Clinical trial NCT03808818
Conditions: Carcinoma In Situ Current Smoker Malignant Neoplasm Primary Neoplasm Recurrent Neoplasm Smoking Cessation
Sponsor: ECOG-ACRIN Cancer Research Group
Start date: 2019-08-01; Completion date: 2023-12-31
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trial studies how well smoking cessation treatment plans work in tobacco-dependent cancer patients when delivered virtually as part of their cancer care in community oncology practices. Virtual information and counseling sessions may help cancer patients quit smoking.

Detailed description:
PRIMARY OBJECTIVE:

I. To compare the proportions of participants in the Enhanced Usual Care (EUC) and Virtual Tobacco Treatment (VIT) study arms with biochemically-verified 7-day point-prevalence abstinence from cigarettes at 6-months post enrollment.

SECONDARY OBJECTIVES:

I. Biochemically-verified 7-day point prevalence abstinence at 3-months follow-up.

II. Self-reported 7-day point prevalence cigarette abstinence at 3- and 6-months follow-up.

III. Significant reduction (\> 50% reduction in reported number of cigarettes per day) in daily smoking from baseline to 3- and baseline to 6-months follow-up.

IV. Continuous (no self-reported smoking since last survey point) and sustained abstinence at 6 months (cotinine-verified at 3-months and 6-months).

EXPLORATORY OBJECTIVES:

I. To assess the potential effect of known and potential moderators on treatment effectiveness between the two arms.

II. To assess the processes of implementation and dissemination (acceptability, adoption, appropriateness, treatment fidelity, cost effectiveness, penetration/reach, and sustainability) of the investigator's intervention at community oncology sites.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A (Enhanced Usual Care \[EUC\]): Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the National Cancer Institute (NCI) Smoking Quitline.

ARM B (Virtual Intervention Treatment \[VIT\]): Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of nicotine replacement (NRT) (patch and lozenge combined or alone).

After completion of study, patients may be followed up for 1 year.

Arms: arm 1: Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline. arm 2: Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).
Interventions: intervention 1: Behavioral, Psychological or Informational Intervention intervention 2: Nicotine Replacement intervention 3: Quality-of-Life Assessment intervention 4: Survey Administration intervention 5: Tobacco Cessation Counseling
Intervention descriptions: intervention 1: Receive information about tobacco cessation intervention 2: Given NRT patch or lozenge (or both) intervention 3: Ancillary studies intervention 4: Ancillary studies intervention 5: Receive virtual tobacco cessation counseling

Protocol documents:
Prot_SAP_000.pdf: 
 
EAQ171CD 
1 
Implementing a Virtual Tobacco Treatment in Community 
Oncology Practices: “Smoke Free Support Study 2.0” 
STUDY CHAIR: 
Elyse R. Park, PhD, MPH 
STUDY CHAIR: 
Jamie S. Ostroff, PhD 
STUDY CO-CHAIRS: 
Angela W. Walter, PhD, MPH, MSW 
 
Doug Levy, PhD 
 
Susan Regan, PhD 
STUDY STATISTICIAN: 
JoRean D. Sicks, MS 
STUDY EPIDEMIOLOGIST 
Ilana F. Gareen, PhD 
CCDR COMMITTEE CHAIR 
Ruth Carlos, MD 
CANCER CONTROL & SURVIVORSHIP 
COMMITTEE CHAIR: 
Lynne I. Wagner, PhD 
Version Date: July 1, 2021 
 
STUDY PARTICIPANTS 
 
ACTIVATION DATE 
ALLIANCE / Alliance for Clinical Trials in 
Oncology, NCORP Sites Only 
 
April 11, 2019 
Addendum #1 
ECOG-ACRIN / NCORP Sites Only 
 
Addendum #2 
NRG / NRG Oncology, NCORP Sites Only 
 
Addendum #3 
SWOG / SWOG, NCORP Sites Only 
 
Addendum #4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Table of Contents 
Patient Schema .......................................................................................................... 6 
NCORP Site Staff Schema .......................................................................................... 7 
1. Introduction ........................................................................................................ 8 
1.1 Study Significance ..................................................................................... 8 
1.2 Background ............................................................................................. 11 
1.3 Approach ................................................................................................. 12 
2. Objectives ......................................................................................................... 15 
2.1 Study Aims: ............................................................................................. 15 
2.2 Primary Objective: ................................................................................... 15 
2.3 Secondary Objectives: ............................................................................. 15 
2.4 Exploratory Objectives ............................................................................ 16 
3. Participant Selection ......................................................................................... 18 
3.1 Selection of NCORP Site Staff Participants .............................................. 18 
3.2 Selection of Patients ............................................................................... 18 
4. Registration and Randomization Procedures ................................................... 21 
4.1 Registration Information Required at Step 0 .......................................... 25 
4.2 Eligibility Verification .............................................................................. 25 
4.3 Registration Information Required at Step 1 .......................................... 25 
4.4 Eligibility Verification .............................................................................. 26 
4.5 Registration Information Required at Step 2 (Randomization) .............. 26 
4.6 Stratification Factors ............................................................................... 26 
4.7 Additional Requirements ........................................................................ 26 
4.8 Instructions for Patients who Do Not Complete Baseline Survey and/or 
Do Not Start Assigned Study Intervention .............................................. 32 
5. Methodology..................................................................................................... 33 
5.1 Recruitment and Accrual......................................................................... 33 
5.2 Enhanced Usual Care (EUC) (Arm A) ....................................................... 35 
5.3 Virtual Intervention Treatment (VIT) (Arm B) ......................................... 36 
5.4 Patient Assessments (Arms A & B) .......................................................... 38 
5.5 Adverse Event Reporting Requirements ................................................. 39 
5.6 Duration of Intervention ......................................................................... 42 
5.7 Duration of Study and Follow-up ............................................................ 43 
6. Measurement of Effect ..................................................................................... 44 
6.1 Biochemical Samples ............................................................................... 44 
6.2 Patient assessments ................................................................................ 44 
6.3 NCORP Site Staff Assessments ................................................................ 49 
6.4 Cost ......................................................................................................... 52 
6.5 Treatment fidelity/adaptations ............................................................... 52 
6.6 Reach and Adoption ................................................................................ 53 
7. Study Parameters .............................................................................................. 54 
7.1 Patient surveys and samples schedule ................................................... 54 


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7.2 Site staff surveys schedule ...................................................................... 55 
7.3 Randomization groups schedule (approximate) ..................................... 55 
7.4 Data collection schedule during eligibility screening, recruitment, and 
enrollment ............................................................................................... 57 
7.5 Data collection schedule for patient enrollees (surveys) ....................... 58 
7.6 Data collection schedule for site staff (surveys) ..................................... 58 
8. Drug Formulation and Procurement ................................................................. 59 
8.1 Nicotine trans-dermal patch (NSC #5065) .............................................. 59 
8.2 Nicotine Polacrilex Lozenge (NSC #741859) ........................................... 62 
9. Statistical Considerations .................................................................................. 66 
9.1 Estimated Effect Size ............................................................................... 66 
9.2 Power calculation: ................................................................................... 66 
9.3 Estimate of drop-outs/loss to follow-up: ................................................ 67 
9.4 Total Sample size: .................................................................................... 67 
9.5 Plans for handling missing data: ............................................................. 67 
9.6 Plans for analyzing the primary objectives: treatment effectiveness (Aim 
1) ............................................................................................................. 68 
9.7 Plans for analyzing the secondary objectives: secondary treatment 
effectiveness (Aim 1) ............................................................................... 68 
9.8 Plans for analyzing the exploratory objectives: ...................................... 69 
9.9 Gender and Ethnicity for Patients ........................................................... 74 
9.10 Gender and Ethnicity for Site Staff ......................................................... 75 
9.11 Study Monitoring .................................................................................... 75 
10. Specimen Submission and Analysis .................................................................. 76 
10.1 Saliva Cotinine Assessments ................................................................... 76 
10.2 Expired CO Assessments ......................................................................... 78 
11. Patient-Reported Outcomes and Quality of Life Administration ..................... 79 
11.1 Data Collection Approach for Patient Reported Outcomes .................... 79 
11.2 Questionnaire Administration Process ................................................... 79 
11.3 Patient Reported Outcomes/Quality of Life Assessment Schedule ........ 81 
12. Electronic Data Capture .................................................................................... 82 
13. Patient Consent and Peer Judgment ................................................................ 82 
13.1 Waivers of Consent ................................................................................. 82 
14. References ........................................................................................................ 83 
 


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STUDY CHAIR 
Elyse R. Park, PhD, MPH 
Massachusetts General Hospital 
100 Cambridge St., Suite 1600 
Boston, MA 02114 
Telephone: 617-724-6836 
Fax: 617-724-4738 
Email: epark@mgh.harvard.edu 
 
STUDY CO-CHAIR 
Jamie S. Ostroff, PhD 
Memorial Sloan Kettering Cancer Center 
641 Lexington Avenue, 7th Floor 
New York, New York 10022 
Telephone: 646-888-0041 
Fax: 212-888-2584 
Email: ostroffj@mskcc.org 
 
STUDY TEAM CONTACT 
Email: smokefreesupportstudy2@partners.org 
Telephone: 617-643-4765 
 


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CANCER TRIALS SUPPORT UNIT (CTSU) ADDRESS AND CONTACT INFORMATION 
For regulatory requirements: 
For patient enrollments: 
For study data 
submission: 
Regulatory documentation 
must be submitted to the 
CTSU via the Regulatory 
Submission Portal. 
Regulatory Submission Portal: 
(Sign in at www.ctsu.org, and 
select the Regulatory 
Submission sub-tab under the 
Regulatory tab.) 
Institutions with patients 
waiting that are unable to use 
the Portal should alert the 
CTSU Regulatory Office 
immediately at 1-866-651-
2878 to receive further 
instruction and support. 
Contact the CTSU Regulatory 
Help Desk at 1-866-651-2878 
for regulatory assistance. 
Please refer to the patient enrollment 
section of the protocol for instructions 
on using the Oncology Patient 
Enrollment Network (OPEN) which can 
be accessed at 
https://www.ctsu.org/OPEN_SYSTEM/ 
or https://OPEN.ctsu.org. 
 
Contact the CTSU Help Desk with any 
OPEN-related questions at 
ctsucontact@westat.com. 
Data collection for this 
study will be done 
exclusively through 
Medidata Rave and the 
ECOG-ACRIN Systems for 
Easy Entry of Patient 
Reported Outcomes 
(EASEE-PRO) system.  
Please see the data 
submission section of the 
protocol for further 
instructions. 
The most current version of the study protocol and all supporting documents must be downloaded 
from the protocol-specific Web page of the CTSU Member Web site located at https://www.ctsu.org. 
Access to the CTSU members’ website is managed through the Cancer Therapy and Evaluation 
Program - Identity and Access Management (CTEP-IAM) registration system and requires user log on 
with CTEP-IAM username and password.  
Permission to view and download this protocol and its supporting documents is restricted and is based 
on person and site roster assignment housed in the CTSU Regulatory Support System (RSS). 
For clinical questions (i.e., patient eligibility or treatment-related) Contact the Study PI of the 
Coordinating Group. 
For non-clinical questions (i.e., unrelated to patient eligibility, treatment, or clinical data 
submission) contact the CTSU Help Desk by phone or e-mail:  
CTSU General Information Line – 1-888-823-5923, or ctsucontact@westat.com. All calls and 
correspondence will be triaged to the appropriate CTSU representative.  
The CTSU Web site is located at   https://www.ctsu.org 
 


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Patient Schema 
EASEE PRO will send an email to all patients requesting 
them to return to the secure portal to 
complete survey at 6-months follow-up.
Study staff responsibilities
A. Pre-Screening – Medical 
Charts (recommended)
NCORP site staff may review new 
patient lists or medical records to 
identify patients to approach who 
may meet the following criteria: 
> 18 years of age, recently 
diagnosed, and smoking cigarettes.
Pre-Screening Log
REDCap Transfer
NCORP site staff will screen all patients 
for study eligibility. This may be assessed 
from medical record review and/or patient 
self-report. Sites will provide weekly 
number totals of smokers seen at this 
subcomponent site, patients ineligible (and 
reason), smokers approached to 
participate, and patients refused (and 
reason).
Documentation
Automatic data systems
B. Pre-Eligibility Screening – 
Patients
NCORP site staff will approach all 
potentially eligible patients to ask 
permission to contact them with an 
informational video (virtual clinician 
referral).
For patients who agree, all eligibility 
criteria will be confirmed, and an 
email address for registration in 
OPEN + EASEE PRO will be 
collected.
Ineligibles 
and 
refusers
OPEN STEP 0 – Screening Step
NCORP site staff will register patients 
who agree into OPEN STEP 0. They will 
enter in OPEN the following information on 
all registered: age, sex, race, ethnicity, 
cancer diagnosis (cancer type), cancer 
stage, date of diagnosis, ECOG PS, 
language spoken, and confirmation of 
eligibility.
Verbal 
Permission
C. Recruitment and Consent
NCORP site staff will follow up (in 
clinic or via phone) with all eligible 
patients to assess interest in 
participation.
NCORP site staff will obtain 
written informed consent and 
collect the contact information from 
all patients who are interested and 
still eligible.
D. Baseline Survey
Patients may elect to complete the 
BL survey in clinic with NCORP 
site staff at the time of their written 
consent. (Entered into secure portal 
via either direct entry or paper-
based and entered by site CRA)
OR
OEAU staff will provide email/
phone outreach reminders to return 
to the secure portal to complete the 
BL survey.
Patients who do not complete the 
BL survey will not continue in the 
study beyond this point.
E. Randomization
NCORP site staff, when notified of 
BL completion, randomize patient 
in OPEN.
EASEE PRO
OPEN STEP 0 registration automatically 
creates an account in EASEE PRO for the 
patient. EASEE PRO will immediately 
send an email to all registered patients 
requesting they return to the secure portal 
to view the Virtual Clinician Referral video.
EASEE PRO will track and record who has 
viewed the video link and notify NCORP 
site staff when a video is watched to assist 
in recruitment outreach.
RAVE – Ineligibility Documentation
Reasons for ineligibility or refusal to 
participate from (C) will be documented in 
RAVE
BL Survey 
Completers
OPEN STEP 1 – Written Consent
NCORP site staff will register all patients 
who sign an informed consent form into 
OPEN STEP 1.
Ineligibles 
and refusers
Written 
Consenters
EASEE PRO
OPEN STEP 1 will trigger EASEE PRO to 
send email to participant requesting they 
return to the secure portal to complete the 
BL survey.
EASEE PRO
Completion of the BL will trigger a 
completion email to the NCORP site staff 
and to MGH.
OPEN STEP 2 – Randomization
NCORP site staff will register all patients 
who complete the BL survey into OPEN 
STEP 2, which will randomize the patient 
to a treatment arm (VIT vs. EUC).
NCORP Site staff will send patient 
contact information, study ID, dates of 
consent and randomization, provider 
information, and randomization arm 
assignment to MGH centralized study 
staff via Enrollment Log REDCap Project.
Post study, Brown will merge the data in 
the study.
EASEE PRO
Randomization to the EUC arm will trigger 
a  quitline referral  email.
EUC
EASEE PRO will send an email to all patients requesting 
them to return to the secure portal to 
complete survey at 3-months follow-up.
E. VIT Intervention
MGH study staff coordinates 
TeleHealth set-up and initiation 
of counseling services.
VIT subjects will be offered up 
to 11 counceling sessions with 
a centralized tobacco 
treatment coach at MGH, and 
up to 12 weeks of NRT over 
approximately 6 months.
VIT
F. 3 Month Follow-Up
OEAU Staff will provide email/phone/text 
outreach reminders to complete the survey
For subjects who report:
being quit and no concurrent use of NRT 
or e-cigarettes, MGH study staff will 
coordinate a saliva sample collection. J2 
will send saliva sample collection results 
and status slip to MGH.
being quit and concurrent use of NRT or 
e-cigarettes, NCORP site staff will 
coordinate CO sample collection. NCORP 
site staff documents data in RAVE and 
emails to MGH.
G. 6 Month Follow-up
OEAU Staff will provide email/phone/text 
outreach reminders to complete the survey
For subjects who report:
being quit and no concurrent use of NRT 
or e-cigarettes, MGH study staff will 
coordinate a saliva sample collection. J2 
will send saliva sample collection results 
and status slip to MGH.
being quit and concurrent use of NRT or 
e-cigarettes, NCORP site staff will 
coordinate CO sample collection.  NCORP 
site staff documents data in RAVE and 
emails to MGH.
MGH Database
Centralized Tobacco treatment 
coach will document all sessions 
notes in Access database.
MGH study staff will document all 
biochemical sample results, 
medication fills, and exit interviews 
completed in Access database.
H. Exit Interviews
MGH study staff will offer a 
subset of VIT 6-month survey 
completers the chance to 
participate in an exit interview 
with Study Investigators.
Ongoing secure data transfers from RAVE 
to MGH.
 
Rev. Add2 


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NCORP Site Staff Schema 
Complete 
Baseline 
Survey2
1. For each NCORP site, the CCDR lead will identify 8-10 multidisciplinary staff members to participate in this study. 
2. Site staff must complete baseline survey prior to first patient enrollment. 
 R1
E
G
I
S
T
E
R
E
N
D
O
F
S
T
U
D
Y
Complete 
12 month 
Survey
Complete 
36 month 
Survey
Participate in 
focus group 
interview
 


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1. 
Introduction 
1.1 
Study Significance 
The landmark 2014 Surgeon General’s Report concluded that for individuals with 
cancer, persistent smoking results in increased toxicity, poor cancer treatment, 
response, and increased risk for disease recurrence and second primary 
cancers.1 Accordingly, in 2016 the Tobacco Control Research Working Group’s 
priorities presented to the NCI’s Board of Scientific Advisors emphasized the 
need to develop and test effective cessation treatments for cancer patients with 
persistent tobacco use.22 We propose to conduct the first study to examine the 
effectiveness and implementation of a virtually-delivered evidence-based 
tobacco treatment into cancer care for patients at NCORP community sites, 
including NCORP minority/underserved community sites (>30% of patients are 
racial/ethnic minorities or rural residents). Since 80% of patients receive their 
cancer care in the community, 17 and as many community-based oncology 
networks serve large rural populations and lack resources, this is a tremendous 
opportunity to examine and implement an evidence-based treatment to an NCI 
priority population of vulnerable patients. NCORP community sites identified 
evidence-based cessation services as a priority. In 2016 the NCI-AACR Cancer 
Patient Tobacco Use Assessment Task Force 23 delineated implementation 
strategies. Our proposal evaluates 3 of these priorities: evaluation of 1) effective 
means of delivering tobacco treatment, including motivational approaches and 
telemedicine; 2) the effects of cessation treatment moderators; and 3) cost-
effectiveness. 
NCORP community sites provide access to a diverse population of cancer 
patients making them ideal for studying effectiveness and implementation of 
tobacco treatment in real-world cancer care settings. The NCI recently launched 
NCORP to coordinate trials among its community sites, which are organized 
networks of community-based oncology programs, including 
minority/underserved community sites. The goal of NCORP is to conduct cancer 
control research in communities where patients receive their care, with a priority 
on improving access and evaluating innovative cancer care delivery models, 
particularly among underserved and underrepresented populations. Our proposal 
is closely aligned with NCORP priorities 
Tobacco use following a cancer diagnosis is prevalent and compromises 
treatment outcomes. About 10% to 30% of cancer patients are smoking at the 
time of diagnosis, 5-8, 24, 25 and the majority of cancer patients who smoke at 
diagnosis continue to smoke following diagnosis.7,26 Quitting smoking upon 
cancer diagnosis may improve cancer treatment effectiveness, reduce risk of 
recurrence and of developing new primary tumors,1,13-15, 27-30 and improve 
chances of survival.5, 31-33 Conversely, continuing to smoke may result in 
diminished quality of life,5, 34, 35 treatment delays and increased treatment 
complications.6,10-12, 36-44 
National initiatives emphasize the importance of identifying smokers in cancer 
care settings. In 2011, the Joint Commission and Medicare adopted National 
Hospital Quality Measures for hospitals to report on how often hospitalized 
smokers receive cessation advice, counseling, and medication.45 Smoking status 
was designated as a core objective in the 2010 “Meaningful Use” EHR 
documentation.46, 47 The 2013 AACR released guidelines emphasize the 


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provision of tobacco cessation services to cancer patients.48 The American 
Society of Clinical Oncology (ASCO) recommends cessation counseling to all 
smokers as a core quality indicator.49 In 2015 the National Comprehensive 
Cancer Network (NCCN) published Smoking Cessation guidelines to formalize 
these initiatives.2We propose to implement a virtually-delivered tobacco 
treatment to help community cancer centers meet national recommendations. 
Integrated, evidence-based services are needed, but are lacking, during cancer 
care. The USPHS Practice Guidelines recommend that evidence-based tobacco 
treatment – specifically, combined medication and counseling– be delivered to all 
smokers in health care settings, yet little progress has been made to integrate 
these guidelines into cancer care.50 A survey of comprehensive cancer centers 
found that almost all believed that having a tobacco treatment program is “very 
important” but only half had any such type of program.51 This is unfortunate, as 
cessation closer to the time of diagnosis results in a higher likelihood for 
continued abstinence,5, 52-55 effective interventions exist,5,52-55 and many cancer 
patients who smoke want to quit smoking.52, 53, 56, 57 Additionally, little work has 
been done to explore the delivery and effectiveness of tobacco treatment among 
racial/ethnic minority cancer patients who are at risk for continued smoking. 3, 58, 
59 Lastly, tobacco use remains unaddressed after treatment completion.60 A 
recent national study61 found that smokers treated for cancer were significantly 
more likely than smokers without cancer to try to quit smoking. 
Tobacco use is not being assessed or intervened upon during cancer care. 
Assessment of tobacco dependence among cancer patients is lacking; 62-64 in 
particular, rates of smoking assessment are lower in non-academic medical 
settings (i.e., community settings).65 Unfortunately, during treatment, many 
smokers are not advised to quit,66, 67 and most cancer patients do not get 
assistance (e.g., medications, counseling) to quit and/or stay quit.68-70 Only 30%-
40% of oncologists provide assistance to help patients quit smoking. 62, 63, 71  
Furthermore, tobacco use assessments and cessation support have not been 
incorporated in most cooperative group clinical trials.72 Lack of adequate training, 
lack of expertise in providing cessation treatment, and lack of patient support 
resources such as dedicated cessation counseling programs, have been 
reported as leading impediments to implementation of cessation treatment in 
cancer care. 51, 62, 63 
Cancer patients who smoke have socioeconomic, biologic and psychosocial 
vulnerabilities. Individuals with lower incomes and education have a higher 
prevalence of smoking.73, 74, 75  Dr. Park found that Cancer Care Outcomes 
Research & Surveillance Consortium (CanCORS) participants who were smoking 
at diagnosis had less education and more often had public health insurance 
(p<.001).7 Cancer patients are at risk of financial hardship.76 A recent study of 
Medicaid patients demonstrated that barriers to treatment access still exist.77,78 
Cancer patients who report persistent smoking need intensive treatment, often 
endorsing high rates of nicotine dependence and household smoking.79 Cancer 
patients who smoke often experience internalized stigma; 80, 81 smokers who 
perceive stigma are less likely to disclose their smoking status and receive 
needed treatment.82 NCORP community sites enable us to reach vulnerable 
cancer patients. 
Implementation of tobacco treatment into community cancer centers would be 
facilitated by cost data. A significant barrier to translation of behavioral 
interventions into practice is failure to conduct analyses of intervention costs.83 


