weeks 1, 6 and 12 of the study and use Vidyo to confirm identity.  To collect this 
sample, participants will blow into a CO monitor (iCOTM Smokelyzer®) that attaches to their smartphone. 


In addition, participants in AHEC/Quitline/mCBTmay provide a saliva swab at the end of the study (week 
12), using a saliva sample kit we provide by mail, to test for cotinine levels. 
 
3. Research Plan 
Study Design: This study uses a mixed methods approach and will inform the design of a pragmatic clinical 
trial to improve the delivery of tobacco use treatment services to cancer patients. 
 
Study Setting: The pilot study will be conducted at the UF Health Medical Oncology, Ear, Nose & Throat 
(ENT), and Radiation Oncology clinics. Smoking is the leading cause of head and neck cancers, and 
almost one-third of patients continue to smoke after their head and neck cancer diagnosis, making this a 
priority population for intervention.  
 
Population: UF Health cancer patients ≥18 yrs old who are current smokers and smartphone users; for 
mCBT, we will also ensure CO breath sample >5 parts per million (ppm). Patients with unstable medical or 
psychiatric illness or use disorder for illicit drugs will be excluded.   
 
Procedures: Patients who are current smokers will be introduced to a research assistant (RA) by someone 
who has a clinical relationship with the patient. Following screening and brief counseling by the provider, 
the RA will offer eligible patients the 3 TUT options (i.e., AHEC, Quitline, or mCBT) and will use the 
“Choose to Quit” flyer to facilitate TUT choice. Three versions of the flyer exist to avoid order bias. Only 
smartphone users will be eligible to enroll in mCBT. If a patient is interested in TUT and the research study, 
the RA will describe the study in detail (based on their TUT selection) and obtain written informed consent.  
If patients are interested in the study but do not want to participate at the moment, the RA will use the back 
of the flyer to obtain the patient’s consent to re-contact. If patients are interested in TUT but not interested 
in the research study, the RA will complete a referral request form to enroll the patient in AHEC/Quitline if 
desired. The RA will give this form to the patient’s clinician or nurse to initiate the referral in EPIC. The RA 
will complete a referral request form for all patients interested in AHEC/Quitline.  
 
Patients who are interested in the study will have the option to choose a paper-based or electronic 
informed consent (eIC) method.  Prior to consenting, the RA will ask for the patient’s preferred method.  If 
the eIC method is selected, paper-based consent forms will be available if partially throughout the eIC 
process a patient changes his/her mind and prefers the paper-based method instead.  Patients will be 
given the opportunity to consider whether or not to participate and to ask questions prior to signing the 
paper-based or eIC form.  A copy of the written informed consent will be provided to patients; Patients who 
choose the eIC method can select to receive a copy via email.   
 
After obtaining informed consent, the RA will administer the Patient Exit Interview (PEI) in REDCap and 
arrange a follow-up phone interview. Patients who choose AHEC/Quitline will be referred by a nurse using 
Epic. Those choosing mCBT will be trained on the use of Vidyo and the iCOTM Smokelyzer® by the RA and 
follow-up will be arranged with a CTTS counselor.  
 
Consent to Re-Contact 
The RA will follow-up with patients via telephone who gave consent to re-contact.  The RA will briefly 
describe the study and the three TUT options, and ask patients if they are interested in participating.  The 
RA will email interested patients a link to the eIC form (based on their TUT selection) and thoroughly 
review the form with the patient. Patients will give consent remotely by signing and submitting the eIC via 
REDCap.  After receiving the signed eIC, the RA will administer the PEI over the telephone and arrange a 
follow-up phone interview. Participants who choose mCBT will receive the iCOTM Smokelyzer® via mail 
with instructions on how to use the CO Monitor and how to download and use the Vidyo app. A 2-week 
supply of nicotine replacement therapy (NRT) will also be provided to participants interested in NRT (see 
next section for NRT details).  
 
mCBT 
Participants in mCBT will meet with a trained certified tobacco treatment counselor on Vidyo for 30 
minutes, once a week, for 6 weeks. The counselor will cover topics that include addiction, withdrawal, 
dealing with triggers, overcoming cravings, and relapse prevention. At enrollment, we will offer mCBT 
participants—if interested—a 2-week supply of nicotine replacement therapy (NRT). The 2-week supply of 


NRT is consistent with what is offered to participants at AHEC and the Quitline. Participants who smoke 
less than 10 cigarettes per day will receive 14 mg of NRT, and those who smoke more than 10 cigarettes 
per day will receive 21 mg of NRT. Medical clearance from the provider will be obtained prior to NRT 
administration. At the end of the study (week 12), participants (all participants in mCBT and a random 
sample of patients referred to AHEC/Quitline) will complete the follow-up telephone interview.  At the end of 
the study, participants (AHEC/Quitline & mCBT) may also provide a saliva sample by mail for us to test 
their cotinine level; this process will be remotely monitored via Vidyo for participants in mCBT and 
participants in AHEC/Quitline will be encouraged to contact study staff to answer any questions they may 
have. 
 
