Assessing Social Determinants of Health to Increase Cancer Screening
Phase: NA
Conditions: Lung Cancer
Sponsor: Hackensack Meridian Health

CLINICAL STUDY PROTOCOL 
 
 
 
Assessing Social Determinants of  
Health to Increase Cancer Screening  
SD-CAN: Social Determinants for Cancer screening Access & Navigation 
 
 
Protocol Version 
03.07.2024 
 

 
Study Number: Pro2023-0374 
09.08.2023
 
Study Personnel 
Principal Investigator/Department:  
Lisa Carter-Bawa, PhD, MPH, APRN, ANP-C, FAAN 
Director, Cancer Prevention Precision Control Institute @ the Center for Discovery & Innovation 
Lisa.CarterBawa@hmh-cdi.org 
Sub-I(s): Elan Shoulders, MPH 
Statistical support: N/A 
Protocol Development support (if applicable): N/A 
Name and information of sponsor: Hackensack Meridian Health 
Research Locations (all non-HMH locations): N/A 
 
Abbreviations 
Abbreviation  
Explanation 
SDOH 
Social Determinants of Health 
LCS 
Lung Cancer Screening 
 
Revision History  
Revision # 
1 
Version Date 
02.16.2024 
Summary of Changes 
Changes to recruitment. 
Changes to study design 
to include a waitlist 
control arm. 
Consent Change? 
 
Summary 
Study Title 
Assessing Social Determinants of Health to 
Increase Cancer Screening 
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Study Design 
Pilot randomized controlled trial with a waitlist 
control arm to compare lung cancer screening 
uptake among individuals who undergo SDOH 
assessment and referral (n=50) compared to 
those who do not (n=50) 
Primary Objective 
Lung cancer screening uptake 
Secondary Objective(s) 
Health literacy, Medical Mistrust, Perceived 
Stigma, Cancer Fatalism, Knowledge: Lung Cancer 
and Screening, Lung Cancer Screening Health 
Beliefs (perceived risk, perceived benefits, 
perceived barriers, self-efficacy) 
Research Intervention(s)  
SDOH Assessment and Referral using SDOH 
screening survey and UniteUs (formerly NowPow) 
website to link to resources to address identified 
SDOH needs 
Study Population 
Men and women who are eligible for lung cancer 
screening (aged 50-80 years, currently smoke or 
quit smoking within the past 15 years, 20 
pack-year tobacco smoking history) 
Sample Size 
N=100 
Study Duration for individual participants 
3 months 
 
 
 
 
1 – Introduction    
The goal of this study is to compare the effectiveness of a community-based lung screening 
educational tool paired with a social determinants of health (SDoH) screening assessment and 
referral process compared to a community-based lung cancer screening (LCS) educational tool alone 
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as part of outreach activities to improve (a) LCS rates (primary outcome); (b) intention to screen; and 
(c) individual-level potential drivers of LCS (health literacy, mistrust, stigma, fatalism, knowledge, 
health beliefs). We hypothesize that providing SDOH screening and referral will result in higher levels 
of LCS, forward movement of intention to screen, and improved individual-level drivers of LCS. 
2 – Background 
2.1. Background/literature review (make sure you provide references) 
Lung cancer kills more people than colorectal, breast, prostate and cervical cancers combined.1 
Despite lung cancer mortality rates being lower in NJ compared to nationally, lung cancer remains 
the leading cause of NJ cancer death regardless of race, ethnicity or gender. Although LCS is 
recommended by the USPSTF, has the potential to detect lung cancer at earlier, more treatable 
stages, has a 20% lung cancer-related mortality reduction in those at risk and is covered by insurance, 
population uptake has been abysmal.2 Even though it has been a decade since the USPSTF released 
its recommendation, only 5.8% of screening-eligible Americans have been screened, and in NJ that 
rate is only 3.7%. Screening-eligible individuals are generally unaware of LCS. Our team’s prior work 
revealed that in addition to lack of awareness, screening-eligible individuals do not screen – when 
they are aware – because of perceived and actual barriers to LCS.3–5 One of the most significant 
barriers is needs related to the social determinants of health (SDoH).6  Engaging screening-eligible 
individuals is challenged by unmet needs related to SDoH. If an individual is dealing with financial 
strain, housing instability, transportation needs, food insecurity or beyond, cancer screening is not a 
priority. Those most vulnerable tend to be those also at high-risk for the development of disease and 
infirmity. Therefore, if the public health benefit of LCS is to be realized, we must first realize that we 
need to address the most basic needs of those most vulnerable. Screening for the SDOH is also 
documented with improving the ability to engage underserved individuals with the healthcare 
system at an entry level and maintaining their engagement over time.6 LCS efforts cannot be 
performed in a silo; LCS efforts cannot stay confined to the health system alone. We must assess and 
connect resources addressing basic needs before we can focus on early detection of cancer to have 
the broadest and most meaningful impact. SDOH screening and referral paired with LCS education 
has the potential to address basic needs while increasing awareness about the importance of early 
detection of lung cancer when more treatment options exist and is associated with better outcomes. 
Improving SDOH has been supported as an evidence-based strategy to promote health equity by 
leveraging SDOH to increase breast, cervical, and colorectal cancer screenings.6 Assessing SDOH and 
intervening with appropriate SDOH referral has the potential to increase LCS in at risk New Jerseyans. 
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Impact. A multilevel lung screening intervention that pairs SDoH screening and referral with a 
tailored health communication and decision support tool for lung screening has the potential to 
significantly impact lung screening uptake among at-risk individuals in the community, particularly 
among those who face barriers related to SDOH. In addition, findings will advance our understanding 
of effective strategies for improving lung screening and prevention efforts in non-traditional settings, 
with the ultimate goal of reducing the burden of lung cancer. As we consider ways to support the 
realization of the public health benefit of lung cancer screening, multiple strategies and venues to 
reach, and intervene, with screening-eligible is key. 
 