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Emerging health care finance mechanisms that move away from fee-for-service 
payment (accountable care organization, episode-based payment, etc.) will 
heighten the demand for cost data. Smoking cessation trials conducted with 
cancer patients have not examined treatment costs. Our current R01 trial results 
will contribute the first cost analyses of smoking cessation treatments for cancer 
patients at the time of diagnosis, but these are limited to comprehensive cancer 
centers. The proposed trial will extend this work and be the first cost analyses to 
be conducted in cancer community settings. 
Implementation outcomes to be gained from the proposed hybrid-
effectiveness trial. In summary, the NCI, ASCO, AACR, and NCCN promote 
incorporating tobacco treatment into the delivery of cancer care, but this has 
never been done in community cancer centers. Trial findings will establish the 
effectiveness and cost of utilizing a virtual strategy to deliver evidence-based 
tobacco treatment in community oncology settings and provide detailed initial 
data on implementation processes that will inform subsequent testing of multi-
level implementation strategies for broad national dissemination into community 
cancer care settings. 
Building on current work to enhance virtual tobacco treatment delivery. Our 
preliminary R01 (the Smokefree Support Study 1) data demonstrates that an 
intensive tobacco treatment, delivered in-person (during outpatient and inpatient 
cancer center appointments) and via phone, targeted to the needs of recently 
diagnosed cancer patients (breast, lung, GU, GI, ob/gyn, lymphoma, head and 
neck, and melanoma), is effective. We believe that face-to-face contact is an 
important ingredient in patient-counselor rapport. In our previous study, patients 
had the opportunity to meet counselors in-person during treatments, but the wide 
geographic distribution of cancer clinics within community-based setting limits the 
ability for tobacco treatment access and in-person contact. Recent pilot studies 
reported on the feasibility of using videoconferencing to deliver psychosocial care 
to cancer patients,117-119 and behavioral interventions using videoconferencing 
technology have been found to be as effective as in-person delivery. 120-123 There 
have been only two studies using videoconferencing to deliver smoking cessation 
programs, but both required patients to come into clinics to use the technology; 
both found it to be feasible to deliver and reported high reported patient 
satisfaction. Dr. Carlson concluded that videoconferencing delivered cessation 
groups produced quit rates similar to in-person groups.120 Dr. Richter compared a 
videoconferencing-delivered program, delivered within primary care clinics, to a 
telephone-delivered program and found that videoconferencing increased 
utilization of cessation medication.124 To our knowledge, our study is the first to 
offer virtual delivery, via remote videoconference, of a tobacco treatment to 
cancer patients. We will leverage existing systems; we developed 
English/Spanish treatment protocols, electronic data capture systems, 
medication algorithms, cost tracking templates, and motivational interviewing 
counseling fidelity and supervision materials. The proposed trial improves reach 
by: 1) using videoconferencing to bring a tobacco counselor (synchronous visits) 
directly to patients; 2) bringing tobacco treatment into community cancer centers; 
3) offering tobacco treatment to diverse patients; and 4) incorporating 
involvement of cancer clinicians, through delivery of brief videos. 


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1.2 
Background 
Dr. Park has conducted multisite tobacco treatment trials with cancer patients 
and low SES smokers.85, 125-127 Dr. Park directed an efficacious 24-site RCT to 
test a smoking cessation intervention for childhood cancer survivors assigned to 
a telephone-based peer motivational counseling plus NRT patch intervention 
versus usual care.125,126 Drs. Park and Rigotti collaborated on an RCT for 607 
low-SES, English and Spanish-speaking smokers that compared quitline referral 
to phone-based motivational counseling calls with a tobacco counselor 
embedded in the health care system and NRT.84 The intervention significantly 
increased tobacco abstinence at 9 months compared to usual care (18% vs. 8%; 
p<.001). Drs. Rigotti and Park also collaborated on an RCT of a smoking 
cessation intervention for 397 hospitalized smokers.95 An intervention using 
automated calls (IVR) and free NRT was significantly more efficacious compared 
to quitline referral (26% vs.15%; p<.01). Dr. Park conducted a pilot smoking 
cessation study which supported the feasibility of an Intensive Treatment 
(motivational counseling plus varenicline) vs. usual care for patients at the MGH 
thoracic clinic.79 Dr. Ostroff led a randomized trial evaluating the efficacy of a 
gradual smoking tapering intervention combined with nicotine patch in 185 
cancer patients awaiting hospitalization for surgical treatment (6-month 
abstinence was 32%).128 Dr. Ostroff also co-led a large cluster,randomized trial 
testing the effectiveness of several systems-level, implementation strategies to 
improve adherence to tobacco treatment guidelines in community-based public 
health dental clinics.129 In June 2016, Drs. Park, Ostroff and Perez participated in 
a new NCI initiative, SPeeding Research-tested INTerventions which focuses on 
integrating research trial-based interventions into real-world settings. They 
conducted 30 interviews with stakeholders to discuss barriers to implementing 
tobacco treatment training and programs for oncology patients. These interviews 
confirmed 1) the need for a national tobacco treatment program, 2) the need for 
tobacco treatment delivery to be specialized for cancer patients, and 3) that 
oncology clinicians, although strongly supportive of tobacco treatment for their 
patients, lacked tobacco treatment training experience and time.130 In September 
2016, Drs. Wagner, Park and Ostroff were awarded an NCI supplement to 
administer the AACR tobacco assessment to 1000 patients (at enrollment, 3 and 
6 months) in ECOG/ACRIN NCORP trials to determine the effects of tobacco use 
on patient’s a) physical and psychological symptoms and b) cancer treatment 
duration, dose intensity, and therapeutic benefit. These developments strengthen 
the team’s ability to assess implementation of tobacco treatment in cancer care 
settings. 
1.2.1 
Current R01 preliminary findings (Smokefree Support Study 1). 
The proposed study was informed by the recently completed RCT 
which Drs. Park and Ostroff conducted at MGH and Memorial Sloan 
Kettering (MSK) to assess integration of an Intensive Treatment (IT; 
11 sessions of motivational counseling, in-person and phone, plus 
choice of FDA-approved medication) versus MSK’s usual care with 
recently diagnosed cancer patients (4 sessions of MI counseling plus 
FDA-approved medication advice).127Among patients who are 
potentially eligible based on chart screen, approximately one-third 
enrolled; among known eligible smokers who agreed to be screened, 
70% enrolled. Based on preliminary analyses as of February 2018, 
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female, mean age = 58; 82% white, non-Hispanic; 10 % Black; 5.0% 
Hispanic). This includes patients diagnosed with thoracic, head and 
neck, GI, GU, breast, lymphoma, melanoma, and ob/gyn cancers. 
Using intention-to-treat analyses counting non-responders as 
“smokers” (86% 6-month survey response rate and 87% cotinine 
validation response rate), cotinine validated 6-month abstinence rates 
are 19% in the Standard Care group and 33% in the Intensive 
Treatment group (p<.02). Using intention-to-treat, 57% of Intervention 
Treatment group participants were adherent to sustained counseling 
(> 7 sessions), which was associated with increased 6-month quit 
rates (p<.0001). These data support preliminary effectiveness of the 
proposed intervention treatment. 
1.3 
Approach 
1.3.1 
Design Overview 
We propose a hybrid-effectiveness design,18 Hybrid Type 1 enabling 
us to test the effectiveness of our clinical intervention while also 
gathering key information on its delivery and potential for 
implementation in a real-world situation. This design choice fits the 3 
recommended conditions for Hybrid Type 1 use, specifically: 1) strong 
face validity for the intervention that would support applicability to the 
new setting (NCORP centers), population (more diverse cancer 
patients), or delivery method (synchronous videoconferencing); 2) 
strong base of indirect evidence (data from different but associated 
populations) for the intervention; and 3) minimal risk associated with 
the intervention, both its direct risk and any indirect risk through 
replacement of a known adequate intervention. Our design compares 
the effectiveness and implementation of Enhanced Usual Care (EUC: 
Asking about tobacco use, Advising current tobacco users to quit and 
Referral to NCI Quitline) versus an evidence-based Virtual 
Intervention Treatment (VIT; Asking about tobacco use, Advising 
current tobacco users to quit and Referral to a centralized NCORP 
tobacco coach for a videoconferencing intervention). 
1.3.2 
Virtual Approach: Referral and Delivery 
An IT platform will be used to recruit patients to the study via a Virtual 
Clinician Referral. Brief, educational videos will be created for 
patients. Through this virtual clinician referral, clinicians can engage in 
a supportive collaborative care approach to underscore the 
importance of cancer patients addressing their tobacco use and 
encouraging treatment participation. 
These brief videos can be accessed via a computer, tablets, or 
smartphones, and sent via secure email platform. To enhance patient 
engagement and standardized clinician care delivery, MGH staff will 
be available to support our brief video development and 
implementation. Working with the MGH team, we will develop a brief 
(approximately 1-2 minutes) video that introduces the study and 
encourages participation in the study. These videos will build on our 
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In an effort to standardize usual care, a script will be provided to each 
individual site, and the virtual clinician referral will be recorded by a 
site-designated oncology provider at each participating NCORP 
center. These brief videos will introduce the tobacco treatment 
program and ask about smoking behavior, normalize tobacco use to 
decrease internalized stigma, advise cancer patients of the 
importance of quitting/decreasing their smoking, encourage 
behavioral and medication support, refer patients to the program, and 
encourage follow-up with the treatment group referral. 
1.3.3 
Conceptual Framework for Treatment 
Our tobacco counseling sessions, which address tobacco use in the 
context of a cancer diagnosis, combines two theoretical lenses—a 
coping with illness model and a health behavior change model. The 
Self-Regulation Model (SRM)147,148 focuses on the dynamic process 
between beliefs, emotions and coping, and has been widely used to 
study patients’ coping with cancer. Applying the SRM to a cancer 
diagnosis, changes in beliefs about cancer outcomes may lead 
smokers to engage in quitting as a strategy to cope with the cognitive 
and emotional threat of cancer. If individuals’ evaluation of the effects 
of quitting, physical changes (e.g., breathing has improved) and 
environmental influences (e.g., smokefree home), make them feel 
better, then they will stay quit. If quitting smoking decreases a sense 
of shame and anxiety, this will increase chances of staying quit. The 
HBM149 posits that when faced with a health threat, individuals are 
more likely to change a behavior if they feel the threat is serious, they 
are at risk, they are able to make the change, and the change would 
decrease their risk. Applying the Health Belief Model (HBM) to a 
cancer diagnosis, smokers will be more likely to engage in tobacco 
treatment and quit if they 1) believe that continued smoking after a 
cancer diagnosis threatens health, 2) understand that continuing to 
smoke puts them at risk for poor outcomes, 3) are confident they can 
quit, and 4) believe quitting will improve outcomes. 
1.3.4 
Rationale for NRT 
The selection of combination NRT is based on the current 
recommendations for the NCCN Smoking Cessation Guidelines2 and 
data from our prior clinical trial demonstrating safety and strong 
patient preferences. Smokefree Support Study 1 intervention arm 
participants were offered a choice of NRT (patch and/or lozenge), 
bupropion sustained release (Zyban, Wellbutrin), or varenicline 
(Chantix). In preliminary analyses as of February 2018, 80% of 
Intervention Treatment group participants elected to receive a 
smoking cessation medication, among which 83% selected NRT. 
Reported NRT medication side effects have been minor (e.g., tingling 
sensation on tongue, vivid dreams). Thus, given patient preferences 
and safety results from the R01 trial, combined with the ability to 
deliver the NRT via mail, patch and lozenge will be used in this trial. 
Additionally, NRT is being used by many state quitlines, has 
successfully been used with cancer patients,150,151 is available over-
the-counter, and is covered by Medicaid and many private insurers. 
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from NRT, including combination NRT, are significantly less than from 
smoking cigarettes; additionally, there is insufficient evidence that 
NRT causes cancer in humans or increases risk of myocardial 
infarction or cardiovascular disease.51,152,153 
1.3.5 
Counseling Approach 
Counselors will contact patients directly (via phone, e-mail, or text 
messaging) to schedule the virtual counseling sessions. Counseling 
sessions will be conducted via MGH TeleHealth, which connects 
providers to patients through virtual HIPAA-compliant 
videoconferencing technology including: phone, video, email, mobile 
applications and remote monitoring. These virtual visits are conducted 
via a videoconference platform that addresses clinical privacy and 
security (e.g., Zoom, Doximity, or other HIPPA-compliant platform). 
2017 Pew findings154, 155 showed that 74% of adults ages 50-64 
(average projected age of proposed study sample) own Smart 
Phones, and 87% use the internet; thus, a web-based option is a 
feasible modality.156 
The VIT session materials have been created at the 8th grade reading 
level.160 The counseling will be delivered by a study-designated 
tobacco treatment coach based at MGH and trained in a Motivational 
Interviewing (MI) style161-162, structured according to the 5As format 
and personalized to participant’s cessation readiness and cancer 
treatment phase (initiation, transitions, surveillance). MI is an 
empathic and supportive style of treatment161 for smoking 
cessation,162 proven effective in treating low SES smokers and 
smokers with medical co-morbidities.16,85 Dr. Park has effectively used 
MI to promote quitting among childhood cancer survivors and lung 
cancer patients.79,126 MI is particularly effective with cancer patients; 1) 
MI focuses on building and maintaining self-confidence, and our pilot 
work showed that cancer patients report low confidence; 2) the main 
MI tools (e.g., affirmations, reflections) are effective when addressing 
sensitive topics, such as cancer and smoking-related beliefs (e.g., 
shame, fear of recurrence), and in delivering sensitive information 
(e.g., risks of smoking during cancer treatment);161 and 3) MI skills will 
encourage and sustain quit motivation. 
Of note, the intervention counseling as delivered here is a psycho-
educational program, and is not being delivered as clinical care. 
 
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2. 
Objectives 
We propose to conduct the first study to examine the effectiveness and implementation 
of a virtually-delivered, evidence-based tobacco treatment into cancer care for patients 
in community oncology settings. Our study is designed to compare the effectiveness and 
implementation of an Enhanced Usual Care (EUC; control group) versus a Virtual 
Intervention Treatment (VIT; intervention group) for tobacco cessation in newly 
diagnosed cancer patients who smoke. Trial findings will establish the effectiveness and 
cost of utilizing a virtual strategy to deliver evidence-based tobacco treatment in 
community oncology settings and provide detailed initial data on implementation 
processes that will inform subsequent testing of multi-level implementation strategies for 
broad national dissemination into community cancer care settings. 
2.1 
Study Aims: 
2.1.1 
Aim 1: To assess treatment effectiveness, by comparing the 
proportions of participants in the Enhanced Usual Care (EUC) and 
Virtual Tobacco Treatment (VIT) study arms abstinent post 
enrollment.  
2.1.2 
Aim 2: To assess the potential effect of potential moderators (e.g., 
sociodemographics, medical and smoking history, cancer variables) 
on treatment effectiveness between the two arms. 
2.1.3 
Aim 3: To assess the processes of implementation and dissemination 
(acceptability, adoption, appropriateness, treatment fidelity, cost 
effectiveness, penetration/reach, and sustainability) of delivering 
tobacco treatment interventions at community oncology sites. 
2.2 
Primary Objective: 
2.2.1 
Treatment effectiveness (Aim 1) 
To compare the proportions of participants in the Enhanced Usual 
Care (EUC) and Virtual Tobacco Treatment (VIT) study arms with 
biochemically-verified 7-day point-prevalence abstinence from 
cigarettes at 6-months post enrollment. 
We will define biochemically-verified 7-day point-prevalence 
abstinence at 6 month follow-up by: 
• 
saliva cotinine (< 15 ng/ml), or 
• 
expired air CO (< 10ppm) 
2.3 
Secondary Objectives: 
2.3.1 
Secondary treatment effectiveness (Aim 1) 
Secondary smoking outcomes (5) include: 
• 
Biochemically-verified 7-day point prevalence abstinence at 3-
months follow-up 
• 
Self-reported 7-day point prevalence cigarette abstinence at 3- 
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• 
Significant reduction (> 50% reduction in reported number of 
cigarettes per day) in daily smoking from baseline to 3- and 
baseline to 6-months follow-up 
• 
Continuous (no self-reported smoking since last survey point) and 
sustained abstinence at 6 months (cotinine-verified at 3-months 
and 6-months) 
2.4 
Exploratory Objectives 
Aim 2: To assess the potential effect of known and potential moderators on 
treatment effectiveness between the two arms. 
Exploratory analyses will examine the moderator and mediator effects on 
treatment effectiveness (Aim 2). 
Moderators/Mediators of primary interest: 
• 
Sociodemographics: Sex, age, marital status, race/ethnicity, education level, 
financial burden, health insurance, internet and smartphone access and 
modality 
• 
Smoking history: Years smoked, daily smoking rate, other tobacco/nicotine 
use (e.g., cigars, cigarettes), current/past use of tobacco treatments, nicotine 
dependence 
• 
Cancer variables: Cancer type, cancer stage, treatment, and days since 
diagnosis 
• 
Site characteristics: Site, geographic location, clinic volume, baseline 
organizational readiness, site usual care 
Additional moderators/mediators to be explored: 
• 
Medical history: ECOG Performance Status, alcohol use 
• 
Quality of life/emotions: Emotional distress, coping, anxiety, depression 
• 
Cancer and smoking beliefs: Stigma, quit motivation, self-efficacy to quit, 
importance of quitting, perceived benefits of quitting smoking, quit-smoking 
medication beliefs 
• 
Physical symptoms: Cravings 
• 
Environmental influences: Level of second-hand smoke exposure, perceived 
social support, perceived provider support 
Aim 3: To assess the processes of implementation and dissemination 
(acceptability, adoption, appropriateness, treatment fidelity, cost effectiveness, 
penetration/reach, and sustainability) of our intervention at community oncology 
sites 
Guided by Proctor and colleagues’ (2011) recommendations for measurement of 
implementation outcomes, we will explore the following to gain an initial 
understanding of the implementation process (Aim 3). 
Implementation Outcomes 
• 
Acceptability: Patient satisfaction with content/delivery of their randomly 
assigned tobacco treatment 
• 
Adoption: Site program uptake, changes in organizational readiness to deliver 
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• 
Appropriateness: Perceived fit and relevance of the VIT and EUC 
interventions from the perspective of representative site staff 
• 
Tobacco Treatment fidelity: Delivery of all components of the Smokefree 2.0 
Study Treatment Interventions (EUC and VIT). 
• 
Cost: Incremental cost per quit of the VIT intervention relative to the EUC 
control over the 6-month follow-up period 
• 
Feasibility: Ease of delivery and suitability for routine care of the VIT and 
EUC interventions 
• 
Penetration/Reach: Patient participation rate at each site, reasons for study 
ineligibility and refusal, comparison of sociodemographic and cancer variable 
characteristics of enrollees and refusers of the study 
• 
Sustainability: Resources needed and preference for a site-based centralized 
tobacco treatment program 
Using existing staff data collection survey and interview tools as well as synthesis 
of notes from minutes of monthly meetings with CCDR Leads and study 
investigators, we will enhance our understanding of the implementation process 
(Aim 3) by: 1) examining organizational characteristics that influence adoption of 
tobacco treatment interventions; and 2) identifying and developing strategies to 
address barriers for implementation of tobacco use assessment and treatment in 
the trial. This exploratory research will add to the limited knowledge about 
contextual factors influencing the engagement of community oncology sites in the 
adoption of tobacco use assessment and treatment; and inform how best to 
engage community oncology practices in the integration of smoking cessation in 
cancer care. 
 
