Clinical trial NCT03611881
Conditions: Smoking, Tobacco
Keywords: lung screening
Sponsor: Massachusetts General Hospital
Start date: 2019-04-01; Completion date: 2024-01-31
Enrollment: 642 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This randomized controlled trial seeks to evaluate the effectiveness of alternative strategies to integrate smoking cessation interventions into the delivery of low-dose CT (LDCT) lung cancer screening. Using a factorial design, current smokers who enroll will be randomly assigned to receive these interventions: (1) smoking cessation counseling support by telephone or videoconferencing (short duration vs. long duration); (2) nicotine patch treatment (NRT) (short vs.long duration); (3) counselor-facilitated referral (vs. no referral) to an online resource to connect smokers to a community-based social service resources.

Detailed description:
Evidence-based tobacco dependence treatment consists of behavioral counseling and pharmacotherapy. Nicotine patch is an FDA-approved cessation aid. The optimal duration of counseling and pharmacotherapy for patients undergoing low-dose CT (LDCT) lung screening is not clear. In addition, helping smokers to address other social and psychological barriers might help them succeed in quitting smoking. This randomized controlled trial will test, in a factorial design, two options for delivering each of 3 interventions to help current smokers stop smoking in the context of having routine CT lung cancer screening. Patients will receive 4 or 8 weeks of behavioral counseling (with their choice of video conferencing or regular telephone calls), 2 or 8 weeks of nicotine patch, and will receive referral (vs. no referral) to an online resource to connect smokers to community-based social service resources. Outcome measures for smoking cessation will be assessed by a survey administered by phone at 3,and 6 months.

Arms: arm 1: 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. arm 2: 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. arm 3: 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. arm 4: 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. arm 5: 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. arm 6: 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. arm 7: 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. arm 8: 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Interventions: intervention 1: Counseling intervention 2: Nicotine patch intervention 3: Community Resource
Intervention descriptions: intervention 1: 4 or 8 weeks of behavioral counseling support to promote smoking cessation. intervention 2: 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg. intervention 3: Counselor-facilitated referral to a community-based program to address social needs.

Protocol documents:
Prot_SAP_000.pdf: 
 
1 
 
 
 
 
 
Assessing the Integration of Tobacco Cessation Treatment 
Into Lung Cancer Screening (LCS)    
 
NCT03611881 
ID: 2018P000539/PHS 
 
Study Protocol and Statistical Analysis 
Version date: 1/30/2024 
 
 


 
2 
 
 
Partners Human Research Committee 
Detailed Protocol 
 
TITLE: Integrating Tobacco Treatment into Lung Screening at PHS. 
PI: Elyse R. Park, PhD, MPH 
 
GRANT NUMBER: 1R01CA218123 - 01A1 
VERSION DATE:   1/30/2024 
I. BACKGROUND AND SIGNIFICANCE (including progress report and preliminary 
studies).  
Public health burden of lung cancer. Lung cancer is the leading cause of cancer death in the 
U.S., accounting for 27% of cancer deaths.1, 2 The prognosis for patients with lung cancer is 
generally poor, largely because only 15% are diagnosed at an early stage.3,4 Racial and ethnic 
minorities and low socioeconomic status (SES) individuals have higher rates of lung cancer 
incidence, late-stage diagnosis, and higher mortality.1 
Smoking and lung cancer. Cigarette smoking is responsible for 87% of lung cancer deaths3,5,6 
and is the leading cause of preventable death in the U.S.7,8 Tobacco use is higher in individuals 
with less education and lower incomes, contributing to disparities in overall mortality in low SES 
individuals.9-13 Lung cancer screening (LCS) has the potential to improve the earlier detection of 
malignancies. LCS and tobacco treatment must be made equally accessible for all patients to 
benefit, thus narrowing, not contributing to, the disparities gap.  
Screening reduces lung cancer mortality. In 2011 the National Lung Screening Trial (NLST) 
demonstrated a 20% reduction in lung cancer mortality among current and former smokers 
(aged 55-74, 30+ pack-years of smoking) who were randomly assigned to 3 annual lung cancer 
screenings with low-dose computed tomography (LDCT) vs. those assigned to 3 annual chest 
X-rays.14 The U.S. Preventive Services Task Force (USPSTF) recommends annual LDCT 
screening for high-risk individuals.15 By NLST criteria, an estimated 8.6 million Americans are 
eligible for LCS;16 LCS could save 18,000 lives annually.16 
LCS provides a critical opportunity to promote cessation. Tobacco cessation services are 
strongly recommended as an adjunct to LCS.17 Payers, including Medicare, cover LDCT for 
high-risk individuals. Medicare requires a shared decision making visit and documentation of 
cessation counseling. Radiology imaging facilities must make cessation assistance available 
and submit LDCT data to a Medicare-approved registry. Smoking cessation during LCS could 
help reduce disparities in access to treatment; not promoting cessation might send a message 
that screening obviates the need to quit.18 Even if screening identifies a malignancy, quitting 
smoking could improve survival6, 19, 20 and decrease treatment complications.21-30 
Evidence-based tobacco cessation treatments exist. Clinical guidelines5, 31 state that 
combining counseling and pharmacotherapy (e.g., nicotine replacement therapy (NRT)) is more 
effective than either alone.5, 31 The challenge is delivering treatments to smokers; 70% want to 