References 
1.​Cancer Facts & Figures 2023. American Cancer Society, Inc.; 2022. 
https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2023-cancer-facts
-figures.html 
2.​Pettit N, Ceppa D, Monahan P. Low Rates of Lung and Colorectal Cancer Screening Uptake Among 
a Safety-net Emergency Department Population. West J Emerg Med. 2022;23(5):739-745. 
doi:10.5811/westjem.2022.5.55351 
3.​Carter-Harris L, Ceppa DP, Hanna N, Rawl SM. Lung cancer screening: what do long-term smokers 
know and believe? Health Expect. 2017;20(1):59-68. doi:10.1111/hex.12433 
4.​Carter-Harris L, Brandzel S, Wernli KJ, Roth JA, Buist DSM. A qualitative study exploring why 
individuals opt out of lung cancer screening. Fam Pract. Published online January 24, 
2017:cmw146. doi:10.1093/fampra/cmw146 
5.​Carter-Harris L, Slaven JE, Monahan PO, Draucker CB, Vode E, Rawl SM. Understanding lung cancer 
screening behaviour using path analysis. J Med Screen. 2020;27(2):105-112. 
doi:10.1177/0969141319876961 
6.​Mohan G, Chattopadhyay S. Cost-effectiveness of Leveraging Social Determinants of Health to 
Improve Breast, Cervical, and Colorectal Cancer Screening: A Systematic Review. JAMA Oncol. 
2020;6(9):1434-1444. doi:10.1001/jamaoncol.2020.1460 
7.​Weinstein D. The Precaution Adoption Process Model. In: Health Behavior and Health Education: 
Theory, Researchm and Practice. 4th Ed. Jossey-Bass; 2008:123-147. 
8.​Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. 
Fam Med. 2004;36(8):588-594. 
9.​Thompson HS, Valdimarsdottir HB, Winkel G, Jandorf L, Redd W. The Group-Based Medical 
Mistrust Scale: psychometric properties and association with breast cancer screening. Prev Med. 
2004;38(2):209-218. doi:10.1016/j.ypmed.2003.09.041 
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10.Cataldo JK, Slaughter R, Jahan TM, Pongquan VL, Hwang WJ. Measuring stigma in people with lung 
cancer: psychometric testing of the cataldo lung cancer stigma scale. Oncol Nurs Forum. 
2011;38(1):E46-54. doi:10.1188/11.ONF.E46-E54 
11.Mayo RM, Ureda JR, Parker VG. Importance of fatalism in understanding mammography screening 
in rural elderly women. J Women Aging. 2001;13(1):57-72. doi:10.1300/J074v13n01_05 
12.Carter-Harris L, Slaven JE, Monohan P, Rawl SM. Development and Psychometric Evaluation of the 
Lung Cancer Screening Health Belief Scales. Cancer Nurs. 2017;40(3):237-244. 
doi:10.1097/NCC.0000000000000386 
13.Harris PA, Taylor R, Minor BL, et al. The REDCap consortium: Building an international community 
of software platform partners. J Biomed Inform. 2019;95:103208. doi:10.1016/j.jbi.2019.103208 
 
