Tele-Navigation of Lung Cancer Screening
Phase: NA
Conditions: Lung Cancer
Sponsor: University of Massachusetts, Worcester

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1. TITLE 
Tele-Navigation of Lung Cancer Screening (Tele-Navi LCS) 
 
 
2. EXTERNAL IRB REVIEW HISTORY* 
NA 
 
 
3. PRIOR APPROVALS: 
NA 
 
 
4. OBJECTIVES* 
The main purpose of our study is to develop Tele-Navigation of Lung Cancer Screening (Tele-
Navi LCS) – an intervention that is designed to improve patient awareness about the importance 
of LCS follow-up and to promote patient-provider communication about low-dose CT (LDCT) 
results, with the ultimate goal of increasing adherence to LCS. Our study has two specific aims: 
 
Aim 1: Develop Tele-Navi LCS, using a co-production approach with patients at 
UMMH, and refine Tele-Navi LCS based on feedback from LCS stakeholders at UMMH, 
Wake Forest, UCHealth, and UPenn.  
 
Aim 2: Pilot test Tele-Navi LCS and evaluate its feasibility, acceptability, and associated 
costs by implementing it in the clinical LCS workflow in primary care clinics at UMMH. 
 
Because the data collected in Aim 1 may influence the activities of Aim 2, we will develop the 
majority of Aim 2 study materials at a later time.  Aim 2 recruitment activities will not 
commence until these materials have been submitted to the IRB for review and approval. 
 
 
5. BACKGROUND* 
Adherence to follow-up after lung cancer screening (LCS) is essential to achieving mortality 
reduction and optimizing cost-effectiveness.1-4  Large clinical trials, with adherence close to 
100%, demonstrated that annual LCS with low-dose CT (LDCT) achieved approximately a 20% 
reduction in lung cancer death.5,6  These benefits resulted from timely detection, evaluation, and 
treatment of early stage lung cancer.  Therefore, adherence to recommended follow-up is critical 
to improve survival in LCS. 
 
Yet, even prior to the COVID-19 pandemic, adherence to follow-up in LCS was suboptimal.  
Adherence rates in community-based programs were between 16-59% compared to more than 
80% in comprehensive LCS programs with greater resources and infrastructure.7-12  In interviews 
with patients who had been screened at UMass Memorial Health (UMMH) (conducted as part of 
my K12 project), I found that: (1) many patients were not aware that LCS required at least 
annual follow-up, and (2) patients desired more communication with their providers about the 
results of their LDCT, including a clear follow-up plan.  Interventions to improve patient 
awareness about the importance of LCS follow-up and to promote patient-provider 

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communication about LDCT results are needed to improve adherence to LCS follow-up and 
achieve the full benefits of LCS. 
 
The COVID-19 pandemic has been a major disruption to LCS, with routine LDCT postponed in 
order to minimize the risk of COVID-19 transmission.13  Since the LCS population is at high risk 
for developing severe COVID-19 infection due to their smoking history and comorbid illnesses, 
these patients may be even more likely to avoid regular health care, including LCS follow-up 
from fear of COVID-19.14,15  With expanded insurance coverage for telehealth during the present 
pandemic, many providers have started offering telehealth visits.16,17  The LCS population is, 
however, older and may have less access to or familiarity with telehealth, and may not be able to 
utilize telehealth to maintain their preventive and medical care without support.18,19  This digital 
divide may negatively affect their health outcomes.  Our proposed intervention of providing 
patient navigation through telehealth will help to improve adherence to follow up among those 
undergoing LCS. In addition, by promoting and supporting the use of telehealth, this intervention 
may also help to reduce the “digital divide” in the LCS population. 
 
Based on the well-established concepts of patient navigation that have been shown to promote 
cancer screening and its follow-up, and increased availability of telehealth, I propose to develop 
Tele-Navigation of Lung Cancer Screening (Tele-Navi LCS) using a patient portal and video-call 
with a navigator to improve adherence to LCS follow-up.20-25  I will co-produce intervention 
components of Tele-Navi LCS with patients who have undergone LCS at UMMH over the last 
three years.  I will obtain feedback from various stakeholders including LCS physician 
champions, navigators, primary care providers (PCPs) and IT leadership at UMMH, designing 
Tele-Navi LCS to be scalable. Tele-Navi LCS will provide: 1) telehealth coaching for patients 
undergoing LCS to access a patient portal and a video-call, 2) a video-call from a Tele-Navigator 
prior to the next follow-up LDCT to a) improve patient knowledge about the importance of LCS 
follow-up, b) identify barriers to follow-up, and c) encourage patients to ask their PCPs about the 
results of LDCT, 3) subsequent secured portal messages to provide continuous support to 
patients, and 4) communication guide to support providers in discussing LDCT results with their 
patients.  
 
