Community Support Program for Lung Cancer Screening
Phase: NA
Conditions: Lung Cancer, Behavior
Sponsor: Abramson Cancer Center at Penn Medicine

 
 
 
 
 
 
 
 
 
 
Community Support Program for Lung Cancer Screening 
NCT06207435 
UPCC 07523 
Study Protocol and Statistical Analysis Plan 
04/13/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Caroline Rosen 
Clinical Research Coordinator 
Department of Radiology | Interventional Radiology 
3620 Hamilton Walk 
Anatomy Chemistry B-25 
Philadelphia, PA 19104 
caroline.rosen@pennmedicine.upenn.edu 
University of Pennsylvania School of Medicine 
Hospital of the University of Pennsylvania 
 
 
 
 
Caroline Rosen, Clinical Research Coordinator 
Department of Radiology  
 

Community Support Program for Lung Cancer Screening 
Abstract 
Lung cancer screening (LCS) using low-dose CT (LDCT) for high-risk individuals is a critical public health tool 
for reducing lung cancer mortality. Despite the recent expansion of the inclusion criteria to be more equitable, 
uptake and adherence remains low and is lowest among low-income and racial/ethnic minority populations and 
in individuals with a negative baseline screening study (Lung-RADS 1&2). Community-based programs 
promoting cancer screening uptake have demonstrated increased screening engagement compared to clinic-
based programs in reaching disadvantaged individuals but suffer from lack of robust funding and limited data 
demonstrating impact on a population level. Community-based participatory research (CBPR) utilizes a 
partnership approach, bringing together researchers and community stakeholders as equal partners 
throughout the research process to contribute expertise and share in decision making. CBPR has 
demonstrated the ability to reduce cancer health disparities and reduce mistrust between academia and 
surrounding communities through reciprocal learning. 
The overall objective of this project is to demonstrate the impact of a community support program (CSP) on 
improve adherence to LCS follow-up guidelines in an urban environment. This project aims to collaborate with 
community partners to develop an infrastructure and iterative process to provide social support to community 
members that facilitates obtaining their follow-up LDCT for LCS. It utilizes novel population level data that 
includes geospatial analysis of neighborhood-level data of patients residing in Philadelphia who have received 
a LDCT for LCS. This allows for targeted community level interventions and the ability to evaluate impact on a 
population level. 
We will target individuals in our healthcare system residing in Philadelphia with a negative baseline screening 
CT and an upcoming or missed follow-up screening CT. Participants will be divided into receiving clinic + 
community support vs routine clinic only (control) based on residential location. The intervention group, 
consisting of individuals residing in West Philadelphia, will receive the option of enrolling in the CSP for 
obtaining their recommended LDCT. Community members designated as CSP representatives will receive 
basic training about LCS, transportation vouchers and information regarding other support services. They will 
also provide feedback to inform an interactive approach to reevaluating the intervention throughout the course 
of the study. Primary analysis will measure the 12-month follow-up LDCT adherence rate difference between 
clinic + CSP group vs clinic only group and its association with CSP enrollment. Additional analyses will 
measure differences in follow-up LDCT utilization before vs after intervention and extent of enrollment in the 
CSP in the intervention group. Planning and evaluation of our program will be performed using the widely 
utilized RE-AIM framework with emphasis on measuring reach, effectiveness, and sustainability of our 
approach. 
Hypothesis: A community support program to facilitate lung cancer screening appointments will improve 
adherence to yearly follow-up screening compared to routine care alone. 