 
3 
 
quit,32 but <30% use available treatments.5,32-34 State-based quitlines are the most accessible 
cessation resource. Quitlines offer free proactive behavioral support to smokers; 76% also send 
free NRT to eligible callers.35 However, quitlines have limitations for smokers undergoing LCS 
because they 1) offer few resources for smokers not ready to quit, 2) provide only short-term 
counseling (e.g., < 5 sessions and only short-term (<4 weeks) NRT, and 3) do not tailor 
counseling to the salient issues of smokers undergoing LCS, as identified in our preliminary 
work. 
Smokers undergoing LCS need tobacco treatment personalized to their quit readiness 
and risk perceptions.  Many smokers undergoing LCS are not ready to make a quit attempt. 
The mean readiness to quit in NLST was 5.1 (1-10),36 only half of smokers tried to quit in the 
year after their initial screen,37 and only 20% were ready to quit within 30 days.38 In Project 
Reach, the mean readiness to quit was similar (5.5). Quit rates in NLST39,40 and other LCS 
studies40-43 were not significantly higher than in the general population, but the effect on risk 
perception was complex.39,44,45 Data are mixed as to whether negative screens provide false 
reassurance and reduce motivation to quit.18, 46Smokers in Dr. Park’s NLST sub-study perceived 
a benefit from quitting but were not confident in their ability to quit,47 avoided thinking about 
risks, and used unhelpful avoidance strategies.45  A smoking intervention in the context of LCS 
should address risk perceptions by (a) assuring that patients understand results and 
recommended follow-up, (b) helping correct erroneous beliefs about test results and lung cancer 
risk, and (c) helping patients process test result information in a motivating way. We propose to 
test tobacco treatment which personalizes counseling based on motivation to quit and perceived 
risk.  
Smokers undergoing LCS are heavy smokers who likely need more intensive support. 
Initiating smoking early in life, heavy smoking, and having strong nicotine dependence are 
factors associated with less success in quitting, and these are common characteristics of 
smokers eligible for LCS. Over 40% of smokers undergoing LCS are heavy smokers 
(>20/day).36 In our Project Reach, patients were older heavy smokers (mean age = 62, 41% 
smoking >1ppd) who had been smoking for an average of 46 years. Older smokers need more 
intensive interventions, but it is not clear what types of interventions would be most appealing 
and motivating for them.48 Long-term heavy smokers also have social barriers to quitting (e.g., 
food insecurity) that may not be otherwise addressed.49 Our work with low income older 
smokers suggests that addressing social barriers is key; use of systematic referral, a community 
resource and referral database, was significantly associated with quitting.50  Reflecting the 
chronic nature of tobacco dependence, a chronic disease management strategy that sustains 
treatment over time is more effective than standard treatment51 and may be appropriate for 
smokers having LCS. We will test 3 intervention components—counseling length, medication 
duration, and systematic screening and referral to community-based services to address social 
barriers. All treatment will be 1) proactively offered, 2) delivered with MI, 3) personalized to quit 
motivation and risk perceptions, and 4) coordinated by a central care service.   
Challenges to offering cessation services at LCS sites. Integrating cessation services into 
LCS screening sites (typically high volume practices that lack cessation resources) is a 
challenge. Most LCS sites report screening patients’ smoking status (99%) and advising to quit 
(91%), but fewer provide cessation counseling or referral (60%); only one-third recommend 
medications.52 Following LCS, primary care clinicians do not often provide any cessation 
support.53 The deployment of health information technology (IT) platforms can promote 
outreach and access at different points in the LCS process, using technologies like patient 
portals, informational videos, and video-conferencing. In our Project Reach evaluation, patients 


 
4 
 
expressed the need for time and repeated offers to engage in a cessation program. Given these 
barriers, it is imperative to offer cessation treatment at multiple points of LCS delivery. We 
propose that the LCS process provide 3 systems-based patient-engagement opportunities that 
1) integrate into the screening process, 2) include primary care and radiology, and 3) use a 
population health management perspective. 
 II. SPECIFIC AIMS (Research Objectives)  
Aim 1: To develop a centralized smoking cessation treatment (care coordination and 
intervention components) at 10 MGB LDCT-LCS screening sites.  
Aim 2: To test the effectiveness of the intervention for smoking cessation in a randomized 
controlled trial using a factorial design to assess 3 intervention components:  
(a) Duration of counseling contact (repeated proactive sessions delivered by a trained 
tobacco treatment specialist using phone or videoconferencing telehealth platform);  
(b) Duration of NRT, and  
(c) Referral to community-based resources to address social barriers.  
Aim 3: To evaluate the reach, adoption, implementation, and maintenance of the intervention. 
The components of the LCS-tailored intervention are informed by our preliminary studies and 
conceptual frameworks. 
III. SUBJECT SELECTION  
Patients: Inclusion and exclusion criteria. Patients who are scheduled to undergo LDCT-LCS 
at a participating PHS LCS site, speak English or Spanish, and are current smokers are eligible. 
Current smokers will be defined as those who have smoked a cigarette, even a puff, in the last 
30 days. Smokers will fulfill the Medicare coverage requirement (age 50-80 years, 20+ 
pack/years). Smokers do not have to be ready to quit smoking. We will exclude patients who 
are: (1) undergoing lung CT as part of a diagnostic or abnormal follow-up evaluation, (2) unable 
to give informed consent due to psychiatric or cognitive impairment as determined in 
consultation with study PI or treating clinician, (3) who do not have access to a telephone or 
cannot communicate by telephone, or (4) do not reside within the United States of America. 
IV. SUBJECT ENROLLMENT  
Recruitment. The study RA will recruit patients on the telephone at 3 points in the process of 
LDCT-LCS delivery: (1) after the test has been scheduled, (2) after the patient has completed 
their LCS, and (3) after the result has been communicated to the patient. At each point, a short 
video recruitment message (see Video Recruitment Message Overview document), explaining 
the purpose of the study will be disseminated to patients. 
Recruitment Point 1: LDCT Scheduled. All orders for LDCT-LCS are made through the EHR, 
which requires clinicians to identify smoking status (current vs. former, packs per day, and years 
smoked) to complete the order. The study team will obtain a regular download from the EHR of 
newly scheduled LDCTs, along with the patient’s smoking status. Study staff will proactively 
contact all smokers after the LDCT is scheduled. First, patients will be mailed an opt-out letter 
within a study packet, which includes a study pamphlet and a detailed information sheet about 


 
5 
 
the study. The opt-out letter will include a link to a short video recruitment message, embedded 
in a REDCap survey and hosted on the Partners approved video platform. Patients will be 
contacted by a research assistant (RA) within approximately two business days after the study 
recruitment materials have been disseminated to reinforce attendance at the LDCT-LCS 
appointment and describe the study. Interested patients will be screened for eligibility, read a 
standard script to elicit verbal informed consent, and the RA will administer a baseline survey if 
verbal consent is obtained. The survey may be completed verbally, digitally through a REDCap 
link, or if patients require a hard copy of the survey, they may be sent it in the mail. Patients who 
wish for more time to consider about participating the study will be asked for permission to re-
contact them at the time of the LDCT test. If they decline, the study team will not approach them 
at later recruitment points.  
Recruitment Point 2 Pre-COVID: LDCT Exam. In March 2020 due to the COVID pandemic we 
stopped all ipad use in the clinics. RP2 procedures from April 2019-March 2020 are described 
below: All patients who arrive for LDCT screening will be given an iPad from front desk staff to 
facilitate study enrollment. The iPad will have a live data feed from the study’s database, 
allowing it to determine if the patient is already in the study or has refused further contact. If the 
patient had already enrolled in the study at Point 1, the iPad will play a short video message 
reinforcing the importance of continuing with the program and study. If patients have consented 
to the study but have not completed the baseline survey, the iPad will play a short video 
message reminding them to complete the survey and offer them the opportunity to have the 
survey resent to them. If the patient had not enrolled at Point 1 and had permitted further 
contact, the iPad will present questions in the form of a REDCap survey to identify patient 
eligibility for the study. Eligible patients will then receive a short video recruiting them to the 
study, and will inform them that they will be contacted soon after the screening test by an RA 
who will explain the study and offer participation. After leaving the LDCT facility, eligible patients 
will be contacted by the RA who will use the same workflow as described at Point 1 (i.e., screen, 
consent, administer baseline survey). If the patient is ineligible for the study, the iPad will play a 
short video encouraging smoking cessation. If patients arriving for the LDCT test had refused 
further contact at Point 1, they will receive brief advice to quit, representing usual care, via the 
iPad but no contact about the study.   
We will develop a live data feed on a secure Partners server to be used for patient tracking, real 
time randomization, and all data entry. Password protected iPads will communicate over the 
secure wireless network with the SQL database. 
We will be providing $5 coffee cards to staff at the study sites for their assistance with the study. 
Recruitment Point 2 Post COVID: LDCT Exam After leaving the LDCT facility, eligible 
patients will be contacted by the RA who will use the same workflow as described at 
Point 1 (i.e., screen, consent, administer baseline survey 
 
