Building on Trust: Navigating Preventive Lung, Breast, and Prostate Cancer Screenings at Community Resource Spots
Conditions: Breast Cancer, Lung Cancer (Diagnosis), Prostate Cancer
Sponsor: AdventHealth

 
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Study Protocol Title: 
Building on Trust: Navigating Preventive Lung, Breast, and Prostate Cancer Screenings at 
Community Resource Spots  
 
Study Sponsor:   
AdventHealth and State of Florida, Department of Health 
 
Principal Investigator: 
Mark Socinski, MD 
 
 

 
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Table of Contents 
Introduction ..................................................................................................................................... 4 
Background Information and Scientific Rationale ......................................................................... 4 
Study Objectives ............................................................................................................................. 5 
Primary Objective/Aim/Goal/Hypothesis ................................................................................... 5 
Secondary Objective/Aim/Goal/Hypothesis ............................................................................... 5 
Study Design ................................................................................................................................... 5 
Research Design.......................................................................................................................... 5 
Research Intervention Description  ............................................................................................. 6 
Study Site(s)/Location(s) and Number of Subjects .................................................................... 6 
Multi-Site Research Logistics/Communication Plan .................................................................. 7 
Research Conducted in a Foreign Country ................................................................................. 7 
Community-Based Participatory Research ................................................................................. 7 
Subject Selection ............................................................................................................................. 7 
Vulnerable Populations (if applicable) ....................................................................................... 7 
Inclusion Criteria ........................................................................................................................ 7 
Exclusion Criteria ....................................................................................................................... 8 
Resources Available........................................................................................................................ 8 
Study Procedures ............................................................................................................................ 8 
Subject Recruitment and Screening ............................................................................................ 8 
Consent Process .......................................................................................................................... 9 
Subjects who are not yet adults (infants, children, teenagers) .................................................... 9 
Cognitively Impaired Adults ....................................................................................................... 9 
Adults Unable to Consent ........................................................................................................... 9 
Documentation of Informed Consent Process ............................................................................ 9 
Waiver of Written Documentation of Consent or Waiver of Consent ...................................... 10 
Non-English Speaking Subjects ................................................................................................ 10 
Randomization .......................................................................................................................... 10 
Study Visits  .............................................................................................................................. 10 
Study Duration .......................................................................................................................... 11 
Materials of Human Origin: Collection, Preparation, Handling and Shipping......................... 12 
Study Outcome Measures (Endpoints) ......................................................................................... 12 

 
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Dashboard and Records ............................................................................................................ 12 
Patient Participants – Quantitative ............................................................................................ 13 
Patient Participants – Qualitative .............................................................................................. 13 
Stakeholder Participants – Qualitative ...................................................................................... 14 
Data Management and Quality Plan ............................................................................................. 14 
Data De-identification ............................................................................................................... 14 
Data Confidentiality, Storage, and Retention ........................................................................... 14 
Data Quality .............................................................................................................................. 15 
Data Sharing.............................................................................................................................. 15 
Sample Size Determination........................................................................................................... 15 
Statistical Analysis Plan ................................................................................................................ 15 
Primary Objective Analysis ...................................................................................................... 15 
Secondary Objective Analysis .................................................................................................. 16 
Potential Risks and Benefits ......................................................................................................... 16 
Potential Benefits ...................................................................................................................... 16 
Potential Risks .......................................................................................................................... 16 
Mitigation of Risks ................................................................................................................... 16 
Provisions to Protect the Privacy Interest of Subjects .............................................................. 16 
Early Withdrawal of Subjects ....................................................................................................... 17 
Investigator Withdrawal of Subjects ......................................................................................... 17 
Subject Request for Withdrawal from Study ............................................................................ 17 
Data Collection and Follow-up for Withdrawn Subjects .......................................................... 17 
Adverse Events - Recording and Reporting.................................................................................. 17 
Safety Monitoring Plan ................................................................................................................. 17 
Safety Monitoring N/A ............................................................................................................. 17 
Data and Safety Monitoring Board (DSMB) or Equivalent ..................................................... 17 
Ethical Considerations .................................................................................................................. 17 
Sharing of Results with Subjects .............................................................................................. 17 
Funding Source ............................................................................................................................. 18 
Subject Stipends or Payments ....................................................................................................... 18 
Publication Plan ............................................................................................................................ 18 
References ..................................................................................................................................... 18 

 
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Introduction 
This document is a protocol for a human research study. This study is to be conducted in 
accordance with AH institutional research requirements and all federal regulations. 
 