 
6. INCLUSION AND EXCLUSION CRITERIA* 
Patient Participants 
Inclusion Criteria: 
• Is eligible for LDCT for LCS follow-up 
• Has technology to complete study activities (e.g., video call visit) 
• English speaker 
 
Aim 1 Additional Inclusion Criteria: 
• Has UMMH PCP 
• Has undergone LCS at UMMH in the past three years 
 
Aim 2 Additional Inclusion Criteria: 
• Has undergone LCS at UMMH  
• Is overdue for LDCT follow-up 

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Exclusion Criteria: 
• Has previous diagnosis of lung cancer 
• Has active cancer diagnosis 
• Is a nursing home or group care resident 
• Is pregnant 
 
Stakeholder/Provider Participants 
Inclusion Criteria Aim 1:  
• Age ≥ 18 
• Primary care provider/IT leader/lung cancer screening program leader/lung cancer 
screening navigator 
• Works at UMass Memorial Health, Wake Forest Baptist Health, UCHealth, or UPenn 
 
Inclusion Criteria Aim 2: 
• Age ≥ 18 
• Primary care provider 
• Works at UMass Memorial Health 
 
Vulnerable Populations 
The following populations will not be included in this study: 
• Individuals who are not yet adults (infants, children, teenagers) 
• Pregnant women 
• Adults unable to consent 
• Prisoners 
 
Since this is a small-scale study (~65 total subjects in 4 groups, with 3 different interviews and 
one intervention) it is not possible to have the study materials translated into other languages.  If 
this pilot study shows promise, larger follow-up studies may focus on translating the intervention 
into additional languages. 
 
 
7. STUDY-WIDE NUMBER OF SUBJECTS* 
NA 
 
 
8. STUDY-WIDE RECRUITMENT METHODS* 
NA 
 
 
9. STUDY TIMELINES* 
Aim 1: Patient participants will begin by completing a baseline survey which will take ~30 
minutes or less.  Stakeholder participants will complete a brief (~5-10 minutes) online 
demographics survey (study factsheet will be included in the REDCap survey).  Both patient and 
stakeholder participation will involve completing a one-time interview session held by telephone 
or by webinar (Please note: we will follow all COVID-19 related guidelines and precautions, 
favoring remote activity whenever possible).  Interviews are expected to last approximately 

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60-90 minutes for patients and about 30 minutes for stakeholders.  Participation will be 
considered complete following the conclusion of the interview.  Medical record review will 
occur to assess annual LCS follow-up; record review may occur over several follow-up years (up 
to 4 years). 
 
Aim 2: Patient participation will involve completing a baseline survey which will take ~30 
minutes or less.  Following the baseline survey, the intervention will include a telehealth support 
call (or multiple calls) (~20 minutes) if the participant feels it would be helpful (to practice using 
a video call or accessing their patient portal), and at least one video call with a tele-navigator 
(educational outreach call) (~10 minutes).  Finally, participants will be asked to complete a 
follow-up survey (~20 minutes).  Participation is expected to take place over approximately 3-6 
months.  Medical record review will occur to assess annual LCS follow-up; record review may 
occur over several follow-up years (up to 4 years). 
 
A sub-set of patient participants and providers of patient-participants will be recruited to engage 
in a one-time in-depth interview which is expected to last approximately 60 minutes. 
 
Study Timeline*: Work Plan and Deliverables 
Quarterly Milestones 
Aim 
Quarters 
1 
2 
3 
4 
5 
6 
7 
8 
1 
Material Development 
X 
 
 
 
 
 
 
 
Co-production 
 
X 
X 
 
 
 
 
 
Stakeholder interview 
 
X 
X 
 
 
 
 
 
2 
Recruitment 
 
 
 
X 
X 
X 
 
 
Data collection 
 
 
 
X 
X 
X 
X 
 
Data analysis 
 
 
X 
 
 
 
X 
X 
Manuscript 
 
 
 
 
 
 
X 
X 
Grant Preparation 
 
 
 
 
 
 
X 
X 
 
*Note: We plan to conduct longer-term collection of clinical follow-up data and additional data 
analysis for ~2 additional years. 
 
 
10. STUDY ENDPOINTS* 
Primary outcomes are adherence to follow up LDCT and feasibility of Tele-Navi LCS.  
Adherence is defined as LDCT completion at 3, 6 and 12 months from the due date (as in 
previous studies; this definition may change depending on the status of COVID pandemic) and 
will be measured by EHR data.7,8,10-12  For feasibility, we will assess how engaged patients are 
during telehealth coaching, video-calls by tele-navigator, telehealth visit and patient portal use.  
We will assess intervention fidelity by recording and comparing all telehealth coaching and 
video-calls by a tele-navigator against a pre-defined checklist of key elements. 
 
Secondary outcomes are occurrence of patient-provider communication after LDCT; 
communication modality used; contents of the communication assessed by EHR review and a 
patient survey; patient understanding of the result of LDCT and follow-up plan assessed by 
patient surveys; and perception and acceptability of the intervention from patient surveys and 

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interviews and provider interviews.  We will also measure cost by tracking time required for 
training for a Tele-Navigator, all the intervention components provided by the Tele-Navigator, 
and time and any other resources required to implement Tele-Navi LCS into clinical workflow. 
 
 
11. PROCEDURES INVOLVED* 
All recruitment and data collection materials will be submitted to the IRB for review and 
approval prior to use in the study.  MyChart patient educational materials utilized by UMMH 
will also be utilized during the study (not research developed materials).  All Electronic Health 
Record (EHR) and MyChart audit log data pulls will be requested following the UMass Chan 
Research Informatics Core processes (currently located here: 
https://www.umassmed.edu/research-informatics/data-services/how-to-obtain-data/).  All 
interviews and study activities will be conducted at the convenience of the study participant and 
with safety precautions in mind; they will happen remotely (via phone, Zoom/Doximity, or 
similar).  With explicit consent, interviews and study call activities will be audio-recorded and 
transcribed.  
 
