Incorporating Veterans Preferences Into Lung Cancer Screening Decisions
Phase: NA
Conditions: Lung Cancer Screening
Sponsor: VA Office of Research and Development

 
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CMCVAMC SPECIFIC PROTOCOL SUMMARY 
Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center (CMCVAMC) 
Institutional Review Board (IRB) 
 
Instructions:  Click in box and start typing or click ‘choose an item’ and choose the applicable entry.  
NOTE:  If you are using a MAC, you may have difficulty with checkboxes and “choose an item” 
boxes. 
 
Section 1. General Information 
 
Protocol Title:   Incorporating Veterans' Preferences into Lung Cancer Screening Decisions- Phase 3  
 
CMCVAMC Protocol Version Number and Date:  Version #8  03/03/2021   
 
Principal Investigator (PI) Name:  Marilyn M. Schapira 
 
PI’s Academic Degree(s):   MD, MPH 
 
Is the study funded?   YES    If “yes”, specify funding agency:  VA Health Services Research & 
Development Service (HSR&D) 
 
Is a grant application requesting funds for the study currently being reviewed?    NO 
 
CMCVAMC is the only institution involved: NO 
 
CMCVAMC is the coordinating center in which the PI is the lead investigator: YES       If this 
answer is yes, complete the next two sections: 
➢ List the name(s) of the other site(s) involved.  West Haven VA Medical Center (WHVAMC) 
Milwaukee VA Medical Center 
➢ Provide the FederalWide Assurance (FWA) numbers for each site.  WHVAMC 00001286, 
Milwaukee VAMC 00000289 
 
State name of coordinating center if this is not CMCVAMC.    n/a 
 
Describe PI’s qualifications to conduct this project and attach a copy of PI’s VA or NIH 
biosketch.  Be specific in regard to PI’s research experience. NOTE:  If PI does not have any prior 
research experience, indicate what provisions are being made to provide oversight or mentoring.  Dr. 
Schapira is a Professor at the University of Pennsylvania and the Center for Health Equity Research 
Program (CHERP) at the Corporal Michael J. Crescenz VA Medical Center (CMVAMC) and co-Director 
of the Cancer Control Research Program the Abramson Cancer Center at the University of 
Pennsylvania (Penn). Her research has focused on risk communication and medical decision-making. 
Her work has advanced methods of shared decision-making including the measurement of health 
numeracy, communication of risk and uncertainty, and preference assessment. The clinical context of 
her research has been oncology, encompassing both screening and treatment decisions. Her work has 
been trans-disciplinary, reflecting the discipline of decision science. She collaborates with experts in 
clinical medicine, cognitive and social psychology, economics, education, and biostatistics. In work 
supported by the NCI and the American Cancer Society, she has developed a theoretically based and 
cross-culturally equivalent measure of health numeracy called the Numeracy Understanding in Medicine 
Instrument (NUMi). The NUMi is being translated into Spanish and a Computer Adaptive Version (CAT) 
version has been developed. She is now conducting a cohort study to evaluate the NUMi as a screening 
test for health numeracy that can be used in the clinical setting and communication strategies in the 
cancer treatment consultation. Her work has also focused on evaluating cancer screening paradigms 
from a population perspective. Her focus in the decision sciences is reflected in my professional 
leadership positions including past President of the Society for Medical Decision-making (SMDM) and 

 
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Associate Editor of Medical Decision-making. She assembled a trans-disciplinary team (clinical 
medicine, economics, biostatistics, human factors engineering, and implementation science) to develop 
an innovative decision support tool for Veterans who are eligible for and considering lung cancer 
screening. This project builds on her prior work in preference assessment and shared decision-making 
in the context of cancer care. 
 
Does any research staff member have an actual and/or perceived conflict of interest with this 
study?   NO         If yes, explain.        
 
Is this study a clinical trial?  YES         If yes, specify the type. Phase 3 
NOTE:  Only ‘applicable clinical trials’ must be registered on ClinicalTrials.gov.  The term ‘applicable 
clinical trial’ means an applicable drug clinical trial or an applicable device clinical trial.  Investigators 
might consider registering all other clinical trials on ClinicalTrials.gov, if journals in which they publish 
studies require such registration prior to starting a trial. 
 
State the estimated length of time to complete enrollment of subjects.  24 Months 
 
State the expected duration of participation by individual subjects (including any follow-up, e.g., 
need to re-contact subject for follow-up questions prior to closure of the study). One Study Visit; 
One 1-Month Phone Follow-Up and One 3-Month Phone Follow-Up     
 
Specify the projected date of completion of the study.   Phase 3 – March 2021 
 
Section 2:  Participating Site Specifications 
2.1. 
Where will the research project be conducted?  (Check all that apply)  
  VA Inpatient Setting 
  VA Outpatient Clinic/Office 
  
  VA Laboratories 
  Subject Homes  
 
  University of Pennsylvania 
  Community Based Outpatient Clinics  
                                                                                          (CBOCs)   
 
 
(Gloucester, NJ, Saracini (Horsham, PA),  
 
 
 Camden, NJ, Burlington, NJ, Fourth Street VA 
Clinic, Chestnut Street VA Clinic, West Philadelphia 
VA Clinic) 
 
  Other (Specify): WHVAMC 
 
2.2. 
If research is conducted at a non-VA site, please specify where and how much of the 
project will be conducted at that location.     
    Dr. Schapira has an office at Penn and some of the work with coded data may occur at that 
office through a VPN connection to VA Secure Computers. The office number 1316 Blockley and 
the location is 423 Guardian Drive, Philadelphia, PA, 19104. The office is located in close 
proximity to the CMCVAMC. All interactions with VA subjects occur at the VA. 
 
Section 3:  Introduction 
3.1. 
Provide scientific background and rationale for study.  Including summary of gaps in 
current knowledge, relevant data, and how the study will add to existing knowledge.   
                Lung cancer is a significant health issue, and especially so within the Veteran population. 
Lung cancer is the top cause of cancer-related deaths, and this risk is higher for Veterans because of 
age and smoking history [1]. The majority of lung cancer prevention has focused on ending smoking, but 
a recent study that compared low dose computerized tomography scans (LDCT) to simple chest-x-ray 
scans saw a 20% decrease in cancer specific mortality rates [2]. Following additional evidence [3], the 
US Preventive Services Task Force and American Cancer Society, along with a number of other cancer 

 
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preventative organizations, issued guidelines in favor of annual lung cancer screenings for older people 
with a history of smoking [4-6]. However, there are concerns that with more screenings an increase in 
false positives and over diagnosis will occur. The effectiveness of lung cancer screening may also vary 
by gender, and initial data suggests some Veterans are reluctant to enter an intensive screening 
process [7]. As the Department of Veteran Affairs expands the paradigm of lung cancer control to 
include lung cancer screening, it is critical to develop and test decision support tools that 1) educate 
Veterans regarding expected outcomes, 2) incorporate Veteran preferences and values into the 
decision-making process, and 3) encourage shared decision-making between Veterans and providers 
 
The VA method of lung cancer screening is unique in that it is designed to increase assessment rates 
and support among Veterans. Lung cancer screening criteria includes age and the modifiable behavior 
of smoking. As stated before, the high rate of false positives negatively impacts screening participation, 
so the assessment of patient preferences will inform participants of strategies to encourage adherence 
to the program [8]. Comorbidity must also be taken into account, as the target screening population is 
older [9], and at a higher risk for vascular diseases than younger people. A successful paradigm will 
include these concerns. The unique aspects of the lung cancer screening paradigm increase the 
importance of preference assessment as part of an informed decision-making process. 
 
A recent Cochrane meta-analysis found that decision aids such as conjoint analysis and best-worse 
scaling (commonly called discrete choice experiments) can improve receptiveness to lung cancer 
screening methods [10]. However, these tools have not been widely used in clinical practice, and these 
assessment methods would have to be geared towards Veteran population and require systems to 
integrate decision support with clinical practice. This proposal will address these gaps by evaluating the 
usability and acceptability of an explicit preference assessment method as part of a lung cancer 
screening decision support tool (LCSDecTool) designed for Veterans. 
 