Background Information and Scientific Rationale 
Screening for cancer in asymptomatic adults can lead to early detection, which has a notable 
impact on the cost of care and on patient outcomes. It is estimated that in the first year after 
diagnosis (2017), the cost of treating Stage IV cancer, compared to Stage I, is increased per 
patient by $37,661 for breast cancer, $18,086 for prostate cancer and $33,128 for lung cancer 
(Kakushadze, Raghubanshi, & Yu, 2017). Adjusting for inflation (2024), those approximate cost 
increases per patient would be $48,959 for breast cancer, $23,512 for prostate cancer and 
$43,066 for lung cancer.   
 
In addition, patients who are uninsured are significantly more likely to receive a late-stage 
diagnosis. In Florida, uninsured patients were 46.9% more likely to be diagnosed with a high-
grade lung cancer, 50% more likely to be diagnosed with late-stage breast cancer, and 39% more 
likely to be diagnosed with late-stage prostate cancer (Sasaki, Parianos, & Rahman, 2021). Those 
in high poverty areas in Florida, both rural and urban, have increased likelihoods of late-stage 
diagnoses, and the overall cancer-related mortality rate was 22% higher in high poverty areas 
than in low poverty areas, including lung (risk ratio 1.24), breast (risk ratio 1.17), and prostate 
(risk ratio 1.29) cancers (Hall et al., 2022; Hall et al., 2023). 
 
In terms of mortality, the overall survival rates for early stage compared to late is 99% to close to 
30% for breast cancer, 64.4% to 7.6% for lung cancer, and 100% to 33.5% for prostate cancer 
(National Cancer Institute, 2024). In light of this, uptake in screening and early diagnosis could 
have tremendous impact on cancer survival outcomes for this vulnerable and underserved 
population. 
 
Advances in novel and innovative approaches to cancer treatment are saving and improving 
lives. However, racial and ethnic minority groups and medically underserved populations 
continue to experience multilevel barriers to screening, timely diagnosis, and access to treatment. 
Integrating an Implementation Science framework is an opportunity to promote the adoption, 
use, and sustainability of interventions and clinical trials in community-based clinical settings to 
improve uptake of cancer screening, preventive services, timely follow-up of abnormal findings, 
and referral to accessible care among adults experiencing social and structural barriers to health. 
 
This proposal aims to reduce disparities in cancer care and outcomes for underserved Central 
Florida adults by increasing rates of lung, breast, and prostate cancer screenings. Distrust and 
lack of access to primary care are barriers to screenings and early detection. Collaborating with 
established community organizations and identifying reasons to accept or decline care will allow 
us to offer sustainable community-based cancer screenings that result in increased cancer 
diagnosis and treatment. 

 
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We hypothesize that implementation of a community-based multi-disciplinary navigation team 
will foster improved cancer screening rates, financial navigation to facilitate timely definitive 
diagnosis and treatment regimens, as well as screening for clinical trial eligibility among 
underserved individuals. Effective patient navigation promotes access to timely treatment by 
overcoming barriers to care. Hospital-based patient navigation programs for cancer and chronic 
diseases have been well-established in improving screening rates and diagnostic resolution (Chen 
et al., 2024). Cancer-related financial hardship is an additional result of cancer diagnosis and 
treatment, and therefore of increased national interest (SWOG Cancer Research Network, 2024). 
While some oncology clinics provide financial navigation services, few community-based health 
care clinics have sufficient resources to proactively facilitate financial counseling and assistance 
ultimately delaying cancer screening, definitive diagnosis, and successful treatment (Bell-Brown 
et al., 2023). 
 
Study Objectives 
Primary Objective/Aim/Goal/Hypothesis 
To evaluate a community-based outreach initiative for screening, diagnosis, and 
treatment of breast, lung, and prostate cancers in underserved adults using the RE-AIM 
implementation science framework. 
 
Secondary Objective/Aim/Goal/Hypothesis 
Secondary goals include:  
• To identify differences between adults who accept or decline cancer follow-up 
diagnosis and treatment, and clinical trial screening  
• To identify barriers and facilitators to cancer screening, diagnosis, treatment, and 
clinical trial screening  
• To understand perceptions towards navigators in the cancer care continuum 
 
Study Design 
Research Design 
The research strategy will employ a prospective, mixed methods implementation science 
design based on the Reach, Effectiveness, Adoption, Implementation, and Maintenance 
(RE‑AIM) framework.  
 
