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

Is there a standalone protocol that outlines the 
following: background, purpose, objectives, design, 
selection criteria, research procedures, recruitment 
methods, informed consent plan, analysis plan, 
monitoring plan, risks, benefits, and a privacy & 
confidentiality plan?
IRB Protocol Application #24-0648 (855800), PI: Farouk Dako 
(dakof)
Title: Community Support Program for Lung Cancer Screening 
Abstract
Initial Approval Date
Expiration Date
Protocol Overall Status
Current Status
Protocol's Review Type
08/02/2024
Approved
Approved
Expedited
Protocol Description
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 uptake47. 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 smokingone of the strongest risk 

Background:
Describe succinctly and clearly the past findings which 
justify the plan for this project. A summary of the 
relevant literature in the area of interest and reports of 
previous studies should be included.
factorsis 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 communities1315. 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 (Penn Employee) and citizen 
scientist2125, 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 

Please detail the study purpose and aims
an intervention, RE-AIM provides a framework for 
planning and measuring impact of health 
promotion and disease prevention initiatives with 
focus on sustainability2830 . 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.
See attached grant submission for list of 
references.
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.

Describe in detail your design and methodology. Use 
nontechnical language.
Will the research involve obtaining, using, studying, or 
analyzing of pre-existing data, documents, records or 
specimens? (I.e., does this protocol involve 
retrospective record/specimen review?)
This is a prospective, two arm community support 
program. 
First, we will identify Community Support Program 
(CSP)Representative. We will do so by posting a job 
advertisement at a local church: The Church of 
Christian Compassion. We will interview candidates 
as we would anyone applying for a job within the 
Penn system.
Once hired, the CSP representative will be trained 
about the basics of lung cancer screening needed 
to provide support for patients with an upcoming 
LDCT appointment. The CSP will be selected by our 
community partners but do not need any medical 
background. Highest level of education needed is a 
high school diploma.
Patient-facing LCS material, adapted from ACR and 
Penn Medicine websites, will be created to ensure 
a fifth-grade readability level and sensitivity to local 
context in collaboration with a Patient Navigator
(Penn Employee) 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 
LUNGevity 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 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.
We will also have the patient navigator (employee 
of Penn)who has access to PennChart and other 
Penn Medicine systems who will help with the 
appointment schedules.
No

The Patient Navigator (PN--Penn Employee) will 
review upcoming and ordered LDCT lung screening 
appointments through PennChart.The PN will keep 
a log divided into two groups: 1. Community 
Support Program (CSP) and 2. Control Group.
1. Community Support Program Group
Patients living within the local radius (see attached
map) will be contacted and asked if they are willing
to be included in this research study.
The PN will contact patients via MyPennMedicine (if 
available), e-mail, text, and/or phone call to ask if 
they are interested in enrolling in the Community 
Support Program (CSP). We do not plan to send 
PHI over these telecommunication mechanisms. 
Please see attached screening form for details.

Describe what participants will be asked to do and, if 
applicable, what information or specimens will be 
collected from them.
The PN will contact patients to ask if they are 
interested in being apart of the Community 
Support Program (CSP). 
If the patient agrees, a CSP Representative will 
reach out to the patient via telephone, text 
messaging and/or email. 
The CSP Representative and Patient Navigator will 
communicate with the patient directly, assist with 
Scheduling, travel and the appointment.
The PN will log the date of the appointment, zip 
code of the patient and the adherence (or lack of) 
of the appointment completion. 
If the patient denies participation, the Patient 
Navigator will log the patient declined and not 
pursue any further contact. 
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 at 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.
2. Control Group
The control group are Penn Medicine patients who 
are scheduled (or recently missed) a LDCT 
appointment and not residing in West Philadelphia 
(under the zip codes listed above). We will monitor 
their adherence to their appointments through 
Penn Chart and missed appointment status 
reports. We will not be in contact with these 
patients. The Patient Navigator will keep a log of 
the control group as well. This log will include a 
subject identifier, gender, zip code, date of LDCT 
scan and the adherence (or lack of) of the 
scheduled appointment.

Provide a sequential list of all study procedures/ 
components, including any follow-up. Include the 
estimated time commitment on the part of participants.
Specify the area(s)/location(s) where the research will 
be conducted and discuss how this is adequate to 
ensure the protection of participants.
Consortium 
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 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. 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.
See attached grant for more details.

Describe the plan to analyze the data. Describe the 
, rationale for the proposed sample size, 
sampling plan
and planned data analysis (quantitative or qualitative 
as applicable). For quantitative data analysis, include 
the statistical power of any planned statistical tests.
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. Mcnemars 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 in the attached grant application.

1.  
2.  
3.  
Please detail how the study has adequate resources 
to protect participants.
Describe research staff and justify that the staff are 
adequate in number and qualifications to conduct 
the research.
Describe how you will ensure that all staff assisting 
with the research are adequately informed about 
the protocol and their research related duties 
(through training, meetings, etc.)
If Penn personnel will be conducting research 
activities at extramural locations, please identify 
any additional resources that will be utilized or 
procedures that will be implemented to ensure 
human subjects protections.
All staff on this project will undergo training on 
departmental processes, CITI, CGP and HIPAA.
Staff are familiar with clinical research, community 
support programs and lung screening.
The CSP Representative will also complete CITI and 
HIPAA training.