3 – Rationale, Objectives and Hypothesis  
3.1. Study Rationale/Problem Statement/Research question or Study significance 
The goal of this study is to compare the effectiveness of a community-based lung screening 
educational tool paired with a social determinants of health (SDOH) screening assessment and 
referral process compared to a community-based lung cancer screening (LCS) educational tool alone 
as part of community outreach activities to improve (a) LCS rates (primary outcome); (b) intention to 
screen; and (c) individual-level potential drivers of LCS (health literacy, mistrust, stigma, fatalism, 
knowledge, health beliefs). 
 
3.2. Hypothesis (if applicable) 
We hypothesize that providing SDOH screening and referral prior to lung cancer screening education 
among screening-eligible individuals will result in higher levels of lung cancer screening, forward 
movement of intention to screen, and improved individual-level drivers of lung cancer screening. 
3.3. Primary and Secondary Objectives 
3.4. Primary Outcome Variable(s) 
1.​ Lung cancer screening uptake 
3.5. Secondary Outcome Variable(s) 
1.​ Intention to screen for lung cancer 
2.​ Health Literacy 
3.​ Medical Mistrust 
4.​ Perceived Stigma 
5.​ Cancer Fatalism 
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6.​ Knowledge: Lung Cancer and Screening 
7.​ Lung Cancer Screening Health Beliefs 
4 - Study Design 
4.1 General Design 
We will conduct a pilot randomized controlled trial (RCT) to compare primary (LCS uptake) and 
secondary outcomes (intent to screen, literacy, mistrust, stigma, fatalism, health beliefs) among 
LCS-eligible men and women in NJ community- and health system-based settings who receive a LCS 
educational tool (LungTalk) paired with a social determinants of health (SDOH) screening assessment 
and referral process (n=50) compared to the LCS educational tool alone (n=50) as part of lung 
screening uptake outreach activities. All individuals who attend a CCOE event are normally assessed 
for cancer risks and appropriate cancer screening education is provided. For those who screen 
eligible for lung cancer screening, the standard of care for the JTCC Cancer Community Outreach & 
Engagement Program for lung screening is LungTalk. For those who are eligible for LCS, they will also 
be invited to participate in this study. In addition, we will identify lung screening eligible patients 
within Hackensack Meridian Health (HMH) system using the electronic health record with the 
assistance of HMH Business Intelligence to create a list of lung screening eligible patients for 
telephone outreach about the study. LCS eligibility includes being aged 50 to 80 years, currently 
smoke cigarettes or quit within the past 15 years, and has a 20 pack-year smoking history. Pack-years 
are calculated by multiplying the total number of packs smoked daily and the total number of years 
smoked. 
Potential Participants Identified in the Community: Informed consent will be provided to everyone 
participating prior to study enrollment with emphasis of the voluntary nature of participation as well 
as time to ask questions. Preferred contact information including telephone, mailing, and email 
addresses will be obtained during enrollment. Participants will then complete the baseline survey via 
REDCap using a study-provided iPad followed by the intervention according to the arm to which the 
participant is randomized (SDoH screening and referral + LCS education versus LCS education alone). 
If the participant does not have time to complete the full intervention component (SDOH screening 
and referral + LCS education or LCS education alone), a follow-up telephone appointment with study 
staff will be made for subsequent outreach. Immediately after the intervention, the participant will 
complete the post-intervention survey on the iPad using REDCap and receive a $25 gift card for their 
time. The primary outcome (screening uptake) will be assessed by telephone 1-month 
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post-intervention; participants will receive a $25 gift card after completing the 1-month follow-up 
survey.  
Potential Participants Identified through BI-generated HMH Patient List: Informed consent will be 
provided to all participants by telephone with a copy of the informed consent emailed prior to study 
enrollment with emphasis of the voluntary nature of participation as well as time to ask questions. 
Preferred contact information including alternative telephone number, mailing, and email addresses 
will be obtained during enrollment. Participants will then receive a link to complete the baseline 
survey via REDCap to their preferred email address followed by the intervention according to the arm 
to which the participant is randomized (SDoH screening and referral + LCS education versus LCS 
education alone). Immediately after the intervention, the participant will receive a link to complete 
the post-intervention survey via REDCap. The participant will receive a $25 gift card for their time. 
The primary outcome (screening uptake) will be assessed by telephone 1-month post-intervention 
and receive a $25 gift card after completing the 1-month  follow-up survey. 
4.1.1 Study Duration (if applicable) 
Total study duration = 1 month 
 