Detailed Research Plan 
Significance and Rationale:   
Lung cancer remains the leading cause of cancer deaths in the United States, accounting for 25% of all cancer 
deaths1. Despite the established impact of lung cancer screening (LCS) with low-dose CT (LDCT) and 
coverage by major health insurances, less than 5% of all eligible individuals receive recommended 
screening2,3. Furthermore, there are significant disparities in the uptake of recommended LCS in the US on the 
basis of sociodemographic factors, with individuals who are black, low-income, underinsured, with low 
education levels, and residing in underserved urban or rural communities having lower rates of LDCT 
screening uptake4–7. For example, eligible black patients were 2.8 times less likely to receive LDCT4 and were 
also less likely to complete follow-up after an initial baseline screening8. This is not inconsequential given the 
pre-existing disparities in incidence, stage of detection and mortality from lung cancer. For example, black 
patients are more likely to present at a younger age, at more advanced stages9, and have reduced survival 
compared to white patients9,10. Furthermore, current cigarette smoking—one of the strongest risk factors—is 
highest among vulnerable patient populations and lower socioeconomic status11,12. These trends in screening 
uptake risk even further exacerbation of disparities in lung cancer outcomes over time.  
This study aims to address disparities in lung cancer screening (LCS) adherence using principles of community 
based participatory research (CBPR) to implement a community support program (CSP) for LCS. By bringing 
researchers and community stakeholders together as equal partners in decision-making and knowledge 
sharing, CBPR has demonstrated an ability to reduce health disparities and reduce mistrust between academic 
and surrounding communities13–15. It has also been shown to improve health literacy in underserved 
populations16,17 which is an independent predictor of adherence to screening programs across multiple cancer 
types18. Interventions applying principles of CBPR have taken the form of decision aids19,20, patient navigators 
and ‘citizen scientist’21–25, and mobile clinics26 and have shown positive impact in cancer screening uptake and 
patient satisfaction among underserved populations, including in LCS. Although there is extensive evidence of 
the efficacy of community-based cancer prevention programs in improving knowledge and screening uptake, 
demonstration of their impact in reducing health disparities on a population level remains a challenge27. Our 
study design overcomes this challenge by utilizing novel population-level data that includes geospatial analysis 
of neighborhood-level data of patients residing in Philadelphia who have received a LDCT for LCS, allowing for 
a targeted population-level intervention and robust impact evaluation.   
The proposed intervention will be guided by the RE-AIM (Reach Effectiveness Adoption Implementation 
Maintenance) framework, a robust implementation strategy, widely applied to interventions at the community 
and population-health levels. With the principal concepts of pragmatic engagement of various stakeholders and 
iterative reevaluation across multiple domains throughout all stages of an intervention, RE-AIM provides a 
framework for planning and measuring impact of health promotion and disease prevention initiatives with focus 
on sustainability28–30 . Utilization of a robust planning and evaluation framework is critical to ensuring external 
validity and sustainability of community-based interventions. Our study aims to leverage an existing strong 
community partnership, novel population-level data, and robust research and evaluation frameworks to 
implement a scalable intervention to reduce disparities in LCS adherence.  
Specific Aims and Objectives: 
1. Develop a community support program for lung cancer screening adherence
2. Measure the impact of the community support program in improving adherence to lung cancer screening
follow-up

Innovation: This study leverages novel neighborhood-level data to design and evaluate a community-based 
intervention using a robust implementation science framework, RE-AIM. This design allows for measuring 
impact on a population level thereby overcoming a common limitation of community-based interventions27. Our 
utilization of CBPR builds on a strong collaborative community partnership with an extensive track record of 
successful community-based events. Led by members of the study team, our department has collaborated with 
the Community of Compassion CDC community center in West Philadelphia over the past two academic years 
to offer 3 events to the surrounding community (see letter of committment). This would support a seamless 
incorporation of CBPR, an approach that is strikingly 
absent from the radiology literature despite evidence 
of its effectiveness in reducing disparities in cancer 
health outcomes.  
Preliminary Data: Using data from our NCI-funded 
Population-based Research to Optimize the Screening 
Process (PROSPR) Center, which assesses LCS 
outcomes in five diverse healthcare systems31, we 
observed low adherence rates to LCS 
recommendations (55% across five systems; 36% 
overall at Penn Medicine)32. Adherence is significantly 
lower in Black patients at Penn Medicine and varies 
by baseline Lung-RADS score (21%-70% in Black 
patients; 32%-88% in White patients). Additionally, 
adherence is lower among patients living in 
impoverished neighborhoods (44% vs 63% in high-
income neighborhoods). Geospatial analysis for 
neighborhood-level data of the 349 and 1,328 
Philadelphia residents who received LCS in 2020 and 
2021 respectively was applied to support our 
intervention at the planning district level (Figure 1). West and Southwest districts contained 28% and 19% of all 
patients respectively. For residents who received a LDCT in 2020 with a Lung-RADS 1 or 2 recommendation, 
which accounted for 90% of all studies, adherence to a 
12-month follow-up study in 2021 was 24%. Data
collection from 2022 is still in progress so estimates from
2020 and 2021 were utilized.
A questionnaire developed by Dr. Dako in 2017 was 
administered to patients visiting Temple University 
Hospital Radiology Department as part of an effort to 
understand modifiable patient barriers to LCS in North 
Philadelphia33. It was completed by 124 predominantly 
African American patients with health insurance. The 
average score was 33% on items accessing knowledge 
about LCS. Perceived cost and inability to get out of 
work were the top two reported reasons for lack of 
adherence to appointments. These preliminary data, 
supported by review of the literature, informed our initial 
approach to reducing barriers to LCS adherence. 
The Philadelphia Lung Cancer Learning Community 
(PLC2) is a collaborative agreement involving a 
multidisciplinary team across Jefferson 
Health, Penn Medicine, and Temple Health 
that aims to decrease lung cancer morbidity 
and mortality across the greater 
Fig 1. Geospatial analysis of distribution
of LCS baseline studies in 2020 and 
Fig 2. Philadelphia Neighborhood Characteristics. Neighborhood-level data were 
mapped for each Planning District or Census Tract in the city of Philadelphia. 