Recruitment Point 3. LDCT Result. After the patient has received the result, patients who have 
not previously enrolled or refused further contacts will be sent a short video recruitment 
message tailored to the result via a secure, encrypted email including a secure REDCap survey 
link, or a letter with a URL to a secure REDCap survey. It will invite them to join the study, and 


 
6 
 
give brief cessation advice from Dr. Rigotti or Haas. Patients will then be contacted by the RA 
who will use the same workflow as described for Point 1 (i.e., screen, consent, administer 
baseline survey). Patients who enrolled at an earlier point will receive a short video embedded 
in a secure REDCap survey tailored to their test result to address why quitting and study 
participation remain important.  
Hispanic/Latino patients that do not enroll will have MRNs shared with study investigators to be 
approach for protocol # 2019P002549. 
Patients may also be contacted for research purposes from the team in the future. 
Recruitment Summary: Our recruitment strategy is designed to require little additional effort at 
busy radiology sites, but make systematic and repeated recruitment offers to enable us to 
achieve maximal reach.5,50,54,55,56,59 To provide data for our implementation evaluation (Aim 3), 
we will record the numbers and characteristics of patients who are identified, eligible, and 
enrolled at each time point. We will document reasons for ineligibility and refusal and document 
EHR-recorded sociodemographic and biological characteristics, medical history, and cancer 
history of refusers.  
Randomization.Patients will be randomized at the time of enrollment (i.e., completed consent 
and baseline survey), stratified into 9 randomization strata (3 groups of LCS study sites and 3 
recruitment points), to a LCS-tailored intervention treatment arm. The intervention arms will 
consist of 8 groups of equal proportions, based on a 3-factor fully crossed factorial design to 
efficiently test components that vary on counseling duration, NRT duration, and provision of 
systematic referral.   
 
V. STUDY PROCEDURES  
Data management. A centralized SQL database will be used for patient identification and 
recruitment, randomization, patient tracking, and data input. It will interface with all data 
collection efforts (RAs will enter in REDCap).   
Intervention arm components 
We will develop 8 versions of the multi-component intervention that differ in 3 critical treatment 
factors: duration of counseling contact (4 vs. 8 sessions), duration of free NRT (2 vs. 8 weeks), 
and offer of systemic referral to community based resources.50   
(1) Counseling. Previous interventions conducted by the PIs are the basis for the personalized, 
algorithm-driven protocol for the short intervention; the longer intervention will be modified from 
Project CLIQ50 and Dr. Park’s tobacco treatment trial with cancer patients.61 Patients 
randomized to the short and long duration counseling conditions will be offered 4 sessions. 
Those assigned to the long duration counseling will also be offered 4 additional sessions.  
Tobacco Counseling Content.  As in Project CLIQ and Reach, counseling sessions will be 
protocolized according to the 5As format for smoking cessation.5 Counseling will incorporate 
patients’ risk perceptions before and after the LCS results. The risk counseling content63 
emphasizes understanding the personal implications of risk beliefs and aims to reduce cognitive 


 
7 
 
biases (protective benefits of a negative screen). The counseling protocol elicits 1) contrasts 
between personal and comparative risk, 2) reasons underlying perceived risk, and 3) beliefs 
about the connections between risk, smoking, and lung cancer. Counselors will: 1) assess 
preferences for health information/numeracy; 2) explore the personal meaning of risk; 3) 
personalize negative and positive risk frames (need to quit, benefits of doing so); 4) emphasize 
personal magnitude of risk reduction; and 5) acknowledge ambivalence. The TTS will use 
Motivational Interviewing (MI) an empathic and supportive treatment style,64 that can deliver 
personalized risk counseling, enhance motivation for behavior change, and is effective for 
patients not ready to quit65 and medically and socio-economically vulnerable smokers MI is well 
suited for LCS patients because: 1) MI focuses on building self-confidence and resolving 
ambivalence; 2) MI tools (i.e., open-ended questions, affirmations, reflections, and summarizing 
statements) are effective when addressing sensitive topics; and 3) MI’s strategy is effective 
when communicating about risk.64 Undergoing LCS might increase or decrease smokers’ risk 
perceptions, motivation to quit, and cessation efforts.18,41, 44, 67, 68 
Counseling delivery. Patients will be given a choice of phone-based or videoconferencing-based 
virtual visits; we will track patient choices. Telephone-based counseling is effective with other 
medical populations69, 70 and has been successfully used by Drs. Park, Haas and Rigotti. 
Technology use among seniors has rapidly increased over the past 5 years; smartphone use 
has quadrupled. 70 A videoconferencing option is innovative and feasible; over 67% of adults 65 
years and older use the internet, almost half own a smartphone, and more than half have high-
speed broadband at home.72 A patient account will be created and RAs will assist patients in 
videoconferencing setup. 
(2) Nicotine Replacement Therapy (NRT) duration. The tobacco cessation counselor will 
promote medication use, describe all FDA-approved options, offer free NRT patches to smokers 
with no contraindication, and assist smokers who choose other medications to obtain 
prescriptions from their clinicians in the Partners System. Although use of medication will be 
promoted, it is not required for study participation. NRT dose will be determined by daily 
cigarette use: 21 mg/d patch for >10 cig/day,14 mg/d patch <10 cig/day. Patients in the short 
duration arm will receive one 2-week kit. Patients in the long duration arm will receive one 4-
week kit and are eligible for one additional 4-week refill, using a tapering dose schedule, for a 
total NRT duration of 8 weeks. The tobacco cessation counselor, in consultation with Drs. 
Rigotti or Haas, will adjust the NRT dose to control withdrawal symptoms and minimize adverse 
effects. NRT will be mailed at no cost to patients. NRT has been safely distributed through 
quitlines in this way, and this approach was used safely in our recent work.50 The tobacco 
cessation counselor will use a protocol to screen for NRT eligibility and discuss any eligibility 
questions or adverse effects with Drs. Haas or Rigotti. NRT kits will include instruction and 
patient information sheets in English or Spanish written for a 6th grade reading level. NRT can 
be initiated at any point during the 8 weeks of the trial and can start before a quit date, a newer 
treatment strategy that is associated with improved outcomes.62 Use of NRT will be supported 
during each tobacco cessation counseling call.  
(3) Systematic screening for social barriers to care. If randomly assigned to receive this 
resource, the tobacco cessation counselor will encourage patients to address social barriers to 
cessation by receiving a personalized referral from a web-based tool named Aunt Bertha 
(https://www.auntbertha.com/) to systematically screen and provide local free or low cost 
referrals for social barriers to care. This approach was used successfully in CLIQ and was found 
to be significantly associated with cessation.50 A branching logic questionnaire to evaluate social 
needs, suggests services near their residence or other desired location that may help them, and 