Significance 
Veterans are at higher risk of lung cancer due to their increased smoking rate when compared to the 
general population, both when active and following service time [1]. Eight VA Medical Centers have 
recently completed studies that demonstrate the need for effective screening tactics. The PI of this 
proposal (Schapira) has completed pilot work with HSR&D Research in this area. and the demonstration 
projects across 8 sites in the VA health care system found that 56% of the Veterans offered screening 
agreed to the tests. Before expanding further, it is imperative that decision-support tools are present to 
encourage participation in lung cancer screening programs. By developing these strategies now, patient 
preferences can be accounted for in the study guidelines. (Figure 1). 
 
 
 
This research is based on the theoretical frameworks of shared decision-making (SDM), implementation 
science, and technology adoption. SDM incorporates normative and dual process reasoning theories. 
Dual process theory recognizes the role of systematic reasoning, which is thought to lead to decisions 
that people are more likely to follow through with [11]. Implementing a decision support tool that 

 
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provides evidence-based information clearly reduces the barriers to dual process reasoning leading to 
higher decision quality and more accurate risk perception [12-15]. 
This study simultaneously collects data to gauge effectiveness of intervention and implementation. Data 
collection pertaining to process evaluation will be guided by the Promoting Action on Research 
Implementation in Health Services (PARIHS) implementation framework [16-18] and the Technology 
Acceptance Model (TAM) [19]. This team is qualified to conduct this work, as the core and 
coinvestigators have a number of relevant experiences to draw from regarding this study. 
 
Pilot data to support this program was conducted at Penn in two parts: 1) an HSR&D pilot (PI Schapira) 
of preference assessment and risk communication among Veterans considering lung cancer screening, 
and 2) a Center for the Evaluation of Patient Aligned Care Teams (CE-PACT) pilot grant to develop a 
web-based health numeracy tutorial for patients enrolled in a Patient Aligned Care Team (PACT) at the 
CMCVAMC. Qualitative interviews with Veterans were conducted in the HSR&D pilot to define the most 
critical attributes of lung cancer screening. In the pilot, it was seen that Veterans found pictographs to be 
useful for conveying expected outcomes, along with gradations indicating risk estimates, and a “margin 
of error” interval analogy. Veteran concerns included the financial and emotional strain of follow-up tests 
resulting from false positives. Fifty-one percent (51%) of study participants were African American, 86% 
were current smokers, and 47% had at least 30 pack years of smoking (this means 1 pack per day for 
30 years or 2 packs a day for 15 years). Participants were asked to choose the attributes most and least 
important to them regarding lung cancer screening from groups of three. Linear regression was used to 
determine the association between race and other factors via importance weights [20, 21]. (Figure 3). 
 
 
 
Dr. Schapira also worked with web developers to improve patient understanding of numeric information 
used in medical diagnosis. Forty-two participants diagnosed with heart failure had the option to learn in 
a classroom setting, or in a web-based program. The pilot study found that 95% of participants preferred 
a computer-based tutorial, with the most viewed modules being Understanding Risk and Taking 
Medications. Knowledge quizzes embedded in the program noted participant knowledge increased after 
module completion. The pilot studies demonstrate the research team’s experience in the field of risk 
communication, preference assessment, and the development of web-based interventions. The 
proposed study is a natural extension of this pilot work. 
 
The methods proposed are put forth to help design a Lung Cancer Screening Decision Tool 
(LCSDecTool) for Veterans. LCSDecTool is intended to improve outcomes and number of high-quality 
decisions for Veterans eligible for lung cancer screening. High quality decisions are broadly defined as 

 
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informed decisions in which the patient’s choice is aligned with their values and preferences. The 
linkages to outcomes are described in the table below (Table 2). 
 
 
The decision regret scale was adapted to lung cancer screening Data Collection Instrument). Anxiety, as 
measured by the STAI, and cancer worry have been used as patient-centered outcomes among lung 
cancer screening recipients [12, 85, 86]. A systematic review reports short-term psychological 
discomfort among many lung cancer screening recipients and short-term increases in distress among 
those with false-positive results [87]. The lung cancer worry scale is adapted from a measure of breast 
cancer worry after mammography screening [88]. A post-visit provider survey will assess whether lung 
cancer screening was discussed at the visit, if a recommendation was made, and if a test ordered. 
 
The following objectives were completed in Phase 1 and 2. 
Phase 1: To elicit stakeholder input to inform the development of a lung cancer screening 
decision tool (LCSDecTool). In this Phase we use structured interview and focus groups among 
patients, providers, and clinical  leaders. Findings from Phase 1 were used to develop the 
LCSDecTool in Phase 2. 
Phase 2: To develop a web based LCSDecTool that will expand existing materials available for 
Veterans through a Web application that can be used on a desktop, laptop, tablet, or mobile 
phone. Outcomes will include measures of feasibility, perceived utility, patient engagement, and 
satisfaction.  

 
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Section 4:  Objectives Section  
4.1. 
Describe the study’s purpose, specific aims, or objectives.     
Phase 3: To test the efficacy of the LCSDecTool compared to usual care on improving decision 
process, clinical, and behavioral outcomes. Primary outcomes include decisional regret, 
decisional conflict, state trait anxiety, lung cancer worry, and lung cancer screening uptake. We 
hypothesize that Veterans randomized to the LCSDecTool compared to the control intervention 
will demonstrate the following: 
• 
H1: 
Decreased decisional regret and decisional conflict at 1 month following the 
intervention 
• 
H2: 
Decreased state anxiety and lung cancer worry at 1 month following the 
intervention 
• 
H3: 
Decreased rates of lung cancer screening at 3 months following the intervention 
 
This work builds directly upon a recently completed HSR&D supported pilot study in the area of 
lung cancer and shared decision-making. We will accomplish these Aims through a mixed 
methods study at the CMCVAMC,the WHVAMC, and the Milwaukee VAMC. The study utilizes 
the expertise of a transdisciplinary research team culminating in a randomized trial to evaluate 
the efficacy of the LCSDecTool as well as feasibility and process outcomes to support future 
wide spread implementation. As a new paradigm of lung cancer control is emerging that 
incorporates both lung cancer screening and smoking cessation, it is imperative to develop a 
patient centered strategy that incorporates Veterans’ values into lung cancer screening decisions 
that can be integrated into the clinical setting. The proposal provides a mechanism to accomplish 
these goals and fills a gap in currently available decision support tools for Veterans. The 
proposed research will augment ongoing efforts by the VHA National Center for Health 
Promotion and Disease Prevention to promote a patient centered approach to lung cancer 
screening. 
 
4.2. 
State the hypotheses to be tested.     
We hypothesize that Veterans randomized to the LCSDecTool compared to the control 
intervention will demonstrate the following: 
• 
H1: Decreased decisional regret and decisional conflict at T2 (1 month after the 
intervention) 
• 
H2: [Decreased overall anxiety and lung cancer worry at T2 (1 month after the 
intervention)] 
• 
H3: Lower rates of lung cancer screening at T3 (3 months after the intervention) 
 
Section 5: Study Procedures 
5.1. 
Study Design 
5.1.1. 
Describe in detail the experimental design, i.e. from recruitment procedures to 
study closure.            
A pilot randomized clinical trial (RCT) will be conducted to compare the efficacy of the 
LCSDecTool to a control intervention among with respect to decision process outcomes, clinical 
outcomes, and health related quality of life. 
 
Eligible patients will be identified through VA Corporate Data Warehouse (CDW), flyers in 
primary care/pulmonary clinics and the use of a study team consult that will allow providers to 
refer eligible patients to the study team. When a potential participant is identified, the study team 
will send the patient an invitation letter to join the study. Use of the CDW database will support 
this approach, as the dates of scheduled visits are included in the CDW database and updated 
daily. Efforts will be made to recruit at least 40% African American, 5% Hispanic, and 10% 
female patients. Eligibility will be determined by in-person or telephone interviews. 
 