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3. 
Participant Selection 
3.1 
Selection of NCORP Site Staff Participants 
In order to achieve Aim 3, we will enroll a subset of staff (n=approximately 110) 
from a minimum of 11 participating NCORP sites. We are seeking to elicit 
implementation process perspectives from key stakeholders (clinicians and 
research administration staff) who would most likely be instrumental in making 
tobacco use assessment and treatment routine part of cancer care. Guided by 
his/her knowledge of key stakeholders’ roles and responsibilities, the Cancer 
Care Delivery Research (CCDR) Leader and site PI from each participating site 
will be responsible for identifying approximately 10 multidisciplinary staff 
members to complete brief (approximately 15 minute) surveys and participate in 
focus group interviews (approximately 45-60 minutes). The focus group interview 
will be conducted approximately 24-36 months after site activation, upon the 
completion of 36-month follow-up surveys by the site. Although specific site staff 
participant composition will vary somewhat by site, we envision participation of 
the CCDR Leader, the Site PI, 2-3 oncology nurses, 2-3 additional medical 
oncologists and 2-3 additional staff members. 
In terms of eligibility criteria, eligible NCORP site staff participants will be English-
speaking, employed at the NCORP site for at least three months, and able to 
provide informed consent to participate in this study (see Informed Consent for 
NCORP Staff). The CCDR Lead and Site PI will be responsible for consenting 
each other and the other staff participants. The CCDR Lead will update the 
REDCap Roster survey with the dates of consent for each participant. The 
consent date entered into the MSK REDCap Roster survey will be used as the 
source documentation by MSK staff to send out the baseline survey to those 
consented participants. Given the minimal risk, minimal burden and broad 
relevance of this research to CCDR priorities for enhancing high quality cancer 
care, we do not anticipate any difficulty recruiting staff participants. In the event 
that there is staff turnover, the CCDR Leader will be responsible for identifying 
one or more replacement staff participants who will provide 12 and 36-month 
follow-up surveys and participate in the focus group interview. Given our 
assumption that the selected staff represent key site stakeholders and that the 
quantitative (baseline, 12 and 36-month follow-up surveys) and qualitative data 
(focus group interview) will be analyzed at the level of the site, some variation in 
pre- and post-trial participants will is allowable and will not diminish the 
accomplishment of Aim 3. 
3.1.1 
Staff Eligibility Criteria 
3.1.1.1 
Must be English speaking 
3.1.1.2 
Must be employed at NCORP site for at least three months 
3.2 
Selection of Patients 
Each of the criteria in the checklist that follows must be met in order for a patient 
to be considered eligible for this study. Use the checklist to confirm a patient’s 
eligibility. For each patient, this checklist must be photocopied, completed and 
maintained in the patient’s chart. 
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In calculating days of tests and measurements, the day a test or 
measurement is done is considered Day 0. Therefore, if a test is done on a 
Monday, the Monday four weeks later would be considered Day 28. 
ECOG-ACRIN Patient No. ____________________________ 
Patient’s Initials (L, F, M) _______________________ 
Physician Signature and Date ___________________ 
NOTE: 
NCI Policy does not allow for the issuance of waivers to any protocol 
specified criteria 
(http://ctep.cancer.gov/protocolDevelopment/policies_deviations.htm). 
Therefore, all eligibility criteria listed in Section 3 must be met, without 
exception. The registration of individuals who do not meet all criteria 
listed in Section 3 can result in the participant being censored from 
the analysis of the study, and the citation of a major protocol violation 
during an audit. All questions regarding clarification of eligibility criteria 
must be directed to the Group's Executive Officer 
(EA.ExecOfficer@jimmy.harvard.edu) or the Group's Regulatory 
Officer (EA.RegOfficer@jimmy.harvard.edu). 
NOTE: 
Institutions may use the eligibility checklist as source documentation if 
it has been reviewed, signed, and dated prior to 
registration/randomization by the treating physician. 
3.2.1 
Patient Eligibility Criteria Step 0 and Step 1 (Registration) 
3.2.1.1 
Inclusion 
3.2.1.1.1 
Age ≥ 18 years. 
3.2.1.1.2 
Patient presenting with any type of cancer 
with a date of diagnosis within the past 4 
months (124 days) at the time of Step 0 
Registration. 
Recurrence, diagnosed within the last 4 
months, of tumors in patients with past 
cancer diagnoses will be considered 
eligible. Patients with a new primary cancer, 
diagnosed within the last 4 months (124 
days) at the time of Step 0 Registration, 
who have been treated previously for other 
types of cancer will also be considered 
eligible. “In situ” cancers, diagnosed within 4 
months (124 days) at the time of Step 0 
Registration), will also be considered 
eligible. 
3.2.1.1.3 
Patient must be a current smoker. Current 
smoker is defined as any cigarette smoking 
(even a puff) in the past 30 days prior to 
Step 0 Registration. 
3.2.1.1.4 
Patient must be fluent in both written and 
spoken, English or both written and spoken, 
Spanish. 
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3.2.1.1.5 
Patient must have telephone, e-mail access, 
and have access to the internet with a 
camera-enabled device (e.g.,. smartphone, 
tablet, computer, laptop with a 
webcam/camera). 
NOTE: 
The restriction to those with web 
and e-mail access is based on 
the primary intention of the 
study; to assess the 
implementation of the virtual 
intervention in the NCORP 
network. 
3.2.1.2 
Exclusion (Subject must not meet any of the criteria listed 
here) 
3.2.1.2.1 
Patient has an ECOG performance status of 
3 or above, or is deemed medically unable 
to participate by study investigators or 
oncology clinician (i.e., referral to hospice). 
3.2.1.2.2 
Patient has no intention to receive their 
cancer care or monitoring at an NCORP 
community cancer site. 
3.2.2 
Patient Eligibility Criteria Step 1 (Registration) 
3.2.2.1 
Patient must still meet all criteria outlined in Step 0 
NOTE: The requirement to register within 4 months from 
cancer diagnosis is determined by the date of the 
Step 0 registration and not the date of the Step 1 
registration. 
3.2.3 
Patient Eligibility Criteria Step 2 (Randomization) 
3.2.3.1 
Patient must have completed Baseline Survey in EASEE-
PRO within 31 days of the date of Written Informed 
Consent (Step 1). 
 
 
 
 
Physician Signature 
 
Date 
OPTIONAL: 
This signature line is provided for use by institutions wishing to 
use the eligibility checklist as source documentation. 
 
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4. 
Registration and Randomization Procedures 
CTEP Investigator Registration Procedures 
Food and Drug Administration (FDA) regulations and National Cancer Institute (NCI) 
policy require all individuals contributing to NCI-sponsored trials to register and to renew 
their registration annually. To register, all individuals must obtain a Cancer Therapy 
Evaluation Program (CTEP) Identity and Access Management (IAM) account 
(https://ctepcore.nci.nih.gov/iam). In addition, persons with a registration type of 
Investigator (IVR), Non-Physician Investigator (NPIVR), or Associate Plus (AP) must 
complete their annual registration using CTEP’s web-based Registration and Credential 
Repository (RCR) (https://ctepcore.nci.nih.gov/rcr). Documentation requirements per 
registration type are outlined in the table below. 
RCR utilizes five person registration types. 
• 
IVR — MD, DO, or international equivalent; 
• 
NPIVR — advanced practice providers (e.g., NP or PA) or graduate level 
researchers (e.g., PhD); 
• 
AP — clinical site staff (e.g., RN or CRA) with data entry access to CTSU 
applications (e.g., Roster Update Management System (RUMS), OPEN, Rave,); 
• 
Associate (A) — other clinical site staff involved in the conduct of NCI-sponsored 
trials; and 
• 
Associate Basic (AB) — individuals (e.g., pharmaceutical company employees) with 
limited access to NCI-supported systems. 
RCR requires the following registration documents: 
Documentation Required 
IVR 
NPIVR 
AP 
A 
AB 
FDA Form 1572 
✔ 
✔ 
 
 
 
Financial Disclosure Form 
✔ 
✔ 
✔ 
 
 
NCI Biosketch (education, training, 
employment, license, and 
certification) 
✔ 
✔ 
✔ 
 
 
GCP training 
✔ 
✔ 
✔ 
 
 
Agent Shipment Form (if 
applicable) 
✔ 
 
 
 
 
CV (optional) 
✔ 
✔ 
✔ 
 
 
An active CTEP-IAM user account and appropriate RCR registration is required to 
access all CTEP and CTSU (Cancer Trials Support Unit) websites and applications. In 
addition, IVRs and NPIVRs must list all clinical practice sites and IRBs covering their 
practice sites on the FDA Form 1572 in RCR to allow the following: 
• 
Added to a site roster 
• 
Assigned the treating, credit, consenting, or drug shipment (IVR only) tasks in OPEN 
• 
Act as the site-protocol PI on the IRB approval 
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In addition, all investigators act as the Site-Protocol PI, consenting/treating/drug 
shipment, or as the CI on the DTL must be rostered at the enrolling site with a 
participating organization (i.e., Alliance). Additional information can be found on the 
CTEP website at <https://ctep.cancer.gov/investigatorResources/default.htm>. 
For questions, please contact the RCR Help Desk by email at 
<RCRHelpDesk@nih.gov>. 
CTSU Registration Procedures 
This study is supported by the NCI Cancer Trials Support Unit (CTSU). 
IRB Approval: 
For CTEP and Division of Cancer Prevention (DCP) studies open to the National Clinical 
Trials Network (NCTN) and NCI Community Oncology Research Program (NCORP) 
Research Bases after March 1, 2019, all U.S.-based sites must be members of the NCI 
Central Institutional Review Board (NCI CIRB). In addition, U.S.-based sites must accept 
the NCI CIRB review to activate new studies at the site after March 1, 2019. Local IRB 
review will continue to be accepted for studies that are not reviewed by the CIRB, or if 
the study was previously open at the site under the local IRB. International sites should 
continue to submit Research Ethics Board (REB) approval to the CTSU Regulatory 
Office following country-specific regulations.  
Sites participating with the NCI CIRB must submit the Study Specific Worksheet for 
Local Context (SSW) to the CIRB using IRBManager to indicate their intent to open the 
study locally. The NCI CIRB’s approval of the SSW is automatically communicated to the 
CTSU Regulatory Office, but sites are required to contact the CTSU Regulatory Office at 
CTSURegPref@ctsu.coccg.org to establish site preferences for applying NCI CIRB 
approvals across their Signatory Network. Site preferences can be set at the network or 
protocol level. Questions about establishing site preferences can be addressed to the 
CTSU Regulatory Office by emailing the email address above or calling 1-888-651-
CTSU (2878). 
In addition, the Site-Protocol Principal Investigator (PI) (i.e., the investigator on the 
IRB/REB approval) must meet the following criteria to complete processing of the 
IRB/REB approval record: 
• 
Holds an Active CTEP status; 
• 
Rostered at the site on the IRB/REB approval (applies to US and Canadian sites 
only) and on at least one participating roster; 
• 
If using NCI CIRB, rostered on the NCI CIRB Signatory record; 
• 
Includes the IRB number of the IRB providing approval in the Form FDA 1572 in the 
RCR profile; and 
• 
Holds the appropriate CTEP registration type for the protocol. 
Additional Requirements 
Additional requirements to obtain an approved site registration status include: 
• 
An active Federal Wide Assurance (FWA) number; 
• 
An active roster affiliation with the Lead Protocol Organization (LPO) or a 
Participating Organization (PO); and 
• 
Compliance with all protocol-specific requirements (PSRs). 
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Downloading Site Registration Documents: 
Download the site registration forms from the protocol-specific page located on the 
CTSU members’ website. Permission to view and download this protocol and its 
supporting documents is restricted based on person and site roster assignment. To 
participate, the institution and its associated investigators and staff must be associated 
with the LPO or a PO on the protocol. 
• 
Log on to the CTSU members’ website at https://www.ctsu.org using your CTEP-IAM 
username and password 
• 
Click on Protocols in the upper left of your screen 
• 
Either enter the protocol # in the search field at the top of the protocol tree, or 
• 
Click on the By Lead Organization folder to expand 
Click on the ECOG-ACRIN link to expand, then select trial protocol EAQ171CD 
Click on Documents, select Site Registration, and download and complete the forms 
provided. (Note: For sites under the CIRB initiative, IRB data will load automatically to 
the CTSU as described above). 
Requirements For EAQ171CD Site Registration: 
• 
Study Chair approval 
Submitting Regulatory Documents 
Submit required forms and documents to the CTSU Regulatory Office via the Regulatory 
Submission Portal on the CTSU website. 
To access the Regulatory Submission Portal log on to the CTSU members’ website → 
Regulatory → Regulatory Submission 
Institutions with patients waiting that are unable to use the Regulatory Submission Portal 
should alert the CTSU Regulatory Office immediately at 1-866-651-2878 in order to 
receive further instruction and support. 
Required Protocol Specific Regulatory Documents 
1. Copy of IRB Informed Consent Document. 
NOTE:  
Any deletion or substantive modification of information concerning risks or 
alternative procedures contained in the sample informed consent 
document must be justified in writing by the investigator and approved by 
the IRB. 
2. A.  CTSU IRB Certification Form. 
 
Or 
B.  Signed HHS OMB No. 0990-0263 (replaces Form 310). 
 