Aim 1 Patient Participants: We will 
recruit patients who underwent LCS 
within the past three years at UMMH.  
Potential subjects will be identified via 
the Electronic Health Record (EHR) (we 
may prioritize recruitment of eligible 
patients who have provided consent to re-
contact from a prior study).  Patients will 
be selected based on their age, gender, 
smoking status, adherence status, LDCT 
results (i.e., negative versus low-risk 
nodule), years in the LCS program, 
previous use of MyChart and telehealth, 
and access to necessary technology to use 
MyChart and telehealth.  Following 
recruitment and screening, we will ask 
patient participants to complete a baseline survey.  Next we will ask participants to complete a 
one-time semi-structured interview to co-produce patient educational materials and the program 
to help patients complete follow-up LCS by using telehealth.  Prior to the interview, the research 
team will select the focus of the interview and the questions based on the participant’s previous 
MyChart and telehealth use, and the research team’s needs to complete the development of Tele-
Navi LCS.  During this co-production, we will first explain current gaps in LCS adherence and 
the goals of Tele-Navi LCS.  We will seek feedback on each element of the intervention: 
education materials and portal messages, as well as the overall concept of Tele-Navi LCS.  
Patient educational materials will be updated based on the input of participants; participant 
suggestions may be incorporated into subsequent interviews to seek additional feedback.  
 
Medical record review will occur to assess annual LCS follow-up; record review may occur over 
several follow-up years (up to 4 years). 

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If a patient mentions having difficulty with MyChart or with a clinical provider/office within our 
clinical system we will provide the patient with appropriate contact information to obtain 
assistance when feasible.   
 
Aim 1 Stakeholder Participants: Additionally, brief demographic surveys and interviews will 
be conducted with LCS Stakeholders (e.g. PCPs, LCS navigators, LCS program leaders, 
Population-Health leaders and IT leaders) from UMMH, Wake Forest, UCHealth, and UPenn.  
All interviews will be audio recorded and transcribed.  We will synthesize feedback from patient 
and clinical stakeholders and refine the workflow and intervention components of Tele-Navi 
LCS accordingly. 
 
Aim 2 Patient Participants: We will 
recruit patients who meet study 
inclusion criteria.  Participants will also 
be selectively enrolled (purposeful 
sampling) based on a variety of 
demographic and other criteria (e.g., by 
age, gender, smoking status, results of 
previous LDCT, years in the LCS 
program, MyChart use, technology 
device, characteristics of the primary 
care and ordering providers).  Following 
recruitment, research staff will 
administer a baseline survey to 
participants.  Study staff will also assist 
participants with obtaining access to the 
patient portal and coach them on how to 
use the portal and video-call (Telehealth 
Support).  Educational materials will be 
sent to participants via mail/email 
(based on participant preference) prior 
to the educational outreach session.  
Participants will receive a call (video call or telephone) from the Tele-Navigator to implement 
the rest of the intervention (Educational Outreach).  Participants will be asked to complete a 
follow-up survey.  We will also offer a truncated (5-item) version of the follow-up survey to 
participants who we have difficulty scheduling and completing the full version with; we will 
offer a reduced incentive ($10) to complete this version.  Finally, we will conduct medical record 
reviews to collect clinical outcomes data. 
 
Pilot Testing: We will recruit (~ 12) Aim 1 patient participants to pilot test the intervention 
processes and data collection (telehealth support and educational outreach calls – we will 
conduct both in one call for the pilot testing).  With participant feedback, we will make iterative 
edits to the intervention materials as they are pilot tested.  We will submit final iterations to the 
IRB for review and approval prior to initiating the intervention.  Pilot testing participants will not 

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complete the Aim 2 surveys.  We will offer a $40 incentive to pilot test the intervention (one 
intervention call, ~40-60 minutes). 
 
Aim 2 Provider/Patient Participants: Following completion of the intervention 
implementation, we will invite a sub-set of patient participants to complete an interview with 
study staff in order to obtain in-depth feedback.  Separately, we will invite providers of patient 
participants to complete an in-depth interview.   
 
 
12. DATA AND SPECIMEN BANKING* 
A limited data set will be securely stored for potential future use by the Principal Investigator.  A 
limited dataset may be shared with study collaborators (with an executed Data Use Agreement) 
or with study funder/sponsors.  A de-identified (by HIPAA standards) dataset may be made 
available to the public with PI approval; a data dictionary will be submitted to the IRB for 
review/approval prior to sharing the de-identified dataset.   
 
 
13. Data Analysis and Management* 
All patient-facing data collection materials will be submitted to the IRB for review and approval 
prior to use in the study.  EHR and MyChart audit log data will be collected as described in the 
ISP, consent/fact sheet, HIPAA authorization/waiver materials reviewed and approved by the 
IRB. 
 
Power analysis: The goal of this feasibility pilot is to determine the acceptability of the 
intervention and to estimate important process parameters (i.e. recruitment rates, completion 
rates of components) to inform a future study, including designing or refining outcome measures.  
As such, we have not conducted a sample size calculation.  
 