 
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Since MyHealtheVet will be used after consent, the research team will ask patients if they are 
registered on MyHealtheVet with a premium account that allows them to access Secure 
Messaging. If they are not registered, the study team will offer that they go to the MyHealtheVet 
office to sign up. The study team may use MyHealtheVet Secure Messaging to confirm and 
schedule research appointments and follow-ups.  The use of MyHealtheVet is optional.  Patients 
will be enrolled prior to upcoming appointments in primary care/pulmonary clinics to ensure an 
opportunity for shared decision-making following the intervention  
 
All primary care providers in the PACT at the respective VA centers will be sent a description of 
the overall study through email and/or office mail. Providers will be able to opt out of the study, in 
which case their patients will not be approached regarding study enrollment. For providers who 
agree to participate, their patients will be approached regarding study enrollment if they meet 
inclusion and exclusion criteria. A provider information page will be sent to all participating 
providers which will include information about the LCSDecTool and example of the LCSDecTool 
summary sheet. This may include the same providers that participated in Phase 1 and Phase 2. 
 
The LCSDecTool will be programmed to randomly assign the participant to 1 of 2 viewing 
experiences (Experimental vs. Control). The study visit will occur either in-person or by 
telephone.  The in-person study visit will be in a quiet, private room. Telephone visits will be 
arranged so that coordinators and participants will both be in a quiet, private setting. After 
completing informed consent and HIPAA Authorization (for baseline in-person visit), the patient 
will sign on to the study site, complete baseline assessments, and be randomly assigned to the 
Experimental or Control intervention. Randomization will occur at the patient level. A research 
assistant will be available to answer questions for participants during the study visit. The visit 
may be observed by a member of the web development team to better understand how the tool 
functions. 
 
Experimental Intervention: Participants randomized to the experimental intervention will 
receive a message on the screen that they are now going to view the LCSDecTool. At the end of 
the tool experience, they will be given the option to print out a summary sheet. Participants will 
complete the immediate post-intervention assessments (T1) on a computer interface.  
 
Control Intervention: Participants will view screen content that that provides general information 
on health promotion and disease prevention unrelated to lung cancer screening. No printout is 
given to subjects in this arm. The control intervention will have the same number of screens to 
review as the LCSDecTool. Participants will complete the immediate post-intervention 
assessment (T1) using a computer interface. The Control group will complete all of the surveys, 
with modified versions of Practical Utility of LCSDecTool, Pt Engagement, and End User 
Satisfaction that cover general cancer screening rather than Lung Cancer specifically. 
 
The baseline visit (T0) research visit will last ~2 hours 
The immediate post-intervention visit (T1) done in person or by phone will last ~1 hour. 
 
The summary sheet that is presented at the end of the LCSDecTool will have the option to be 
downloaded, emailed,  or printed and a copy given to the subject to have available to refer to 
during an in-person clinic visit or telehealth visit and serve as a prompt for shared decision-
making. The subject or study team will also send the summary sheet to the provider through 
MyHealtheVet Secure Messaging. Studies suggest that printed action plans can be effective in 
supporting shared decision-making for collaborative goal setting in primary care. [83] Note, that if 
the subject chooses use email, the subject will type in their own email address.  The study will 
not be storing that email information in the application back end. 
 
Participants in the control group will NOT be given any materials to bring to their clinical 
appointment  

 
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Outcome assessment will be blinded to group assignment (Table 4). Primary outcomes include 
decisional conflict, decisional conflict, general anxiety, lung cancer worry, and lung cancer 
screening uptake at T1 (1 month post-intervention). Health related quality of life and feasibility 
measures will also be assessed (Table 4)]. Patient measures will be obtained at baseline (T0), 
immediately post-intervention (T1), 1 month post-intervention (T2), and 3 months post-
intervention (T3). The T2 and T3 survey assessments will be assessed by a telephone interview.  
At the conclusion of the study, we will mail summary findings of the study to participants.     
 
Provider participation in this study 
Healthcare providers participating in this study will undergo oral consent prior to recruiting 
patients.  
 
For those patient-provider dyads in which the patient was randomized into the intervention, their 
patient may bring the LCSDecTool to the appointment so that they can review it with the 
provider. Their patient may also bring their summary page to be reviewed with the provider. The 
subject or study team will also send the summary sheet to the provider through MyHealtheVet 
Secure Messaging, for those randomized to the experimental arm. They will have the opportunity 
to engage in shared decision-making regarding Lung Cancer Screening. For those patient-
provider dyads in which the patient was randomized into the control, they will have the 
opportunity to engage in shared decision making regarding general cancer screening and 
prevention. For either randomized group, the provider will complete a one page “Post-Visit 
Provider Survey” after each appointment with participating patients. Each participating provider 
will have between 0 and 20 patients enrolled in the study. At the conclusion of the study, every 
provider will complete a 3-page survey, which includes System Usability Survey, Technology 
Acceptance Model, and End User Computing Satisfaction. Total involvement in the study will 
take approximately 1 hour. 
 
Power and Sample Size -  We will enroll 200 Veterans  in addition to up to 240 Providers in this 
pilot RCT, a sample size that is feasible to enroll and that will provide adequate power to permit 
testing of key study outcomes. We conducted our power analysis comparing the LCSDecTool to 
usual care with respect to the two primary outcomes, Decisional Regret and Decisional Conflict, 
assessed at T2 (1 month post-intervention). We will conclude that the intervention was superior if 
we reject the null hypothesis of no difference for either or both of these outcomes. Tests will be 
two-sided and will be conducted using α=0.025 to control the family-wise type I error rate at 0.05. 
Assuming 10% loss to follow-up at one month post-intervention, 180 patients will be available for 
analysis. For Decisional Regret at T2, we will have 96% power to detect a medium effect size of 
0.60 corresponding to a 10 point difference between intervention and control groups.  Assuming 
SD = 16.6 [95]. For the Decisional Conflict outcome, we will have 96% power to detect a 
medium-sized standardized effect size of 0.5, corresponding to a difference of 2.0 points 
between groups assuming SD = 3.9. In exploratory analyses of Africa. We will conclude that the 
intervention was superior if we reject the null hypothesis of no difference for either or both of 
these outcomes. Tests will be two-sided and will be conducted using α=0.025 to control the 
family-wise type I error rate at 0.05. Assuming 10% loss to follow-up at one month post-
intervention, 180 patients will be available for analysis. For Decisional Regret at T2, we will have 
96% power to detect a medium effect size of 0.60 corresponding to a 10 point difference 
between intervention and control groups, an American participants, we will have 80% power to 
detect a standardized effect size of 0.74 or larger in either outcome. 
 
 

 
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Amendment February 2019 
The purpose of this amendment is to speak to interactions with MyHealtheVet as written in the 
grant. MHV letter of support attached.  In addition, we wanted to add a comment regarding 
sharing a summary of findings with the patients.  There is a small edit to the Post visit provider 
survey regarding the web based LCS Tool. Last, we changed the scaling on the EUCS survey to 
mirror the original widely used survey.  We removed (6 not applicable from the survey) 
 
Amendment March 2019 
The purpose of this amendment is to make minor changes to the post-visit provider survey, 
future screening intentions and replace the former table 4 with the above. 
 
Amendment April 2020 – addition of the Milwaukee VA site  
Veteran recruitment at the West Haven site was low and recruitment at that site will. We are 
adding the Milwaukee site to try to reach our original goals for patient recruitment. However, 
each site involves essentially all the primary care providers at the site - hence there will be 

 
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another 80 providers recruited from Milwaukee 
 
Amendment September 2020 
Due to COVID-19 and the increasing amounts of primary care telehealth appointments we are 
modifying our protocol to include telephone baseline visits to meet our recruitment goals. 
In addition, we are modifying our protocol to increase compensation for follow-up telephone visits 
for participants at the Philadelphia site. The reasons for increased compensation are to increase 
follow-up participation and to properly compensate Veterans for their time spent answering 
survey questions for the study as follow-up calls are taking up to sixty minutes to complete. 
Currently, we provide Veterans with a $25 stipend after completion of both 1- and 3-month 
follow-ups. In this modification, we will provide Veterans with $25 stipends for each of the 
telephone visits. With the modification, the total amount participants receive will increase from 
$75 to $100.  
  