Reach will include the number of patients in the community that are offered and undergo 
cancer screening. Effectiveness will be determined by comparison of monthly breast, 
lung, and prostate cancer screening referral uptake to baseline. Adoption will be 
evaluated by the number of patients with positive screens that are referred for screening 
and for treatment.  Implementation will occur via the cyclical improvement triad 
approach that includes repeated evaluation and modification to ensure that barriers to care 
are addressed. Maintenance and sustainability will be supported by the return on 
investment by early cancer detection and treatment. 
 

 
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Research Intervention Description  
The proposed intervention integrates cancer screenings at pop-up clinics located at 
community resource spots in partnership with well-established community-based 
organizations for the underserved, as well as in local emergency departments that serve 
this population. Currently, cancer screenings are offered as standard of care in primary 
care settings; however, this population rarely has access to primary care. Instead, this 
population often seeks episodic care for symptom management and does not benefit from 
preventive care services in primary care settings. Integrating cancer screenings into 
episodic care will be accomplished through a multi-faceted approach which includes 
leveraging a team of navigators to help connect those with positive screening results to 
community health resources, treatment financial advocacy, care coordination, and access 
to screening for clinical trials. Navigators will guide access to a continuum of care 
including diagnosis, treatment, and clinical trials. 
 
National guidelines exist for primary care providers to conduct annual screenings to 
detect and treat common cancer tumors before they progress to systemic disease. These 
guidelines are not routinely followed in non-primary care settings, like pop-up clinics and 
emergency rooms. The study team will provide education to community-based healthcare 
providers on United States Preventive Services Taskforce Screening Guidelines for 
breast, lung, and prostate cancers. The USPSTF recommends annual screening for lung 
cancer with low-dose computed tomography (LDCT) in adults aged 50 to 80 years who 
have a 20 pack-year smoking history and currently smoke or have quit within the past 15 
years. The USPSTF recommends biennial screening mammography for women aged 40 
to 74 years. The USPSTF recommends that the decision to undergo periodic prostate-
specific antigen (PSA)-based screening for prostate cancer should be an individual one 
among men aged 55 to 69 years. All participant-facing education materials will be 
reviewed and approved the Institutional Review Board (IRB) before use in the research 
study.   
 
Screenings will take place at pre-established pop-up clinics associated with community-
based outreach organizations or other settings such as emergency departments and urgent 
care centers where patients may show for symptom management and result in a positive 
screen. A bilingual field- and a bilingual hospital-based navigator will connect 
participants with screening (e.g. mammograms) and confirmatory diagnostics, treatment 
and/or clinical trials when applicable. In addition, a financial navigator will identify free 
and reduced cost diagnostic testing and assist with Medicaid enrollment and other 
financial aspects of care for patients who screen positive. 
 
Study Site(s)/Location(s) and Number of Subjects 
 
AdventHealth sites (hospital(s), campus, physician offices, etc): AdventHealth Central 
Florida Division (e.g., AdventHealth Apopka, AdventHealth East Orlando, AdventHealth 
Kissimmee) emergency departments, CentraCare locations 
Estimated number of subjects at AdventHealth sites: Unable to determine until screenings 
provided 

 
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Name of external site(s) outside of AdventHealth: Community health clinics or health 
systems willing to provide free or low-cost diagnostics to under-resourced patients on 
referral 
Estimated number of subjects at external sites: Unable to determine until screenings 
provided 
 
Total number of all sites: 20 
Estimated number of subjects at all sites combined: 200  
 
Multi-Site Research Logistics/Communication Plan 
 
N/A 
 
Research Conducted in a Foreign Country 
 
N/A 
 
Community-Based Participatory Research 
 
N/A 
 
Subject Selection 
Vulnerable Populations (if applicable) 
N/A 
 
Inclusion Criteria 
The inclusion criteria for patients will be the following: 
1. Adult aged 18 or older 
2. Seeking care at a CRS or emergency department 
3. Meets criteria for lung, breast, and/or prostate cancer screening, as outlined below: 
a. Lung cancer: Adults aged 50 to 80 years who have a 20 pack-year smoking 
history and currently smoke or have quit within the past 15 years  
b. Breast cancer: Women aged 40 to 74 years  
c. Prostate cancer: Men aged 55 to 69 years 
4. Receives a positive screening result for lung, breast, and/or prostate cancer at a study 
site 
 
The inclusion criteria for stakeholders will be the following:  
1. Speaks English or Spanish through study interpreters 
2. Able to attend 75% or more of scheduled meetings 
3. Must be key individuals providing critical services to address food insecurity, 
employment assistance, government support, mental and physical health, and health 
education within identified Community Resource Spots, emergency departments, and 
urgent care centers. 
 