Or 
 
C.  IRB Approval Letter 
NOTE:  
The above submissions must include the following details: 
• 
Indicate all sites approved for the protocol under an assurance 
number. 
• 
OHRP assurance number of reviewing IRB 
• 
Full protocol title and number 
• 
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• 
Type of review (full board vs. expedited) 
• 
Date of review. 
• 
Signature of IRB official 
Checking Your Site’s Registration Status: 
You can verify your site registration status on the members’ section of the CTSU 
website. 
• 
Go to https://www.ctsu.org and log in to the members’ area using your CTEP-IAM 
username and password 
• 
Click on Regulatory at the top of the screen; 
• 
Click on Site Registration; 
• 
Enter your 5-character CTEP Institution Code and click on Go; 
• 
Additional filters are available to sort by Protocol, Registration Status, Protocol 
Status, and/or IRB type. 
NOTE: The status shown only reflects institutional compliance with site registration 
requirements as outlined above. It does not reflect compliance with protocol 
requirements for individuals participating on the protocol or the enrolling 
investigator’s status with the NCI or their affiliated networks. 
Patient Enrollment 
Patients must not start protocol intervention prior to registration. 
The Oncology Patient Enrollment Network (OPEN) is a web-based registration system 
available on a 24/7 basis. OPEN is integrated with CTSU regulatory and roster data and 
with the Lead Protocol Organization (LPOs) registration/randomization systems or 
Theradex Interactive Web Response System (IWRS) for retrieval of patient 
registration/randomization assignment. OPEN will populate the patient enrollment data in 
NCI’s clinical data management system, Medidata Rave. 
Requirements for OPEN access: 
• 
A valid CTEP-IAM account; 
• 
To perform enrollments or request slot reservations: Be on a LPO roster, ETCTN 
Corresponding roster, or PO roster with the role of Registrar. Registrars must hold a 
minimum of an AP registration type; and 
• 
Have an approved site registration for a protocol prior to patient enrollment. 
To assign an Investigator (IVR) or Non-Physician Investigator (NPIVR) as the treating, 
crediting, consenting, drug shipment (IVR only), or receiving investigator for a patient 
transfer in OPEN, the IVR or NPIVR must list the IRB number used on the site’s IRB 
approval on their Form FDA 1572 in RCR. Prior to accessing OPEN, site staff should 
verify the following: 
• 
All eligibility criteria have been met within the protocol stated timeframes.  
• 
All patients have signed an appropriate consent form and HIPAA authorization form 
(if applicable). 
NOTE: 
The OPEN system will provide the site with a printable confirmation of 
registration and treatment information. Please print this confirmation for your 
records. 
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Access OPEN at https://open.ctsu.org or from the OPEN link on the CTSU members’ 
website. Further instructional information is provided on the OPEN tab of the CTSU 
members’ side of the CTSU website at https://www.ctsu.org or at https://open.ctsu.org. 
For any additional questions contact the CTSU Help Desk at 1-888-823-5923 or 
ctsucontact@westat.com. 
4.1 
Registration Information Required at Step 0 
4.1.1 
Protocol Number 
4.1.2 
Investigator Identification 
• 
Institution and Affiliate Name 
• 
Investigator’s Name 
4.1.3 
Patient Identification 
• 
Smoking Status 
• 
ECOG Performance Status 
• 
Cancer Diagnosis 
• 
Verbal Consent 
• 
Patient Demographics 
• 
Gender 
• 
Age 
• 
Race 
• 
Ethnicity 
• 
Method of Payment 
• 
Language 
• 
Care at NCORP 
• 
Cancer Stage 
• 
Email Address 
4.2 
Eligibility Verification  
Patients must meet all of the eligibility requirements listed in Section 3.2. 
4.3 
Registration Information Required at Step 1 
4.3.1 
Protocol Number 
4.3.2 
Investigator Identification 
• 
Institution and Affiliate Name 
• 
Investigator’s Name 
4.3.3 
Patient Identification 
• 
Patient Demographics 
• 
Gender 
• 
Age 
• 
Race 
• 
Ethnicity 
• 
Written Informed Consent 
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• 
HIPAA authorization 
NOTE: 
The Registration Information listed in Section 4.3 does not need to be 
re-entered into OPEN if there are no changes since Step 0. 
4.4 
Eligibility Verification 
Patients must meet all of the eligibility requirements listed in Section 3. 
4.5 
Registration Information Required at Step 2 (Randomization) 
4.5.1 
Protocol Number 
4.5.2 
Investigator Identification 
• 
Institution and Affiliate Name 
• 
Investigator’s Name 
4.5.3 
Patient Identification 
• 
Patient Demographics 
• 
Gender 
• 
Age 
• 
Race 
• 
Ethnicity 
• 
Method of Payment 
• 
Baseline EASEE-PRO completed within 30 days of date of 
written informed consent 
• 
Previously enrolled in ECOG-ACRIN study 
NOTE: 
The Registration Information listed in Section 4.5 does not need to be 
re-entered into OPEN if there are no changes since Step 0. 
4.6 
Stratification Factors 
Stratification within site 
4.7 
Additional Requirements  
4.7.1 
Patients must provide a signed and dated, written informed consent 
form in order to continue into Step 1. 
NOTE: 
Copies of the consent are not collected by the ECOG-
ACRIN Operations Office – Boston. 
4.7.2 
See Section 10 for submission of biochemical validation of smoking 
status by saliva samples or collection of CO measurements. 
4.7.3 
Registration of Patients 
Prior to enrollment of the first patient sites must confirm they have 
completed the following to receive final IRB approval in the CTSU 
system: 
• 
Baseline surveys must be completed by 10 staff members as 
outlined in Sections 3.1 and 6.3 of the protocol. 
• 
Brief videos videos must be completed and approved by study 
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For approval of brief videos and to confirm all baseline surveys have 
been completed, please email the study alias at 
smokefreesupportstudy2@partners.org. The study staff will then 
inform the CTSU that your site is ready for enrollment. 
4.7.4 
Medidata Rave is a clinical data management system being used for 
data collection for this trial/study. Access to the trial in Rave is 
controlled through the CTEP-IAM system and role assignments. 
Requirements to access Rave via iMedidata:: 
• 
A valid and active CTEP-IAM account; and  
• 
Assigned a Rave role on the LPO or PO roster at the enrolling site 
of: Rave CRA, Rave Read Only, Rave CRA (LabAdmin), Rave 
SLA, or Rave Investigator.To hold Rave CRA or Rave CRA (Lab 
Admin) role, site staff must hold a minimum of an AP registration 
type; 
Rave role requirements: 
• 
Rave CRA or Rave CRA (Lab Admin) role must have a minimum 
of an Associate Plus (AP) registration type; 
• 
Rave Investigator role must be registered as an Non-Physician 
Investigator (NPIVR) or Investigator (IVR); and 
• 
Rave Read Only role must have at a minimum an Associates (A) 
registration type. 
Refer to https://ctep.cancer.gov/investigatorResources/default.htm for 
registration types and documentation required. 
Upon initial site registration approval for the study in Regulatory 
Support System (RSS), all persons with Rave roles assigned on the 
appropriate roster will be sent a study invitation e-mail from iMedidata. 
To accept the invitation, site staff must log in to the Select Login 
(https://login.imedidata.com/selectlogin) using their CTEP-IAM 
username and password, and click on the accept link in the upper 
right-corner of the iMedidata page. Site staff will not be able to access 
the study in Rave until all required Medidata and study specific 
trainings are completed. Trainings will be in the form of electronic 
learnings (eLearnings),and can be accessed by clicking on the link in 
the upper right pane of the iMedidata screen. If an eLearning is 
required and has not yet been taken, the link to the eLearning will 
appear under the study name in iMedidata instead of the Rave EDC 
link; once the successful completion of the eLearning has been 
recorded, access to the study in Rave will be granted, and a Rave 
EDC link will display under the study name.  
Site staff that have not previously activated their iMedidata/Rave 
account at the time of initial site registration approval for the study in 
RSS will also receive a separate invitation from iMedidata to activate 
their account. Account activation instructions are located on the CTSU 
website in the Rave section under the Rave resource materials 
(Medidata Account Activation and Study Invitation Acceptance). 
Additional information on iMedidata/Rave is available on the CTSU 
members’ website in the Data Management > Rave section at 
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www.ctsu.org/RAVE/ or by contacting the CTSU Help Desk at 1-888-
823-5923 or by e-mail at ctsucontact@westat.com. 
4.7.4.1 
The Data Quality Portal (DQP) provides a central location 
for site staff to manage unanswered queries and form 
delinquencies, monitor data quality and timeliness, 
generate reports, and review metrics.  
The DQP is located on the CTSU members’ website under 
Data Management. The Rave Home section displays a 
table providing summary counts of Total Delinquencies 
and Total Queries. DQP Queries, DQP Delinquent Forms 
and the DQP Reports modules are available to access 
details and reports of unanswered queries, delinquent 
forms, and timeliness reports. Review the DQP modules 
on a regular basis to manage specified queries and 
delinquent forms. 
The DQP is accessible by site staff that are rostered to a 
site and have access to the CTSU website. Staff that have 
Rave study access can access the Rave study data using 
a direct link on the DQP. 
To learn more about DQP use and access, click on the 
Help icon displayed on the Rave Home, DQP Queries, and 
DQP Delinquent Forms modules. 
NOTE: 
Some Rave protocols may not have delinquent 
form details or reports specified on the DQP. A 
protocol must have the Calendar functionality 
implemented in Rave by the Lead Protocol 
Organization (LPO) for delinquent form details 
and reports to be available on the DQP. Site 
staff should contact the LPO Data Manager for 
their protocol regarding questions about Rave 
Calendaring functionality. 
4.7.5 
ECOG-ACRIN Systems for Easy Entry of Patient Reported Outcomes 
(EASEE-PRO) System 
We will use a combination of EASEE-PRO and mailed questionnaires 
for this study. A proxy or family member can complete the 
questionnaires on behalf of the patient as long as they can speak 
English or Spanish. The questionnaires are only available in English 
or Spanish. 
Access to the study in EASEE-PRO is granted to all participants 
registered to the study through the OPEN registration system with a 
valid participant email address. Upon registration, an account 
verification email will be sent to the user with a link to activate their 
account. The user will be required to enter some verification 
information (e.g. DOB) in order to activate their EASEE-PRO account. 
Additionally, site persons with the appropriate roles in RSS will be 
granted access after IRB approval is obtained. In some studies, this 
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EASEE-PRO Participant Access: 
To access EASEE-PRO, the participant must have an active EASEE-
PRO user account. Upon registration to the study in OPEN, an 
account activation email will be sent to the address entered for the 
participant in OPEN eligibility checklist. This email address must be a 
valid email address for the participant. All participants in the 
EAQ171CD Study are required to have access to the internet and a 
valid email address to participate. (If the patient email address were 
entered incorrectly in OPEN, the CRA must contact the OEAU (pro-
help@stat.brown.edu to manually correct the error.) To activate their 
account, users must click the link in the email and verify their account 
before they can login and complete surveys or view web education 
materials. Once the account is activated, participants may login to the 
EASEE-PRO system through the OEAU-PRIDE web portal 
(https://pride.stat.brown.edu/Participant-Login). Upon login, users will 
be presented with a list of available surveys and materials they can 
view. 
EASEE-PRO CRA Access: 
To access EASEE-PRO, the site user must have an active CTEP IAM 
account (https://eapps-ctep.nci.nih.gov/iam). In addition, site users 
that are a member of ECOG-ACRIN must have the mapped ECOG-
ACRIN roles or explicit Rave roles (Rave CRA) in RSS at the enrolling 
site. Site users that are not members of ECOG-ACRIN must have the 
Rave roles on the CTSU roster at the enrolling sites. The Site 
Administrator or Data Administrator at the enrolling site may assign 
the appropriate roles from the Site Roles tab on the CTSU website. To 
login, CRAs will use their CTSU(IAM) credentials on the OEAU-
PRIDE web portal (https://pride.stat.brown.edu/CRA-Login) using the 
familiar IAM interface.  No e-learnings are required for use of this site. 
The ECOG-ACRIN Outcomes and Economics Assessment Unit can 
be contacted for Patient Reported Outcome Questions via email at 
pro-help@stat.brown.edu. An EASEE-PRO instructional guide for 
both sites and patients can be found on both the E-A and CTSU 
websites. 
Please see below for additional details on the EASEE-PRO system. 
1. A secure environment for control of user records, information, and 
transactions (SECURIT): Provides a secure – limited access point 
for entering data into the restricted secure PII Database, for 
management of user data, creating user accounts, and reporting. 
The SECURIT web management interface requires the secure 
hypertext transfer protocol (HTTPS) to ensure encryption of 
transmitted data. 
a) PII database: is a dedicated secure limited access database, 
used to store protected PII. 
i) Secure: All communications to the PII database through 
SECURIT are encrypted. The database resides behind a 
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ii) Limited access: this database is restricted not only by 
username and password but is also restricted to specified 
internal OEAU computers by IP address, so that only 
authorized users logging in at the OEAU from pre-specified 
computers may access/enter PII.  At no time is outside 
access allowed to this database. 
iii) Protected restricted PII (e.g. SSN) are encrypted at the 
time of data entry and double data entered for verification. 
All users regardless of their security level are blinded to 
this protected data, and it cannot be decrypted without the 
encryption key, housed in a safe, in a location separate 
from the OEAU. This type of data is generally collected for 
long term follow-up where it may be needed to be 
decrypted for select patients in order to search registries 
like the national death index to determine survival status of 
lost participants. In these instances, with appropriate 
approvals, the Database Administrator will decrypt this 
data in accordance with the approved retrieval 
specification. 
b) User records: This functionality allows OEAU personnel, using 
specific computers within the OEAU, to create user records, 
enter user information into the PII database, and establish 
user web accounts in the separate user database. Allows the 
management of users and their data, including the ability to 
update a participant’s preferred contact method, address, and 
participation status (e.g., no longer wishes to be contacted 
with respect to the PRO component of the study). 
c) Information: This functionality allows the OEAU to record all 
participant contact, document any changes to the participant, 
and make any important notes related to the participant. Note 
that a paper based patient contact form will require completion 
by the patient. Site staff will need to fax the patient contact 
forms to the OEAU office. See section 11.2. 
d) Transactions: SECURIT provides a reporting and monitoring 
interface to the PRO database, which is used to store non-PII 
patient reported survey responses. 
i) Allows OEAU to monitor per patient form completion status 
using the tracking management facility. This facility reports 
on what data is currently expected from participants, 
CRAs, and the OEAU interviewers. 
ii) Aggregate reporting: this series of reports allows the 
OEAU to monitor the distribution of patients over data 
completion methods and form completion methods (both 
overall and by site). 
2. Database utility and control environment (PRO-DUCE): This 
utility interfaces with the main clinical database containing 
CRF/trigger data (Medidata RAVE), monitors the clinical 
database for events (eg., participant registrations, scheduled 
procedures, and other triggers) and establishes event 
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participants [and SMS text message reminders, when 
applicable to the study], and OEAU personnel to ensure timely 
completion of surveys. 
3. Web entry systems (PROWESs): a Web site where 
participants complete online surveys 
a) PROWESs provides a front facing web portal for 
participants to complete questionnaires and have those 
results stored in the PRO database. 
b) Secure site using HTTPS and requiring a username and 
password login. 
c) On login, user is presented with brief instructions; including 
approx. time for completion, number of questions to be 
completed in this session, any important information 
regarding this survey (including help and contact 
information) 
d) PROWESs is a one-way interface, data cannot be returned 
from the PRO-DB to the user. 
4. Valet Interface and data entry system (PROVIDES). 
a) The PROVIDES system is a web interface that allows site 
CRAs to act as a valet and enter a participant’s responses 
to a survey into the PRO database should the survey be 
completed on paper. This allows Site CRAs to enter forms 
completed by the patient on site. 
b) Secure site using HTTPS and requiring a username and 
password login. 
c) Which forms can be entered is restricted by username, site 
affiliation, and role, thus Sites RAs can only enter surveys 
predesignated as on-site data collection surveys and only 
for their own patients. 
d) On login, user is presented with brief instructions; is 
requested to select the protocol, case number, timepoint 
and verify the case Id by providing the participant 
birthdate. 
e) PROVIDES is a one-way interface, data cannot be 
returned from the PRO-DB to the user. 
4.7.6 
REDCap System to be used for Site Staff Surveys 
The site staff roster and survey data collected for this study will be 
managed through REDCap (Research Electronic Data Capture). 
REDCap is a free, secure, web-based application designed to support 
data collection and storage for research studies. REDCap is fully 
compliant with HIPPA regulations. REDCap is a tool for the creation of 
customized, secure data management systems including web-based 
data entry forms, reporting tools, and a full array of security features 
including user and group based privileges with a full audit trail of data 
manipulation and export procedures. More specifically, REDCap will 
be used to distribute and collect the roster, baseline, 12-month follow-
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the REDCap data management software system will be supported by 
Memorial Sloan Kettering Cancer Center (MSKCC). REDCap is 
maintained on MSKCC-owned servers that are kept in a locked server 
room with appropriate environmental modifications (e.g. proper 
ventilation, power redundancy and fault tolerance arrangement) and 
backed up nightly with some back-up tapes stored off-site. The 
MSKCC Information Systems group is responsible for applying all 
operating system patches and security updates to the REDCap 
servers. All connections to REDCap utilize encrypted (SSL-based) 
connections. Nationally, the REDCap software is developed, 
enhanced, and supported through a multi-institutional consortium led 
by Vanderbilt University. 
4.7.7 
Qualitative Data 
Focus Groups: This data will be stored using qualitative database 
software (NVivo) located on the MSKCC secure file network. 
Patient Exit Interviews: This data will be stored using qualitative 
database software (NVivo) located on the MGH secure file network. 
4.8 
Instructions for Patients who Do Not Complete Baseline Survey and/or Do Not 
Start Assigned Study Intervention 
If a patient is registered to Step 1 and does not complete the baseline survey 
within 30 days, the patient is considered off study and no additional data will be 
requested and patients will not be available to register to Randomization (Step 
2). 
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5. 
Methodology 
5.1 
Recruitment and Accrual 
Participants will be recruited from NCORP Community and Minority/Underserved 
sites. 
Screening may occur in accordance with local site policies and procedures. 
NCORP site staff may determine the following criteria by screening new patient 
lists/schedules, medical record reviews, or by approaching patients in clinic or via 
phone. Sites will provide weekly number totals (via a distributed REDCap survey) 
of smokers seen at this subcomponent site, patients ineligible (and reason), 
smokers approached to participate, and patients refused (and reason). 
For potentially eligible patients, the site staff will also verbally confirm the 
following additional criteria (as it is less readily-discernable from chart review), 
via phone or in clinic (in accordance with local site policies and procedures): 
• 
ECOG performance status (ineligible if 3 or above; eligible if 2 or below or no 
ECOG listed) 
• 
Cancer diagnosis (type; i.e., lung) and date (subject step 0 registration must 
be within 124 days of diagnosis date) 
• 
Age (must be 18 years or older) 
• 
Language (must be English or Spanish speaking) 
• 
Confirm they have smoked, even a puff, of a cigarette in the last 30 days 
• 
Confirm they intend to receive their cancer care or monitoring at NCORP site 
(not a one-time consult or second-opinion) 
• 
Confirm they have telephone, e-mail access, and have access to the internet 
with a camera-enabled device (e.g., smartphone, tablet, computer, laptop 
with a webcam/camera). 
The recommended process is as follows: Site staff to review new patient list or 
schedules, particularly the electronic medical records (EMR) of patients with 
upcoming visits to identify all patients who are identified as current smokers. This 
list can either be created using an automated report with information obtained 
from the relevant EMR fields (e.g., tobacco use) or manually by site staff. It is 
recommended that this list of potentially eligible patients be generated at least on 
a weekly basis. If information on the smoking status of patients is either missing 
or unknown, site staff should ask the patient about their current smoking status 
and update their record. The total count of current smokers onsite should be 
documented in the MSK REDCap Survey. 
EMRs of current smokers should be reviewed for patients who are adult (≥ 18 
years) and newly diagnosed (within past 4 months). Site staff should then 
approach these patients to confirm smoking status, receipt of care at the NCORP 
site, and email/web access, as well as any above-listed criteria that were unable 
to be discerned from chart review. 
Only patients who are still eligible after this initial chart review step should be 
approached about the study. For patients who are deemed ineligible, or whom 
refuse to be fully screened upon approach, during this screening process, site 
staff will document reasons in the MSK REDCap Survey (see Section 5.1.1). 
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For patients who meet study criteria, the site staff will ask the patient if it is okay 
for central coordinating study staff to contact them with a brief, informational 
video about the study. Verbal permission may occur per sites usual practice (via 
telephone or in clinic). For patients who refuse, reasons for refusal will be 
documented and tracked in the study specific enrollment log. Patients who agree 
to be contacted about the study will be registered in OPEN (Screening Step 0). 
Patient contact information and screening characteristics (criteria collected 
above) will be entered into OPEN. Once a Patient’s information is in OPEN, the 
virtual clinician referral (informational video) will be sent to the email address 
provided by EASEE PRO. It is highly recommended that site staff have an 
interested and eligible participant view the video at the time of visit and then also 
obtain written consent (OPEN Step 1). 
Participants may choose to wait to sign consent, but give verbal consent to view 
the outreach recruitment video. Site staff will then follow-up with all patients who 
received a virtual clinician referral to assess their interest in participating in the 
study. Additionally, EASEE-PRO will prompt site staff when a patient has 
watched the virtual clinician referral video, to help facilitate recruitment efforts. 
Follow-up attempts may occur at upcoming clinic visits or via phone. It is 
recommended site staff make at least 3 outreach attempts (e.g., approaches in 
clinic, or voicemails), unless a refusal or enrollment decision is received first. For 
those who refuse or are ineligible for the study, reasons will be documented in 
RAVE and ongoing secure data transfers will be sent to MGH. Otherwise, 
interested, eligible patients will be given an informed consent form to review and 
sign, and will be consented to the study by the NCORP site staff. 
Once a patient has signed written consent, they will be registered to OPEN Step 
1 of the study and be prompted to complete the Baseline Survey in EASEE-PRO. 
After completion of the Baseline Survey, the patient will then be eligible to 
register to OPEN Step 2 of the study, which will randomize them to a treatment 
arm. Following OPEN Step 2, NCORP site staff will send patient contact 
information, study ID, dates of consent and randomization, provider information, 
and randomization arm assignment to MGH centralized study staff via the site’s 
Enrollment Log REDCap project. MGH site staff will then email participants’ 
provider an email notification of enrollment in the study. 
5.1.1 
Screening Procedure and Log 
All smokers on new patient lists or schedules should be screened. 
Inclusion criteria are: 
• 
Age >18 
• 
Diagnosed within the past 124 days (Note: patient must still be in 
the 124 day window at step 0 registration.) 
• 
Primary language English or Spanish 
• 
ECOG performance score < 3 
Patients who meet inclusion criteria are approached directly to confirm 
eligibility. To be eligible patients must: 
• 
have smoked a cigarette in the past 30 days, 
• 
plan to receive care at the site, and 
• 
have telephone, e-mail access, and have access to the internet 
with a camera-enabled device (e.g., smartphone, tablet, computer, 
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laptop with a webcam/camera). Sites will provide the cumulative 
total number of smokers seen at their site, the number of smokers 
approached, number of patients who are ineligible and refuse, and 
reasons for ineligibility and refusal. These totals will be provided to 
the MSK coordinating center via a REDCap survey. 
Eligible patients are asked for consent to be contacted about the 
study. Those consenting are entered in OPEN and their OPEN ID is 
recorded. If the patient refuses to be contacted, the reason for refusal 
is recorded. 
For patients who are eligible and provide written consent (OPEN Step 
1), the site staff will enter sociodemographic, clinical, and contact data 
into their site specific REDCap Project Enrollment Log. 
The data will be securely exported from REDCap and assessed for 
completeness at the DCC on an ongoing basis. Complete screens will 
be stored in the study database at the DCC. DCC staff will provide 
feedback to the site contact about any data quality issues via 
password-protected emails. The timing and frequency of the data 
exports will be coordinated between the site and DCC staff. 
5.1.2 
Accrual Target 
Sites participating in this trial should anticipate an accrual goal (i.e., 
patients who complete the baseline survey) of 25 cases per 
subcomponent site. In recognition of variability of patient flow across 
NCORPS, please contact the MGH Coordinating Center to discuss 
more feasible recruitment targets. 
5.1.3 
Brief Video Development 
The original template script will be developed by the study 
investigative team and vetted by ECOG-ACRIN NCORP PI advisory 
committee chair. This approved script will be disseminated to 
participating sites. Sites will follow the brief video instructions on how 
to record and upload the video to the online study account. Final 
approval of the brief video will be conducted by Drs. Park, Ostroff, and 
Wagner. The approved video will be uploaded to the site’s study 
account. The video will then be sent to the patient via the site’s patient 
portal. 
5.2 
Enhanced Usual Care (EUC) (Arm A) 
The EUC reflects the NCCN Smoking Cessation Guideline recommendations2 
and mirrors what is often delivered at cancer centers and community settings: 
assessment of smoking status, provision of quitting advice, and referral to the 
national NCI Smokers’ Quitline for free counseling. Some participating NCORP 
community sites might provide additional tobacco treatment, which we will 
assess and document as well. 
All participants randomized to EUC will have received the assessment of 
smoking status and provision of quitting advice through the screening and 
recruitment (virtual clinician referral) process, and will additionally be referred to 
the NCI Smoking Quitline (smokefree.gov). Referrals will be sent via email by 
EASEE PRO automatically upon randomization to the EUC arm see 
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supplemental Appendix P). Referrals will also be sent via mailed letter (see EUC 
Referral Letter Supplemental Appendix Z1A) by the MGH study staff to the 
address provided by EUC participants. 
On an ongoing basis, the NCI Quitline will provide reports on participant 
engagement (date and duration of Quitline call) with quitline services. This 
interaction will be documented in Rave. 
5.3 
Virtual Intervention Treatment (VIT) (Arm B) 
The VIT group will be offered up to 11 counseling sessions over approximately 6 
months (approximate schedule: 4 weekly sessions through week 4; 4 biweekly 
sessions through week 12; and 3 monthly sessions through week 24) and up to 
12 weeks of free FDA-approved combination NRT (patch and lozenge combined, 
or may elect to receive either option alone). 
VIT participants will receive their 11 counseling sessions via MGH TeleHealth, 
which connects providers to patients through virtual HIPAA-compliant 
videoconferencing technology including: phone, video, email, mobile applications 
and remote monitoring. These virtual visits are conducted via a videoconference 
platform that addresses clinical privacy and security (e.g., Zoom, Doximity, or 
other HIPPA-compliant platform). Participants can use this videoconference 
platform on their computer, tablet or smartphone. The counseling will be 
delivered by a study-designated tobacco treatment coach based at MGH. Since 
the counseling takes place virtually, participants will be emailed handouts that 
are traditionally provided as hardcopies in person. These handouts, distributed at 
the end of Session 1, include a pill diary, 11 Reasons for Cancer Patients to Quit 
Smoking, and Health Benefits When You Quit Smoking. 
5.3.1 
Terminology 
Counseling structure and content: The initial session will last 
approximately 40 minutes; follow-up sessions will last approximately 
15 minutes. 
All counseling sessions will be structured in a 5 As, patient-centered 
format16 and will include a variety of psycho-educational topics (see 
Table below). 
Session # 
Counseling Topics 
Cessation 
Medication 
1 
Weekly 
• Smoking assessment 
• Barriers to quitting and strategies to enhance readiness 
• Medication education and assistance 
• Introduction to 
NRT & use 
2 
• Cancer related care and distress, care team communication 
• Assess medication adherence and managing side effects 
• Knowledge about quitting at the time of diagnosis 
• NRT 
question/side 
effects 
3 
• Coping with cravings and withdrawal 
• Introduction to social support 
• Introduction to mindfulness 
• Assess NRT 
use & 2nd dose 
4 
• Introduction to Stress management – deep breathing exercises  
• Review 2nd 
dose/NRT fit 
5 
Bi-Weekly 
• Introduce beginning with appreciations 
• Assess 
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Session # 
Counseling Topics 
Cessation 
Medication 
• Values clarification exercise 
• Smoke free home and car 
• Nicotine and addiction 
• Pleasurable behaviors 
adherence 
during 
treatment 
6 
• Smoking associated stigma and negative self-talk 
• Stress Management 2 – battery exercise 
• Weight gain concerns 
• Review values clarification exercise 
• Assess 
adherence 
during/post 
treatment 
7 
• Risk of other forms of tobacco 
• Types of social support 
• Stress management 3 – stress signs and coping 
• Assess 
adherence 
during/post 
treatment 
8 
• Rewards and financial costs of smoking 
• Sleep and self-care 
• Picturing positive change 
• Breath awareness 
• Review NRT 
completion 
9 
Monthly 
• Fear of recurrence  
• Managing physical symptoms 
• Discuss if any 
continued NRT 
10 
• Managing slips and relapses during following treatment 
• Stress management 4 – single pointed focus exercise 
• Discuss if any 
continued NRT 
11 
• Review overall smoking progress 
• Finalize smoking goals, relapse prevention 
• Post treatment Support 
• Discuss if any 
continued 
NRT 
During the initial session, the tobacco counselor: 
1. introduces the study and provides an overview of the goals and 
structure of the program; 
2. gathers a comprehensive smoking history; 
3. assesses participants’ concerns about smoking; 
4. offers a personalized message to quit smoking; 
5. assess participants’ importance and confidence to quit and pros 
and cons for quitting and continuing to smoke; and 
6. evaluates participants’ readiness to quit. 
The tobacco counselor tailors participants’ quit plan based on their 
quit stage, which falls into one of 3 branching logics: 
1. not ready to quit or make changes; 
2. not ready to quit, but ready to make changes; and 
3. ready to quit. 
The tobacco counselor assists the participant in setting a goal for the 
week and schedules a follow-up session for the next week. 
Participants then receive 3 weekly sessions, 4 biweekly sessions, and 
3 monthly (booster) sessions. The structure of each follow-up 
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tobacco counselor assesses quit progress and cancer care treatment, 
examines importance and confidence to quit, monitors and intervenes 
on medication use, and tailors quit advice and strategies based on 
participants’ quit readiness; however, each session also introduces 
novel topics identified to be relevant concerns among cancer patients 
who are trying to quit 
5.3.2 
Provision of medication: Nicotine Replacement Therapy (NRT) 
At the initial counseling session, the tobacco counselor will discuss 
use of NRT. Using a decision tree (see Appendix VII and Appendix 
VIII) the tobacco counselor will review contraindications of the patch 
and lozenge. The lead CRA and oncology clinicians will be informed, 
via password protected emails sent by the tobacco counselor, that 
over-the-counter nicotine replacement therapy (patch/lozenge) 
medication was dispensed as a means of collaborative care; this is 
the standard of care for nicotine replacement therapy. This method 
was reviewed by the ECOG-ACRIN regulatory officer and MGH IRB 
and it was determined that oncology clinician notification prior to 
treatment was not needed. The coordinating site staff will inform the 
NCORP oncology provider of the NRT assignment and participants 
will be offered an initial 4-week supply of nicotine replacement 
patches and lozenges. Although use of medication will be promoted, it 
is not required for study participation. Medication will be administered 
according to the USPHS guidelines16. Two 4-week refills will be 
discussed with the patient and dispensed accordingly. Side effects will 
be monitored and discussed weekly with the MPIs. Treating clinicians 
will be contacted for NRT-related questions/concerns. The tobacco 
counselor will adjust the NRT dose to control withdrawal symptoms 
and minimize adverse effects. NRT will be housed at the MGH and 
mailed to participants by MGH study staff. NRT has been safely 
distributed through quit lines in this way. 85, 127 NRT kits will include 
instruction and patient information sheets in English and Spanish 
written for a 6th grade reading level. Use of NRT will be supported 
during each session. 
5.4 
Patient Assessments (Arms A & B) 
Patients assigned to both arms will complete surveys in the EASEE-PRO system 
at the following time points: 
• 
Baseline (Supplemental Appendix A) 
• 
3 months (Supplemental Appendix B) 
• 
6 months (Supplemental Appendix C) 
The baseline survey (Supplemental Appendix A) should take approximately 20 
minutes to complete. The 3 month (Supplemental Appendix B) and 6 month 
(Supplemental Appendix C) survey should each take approximately 15 minutes 
to complete. While the preferred method of follow-up data collection is 
participants completing the surveys through the EASEE-PRO system, study staff 
may contact participants to assist with data collection over the telephone. If the 
study participant prefers a paper copy of the survey, study staff may mail 
participants surveys to be completed and returned. 
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5.5 
Adverse Event Reporting Requirements 
All adverse event grades described throughout this protocol and all 
reportable adverse events will be graded using the NCI Common 
Terminology Criteria for Adverse Events (CTCAE) version 5.0. 
All appropriate treatment areas should have access to a copy of the CTCAE 
version 5.0. A copy of the CTCAE version 5.0 can be downloaded from the 
CTEP website (http://ctep.cancer.gov). 
5.5.1 
Purpose 
Adverse event (AE) data collection and reporting, which are a 
required part of every clinical trial, are done so investigators and 
regulatory agencies can detect and analyze adverse events and risk 
situations to ensure the safety of the patients enrolled, as well as 
those who will enroll in future studies using similar agents.  
5.5.2 
Terminology 
• 
Adverse Event (AE): Any untoward medical occurrence 
associated with the use of an agent in humans [(in this protocol 
Nicotine Replacement Therapy (NRT)], whether or not considered 
agent related. Therefore, an AE can be ANY unfavorable and 
unintended sign (including an abnormal laboratory finding), 
symptom, or disease temporally associated with the use of a 
medicinal product, whether or not considered related to the 
medicinal product. 
• 
Attribution: An assessment of the relationship between the 
adverse event and the protocol agent (NRT), using the following 
categories. 
ATTRIBUTION 
DESCRIPTION 
Unrelated 
The AE is clearly NOT related to the Nicotine 
Replacement Therapy (NRT) 
Unlikely 
The AE is doubtfully related to the Nicotine 
Replacement Therapy (NRT) 
Possible 
The AE may be related to the Nicotine 
Replacement Therapy (NRT) 
Probable 
The AE is likely related to the Nicotine 
Replacement Therapy (NRT). 
Definite 
The AE is clearly related to the Nicotine 
Replacement Therapy (NRT) 
• 
CTCAE: The NCI Common Terminology Criteria for Adverse 
Events provides a descriptive terminology that is to be utilized for 
AE reporting. A grade (severity) is provided for each AE term. 
• 
Expectedness: Expected events are those that have been 
previously identified as resulting from administration of the agent 
(NRT). An adverse event is considered unexpected, for expedited 
reporting purposes, when either the type of event or the severity of 
the event is NOT listed in the protocol (please refer to Section 8) 
or drug package insert. 
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5.5.3 
Expedited Adverse Event Reporting Procedure 
Adverse events requiring expedited reporting will use CTEP’s Adverse 
Event Reporting System (CTEP-AERS). CTEP’s guidelines for CTEP-
AERS can be found at http://ctep.cancer.gov.   
A CTEP-AERS report must be submitted electronically via the CTEP-
AERS Web-based application located at http://ctep.cancer.gov, so 
that ECOG-ACRIN and all appropriate regulatory agencies will be 
notified of the event in an expeditious manner. 
In the rare event when Internet connectivity is disrupted a 24-hour 
notification is to be made by telephone to  
• 
the AE Team at ECOG-ACRIN (857-504-2900) 
• 
the FDA (1-800-FDA-1088) 
For this study, an electronic report MUST be submitted via CTEP-
AERS immediately upon re-establishment of internet connection. 
Supporting and follow up data: Any supporting or follow up 
documentation must be uploaded to the Supplemental Data Folder in 
Medidata Rave within 48-72 hours. In addition, supporting or follow up 
documentation must be faxed to the FDA (800-332-0178) in the same 
timeframe. 
CTEP Technical Help Desk: For any technical questions or system 
problems regarding the use of the CTEP-AERS application, please 
contact the NCI Technical Help Desk at ncictephelp@ctep.nci.nih.gov 
or by phone at 1-888-283-7457. 
Many factors determine the requirements for expedited reporting of 
adverse events on each individual protocol. The instructions and 
tables in the following sections have been customized for protocol 
EAQ171CD and outline the specific expedited adverse event reporting 
requirements for study EAQ171CD. 