Data analysis plan: To evaluate feasibility of Tele-Navi LCS, we will study process measures 
and effectiveness.  Data sources include field notes, patient surveys, patient and provider 
interviews, Electronic Health Record (EHR) chart review, EHR administrative data and 
recording of telehealth coaching and a video-call.  We will employ a mixed-methods process-
outcomes pathway analysis. 
 
Quantitative analysis: For measures of outcomes and intervention fidelity, we will 
present summary statistics with means and standard deviations of study variables.  
Further, we will create useful visualizations, including treatment cascades – a common 
graph used in quality improvement to identify gaps in the flow of patients to treatment (or 
follow-up screening and post-LDCT patient-provider communication in this case).  
 
Qualitative analysis: We will analyze patient and provider interview transcripts to 
evaluate the acceptability of Tele-Navi LCS, understand their experiences, and elicit 
suggestions for improvement.  Our analysis will be informed by constructs from the SCT, 
PRISM, and STM. 
 
 

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14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 
As the proposed study involves no more than minimal risk to participants, an intensive data and 
safety monitoring plan is not needed.   
 
This study will be reviewed and approved by the Institutional Review Board of the UMass Chan 
Medical School (UMass Chan) prior to the initiation of any study activities.  The study will 
continue to be monitored and reviewed by the IRB for the duration of the study. 
 
See #16 for details related to the protection against risks to study subjects.   
 
 
15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT* 
We do not anticipate withdrawing any participants without their prior consent.  Any participant 
enrolled who later does not meet inclusion criteria (or meets an exclusion criterion) may be 
withdrawn.  Participants will be notified by study staff and withdrawal documented in study 
records.   
 
 
16. RISKS TO SUBJECTS* 
Risks to All Study Subjects (Patients, Stakeholders, and Providers) 
The proposed study poses minimal risks to the participants.  The risks that do exist fall into three 
categories: (a) risks associated with participating in research interviews; (b) risks associated with 
potential loss of confidentiality; and (c) risks associated with the research content area.  We 
address each in turn below.  
 
Risks Associated with Participating in Research Interviews: Subjects will be recruited to 
participate in interviews and simulations.  These activities can be time-consuming to complete 
and inconvenient to attend.  Our procedures for protecting against such risks are described 
below. 
 
Risks Associated with Potential Loss of Confidentiality: There is a slight risk that research 
records (data collection forms, interview notes and electronic data) might be obtained by persons 
not authorized to do so.  There is a slight risk that research data files might be compromised, and 
obtained or viewed by unauthorized persons.  Our procedures for protecting against such risks 
are described below. 
 
Risks Associated with the Research Content Area: We recognize that the content of the 
interviews may be emotionally sensitive (related to lung cancer screening, healthcare practices 
and communication with providers).  Our procedures for protecting against such risks are 
described below. 
 
Protections Against Risk 
Minimizing Risks: The training and monitoring of all study staff performance in accordance 
with an IRB-approved study plan will be the responsibility of the Principal Investigator.  All 
efforts will be made to minimize risks and participant inconvenience. 
 

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Risks will be minimized by: 1) adequate training of all staff with proficiency testing; 2) ensuring 
participants are verbally informed of the details of the study activities in advance; 3) encouraging 
participant questions throughout the consent process; and 4) providing participants with 
resources to contact if they have any questions or require assistance. 
 
Protection for Risks Associated with Participating in Research Interviews: Recruitment 
methods, standard informed consent procedures, and the entire study protocol will be reviewed 
and approved by the UMass Chan Institutional Review Board to ensure the protection of human 
subjects.  Informed consent will be obtained prior to the interview.   
 
Subjects will be recruited to participate in interviews and tele-health training sessions.  
Interviews and training sessions can be time-consuming to complete and inconvenient to attend.  
We will minimize the inconvenience by offering to conduct the interviews at a convenient time 
and mode (remote) of their choice. 
 
All interviewees will be told that participation is voluntary, that they are free to not respond or to 
terminate involvement at any time, with no adverse consequences.  Participation in the study will 
have absolutely no bearing on participants’ medical care or employment.  At the start of each 
interview, participants will be told that they can decline to answer any questions and that they 
can leave the interview at any time.   
 
If a participant appears to be distressed at any point during any of these activities, study staff will 
suggest that the participant take a break.  The session will recommence with the activity only 
when and if the participant reports the desire to do so.  The interviews during the course of the 
study involve no specific risk or discomfort beyond those of a standard interview, and the 
simulation poses no risk beyond that of an outpatient encounter.  Interviews will be conducted by 
a trained research interviewer sensitive to these issues.  
 
Protection for Risks Associated with Potential Loss of Confidentiality: The organizations 
proposing this study have systems, oversight, experienced personnel, and an organizational 
culture that supports the appropriate use, access and storage of confidential information.  All 
persons collecting or handling data will be trained in human subjects’ procedures, confidentiality 
and privacy protection.  All investigators and project staff are required to receive and complete 
IRB and HIPAA training.  Data for all participants will be kept strictly confidential.  See section 
#26 Confidentiality for additional details on our procedures for protecting against such risks. 
 