4.1.2 Number of Study Sites 
1 (HMH) 
4.2 Study Population 
Men and women eligible for lung cancer screening 
4.2.1. Number of Participants 
100 
4.2.2. Eligibility Criteria 
Inclusion Criteria: 
●​ Aged 50 years to 80 years 
●​ Currently smoke cigarettes or quit smoking cigarettes within the past 15 years 
●​ 20 pack-year smoking history 
●​ Has never had lung cancer screening 
●​ Able to provide informed consent 
●​ Able to speak and understand English 
Exclusion Criteria: 
●​ Diagnosed with lung cancer 
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●​ Has a history of having a lung cancer screening scan 
●​ Unable to speak and understand English 
4.3.1. Study discontinuation (if applicable) n/a 
4.3.2. Concomitant medication (if applicable) n/a 
4.4. Risks and Benefits  
4.4.1. Risks 
Risks to participants are deemed minimal. There is a potential risk of loss of confidentiality 
but that is protected against by coding all data with study IDs only, presenting results of 
statistical analyses only in aggregate form, and limiting the use of the data to research staff 
who are IRB approved to participate in the research, have been trained in methods of 
maintaining confidentiality, and have completed training in the protection of human subjects 
and research integrity at regular intervals. There is also the potential for discomfort in 
answering survey questions about lung cancer risk. Participants may choose to skip any 
question they do not feel comfortable answering with no repercussions.  
4.4.2. Benefits 
Potential benefits are related to lung cancer screening and early detection and 
addressing health-related social needs. 
5 – Methods 
5.1. Screening 
We will identify potential participants during community-based outreach efforts using current 
standard practices at these events in which we screen individuals who attend Cancer Community 
Outreach & Engagement (CCOE) programming for eligibility for various types of cancer screening. For 
those eligible for lung cancer screening, we will share the study opportunity with them. We will also 
identify potential participants by enlisting HMH Business Intelligence (BI) to identify current patients 
who are eligible for lung cancer screening, have not been screened, and do not have a diagnosis of 
lung cancer. 
5.2. Recruitment, enrollment, and retention (including screen failures as applicable) 
We will recruit eligible study participants in two ways: (1) community-based outreach efforts, and (2) 
from the lung screening-eligible patient population at Hackensack Meridian Health (HMH). 
Community-based Recruitment/Enrollment. Recruitment will occur at CCOE programming events in 
Bergen, Hudson, and Passaic Counties to recruit LCS-eligible individuals. All individuals who attend a 
CCOE event are assessed for cancer risks and appropriate cancer screening education is provided to 
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them. For those who are LCS eligible, they will also be invited to participate in this study. A study 
brochure will be shared with the potential participant, the study explained and time given to ask and 
have questions answered. If the participant agrees to enroll in the study, a signed informed consent 
document will be obtained prior to study enrollment. Each community-based setting is unique and 
offers different levels of ability to provide privacy in a community outreach setting. We provide the 
LungTalk educational program on an iPad and a headset so that privacy to what is being listened to is 
provided. If the participant is unable to complete the intervention at the CCOE event venue, 
arrangements will be made to follow-up by telephone and provide a weblink to the participants 
preferred email address to send the link to LungTalk and to all surveys for completion. 
Health System-based Recruitment/Enrollment. Potential participants will be identified from 2 
sources: (1) lung cancer screening-eligible patients of the HMH Tobacco Quit Center, and (2) lung 
cancer screening-eligible primary care patients of HMH.  
Lung Cancer Screening-Eligible Patients of the HMH Tobacco Quit Center: For lung screening-eligible 
patients of the HMH Tobacco Quit Center, the Quit Center routinely screens patients for lung cancer 
screening eligibility during their intake process for tobacco treatment. For individuals who are lung 
cancer screening eligible, a list will be shared with the CCOE team for outreach related to lung cancer 
screening education. During the outreach telephone call, patients will be informed about the study 
opportunity. If they are interested, study details will be shared during the outreach telephone call, 
time allotted for the patient to ask questions, verbal informed consent obtained, and enrolled in the 
study. A link will then be emailed to the participant to the informed consent document and 
electronic signature requested on the informed consent. The research study staff member will then 
schedule them for a telephone appointment with the CCOE Patient Navigator. 
Lung Cancer Screening-Eligible Primary Care Patients of HMH: HMH lung screening-eligible primary 
care patients will be identified with the assistance of HMHN Business Intelligence (BI). Using 
parameters of age (50-80 years), smoking status (current or former), and lack of a lung cancer 
diagnosis, BI will generate a patient list of potential participants that can be used for telephone 
outreach by IRB-approved research study staff. We will email a study information sheet to the 
potential participant to their email on record in the EHR. Twenty-four (24) hours to one week post 
email, the research study team will reach out to potential participants by telephone. For individuals 
without an email on record in their EHR, we will mail the recruitment letter with study information 
sheet. One week post mailing, the research study team will reach out to potential participants by 
telephone. We will attempt to contact the potential participant up to 5 times by telephone in a 30 
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day time period. After the 5th attempt, we will document on the study recruitment sheet that the 
participant is a passive decline and we will not re-contact.  
When reached by telephone, the research study staff member will clearly introduce themselves, 
confirm they are speaking with the intended individual (see Box A for Plan to Identify and Confirm 
Contact below), briefly explain how the researcher obtained the potential participants’ contact 
information and clearly state the purpose of the call. The research study staff member will then offer 
an explicit opt-out option here at the beginning of the call, allowing individuals to decline 
participation without pressure while maintaining a respectful and courteous tone throughout the 
conversation. If the potential participant would like to continue the conversation to learn more, the 
research study staff member will share the study opportunity, share study details, answer questions 
about the study, and if interested, confirm eligibility, obtain verbal informed consent, and enroll into 
the study. A link will then be emailed to the participant to the informed consent document and 
electronic signature requested on the informed consent. The research study staff member will then 
schedule them for a telephone appointment with the CCOE Patient Navigator. 
Box A. Plan for Study Staff to Identify Themselves & Confirm Contact) 
1. Introduction and Affiliation: 
●​
We will start by politely greeting the individual. "Hello, this is [Research TM’s Name] calling." 
●​
Clearly state our affiliation with the research project. "I'm calling from Hackensack Meridian 
Health on behalf of a research study about lung health and screening." 
●​
We will mention the recruitment email sent. "You may have received an email invitation from us 
in the past couple of days regarding this research project." 
2. Confirmation of Contact: 
●​
We will ask for their name. "May I please confirm I'm speaking with [Name on recruitment list]?" 
●​
If there's a slight discrepancy: (e.g., nickname used in email)  
o​
We will acknowledge the difference politely. "I see the email went to [name on list]. Is this 
[participant's preferred name]?" 
o​
If unsure, clarify. "Our records show [name on list]. Apologies if there's a mistake." 
●​
If it's the wrong person:  
o​
We will thank them for their time. "Thank you for answering. I apologize for the 
inconvenience. I'm looking for [name on list]." 
o​
We will offer to remove them from the call list if desired. "Would you like me to remove 
you from our contact list?" 
o​
We will politely end the conversation. 
 