5.1.2. 
What research methods will be used in the project? Check all that apply. 
 Surveys/Questionnaires 
 Interviews               
 Audio Taping 
 Behavioral Observations        
 Chart Reviews        
 Video Taping 
 Focus Groups 
       
 Randomization       
 Double-Blind 
 Control Group 
       
 Placebo 
          
 Withhold/Delay Treatment 
 Specimen Collection 
       
 Deception           
 Telephone Survey 
 Other (Describe)        
 
5.1.3. 
Provide description of the study population (delineate all categories of subjects – 
male, female, inpatients, outpatients, providers, family members, employees, 
etc.).   Include anticipated initial enrollment numbers (and number of subjects 
anticipated to complete all aspects of the protocol).    
This project involves the recruitment of 200 Veterans and up to 240 Providers. Patient 
recruitment efforts at the three sites (CMCVAMC, WHVAMC, and Milwaukee VAMC) will 
target male and female patients enrolled in a Patient Aligned Care Teams (PACT) who 
are eligible for lung cancer screening. Our recruitment goals for patients are 40% African 
American, 5% Hispanic patients, and 10% women. 
 
5.1.4. 
As applicable, provide rationale and information on any added protections and 
safeguards for vulnerable populations (children, prisoners, pregnant women, 
physically or mentally-disabled persons, and economically or educationally 
disadvantaged persons).      
N/A 
 
5.1.5. 
Does this project target a specific race or ethnic group as subjects? Yes.         If yes, 
check all that apply.  
Race 
                                                        Ethnicity 
American Indian or Alaska Native 
 
Hispanic or Latino  
Asian 
 
Not Hispanic or Latino 
 
Black or African American 
 
 
 
Native Hawaiian or other Pacific Islander 
 
 
 
 

 
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White 
 
 
 
 
Other       
 
5.1.6. 
Will this study bank/store specimens for future research?  NO        
NOTE:  Banking is for future specified research.  Storage is for the life of this protocol. 
5.1.6.1. 
 If yes,  include information on specimens to be banked/stored.   
             
5.1.6.2. 
If specimens will be banked/stored, specify location.   
             
5.1.6.2.1. 
IF BANKING SPECIMENS, IT MUST BE AT A VA APPROVED 
FACILITY. (For additional information, go to the following 
website 
http://www.research.va.gov/programs/tissue_banking/, or 
contact the IRB office.) 
5.1.6.3. 
If applicable, explain how destruction of banked samples will be 
substantiated.   
                
5.1.6.4. 
Do you anticipate using the banked specimens for other studies 
beyond the defined study period and defined study parameters?    
Choose an item. 
5.1.6.4.1. 
If yes, will you need to re-contact subjects?  How will this 
be done?      
 
5.1.7. 
Will this study create a data repository for future studies?    NO 
5.1.7.1. 
If yes, describe and/or provide the following: 
5.1.7.1.1. 
The type of data (identified or de-identified) including what 
protected health elements are to be collected. 
 
      
5.1.7.1.2. 
The source from which data will be collected (e.g., 
subjects, non-research data repositories, research data 
repositories, publicly available, VA source, non-VA source. 
 
      
5.1.7.1.3. 
How and where the data will be stored (e.g., electronic, 
paper records, approved VA-owned or VA-leased space). 
 
      
5.1.7.1.4. 
How the data will be transmitted, if applicable. 
 
      
5.1.7.1.5. 
How the data will be secured during storage, use, and 
transmission both during the conduct of the research 
protocol and after the protocol is completed.  
      
5.1.7.1.6. 
Plans to store data for future research. If the data is stored 
for future research, there must be a description of a 
research data repository, its location, and its security 
measures.  
      
5.1.7.1.7. 
Plans to share with others including other researchers (VA 
and non-VA). If the data were collected through a research 
project, discussion of whether or not the original informed 
consent allowed for such reuse of the data and if the reuse 
is consistent with the HIPAA authorization that was 
obtained. 
 
      

 
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5.1.7.1.8. 
Justification for the use of any identifiers. 
      
5.1.7.1.9. 
Justification that the data requested represent the 
minimum necessary to conduct the research. 
      
5.1.7.1.10. A discussion of plans for obtaining informed consent and 
HIPAA Authorization, or for requesting the IRB to waive 
these requirements. If the investigator requests that the 
requirement for a HIPAA Authorization be waived, 
justification for this request must be included in 
information submitted to the IRB. 
      
5.1.7.1.11. In addition to the above, provide a Standard Operating 
Procedures Manual for the data repository.  Contact IRB 
office for additional details. 
(NOTE: The investigator is encouraged to consult the facility’s ISO during the development of the 
protocol to ensure compliance with all information security requirements and physical security 
requirements.) 
 
5.2. 
Subject Recruitment Methods 
NOTE:  Details of recruitment should be included in the ‘procedures’ section.  Only ‘short’ 
responses should be included in the below sections. 
5.2.1. 
State how many subjects will be needed.    
This project involves the recruitment of up to 100 Veterans and 80 providers from the 
CMCVAMC/CBOCS. 
 
 This project involves the recruitment of up to 200 Veterans between 
CMCVAMC/CBOCS, WHVAMC, and Milwaukee VAMC. This project also involves the 
recruitment of up to 240 Providers (80 from each site). 
 
5.2.2. 
Who will be responsible for recruiting potential subjects?   Provide titles of 
individuals.  
     Principal Investigator, Sr. Coordinator, and the Research Assistant 
 
5.2.3. 
How will initial contact with potential subjects be made? (e.g., local clinics, 
physician referrals, letters to prospective subjects)  
NOTE: VA policy prohibits “cold calls” to potential VA research subjects. Provide an introductory 
letter and telephone script.    
     Eligible Veterans will be mailed a recruitment letter with study information and an 
invitation to participate. A study staff member will make a follow-up phone call to the 
Veteran if there is no reply after one week. During screening phone call, 
inclusion/exclusion criteria will be confirmed. A second recruitment strategy will be to 
post study flyers and brochures in the primary care and pulmonary clinic setting and 
have a recruitment table in the waiting room to provide study information. Study visits 
will be scheduled the same day as clinic appointments when possible. If necessary, 
due to the timing, participants can be scheduled up to 2 weeks prior to their 
appointment time .    
 
5.2.4. 
Will you be using any of the following methods to recruit subjects? (Check all 
that apply.) 
  N/A 
  Local database for which subjects have NOT given prior permission to be 
contacted for Research.   

 
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NOTE:  If this option is checked, please submit a Waiver of Individual Authorization for 
Disclosure of Protected Health Information.      
  Personal contact with patients over whom you have direct/indirect oversight 
  Provider (Clinician) Referrals of potential subjects 
 
5.2.5. 
Indicate the types of recruitment/advertisement materials that will be used:  
Check all that apply.  Submit copies of recruitment materials, for IRB review. 
     
Not applicable; none to be used 
     
Fliers       
Newspapers      
Letters      
Websites      
Television 
     
Radio      
Audio      
Video      
Surveys 
     
Other (Specify, e.g. employee newsletters)  Study Brochure, Emails to Providers 
5.2.6. 
Non-Veteran Subjects will be given a copy of the Notice of Privacy Practices.   
YES 
NOTE: 
➢ Every non-Veteran should sign VA form 10-0483, Acknowledgement of the Notice of Privacy 
Practices (ANOP) 
➢ Once the ANOP is signed, the research study staff must send the non-Veteran's name to the 
CMCVAMC Privacy Officer via encrypted e-mail.  The signed ANOP must be kept in the 
research study binder. 
➢ If an oral informed consent is used, the NOP should be sent to the non-Veteran via postal 
mail.  In addition, the research study staff must write a Note-to-File that the NOP was sent to 
the non-Veteran. 
 
5.3. 
Compensation for Participation -   YES.        If yes, complete the following. 
5.3.1. 
Summarize any financial compensation that will be offered to subjects.     
    Veterans will be compensated $100 total incentive ($50 for completing the baseline 
and immediate post-intervention surveys; and $25 each for completing the 1 and 3-month 
telephone follow-ups). 
 
5.3.2. 
Provide the schedule for compensation.  
5.3.2.1. 
Per study visit or session.      
       $50 for completing the baseline and immediate post-intervention surveys, 
$25 for completing the 1-month telephone follow-up, and $25 for completing the 
3-month telephone follow-up. 
5.3.2.2. 
Total amount for entire participation.   
       $100 total incentive 
5.3.3. 
State how compensation will be provided:   In-person visits– voucher given in 
personTelephone visits – vouchers given to research budget office who mails 
participant the checks.   
 