Protection for Risks Associated with the Research Content Area: We recognize that the 
content of the intervention and interviews may be emotionally sensitive (related to lung cancer 
screening, healthcare practices and communication with providers). 
 
Interviews will be conducted by a trained research interviewer sensitive to these issues.  The 
interviews during the course of the study involve no specific risk or discomfort beyond those of a 
standard clinical interview.  If a participant appears to be distressed at any point during any of 
these activities, the interviewer will suggest that the participant take a break.  The interviewer 
will recommence with the activity only when and if the participant reports the desire to do so.  
 

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Content of Intervention Materials, Interview Guides, and Questionnaires.  All of the materials for 
the study will be developed in collaboration with the interdisciplinary research team members.  
All materials will be submitted to the IRB for review and approval prior to use with study 
participants. 
 
 
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS* 
It is possible that patients may directly benefit from taking part in this research.  For example, 
they may gain skills and confidence to use telehealth modalities from their experience of 
telehealth coaching and the workflow of Tele-Navi LCS.  In addition, patients may gain intrinsic 
knowledge about LCS and LCS follow-up. 
 
 
18. VULNERABLE POPULATIONS* 
The following populations will not be included in this study: 
• Individuals who are not yet adults (infants, children, teenagers) 
• Pregnant women 
• Adults unable to consent 
• Prisoners 
 
While we will be recruiting employees as part of the stakeholder interviews, no study team 
member will engage in recruitment/other study activities with a person whom they have 
supervisory responsibility of.  All stakeholder potential participants will be informed that their 
decision to participate will not impact their employment in any way.  We additionally will seek a 
waiver of documentation of consent for these participants (stakeholders/providers) as their 
consent document itself would be a confidentiality risk. 
 
 
19. MULTI-SITE RESEARCH* 
NA 
 
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH* 
NA 
 
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
There are no specific plans to share research results with patient subjects.  If specifically 
requested, we will share any published study results with research subjects via e/mail (or as 
otherwise requested).  Published results of the research will be made available to the greater 
community at large, including to study subjects.  Stakeholder/provider subjects will be provided 
with study results in hopes to inform clinical practice.   
 
 
 
 

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22. SETTING 
Patients will be recruited from primary care clinics at UMMH, as will stakeholders for Aim 2.  
Aim 1 stakeholders will be recruited from UMMH, Wake Forest, UCHealth, and UPenn. 
Research staff conducting recruitment, data entry, and analysis will complete study activities at 
the UMass Chan Medical School located in Worcester, MA. 
 
 
23. RESOURCES AVAILABLE 
All research personnel listed on this study will read the protocol and receive the appropriate 
supervision and possess the appropriate experience (both higher education and related work 
experience) needed to fulfill their roles and complete their responsibilities for this study.  All 
investigators and project staff are required to receive and complete IRB and HIPAA training.  
 
The Principal Investigator will oversee all personnel and all research activities conducted 
within this study.  The Principal Investigator will have responsibility for the overall conduct of 
the project at this study site. She will have primary oversight of all study personnel.  She will 
participate in the design and the execution of the respective study analyses and will be 
responsible for the reporting of study results.  The Principal Investigator has extensive 
experience and expertise in pulmonary medicine and has qualified as PI under NIH guidelines.  
She will be responsible for recruiting and consenting study participants. 
 
The Co-Investigator(s) will assist the Principal Investigator in research design and intervention 
development, as well as analytic aspects of the study.  The Co-Investigators may include 
clinicians and researchers with varied expertise including: healthcare services research, 
qualitative and quantitative research design, health communication and health literacy, and 
biostatistics. 
 
The Programmer(s)/Analyst(s) will perform a range of essential programming and data 
management activities.  S/he will develop study data bases and perform analyses under the 
direction of the PI.  Programmers in the Division of Health Systems Science at the UMass Chan 
Medical School all hold graduate-level degrees and have vast experience working with 
administrative claims data for research purposes. 
 
The Project Manager(s) will assist the Principal Investigator and Co-Investigators in 
implementing all aspects of the project.  Under the direction of Principal Investigator, the Project 
Manager will be responsible for day-to-day coordination and oversight of the project, including: 
developing timelines, allocating work, directing workflow, monitoring project progress, task 
completion, and spending and effort allocation, and managing correspondence and administrative 
tasks.  S/he will monitor/manage ethics and regulatory approvals (IRB, HIPAA/DUA).  The 
Project Manager will attend and plan for all project-related meetings as needed.  S/he will work 
under the direction of the Principal Investigator to assist with all study activities, preparing IRB 
submissions and reports, and developing study materials such as data collection instruments and 
intervention-related tools.  S/he will be responsible for maintaining communications with all 
parties participating in the project.  S/he will track and provide feedback and serve as liaison 
between the research team.  S/he will maintain project documentation and assist in developing 
and filing required project reports.  Project Managers in the Division of Health Systems Science 

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at the UMass Chan Medical School all hold graduate-level degrees and have vast experience 
working on healthcare services research projects. 
 
The Research Assistant/Coordinator(s) will work under the direction of the Principal 
Investigator and Project Manager to assist with all study activities.  S/he will assist the PI and 
other project staff in managing the administrative activities of the project.  S/he will prepare 
materials for team meetings and will facilitate communication between all project staff.  S/he 
will be responsible for recruiting and consenting study participants.  S/he will assist with 
database development, data collection and QA processes.   
 