 
8 
 
then selects the referrals that meet their needs. Once services are selected, the tobacco 
cessation counselor can mail/encrypted email/text the selected referrals to patients. 
Research staff will use a Partners approved text messaging service to contact patients whom 
have consented to be sent study text messages. 
 
Treatment fidelity  
Treatment fidelity will be monitored using recommendations by the Treatment Fidelity 
Workgroup of the NIH Behavior Change Consortium (BCC). The BCC cites monitoring 5 areas 
to promote reliability of behavioral interventions: Design (review tobacco counseling 
documentation weekly), Training (ongoing: a randomly selected 15% of session recordings will 
be reviewed by Dr. Park for MI and protocol adherence), Treatment Delivery (recordings and 
documentation of session content), Receipt of Treatment (session review of topics covered) and 
Enactment of Treatment skills/knowledge (patients set treatment goals and progress).  
Assessments 
Baseline: At enrollment, data will be collected from the patient either on the phone by the RA or 
on an iPad via REDCap, as described above. Additional baseline information will be obtained 
from the EHR (see assessment plan below for specific data collected). Patients will be offered a 
$20 incentive to complete the survey. 
Outcome assessments: Patient-reported outcomes will be assessed at 3 and 6 months post-
enrollment by telephone, email or mail and recorded in REDCap. Individuals will be offered a 
$20 incentive to complete each outcome assessment. To minimize patient burden, the survey 
will be piloted and kept to approximately 10-15 minutes. Other outcome measures will be 
obtained from the EHR. Prior to a patient’s 6 month survey, we will be sending out promotional 
items such as notepads, reusable bags, stress balls, and hand sanitizer. 
Additional questions will be added to the 6-month survey to assess participants’ knowledge about 
electronic cigarettes, the addictiveness of electronic cigarettes in comparison to combustible cigarettes 
and other nicotine replacement products, their perception of the risk and benefits of electronic 
cigarettes, their interest in trying electronic cigarettes and their financial and employment status. 
Participants will also be asked about their willingness to be contacted for future research about 
switching from cigarettes to electronic cigarettes. These questions will be administered to those 
participants who haven’t completed their 6-month survey yet . Participants will be offered a $30 
incentive in addition to the current $20 incentive to complete the survey with the additional questions. 
The additional $30 in compensation will be given to those who qualify (i.e. those who are still smoking) 
and complete the additional questions. 
Participants will be compensated an additional $30 for completing the additional questions due to the 
increased effort and time it will take to answer the questions. The survey will take nearly double the 
time, so we found it fair to increase the remuneration to reflect the additional time and effort. A future 
amendment will be submitted to reach back out to those who have already completed their 6-month 


 
9 
 
survey to also give them the opportunity to complete a survey with the additional questions and earn an 
additional $30. 
All participants in the Screen ASSIST smoking cessation trial who reported having smoked a 
cigarette in the past 7 days  at the trial’s final 6-month follow-up assessment will be sent a letter 
informing them of the opportunity to participate in an additional survey. The opt-out letter will 
inform them that a study team member will be calling them with an invitation to complete an 
additional survey about e-cigarettes. The opt-out letter will also provide participants with the 
opportunity to call or email a study team member if they are not interested in participating.  A 
study team member will reach out to participants a week after the opt-out letter has been sent to 
ask about their willingness to complete the survey.    
Participants who already completed the additional questions during their 6-month survey will not 
be sent the opt-out letter 
The additional survey will assess participants’ knowledge about electronic cigarettes, perception 
of electronic cigarette benefits and risks, willingness to use electronic cigarettes as a substitute 
for combustible cigarettes and will ask about their willingness to be contacted for future research 
about switching from cigarettes to electronic cigarettes. 
Participants who agree to complete the survey will be provided with the options to complete the 
survey over the phone with a study team member or to have the survey emailed or texted out to 
them after a study team member has received their consent.  Participants who are eligible for 
and complete the additional survey will receive a $30 gift card.  
We will aim to have 400 participants complete this survey. 
Verification of smoking cessation: Due to COVID-19 and after discussion with the NCI Project 
officer, we will no longer be sending biochemical verification to patients. Patients who self-report 
7-day abstinence at 3 and 6 months follow up will be considered non-smokers. Those who are 
enrolled prior to his change will continue to be sent biochemical verification and offered a $20 
incentive for each sample. 
Biochemical verification of smoking cessation: Patients who self-report 7-day abstinence at 3 
and 6 months follow-up will be asked to provide a saliva sample to assay for cotinine. 
Individuals will be offered a $20 incentive for each sample.  
Biochemical verification process: (This process ceased in March of 2020 due to the COVID 
pandemic)The study RA will send to patients who report 7-day cigarette abstinence at 3 and 6 
months follow-up a saliva cotinine collection kit and pre-paid packaging for return to the J2 
laboratory (J2 Laboratories is a premier forensic drug and alcohol testing and clinical diagnostic 
laboratory located in Tuscon, AZ that has successfully partnered with the study team for 
previous saliva cotinine testing). The saliva sample will be tested for cotinine, which is a 
chemical the body makes from nicotine. The test will determine the study participant’s exposure 
to cigarette smoke and nothing else. The cotinine and expired CO samples collected for the 
purposes of this study will not be stored for future uses not described in the protocol. Saliva 
samples will be destroyed after they are assayed for cotinine. After each results transfer, 
participants’ data will be purged from the test company’s files. The saliva cotinine collection kit 
will be marked only with the patient’s unique study identification code, and will include: 1) 
instructions for successfully completing a sample; 2) an information sheet detailing the time and 