 
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Exclusion Criteria 
 
The exclusion criteria for patients will be the following: 
1. Displays behavior disruptive to other patients or staff 
2. Refusal to accept screening for breast, lung, and/or prostate cancers 
 
The exclusion criteria for stakeholders will be the following: 
1. Speaks language other than English or Spanish 
2. Unable to attend 75% or more of stakeholder meetings 
 
Resources Available 
Research Personnel Qualifications 
All members of the study team are employed by AdventHealth in full-time positions with 
training in research processes and methodologies. All personnel have completed the necessary 
AdventHealth IRB training and credentialing requirements. A study start-up meeting will be held 
to describe the research study and clarify each team member’s duties and functions. Biweekly 
meetings will be held either in person or by teleconference for the duration of the study to review 
the study and to ensure that the protocol is being followed, report the study progress, share 
reportable information, and implement any amendments made to the protocol. 
 
The research team will be comprised of a principal investigator, implementation scientists, 
qualitative researcher, RN clinical research study coordinator/clinical educator, statistician, 
project managers, cancer care navigator, financial navigator, research trials navigator, 
community outreach coordinator, advanced practice provider (APP), data manager, and 
information architect. As these individuals are hired and/or added to the research team, the 
delegation log will be revised to include them.  
 
Study Procedures 
Subject Recruitment and Screening 
Recruitment of Stakeholders 
Investigators will establish relationships with community stakeholders, providers, and 
other key personnel to inform them of the program, the study, and opportunities to 
engage in stakeholder focus groups to provide feedback about program operations. For 
those interested in participating, a study team member will explain the study and the 
requirements for participation, review the informed consent form in detail, and obtain 
consent. 
 
Recruitment of Patients 
Patients undergoing screening as standard of care will have access to clinic-based 
educational materials, i.e. signage and pamphlets in English and Spanish on cancer 
screening, diagnosis and care and on the study opportunity. 
 
As standard of care for patients who screen positive, a care navigator will be assigned. 
The care navigator will provide patients with study recruitment materials and 
information, ensuring patients are aware that study involvement does not impact care 
navigation or treatment. 

 
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After positive breast, lung, and/or prostate cancer screening in the field or at an 
emergency room or care facility, study team members will be informed of positive field 
screens. Patients with positive screens will be referred for confirmatory diagnostic testing 
and will receive guidance from care navigator and the financial navigator to set up 
appointments. A study team member will meet the potential participant at the site of 
diagnostic testing and/or at emergency departments or other urgent care sites to introduce 
the study and obtain informed consent for research activities.  
 
Consent Process  
The researchers will follow SOP CW AHC 216 Informed Consent Process and Written 
Documentation of Informed Consent. Also, the researchers will follow SOP CW AHC 
249 Remote and Electronic Methods for Conducting Informed Consent in Non-Exempt 
Research. 
 
For Patients: Upon referral for definitive diagnosis based on their cancer screening 
results, patients will be contacted by a study team member for informed consent for 
survey completion, interviews and electronic health record access to monitor outcomes. 
All consent forms will be completed on paper or electronically via REDCap on a tablet 
device provided by the study team.  
 
For Stakeholders: Study team members will contact community stakeholders in person, 
or via phone or email to re-explain the study and obtain consent. Consent forms may be 
completed on paper or electronically via REDCap. 
 
Subjects who are not yet adults (infants, children, teenagers) 
N/A 
 
Cognitively Impaired Adults 
N/A 
 
Adults Unable to Consent 
N/A 
 
Documentation of Informed Consent Process 
A member of the study team will note the following in the Enrollment Log: the 
participant’s name, phone number, email address (if applicable), the date of screening, 
the date the informed consent was signed, whether inclusion/exclusion criteria were met 
(and reason if excluded), screening outcome, completion of study or withdrawal (and 
reason if withdrawal), and investigator terminated (and reason) if applicable. The 
Enrollment Log will be saved in the shared Microsoft OneDrive folder. 
 