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5.5.4 
Steps to determine if an event is to be reported in an expedited 
manner – Arm B only 
 
Identify the type and grade of the event 
using the CTCAE. 
Determine if the event is related to the 
Nicotine Replacement Therapy (NPT) 
With this information, review the chart in 
Section 5.5.5 to determine if event 
requires expedited reporting 
Refer to footnote b in 
Section 5.5.5 to determine 
if the event meets the 
protocol specific reporting 
requirements for this 
study. If so, report the 
event in CTEP-AERS. 
Is the event 
reportable?
No 
Yes 
Report the event in CTEP-AERS 
Determine the expectedness of the 
event. An unexpected event is defined as 
one where the type of severity of the 
event is not listed in the package insert or 
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5.5.5 
Expedited Reporting Requirements for Arm B on protocol EAQ171CD 
Commercial Agents: Over-The-Counter Nicotine Replacement 
Therapy (NRT) - patch/lozenge 
Expedited reporting requirements for adverse events experienced by patients on arm(s) with 
commercial agents only (NPT) – Arm B   
Attribution 
Grade 4 
Grade 5a 
ECOG-ACRIN 
and Protocol-
Specific 
Requirements 
Unexpected 
Expected 
Unexpected 
Expected 
See footnote  
(b) for special 
requirements. 
Unrelated or 
Unlikely 
 
 
7 calendar 
days 
7 calendar 
days 
Possible,  
Probable,  
Definite 
7 calendar 
days 
 
7 calendar 
days 
7 calendar 
days 
7 Calendar Days: 
Indicates a full CTEP-AERS report is to be submitted within 7 calendar days of 
learning of the event. 
a 
A death while on study treatment (NRT) or within 30 days of the last dose of NRT requires both 
routine and expedited reporting, regardless of causality. Attribution to NRT or other cause must 
be provided. 
NOTE: 
A death due to progressive disease of the patient’s cancer should be reported as a 
Grade 5 “Disease progression” under the System Organ Class (SOC) “General disorder 
and administration site conditions”. Evidence that the death was a manifestation of 
underlying disease (e.g. radiological changes suggesting tumor growth or progression: 
clinical deterioration associated with a disease process) should be included within the 
CTEP-AERs report. 
NOTE: 
Any death that occurs > 30 days after the last dose of NRT and is attributed 
possibly, probably, or definitely to the NRT must be reported within 7 calendar 
days of learning of the event.   
b 
Protocol-specific expedited reporting requirements: The adverse events listed below also require 
expedited reporting for this trial: 
Serious Events: 
Any event following treatment that results in persistent or significant 
disabilities/incapacities, congenital anomalies, or birth defects must be 
reported in CTEP-AERS within 7 calendar days of learning of the event. For 
instructions on how to specifically report these events, please contact the 
AEMD Help Desk at aemd@tech-res.com or 301-897-7497. This will need to 
be discussed on a case-by-case basis. 
5.5.6 
Other recipients of adverse event reports and supplemental data 
Adverse events determined to require expedited reporting must also 
be reported by the institution, according to the local policy and 
procedures, to the Institutional Review Board responsible for oversight 
of the patient. 
5.6 
Duration of Intervention 
Patients assigned to Arm B will receive up to 12 weeks of NRT. NRT will be 
dispensed in 4-week increments. 
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Patients will receive protocol counseling and NRT (if randomized to Arm B) 
unless: 
• 
Extraordinary Medical Circumstances: If at any time the constraints of this 
protocol are detrimental to the patient's health, protocol treatment should be 
discontinued. In this event submit forms according to the instructions in the 
EAQ171CD Forms Packet. 
• 
Patient withdraws consent. 
5.7 
Duration of Study and Follow-up 
Patients in this study may be followed for up to one year. 
 
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6. 
Measurement of Effect 
6.1 
Biochemical Samples 
6.1.1 
Primary effectiveness outcome 
The primary outcome is 7-day point-prevalence tobacco abstinence at 
6-months follow-up, confirmed biochemically by saliva cotinine or 
expired air CO. Point-prevalence is biochemically verifiable and highly 
correlated with continuous and sustained abstinence.168 
6.1.2 
Secondary effectiveness outcome 
7-day point-prevalence tobacco abstinence at 3-months follow-up is a 
secondary effectiveness outcome, confirmed biochemically by saliva 
cotinine or expired air CO. Point-prevalence is biochemically verifiable 
and highly correlated with continuous and sustained abstinence.168 
6.1.3 
Definition of biochemically-confirmed quit 
6.1.3.1 
Saliva samples 
Saliva samples will be collected from all subjects who 
report being quit at 3- and/or 6-month follow-up who do not 
report concurrent NRT or e-cigarette use. Saliva samples 
will be tested for cotinine, which is a chemical the body 
makes when exposed to nicotine. 
6.1.3.1.1 
Saliva cotinine scores of < 15ng/ml167, 168 will 
be considered biochemically-confirmed quit. 
6.1.3.2 
Expired air CO samples 
Expired air CO breath tests will be offered to all subjects 
who report being quit at 3- and/or 6-month follow-up who 
also report concurrent NRT or e-cigarette use. The expired 
air tests will show carbon monoxide levels in the breath. 
6.1.3.2.1 
Expired air CO samples with a reading of  
< 10ppm168 will be considered 
biochemically-confirmed quit. 
6.2 
Patient assessments 
6.2.1 
Secondary smoking outcomes are commonly used in tobacco 
cessation trials and in our previous work.127 Reduction in smoking is 
important as most adult smokers reduce smoking as they try to 
quity206; self-reported smoking status will additionally be used as it has 
been reported that deception of smoking status classification among 
cancer patients is low.207 
6.2.1.1 
Self-reported quit status 
Patients will be asked on the 3- and 6-month follow-up 
surveys, how long it has been since they last smoked a 
cigarette, even one or two puffs. “Current smoker” will be 
defined as smoking a cigarette, even one or two puffs, in 
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month Survey and C: 6-month Survey). This will be used to 
generate secondary outcomes of self-reported 7-day point 
prevalence abstinence, continuous and sustained 
abstinence (See Section 2.3 for definitions). 
6.2.1.2 
Significant reduction in daily smoking 
Patients will be asked at baseline, 3-, and 6-month follow-
ups, in the past 30 days, (1) on how many days they 
smoked cigarettes, and (2) how many cigarettes per day 
they typically smoked. “Significant reduction” will be 
defined as a > 50% reduction in cigarettes per day from 
baseline to 3- and 6-month follow-ups. (See Supplemental 
Appendix A: Baseline Survey) 
6.2.2 
Exploratory objectives – Moderators and Mediators: We will collect 
information on the following baseline factors and modifiable 
characteristics that may affect the association between treatment 
group and effectiveness outcomes. The following factors have been 
selected from the theoretical models, the Self-Regulation Model 
(SRM)147,148 and the Health Belief Model (HBM)149, that have informed 
this intervention, as well as based on our previous research.127 
6.2.2.1 
Sociodemographics 
Patients will be asked information about their 
sociodemographic characteristics (i.e., sex, age, marital 
status, race/ethnicity, education level, health insurance) at 
baseline. Financial burden will be assessed using 3 items 
from Dr. Park’s national health insurance survey.205 
6.2.2.2 
Medical history 
Alcohol use   
Patients will be asked about alcohol use using the Alcohol 
Use Disorders Identification Test (AUDIT-C), 194 a three-
item brief screening test for heavy drinking or alcohol 
dependence. 
6.2.2.3 
Smoking history 
Patients will be asked information about their smoking 
history (i.e., # of years smoked, daily smoking rate, 24-
hour quit attempts, other tobacco/nicotine use, current and 
past use of tobacco treatments) using items adapted from 
the Cancer Patient Tobacco Use Questionnaire (C-TUQ), 
developed by the NCI-AACR Cancer Patient Tobacco Use 
Assessment Task Force designed to capture information 
about tobacco use for cancer patients and survivors. 195, 
196Nicotine dependence will be assessed using the 2-item 
Heaviness of Smoking Index from the Fagerstrom Test for 
Nicotine Dependence (FTND), which has predictive validity 
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6.2.2.4 
Quality of life and emotions 
Emotional distress will be assessed using the NCCN’s 
one-item Distress Thermometer that asks the respondents 
to rate their current level of distress on a scale ranging 
from “0” (No distress) to “10” (Extreme distress).174,175 
Coping will be assessed using a 1-item, 10-point scale 
asking how the subject has been able to cope with the 
current stress in their life, ranging from “0” (Not at all able) 
to “10” (Very much able). 
Anxiety will be assessed using the PROMIS Item Bank 
Emotional Distress-Anxiety-Short Form 4a which was 
developed for the general adult population and which 
evaluates anxiety symptoms (e.g., “My worries 
overwhelmed me”) over the past 7 days on a 5-point Likert 
scale with raw scores ranging from 4-20. 188, 198 
Depression will be assessed using the PROMIS Item Bank 
Emotional Distress-Depression Short Form 4a which was 
developed for the general adult population and which 
evaluates depression symptoms (e.g., “I felt hopeless”) 
over the past 7-days on a 5-point Likert scale with raw 
scores ranging from 4-20. 188, 198 
If a patient is determined as at acute risk, the study 
investigators will reach out to the patient’s oncology team 
immediately to recommend a visit to the emergency room. 
The tobacco counselors will be trained to assess suicidality 
and be supervised by licensed psychologists to assess the 
best real-time approach to the safety issues that may arise. 
We will include a standard disclaimer at the end of each 
study survey that stipulates that survey responses are not 
reviewed in real time. We will also provide guidance for 
individuals who feel that they need additional psychosocial 
support and possibly mental care: 
“We do not review these surveys in real time. Many 
individuals in a similar situation may feel distressed, and 
the study investigators encourage you to speak to your 
cancer care team to find out about local psychosocial 
support services. Your well-being is important to us. The 
American Psychosocial Oncology Society (APOS) helpline 
and chat services are available to anyone who may need 
psychosocial support for coping with cancer and its 
treatment (1-866-APOS-4-HELP). If you are feeling highly 
depressed or anxious, you may call and speak to a 
professional hotline counselor at 800-273-8255.” 
6.2.2.5 
Cancer beliefs 
Cancer stigma will be measured using the Internalized 
Stigma and Constrained Disclosure subscales of the Lung 
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been modified in wording for use in the general cancer 
population. The LCSI has preliminary psychometric 
evidence demonstrating reliability and validity. 199, 200 Items 
assess to what degree the subject has experienced certain 
situations since their cancer diagnosis (i.e., “I have been 
careful who I’ve told about my cancer”), and are scored on 
a 5-point Likert scale ranging from “Not at all” to 
“Extremely”. 
6.2.2.6 
Smoking beliefs 
Quit-smoking medication beliefs will be assessed using a 
modified version of the Attitudes about Nicotine 
Replacement Therapy Scale (ANRT-12)201, which asks 
about the subjects’ thoughts on the benefits of using 
nicotine replacement therapy (i.e., “NRT is easy to use”) on 
a 5-point agreement scale ranging from “1” (Strongly 
disagree) to “5” (Strongly agree). 
Self-efficacy to quit and importance of quitting will be 
assessed using two 1 item, 10-point measurements161 
ranging from “0” (Not confident at all; or; Not important at 
all) to “10” (Very confident; or; Very important). 
Perceived benefits of quitting smoking will be evaluated 
using 5 questions about the benefits of quitting for 
decreasing risk for second primary cancer or recurrence 
and increasing cancer treatment efficacy, scored on a 
scale from “0” (Not at all) to “10” (Very much) (i.e., how 
much does quitting smoking reduce your chances of 
developing your cancer again?”).87   
Quit-smoking medication beliefs will be assessed using a 
modified version of the Attitudes about Nicotine 
Replacement Therapy Scale (ANRT-12)201, which asks 
about the subjects’ thoughts on the benefits of using 
nicotine replacement therapy (i.e., “NRT is easy to use”) on 
a 5-point agreement scale ranging from “1” (Strongly 
disagree) to “5” (Strongly agree). 
Stigma will be assessed using a 6-item scale measuring 
stigma related to being a smoker, which has been modified 
from a previously used measuring smoking related stigma 
among smokers with comorbid behavioral health 
conditions.208 Items ask how strongly subjects agree or 
disagree with statements such as “I have avoided telling 
others that I am a smoker” or “I have worried that others 
will view me unfavorably because I am a smoker”. 
6.2.2.7 
Physical symptoms 
Cravings will be assessed using a single item from the 
Mood and Physical Symptoms Scale (MPSS)202 which 
evaluates urges to smoke over the last 24 hours on a scale 
from “0” (Not at all) to “5” (All the time). 


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6.2.2.8 
Environmental influences 
Level of second-hand smoke exposure will be assessed by 
evaluating the number of smokers in the household and 
existence of a household smoking policy using 2 questions 
from the 2008 National Social Climate Survey of Tobacco 
Control.187 
Perceived social support will be assessed using the 
PROMIS Item Bank Emotional Support 4a Short Form188 
203 which was developed for the general adult population 
and which evaluates perceived feelings of being cared for 
and valued as a person (e.g., “I have someone who will 
listen to me when I need to talk”) on a 5-point Likert scale 
ranging from “1” (Never) to “5” (Always). 
Perceived provider support will be assessed using the 
Patient Reported Oncology Provider 5As Delivery, a 
Yes/No scale asking subjects if their cancer doctor or 
nurse has delivered any of the 5A’s (i.e., “Advised you to 
quit smoking cigarettes”) in a recent consult. 204 
6.2.3 
Exploratory objectives – implementation outcomes: We will assess 
patient satisfaction with the proposed virtual treatment delivery 
modality and intervention content. Patient feedback will be taken into 
consideration in further refining of intervention protocols, and is 
important for gathering key information on intervention delivery and 
potential for implementation in real-world situations. 
6.2.3.1 
Acceptability 
Satisfaction with various aspects of the tobacco treatment 
program will be evaluated through participant survey 
responses and post-treatment interviews. 
6.2.3.1.1 
Surveys 
At the 6-month survey (Supplemental 
Appendix C), participant satisfaction will be 
assessed using a mixture of multiple-choice 
question items: (1) To what extent has the 
tobacco treatment program met your 
needs? (2) Did you get the kind of smoking 
cessation assistance that you wanted; (3) 
How helpful was the smoking cessation 
assistance?; (4) How would you rate the 
quality of the assistance you received? (5) 
Would you recommend this program?; as 
well as open-ended free-text items about 
aspects of the program they found the 
most/least helpful, challenges faced to 
participation, and any recommendations for 
additional topics or programs that would 
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6.2.3.1.2 
Semi-Structured Individual Patient 
Interviews 
Following completion of their 6-month 
follow-up surveys, 40 intervention VIT 
participants will be randomly selected 
(based on smoking status) to participate in 
in-depth exit interviews. Using a semi-
structured interview guide, study staff will 
conduct these virtual interviews. All 
participants will be asked open-ended 
questions about a) program engagement: 
(1) What did you think of the clinician video 
that you received encouraging you to enroll 
in the study?, (2) reasons for it being helpful 
or not; b) counseling: (1) What counseling 
components/NRT did you find the most 
helpful? Why?; (2) What counseling 
components/NRT did you find the least 
helpful? Why?; c) NRT medication dose and 
access: (1) Please tell me if you used any 
NRT medication. How much? How 
difficult/easy was it to access?; d) logistics 
and overall impressions: (1) What were 
some of the challenges you faced to 
participating?, (2) Probe: virtual 
assessments, mailed NRT, etc.; e) 
videoconferencing delivery: (1) Please tell 
me about your experience connecting with 
your tobacco counselor via a virtual screen. 
What did you like about it? Dislike about it? 
Difficulties to using the program? Benefits to 
using the program?; and f) cessation advice 
and assistance received from oncology care 
team. 
6.2.4 
Patient Remuneration 
Patient participants will receive $20 in gift cards for each survey 
completed (baseline, 3 months, and 6 months; 3 total possible). 
Subjects who complete a biospecimen sample (saliva or CO breath 
test) will receive $40 in gift cards for each sample completed (3mo., 
and 6mo; 2 total possible). Subjects who are randomly selected for an 
exit interview will be provided $20 in gift cards for participation (1 
possible). Therefore, subjects have the opportunity to receive up to 
$160 in remuneration. (See Supplemental Appendices G-M for Patient 
Remuneration Letters). The central coordinating site (i.e., MGH) will 
be responsible for managing the disbursement of gift cards directly to 
participants. 
6.3 
NCORP Site Staff Assessments 
At the practice (organizational) level, little is known about the acceptability of 
integrating tobacco treatment delivery into routine oncology care. In this trial, 


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implementation outcomes will be assessed with mixed methods using qualitative 
(focus group interviews) and quantitative (surveys) data to be collected from a 
subset of Site PI, CCDR Leader, and other oncology clinicians and research 
administrative staff from each participating NCORP site (See Section 3.1). As 
shown in the NCORP Site Staff Schema (p 7), surveys will be collected at 
baseline (pre-patient participant enrollment, and then again at approximately 12 
and 36 months following baseline). 
The NCORP Site Staff assessments will be managed by Dr. Ostroff and her 
study designated research assistant. The baseline, 12 and 36 month follow-up 
surveys will be collected using REDCap, (Research Electronic Data Capture), a 
data management software system supported by the Memorial Sloan Kettering 
Cancer Center (MSKCC) Information Systems group. 
Staff Survey of Site Characteristics, Organizational Readiness and 
Perceived Tobacco Treatment Feasibility, Acceptability and 
Appropriateness: 
As described in Section 3.1, the CCDR Leader and site PI from each 
participating NCORP site will identify a subset of approximately 10 clinicians 
(nurses, oncologists) and administrative staff (site coordinators, support staff)] to 
provide data about the implementation of tobacco use assessment and 
treatment. Data collection will include qualitative (focus group interviews) and 
quantitative (survey) research methods. The baseline site staff surveys will be 
administered prior to the first site patient enrollment. Post surveys will be 
conducted approximately 12 and 36 months post the baseline survey. The group 
interview will be conducted at the 36-month follow-up as well. (See Supplemental 
Appendices D: Baseline Site Staff Survey, E: 12-month Site Staff Survey, F: 36-
month Site Staff Survey). 
The content of the mixed methods data collection will focus on several 
implementation outcomes including Appropriateness, Feasibility, Acceptability, 
and Sustainability. The focus group interviews will last for approximately 45-60 
minutes, and the surveys will require approximately 15 minutes for completion. 
Site staff participants will be remunerated $100 incentive in total for completion of 
each wave of pre- and post-trial surveys ($20 per survey) and focus group 
interview ($40). 
6.3.1 
NCORP Site Characteristics: 
At the time of site registration, the CCDR Lead or their designee(s) 
will complete the site rostering survey. This survey requests that 
applicable CTEP IDs be grouped into larger practice groups with 
shared providers, populations served and services offered. For each 
practice group, the CCDR Lead or their designee(s) will complete 
items regarding practice characteristics including safety net 
designation, minority/underserved NCORP status, geographic site 
location, practice volume, provider mix and ownership, and tobacco 
cessation services that are available for patients treated at each 
practice group. 
6.3.2 
Organizational Readiness for Implementing Tobacco Use Assessment 
and Treatment: 
Organizational readiness for the treatment of tobacco use in the 
context of cancer care and the feasibility of implementing the various 
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components of the tobacco treatment interventions (EUC and VIT) will 
be assessed by participating staff pre- and post-trial. Perceptions of 
site organizational readiness will be measured using the 7-item 
Organizational Readiness for Implementing Change (ORIC, Shea et 
al 2014) measure assessing two subscales, change commitment and 
change efficacy, on a 5-point ordinal scale ranging from ‘Agree’ to 
‘Disagree’. A total organizational readiness score, and subscale 
change commitment and change efficacy score are created. 144,145 
6.3.3 
Perceived Tobacco Treatment Feasibility, Acceptability and 
Appropriateness: 
Staff participants will also rate perceived feasibility, acceptability and 
appropriateness of the various tobacco treatment interventions being 
tested in this trial (Weiner et al, 2017) on a 6-point ordinal scale 
ranging from ‘Strongly Disagree’ to ‘Strongly Agree’ Aggregate and 
intervention-specific summary scores for tobacco treatment feasibility, 
acceptability and appropriateness are derived. The NCORP Staff 
Survey will take approximately 20 minutes to complete and will be 
administered at baseline, defined as after site registration and before 
the first patient is registered, and at approximately 12 and 36 months 
after site registration (See Supplemental Appendices D: Site Staff 
Baseline Survey, E: Site Staff 12-month survey and F: Site Staff 36-
month survey). 
6.3.4 
Focus Group Interview 
The focus group interview will assess implementation processes 
including barriers and facilitators for sustaining tobacco treatment as 
routine cancer care practice in the NCORP site. The question probes 
for our implementation-focused focus group interviews will be guided 
by the Consolidated Framework for Implementation Research 
(CFIR)20 and will address the 1) the intervention, 2) inner setting, 3) 
outer settings, 4) individuals involved, and 5) the process for 
sustaining tobacco treatment following trial completion. 
The focus group interview will be conducted using videoconference 
software (e.g., Zoom, Doximity, or other HIPPA-compliant platform).  
enabling audio recording of the focus group interview for subsequent 
coding of primary implementation themes. The focus group interviews 
will be scheduled at the convenience of the NCORP staff participants 
and is expected to take about 45-60 minutes to complete. Focus 
group interviews will take place at the end of the trial (after patient 
participant enrollment is closed and 36-month follow-up surveys 
completed) 
Focus group Interviews will be recorded, transcribed and analyzed 
using NVivo qualitative software. Content analyses will be conducted 
by the two RAs and overseen by Drs. Park and Ostroff. The coders 
will meet to develop the thematic framework, categories, and coding 
plan. To ensure coding reliability, coding discrepancies will be 
resolved through discussion and comparison of raw data. Coding will 
continue until a high level of reliability (Kappa= >0.80) is established. 
Drs. Ostroff and Park will provide an expert review of the analyses. 
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The qualitative and quantitative findings will provide detailed initial 
data on implementation processes that will inform subsequent testing 
of multi-level implementation strategies for broad national 
dissemination into community cancer care settings. 
6.3.5 
Monthly Meeting Minutes Data 
We will conduct content analysis of monthly meeting minutes with 
CCDR Leaders and other NCORP site staff to summarize 
engagement of participating sites. We will explore indicators of 
engagement (quantity and quality) by documenting the proportion and 
representativeness of participating stakeholders (Site PIs, CCDR 
leads, oncology nurses) engaged in monthly meetings, how 
(approaches used and level of engagement) and when (which parts of 
the research process) stakeholders engage, and what they did to 
facilitate integration of tobacco assessment and treatment in cancer 
care delivery (strategies for identifying current smokers). 
6.4 
Cost 
We will assess NCORP staff time required to screen all patients for smoking 
status and identify all current smokers. Each CCDR Leader will fill in costs, 
including local staff effort (time x base salary) related to eligibility screening. This 
data will be collected via the weekly Patient Screening Log (Appendix Z2D) All 
staff time costs will be estimated based on national average wages by job type. 
Counseling delivery costs will include the counselor’s time, including efforts to 
contact patients, as well as supervisors’ time, all of which will be tracked within 
study databases. 
NRT delivery costs will be estimated using national average retail prices. Overall 
costs will be standardized per randomized study participant across sites for the 
cost-effectiveness. 
6.5 
Treatment fidelity/adaptations 
We will collect data about EUC fidelity by asking patients at follow-up whether 
they were advised to quit by their oncology providers and whether they were 
referred to the Quitline or other tobacco cessation counseling services. All trial 
participants will be given a Smokefree Study 2.0 brochure about the NCI Quitline 
providing instructions to call for tobacco treatment. The MGH Coordinating 
Center will be responsible for providing and documenting distribution of the 
Quitline brochure to all Smokefree Study 2.0 Trial participants. The Quitline call 
center routinely asks participants to identify how they found out about the 
Quitline. For the duration of this trial, the Quitline will record whether callers 
identify the Smokefree Study as the source of referral. In addition, the Quitline 
routinely collects limited demographic information, including caller’s telephone 
number, which will serve as the caller identifier allowing us to link the Quitline 
database with Smokefree Study 2.0 participants. Twice yearly, the MGH 
Coordinating Center will send an Excel list of Smokefree Study 2.0 participant 
study IDs with corresponding telephone numbers to the NCI Quitline Call Center 
requesting lookback for any caller NCI Quitline contact within the past 6 months. 
In other words, a data manager from the NCI Quitline Call Center will review the 
data every 6 months to see if a person who entered the study on Smokefree has 
also contacted the NCI Quitline. The MGH Coordinating Center will record the 
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date(s) and duration of Quitline contact into Smokefree Study 2.0 Access 
database. The NCI Quitline will be listed in the Research Authorization.   
For VIT intervention participants, the number of contacts, session content and 
completion, and NRT dispersal will be documented. For EUC participants, 
information on the number of quitline sessions and NRT dispensed will be 
obtained from quitline vendors. MGH research staff will also record the 
percentage of virtual clinician referral videos (brief videos) opened. Patient 
engagement will be assessed by documenting dispensal and patient-reported 
NRT use. All of the treatment fidelity of this data will be monitored by MGH 
research staff and recorded in an Access database (see MGH protocol). 
Following Stirman and colleagues’ recommendations (2013),165 we will track any 
intervention modifications (e.g., counselor adherence to the VIT manual, 
medication changes). 
6.6 
Reach and Adoption 
Site coordinators will document the percentage of all current smokers who 
participate at each site. Using a Patient Screening Log (Appendix Z2D), we will 
assess the number of eligible patients who were approached and the number of 
eligible patients who enrolled. Reasons for ineligibility, refusal, and 
characteristics of refusers, ineligibles, and drop outs will be documented. 
Consistent with the hybrid effectiveness implementation trial design, we will 
collect characteristics of ineligibles and refusers to inform future dissemination 
efforts such that we can evaluate the critical question of whom we are not 
reaching for tobacco treatment. 
The MGH RA will track uptake and utilization on the sites that are engaged in 
study activities (i.e., participation in monthly calls and patient program 
enrollment). 
 