5.4. 
Informed Consent Procedures 
5.4.1. 
Indicate if informed consent will be obtained and/or if you are requesting a 
waiver of informed consent or waiver of documentation of informed consent.  
Consent to be obtained at baseline; written consent for Veteran with in-person baseline 
visits; oral consent for Veteran telephone visits.  Oral consent for providers. 
 
5.4.2. 
If the research involves multiple phases, specify for which phases of the 
research the waiver(s) is/are being requested.   
HIPAA waiver will be obtained to screen computer databases for potential Veteran 

 
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subjects who will be contacted to see if they are interested in participating in research.  
HIPAA waiver is not needed for Provider subject because study team is NOT 
collecting patient PHI from the provider. 
 
5.4.3. 
Describe circumstances, if any, that may need to be addressed in seeking 
informed consent (e.g., subjects with impaired decision-making ability and the 
use of a legally authorized representative, etc.)      
     NA 
 
5.4.4. 
If applicable, indicate how study personnel will be trained regarding human 
subjects protections requirements and how to obtain and document informed 
consent.   
     All study personnel will be trained/overseen by PI. They will have completed relevant 
training regarding human subjects protection and how to obtain informed consent. All 
personnel are required to have CITI (Good Clinical Practices and Ethical Principles), VA 
Privacy and Information Security Awareness and Rules of Behavior, and Privacy and 
HIPAA trainings.  In addition, all study personnel obtaining informed consent will have 
taken the VA Research Compliance Officer training. 
 
5.4.5. 
Inclusion/Exclusion Criteria:  Describe the criteria that determine who will be 
included in or excluded from the study.  
5.4.5.1. 
Inclusion Criteria 
           All Veterans must be enrolled in a Patient Aligned Care Teams (PACT) 
who are eligible for lung cancer screening. Veterans will be age 55 to 80 years, 
smoking history of 30 or more pack years, and current smoker or smoker who 
quit within 15 years whose providers have agreed to also participate in the study 
 
Inclusion criteria for providers will include practicing or providing leadership in a 
PACT or involvement in the lung cancer screening through the clinical services 
of Radiology, Oncology, or Pulmonary Medicine, services that are most involved 
with the lung cancer screening.  
 
5.4.5.2. 
Exclusion Criteria 
           Exclusion criteria for Veterans will be cognitive impairment as determined 
by clinical history, previous diagnosis of cancer with the exception of non-
melanoma skin cancer and localized prostate cancer that is 1-year post-
diagnosis or more and with no indication of progression, active surveillance of 
Lung Nodule, Enrolled in CMCVAMC Lung Cancer Screening Program,  life 
expectancy of less than 2 years as indicated by chart review and confirmation 
with PCP, and inability to speak English during the phone screen. 
 
5.5. 
Withdrawal of Subjects 
5.5.1. 
Describe how a subject can withdraw from the study.   
     Veteran subjects who want to withdrawal from the study should do so using the HIPAA 
Revocation form. Providers who want to withdrawal from the study may do so verbally.  
 
5.5.2. 
Describe any anticipated circumstances under which subjects will be withdrawn 
from the research without their consent. 
                NA 
 
5.5.3. 
Describe the consequences of a subject's decision to withdraw from the 
research and the procedures for orderly termination of participation by the 
subject (e.g., the subject contacting the investigator for an end-of-study visit).   

 
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No consequences for withdrawal. Once we are notified of a participant’s decision to 
withdraw, we can continue to use information about them that has been collected up 
to that point. No information will be collected after a participant formally withdraws 
 
5.6. 
Potential Risk/Benefit Analysis 
5.6.1. 
Potential Study Risks 
5.6.1.1. 
Describe and assess all of the following risks that may be associated 
with the research: 
5.6.1.2. 
Physical (Physical risks include physical discomfort, pain, injury, illness or 
disease brought about by the methods and procedures of the research. A 
physical risk may result from the involvement of physical stimuli such as 
noise, electric shock, heat, cold, electric magnetic or gravitational fields, etc. 
Engaging a subject in a social situation which could involve violence may 
also create a physical risk.) 
                 NA 
 
5.6.1.3. 
Psychological (Psychological risks include the production of negative 
affective states such as anxiety, depression, guilt, shock and loss of self-
esteem and altered behavior. Sensory deprivation, sleep deprivation, use of 
hypnosis, deception or mental stress are examples of psychological risks.) 
The Veteran subjects may risk distress from considering the topic of lung 
cancer. Veterans in the study will be at increased risk for lung cancer due to 
the smoking exposure eligibility requirements. Therefore, it is possible that a 
discussion of lung cancer screening may lead to anxiety or distress. 
Subjects with anxiety or concerns will be referred to their primary care 
physician as all subjects are enrolled in a primary care clinic as it is an 
inclusion criterion for the study. The primary care physician will be able to 
evaluate Veteran’s level of anxiety/distress and refer them to mental 
counseling if needed. 
 
Provider and clinical leader participants may risk anxiety regarding the 
potential implementation of a new clinical procedure (Lung cancer screening 
shared decision-making) in a busy clinical practice. 
 
5.6.1.4. 
Social/Economic (Social/Economic risks include alterations in relationships 
with others that are to the disadvantage of the subject, including 
embarrassment, loss of respect of others, labeling a subject in a way that will 
have negative consequences, or in some way diminishing those 
opportunities and powers a person has by virtue of relationships with others. 
Economic risks include payment by subjects for procedures not otherwise 
required, loss of wages or other income and any other financial costs, such 
as damage to a subject's employability, as a consequence of participation in 
the research.) 
                 NA                
 
5.6.1.5. 
Legal (Legal risks exist when the research methods are such that the 
subject or others will be liable for a violation of the law, either by revealing 
that the subject or others have engaged, or will engage, in conduct for which 
the subject or others may be criminally or civilly liable, or by requiring 
activities for which the subject or others may be criminally or civilly liable.) 
                 NA 
 
5.6.1.6. 
Loss of Confidentiality (In all research involving human subjects, 
confidentiality of identifiable information is presumed and must be 
maintained unless the investigator obtains the express permission of the 

 
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subject to do otherwise. Subjects have the right to be protected against injury 
or illegal invasions of their privacy and to preservation of their personal 
dignity. The more sensitive the research material, the greater the care that 
must be exercised in obtaining, handling, and storing data. In order to 
minimize the risk for loss of confidentiality, investigators should only collect 
personal information that is absolutely essential to the research activity. If 
personal data must be collected, it should be coded as early in the activity as 
possible and securely stored so that only the investigator and authorized 
staff may access it. Identities of individual subjects must never be released 
without the express consent of the subject. In addition, if an investigator 
wishes to use data for a purpose other than the one for which it was 
originally collected, and the data are still identifiable (e.g., a code list for the 
data still exists), the investigator may need to obtain consent from the 
subjects for the new use of the data.) 
There is some risk of confidentiality. Efforts will be made to minimize this 
risk by collecting only information that is absolutely essential to research. 
Veteran's protected health and personally identifiable information will be 
coded and securely stored in a file cabinet behind locked doors in CHERP 
Annex Room 232. Identified and coded data will be kept in two separate file 
locations, both located in Room 232. The data collected will only be used for 
the purposes of the study protocol 
 
5.6.1.7. 
Other, e.g. radiation, placebo, washout of medications  
                  NA 
 
5.6.1.8. 
Assess the likelihood and seriousness of such risks. 
The risk of Veterans feeling distress about discussing cancer screening is 
not likely to be serious since this targeted group would have most likely 
discussed lung cancer screening with their providers. The risk of 
clinicians/leaders’ facing negative social opinions is highly unlikely since 
participants will be working together and inputting ideas. Theft, loss and 
unauthorized access will be reported immediately to the Privacy Officer, 
Information Security Officer and IRB 
 
5.6.2. 
Include a description of how anticipated risk will be minimized and include an 
analysis of risk vs. potential benefit.  
Veterans with anxiety or concerns will be referred to their primary care physician. Each 
Veteran will be assigned an ID number that is not related to any PHI. The 
providers/leaders will be assigned an ID number so that their baseline assessment can 
be linked to an ID number.  The key containing the link between the study identification 
number and participant will be maintained on the CMCVAMC’s secure server 
(\\vhaphifpccherp.v04.med.va.gov\shares2\Schapira_Marilyn ) on a separate fold from 
the collected data.  Only Dr. Schapira (PI), Research Coordinator, and Research 
Assistant will have access to this key.   
 