The REDCap Administrator(s) will assist with all REDCap administrative needs throughout 
the study.  As the appointed REDCap administrator s/he will have access to all study data 
collected within REDCap. 
 
 
24. LOCAL RECRUITMENT METHODS 
All recruitment materials will be submitted to the IRB for review and approval prior to use in the 
study.  While we will not accept referrals for the study, for communication purposes with clinical 
providers we will share/post a study flyer with various clinical groups within UMass Memorial 
Health (from which we will be recruiting patients).  This flyer is intended to provide clinicians 
notification that the study is active and to provide contact information in case clinicians have 
questions about the study; it will not be patient-facing.   
 
Patients: We will use a variety of methods to identify and recruit a diverse group of patient 
participants.  Working with the informatics group at UMMH/UMass Chan we will search the 
UMMH patient database to identify eligible patients.  Eligible patients will be sent an invitation 
to participate.  The invitation will make clear that participation is voluntary, and will include 
contact information for expressing interest, or declining participation.  We will follow-up about 
one week later by telephone with invitees who do not respond.  We will make up to 10 phone 
call attempts (over a period of two to three weeks, varying the time of day and day of week 
phone attempts are made) and leave no more than 3 total voicemail messages.  Research staff 
will confirm eligibility prior to enrolling subjects.  We have successfully recruited and completed 
comparable interviews and research activities with patients in previous studies utilizing similar 
recruitment methods.  
 
Stakeholders/Providers: We will recruit stakeholders/providers to complete a one-time 
interview.   
 
Aim 1: Potential stakeholder participants (for example PCPs, LCS navigators, LCS program 
leaders, and IT leaders from UMMH, Wake Forest, UCHealth, and UPenn) will be identified by 
the Principal Investigator, leadership at LCS programs, leadership within the Implementation 
Science Center for Cancer Control at Wake Forest UCHealth, and UPenn (which have already 
provided letters of support), and stakeholder participants in Aim 1 using snowball sampling.  
Aim 2: Potential UMMH provider participants (providers of patient participants in the 
intervention group) will be recruited as study participants.  
 

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The Principal Investigator (or study staff designee) will contact stakeholders/providers by email 
and potentially telephone.  Introduction to non-UMMH stakeholders will be facilitated via email 
by the Principal Investigator’s collegial relationship with leadership at LCS programs and the 
Implementation Science Center for Cancer Control at Wake Forest, UCHealth, and UPenn or the 
stakeholder participants in Aim 1.  For UMMH personnel we will ask clinic leadership to 
forward the initial recruitment email (sent on the behalf of the PI).  This email will also include a 
factsheet.  If we are unable to identify sufficient numbers of participants via email request, the 
study’s Principal Investigator will send a follow-up e-mail, and potentially reach out via 
telephone to encourage their participation.  We will make up to three attempts to reach out to 
each stakeholder/provider..  We have successfully recruited providers for prior studies in this 
manner.  Eligibility will be confirmed prior to scheduling sessions. 
 
Stipends: As a thank you for their time participants will receive a gift card at the completion of 
study activities (see Figures 1 and 2 for further details and the table below). 
 
Study Aim 
Participant Type 
Study Activity 
Gift Card Amount 
1 
Patient 
Baseline Survey 
$25 
1 
Patient 
Co-Production Interview 
$40 
1 
Stakeholder 
Survey & Co-Production 
Interview 
$50 
2 
Pilot Test Intervention 
(Recruit Aim 1 Participants) 
Telehealth Support and 
Educational Outreach Call 
$40 
2 
Patient 
Baseline Survey 
$40 
2 
Patient 
Follow-Up Survey 
$40 
2 
Provider 
In-Depth Interview 
$50 
2 
Patient Subset 
In-Depth Interview 
$40 
 
 
25. LOCAL NUMBER OF SUBJECTS 
Aim 1: We will recruit up to 50 participants for Aim 1.  We aim to recruit a diverse sample of 
stakeholders including: patients (~6-12), PCPs (n~8), LCS navigators (n~7), LCS program 
leaders (n~8), Population Health leaders (n~6) and IT leaders (n~5). 
 
Aim 2: Up to ~12 Aim 1 participants will be recruited to pilot test the intervention (but not 
enrolled in the Aim 2 intervention study).  ~20 patients will be recruited to participate in the 
intervention.  A smaller subset of ~5 intervention patients and ~5 providers whose patient 
participated in the study will be interviewed for in-depth feedback.  Approximately 25 
participants will be enrolled for Aim 2. 
 
 
26. CONFIDENTIALITY 
We will use the data security procedures outlined by the UMass Chan Research Informatics Core 
to obtain, transfer, and secure data. 
 

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Training: All persons collecting or handling data will be trained in human subjects’ procedures, 
confidentiality and privacy protection.  All investigators and project staff are required to receive 
and complete IRB and HIPAA training. 
Computerized Data: All computerized data will be kept on secured computers or network 
servers.  These data will be accessible only to research staff with approved access, using 
confidential usernames and passwords.  
 
Hard Copies/Paper Data: Any paper data will be kept in locked cabinets or a locked file room 
accessible only by research staff.  
 