Evaluation Procedures:  
 
i. 
Patient Exit Interviews (PEIs): To assess provider adherence to TUT guidelines, the RAs will conduct 
PEIs after recruitment with all smokers at checkout (regardless of TUT choice). The RA will use an 
iPAD to administer the PEI in REDCap. The PEI is a brief patient-reported assessment of provider 
delivery of counseling.17 A PEI index score (0-10) is the sum of intervention steps each patient reports 
that the provider implemented. All socio-demographics (e.g., age, gender, race/ethnicity, rural/urban 
residence) will be obtained at intake using questions from the PhenX toolkit;18 We will also examine 
reasons for TUT selection and measure self-reported past-7-day point prevalence of cigarette 
smoking, number of cigarettes/day, cigarette type, age of onset19 and cancer diagnosis experiences. 
 
ii. 
Telephone Survey: Patients who participate in mCBT (n=50), and a random sample of patients 
referred to AHEC/Quitline (n=25/each), will complete a telephone survey at week 12 that includes: (1) 
Treatment Acceptability Questionnaire (TAQ), 16-items/7-point Likert scales assessing treatment 
acceptability (i.e., helpfulness in reducing smoking, and thoughts and feelings related to the 
treatment).  Questions will relate to barriers/facilitators of TUT, and open-ended questions assessing 
suggestions for improvement. (2) Quality of Life: 26-item cross-culturally valid WHO Quality of Life-
BREF,20 and (3) prolonged abstinence (i.e., sustained abstinence after an initial period in which 
smoking is not counted as a failure) and past-7-day point prevalence of cigarette smoking.19 A $20 
incentive will be offered at completion.  
 
iii. 
CO Monitor (mCBT only): Abstinence point prevalence will be defined as CO sample ≤4 ppm and 
reporting not smoking in the last 7 days.  Abstinence will be assessed at weeks 1, 6 & 12. Missing 
data will be counted as positive for smoking.16 We will also use CO to test for reduction in smoking 
over the 3 time points. 
 
iv. 
Cotinine level measurement (AHEC, Quitline, & mCBT participants): At week 12, participants may be 
asked to provide a saliva swab using a saliva sample kit we provide . Participants will mail the swab 
in a prepaid envelope to the lab directly. The lab will send the test results to the study team at UF. We 
will use the test result to measure participants’ cotinine levels. 
 
Analysis Plan: All data collected will be entered in a REDCap database. The primary analysis will be the 
estimation of rates/means, with 95% CIs. To demonstrate the feasibility of the 3 implementation strategies, 
we will measure reach as the number of smokers visiting the 2 clinics who are referred to any TUT (i.e., 
AHEC/Quitline/mCBT) divided by the total number of smokers visiting the clinics. For each TUT, we will 
calculate enrollment as the total number of smokers who enroll in a given treatment divided by the total 
number of referred smokers; we will compare the rates of patients selecting into each of the 3 TUT 
programs. We will assess TUT completion as the number of enrolled smokers who complete the program. 
We will also evaluate acceptability using TAQ. As secondary outcomes, we will measure prolonged 
abstinence at week 12 and the change (baseline to week 12) in past-7-day point prevalence (all programs), 
as well as CO-verified abstinence at weeks 6 &12 (mCBT only). CO levels will also be modeled across time 
(weeks 1, 6, 12) to assess for reductions over time via linear mixed models. 
 
Sample Size Justification: Sample sizes were chosen to obtain sufficiently precise estimates of outcomes 
to demonstrate feasibility and to provide estimates to power a future R01.21 Assignment to TUT options will 
be based on patient preferences. Recruitment will end at week-30 post-trial initiation or sooner if 50 
smokers enroll in mCBT. We estimate 14 smokers/week visit the 2 clinics (source: i2b2); thus, we are 
confident that, using the opt-out approach to TUT referral,13 an average of 2 patients/week will choose 


mCBT and ≥2 patients/week will choose AHEC/Quitline. For reach, 14 smokers/week x 25 weeks=350 
leads to a 95%CI whose largest width=0.10 if the observed rate=0.50; any other rate would lead to more 
precision. If only ½ of 350 enroll in TUT, in obtaining rates of patient choices for the 3 TUT options, our 
maximum 95%CI width=0.15. Specific to the outcomes among the 50 in mCBT, our maximum 95%CI width 
for rates on completion/abstinence=0.28. We do not suspect abstinence rates to be as high as 0.50, in 
which case we will have more precision (95%CI =0.09, 0.31) when the rate=0.20. We expect 175 to enroll 
in any TUT by study end (when 50 enroll in mCBT).  We will thus have 125 in the other 2 groups 
(AHEC/Quitline). We will randomly sample 25 from each of these 2 groups for follow-up. The 
corresponding 95%CI for a 0.20 abstinence rate for n=25 would be (0.04, 0.36). In assessing acceptability 
using TAQ, a similar study observed a SD=13.4.22 Based on this estimate, n=40 (20% dropout) in mCBT 
would lead to a 95%CI width=8.6, and n=20 in the other 2 groups would lead to a 95%CI width=12.6. 
 
4. Possible Discomforts and Risks 
 
The risks or discomforts to participating in this study are minimal. The loss of confidentiality is the greatest 
potential risk to participants.  We will take appropriate steps to protect participant confidentiality, and any 
information we collect from participants, including any identifying information, will be kept in REDCap, a 
secure, password-protected database. We will de-identify all data prior to moving it outside the REDCap 
environment. The de-identified data will be kept on a secure, password-protected server. These data will 
be associated with a unique identification number that we give participants at the beginning of the study. All 
identifying information in REDCap, including the link that matches participants with their unique 
identification number, will be destroyed at the end of the study.  
 
5. Possible Benefits 
 
Patients who participate in this program will have the benefits of improved access to tobacco treatment 
services. Some patients may individually experience no benefit. The information provided by this study will 
assist in the development of a larger study aimed at increasing tobacco treatment services for cancer 
patients across the UF Health system.  
 
6. Conflict of Interest 
 
None. 
 


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