 
10 
 
date of the collection, 3) a brief survey reporting recent patient smoking history. The pre-paid 
packaging will include a FedEx package and pre-paid airbill for the subject to return their saliva 
sample directly to the lab. The lab will provide MGH directly with pre-paid airbills to be provided 
to participants. The return address on the airbill includes only the location of the research offices 
at MGH; no identifiable patient data will be provided to the lab. The J2 lab will send MGH a 
notice immediately upon receipt of a sample, and again upon testing with the results of the 
sample. Notices from the lab will be shared with MGH via email or a secure fax machine, and all 
attachments (invoices, testing results) include no identifiable information and are password 
protected.  
Patients who return a sample that is designated insufficient for testing by the lab will be offered 
the opportunity to complete additional samples. Patients who report use of NRT or e-cigarettes 
within the last week will be offered the opportunity to instead complete an expired air CO 
sample. The study RA will be trained in safe and proper use of the CO monitor and test results 
interpretation. As CO samples must be completed in-person, and with the aim of decreasing 
patient burden, samples will be completed at an existing clinic visit in accordance with patient 
preferences. We have successfully used these methods in previous work, with excellent return 
results (88%).58,60, 61  
 
. 
Exit interviews: A sample of 72 patients (approximately 10% of anticipated 6-month survey 
completers) will be asked to participate in an in-depth individual interview, with one of the study 
staff, after completing the final survey. Sampling selection will be stratified by intervention group 
(approximately 9 per group). A semi-structured interview guide will be developed for telephone 
interviews. All patients will be asked about 1) smoking and quitting behaviors, 2) the enrollment 
process (e.g., timing, video recruitment messages, iPad use), 3) coordination with the LCS 
process, 4) understanding of their test results, and 5) adherence to LCS recommendation. 
Patients will be also asked for feedback on the intervention components (counseling content 
and duration, medication dose and access, and the community resources referral process) and 
about their overall satisfaction with the tobacco cessation counseling received. The sample size 
was determined to allow for 9 patients in each strata; analyses will compare results by strata. 
Interviews will last about 60 minutes, and patients will be provided $20 remuneration. 
Interviews will be audio-recorded, transcribed and analyzed. To ensure coding reliability, 
discrepancies will be resolved through discussion and comparison to raw data. Coding will 
continue until a high level of reliability (Kappa = >0.80) is established. Utilizing the mixed 
methods convergent design approach), qualitative data will be compared and contrasted to 
baseline and follow-up survey data.  
Organizational Readiness. Site characteristics and site readiness will be measured at each 
study site. Employees will undergo local training and then each attending employee will answer 
the readiness items, identified by the SCALE collaboration. Data will be collected anonymously, 
and employees will be consented through a waiver of documented informed consent. 
Responses to these items will be collected at baseline and at the end of the intervention phase 
of the study. 
Research staff may also use a Partners approved text messaging service to contact patients 
who have agreed to be sent text messages during the consent process. This will be used to 
maximize outcomes from study videos, follow up surveys, and study reminders. 


 
11 
 
The Area Deprivation Index (ADI) is a measure for social economical status. We plan on using 
ADI to control for social and economical factors that are not otherwise reported. We plan on 
using census.gov to import a csv file of participant addresses which will return the 2020 census 
block group for those addresses. Names and study details will not be included in the process.   
By knowing the census block group of an address, we can then link that address to the 2020 
ADI score.  
 
VI. BIOSTATISTICAL ANALYSIS  
Assessment Plan 
Outcomes 
Primary smoking outcome: 7-day point-prevalence tobacco abstinence at 6-month follow-up.  
Secondary smoking outcomes (1) self-reported 7-day abstinence at 3-,and 6- months follow-
up; (2) significant reduction (>50% decrease from baseline in cigarettes/day81); and (3) >24-hour 
intentional quit attempt at 3-,and 6-months follow-up. 
Measures 
Moderators 
Sociodemographic and biological characteristics [baseline only]. EHR: Sex, age, primary 
insurance, language preference for sessions and study materials. Survey: Race/ethnicity, 
education level, employment, and religiosity. Medical history [baseline and follow-up]. EHR: 
Comorbid tobacco-related disease, ambulatory visits, alcohol consumption. Screening result. 
EHR: Lung RADS score, results of any diagnostic tests (CT or biopsy). Smoking characteristics 
[baseline and follow-up]. Survey: Current cigarettes/day, number of years smoked, e-cigarette 
use, past and current use of cessation medication and other tobacco products, 24-hour 
intentional quit attempt, nicotine dependence (2-item Heaviness of Smoking Index from the 
Fagerström Test for Nicotine Dependence [FTND] which have predictive validity with the overall 
FTND82, 83).  
Proximal Outcomes/Mediators 
All proximal outcomes/mediators will be assessed via survey at baseline and follow-up. 
Smoking beliefs.  Readiness to quit (1 item 10-point ‘contemplation ladder 84,85), importance and 
confidence to quit (1 item 10-point scales), 4 item perceived lung cancer risk, and 2 item 
perceived benefits of quitting.47,57 Health and screening beliefs. Self-reported overall health 
status (1 item from the SF-36 survey86), 2 item perceived benefits of screening.47,57 Emotional 
symptoms. Anxiety and depression symptoms (PROMIS Anxiety and Depression 4a short-
forms), worry about lung cancer (1 item about level87, 88). Environmental factors. Living with a 
smoker in the household, 1 item 4-point scale about rules about smoking in the household89, 
environmental workplace/hobby exposure and social support (PROMIS emotional and 
informational 4a short forms).88  
Analysis plan 