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7. 
Study Parameters 
7.1 
Patient surveys and samples schedule 
Item 
Baseline 
3 months follow-up 
6 months follow-up 
Baseline 
survey 
(Supplemental 
Appendix A) 
within 30 days of 
enrollment 
 
 
Vital status 
update 
 
-14 days of target 
date 
 
3 month 
survey 
(Supplemental 
Appendix B) 
 
within -7 to +49 days 
of target date 
 
3 month 
sample 
(saliva)1 
 
within 30 days of 
3mo survey 
completion 
 
3 month 
sample (CO)1 
 
within 30 days of 3 
mo survey 
completion 
 
Vital status 
update 
 
 
-14 days of target date  
6 month 
survey 
(Supplemental 
Appendix C) 
 
 
within -7 to +90 days of 
target date (VIT subjects: 
must occur after 
counseling session 11 
has a final status) 
6 month 
sample 
(saliva)1 
 
 
within 30 days of 6 mo 
survey completion 
6 month 
sample (CO)1 
 
 
within 30 days of 6 mo 
survey completion 
Interview 
 
 
within 90 days of 6 mo 
survey completion 
1  Participants who self-report smoking abstinence of at least 7 days at month 3 and/or 
month 6, on either the survey or during survey outreach, will be requested to provide 
saliva for cotinine assessments (Section 10.1). Saliva samples will be tested only for 
cotinine. To avoid false-positives, participants who report use of NRT or e-cigarettes 
within the last week will be offered the opportunity to instead complete an expired air 
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7.2 
Site staff surveys schedule 
Item 
Baseline 
12 - 15 months post 
Baseline Survey 
Approximately 36 
months post Baseline 
Survey 
Baseline 
survey 
(Supplemental 
Appendix D) 
Prior to first 
patient 
enrollment 
 
 
12-month 
survey 
(Supplemental 
Appendix E) 
 
X 
 
36-month 
survey 
(Supplemental 
Appendix F) 
 
 
After last patient is 
enrolled 
Focus Group 
Interview 
 
 
To be held after initiation 
of 36 month survey 
collection 
7.3 
Randomization groups schedule (approximate) 
 
Week 
EUC (Control) 
VIT (Intervention) 
Randomization 
0 
Quitline referral email 
TeleHealth test call 
Month 1 
1 
 
Session 1 + 
1st medication fill 
2 
 
Session 2 
3 
 
Session 3 
4 
 
Session 4 
Month 2 
5 
 
Session 5 + 
2nd medication fill 
6 
 
7 
 
Session 6 
8 
 
Month 3 
9 
 
Session 7 +  
3rd medication fill 
10 
 
11 
 
Session 8 +  
3 month follow-ups 
12 
3 month follow-ups 
Month 4 
13 
 
Session 9  
14 
 
15 
 
16 
 
Month 5 
17 
 
Session 10 
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Week 
EUC (Control) 
VIT (Intervention) 
18 
 
19 
 
20 
 
Month 6 
21 
 
Session 11 + 
6 month follow-ups 
22 
 
23 
 
24 
6 month follow-ups 
Study completion 
 
Exit interviews 


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7.4 
Data collection schedule during eligibility screening, recruitment, and enrollment 
 
Pre-screen4 
Step 05 
Step 15 
Step 25 
Sex 2 
 
X 
 
 
Age* 2 
 
X 
 
 
Race 2 
 
X 
 
 
Ethnicity 2 
 
X 
 
 
Language* 2 
X 
X 
 
 
Cancer diagnosis* 2 
 
X 
 
 
Cancer stage 1,2 
 
X 
 
 
Date of diagnosis* 2 
X 
X 
 
 
Smoking status* 3 
X 
X 
 
 
Care at NCORP site* 3 
 
X 
 
 
Email/web access* 3 
X 
X 
 
 
ECOG PS* 1  
X 
 
 
 
Reasons for ineligibility 2 
X 
X 
X 
 
Reasons for refusal 3 
X 
X 
X 
 
Contact information 3 
 
 
X 
 
Randomization group 
 
 
 
X 
* Characteristics from eligibility criteria 
1. Will only be collected if the information is available 
2. May be patient self-reported or pre-screened from medical records 
3. Must be patient self-reported 
4. This data will be transmitted via MSK REDCap survey. 
5. This data will be entered in OPEN, RAVE and REDCap Enrollment Log. 
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7.5 
Data collection schedule for patient enrollees (surveys) 
 
Baseline 
3 Mo. 
6 Mo. 
Patient Enrollees 
 
 
 
Point-prevalence tobacco abstinence 
 
X 
X 
Self-reported tobacco abstinence 
 
X 
X 
Cigarettes per day 
X 
X 
X 
24-hr quit attempts 
 
X 
X 
Sociodemographics 
X 
 
 
Smoking history 
X 
X 
X 
Cancer variables 
X 
 
 
Medical history 
X 
 
 
Quality of life 
X 
X 
X 
Cancer and smoking beliefs 
X 
X 
X 
Physical symptoms 
X 
X 
X 
Environmental influences 
X 
X 
X 
Acceptability 
 
 
X 
7.6 
Data collection schedule for site staff (surveys) 
 
Baseline1 
12 Month 
36 Month 
Site Staff 
 
 
 
Adoption 
X 
X 
X 
Appropriateness 
X 
X 
X 
Treatment fidelity 
X 
X 
X 
Cost 
 
X 
X 
Feasibility 
X 
X 
X 
Site characteristics 
X 
X 
X 
Penetration/reach 
 
X 
X 
Sustainability 
X 
X 
X 
1. Site staff must complete baseline survey prior to first patient enrollment 
2. CCDR Leads will complete Site Characteristics at approximately 12 and 36 Month 
Follow-up (Appendices E and F) 
 
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8. 
Drug Formulation and Procurement 
This information has been prepared by the ECOG-ACRIN Pharmacy and Nursing 
Committees. 
8.1 
Nicotine trans-dermal patch (NSC #5065) 
8.1.1 
Description 
Nicotine transdermal patches are supplied as transdermal patches for 
application to the skin containing nicotine as the active ingredient. The 
patches are available in dose concentrations of Nicotine 21mg 
delivered over 24 hours; Nicotine 14mg delivered over 24 hours; or 
Nicotine 7mg delivered over 24 hours. 
Depending on specific commercial product, the patch may also 
contain the following inactive ingredients (not all inclusive) ethylene 
vinyl acetate-copolymer, polyisobutylene and high density 
polyethylene between clear polyester backings. Please refer to 
commercial package insert” as necessary. 
8.1.2 
Pharmacology 
Mode of Action: 
Absorbed systemically; binds to nicotine receptors thereby reducing 
withdrawal symptoms (including nicotine craving) associated with 
smoking cessation. 
Absorption: 68% 
Duration: 24 hr 
Peak plasma time: 8-9 hr 
Peak plasma concentration: 5-17 ng/mL (average) 
Elimination Half-life: 3-4 hr 
Excretion: Urine 
8.1.3 
Storage and Stability 
Store at 20-25°C (68-77°F). 
8.1.4 
Administration 
See package insert for complete details for specific product used. 
Dosing is determined by the number of cigarettes smoked daily when 
the patch is started. 
>10 cigarettes per day AND weight >45 kg 
• 
Start with the highest dose nicotine patch (21 mg/day) for six 
weeks, followed by 14 mg/day for two weeks, and finish with 7 
mg/day for two weeks. 
≤ 10 cigarettes per day OR weight < 45 kg 
• 
Start with the medium dose nicotine patch (14 mg/day) for six 
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Patient is advised to pick "quit day" and begin using nicotine 
transdermal patches on that day and simultaneously stop smoking. 
They may continue to smoke if not immediately able to/willing to stop 
smoking, however every effort should be made to decrease the 
amount smoked while on replacement therapy, as continued smoking 
can increase adverse effects. It is important for patients to complete 
the full program, but some may need to use NRT for longer periods to 
keep from smoking. 
Apply to clean, dry, non-hairy area of skin (typically upper arm or 
shoulder), being sure to rotate sight placed. Do not use the same 
sight for two consecutive applications. Try to not repeat any sight 
more than once in a 7 day period. 
Apply new patch upon awakening and wear patch for 24 hours. In the 
event patient experiences vivid dreams or insomnia, remove patch 
before bedtime. 
Do not cut patch, as this will result in uneven administration of 
medication and can increase risk of adverse effects and decrease 
efficacy. 
After removing a patch, fold in half placing the sticky ends together, 
place in its original pouch, and discard out of the reach of children and 
pets. The patch still contains small amounts of nicotine which are 
poisonous children and pets. 
8.1.5 
Availability/How Supplied 
Nicotine transdermal patches are FDA approved for smoking 
cessation aid and are commercially available. 
8.1.6 
Side Effects 
There are no significant safety concerns associated with using more 
than 1 over-the-counter (OTC) nicotine replacement therapy (NRT) 
simultaneously or at same time as another nicotine-containing product 
(including cigarettes), however the potential for nicotine overdose is 
increased if patient continues to smoke. Every effort should be made 
to decrease the number of cigarettes smoked to zero while using 
replacement therapy. 
Below are the most commonly reported adverse events related to 
nicotine transdermal patch. Please refer to the package 
insert/investigator’s brochure for the comprehensive list of adverse 
events. 
Gastrointestinal symptoms (nausea, vomiting, abdominal pain, 
diarrhea), headache, insomnia, vivid dreams, and application site 
irritation. 
Contact your doctor if you experience these side effects and they are 
severe or bothersome. 
The incidence of developing dependence on nicotine replacement is 
considered to be very low. Smokers may worry that they will become 
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occurs. Nicotine replacement therapy has not been shown to increase 
or cause development of cancer. 
Use of nicotine transdermal patches may not be appropriate in the 
following populations and should be carefully monitored by a 
physician 
• 
non-smokers, occasional smokers, and children under 18 years of 
age (see Warnings), 
• 
known hypersensitivity of the skin, allergy to nicotine or any patch 
components, 
• 
generalized skin disorders, 
• 
recovery phase of acute myocardial infarction, unstable or 
worsening angina pectoris, severe cardiac arrhythmias, and 
recent cerebrovascular accident. 
Pregnancy and Breastfeeding: 
Transdermal nicotine is considered US FDA Category D. The adverse 
effects on fetal and maternal health caused by cigarette smoking are 
clearly established. Nicotine freely passes into the placenta and is 
found in both amniotic fluid and umbilical cord blood (Luck & Nau, 
1984; Hibberd et al, 1978). Nicotine is readily transferred to the fetus 
throughout pregnancy; the fetus is actually exposed to higher nicotine 
concentrations than the mother (Luck et al, 1985). The use of 
cigarettes or nicotine gum during the third trimester of pregnancy has 
been associated with diminished breathing movement in the fetus. 
There are no conclusive data to support different pregnancy 
categories for the various nicotine replacement therapy (NRT) 
products (Lyman & Raebel, 2001). 
If you are pregnant or breast-feeding, only use this medicine on the 
advice of your health care provider. Smoking can seriously harm your 
child. Try to stop smoking without using any nicotine replacement 
medicine. This medicine is believed to be safer than smoking. 
However, the risks to your child from this medicine are not fully 
known." 
8.1.7 
Potential Interactions 
There is increased risk of nicotine overdose in patients who continue 
smoking while using a nicotine replacement therapy, or those utilizing 
more than one form of nicotine replacement therapy. Caution should 
be used to prevent overdose, and smoking should be completely 
discontinued while using therapy. 
Signs and symptoms of nicotine overdose may include: 
abdominal or stomach pain, cold sweat, confusion, convulsions 
(seizures), disturbed hearing and vision, drooling, extreme 
exhaustion, pale skin, rapid heartbeat, and tremors. Contact your 
doctor if you experience any of these symptoms. 
8.1.8 
References 
1. Product Information: NICORDERM CQ - nicotine patch, extended 
release. GlaxoSmithKline Consumer Healthcare Holdings (US) 


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LLC. U.S. National Library of Medicine. 
https://dailymed.nlm.nih.gov/dailymed/index.cfm. Accessed March 
28th 2018 
2. Product Information: HABITROL STEP 1- nicotine transdermal 
system patch patch, extended release; HABITROL STEP 2- 
nicotine transdermal system patch patch, extended release; 
HABITROL STEP 3- nicotine transdermal system patch patch, 
extended release. Dr. Reddy's Laboratories Inc. 
https://dailymed.nlm.nih.gov/dailymed/index.cfm. Accessed March 
28th 2018 
3. Rigotti NA. (2017). Pharmacotherapy for smoking cessation in 
adults. In J. A. Melin (Ed.), UpToDate. Retrieved March 29, 2018, 
from https://www.uptodate.com/contents/pharmacotherapy-for-
smoking-cessation-in-
adults?search=nicotine%20replacement%20therapy&source=sear
ch_result&selectedTitle=1~31&usage_type=default&display_rank
=1 
8.2 
Nicotine Polacrilex Lozenge (NSC #741859) 
8.2.1 
Description 
Nicotine Polacrilex Lozenges are a form of Nicotine Replacement 
Therapy that deliver nicotine to your body, temporarily relieving 
craving and nicotine withdrawal symptoms when you quit smoking. 
The lozenges are available in dose concentrations of 4mg or 2mg. 
Depending on specific commercial product, may also contain the 
following inactive ingredients (not all inclusive): aspartame, calcium 
polycarbophil, flavor, magnesium stearate, mannitol, potassium 
bicarbonate, sodium alginate, sodium carbonate, xanthan gum. 
Please refer to commercial package insert” as necessary. 
8.2.2 
Pharmacology 
Mode of Action: 
Absorbed systemically; binds to nicotine receptors thereby reducing 
withdrawal symptoms (including nicotine craving) associated with 
smoking cessation. Nicotine lozenges deliver nicotine at a lower and 
steadier rate compared to smoking cigarettes through the oral mucosa 
as opposed to the skin or gastrointestinal tract. 
Excretion: Urine 
8.2.3 
Storage and Stability 
Store at 20-25°C (68-77°F). 
Keep lid tightly closed and protect from light 
8.2.4 
Administration 
See package insert for complete details for specific product used. 
Dosing is determined by the time to patients’ first cigarette after 
waking up. 


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Smokers who smoke first cigarette within 30 minutes of waking up: 
• 
Use one 4-mg lozenge every 1 to 2 hours for weeks 1 to 6, 
followed by one 4-mg lozenge every 2 to 4 hours for weeks 7 to 9, 
then one 4-mg lozenge every 4 to 8 hours for weeks 10 to 12. 
Smokers who smoke their first cigarette > 30 minutes after waking up: 
• 
Use one 2-mg lozenge every 1 to 2 hours for weeks 1 to 6, 
followed by one 2-mg lozenge every 2 to 4 hours for weeks 7 to 9, 
then one 2-mg lozenge every 4 to 8 hours for weeks 10 to 12. 
Patient is advised to pick "quit day" and begin using nicotine polacrilex 
lozenge on that day and simultaneously stop smoking. They may 
continue to smoke if not immediately able to/willing to stop smoking, 
however every effort should be made to decrease the amount smoked 
while on replacement therapy, as continued smoking can increase 
adverse effects. It is important for patients to complete the full 
program, but some may need to use NRT for longer periods to keep 
from smoking. 
Place the lozenge in your mouth and allow the lozenge to slowly 
dissolve (20 - 30 minutes). Avoid chewing or swallowing the lozenge. 
Patients should also avoid eating or drinking 15 minutes before using 
or while the lozenge is in your mouth. 
Patients may experience a tingling sensation in their mouth when 
using the lozenge. While using the lozenge occasionally move the 
lozenge from one side of your mouth to the other until completely 
dissolved. 
To improve your chances of quitting, use at least 9 lozenges per day 
for the first 6 weeks 
Avoid using more than one lozenge at a time or continuously use one 
lozenge after another since this may cause hiccups, heartburn, 
nausea or other side effects. Do not use more than 5 lozenges in 6 
hours or 20 lozenges per day. 
8.2.5 
Availability/How Supplied 
Nicotine polacrilex lozenges are FDA approved for smoking cessation 
aid and are commercially available. 
Product is supplied as a 2 mg or 4 mg oral lozenge or troche. 
8.2.6 
Side Effects 
There are no significant safety concerns associated with using more 
than 1 over-the-counter (OTC) nicotine replacement therapy (NRT) 
simultaneously or at same time as another nicotine-containing product 
(including cigarettes), however the potential for nicotine overdose is 
increased if patient continues to smoke. Every effort should be made 
to decrease the number of cigarettes smoked to zero while using 
replacement therapy. 
Below are the most commonly reported adverse events related to 
nicotine lozenge. Please refer to the package insert/investigator’s 
brochure for the comprehensive list of adverse events. 


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Gastrointestinal symptoms (nausea, vomiting, abdominal pain, 
diarrhea, unpleasant taste), arthralgia, jaw pain, myalgia, dizziness, 
lightheadedness, headache, insomnia, hiccups 
Contact your doctor if you experience these side effects and they are 
severe or bothersome. 
The incidence of developing dependence on nicotine replacement is 
considered to be very low. Smokers may worry that they will become 
dependent on nicotine replacement, but nicotine dependence rarely 
occurs. Nicotine replacement therapy has not been shown to increase 
or cause development of cancer. 
Use of nicotine polacrilex lozenges may not be appropriate in the 
following populations and should be carefully monitored by a 
physician: 
• 
non-smokers, occasional smokers, and children under 18 years of 
age (see Warnings), 
• 
known hypersensitivity of the skin, allergy to nicotine or any patch 
components, 
• 
generalized skin disorders, 
• 
recovery phase of acute myocardial infarction, unstable or 
worsening angina pectoris, severe cardiac arrhythmias, and 
recent cerebrovascular accident. 
Pregnancy and Breastfeeding: 
Nicotine Polacrilex is considered US FDA Category C. The adverse 
effects on fetal and maternal health caused by cigarette smoking are 
clearly established. Nicotine freely passes into the placenta and is 
found in both amniotic fluid and umbilical cord blood (Luck & Nau, 
1984; Hibberd et al, 1978). Nicotine is readily transferred to the fetus 
throughout pregnancy; the fetus is actually exposed to higher nicotine 
concentrations than the mother (Luck et al, 1985). Nicotine use during 
the third trimester of pregnancy has been associated with diminished 
fetal breathing movements possibly due to decreased placental 
perfusion. 
If you are pregnant or breast-feeding, only use this medicine on the 
advice of your health care provider. Smoking can seriously harm your 
child. Try to stop smoking without using any nicotine replacement 
medicine. This medicine is believed to be safer than smoking. 
However, the risks to your child from this medicine are not fully 
known. 
8.2.7 
Potential Interactions 
There is increased risk of nicotine overdose in patients who continue 
smoking while using a nicotine replacement therapy, or those utilizing 
more than one form of nicotine replacement therapy. Caution should 
be used to prevent overdose, and smoking should be completely 
discontinued while using therapy. 