5.3. Study intervention (including schedule of events and study visits) 
Interventions. Unite Us is an electronic SDoH screening and referral tool assessing: (1) financial 
resource strain; (2) housing stability; (3) transportation needs; and (4) food insecurity. Upon 
completion, the Unite Us platform identifies a list of geographically-tailored resources to connect the 
individual in need. A CCOE staff member will administer the SDoH screening and referral tool, review 
the results with the participant, and use the geographically-tailored resources to make SDoH-related 
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referrals.  LungTalk is a novel theoretically grounded health educational tool that will be delivered via 
iPad and is an interactive computer-based program that includes audio, video and animation 
segments with scripts presented from a master content library in consideration of different ways 
people like to learn. Informed by our prior research, LungTalk tailors its content based on smoking 
status and perceived barriers. In prior work, LungTalk more than doubled LCS knowledge and health 
beliefs (p < 0.01), and was associated with a significant increase in deciding to screen for lung cancer 
compared to control group; OR 1.99; 95% CI, 1.03, 3.85, p = 0.03. 
5.4. Assignment / Randomization (if applicable) 
Participants in the study will be randomly assigned to one of two groups: intervention (n=50) or 
waitlist control (n=50). For those randomized into the intervention arm, they will complete SDOH 
screening assessment with the CCOE Patient Navigator and receive referral to local resources based 
upon identified needs followed by viewing the LungTalk educational program. For those randomized 
into the waitlist control group, they will view the LungTalk educational program. One month 
following viewing the LungTalk educational program, participants in the waitlist control group will 
receive an outreach call for SDOH screening assessment and referral to local resources based upon 
identified needs. 
5.5. Section of instruments. 
Table 1. Data Collection Timeline / Measurement Tools 
in person via iPad 
or by phone 
by 
phone 
Measure (Cronbach’s α, if applicable) (# of items) 
Pre 
Post  
1 mo. 
Sociodemographic & Health Status Characteristic Survey (11 items) 
X 
 