Audio Data: All audio-recordings will be kept in locked file cabinets, and never played for 
anyone who is not a member of the research team.  Once transcribed and checked, the audio-
recordings will be destroyed.  Transcripts will be stripped of personal identifiers and labeled only 
with Study IDs. 
 
Audio recordings will be transcribed utilizing a speech-to-text application Rev.ai 
(https://www.rev.ai/).  All the files in Rev.ai are encrypted both at rest and transit (security 
information: https://cf-
public.rev.com/security/Rev.com+Information+Security+Privacy+Overview.pdf). 
 
Alternatively, we will use a professional transcriptionist or available study staff to complete 
transcription if needed.   
 
If necessary, recordings will be transferred via upload to a secure folder on the network drive and 
removed from the portable device as soon as possible after the recording takes place.  Recordings 
will then be uploaded to a secure file transfer site (e.g. https://www.sendthisfile.com, a HIPAA 
compliant website, which uses SAS70 type II/SSAE16 compliant data centers to ensure that 
private data is protected; features of this service include 128-bit Transport Layer Security (TLS) 
encryption and password protection, among other security precautions), to be transferred to a 
professional transcriptionist.  The transcriptionist will use a password to access uploaded 
materials, work on a password-protected computer, and delete the audio file after the transcribed 
file is received by the client.   
 
Data Collected via REDCap: Data will be captured via REDCap (Research Electronic Data 
Capture).  The REDCap Consortium is comprised of thousands of active institutional partners 
from Clinical and Translational Science Awards (CTSA) and other institutions, and supports a 
secure web application (REDCap) designed exclusively to support data capture for research 
studies (http://www.project-redcap.org).  University of Massachusetts Medical School is a 
REDCap Consortium site. 
 
REDCap is used to build and manage online surveys and databases.  The front end of REDCap is 
written in PHP, which is widely used, robust, open source scripting language.  Web servers, 
database servers, and security of communication between servers occur locally at each 
Consortium site where data capture is stored.  Thus, all project data is stored and hosted at the 
local institution, and no project data is ever transmitted at any time by REDCap from that 
institution to another institution or organization. 

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Some additional security features include: (a) Specification of “user access”: by account, by 
project, or by User Access group; (b) System Log-in: assigned username and user-identified 
password required, automatic inactivity logout, password specificity requirements; and (c) 
System lock-out: following succession of unsuccessful login attempts, or if no login to the 
system within 30 days. 
 
Data Processing/Management of Identifiers: Individual identifier information will be removed 
from study data files as soon as possible in the data processing steps.  Study participants will be 
assigned a numerical code (Study ID) for identification in the files.  Analyses will be performed 
using limited datasets and only de-identified data will be reported/shared publicly.  All data will 
be used for research purposes only; published data will not contain any individual identifiers and 
will be reported in the aggregate. 
 
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
Privacy: All study activities will occur with one participant at a time.  Study activities will occur 
over the telephone/video calls/webinar.  Confidentiality/privacy concerns will be addressed 
during recruitment, the consent process, and at additional times deemed necessary.   
 
HIPAA Waiver Request: We are requesting a HIPAA Waiver of Authorization to access 
medical record (EHR) data; these data will be used for the purpose of recruitment and to conduct 
study procedures.  See HIPAA Waiver request. 
 
HIPAA Waiver of Documentation Request: Patient participants will be asked to provide 
HIPAA authorization to access and use medical record/healthcare data for study purposes.  Each 
participant will be provided a copy of the consent/Fact Sheet/HIPAA Authorization form 
(enclosed with the recruitment letter) via USPS mail.  Because all study procedures are being 
conducted remotely with no opportunity to obtain a “wet” signature, a waiver of HIPAA 
Authorization documentation is also being requested.  See HIPAA Waiver request. 
 
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
None; there are no resources available.  We do not anticipate any research-related injuries as the 
research poses no more than minimal risk to subjects. 
 
 
29. ECONOMIC BURDEN TO SUBJECTS 
NA 
 
 
30. CONSENT PROCESS 
Informed Consent 
We will obtain informed consent from participants in accordance with HRP-802 INVESTIGATOR 
GUIDANCE: Informed Consent.   
 

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Participants may opt out of the research study at any time.  If necessary, all participants will be 
given additional information throughout the course of the study to maintain informed consent.  
 
All Interview Participants (Patients, Stakeholders, Providers) 
All participants will provide verbal consent upon enrollment.  Recruitment scripts will be 
submitted to the IRB for review and approval prior to use in the study.  Consent for audio 
recording of interviews will be obtained prior to recording.  Participants may choose to consent 
to the interview but not to audio recording of the interview.  No audio recording will occur 
without explicit consent.   
 
The process of informed consent will begin before the interview completed/intervention 
initiation or any data are collected for research purposes.  The study procedures will be explained 
during the informed consent process.  Participants will be given the opportunity to ask any 
questions or for clarifications before consenting to participation.  It will be explained that the 
healthcare they receive at UMMH/or their employment with UMMH/Wake Forest Baptist 
Health/UCHealth/UPenn will not be affected by their decision to participate or to not participate 
in the study.   
 