 
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Waiver of Written Documentation of Consent or Waiver of Consent  
Waiver of Written documentation of Consent (consent will be obtained but 
signatures will not be required)   
N/A 
 
Waiver or Alteration of the Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) 
N/A 
 
Waiver or Alteration of HIPAA Authorization 
N/A 
 
Non-English Speaking Subjects 
x Check here to confirm you will follow HRP-804 INVESTIGATOR GUIDANCE 
Short Form Consent Process 
 
Consent forms and all study materials will be translated into Spanish for both Spanish-
speaking patients and stakeholders. 
 
For patients and stakeholders that speak Spanish as a primary/preferred language, the 
study team will ensure that a Spanish-speaking research team member is in place to 
navigate the consent process, study activities, provide directions, and guidance on next 
steps.  
 
For patients: 
Spanish-speaking participants will be included only in surveys that are validated in 
English and Spanish. Spanish-speaking participants will be eligible for focus groups and 
interviews with a Spanish-speaking team member.  
 
Those patients who do not speak English or Spanish as a primary language will be 
consented appropriately using a consent form that is fully translated and provided to the 
participant as soon as possible. These individuals will be eligible for medical record 
tracking for follow-up but will not participate in surveys or interviews.  
 
For all non-English speakers, short form consents will be utilized using medical 
translators until regulatory requirements dictate translation of consent. 
 
Randomization 
N/A  
 
Study Visits  
For patients, study visits include: 
• Consent and enrollment and at the site of confirmatory diagnostics and/or 
emergency room or healthcare center 

 
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• 1 or more interviews with the research team throughout the study period  
• Survey package completion with coordinator at a site of diagnosis or care 
 
Study Visit 
1 
2 
3 
4 
5 
6 
7 
8 
Consent/Enrollment 
X 
 
 
 
 
 
 
 
Baseline Surveys 
 
X 
 
 
 
 
 
 
First Interview 
 
 
X 
 
 
 
 
 
3-Month Surveys 
 
 
 
X 
 
 
 
 
Optional Follow-Up Interviews 
 
 
 
 
X 
X 
X 
X 
 
For stakeholders, study visits include: 
• Consent and enrollment  
• Ongoing stakeholder meetings throughout the duration of the study up to 12. 
• 1 or more interviews with the research team throughout the study period. 
 
Study Visit 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
Consent/Enrollment 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stakeholder Meetings 
 
X 
X 
 
X 
X 
 
X 
X 
 
X 
X 
 
X 
X 
 
X 
X 
First Interview 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Optional Follow-Up 
Interviews 
 
 
 
 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
 
 
Study Duration 
The project is projected to begin on August 1, 2025. Study subjects will be enrolled for 9 
months. Participants will remain active in the study until they have received a definitive 
diagnosis and treatment plan or declined further care. The study activities, including data 
analysis, will be completed within 12 months from the start date.  
 
The implementation plan that details study activities and timelines will be developed 
according to current best practice for evaluating effectiveness and will be informed by 
input from the stakeholder group at each site.  The implementation plan is as follows:  
 
• Month 1: Finalize key stakeholders at each site and initiate monthly implementation 
meetings with study team and including stakeholders as needed, collect baseline data 
and initiate ongoing data gathering (i.e., lung, breast, prostate cancer screening 
knowledge, attitudes, and practices, cancer screening barriers and facilitators), 
establish care navigation and communication processes and launch project.  
• Month 2: Data collection and monitoring of all sites, implementation meetings. 
• Month 3: Data collection and monitoring of all sites, implementation meetings.  
• Month 4: Data collection and monitoring, implementation cycle 1 adjustments, 
stakeholder meetings for data sharing and plans, patient study enrollment.  
• Months 5-7: Continue monthly implementation meetings, data collection, study 
enrollment, data-driven process improvement.  
• Month 8: Stakeholder meetings, implementation cycle 2 adjustments.  

 
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• Months 9-10: Continue monthly implementation meetings, data collection, study 
enrollment, process improvement.  
• Month 11: Final data collection and analyses.  
• Month 12: Final reporting, stakeholder meeting and sustainability plan development. 
 
 
 
Materials of Human Origin: Collection, Preparation, Handling and Shipping 
N/A 
    
Study Outcome Measures (Endpoints) 
Dashboard and Records 
There will be an information architect on the study team who will build and maintain a 
dashboard to track the project metrics. These metrics can be categorized into the RE-AIM model 
dimensions of Reach, Effectiveness, Adoption, Implementation, and Maintenance, which are 
outlined below. 
 