 
PRIMARY OUTCOME 
LCS Uptake (self-report) (1 item) and verification of lung cancer 
screening (LDCT of the chest) via EHR 
 
 
X 
SECONDARY OUTCOMES 
Stage of Adoption for LCS (algorithm allows assessment of intent)7 
X 
X 
X 
Health Literacy (0.80) (3 items)8 
X 
X 
X 
Medical Mistrust Scale (0.84) (5 items)9 
X 
X 
X 
Perceived Stigma Scale (0.89) (5 items)10 
X 
X 
X 
Lung Cancer Fatalism (0.89) (8 items)11 
X 
X 
X 
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Knowledge: Lung Cancer and LCS Scale (7 items) 
X 
X 
X 
Perceived Risk of Lung Cancer Scale (0.88) (3 items)12 
X 
X 
X 
Perceived Benefits of LCS Scale (0.76) (6 items)12 
X 
X 
X 
Perceived Barriers to LCS Scale (0.87) (17 items)12 
X 
X 
X 
Self-Efficacy for LCS Scale (0.92) (9 items)12 
X 
X 
X 
 
5.6. Data management (data collection, source and storage) 
All data collected (baseline and follow-up) will be collected via REDCap (Research Electronic Data 
Capture) which is a secure web-based application for building and managing online surveys and 
databases. REDCap provides audit trails for tracking data manipulation and user activity as well as 
export procedures for secure data downloads to common statistical packages.13  
5.7. Follow-up and end-of study (if applicable) 
One follow-up survey will be conducted at 1-month post-intervention and will be collected by phone 
and entered into REDCap. 
5.8. Statistical Method 
Baseline characteristics of the two study arms will be compared using descriptive statistics. 
Continuous variables will be summarized using means and standard deviations, while categorical 
variables will be summarized using frequencies and percentages. To assess feasibility, we will assess 
the study procedures (recruitment and retention rates), adherence to the intervention, and 
completion rates for the study measures. 
5.8.1. Sample size calculation and justification 
As a pilot study, the primary analytic purpose is feasibility analysis and descriptive analysis to inform 
a larger, fully powered trial. At least 12 subjects per arm are required to obtain reasonable effect size 
estimates to design a larger well-powered trial. We will recruit 100 participants (50 per arm). This 
sample size is also sufficient for providing a precise attrition rate estimate. 
5.8.2. Statistical Analysis Plan 
The primary analysis will use an intention-to-treat approach, with all randomized participants 
included in the analysis. The proportion of participants whose follow-up assessment indicate 
‘intention to screen’ will be compared between the intervention and enhanced control arms using a 
chi-squared test. Because we will be enrolling all screening-eligible individuals at CCOE programming 
events, we will perform subgroup post-hoc analyses to compare the primary outcomes by race. 
Logistic regression will be used to adjust for any baseline differences between the two arms that may 
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have influenced the primary outcome. Secondary outcomes will be analyzed using appropriate 
statistical tests, such as t-tests for continuous variables and chi-squared tests for categorical 
variables. We will also use regression analysis to identify factors associated with intention to screen 
and lung cancer screening uptake. 
6 - Trial Administration 
6.1. Ethical Considerations - Institutional Review Board (IRB) Review 
This study will be conducted according to the International Conference on Harmonization (ICH), 
Good Clinical Practice (GCP), the Declaration of Helsinki, Institutional Review Boards (IRB) and in 
accordance with the U.S. Code of Federal Regulations on Protection of Human Rights (21 CFR 50). 
 