Philadelphia region by developing and implementing effective ways to increase LCS and tobacco treatment, 
particularly in populations at greatest risk. The PLC2 has systematically characterized LCS using a city-wide, 
multi-institutional approach and applied geospatial analyses for neighborhood-level data34 (Figure 2). This 
allows for comprehensive strategies that integrate population health approaches and the ability to measure 
impact on a population health level. Our data sharing and collaboration agreement would support scaling our 
intervention to a multi-institutional and city-wide level for external validation and increased population impact. 
Experimental Design and Methods: 
Specific Aim 1. Develop a community support program for lung cancer screening adherence 
A consortium of representatives chosen by an established community center with a track record 
of providing social services to their surrounding communities and Penn 
Medicine multidisciplinary team will be formed and will work to develop rules of 
operation and decision making for the community support program (CSP). Penn 
Medicine team members include researchers in radiology, implementation 
science and CBPR and a patient navigator (PN). CSP representatives will 
be individuals chosen by our partner community center that have 
demonstrated commitment and prior experience in providing social 
support to their surrounding communities. The consortium members 
will meet over the course of 2 weeks at the commencement of the 
study to agree on goals, timeline, organizational structure, and 
standardized processes. Using the collaborative principles of CBPR, 
representatives from academia and the community will engage in 
reciprocal learning sessions to create CSP material that is socially 
and culturally sensitive to the needs of the community. Initial 
community support will be developed based on preliminary data and 
evidence that two of the main barriers to utilization of lung cancer 
screening are transportation cost/availability and limited education 
about lung cancer screening35,36. We therefore propose providing transportation assistance and education 
augmentation. In addition, resources will be allocated to provide additional support throughout the study period 
based on feedback from CSP representatives. 
Education: CSP representatives will be trained about the basics of lung cancer screening needed to provide 
support for patients with an upcoming LDCT appointment. Patient-facing LCS material, adapted from ACR and 
Penn Medicine websites37, will be created to ensure a fifth-grade readability level and sensitivity to local 
context in collaboration with a PN experienced in patient education and the CSP representatives. To adapt 
resources for fifth-grade readability, we will utilize an interactive process guided by resources from 
LUNGevity38  and the Centers for Medicare and Medicaid Services (CMS) health literacy resource toolkit for 
making written material clear and effective42. Readability will be assessed with a commercial web-based suite 
of tools (readable.com) using a mean score from multiple validated indices 39,40,41. Patient LCS education 
material would include information on lung cancer, cost and payment options, risks and benefits of screening, 
radiation exposure, treatment options and smoking cessation. 
Transportation: We will utilize the Uber or Lyft transportation vouchers to provide rides to participants from 
their home location in West Philadelphia to and from the Penn Medicine downtown hospital locations on the 
day of their LCS study. Transportation vouchers will be created at an upper limit of $30, which is expected to 
result in no out of pocket cost for most patients. The mean distance from the patient's residential address to 
the closest Penn Medicine hospital location is 2 miles and an approximate round trip ride costs $22. 
Participants will also be given the option of a CSP representative arranging their transportation if they do not 
have access to Uber or Lyft transportation software. Based on projections from our preliminary data, allocation 
would be made to provide transportation support to 450 patients throughout the study period.  
The CSP program will be set up to have month-long intervention periods that end with a review process and 
planning for the next intervention period, utilizing the agile principle of sprint planning43 (Figure 3). This process 
Fig 3. Monthly 
“Sprints” 