• Reach 
o Percentage and characteristics of patients included or excluded 
o Percentage of patients who receive screening at point of care or referral 
o Characteristics of participants and non-participants 
• Effectiveness 
o All positive screens referred for confirmatory diagnostics 
o Measure of screening rates with comparison to the goals set forth in Healthy 
People 2030 (HP2030) 
▪ Increase the proportion of adults aged 55 to 80 years (30-pack-year 
smoking history, currently smoking or quit in the past 15 years) who 
receive a lung cancer screening to meet the HP2030 target of 7.5% 
▪ Increase the proportion of females aged 40 to 74 years who receive 
biennial screening mammography to meet the HP2030 target of 80.3% 
▪ Increase the proportion of men ages 55 to 69 years that discuss the 
possible benefits and harms of prostate-specific antigen (PSA) 
screening with their health care provider and make an individualized 
decision about whether to get screened 
• Adoption 
o Percentage of providers who receive education on screening guidelines for 
breast, lung, and prostate cancer 
o Uptake of cancer screening in the field by number of providers 

 
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o Percentage of provider staff that engaged with navigation program 
• Implementation 
o Number of patients referred to navigation program 
o Rates of 1) low dose CT lung cancer screens 2) biennial screening 
mammography, and 3) prostate specific antigen (PSA) 
o For those who have a positive screen: 1) time to referral, 2) time and 
barriers/facilitators to diagnosis 3) uptake of treatment, and 4) number 
screened for clinical trials 
• Maintenance 
o Measure of primary outcomes at 3 months post-intervention with progress 
towards Healthy People 2030 goals 
o Short-term attrition rate 
o Differential rates by patient characteristics 
 
Medical records will be followed until definitive diagnosis and treatment disposition to track the 
patients’ progress through the cancer care continuum. If diagnosis is negative, then interaction 
with the medical record ends upon confirmation of negative test. If diagnosis is positive, then the 
medical record is followed monthly to determine: diagnostic codes, treatment decisions, 
treatment course, and treatment outcomes. This may include labs, demographics, medication 
histories, referrals, outpatient visit notes, inpatient progress notes, and imaging.  
 
Patient Participants – Quantitative 
English-speaking patients will complete a package of surveys regarding health and perceptions 
of cancer navigators. Patient demographics will be obtained to include age, race, ethnicity, sex 
and gender, marital status, primary language, birth country, employment, education level, 
household income, insurance and type, housing/shelter, food, transportation insecurity, and 
environmental safety.  
 
Patient-reported outcomes will occur at baseline and 3-month follow-up. These outcomes will 
include the PROMIS Global Health (HR-QoL) scale (Hays et al., 2009) to ascertain health-
related quality of life to assess physical, mental, and social health and the Patient Satisfaction 
with Logistical Aspects of Navigation Scale (PSN-L) (Carle et al., 2014) to assess satisfaction 
with the navigation program. Additionally, barriers will be measured by the barriers to cancer 
care assessment used in the NCI Patient Navigation Research Program (Freund et al., 2008).  
 
Patient Participants – Qualitative 
Patients will be invited to participate in interviews regarding decision points in diagnostics and 
care. They will be invited to at least one, and up to five, interviews with a study team member. 
Interviews will be no longer than one hour each. Virtual interviews will take place via video 
conferencing software and will be recorded and transcribed electronically. In-person interviews 
will be recorded with a portable digital recording device and will be manually transcribed. An 
open-ended interview guide will be available in English and Spanish. Both versions will be IRB-
approved prior to use. Questions regarding barriers and facilitators to cancer diagnosis and the 
care continuum will be addressed in addition to process and program feedback for improvement. 
 

 
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Stakeholder Participants – Qualitative  
Stakeholders will be invited to participate in interviews and/or focus groups about their 
knowledge, attitudes, and practices related to cancer screening processes, as well as the RE-AIM 
model dimensions. They will be invited to at least one, and up to five, interviews with a study 
team member. These will occur over the 12-month study period, alongside the monthly 
stakeholder focus group meetings. Interviews/focus groups will be no longer than one hour each. 
All stakeholder interviews/focus groups will take place via video conferencing software and will 
be recorded and transcribed electronically. 
 