6.2. Institutional Review Board (IRB) Review (list the IRB of record) 
The final study (ICF, HIPAA form as applicable) and data collection tools will be approved by the 
Institutional Review Board (IRB) at HMH. Approval will be received in writing before study initiation. 
Any changes to the study design will be formally documented in amendments and be approved by 
the IRB prior to implementation. 
6.3. Confidentiality 
A unique identifier (study ID number) will be assigned to each participant. The study ID number will 
be included in the data collection tools and analysis software while the list with direct identifiers and 
ID numbers will be stored separately in an HMH-password protected computer and locked office.  
If results of the study are published, individual names or other identifying information will not be 
used, and findings will be reported in aggregate data only. 
6.4. Informed Consent  
Written informed consent will be provided to everyone enrolled in the study. During the 
recruitment process, potential participants will be screened for inclusion and exclusion 
criteria. During the screening process, the study personnel will speak with the individual to 
determine that they can give informed consent for themselves. At that time, the study 
personnel will read through and discuss the informed consent with the individual. Once they 
have finished discussing the informed consent, the individual will be given an opportunity to 
ask any questions they may have. The study personnel will stress that the individual can 
withdraw from the study at any time with no penalty. The individual will then be asked to 
provide written informed consent to enroll in the study, or to decline to participate. If the 
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individual provides written informed consent, a copy of the consent form will be provided to 
the participant for their records. 
6.5. Data Quality Assurance (if applicable) 
The REDCap survey will be monitored by the study team to assess survey/data collection issues and 
any unusual events. Modifications will be made as necessary and recorded to ensure maintenance of 
protocol integrity. In addition, any problems identified will be discussed at team meetings and 
corrected. 
6.6. Study Records (retention etc.) 
Study records will be retained in accordance with regulatory and organizational requirements, but for 
no less than six (6) years following the completion of the study.  Disposal of records will be 
performed according to regulations and in a manner in which no identifiable information can be 
linked back to the study. 
6.7. Compensation for Research-Related Injury (if applicable) 
N/A 
6.8. Economic Burden to Subjects (if applicable) 
N/A 
6.9. Credentials, Training 
All research personnel will be up to date with required CITI training. 
6.10. Financing and Insurance (if applicable) 
N/A 
6.11. Publication Plan (if applicable) 
N/A 
7- Resources Available 
7.1. Describe the resources available to conduct the research:  
Both the Cancer Prevention Precision Control Institute and the John Theurer Cancer Center Cancer 
Community Outreach & Engagement Program are led by the principal investigator. There is primary 
office space for both programs at the Center for Discovery & Innovation on the Nutley campus. The 
space is well equipped with individual offices, cubicles, and several multipurpose rooms for 
conducting interviews and convening research team meetings.  
Computer The PI and research team have designated computer workstations that are networked to 
the various secure campus-wide hospital systems. CDI has a well-maintained computing environment 
that includes frequent software updates, proper hardware maintenance schedules, and 24/7/365 
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Study Number: Pro2023-0374 
09.08.2023
 
help desk and network administration support. CDI has an institutional site license for many software 
programs including Microsoft Office Suite, Adobe Acrobat, SAS, and SPSS. The computers are also 
equipped with the statistical program R, and bibliographic manager software (EndNote). The CDI has 
its own web and database servers based on Microsoft platform to streamline data collection and 
maintain data integrities. 
Administrative Support: The PI has full time administrative support who provide administrative 
services for all research projects including a full time Sponsored Programs Manager to help 
investigators comply with all relevant regulations and policies and managing grants. A financial 
analyst supports financial needs in sponsored research, cost analysis, procurement, and budgeting. 
The Research Department also has comprehensive administrative support for all researchers. 
Appendices 
Appendix # 
Name 
1 
Measures 
  
16