5.6.3. 
Potential Study Benefits 
5.6.3.1. 
Indicate potential benefits to be gained by the individual subjects, as 
well as benefit(s) that may accrue to society in general as a result of 
the planned work. If the subject will not receive any direct benefit, this 
fact must be stated here and in the consent form.  
The study may not benefit participants. It could benefit future Veterans if a 
patient centered approach to decision-making regarding lung cancer 
screening works. This may benefit Veterans and others who are considering 

 
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lung cancer screening and would like a structured way to assess whether 
lung cancer screening is good option for them 
 
5.6.4. 
Alternative Treatments Outside the Study 
5.6.4.1. 
Describe alternatives available to the subject outside the research 
context. If there are no such alternatives, state that the alternative is 
not to participate in the research study.  
                 This is not a treatment study. The alternative is not to participate. 
 
5.7. 
Data Monitoring (Monitoring plans describe how study records are inspected to ensure the study 
is adhering to the study protocol and applicable research regulations and CMCVAMC requirements.  
Monitoring plans do not necessarily require the use of an independent Data and Safety Monitoring 
Board (DSMB).  Such independent boards are usually reserved for high-risk phase I studies, or 
large, multi-center phase III trials.  Federally funded studies may require the use of an independent 
DSMB.) 
5.7.1. 
Will a Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee 
(DMC) oversee the project?   YES 
5.7.1.1. 
If yes, provide contact information for the DSMB or DMC 
representative. 
       A data and safety monitoring committee will be formed  and include Dr. 
Chhatre (Co-I) and Dr. Hubbard (biostatistics). The committee will report to the 
investigative team on a monthly basis. The committee will review the accuracy 
and integrity of the data and monitor adequate subject recruitment and 
enrollment. Dr. Hubbard (biostatistics) is experienced in data management 
methods. This committee will review all reports of adverse events within 24 
hours of their occurrence and on a monthly basis and determine if a change in 
protocol is indicated due to the occurrence of adverse events 
5.7.1.2. 
If no, describe the data and safety monitoring plan to be followed. 
      
 
5.8. 
Reporting of Protocol Deviations, Adverse Events (AEs), Serious Adverse Events (SAEs), 
Breaches of Confidentiality, Unanticipated Adverse Device Effects (UADEs), and 
Unanticipated/Unexpected Problems  
5.8.1. 
Include procedures for reporting these events to the CMCVAMC IRB and 
sponsor.  NOTE: Except for AEs, all other events must be reported to the CMCVAMC 
IRB within 5 business days of discovery. Use the CMCVAMC Serious-Adverse Event 
form for reporting SAEs, UADEs, and unanticipated/unexpected problems.  Use the 
CMCVAMC Protocol Deviation form for reporting protocol deviations.  On-site AEs 
should be reported at the time of continuing review.) 
Protocol deviations, unanticipated/unexpected problems will be reported to the IRB 
within 5 business days of discovery. Since this study involves interviews, survey 
assessments, and obtaining feedback for the LCSDecTool, we do not anticipate any 
adverse events or serious adverse events. However, any serious adverse event 
related to this study would be reported to the IRB within 5 business days of 
discovery. Any adverse event would be reported to the IRB at continuing review 
 
5.9. 
Privacy and Confidentiality 
5.9.1. 
Describe whether the study will use or disclose subjects’ Protected Health 
Information (PHI). 
For Veterans, we will need to obtain name, date of birth, complete mailing address, 
social security numbers, race, gender, and medical history such as smoking history, 
lung cancer history, and life expectancy 
 

 
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No medical history will be collected from clinical providers. We will collect information 
such as name, gender, job title, years in current job, email, phone number for clinical 
leaders/providers. 
 
5.9.2. 
Check the PHI to be collected on all subjects for this research protocol. 
 Name 
 All geographic subdivisions smaller than a State, including street address, city, 
county, precinct, ZIP code, and their equivalent geographical codes, except for 
the initial three digits of a ZIP code if, according to the current publicly 
available data from the Bureau of the Census: 
a. The geographic unit formed by combining all ZIP Codes with the same three 
initial digits contains more than 20,000 people; and 
b. The initial three digits of a ZIP Code for all such geographic units containing 
20,000 or fewer people are changed to 000. 
 All elements of dates (except year) for dates directly related to an individual, 
including birth date, admission date, discharge date, date of death; and all ages 
over 89 and all elements of dates (including year) indicative of such age, except 
that such ages and elements may be aggregated into a single category of age 
90 or older.   
 Telephone numbers 
 Fax numbers 
 Electronic mail addresses 
 Social Security/Medical Record Number 
 Health plan beneficiary numbers 
 Account Numbers 
 
 Certificate/license numbers  
 Vehicle identifiers and serial numbers, including license plate numbers 
 Device identifiers and serial numbers  
 Web universal resource locators (URLS) 
 Internet protocol (IP) address numbers 
 Biometric identifiers, including fingerprints and voiceprints 
 Full-face photographic images and any comparable images 
 Any other unique identifying number, characteristic, or code, unless otherwise 
permitted by the Privacy Rule for re-identification. 
 HIV (testing or infectious disease) records 
 Sickle cell anemia 
 Drug Abuse Information 
 
 
 Alcoholism or Alcohol Use 
 
5.10. Information Security (Contact the Information Security Officer for additional assistance 
regarding confidentiality (storage/security) of research data.) 
5.10.1. 
List the data/information that will be stored (including signed, original informed 
consent and HIPAA authorization forms, if applicable, case report forms, etc.)  
                Subject log, signed Consent documents, signed  HIPAA authorizations, paper 
surveys and electronic database of survey data 
 

 
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5.10.2. 
Describe the steps that will be taken to secure the data (e.g., training, 
authorization of access, password protection, encryption, physical controls, 
Certificates of Confidentiality and separation of identifiers and data). 
All paper/hard copy data - signed consent and HIPAA authorization forms, subject logs, surveys 
will be maintained in study binders. The study binders in CMCVAMC will be kept in CHERP, 
4100 Chester Ave, Ste 202 in a locked file cabinet. Any electronic data—the subject logs and the 
key linking participants to their study ID at CMCVAMC will be kept on the secured CMCVAMC 
server vhaphicherpnas. (\\vhaphifpccherp.v04.med.va.gov\shares2\Schapira_Marilyn ) The log 
and the key will be kept in separate folders on the server and will not be printed out. 
 
Study personnel with access to study data who are no longer involved with the study data will 
have access revoked and will be removed from the research staff form 
 
5.10.3. 
Indicate how and where data/information will be stored and specify pertinent 
security systems.  
All paper/hard copy data-consent forms, subject logs, HIPAA authorization, surveys 
will be maintained in study binders. The study binders in CMCVAMC will be kept in 
CHERP, 4100 Chester Ave, Ste 202 in a locked file cabinet. Study staff will walk the 
hard copy documents to CHERP from the CMCVAMC after interviews sessions. Any 
electronic data-- the subject logs and the key linking participants to their study ID-- 
at CMCVAMC will be kept on the secured VA server vhaphicherpnas. The log and 
the key will be kept in separate folders. 
 
Electronic Survey data will be entered into the VA REDCap database. No 
Identifiable information will be included with this data. The VA REDCap database is 
kept on a VA secured server that is only accessible through an application process 
 
5.10.4. 
Will PHI be transmitted or transported outside of CMCVAMC?      NOT 
APPLICABLE                            If yes, complete sections 5.10.4.1 through 5.10.4.3, 
and an Off-site Storage/Transfer of Research Data form.  If no, go directly to 
section 5.11. 
5.10.4.1. Does the informed consent document and Authorization for Use & 
Release of Individually Identifiable Health Information for Veterans 
Health Administration (VHA) Research form disclose 
entities/individuals to which/whom PHI will be transported or 
transmitted?    Choose an item. 
5.10.4.2. Specify entities/individuals outside CMCVAMC to which/whom data will 
be disclosed, the justification for such disclosure and the authority, 
and how they will access it.   
            