Questions will be asked to further the understanding of factors influencing reach, screening, and 
study recruitment (Reach), effectiveness and impact on outcomes (Effectiveness), and staff 
participation (Adoption), as well as implementation facilitators and barriers for screening, 
diagnosis, treatment, and clinical trials (Implementation). An open-ended interview guide will be 
available in English and Spanish.  
 
Qualitative data gathering will inform timely actionable changes to improve cancer screening, 
identification, treatment, and outcomes. Other ad hoc groups will be formed as needed to address 
specific questions or concerns that arise in processes or from feedback. 
 
Data Management and Quality Plan 
Data De-identification 
Participants will be added to the EDC system called REDCap using a unique participant 
identification number (PID). This PID is a code consisting of a combination of numerals 
and letters, which will serve as the identifier for this participant for this study. Access to 
the “link” between PIDs and participants’ identities will exist only in the Enrollment Log 
and the EDC, which can only be accessed by study team members.  
 
Survey data will be exported from REDCap in Excel format. An Excel file used for 
analysis will be de-identified and only include the PIDs. The storage location will be 
secured and only accessible by study team members in the Microsoft OneDrive folder. 
 
All interview data will have names deleted and replaced with a unique identifier for the 
participant. 
 
The electronic health record data that is collected as part of a clinic visit will be added in 
a de-identified manner (i.e., by the PID) to the Excel file used for analysis and stored 
securely in the Microsoft OneDrive folder that is only accessible by study team members. 
     
Data Confidentiality, Storage, and Retention 
The participants’ identities will be kept confidential to the extent permitted by the 
applicable laws and/or regulations and will not be made publicly available. If study 
results are published or presented, participants’ identities will not be revealed. 
Confidentiality will be maintained during and after the study. 
 

 
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Study documentation and data records will be stored as electronic records. All data are 
safeguarded so that only members of the study team have access to it via role relationship 
(electronic). The electronic data are maintained under AIT security controls. Email 
addresses of enrolled participants will be stored in the shared folder and will be retained 
for 7 years following study closure. Electronic de-identified data will also be kept in our 
database for 7 years. Paper records, if any, will be stored in a locked facility for 7 years.  
 
For qualitative interviews, an interview transcript will be obtained using transcription 
from the Microsoft Teams recording. Alternatively, an audio file will be obtained through 
portable digital recording device and will be transcribed. A member of the research team 
will verify the accuracy of transcriptions. The recording and transcript of the interview on 
Microsoft Teams, as well as the original audio file on the portable digital recording 
device, will be deleted after transcription is complete and verified. Participants will be 
advised that Microsoft Teams saves a record of the meeting via the Chat feature 
indefinitely. Transcripts will be saved electronically on the personal protected drive of 
the qualitative researcher. All identifiable information will be deleted from transcripts 
and replaced with a unique identifier based on participant role, e.g. CRS Stakeholder 1; 
Provider 1. 
 
Data Quality  
Participants will complete all surveys electronically through REDCap, and this data will 
be exported into an Excel file, limiting the need for transcription and potential errors to 
occur. Quality of qualitative data will be ensured by checking transcripts against 
recordings of focus groups and interviews. 
 
Data Sharing  
N/A 
  
Sample Size Determination 
Sample sizes for the qualitative data component of implementation research range between five 
and 10 key stakeholders to provide sufficient information power and saturation (Hamilton & 
Finley, 2019).  
 
Sample size for patients will be a convenience sample based on the number of positive screens. 
Approximately 10% of those screened for breast cancer require follow-up diagnostics (Kumar et. 
al, 2020), 20% of those screened for lung cancer require follow-up diagnostics (Babar et. al, 
2023) and 6-20% of those screened for prostate cancer require follow-up diagnostics (McFall & 
Smith, 2009). 
 
Statistical Analysis Plan 
Primary Objective Analysis 
Patient-reported demographic characteristics will be analyzed using descriptive statistics 
associated with the Reach aim. To address the Effectiveness aim pre- and post-
intervention barriers data and patient-reported outcomes will be analyzed using 
univariate, bivariate, and repeated measures analyses. Referral data will be 

 
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descriptively evaluated based on percent increase/decrease across the intervention. 
Qualitative data will be analyzed to determine the extent to which the Adoption aim was 
met. Analyses of the fidelity of the intervention, including timeliness and consistency will 
be documented as part of the Implementation aim. Finally, process-level descriptions, 
including the summation of monthly team meetings and direct communications with the 
Implementation Scientist of the community-focused multi-disciplinary navigation 
intervention will be used to assess the Maintenance aim.  
 