 
12 
 
All analyses will be intent-to-treat; we will classify patients who are lost to follow-up and those 
who do not provide a sample as current smokers.92 We will explore whether the mechanism of 
missing data is missing at random by comparing patient characteristics between those who 
complete follow-up vs. those who do not. We will perform sensitivity analysis: 1) limited to those 
who have complete data, and 2) multiple imputation for missing data.93 
Factorial design 
In a factorial research design, two or more independent variables are concurrently examined 
within the same trial.94, 95 The three proposed factors will be crossed with one another to create 
a total of eight experimental conditions. An equal number of subjects will be randomly assigned 
to each condition, using a random number generator. This is not an 8-arm randomized 
controlled trial, but instead allows for an efficient examination of main effects for each variable 
over the entire sample of 640 subjects. This approach allows examination of three key treatment 
development questions in a much more time-efficient and economical manner by 
simultaneously performing three studies within the single trial. This achieves power to detect 
between-group differences that is equivalent to performing three separate randomized trials.94  
Outcomes/analysis 
Outcome measures will be assessed at baseline, 3-, and 6-months follow-up. At the outset, we 
will examine the frequency distributions of all variables. Data from all PHS sites will be pooled 
for analysis, after confirming there is no significant heterogeneity among sites or adjusting as 
needed. We will compare the baseline characteristics to assess whether randomization 
distributed covariates evenly. We will determine whether there is differential dropout in the 
groups and consider developing probability-of-completion weights to obtain unbiased estimates 
of treatment effect. The primary analysis will assess the effects of each intervention component 
in terms of its association with the primary outcome (cotinine-confirmed or self report of 
cessation at 6-months follow-up), secondary smoking outcomes and proximal 
outcomes/mediators: (a) short vs long counseling (conditions 1/2/5/6 vs. 3/4/7/8), (b) short vs 
long NRT (conditions 1/3/5/7 vs conditions 2/4/6/8), and (c) provision of systematic referral or 
not (conditions 1-4 vs. 5-8). Given the balanced complete factorial design,94 each of the three 
main effect estimates will be based on the full sample size of 640. Cross-sectional analyses will 
be conducted for outcomes assessed at 3, and 6 months separately. For binary outcomes, chi-
square tests will be used to compare the outcomes between groups for each follow-up time. For 
continuous outcomes two-sample t-tests or Wilcoxon rank sum tests, whichever more 
appropriate, will be used to compare between groups. A longitudinal analysis using Generalized 
Estimating Equations (GEE) techniques will also assess the overall impact of each component 
by including data from all follow-up time points. The secondary analysis will examine the 
interaction between components, which will provide insight into whether certain combinations of 
components are most useful. We will test the three-way and two-way interaction terms in the 
regression models. If there are component interactions, we will determine whether the 
components are synergistic or antagonistic. Exploratory analyses will examine the moderator 
effects on treatment effectiveness of the intervention components and groups. Of primary 
interest are sociodemographic characteristics (sex, race/SES, age), smoking characteristics 
(quit motivation, nicotine dependence), medical history, LCS-related factors (test results, and 
point of study entry), delivery modality selected (phone vs. video) and language of participation 
(English vs. Spanish). We will test the effects of these factors in multivariable logistic regression 
models to determine their association with the primary and secondary smoking outcomes. We 
will test for interactions between intervention and these factors to determine whether 


 
13 
 
intervention effects vary among subgroups. Those with significant interactions (p<.15) will be 
considered as candidates for identifying subpopulations.  
Cost 
We will calculate the incremental cost per quit of the interventions over the 6-month follow-up 
period as follows: (total per-person costs of LCS-tailored intervention – total per-person costs of 
the lowest intensity comparator/(cessation rate with the LCS-tailored intervention – cessation 
rate with the lowest intensity comparator).96 From these comparisons, we will also be able to 
construct a “league table” comparing the relative cost-effectiveness of different intervention 
components.97 While the study is specifically powered to detect differences across factorial 
dimensions, we will develop incremental cost per quit estimates for all intervention comparisons 
that are proven effective, whether it be for individual factorial dimensions’ main effects 
(counseling duration, NRT duration, or systematic referral), for specific permutations of the 
intervention components versus usual care or for intervention permutations versus each other. 
Costs of implementation included in our analyses will be: 1) personnel time related to 
intervention delivery (training, minutes of counseling, contact attempts, maintaining data and 
information systems), 2) NRT costs (medication, delivery), and 3) systematic referral to 
community resources. While systematic referral is free in Boston, access to similar services 
elsewhere in the country may not be, so this will be an element of our sensitivity analyses. We 
will also include patient time as an indirect cost. The TTS database will document all 
implementation costs. All intervention costs incurred will be included in the analysis, even for 
patients who do not complete their intervention course. Research costs will be excluded. The 
denominator for the cost analyses will be based on the primary outcome. Uncertainty in cost 
and effectiveness inputs will be incorporated into the incremental cost per quit comparisons 
using Monte Carlo methods allowing us to determine whether these ratios are significantly 
different from zero. The robustness of the cost-effectiveness ratio estimates will be further 
examined in sensitivity analyses in which each parameter is varied, singly and in combination, 
through plausible ranges. Sensitivity analyses will also consider how cost-effectiveness changes 
based on payment arrangements and stakeholder (provider, payer, and patient) perspectives to 
identify where incentives to adopt the interventions differ. For example, overhead costs such as 
counseling training and data/information systems are borne by the provider, and indirect costs 
are borne by patients, but treatment costs (counseling, NRT) and the cost of systematic referral-
style resources may be borne by providers, payers, and/or patients (e.g., copayments). 
Assessing how assignment of costs to different stakeholders changes cost-effectiveness from 
different perspectives will be critical to understanding how to scale up the intervention to other 
LDCT screening settings and what payment policies will produce the best public health 
outcomes. 
Sample size/ Power calculations 
Power calculations are based on our primary analysis, which is to assess the 
effect of each intervention component (e.g., shorter counseling vs. longer 
counseling) on our primary outcome, 7-day point-prevalence tobacco abstinence 
at 6-month follow-up. This is a two-sample comparison between patients that 
receive one intervention component (e.g., longer counseling) and those that 
receive the other (e.g., shorter counseling). We conservatively estimate that 160 
patients/month will have LCS, of whom 50% will be current smokers. Assuming a 
50% enrollment rate, we aim to recruit a total N of 720 patients. This sample size 
allows us to allocate N=360 to each treatment component comparison (main effect). Our 
Reference 
rate 
Relative Risk 
1.4 
1.45 
1.5 
16% 
0.71 
0.80 
0.87 
17% 
0.74 
0.83 
0.90 
18% 
0.77 
0.86 
0.92 
19% 
0.80 
0.88 
0.93 
20% 
0.83 
0.90 
0.95 
21% 
0.85 
0.92 
0.96 
22% 
0.87 
0.93 
0.97 
 