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Signs and symptoms of nicotine overdose may include: 
abdominal or stomach pain, vomiting, cold sweat, confusion, 
headache, convulsions (seizures), disturbed hearing and vision, 
drooling, extreme exhaustion, pale skin, rapid heartbeat, and tremors. 
Contact your doctor if you experience any of these symptoms. 
8.2.8 
References 
1. Product Information: NICORETTE- nicotine polacrilex lozenge. 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. U.S. 
National Library of Medicine. 
https://dailymed.nlm.nih.gov/dailymed/index.cfm. Accessed March 
29th 2018 
2. Product Information: NICOTINE, oral lozenge, nicotine polacrilex, 
oral lozenge. Meijer Distribution Inc, Grand Rapids, MI. U.S. 
National Library of Medicine. 
https://dailymed.nlm.nih.gov/dailymed/index.cfm. Accessed March 
29th 2018 
3. Product Information: NICORETTE (R), nicotine polacrilex. 
Lakeside, Cincinnati, OH, 1991. 
https://dailymed.nlm.nih.gov/dailymed/index.cfm. Accessed March 
29th 2018 
4. Product Information: COMMIT(TM) oral lozenge, nicotine 
polacrilex oral lozenge. GlaxoSmithKline Consumer Healthcare, 
LP, Pittsburgh, PA, 2003. 
https://dailymed.nlm.nih.gov/dailymed/index.cfm. Accessed March 
29th 2018 
 


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9. 
Statistical Considerations 
9.1 
Estimated Effect Size 
Based on our current trial preliminary findings (Preliminary Studies) and previous 
trial with low SES smokers, 85 we conservatively estimate 7-day point-prevalence 
tobacco abstinence at 6-month follow-up will be 15% for the standard care group 
and 32% for the intervention group. This estimate is based on our current trial, 
which has a higher intensity control group. 
9.2 
Power calculation: 
9.2.1 
Aim 1. Primary effectiveness outcome. 
The study will have 80% power to detect a 17% difference in 7-day 
point-prevalence tobacco abstinence with a two-sided significance 
level of 0.01 with 280 participants. 
Numeric Results for Testing Two Proportions using the Z-Test 
with Unpooled Variance 
H0: P1 - P2 = 0.   H1: P1 - P2 = D1 ≠ 0. 
Target Actual  
 
 
 
 
Diff 
 
 
Power Power* N1 
N2 
N 
P1 
P2 
D1 
Alpha  
0.80 
0.80400 
117 
117 
234 
0.2700 0.1000 0.1700 0.0100  
0.90 
0.90042 
148 
148 
296 
0.2700 0.1000 0.1700 0.0100  
0.80 
0.80014 
78 
78 
156 
0.2700 0.1000 0.1700 0.0500  
0.90 
0.90167 
105 
105 
210 
0.2700 0.1000 0.1700 0.0500  
0.80 
0.80045 
126 
126 
252 
0.2900 0.1200 0.1700 0.0100  
0.90 
0.90130 
161 
161 
322 
0.2900 0.1200 0.1700 0.0100  
0.80 
0.80185 
85 
85 
170 
0.2900 0.1200 0.1700 0.0500  
0.90 
0.90186 
114 
114 
228 
0.2900 0.1200 0.1700 0.0500  
0.80 
0.80184 
140 
140 
280 
0.3200 0.1500 0.1700 0.0100  
0.90 
0.90061 
178 
178 
356 
0.3200 0.1500 0.1700 0.0100  
0.80 
0.80115 
94 
94 
188 
0.3200 0.1500 0.1700 0.0500  
0.90 
0.90119 
126 
126 
252 
0.3200 0.1500 0.1700 0.0500  
0.80 
0.80095 
148 
148 
296 
0.3400 0.1700 0.1700 0.0100  
0.90 
0.90146 
189 
189 
378 
0.3400 0.1700 0.1700 0.0100  
0.80 
0.80289 
100 
100 
200 
0.3400 0.1700 0.1700 0.0500  
0.90 
0.90024 
133 
133 
266 
0.3400 0.1700 0.1700 0.0500  
0.80 
0.80043 
159 
159 
318 
0.3700 0.2000 0.1700 0.0100  
0.90 
0.90101 
203 
203 
406 
0.3700 0.2000 0.1700 0.0100  
0.80 
0.80088 
107 
107 
214 
0.3700 0.2000 0.1700 0.0500  
0.90 
0.90015 
143 
143 
286 
0.3700 0.2000 0.1700 0.0500  
* Power was computed using the normal approximation method. 


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9.2.2 
Aim 1. Secondary effectiveness outcome 1. 
For biochemically-confirmed 7-day point prevalence abstinence at 3-
months, with a sample size of 140 in each arm then smallest 
detectable difference will be 18% with 80% power and a Bonferroni 
corrected alpha of 0.002 using and an estimated control rate of 
20%.209, 210 
9.2.3 
Aim 1. Secondary effectiveness outcome 2. 
For self-reported 7-day point prevalence abstinence at 6-months, with 
a sample size of 140 in each arm then smallest detectable difference 
will be 22% with 80% power and a Bonferroni corrected alpha of 
0.002 using and an estimated control rate of 31%.   
9.2.4 
Aim 1. Secondary effectiveness outcome 3. 
For self-reported 7-day point prevalence abstinence at 3-months, with 
a sample size of 140 in each arm then smallest detectable difference 
will be 22% with 80% power and a Bonferroni corrected alpha of 
0.002 using and an estimated control rate of 28%. 
9.2.5 
Aim 1. Secondary effectiveness outcome 4. 
For continuous abstinence, with a sample size of 140 in each arm 
then smallest detectable difference will be 21% with 80% power and a 
Bonferroni corrected alpha of 0.002 using and an estimated control 
rate of 20%. 
9.2.6 
Aim 1. Secondary effectiveness outcome 5. 
For sustained abstinence, with a sample size of 140 in each arm then 
smallest detectable difference will be 19% with 80% power and a 
Bonferroni corrected alpha of 0.002 using and an estimated control 
rate of 13%. 
9.3 
Estimate of drop-outs/loss to follow-up: 
We estimate that 10% of participants will die within 6-months of enrollment, so an 
additional 10% (n=28) will be recruited.   
9.4 
Total Sample size: 
308 patient participants. 
9.5 
Plans for handling missing data: 
At the outset, we will examine the frequency distributions of all variables. Data 
from all 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. 
Outcome analyses will be intent-to-treat; we will classify participants who are lost 
to follow-up and those who do not provide a saliva or an expired air sample as 
current smokers. We will determine whether there is differential dropout in the 
groups and consider developing probability-of-completion weights189 to obtain 
unbiased estimates of treatment effect. We will assess whether data are missing 
at random. We will perform sensitivity analysis using: 1) a complete case 
analysis and 2) multiple imputation for missing data.190 


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9.6 
Plans for analyzing the primary objectives: treatment effectiveness (Aim 1) 
The primary objective is to compare the proportions of participants in the study 
arms with 7-day point-prevalence abstinence from cigarettes at 6-months post 
enrollment. We will define 7-day point-prevalence by saliva cotinine (< 15 ng/ml) 
or expired air CO (<10 ppm). All participants who report being quit and no NRT or 
e-cigarette use will be requested to provide saliva samples, expired air CO will be 
measured in participants who report being quit and report concurrent NRT or e-
cigarette use. If a participant is lost to follow-up or does not provide a saliva or 
CO sample, they will be considered a current smoker. The primary analysis will 
be performed from an intent-to-treat perspective. Chi-square tests will be used to 
compare the outcomes between treatment groups. Outcomes will be considered 
different with p<0.01. 
As a randomized study, it is hoped that the two groups will be balanced between 
potential confounders. Appropriate comparisons between the groups will be 
performed (chi-squared tests, t-tests, etc.) to identify any potential confounders 
that were not balanced. If significant areas of imbalance are identified, logistic 
regression modelling will be performed to adjust for potential confounding. 
9.7 
Plans for analyzing the secondary objectives: secondary treatment effectiveness 
(Aim 1) 
The 5 secondary objectives (defined in Section 2.3) include various ways of 
measuring abstinence at different times of assessment. In order to adjust for 
multiple comparisons, differences will be considered significant at 
0.01/N=0.01/5=0.002 level. 
Similar to the primary objective is to compare the proportions of participants in 
the study arms with 7-day point-prevalence abstinence from cigarettes at 3-
months post enrollment. We will define 7-day point-prevalence by saliva cotinine 
(< 15 ng/ml) or expired air CO (< 10 ppm). All participants who report being quit 
and no NRT or e-cigarette use will be requested to provide saliva samples, 
expired air CO will be measured in participants who report being quit and report 
concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not 
provide a saliva or CO sample, they will be considered a current smoker. Chi-
square tests will be used to compare the outcomes between treatment groups. 
Another secondary objective is to compare the proportions of participants in the 
study arms that self-report cigarette abstinence at 3-months. The participant will 
be asked, “In the past 7 days, have you smoked a cigarette, even a puff.” With 
the answer recorded as “Yes” or “No”. If the self-report response is unavailable, 
the participant will be considered a current smoker. Chi-square tests will be used 
to compare the outcomes between treatment groups. The process will be 
repeated using self-reported cigarette abstinence at 6-months. 
Another secondary objective is to compare the proportions of participants in the 
study arms that report a continuous abstinence at 6 months. The participants will 
be asked, “How long has it been since you last smoked a cigarette (even one or 
two puffs)?” at 6 months. If the response is more than or equal to 3 months (e.g. 
time since previous survey), the participant will be considered having a 
continuous abstinence at 6 months. If the self-report response is unavailable, the 
participant will be considered not having a continuous abstinence at 6 months. 
Chi-square tests will be used to compare the outcomes between treatment 
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Another secondary objective is to compare the proportions of participants with 
sustained abstinence at 6 months. To qualify as a sustained abstinence at 6 
months, the participant must qualify as biochemically-verified 7-day point 
prevalence cigarette abstinence at 3 and 6 months, using the definition above. If 
either measure is not available the participant will not be considered sustained 
abstinence at 6 months. Chi-square tests will be used to compare the outcomes 
between treatment groups. 
Generalized Estimating Equations (GEE) approach will be used to study the 
treatment effect over time, incorporating 3 & 6 month follow-up data. This will 
take into account the repeated measures structure of observations within the 
same individuals over time and allow for analysis of incomplete data across time. 
9.8 
Plans for analyzing the exploratory objectives: 
9.8.1 
Aim 2: To assess the potential effect of known and potential 
moderators on treatment effectiveness between the two arms. 
We will export the moderator effects on treatment effectiveness. 
There are 2 outcomes collected at 2 time points and 2 outcomes at 1 
time point: 
• 
Biochemically-verified 7-day point prevalence abstinence at 3- and 
6-months follow-up 
• 
Self-reported cigarette abstinence at 3- and 6-months follow-up 
• 
Continuous abstinence at 6 months (no self-reported smoking 
since last survey point) 
• 
Sustained abstinence at 6 months (biochemically-verified 
abstinence at 3 and 6 months) 
The moderators of primary interest are: 
• 
Sociodemographics: Sex, age, marital status, race/ethnicity, 
education level, financial burden, health insurance, internet and 
smartphone access and modality 
• 
Smoking history: Years smoked, daily smoking rate, other 
tobacco/nicotine use (e.g., cigars, cigarettes), current/past use of 
tobacco treatments, nicotine dependence (2-item “Heaviness of 
Smoking Index” from the FTND) 
• 
Cancer variables: Cancer type, cancer stage, treatment, and days 
since diagnosis 
• 
Site characteristics: 
• 
Site, geographic location, clinic volume, 
• 
baseline organizational readiness (9-item survey for readiness 
to implement NCCN Guidelines for Smoking Cessation using 
Weiner’s Organizational Readiness for Implementing Change 
(ORIC) survey144,145) 
• 
site usual care (recorded on the 2017 landscape survey) 
Additional moderators to be explored: 
• 
Medical history: ECOG Performance Status, alcohol use (3 items 
form the AUDIT-C) 


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• 
Quality of life/emotions: Emotional distress, coping, anxiety, 
depression 
• 
Cancer and smoking beliefs: Stigma, quit motivation, self-efficacy 
to quit, importance of quitting, perceived benefits of quitting 
smoking, quit-smoking medication beliefs 
• 
Physical symptoms: Cravings 
• 
Environmental influences: Level of second-hand smoke exposure, 
perceived social support, perceived provider support 
For each of the 6, we will test the effects of these moderators listed 
above on the outcomes. We test the effects of these moderators in 
logistic regression models to determine their association with tobacco 
abstinence. Once a parsimonious multivariate model is developed, 
treatment arm will be included to test for the effect of the intervention 
on the moderators. Interactions between the treatment arm and the 
moderators will assess the relationship between the moderators and 
the treatment group on the effectiveness outcomes. 
Also, GEE will be used to look at longitudinal models. 
Multiple comparisons will be accounted for by considering Bonferroni 
adjustments. 
9.8.2 
Aim 3: To assess the processes of implementation and dissemination 
(acceptability, adoption, appropriateness, treatment fidelity, cost 
effectiveness, penetration/reach, and sustainability) of our intervention 
at community oncology sites. 
To gain an initial understanding of implementation processes, for Aim 
3 we will follow Proctor and colleagues’ recommended taxonomy for 
measurement of implementation outcomes19. Specifically, we will 
measure acceptability (satisfaction with content/delivery), adoption 
(program uptake), appropriateness (relevance), cost, and treatment 
fidelity/adaptation and penetration (reach) and sustainability. These 
implementation outcomes will be assessed with mixed methods using 
qualitative and quantitative data to be collected from patients, tobacco 
treatment counselors, NCORP oncology PIs and provider 
clinicians/staff, and EHR documentation. 
We will use descriptive statistics to summarize implementation 
outcomes (Acceptability, Adoption, Appropriateness, Fidelity, Cost, 
Penetration and Sustainability) and conduct treatment group 
comparisons (i.e., Acceptability). 
We will explore organizational readiness and site level engagement 
using existing quantitative and qualitative data respectively.  In order 
to examine the generalizability of the study findings to the full NCORP 
network of cancer care delivery sites, we will use the most recent 
(2017) existing NCORP Landscape data to conduct preliminary 
analyses comparing participating and nonparticipating sites on 
relevant site characteristics. 
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9.8.2.1 
Acceptability 
Satisfaction with various aspects of the tobacco treatment 
program will be evaluated through participant survey 
responses and post-treatment interviews with a subset of 
patient participants. Patient Surveys. At the 6-month 
surveys, participant satisfaction will be assessed: 
1 To what extent has the tobacco treatment program met 
your needs?; 
2 How satisfied were you with the smoking cessation 
assistance received?; 
3. How helpful was the smoking cessation assistance?; 
4. Would you recommend this program? 
Proportions of participants answering these questions will 
be compared between the arms using chi-squared tests. 
9.8.2.2 
Adoption 
Using the baseline, 12- and 36-month staff surveys, we will 
conduct paired t-tests and chi-square test to assess 
pre/post changes in organizational readiness (ORIC) and 
tobacco treatment delivery practices. 
9.8.2.3 
Appropriateness 
To measure perceived fit and relevance, we will report on 
the 12- and 36-month staff surveys and interviews of 
NCORP PIs, clinicians, and staff about the VIT’s a) 
suitability, b) applicability, and c) match for their patients 
and site, as well as d) perceptions of site usual care 
content and implementation. 
9.8.2.4 
Fidelity 
We will evaluate the use and effectiveness of brief videos 
on enrollment using the Fisher’s exact test: brief videos 
open (y/n) and enrollment (y/n). Using participant self-
reported survey data, counselor process data, and quitline 
data, we will evaluate study treatment and non-study 
treatment (i.e., site-specific usual care, outside resources) 
utilization. We will dichotomize medication and counseling 
use into low vs. high (≥ 8 weeks of NRT; ≥ 8 sessions) 
levels of treatment utilization.191 Within each group, we will 
use chi-square tests and ANOVAs to explore the 
association between participant characteristics and 
treatment utilization. We will use chi-square tests to 
compare the association of treatment utilization (brief 
videos open, level of medication and counseling use) on 
smoking outcomes. To predict smoking outcomes, we will 
use logistic regression models, which will include 
medication and counseling use levels, adjusting for 
confounders. 
9.8.2.5 
Cost 
Rev. Add2 
Rev. Add3 
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We will calculate the incremental cost per quit of the 
intervention relative to EUC over the 6-month follow-up 
period as follows: (total per-person costs of intervention – 
total per-person costs of EUC)/(cessation rate with the 
intervention – cessation rate with EUC ).192 Cessation rates 
will be based on the primary outcome. Statistical 
uncertainty in cost and effectiveness inputs will be 
incorporated into the incremental cost per quit 
comparisons using Monte Carlo simulation methods 
allowing us to determine whether these ratios are 
significantly different from zero and allowing us to assess 
the proportion of simulation outcomes above or below 
relevant thresholds. 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. We 
will also generate “best case” and “worst case” analyses. 
Using Wilcoxon rank sum tests and trend tests (Cochran–
Armitage), we will explore patient and site characteristics 
associated with implementation outcomes. We will also 
collect cost data on EUC components including staff time 
required to assess smoking status and refer current 
smokers to this tobacco treatment trial. 
9.8.2.6 
Penetration 
We will compare proportion of smokers who participate at 
each NCORP site using chi-square tests. We will analyze 
data collected from the study sites’ screening logs 
maintained in REDCap (see Appendix Z2D). This 
procedure is outlined in Section 5.1. We will compare 
patient characteristics between enrollees and refusers and 
screenees from DCP-001 using univariate analyses (chi-
square or Fisher’s exact tests and Wilcoxon rank sum 
tests) to examine the associations of patient characteristics 
(e.g. sociodemographics, medical and smoking history, 
cancer treatment, when available) with enrollment (Y/N). 
9.8.2.7 
Sustainability 
We report on interviews with the NCORP site 
PIs/clinicians/staff to assess sustainability. Specifically, we 
report on: a) challenges likely to be encountered in 
providing cessation medications, b) challenges likely to be 
encountered in providing cessation counseling, c) 
resources needed to maintain delivery of tobacco 
treatment and d) preferences for a site-based centralized 
tobacco treatment program. 
9.8.2.8 
Organizational readiness 
We will use staff survey data collected at baseline and 
follow-up to explore the association between 
organizational readiness and site characteristics, and 
whether there are differences in organizational readiness 
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Rev. Add3 
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by professional/specialty groups, practice type, etc. Within 
site/practice level analysis will examine aggregate ORIC 
scores stratified by survey respondent type (e.g., CCDR 
leads, medical oncologists, oncology nurses) and how 
organizational readiness differs across these individuals. 
Organizational readiness will be operationalized as an 
ORIC survey score from the 12-item ORIC survey which 
uses a five-point Likert scale ranging from 1 (disagree) to 5 
(agree). Seven items represent the change efficacy 
subscale and five items represent the change commitment 
subscale. Change efficacy scores will be calculated from 
five items assessing expertise, coordination, ability to 
manage site politics, ability to handle challenges, 
organizational supports, and tracking implementation 
progress. Change commitment scores will be computed 
from the five items assessing staff commitment, 
determination, motivation and the ability to do whatever it 
takes to implement tobacco use assessment and 
treatment. Predictors of baseline organizational readiness 
will be implementation context variables such as NCORP 
site designation, organizational, clinical staff, and 
population characteristics, and the capacity to provide 
cancer care delivery services. Additional determinants of 
organizational readiness, particularly, change valence, a 
determinant of change commitment211 – how staff 
perceive tobacco treatment interventions and informational 
assessment, a determinant of change efficacy211 – staff 
perceptions of resource availability and situational factors 
favorable to implementing tobacco treatment interventions 
will be explored in multivariable models. Baseline, 12-and 
36-month ORIC survey scores will be analyzed for 
longitudinal changes in change efficacy and commitment 
over the course of the study period. 
9.8.2.9 
Site level engagement 
We will carry our content analysis of monthly meeting 
minutes. Data will be stratified by representation of 
stakeholders in monthly meetings (Who); at what point in 
the project stakeholders are engaged (When); how 
stakeholders engage in the research project e.g., 
consultations, advisors/experts, information, recruiting or 
retaining participants, dissemination efforts (How and how 
much); and the impact stakeholders have on the project 
(What). Engagement interactions will be quantified into 
high, moderate and low levels of engagement. We will then 
assess the association between engagement level and 
organizational and clinical characteristics (i.e., 
organizational, clinical, patient population, characteristics) 
and capacity to provide cancer care delivery services (i.e., 
smoking cessation and treatment services). 
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Qualitative data from focus groups described in Aim 3 will 
be used to examine the process of engaging community 
oncology sites in community engaged research (CEnR), 
evaluate facilitators and barriers to engagement, and 
identify implementation strategies to facilitate engagement 
and the adoption of tobacco treatment at the sub affiliate 
level. Guided by the CFIR20 we will use domains depicting 
engagement (inner setting, process, characteristics of 
individuals) and select constructs within the domains20 to 
examine determinants of engagement, select appropriate 
implementation strategies to facilitate engagement, and to 
understand where those strategies can be employed in the 
implementation process.  
Data will be analyzed using an inductive approach and the 
constant comparative method.212 Using a three-stage 
analytical approach,213 we will begin with open coding, 
data immersion and marginal remarks. Axial coding will 
then be used to allow for the identification of relationships 
between codes. Finally, selective coding will be used for 
the integration of all codes into core categories/themes. 
We will code for 1) facilitators and barriers to engagement 
and 2) implementation strategies to facilitate engagement 
and the adoption of tobacco treatment interventions within 
the CFIR domains and constructs. Independent coding 
with clear documentation of thematic development followed 
by assessing for inter-rater reliability (alpha >.80) among 
coders and iterative data processing will ensure that the 
qualitative results are confirmable. Strategy domains such 
as the action, action target, and implementation outcome 
affected will be described. 
9.9 
Gender and Ethnicity for Patients 
Based on previous data from NCORP reports the anticipated accrual in 
subgroups defined by gender and race is: 
Racial Categories 
DOMESTIC PLANNED ENROLLMENT REPORT 
Ethnic Categories 
Not Hispanic or Latino 
Hispanic or Latino 
Total 
Female 
Male 
Female 
Male 
American 
Indian/Alaska Native 
2 
3 
0 
0 
5 
Asian 
8 
8 
0 
0 
16 
Native Hawaiian or 
Other Pacific 
Islander 
2 
2 
0 
0 
4 
Black or African 
American 
12 
14 
3 
2 
31 
White  
110 
103 
13 
17 
243 


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Racial Categories 
DOMESTIC PLANNED ENROLLMENT REPORT 
Ethnic Categories 
Not Hispanic or Latino 
Hispanic or Latino 
Total 
Female 
Male 
Female 
Male 
More Than One 
Race 
4 
5 
0 
0 
9 
Total 
138 
135 
16 
19 
308 
9.10 
Gender and Ethnicity for Site Staff 
Racial Categories 
DOMESTIC PLANNED ENROLLMENT REPORT 
Ethnic Categories 
Not Hispanic or Latino 
Hispanic or Latino 
Total 
Female 
Male 
Female 
Male 
American 
Indian/Alaska Native 
1 
1 
0 
0 
2 
Asian 
3 
3 
0 
0 
6 
Native Hawaiian or 
Other Pacific 
Islander 
1 
1 
0 
0 
2 
Black or African 
American 
4 
5 
1 
1 
11 
White  
39 
36 
5 
6 
86 
More Than One 
Race 
1 
2 
0 
0 
3 
Total 
49 
48 
6 
7 
110 
9.11 
Study Monitoring 
This study will be monitored by the ECOG-ACRIN Data Safety Monitoring 
Committee (DSMC). The DSMC meets twice each year. For each meeting, all 
monitored studies are reviewed for safety and progress toward completion. When 
appropriate, the DSMC will also review interim analyses of outcome data. Copies 
of the toxicity reports prepared for the DSMC meetings are included in the study 
reports prepared for the ECOG-ACRIN group meeting (except that for double 
blind studies, the DSMC may review unblinded toxicity data, while only pooled or 
blinded data will be made public). These group meeting reports are made 
available to the local investigators, who may provide them to their IRBs. Only the 
study statistician and the DSMC members will have access to interim analyses of 
outcome data. Prior to completion of this study, any use of outcome data will 
require approval of the DSMC. Any DSMC recommendations for changes to this 
study will be circulated to the local investigators in the form of addenda to this 
protocol document. A complete copy of the ECOG-ACRIN DSMC Policy can be 
obtained from the ECOG-ACRIN Operations Office. 