5.10.4.3. List the data/information that will be transmitted or transported, and  
specify how data will be transported or transmitted from one location to 
another and how it will be protected during transmission or 
transportation outside of CMCVAMC. 
                        
 
5.11. Data Management Access Plan - NOTE:  Effective January 1, 2016, all new proposals for VA 
research (regardless of how the research is to be supported) must include a Data Management 
and Access Plan (DMAP) that describes how PUBLICATIONS resulting from the research and 
the FINAL DATA SETS underlying such publications will be made available to the public. 
5.11.1. 
DMAP form must be included with all initial submissions.  The DMAP form can be 
found on the Research and Development SharePoint site 
https://vaww.visn4.portal.va.gov/philadelphia/home/Research/default.aspx or obtained 
from one of the IRB Administrators. 

 
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5.12. Communication Plan  
5.12.1. 
Include plan for ensuring that the study is conducted according to the IRB-
approved protocol. 
Monthly team meetings will be held with the PI and study staff to discuss the study 
progress. The PI will ensure that all study activities are being conducted according to 
the IRB approved protocol 
5.12.2. 
If a multi-site study, include information on 
• 
ensuring that all required local site approvals are obtained and notifying the 
Director of any facility where the research is being conducted but the facility 
is not engaged, and 
• 
keeping all engaged sites informed of changes to the protocol, informed 
consent, and HIPAA authorization, and 
• 
informing local sites of any Serious Adverse Events, Unanticipated Problems, 
or interim results that may impact conduct of the study, and 
• 
notifying all local facility directors and local site investigators (LSI) when a 
multi-site study reaches the point that it no longer requires engagement of the 
local facility (e.g., all subsequent follow-up of subjects will be performed by 
the PI from another facility). 
Dr. Schapira (PI) will have overall responsibility for the coordination of the study 
sites, study team members, and the achievement of scientific goals and 
objectives.  
 
Dr. Bastian, site PI for WHVAMC, will have direct oversight for activities at the 
WHVAMC. Dr. Schapira and Dr. Bastian will have bi-weekly conference calls to 
coordinate study protocol and recruitment efforts. 
 
Dr. Whittle, site PI for Milwaukee VAMC, will have direct oversight for activities at 
the Milwaukee VAMC. Dr. Schapira and Dr. Whittle will have bi-weekly conference 
calls to coordinate study protocol and recruitment efforts  
 
Dr. Schapira will also have bi-weekly meetings with the analysis team, led by Dr. 
Hubbard (biostatistics) and including Christopher Roberts (Data Analyst) and Dr. 
Chhatre to review data collection and recruitment procedures.  
 
Drs. Schapira, Bastian, and Whittle will have quarterly calls with the advisory 
committee members.  
 
The advisory committee members are Tanner Caverly, MD of Ann Arbor VAMC 
and Sarah Lillie, PhD of Minneapolis VAMC.  
 
A Data Review and Monitoring Board (DRMB) will be established led by Dr. 
Hubbard (along with Dr. Chhatre). The DRMB will meet on a monthly basis to 
monitor all data collection procedures and ongoing data analysis regarding 
recruitment rates and outcomes at appropriately pre-determined intervals 
 
5.13. Is this Study Investigating the Use of a Drug or Biological Agent?   NO       If yes, complete 
the rest of this section.  If no, go directly to section 6, unless 5.13 applies. NOTE:  If this 
study involves an investigational drug, investigator must contact the Pharmacy and Therapeutics 
(P&T) Committee and provide its approval to IRB. 
5.13.1. 
Specify if the drug or biological agent is:   
5.13.1.1. FDA approved:   Choose an item. 
5.13.1.2. Used for off-label purposes:   Choose an item. 

 
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5.13.2. 
Include the FDA Investigational New Drug (IND) number for all non-FDA 
approved and off-label drugs, biological agents or nutritional supplements.  If not 
applicable state, “Not Applicable.”  
             
5.13.3. 
Provide all relevant information about the drug, including pre-clinical data. 
             
5.13.4. 
Explain any wash-out periods, rescue medications permitted, and any type of 
medications not permitted while enrolled in the study.   
             
5.13.5. 
Describe blinding and un-blinding procedures.  
             
5.13.6. 
Include the dosage, route of administration, previous use, and the safety and 
efficacy information on any drug used for research purposes. 
            
5.13.7. 
Describe rationale for the dosage in this study. 
            
5.13.8. 
Justify why the risks are reasonable in relation to anticipated benefits and/or 
knowledge. 
           
5.13.9. 
Describe where drug preparation will be done. 
           
5.13.10. All drugs for CMCVAMC subjects must be dispensed through the VA 
investigational pharmacy. 
           
5.13.11. Describe where the study treatment will be administered. 
           
5.13.12. Describe plan for tracking a non-compliant treatment study subject. 
          
5.13.13. Describe the process for the storage, security, dispensing and return of an 
investigational drug. 
           
5.13.14. Has this protocol has been submitted to the Medical Center’s Pharmacy and 
Therapeutics Committee?     Choose an item. 
 
5.14. Is this Study Investigating the Use of a Device – NOT APPLICABLE        If yes, complete 
the rest of this section.  If no, go directly to section 6. 
5.14.1. 
The Investigational Device Exemption (IDE) number must be submitted for all 
significant risk devices and if an IDE exists for a non-significant risk device. 
            
5.14.2. 
Significant Risk or Non-significant Risk - If a device is not approved by the FDA, 
specify whether or not the sponsor has determined this device to be a 
“significant risk” or “non-significant risk” as defined by the FDA. 
             
5.14.3. 
Provide all relevant information about the device. 
             
5.14.4. 
Describe blinding and un-blinding procedures. 
              
5.14.5. 
Specify if device is:   
5.14.5.1. FDA approved:  Choose an item. 
5.14.5.2. Used for off-label purposes:  Choose an item. 
5.14.6. 
Explain if the investigational device will be delivered and/or stored by the 
Principal Investigator or Pharmacy Service. 
            

 
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5.14.7. 
Describe the process for the storage, security, dispensing and return of an 
investigational device. 
           
5.14.8. 
For research involving an investigational device, describe the SOP or plan for 
device control. 
           
5.14.9. 
Address how the device will be stored in such a way that only research staff 
associated with the protocol will have access to the device. 
           
5.14.10. Describe measures that will be put into place to ensure that the device will only 
be used in subjects of this research protocol. 
                        
 
Section 6:  Resources and Personnel 
6.1. 
Include where and by whom the research will be conducted.  
                The study will be conducted by the PI, Co-Investigators, and other trained research staff at the 
CMCVAMC 
 
6.2. 
Provide a brief description of each individual’s role in the study.   Indicate who will have 
access to protected health information and who will be involved in recruiting subjects; 
obtaining informed consent; administering survey/interview procedures; and performing 
data analysis.  
➢ The Principal Investigator will have access to all study data, be involved with 
recruitment, obtaining informed consent and HIPAA authorization, administering 
interviews, and performing data analysis. 
➢ The Co-Investigators meet monthly to discuss study design and oversee study 
progress.  
➢ The Research Coordinator and research assistants will be involved with recruitment, 
obtaining informed consent and HIPAA authorization, and administering interview 
➢ Collaborator will be involved in qualitative analysis and development of value 
clarification tool. This person will not have access to PHI. 
➢ Biostatistician will be involved in quantitative data analysis. This person will not have 
access to PHI   
➢ Dissemination Manager will be involved in communication of study findings. This 
person will not have access to PHI   
➢ Dataset Administrator will be involved in data pulls from CDW for recruitment lists. This 
person will have access to PHI but not involved in recruiting subjects, obtaining 
informed consent and administering survey/interview procedures. 
➢ The Qualitative Researcher will be involved with assisting in qualitative analysis and 
development of value clarification tool. This person will not have access to PHI. 
 