Table 1. Demonstrating the RE-AIM planning and evaluation metrics 
will allow for iterative changes that incorporate feedback from CSP representatives and foster an equitable 
research partnership. The radiology PN and CSP representatives will meet weekly to discuss day-to-day 
activities and hurdles and maintain an open line of communication for daily interactions. Time-sensitive issues 
will trigger consortium meetings separate from the scheduled monthly review meetings. The initial and monthly 
consortium meetings will be guided by the RE-AIM framework with emphasis on improving the reach, 
effectiveness, and maintenance of our interventions (Table 1). The meeting following the 6-month intervention 
period will be focused on future planning. The Mixed Methods Research Lab (MMRL), under the guidance of 
co-investigator Dr. Rendle, will provide technical support to facilitate and evaluate the equitable inclusion of the 
various stakeholder perspectives into the study design and interactive changes. 
Specific Aim 2. Measure the impact of the community support program in improving adherence to lung 
cancer screening follow-up. 
A prospective study would be designed to measure the impact of the CSP on a population level by utilizing 
aggregated neighborhood level data. The database contains information of patients who received baseline 
LCS with individual level residential address geocoded to determine neighborhood level characteristics (see 
preliminary data). The West Philadelphia planning district will be chosen as the intervention group because it is 
within the catchment area of Penn Medicine, has the highest number of LCS patients and is one of the districts 
noted to have consistent high rates of smoking prevalence and lung cancer mortality. In addition, we have 
strong community partnerships in the region. The control group would be individuals residing in the adjacent 
Southwest Philadelphia planning district which has a similar Yost score - a composite index of socioeconomic 
status41. Patients will be stratified into those with upcoming or missed appointments with primary analysis 
focused on patients with upcoming appointments. Informed consent will be provided prior to patient inclusion in 
the CSP. All activities will be approved by our Institutional Review Board prior to study commencement 
We will identify patients residing in West Philadelphia who underwent lung cancer screening in 2020-2022 with 
a Lung-RADS 1 or 2 result and have an upcoming or missed appointment in our healthcare system downtown 
hospitals. We will analyze the EHR and RIS data to identify dates of LDCT upcoming appointments over 6 
consecutive months with plans for 6 monthly cycles of intervention (Figure 3). A trained radiology PN will 
contact patients two weeks prior to their upcoming appointment, provide descriptions of the CSP and offer 
participation. Patients who agree to participate in the CSP would be contacted by a community representative 
RE-AIM 
components 
Question answered
Metric
Future Planning
Reach 
How many patients that were 
offered entry into the community 
support program engaged with 
the representative 
Reasons for non-participation in 
program. 
Number of patients who chose 
community support / total number of 
patients who were offered it; 
demographic and geographic differences 
of patients reached vs. not reached 
Identify potential reasons for 
patients not choosing community 
support 
Identify other possible forms of 
community support. 
Effectiveness
Did addition of community 
support option lead to increased 
adherence to follow-up 
recommendation? 
% Of patients who obtained yearly follow-
up LDCT in intervention vs control groups 
% Of patients in intervention group who 
obtained yearly follow-up LDCT after 
intervention vs during a similar prior time 
frame 
Identify and compare 
characteristics of adherent vs non-
adherent patients 
Capture any unintended 
consequences of community 
support for LCS 
Capture additional barriers to LCS 
adherence 
Maintenance 
(Sustainability) 
If the lung cancer screening 
community support program is 
effective, how can it be 
sustained? 
Measure actual cost of community 
support program 
Explore options for additional 
funding including through grants 
and institutional support 
Explore institutional return on 
investment for increased lung 
cancer screening utilization through 
community support program 