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10. 
Specimen Submission and Analysis 
Participants who self-report smoking abstinence of at least 7 days at month 3 and/or 
month 6 (Supplemental Appendix B or C), on either the survey or during survey 
outreach, will be requested to provide saliva for cotinine assessments (Section 10.1). 
EASEE PRO triggers a notification to MGH and/or NCORP site staff based on the 
following criteria: 1) smoking status; 2) NRT use; and 3) e-cigarette use. Saliva samples 
will be tested only for cotinine. To avoid false-positives, participants 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 (Section 10.2). Saliva cotinine results will not be 
provided to the site or the patients. The expired air CO sample results may be shared 
with the patient by site staff at time of the measure, at the discretion of the physician. 
Smokerlyzers® will be deployed as needed to the centralized site coordinator or 
administrator. We will include a mailing label for them with a pre-stamped address to 
ship it back to us. Saliva kits will be mailed directly to the patient by MGH. Only one 
Smokerlyzer® will be distributed to each site. To request a Smokerlyzer®, please 
contact the study team. 
Questions may be directed to the Smokefree Support Study team at 617-643-4765 or 
SmokefreeSupportStudy2@partners.org. 
10.1 
Saliva Cotinine Assessments 
For this trial, saliva will be submitted to J2 Laboratories to assay and tested for 
cotinine levels. 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 (Smokefree 
Support Study 1). Saliva sample testing results will be sent to the EAQ171CD 
research staff at Massachusetts General Hospital (MGH). The results will not be 
returned to the participant or the institution. 
The saliva sample will be tested only for cotinine to determine the study 
participant’s exposure to cigarette smoke and nothing else. Saliva samples will 
be destroyed after they are assayed for cotinine. No samples will be retained for 
additional research purposes. 
10.1.1 
Saliva Submission 
Saliva assessments are requested from patients who self-report 
smoking abstinence of at least 7 days and who do not report the use 
of NRT or e-cigarettes within the last week. Saliva kits will be shipped 
directly to the patient by MGH for all subjects who report being quit on 
3- and/or 6-month follow-up surveys. 
If a sample is designated insufficient for testing by the lab, MGH will 
notify the participant, who will be offered the opportunity to complete 
additional samples. 
NOTE: 
To avoid false-positives, participants 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 
(Section 10.2). 


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10.1.1.1 
Saliva Cotinine Collection Kits 
Participants who complete a saliva cotinine sample will be 
provided with $40 in remuneration to thank them for their 
time. 
The collection kit contains: 
a. 1 plastic tube 
b. 1 plastic insert 
c. 1 cotton swab 
d. 1 cap to the tube 
e. Plastic bag 
f. Instructions for the patient regarding the collection and 
submission of saliva. An example of the instruction 
sheet is in Appendix II 
g. Smoking Status Slip – MGH Research Staff will 
COMPLETE THE ECOG-ACRIN Participant ID field 
prior to giving the kit to the patient. 
h. Pre-paid packaging: FedEx package and pre-paid 
airbill with MGH return address only. 
10.1.1.2 
Saliva Collection 
The instructions for the collection and submission of the 
saliva are provided within the kit. 
1. Prior to distributing the saliva collection kit to the 
participant, MGH Research staff will COMPLETE THE 
ECOG-ACRIN Participant ID with the EAQ171CD 
patient ID on the Saliva Smoking Status Slip 
(Appendix III). 
2. BEFORE USING THE KIT the participant is not to eat, 
drink, chew gum, or have anything in their mouth for at 
least 15 minutes before using the kit 
3. Collecting the saliva – 
a. Pop open the cap. The participant is to take out the 
cotton swab, Leaving the plastic insert inside the 
tube 
b. The swab is placed under the tongue for at least 4 
minutes 
Participant is not to chew, suck on, or play with the 
swab 
c. After at least 4 minutes, the wet swab is placed 
back into the tube 
d. Put the cap firmly on the plastic tube 
4. After collection of the saliva 
a. 
Put the sealed tube in the plastic bag 


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b. 
Put the bag with the kit in the prepaid, pre-
addressed envelope 
c. 
Complete the Saliva Smoking Status Slip. 
Indicate the date and time of the saliva collection 
and respond to the brief questions. Place the slip 
in the package with the kit. 
NO PARTICIPANT IDENTIFYING INFORMATION 
other than the EAQ171CD patient ID is to be 
provided with the sample. 
5. Sample shipment: 
Using the pre-paid shipping label provided with the kit, 
samples are to be shipped to: 
Processing Department 
J2 Laboratories, Inc. 
3640 N. 1st Ave, Suite 130 
Tucson, AZ 85719 
It is recommended that the sample can be mailed the 
day of collection. If it cannot be mailed the day of 
collection, the sample is to be placed in a fridge or 
freezer until it can be mailed. 
After completing the kit, participants may simply drop 
the packaged sample in the nearest FedEx dropbox. 
10.2 
Expired CO Assessments 
As CO samples must be completed in-person, samples will be completed with a 
member of the local research staff at the site at which the subject was recruited 
and is receiving their cancer care. The NCORP site research staff will be trained 
in safe and proper use of the CO monitor and test results interpretation. With the 
aim of decreasing participant burden, samples may be completed at an existing 
clinic visit in accordance with patient preferences. 
Sites will be provided with an Expired CO Smokerlyzer® which will be used for all 
participants on EA171CD requiring an expired CO assessment. 
Prior to first assessments, contact the Smokefree Support Study team at 617-
643-4765 to receive training on the use of the Smokerlyzer®, including use of the 
required software or app. 
For each assessment, follow the Test Instructions and operation manual 
provided. Quick summary of instructions are: 
• 
Fill in the patient ID, date and time of assessment on the Expired CO 
Smoking Status Slip (Appendix IV) 
• 
Have the participant complete the questions on the Expired CO Smoking 
Status Slip 
• 
Obtain the CO assessment, following the instructions provided with the 
instrument 
• 
The participant should be standing, to allow proper exhalation 


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• 
The participant is to inhale as deeply as possible and hold their breath 
while the display counts down 15 seconds. If they are unable to do so, 
please see the manual on how to address this. 
• 
At the end of the countdown, the participant is to blow slowly into the 
mouthpiece until their lungs are empty 
• 
Record the results of the assessment on the Expired CO Smoking 
Status: ppm, and %COHb 
The results of the CO expiration assessment results and the participant’s 
answers to the Expired CO Smoking Status Slip are to be entered into 
mediDATA Rave. It is requested that the actual form be uploaded to Rave as 
well. Site staff should please also scan or send the Expired CO Smoking Status 
Slip to the MGH Research team via secure email. A copy of the results may be 
given to the participant using the Smokerlyzer® breath CO Test Results, a copy 
which is provided in Appendix IV. 
11. 
Patient-Reported Outcomes and Quality of Life Administration 
11.1 
Data Collection Approach for Patient Reported Outcomes 
We will use a combination of EASEE-PRO and mailed questionnaires for this 
study as described in Section 4.7.5. A proxy or family member can complete the 
questionnaires on behalf of the patient as long as they can speak English or 
Spanish. The questionnaires are only available in English or Spanish. 
EASEE-PRO’s PRODUCE sub-system allows for the collection and notification of 
study critical events. This allows EASEE to interface with a variety of systems 
and use external APIs to retrieve data necessary for study operations. 
11.2 
Questionnaire Administration Process 
At the time EASEE-PRO account activation, patients will be asked to complete 
paper-based Patient Contact Information Form. The form collects information 
used to maintain contact with the participant over the course of the study, 
including name, home address, phone number, and may include the name of a 
primary (or other) physician to whom requests for patient location may be made 
and a close friend or family member. 
This form is retained in the study participant’s chart at the site and is not 
submitted to the ECOG-ACRIN RAVE database; the completed form is faxed to 
the central ECOG-ACRIN Outcomes and Economic Assessment Unit (OEAU) 
located at Brown University so that the participants can be contacted for the 
Patient Reported Outcomes (PRO) portion of the study. The contact information 
is stored in a dedicated SQL database (PII-DB) and IS NOT accessible by 
ECOG-ACRIN database. The OEAU RA will not have access to the main ECOG-
ACRIN database that contains clinical data. 
11.2.1 
Patient Contact Information Form 
On the Patient Contact Information Form, patients will be asked for 
telephone numbers and addresses to facilitate contacting for 
completion of questionnaires.  Patients will be asked if they would like 
text message reminders of survey availability as well as email 
reminders.  While the default survey administration method will be on-
line, questionnaires will be sent by mail as requested by the patient or 
Rev. Add2 


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as needed by the study personnel. Administration of questionnaires, 
both web-based and paper will be coordinated by the OEAU. 
Administration of the questionnaires will be triggered based on 
completion of study milestones marked by submission of forms in 
RAVE and EASEE-PRO. 
Patients will be prompted to complete web-based forms via an email 
prompt (push notifications or SMS as applicable to the study). These 
notifications will include a link to the web site for questionnaire 
completion. Questionnaires will be completed on line using a unique 
patient account. The web site will reference a toll-free phone number 
and email address that patients can use to reach the OEAU staff 
should they have questions or need assistance. All data will be stored 
on a secure server. Patients who do not complete the web 
questionnaires within 3 working days of the initial request e-mail will 
receive up to 3 additional reminders, each 3 days apart. These 
reminders, like the initial notification, will provide a link to the website 
for the current surveys, ask the participant to confirm that they have 
been able to access the web site, and provide both the e-mail address 
and the toll free help number for support. 
If patients still have not responded within 14 days of the original e-
mail, the OEAU Research Associate may attempt to telephone the 
patient and administer the questionnaire over the telephone. The 
OEAU may send a questionnaire in the mail if the on-line version is 
not completed.  If questionnaires are telephone-administered, they will 
be marked as such in the database. All surveys, while desired within 3 
days of the event, will remain available for participants until either the 
surveys are completed or they are off-study.  Since the completion 
date is recorded for all surveys, the study team will be able to make 
relevant determinations for inclusion of this data in specific analyses. 
However, after telephone follow-up, no additional or extraordinary 
means will be employed to collect overdue/missing questionnaires. 
11.2.2 
Mailed questionnaire completion  
Mailed questionnaire packets will include a letter introducing the study 
and include a study-specific toll-free phone number that patients can 
use to reach the OEAU staff should they have questions or need 
assistance, questionnaires, and pre-addressed, stamped envelopes 
for return mailing to the OEAU. If patients do not complete the paper 
questionnaire within 10 working days of the date of the mailing, the 
OEAU RA may attempt to telephone or text the patient. If the patient 
has not received the paper questionnaires, additional questionnaires 
will be sent after confirming the correct mailing address. If the 
questionnaire is available to the patient, the OEAU RA will urge the 
study patient to complete and return the questionnaire. If the patient 
has still not responded within 20 working days of the original mailing, 
the OEAU may attempt to telephone the patient and telephone 
administer the questionnaire. If questionnaires are telephone-
administered, they will be marked as such in the data base. 


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11.3 
Patient Reported Outcomes/Quality of Life Assessment Schedule 
PATIENT COMPLETED SURVEYS 
 
Survey time point 
Survey items 
Baseline survey:  
Cigarettes per day 
Sociodemographics 
Smoking history 
Cancer variables 
Medical history 
Quality of life 
Cancer and smoking beliefs 
Physical symptoms 
Environmental influences 
Follow-up survey: administered at 3 
months and 6 months after baseline 
survey 
Point-prevalence tobacco abstinence 
Self-reported tobacco abstinence 
Cigarettes per day 
24-hr quit attempts 
Smoking history 
Quality of life 
Cancer and smoking beliefs 
Physical symptoms 
Environmental influences 
Acceptability (only at 6 months) 
 
 


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12. 
Electronic Data Capture 
Please refer to the EAQ171CD Forms Completion Guidelines for the forms submission 
schedule. Data collection will be performed in Medidata Rave, EASEE-PRO, and 
REDCap. 
This study will be monitored by the Clinical Data Update System (CDUS) version 3.0. 
Cumulative CDUS data will be submitted quarterly from the ECOG-ACRIN Operations 
Office – Boston to CTEP by electronic means. 
Patient individual and NCORP PI/Clinician/Staff Focus Group Interview Analyses: 
Data analyses will occur coincident to data collection so that we can ascertain if thematic 
saturation (the point at which no new data are generated) has been achieved for each 
strata (treatment group, site). Interviews will be recorded, transcribed and analyzed 
using NVivo qualitative software. Content analyses will be conducted by the two RAs 
and overseen by Drs. Park and Ostroff. The coders will meet to develop the thematic 
framework, categories, and coding plan. To ensure coding reliability, coding 
discrepancies will be resolved through discussion and comparison of raw data. Coding 
will continue until a high level of reliability (Kappa=>0.80) is established. Patient 
individual interview results will be analyzed by strata comparisons. NCORP site 
participants’ focus group interviews will be analyzed according to appropriateness and 
feasibility. 
13. 
Patient Consent and Peer Judgment 
Current FDA, NCI, state, federal and institutional regulations concerning informed 
consent will be followed for the main portion of the study. 
13.1 
Waivers of Consent 
13.1.1 
Screening 
Per 45 CFR 46.117c, a waiver of documentation of consent for the 
screening of study eligibility and recruitment of smokers is justified for 
the following reasons 
• 
screening eligibility review of medical records by clinical research 
staff does not affect the rights or welfare of subjects because 
medical record information is screened to establish preliminary 
eligibility prior to approaching a potential subject, 
• 
screening eligibility review of medical records cannot practicably 
be done with the waiver due to the number of services 
participating in which the patients may be eligible. Screening 
eligibility decreases the burden on patients of introducing a 
research study to patients who can easily be identified through 
screening activities as not eligible for a research study, 
• 
screening eligibility review of medical records involves no more 
than minimal risk because the person accessing the information 
has undergone training in confidentiality of medical records, and 
the records are viewed solely to screen for eligibility criteria and 
only minimal information found in the screening process will be 
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13.1.2 
Waiver of elements of informed consent – site staff 
We request a waiver of specific elements of consent regarding 
medical treatment, medical risks, and injury to site staff participants. 
This study does not involve medical treatment of site staff, and these 
elements of informed consent would not apply to site staff 
participating in the individual staff surveys and focus group interviews. 
We have therefore removed these sections from the model consent 
form. Omission of this information does not constitute greater than 
minimal risk and would not adversely affect the site staff participants. 
14. 
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Research Study Informed Consent Document 
Study Title for Participants: Smoke Free Support Study 2.0 
Official Study Title for Internet Search on http://www.ClinicalTrials.gov: 
EAQ171CD Implementing a Virtual Tobacco Treatment in Community 
Oncology Practices NCT03808818 
Version Date: July 1, 2021 
Overview and Key Information 
What am I being asked to do? 
We are asking you to take part in this research study because you routinely assist in the care 
or study of patients diagnosed with cancer. This study will enroll approximately 10 oncology 
care providers, oncology-research and oncology-care-support staff per NCORP site, across 
multiple NCORP sites in the United States. 
Taking part in this study is your choice. 
You can choose to take part or you can choose not to take part in this study. You also can 
change your mind at any time. 
This document has important information to help you make your choice. Take time to read it. 
Talk to your colleagues about taking part in the study. It is important that you have as much 
information as you need and that all your questions are answered. 
Why is This Study Being Done? 
The purpose of this study is to compare the effectiveness of two smoking cessation treatment 
strategies for tobacco dependent cancer patients and to examine barriers that might facilitate 
or impede implementation of tobacco treatment delivery in community oncology practices. 
What will happen if I decide to take part in this study? 
If you decide to participate in this study, you will be asked to complete three surveys: one at 
the start of the study and again at about 12 months and 36 months after starting the study. 
You will also be asked to participate in one focus group about tobacco treatment delivery in 
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your community oncology setting. 
What are the risks and benefits of taking part in this study? 
There are both risks and benefits to taking part in this study. It is important for you to think 
carefully about these as you make your decision. 
Risks 
There is minimal risk associated with participating in this study. There are no physical risks. 
There is some potential risk that you may feel uncomfortable answering survey questions 
about the challenges of assessing and treating tobacco dependence at your NCORP worksite. 
However, survey questions are brief and have been used in other similar health care delivery 
studies without untoward effects. Nonetheless, you are entitled to decline to answer any 
questions that you may find sensitive. There will be no penalty or loss of employee benefits 
to you if you decline to answer a question. 
Benefits 
You are not expected to benefit directly from participating in this study. Your participation in 
this research study may benefit other people in the future by helping us learn more about 
delivery of tobacco treatment in cancer care settings. 
If I decide to take part in this study, can I stop later? 
Yes, you can decide to stop taking part in the study at any time. If you decide to stop, let the 
study researchers know as soon as possible. The researchers will tell you about new 
information or changes in the study that may affect your willingness to continue in the study. 
It is important that you understand the information in the informed consent before making 
your decision. Please read, or have someone read to you, the rest of this document. If there is 
anything you don’t understand, be sure to ask your study doctor or nurse. 
What is the purpose of this study? 
The purpose of this study is to compare the effectiveness of two smoking cessation treatment 
strategies for tobacco dependent cancer patient. The study will compare a virtual telehealth 
intervention and a referral to a national quitline in producing abstinence at 3 and 6 months. 
At the organizational level, this study will also examine potential barriers that might impede 
implementation of tobacco treatment delivery in community oncology practices. The goal of 
this study is to establish the effectiveness and cost of delivering a virtual tobacco cessation 
intervention in community oncology settings and provide initial implementation data to 
inform broader national dissemination. 
What is involved in this study? 
If you decide to participate in this research study, you will be asked to complete three online 


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surveys and participate in one focus group interview focusing on possible barriers and 
facilitators of tobacco treatment delivery in your community oncology setting. The three 
surveys will each require approximately 15 minutes of your time and will be administered at 
baseline and at 12 and 36 months follow-up. The content of the survey and focus group 
interview questions will examine your beliefs, attitudes and current practices regarding 
tobacco treatment in the context of cancer care. The focus group interview will be conducted 
using WebEx conference call software, will require about 60 minutes of your time and the 
audio portion will be recorded. 
What risks can I expect from taking part in this study? 
General Risks 
There is some potential risk that your study information could become known to someone 
who is not involved in performing or monitoring this study. It is also possible that you may 
feel anxious from knowing that your conversations with the study staff and other colleagues 
at your NCORP site are being audio-recorded. If you feel uncomfortable about being audio-
recorded after the recording has begun, you may request that the study team stop the audio 
recorder at any time. Please be advised that although the study staff will take every 
precaution to maintain confidentiality of the focus group interview data, the nature of focus 
group discussion prevents the study staff from guaranteeing confidentiality. The study staff 
have extensive experience collecting focus group data and will remind participants to respect 
the privacy of fellow group members and not repeat what is said in the focus group to others. 
To further protect your confidentiality, we will ask participants to avoid using their full name 
or the full names of their NCORP site colleagues during the discussion. We will also remind 
participants to respect different perspectives and opinions of focus group participants so as to 
allow for open discussion of the perceived challenges of assessing and treating tobacco 
dependence within NCORP sites. 
What are the costs of taking part in this study? 
There are no costs involved with participation in this study. Depending on your institution’s 
regulations, you may receive small financial remuneration as a token of appreciation for your 
participation in the study. This may include up to $100 in gift card incentive, in total, for 
completion of the baseline, 12 month, and 36 month surveys, ($20 per survey) and the focus 
group interview ($40). 
Who will see my information? 
Your privacy is very important to us. The study researchers will make every effort to protect 
it. The study researchers have a privacy permit to help protect your records if there is a court 
case. However, some of your information may be given out if required by law. If this should 
happen, the study researchers will do their best to make sure that any information that goes 
out to others will not identify who you are. 
Conversations that are recorded throughout your participation will be transcribed and coded 
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with a study ID number. Only study staff and trained transcriptionists will have access to the 
audio files. All identifying information will be redacted in the written transcript. The audio 
files will be destroyed once the study is complete. Retained data (transcripts and surveys) 
will be de-identified once data collection is complete. 
While there will likely be publications as a result of this study, your name will not be used. 
Only group characteristics will be published. If you participate in this study, we would like to 
be able to quote the words you have used without using your name. If you agree to allow us 
to quote you in publications, please initial the statement at the bottom of this form. 
There are organizations that may look at your study records. Your information in the research 
database also may be shared with these organizations. They must keep your information 
private, unless required by law to give it to another group. 
Some of these organizations are: 
• Memorial Sloan Kettering Cancer Center 
• Massachusetts General Hospital 
• The IRB, which is a group of people who review the research with the goal of protecting 
the people who take part in the study. 
• The NCI and the groups it works with to review research. 
In the future, other researchers may find it valuable to use the transcripts of the audio 
recorded conversation obtained from this study. While we are primarily interested in the 
conversation to analyze your feedback on tobacco treatment implementation, because the 
transcripts of the audiotapes have possible value to other researchers, we would like your 
permission to let other researchers use these transcripts for future research studies. These 
researchers would not have any information about who you are. 
I give my permission for the use of the de-identified transcripts for future research: 
______YES 
______NO 
Where can I get more information? 
You may visit the NCI web site at http://cancer.gov/ for more information about studies or 
general information about cancer. You may also call the NCI Cancer Information Service to 
get the same information at: 1-800-4-CANCER (1-800-422-6237). 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site at any 
time. 
You can talk to the study coordinator about any questions or concerns you have about this 
study. Contact the study coordinator (*insert name of study coordinator[s]*) at (*insert 


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telephone number, and email address if appropriate*). 
For questions about your rights while in this study, call the (*insert name of organization or 
center*) Institutional Review Board at (*insert telephone number*). 
^Note to Local Investigator: Contact information for patient representatives or other 
individuals at a local institution who are not on the IRB or research team but take calls 
regarding clinical trial questions can also be listed here. ^ 
My signature agreeing to take part in the study 
I have read this consent form and my questions have been answered. I will be given a signed 
and dated copy of this form. I agree to take part in the main study.  I also agree to take part in 
any additional studies where I circled “yes”. 
 
Participant’s signature ________________________________ 
 
Date of signature _____________________________________ 
 
Signature of person(s) conducting the informed consent discussion ___________________ 
 
Date of signature _____________________________________