6.3. 
If applicable, provide information on any services that will be performed by contractors, 
including what is being contracted out and with whom.  
Pun’k Ave is a web site developer that has an extensive experience in the development of 
interactive patient oriented interventions that are integrated into clinical trials of behavioral 
interventions. The activities conducted by Pun’k Ave as outlined in their letter of support 
include server set up with coordination with VA IT and HIPAA compliant infrastructure, visual 
design, development of the basic application framework, incorporation of a randomized 
questionnaire module, user management and authentication capability, design of a basic 
administrative module for data reporting, and consideration of user experience and strategy. 
This contract will include server and technical support during the full course of the study 
 
6.4. 
If applicable, provide information on any Memoranda of Understanding (MOUs) or Data 
Use Agreements (DUAs) that are being entered into, including with whom and for what 

 
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reason.  
    NA 
 
Section 7: Genetic Testing 
7.1. Does the project involve genetic testing?  Not Applicable, SKIP TO SECTION 8  
7.2. Will specimens be kept for future, unspecified use? Choose an item. 
7.3. Will samples be made anonymous to maintain confidentiality? Choose an item.  (If there is a 
link, it is not anonymous.  Coding is not anonymous.) 
7.4. Will specimens be destroyed after the project-specific use is completed? Choose an item. 
7.5. Will specimens be sold in the future? Choose an item. 
7.6. Will subjects be paid for their specimens now or in the future? Choose an item. 
7.7. Will subjects be informed of the results of the specimen testing? Choose an item. 
7.8. Are there any implications for family members based on specimen testing results? Choose 
an item. 
7.8.1. If answer to section 7.8 is yes, they may be subjects. 
7.9. Will subjects be informed of results obtained from their DNA? Choose an item. 
7.10. Explain if the study is looking for an association between a genetic marker and a specific 
disease or condition, but at this point it is not clear if the genetic marker has predictive 
value.  
                 
7.11. Describe if the study is based on the premise that a link between a genetic marker and a 
specific disease or condition is such that the marker is clinically useful in predicting the 
development of that specific disease or condition.  
                 
7.12. Will the subject be notified of the results and the provision for genetic counseling?  Choose 
an item. 
 
Section 8:  International Research 
8.1. 
Does this study involve international research?   NOT APPLICABLE     If no, go directly to 
section 9. 
NOTE:  Refer to VHA Handbook 1200.05 and contact the IRB office for additional guidance.  
 
Section 9:  Statistical Analysis 
9.1. 
Include statistical power calculations and the assumptions made in making these 
calculations.  
Specific Aim 3 To test the efficacy of the LCSDecTool compared to usual care on decision 
process, psychosocial, and behavioral outcomes. We hypothesize that Veterans randomized to 
the LCSDecTool compared to the control intervention will demonstrate the following: 
• 
H1: Decreased decisional regret and decisional conflict at T2 (1 month after the 
intervention) 
• 
H2: [Decreased overall anxiety and lung cancer worry at T2 (1 month after the 
intervention)] 
• 
H3: Lower rates of lung cancer screening at T3 (3 months after the intervention) 
 
Descriptive Analysis - Descriptive statistics will include frequencies and percentages for 
categorical variables, and either mean and standard deviation or median and interquartile range 
for continuous variables, as appropriate based on distributional characteristics. We will compare 
baseline characteristics between groups to assess the adequacy of randomization, using t-tests 
to compare continuous variables and chi-square tests for categorical variables. Characteristics 
found to differ significantly between intervention groups (defined as p<0.15) will be included as 
covariates in adjusted analyses. We will examine the distributions of decisional regret, decisional 
conflict, STAI, and lung cancer worry at T2 (1-month post-intervention) graphically and will 
calculate summary statistics to assess symmetry and substantial departures from normality. 

 
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9.2. 
Define plans for data and statistical analysis, including key elements of the statistical 
plan, stopping rules and endpoints. 
Statistical Analysis for H1 - Our primary analysis for H1 outcomes will be intention to treat, 
including all patients as randomized in the analysis, using linear regression to test whether 
decisional regret and decisional conflict scores differ by intervention group at T2 after adjustment 
for baseline characteristics and study site. If the outcome distribution exhibits substantial skew or 
deviates in other ways from approximate normality, generalized linear mixed models or 
alternative methods will be used. The dependent variable will be either Decisional Regret or 
Decisional Conflict, and the primary independent variable will be intervention group. We will 
include in all models fixed effects for study site to account for potential variation in outcomes 
associated with care environment. Adjusted analyses will include variables not balanced by 
randomization. Standard regression diagnostics will be performed and robustness of results to 
analysis assumptions will be assessed in sensitivity analyses. Tests will be conducted at the two-
sided α=0.025 level so that the overall type 1 error rate is controlled at the 0.05 level (Bonferroni 
adjustment). 
 
Statistical Analysis for H2 - Our analysis for H2 outcomes will be intention to treat, including all 
patients as randomized in the analysis, using linear regression to test whether STAI and lung 
cancer worry differ between interventions at T2 after adjustment for baseline characteristics and 
study site. The approach de-scribed above for H1 will be used, with outcomes defined as STAI 
and lung cancer worry at T2. Standard regression diagnostics will be performed and robustness 
of results to analysis assumptions will be assessed in sensitivity analyses. Tests will be 
conducted at the two-sided α=0.025 level so that the overall type 1 error rate is controlled at the 
0.05 level (Bonferroni adjustment). 
 
Statistical Analysis for H3 - For H3, we hypothesize that the LCSDecTool intervention, 
compared to usual care, will result in lower rates of lung cancer screening assessed at 3 months. 
In this aim, the effect of the LCSDecTool intervention compared to usual care on completion of 
lung cancer screening will be assessed. Our analysis for H3 will be intention to treat, including all 
patients as randomized in the analysis using logistic regression adjusted for study site. The 
dependent variable will be receipt of lung cancer screening within 3 months of the index visit; the 
primary independent variable will be intervention group, and study site will also be included as a 
covariate in all analyses. Analyses will also be adjusted for characteristics not balanced by 
randomization as described above. Because H3 tests only one outcome, tests will be conducted 
at the two-sided α=0.05 level 
 
9.3. 
Provide sample size determination and analysis (include anticipated rate of screen 
failures, study discontinuations, lost to follow-up, etc.) 
The sample size includes up to 200 Veterans across the 3 sites.In addition, up to 240 
providers across the 3 sites with80 Providersat the CMCVAMC site,80 Providers at the West 
Haven CT Site, and 80 providers at the Milwaukee WI Site.   
 
9.4. 
Describe how, where and by whom the data will be analyzed.   
    Power and Sample Size -  We will enroll 200 persons in this pilot RCT, a sample size that is feasible to 
enroll and that will provide adequate power to permit testing of key study outcomes.  
 
• 
H1: We conducted our power analysis comparing the LCSDecTool to usual care with respect to 
the two primary outcomes, Decisional Regret and Decisional Conflict, assessed at T2 (1-month 
post-intervention). Assuming SD = 16.6 [95]. For the Decisional Conflict outcome, we will have 
96% power to detect a medium-sized standardized effect size of 0.5, corresponding to a 
difference of 2.0 points between groups assuming SD = 3.9. In exploratory analyses of Africa. We 
will conclude that the intervention was superior if we reject the null hypothesis of no difference for 
either or both of these outcomes. Tests will be two-sided and will be conducted using α=0.025 to 
control the family-wise type I error rate at 0.05. Assuming 10% loss to follow-up at one-month 

 
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post-intervention, 180 patients will be available for analysis. For Decisional Regret at T2, we will 
have 96% power to detect a medium effect size of 0.60 corresponding to a 10-point difference 
between intervention and control groups, an American participant, we will have 80% power to 
detect a standardized effect size of 0.74 or larger in either outcome.  
• 
H2: Using the same approach as H1, tests will be two-sided comparisons between the 
intervention and control group at T2 conducted at the α=0.025 level to control the family-wise 
type I error rate at 0.05. With180 patients available for analysis at T2, we will have 80% power to 
detect a medium standardized effect size of 0.46 SD. This corresponds to absolute differences 
between intervention and control arms of approximately 5.5 in STAI assuming SD = 12.0 and 1.6 
in lung cancer worry assuming SD = 3.5. In the African American subgroup, we will have 80% 
power to detect a standardized effect size of 0.74 (medium).   
 
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