 
14 
 
outcome of interest will also be assessed at 3-month followup, which allows us to use a 
longitudinal generalized estimating equations approach wherein power is proprotional to the 
within-person correlation. We estimate the correlation between 3 month and 6 month smoking 
cessation to be 0.6. Assuming N=360 patients in each condition, a Type 1 error rate of 0.05, a 
25% attrition rate by 6 month follow-up, and a 15% cessation rate for the reference group, we 
will have 92.3% power to detect a risk ratio of 1.6 (15% vs. 21%). Under those same conditions, 
but with a 10% cessation rate for the reference group, we will have 79.0% power to detect a risk 
ratio of 1.6 (10% vs. 16%). Given that this is full factorial design, we will have the same power to 
detect two-way interactions between components. Further, we will also have 77.9% power to 
detect a risk ratio of 2.0 in the difference between our most intensive set of treatments (longer 
counseling, longer NRT, and community support; N=90) and our least intensive set of 
treatments (shorter counseling, shorter NRT, and no community support; N=90) after six 
months, assuming a 15% reference rate and 25% attrition.  
Reduction from initial power calculations 
This study was initially powered conservatively to detect a smaller risk ratio of 1.4 and did not 
account for additional power provided through within-person correlation via repeated 
measurement of our outcome of interest. Initial power calculations, assuming a Type 1 error rate 
of 0.05, 25% attrition at 6 months, and no within-person correlation showed that our original N of 
960 patients (N=480 per condition) gave us 85.0% power to detect a risk ratio of 1.4 with a 
reference rate of 15%. Updated power calculations accounting for within-person correlation of 
0.6 show that this original N gives us 96.8% power to detect our target risk ratio of 1.6, 
assuming 25% attrition at 6 months and a 15% reference cessation rate. 
Our previous power calculation assumed a 25% attrition rate at 6 months.  We re-examined this 
assumption after halfway through the recruitment.  Our new estimates are 12.7% attrition rate at 
3 months and 15.9% attrition rate at 6 months.  Based on these estimates, we further reduce 
the target recruitment from 720 to 640.  Combining data from both 3-month (estimated N=559) 
and 6-month (estimated N=539) assessments, the effective sample size will be 768 after taking 
into account of within-person correlation using a conservative estimate of 0.6.  The new sample 
size will have 70% power to detect a risk ratio of 1.6 (10% vs. 16%) and 81% power to detect a 
risk ratio of 1.7 (10% vs. 17%). 
 VII.. RISKS AND DISCOMFORTS (Stratify by common and uncommon)  
Prior to enrollment, potential patients will be cautioned about the potential negative 
psychological and physical implications of joining the study and/or quitting smoking.   
Psychological Risks 
Individuals may find it stressful to answer questions and discuss their smoking behaviors. The 
risks associated with these discussions are minimal, especially when compared to the benefits 
of smoking cessation.  
The potential risks to subjects include: 1) speaking with a counselor about smoking and/or 
cancer-related topics has the potential for increasing psychological vulnerability; 2) experiencing 
physical and emotional withdrawal symptoms from smoking cessation; and 3) potential side 
effects of using nicotine replacement therapy.   


 
15 
 
These risks will be described by the research assistant and will be clearly outlined in the 
consent script. Among enrolled patients, in the event that a patient is determined to be actively 
suicidal and at risk for self-harm at any of the study contact points, the study PIs will be 
immediately contacted and the appropriate clinical intervention effected. These procedures 
would be followed in the case of active suicidality or homicidality, as well as in the case of 
abuse, neglect or risk of harm to a minor or elder.   
Toxicities and Side Effects 
Nicotine Replacement Therapy (Nicotine Patch) 
The transdermal nicotine patch has been an FDA-approved treatment for nicotine dependence 
since 1991, and in 1996, the patch was approved for over-the-counter sale. Up to 50% of 
patients using the nicotine patch will have a local skin reaction. Skin reactions are usually mild 
and self-limiting but may worsen over the course of therapy. Local treatment with hydrocortisone 
cream (1%) or triamcinolone cream (0.5%) and rotating patch sites may ameliorate such local 
reactions.  In less than 5% of patients, such reactions require the discontinuation of nicotine 
patch treatment.   
Nicotine is not an independent risk factor for acute myocardial events, but NRT should be used 
with caution among those in the immediate (within 2 weeks) postmyocardial infarction period, 
those with serious arrhythmias, and those with serious or worsening angina pectoris. Mild sleep 
disturbances, such as vivid dreaming or insomnia, have been reported for approximately 12% of 
patients wearing the transdermal nicotine patch for 24 hours.98 Other less common side effects 
are nausea, dizziness, tachycardia, upset stomach, restlessness, and headaches.  
As our patient population may have existing physical and psychological symptoms, we will make 
every effort to determine if any symptom reported has its onset concurrent with or is 
exacerbated by medication use. In cases of severe or intolerable symptoms, patients will be 
instructed to discontinue use of the study medication and to contact their physician.      
VIII. POTENTIAL BENEFITS  
There are substantial benefits for individual subjects participating in this research study. Quitting 
smoking reduces risk of developing cancer, as well as improving cancer treatment effectiveness 
for patients diagnosed during the LCS, reducing risk of recurrence and of developing new 
primary tumors, and may improve chances of survival. Conversely, continuing to smoke may 
result in diminished quality of life (e.g., elevated pain, shortness of breath). If they succeed in 
quitting, the greatest potential benefit is improved outcomes and quality of life (e.g. increased 
breathing capacity). The potential short-term (e.g. improved breathing) and long-term (e.g. 
improved treatment outcome) health benefits of this study are tremendous. In addition, all 
patients will receive counseling during a potentially difficult time, which can bolster their sense of 
support and self-efficacy. Patients will receive support and counseling that may assist them with 
medication adherence and increased rates of tobacco cessation and continued abstinence. 
Patients may receive access to community resource database to address sociocultural barriers 
to cessation. Therefore, the overall risk to benefit ratio is favorable. 
IX. Data and Safety Monitoring (DSM) Plan  


 
16 
 
The PIs will be responsible for monitoring the safety and effectiveness of this trial, executing the 
DSM plan, and complying with reporting requirements. The final protocol will be reviewed by the 
Partners IRB. The PIs will supply a summary of the DSM report to the NIH on an annual basis 
as part of the progress report. This report will include descriptive reports of the patients’ 
sociodemographic characteristics, expected and actual recruitment rates, retention rates in each 
treatment condition, quality assurance, and regulatory issues that arose since the last report, 
summary of adverse events and serious adverse events, and any protocol changes.  This report 
will include the results of any effectiveness data analyses conducted. Throughout the study, 
adverse events and serious adverse events will be reported in a timely fashion to the IRB. The 
PIs are responsible for protecting the rights, safety, and welfare of the study patients and for 
ensuring that the study is conducted in accordance with the IRB-approved protocol and 
applicable regulations and requirements of the IRB. 
 