Secondary Objective Analysis 
Qualitative analysis will be utilized to explore and explain influential factors for each 
RE-AIM dimension (Holtrop, Rabin, & Glasgow, 2018). Transcripts from interviews, 
field observations, and stakeholder meetings will be analyzed utilizing thematic analysis 
to explore factors that influence uptake patterns across patients, providers, navigators, 
and implementation sites (Braun & Clarke, 2006). Prompt turnaround of qualitative data 
analyses will inform timely action plans with stakeholders (Kowalski et al., 2024; 
Lewinski et al., 2021).  
 
Potential Risks and Benefits 
Potential Benefits 
There are no direct benefits of participation. 
 
Potential Risks 
 
There are no risks involved beyond what would reasonably be encountered in everyday 
life. It is possible that participants may experience the following during the study: 
• Loss of privacy as a result of a breach of confidentiality  
• Undue stress related to the questionnaires which ask about physical and emotional 
well-being 
 
Mitigation of Risks  
Participants will be informed that measures are in place to prevent the loss of privacy and 
to protect data, such as deidentification of responses and the use of HIPAA-compliant 
electronic data capture system. In addition, the organization has safeguards in place to 
secure information technology. Participants will be given hotline numbers for mental 
health support if needed. 
 
Provisions to Protect the Privacy Interest of Subjects 
The protection of study participants will be accomplished by adhering to ethical and legal 
guidelines. All policies for the protection of human subjects mandated by the 
AdventHealth IRB and U.S. Federal Guidelines for conducting research with human 
subjects will be followed. Subjects will be assigned unique identifiers for study-related 
records. Precautions will be taken to make sure that only authorized individuals will 
access subject research records. The collection of sensitive information about subjects 
will be limited to the minimum necessary to achieve the aims of the research so that no 
unneeded sensitive information will be collected. 

 
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Early Withdrawal of Subjects 
Investigator Withdrawal of Subjects 
Participants may be withdrawn from the study if they are unable or unwilling to comply 
with the study protocol.  
 
Subject Request for Withdrawal from Study 
Participants may request to be withdrawn from the study at any point for any reason 
without penalty by notifying a member of the study team.  
 
Data Collection and Follow-up for Withdrawn Subjects 
Participants who are withdrawn from the study for any reason will have their previous 
data included in summary reports (i.e., baseline characteristics) and pre-post comparison 
analyses up to the point of withdrawal unless they specifically request that their data be 
excluded from future use. They will be counted in the participant flowchart. A study team 
member will contact participants who do not complete the entire research study to find 
out the reason(s) to guide future program development and improvement. 
 
Adverse Events - Recording and Reporting 
All adverse events will be reported in accordance with AdventHealth IRB guidelines and 
documented using the HRP-204 form for Promptly Reportable Information. 
 
Safety Monitoring Plan   
Safety Monitoring 
N/A  
 
Data and Safety Monitoring Board (DSMB) or Equivalent 
N/A 
 
Ethical Considerations 
All members of the study team will adhere to standards of ethical conduct during the study. To 
ensure the integrity of the research, members of the study team will adhere to all components of 
the protocol. Members of the study team will ensure that all potential participants are provided 
with informed consent, consent is obtained, and all participants have all questions answered 
before performing any study procedures. Members of the study team will ensure that 
participation is voluntary by noting that participants may withdraw from the study at any time 
without consequence.  
 
Sharing of Results with Subjects 
Participants will not receive a copy of the manuscript of the study once it is completed. 
However, dissemination of the project is anticipated. 
 

 
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Funding Source 
This study will be supported by funding from the State of Florida, Department of Health 
(2265446). The IRBNet # for this grant is 2338019.  
 
Subject Stipends or Payments 
Patient participants will receive $25 for participating in the study. Provider participants will 
receive up to $240 for participating in the study (i.e., receive $20 after each completed monthly 
stakeholder meeting). These payments will be distributed through Greenphire payment cards. 
The Terms and Conditions for the card will be provided to participants for review. 
 
Publication Plan 
The study results will be reported to AdventHealth leadership and the Florida Department of 
Health. The study results will also be submitted for publication in a peer-reviewed journal. An 
authorship plan describing the assignment of authorship and each author’s contribution will be 
completed based on the guidelines by the International Committee of Medical Journal Editors 
(ICMJE). 
   
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