All Patient Participants 
We will mail a written Fact Sheet to all patients invited to participate as study subjects.  The 
study staff will review all elements of the Fact Sheet with study subjects by phone during the 
recruitment call (the recruitment script containing all elements of consent will be reviewed and 
approved by the IRB prior to use in the study).  We will obtain verbal informed consent during 
the initial recruitment and screening phone call(s).  Verbal consent will be documented by study 
staff (including who obtained informed consent and the date informed consent was obtained). 
 
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
Consent documents (Fact Sheets) will be submitted to the IRB for review and approval prior to 
use in the study.  Because all study procedures are being conducted remotely with no opportunity 
to obtain a “wet” signature, a waiver consent documentation is being requested. 
 
Waiver of Documentation of Consent 
A waiver of documentation of consent is being requested for participants.  We believe the 
research study activities meet the criteria for both documentation not required outside of the 
research context (for all study subjects), as well as, for stakeholder/provider participants, the 
consent document would be the principal confidentiality risk.  We attest that the following 
criteria are met: 
 
Consent Documentation Not Required Outside the Research Context 
1. The research involves NO more than Minimal Risk to subjects (see below); 
2. The research involves NO procedures for which written consent is normally 
required outside of the research context (see below); 
3. The investigator has provided a written statement regarding the research that 
embodies the elements of consent; 
4. The investigators will: 

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o offer to provide subjects with that written statement; and  
o communicate the statement's information to subjects. 
 
Consent Document is the Principal Confidentiality Risk (For Stakeholder/Provider 
Participants) 
1. The only record linking the subject and the research would be the informed 
consent form; 
2. The principal risk is potential harm resulting from a breach of confidentiality; 
3. Each subject will be asked whether the subject wants documentation linking the 
subject with the research, and the subject’s wishes will govern; 
4. The investigator will provide a written statement regarding the research that 
embodies the elements of consent; 
5. The investigator will: 
o offer to provide subjects with that written statement, and 
o communicate the statement's information to subjects; 
6. The research is NOT FDA-regulated. 
 
Minimal Risk Definition: 
The probability and magnitude of harm or discomfort anticipated in the research are not greater 
than those ordinarily encountered in daily life or during the performance of routine physical and 
psychological examinations or tests and that confidentiality is adequately protected.   
 
Examples of Minimal Risk (similar to this current study): 
• Study poses no more risk than expected in daily life (e.g., blood draw, physical exam, 
routine psychological testing). 
• Survey/Questionnaire studies of a non-sensitive nature. 
 
Completing surveys, interviews, and a training/coaching session to use technology readily 
available for clinical care meet the above criteria.  Additionally, these activities do not in 
general require consent outside of research.  
 
 
32. DRUGS OR DEVICES 
NA. 
 
 

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Mazzone PJ, Silvestri GA, Patel S, et al. Screening for Lung Cancer: CHEST Guideline 
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Cattaneo SM, 2nd, Meisenberg BR, Geronimo MCM, Bhandari B, Maxted JW, Brady-
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Hirsch EA, New ML, Brown SP, Barón AE, Malkoski SP. Patient Reminders and 
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Spalluto LB, Lewis JA, LaBaze S, et al. Association of a Lung Screening Program 
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Tanner NT, Brasher PB, Wojciechowski B, et al. Screening Adherence in the Veterans 
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Vachani A, Saia C, Schnall MD, Doubeni CA, Rendle KA. Adherence to Annual Lung 
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Mazzone PJ, Gould MK, Arenberg DA, et al. Management of Lung Nodules and Lung 
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Hamel L, Kearney, A, Kirizinger, A, Lopes, L, Munana, C and Brodie, M. KFF Health 
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Zheng Z, Peng F, Xu B, et al. Risk factors of critical & mortal COVID-19 cases: A 
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eIRB Section 7.0 Attachments Upload Checklist 
Follow How to Manage Files in eIRB and upload the following items as applicable to your 
submission. This checklist is provided for your convenience and is not a requirement for review. 
 
 
Investigator Study Plan 
 
Sponsor protocol 
 
Research portion of the grant 
 
Human subjects portion of the grant 
 
Written approvals from ancillary reviews (Clinical Engineering, COI, IBC, PRC, RSC, 
Students as Subjects, etc.) 
 
Recruitment materials such as flyers, brochures, posters, scripts of radio ads, etc. 
 
Data collection sheets, case report forms, etc. 
 
Surveys, measures, instruments, etc. 
 
Measures to assess capacity to consent 
 
DMC or DSMB charter 
 
Data safety monitoring plan 
 
Adverse event log 
 
Investigator brochure or package insert for drugs  
 
Instructions for use or approved FDA labeling for devices 
 
Sponsor justification or FDA documentation for non-significant risk device study  
 
IND or IDE documentation 
 
Patient information sheet for Humanitarian Use Device 
 
Approval order for Humanitarian Use Device 
 
Product labeling for Humanitarian Use Device 
 
HIPAA waiver 
 
HIPAA authorization 
 
Authorization to contact form 
 
Consent form(s) 
 
Assent forms(s) 
 
Fact sheet(s) 
 
Multi-site communication plan 
 
Study staff training plan 
 
SOPs or Manuals of Operations 
 
Screening log 
 
Compensation log 
 
Certificates of translation or translator attestations 
 
Data use agreements, memoranda of understanding,  
 
Documentation of data/specimen anonymity (i.e., provider will never break the code)