Data monitoring plan: Study procedures and data collection will be piloted before the trial 
begins. Participant data collected using paper and pencil records (participant questionnaires, 
progress notes from smoking cessation counselors) will be stored in a locked filing cabinet in a 
locked room; electronic participant tracking databases will be stored on a secure server 
accessible only by IRB-approved members of study staff. Data collected on paper and pencil 
forms will be thoroughly cleaned and entered into an electronic database with a 10% check; 
discrepancies will be resolved by the investigator team through a monthly data review meeting. 
Data collected using REDCap will identify patients by their names, email address, date of birth, 
medical record number, and by study ID. Participants will be identified on study forms and in the 
database by their names, email address, date of birth, medical record number, and by study ID. 
To further prevent the loss of confidentiality, all electronic information stored on the main 
database within the MGH/Partners Healthcare System, Inc. firewall, is password protected, and 
is protected by anti-virus software. Only study staff will have access to the study data on Shared 
File Areas. Dr. Park will review the data for quality assurance and discuss data quality problems 
with the PIs. Data quality (including visits completed during the intervention window, data 
missingness, and recruitment rates) will be monitored monthly. Interim data analysis will be 
conducted throughout the trial and results will be reported in the annual NIH progress report. In 
addition, the RAs will participate in weekly study evaluation meetings to review any difficulties 
that arise with survey administration and the status of follow-up survey and biochemical 
collection. 
 
If patients report significant complaints about our recruitment approach, the study RA will 
document all patient concerns and provide a detailed report to the IRB in real time about the 
nature of the complaint. Study staff will discuss with the PIs on how to adapt recruitment 
approaches to prevent future complaints, and include any changes required by the IRB. 
 
Safety monitoring plan: The exclusion criteria are designed to prevent patients at a high risk of 
medical and psychiatric complications from participating in study. However, if unexpected 
conditions appear to be placing patients at a higher risk than anticipated, the exclusion criteria 
will be amended. Any medical complications, which are considered to be related to the study, 
will be reported to the site PI, who will report them to the subject’s treating physician. The site PI 
will review the progress of all study participants on an at least monthly basis. Any adverse 
events related to study participation will be reported to the IRB. 
 
 
The main safety risks for the study include the potential for psychological discomfort with 


 
17 
 
surveys and counseling as well as side effects from study medications. In order to protect 
against risk from pharmacotherapy usage, these steps will be taken: 
 
(1) Medication is being provided only to patients who receive counseling sessions. At each call, 
patients are specifically asked about any side effects or problems. Study staff will be required to 
report any unexpected or questionable reports of adverse effects to the study PIs. These will be 
reviewed at the weekly study staff meeting. If more urgent, the PI will review immediately. 
 
(2) The study physicians (Drs. Rigotti and Haas) will provide back up to study staff for all 
medical questions that arise during participant enrollment or study progress. 
 
(3) The PIs will review any serious adverse events and report them appropriately to the 
IRB and NIH. Reports are to be submitted within 5 working days/7 calendar days of the date 
the investigator first becomes aware of the problem. Each will be reviewed by the PIs to ensure 
that the readmission is not related to study medication. 
 
Data Sharing 
 
De-identified data will be periodically shared with NCI for cross-project research within 
the SCALE study sites. Data will be shared through a secure online portal developed by 
Information Management Services, Inc. (IMS), in which each SCALE study site will only 
have access to the data uploaded by members of that site. IMS provides a firewall, VPN, 
and intrusion prevention system. Routine security checks of the IMS computer resources 
are made with security analysis software tools. The production network is housed in 
physically separate and secured computing facilities. Only authorized user ID and 
password protected access is allowed to the network. In addition, IMS has an NIH 
approved IT System Security Plan in place that meets the OMB Circular A-130 guidelines 
and the NIST guidelines for IT system security at the “moderate” level.  
As part of the SCALE collaboration, a data transfer agreement written by the NCI legal 
office will be sent to each study site for review by each site’s legal offices. Research 
proposals will be sent to the soon-to-be formed Steering Committee (in which NCI is a 
non-voting member) and vetted. When approved, NCI will send data to the researchers 
who are leading a given analysis; NCI may also conduct analyses with the approval of 
the Steering Committee. NCI will only send data to non-SCALE members when approved 
by the Steering Committee, except in very specific, limited circumstances described in 
the data transfer agreement. 
 
We will send a limited data set to our collaborator at UMass Boston, Dr. Jaqueline Contrera 
Avila. Dr. Avila will assist us with the data analysis. Data will be stored behind the UMB firewall 
on a password protected computer, for adding safety the data will be stored the University 
OneDrive under a two-way steps verification. 
 
Protection of Human Subjects 
Prior to enrollment, potential patients will be cautioned about the potential negative psychological 
(stress and loss of positive experiences from smoking) and physical implications of quitting 
smoking. A clear risk/benefit ratio will be presented to each potential patient. These risks will be 
described by the research assistant and will be clearly outlined in the consent script. Patients will 


 
18 
 
be encouraged to discuss any concerns with their provider, prior to enrolling. Patients who need 
time to consider these risks will be given the option of calling back and/or enrolling at a later date.  
There are three potential reasons for elevated psychiatric risk in our study patients. Lung cancer 
screening could be a vulnerable time for patients, patients may be uncomfortable talking about 
their smoking given the stigma of smoking and lung cancer, and withdrawal symptoms and 
cravings from quitting smoking.   
In order to protect against psychiatric risks, we will not enroll anyone who is potentially 
psychiatrically unstable. Individuals found to be psychiatrically unstable at screening will be 
referred for psychological/psychiatric evaluation. Once patients are enrolled in the study, study 
staff will notify the MPIs if a patient seems distressed during the surveys or counseling. In 
addition, patients will be given the contact information for the study MPIs at the beginning of the 
study and told that they can contact with any concerns about their study participation. If a 
patient appears to be in high distress/risk the tobacco counselor will page Dr. Park, who will 
immediately contact the patient and utilize a suicide prevention assessment and protocol 
previously developed for smoking cessation studies with other vulnerable medical patient 
populations. This protocol assesses for risk to self or others, including whether the patient has 
suicidal thoughts, a suicide plan, and a means to complete their plan. If a patient is deemed 
high risk of suicide/homicide, confidentiality may be suspended. Patients in the midst of a 
psychiatric emergency will be required to go to the emergency room for evaluation (if they are 
unwilling, paramedics will be sent to their location). Suicidal patients who are able to contract for 
safety will be required to follow up immediately  
The study staff will immediately discuss any patients whom they are concerned about with the 
Drs. Rigotti or Haas, both licensed internists, who will decide an appropriate course of action. In 
the event of a psychiatric emergency, confidentiality may be suspended. Patients will be 
informed of the limits of confidentiality at the beginning of the study.   
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