1 week and 1 day prior to their appointment to offer support based on their identified needs and the available 
resources. The CSP representatives will be provided transportation vouchers, educational material and 
resources for other social support and liaise with the radiology PN to report information from patient encounters 
including additional needs and patient plans to attend appointments. Patients with missed follow-up 
appointments who still receive care at Penn Medicine will be contacted by the radiology PN for inclusion in the 
CSP program. The CSP representative will offer appointment support and collaborate with the radiology PN to 
offer a rescheduled LDCT appointment to this group of study participants.  
Recruitment and Sample: The eligibility criteria for study inclusion are 1) obtained LDCT in 2020-2022 with a 
Lung-RADS 1 or 2 result 2) upcoming or missed follow-up LDCT 3) residence in the city of Philadelphia. 
Preliminary data revealed that 1,328 individuals residing in Philadelphia received a LDCT in 2021, 90% of 
which are Lung-RADS 1 or 2. Assuming the same number of patients receive LCS in 2022 and follow-up LDCT 
scans are evenly distributed throughout the year, we anticipate that 598 individuals will have an upcoming 
LDCT study in the first 6 months of 2023 of which 167 (28%) in West and 114(19%) in Southwest planning 
district will be included in our primary analysis. For secondary analysis, patients residing in West Philadelphia 
(28%) with missed appointments (66%) following a Lung-RADS 1 or 2 recommendation on LDCT(90%) in 
2020 and 2021 will be included, resulting in an additional 278 patients.  
Evaluation: Evaluation will be guided by the RE-AIM framework with focus on Reach, Effectiveness and 
Maintenance of our program (Table 1). Primary outcomes of the study include: 1) difference in obtaining the 
recommended follow-up LDCT screening study in patients with upcoming appointments between the 
intervention and control group 2) association between participation in the CSP and adherence to follow-up 
LDCT. An intention-to-treat approach will be used for our primary analysis to measure the effectiveness of the 
CSP and will be done 2 weeks after completion of the 6-month intervention period. Chi-squared test will be 
used to measure a difference in adherence to follow-up LDCT between groups. A logistic regression model will 
be used to determine the association between adherence and utilization of CSP while controlling for 
demographic, geographic and socioeconomic variables. Secondary outcomes include: 1) difference in follow-
up LDCT utilization in the intervention group compared to a similar period prior to implementation of CSP 2) 
reach of the CSP (what percentage of participants who were offered it engaged with the CSP representative). 
Evaluation of reach of the CSP would include descriptive analysis to evaluate differences in characteristics 
between participants who utilized 
the CSP and those who did not. 
Secondary analysis will include 
patients with upcoming and 
previously missed appointments 
following a negative screening 
study from 2020-2022. 
Mcnemar’s test will be used to 
measure a difference in follow-up 
LDCT utilization after the 
intervention compared to a similar 
period pre-intervention. Power Considerations: All sample size and power calculations were conducted using 
PASS 2022 (NCSS, version 22.0.2), assuming a 5% type I error rate and using two-sided hypothesis tests. 
With a proposed sample size of 281 patients (167 in West and 114 in Southwest Philadelphia), we will have 
80% power to detect an effect size W = 0.17 or larger using one degree of freedom to determine the difference 
in the proportion of adherence to follow-up LDCT between groups. See Table 2 for project deliverables and 
timeline. 
References 
Table 2. Deliverables and Timeline (assuming start date of 11/1/2022)
Deliverable
Target 
Completion 
IRB Approval 
11/30/2022
Identification of CSP Representatives 
11/15/2022
Establishment of Consortium 
11/30/2022
Development of Support Material: Education, Transportation etc 
12/31/2022 
Initiation of the CSP 
01/01/2023
Completion of the CSP 
06/30/2023
Data and Feedback Analysis 
07/31/2023 
Manuscript and Presentation Preparation 
09/30/2023 
Develop Structure for Future City-wide CSP 
10/31/2023 

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