Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting
Conditions: Lung Cancer Patients, Caregivers
Sponsor: LUNGevity Foundation

Study title: Project PEER: Understanding the lung cancer Patient ExperiEnce in the 
Real-World setting 
 
ClinicalTrials.gov Identifier: NCT05826756 
 
 
Cover Letter Date: April 26, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
  
 
 
Project PEER: Understanding the lung cancer Patient ExperiEnce in the Real-World setting 
WCG IRB 
March 31, 2023 
 
PROTOCOL NUMBER:  
 
LUNGevity-2020-01—Version 6 
 
TYPE OF STUDY  
Prospective longitudinal online survey with no 
experimental treatment or intervention 
 
STUDY START DATE:   
             August 15, 2020 
STUDY END DATE:  
 
 
Open-ended 
 
SPONSOR:  
 
 
 
LUNGevity Foundation  
6917 Arlington Road, Suite 352 
Bethesda, MD 20814 
Phone: 240-454-3100 
Fax: 240-497-0034 
Email: info@LUNGevity.org  
 
PRINCIPAL INVESTIGATOR CONTACT: 
 
 
 
 
 
 
Upal Basu Roy, PhD 
Vice President of Research 
LUNGevity Foundation   
917 Arlington Road, Suite 352 
Bethesda, MD 20814 
Phone: 202.603.3379 
Email: UBasuroy@LUNGevity.org 
 
 
 
 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
1.0 
PROTOCOL SYNOPSIS 
Protocol title: Project PEER: Understanding the lung cancer Patient ExperiEnce in the Real-
World setting 
Type of study: Prospective online longitudinal survey study with no experimental treatment or 
intervention 
Study period: Open-ended 
Objective: To collect longitudinal data that facilitates a more rigorous understanding of the 
treatment experiences and needs of lung cancer patients―either reported by patients or through 
their caregivers.   
Study population and sample size: Patient with lung cancer and caregivers in the US and 
internationally who are able to read and answer questions in English 
- 
Inclusion/exclusion criteria: Inclusion: 
▪ Adults with self-reported lung cancer diagnosis or caregiver of someone with a self-
reported lung cancer diagnosis (patient has to be alive) 
▪ Ability to read and answer questions in English 
▪ Access and ability to use a computer or other internet-connected device 
- 
Exclusion: 
▪ Younger than 18 
▪ Healthcare providers and healthcare professionals who provide care to lung cancer 
patients except for those who are themselves a patient or a caregiver to a loved one. 
▪ Not able to provide informed consent 
Study design: Online longitudinal study; participants will sign up and consent to be part of the 
study. Participants will receive follow-up emails to inform them of new surveys available to be 
completed. They will be sent periodic surveys to complete. Participants will complete a baseline 
survey on their 1) lung cancer experience, 2) lung cancer diagnosis, 3) treatment experience, 4) 
lung cancer outcomes and symptoms, and 5) demographic characteristics. They will then be 
asked to complete 11 periodic surveys (one per month) to update the baseline information to 
help understand their disease and treatment progression. Participants will have the option of 
accessing aggregate responses at the end of the study. A (de-identified) summary of results will 
also be made available publicly. No individual results will be presented. 
Data management and protection: A two-pronged approach will be used: 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
1. Self-selected participants who self-identify as being diagnosed with lung cancer or being 
the caregiver of someone diagnosed with lung cancer and participate through an open 
link on social media or other digital platforms (not identified through a clinic) .  
2. Lung cancer patients receiving care at a participating clinic site will be identified by a 
member of the research clinic staff reviewing their medical records. These patients and 
their caregivers will be invited to participate in PEER by a member of the research clinic 
staff. The clinic site will not have access to participants survey responses, and, 
LUNGevity Foundation will not have access to the clinic site’s patient data. Authorized 
research personnel from LUNGevity Foundation will only have access to participants’ 
who consented to participate in Project PEER. 
 
All Private Health Information (PHI) for clinic and non-clinic participants will be encrypted 
within the EmpiraMed™ PRO Portal™ Software Platform (PRO Portal). Access will be provided 
only to those authorized research personnel from LUNGevity Foundation and EmpiraMed with 
a need to access such information and will be provided through secure connections to maintain 
full Health Insurance Portability and Accountability Act (HIPAA) compliance of PHI. Participants 
in the study will be assigned a unique study identification number. Study participants will 
consent to participate in the study. They can fully withdraw their consent to participate in the 
study at any time for any reason. Additionally, the Principal Investigator may remove study 
participants from the study if he feels it poses harm to participants or suspects fraud. 
Additionally, external researchers may apply to LUNGevity to have limited access to de-identified 
study data. Any data transfers will occur through protected files and platforms. External 
researchers will not be able to identify individual responses. Data access to external researchers 
will be controlled by LUNGevity.  
Data will be collected and stored through a survey platform (PRO Portal) that complies with 
HIPAA and General Data Protection Regulation (GDPR). 
Data analysis:  All data analysis will be conducted using Excel, SPSS, Stata, R, or another similar 
software package. Data will be analyzed using frequencies, cross tabulation, and regression 
analysis. All analyses will include aggregate results and presented as tables, graphs, or charts. No 
individual-level data comparisons will be made. However, individual level responses will not be 
presented and any analyses presented will not contain personally identifiable information. 
 
 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
2.0 
Study Synopsis 
The study objective is to collect longitudinal data to facilitate a more rigorous understanding of 
the diagnostic and treatment journey of people diagnosed with lung cancer and to identify 
determinants of treatment heterogeneity. Study data will facilitate a deeper and more 
scientifically rigorous understanding of the needs and wants of people living with lung cancer 
and assist with the integration of patient experiences into the development of lung cancer 
treatments and research. It supports ongoing efforts at the U.S. Food and Drug Administration 
(FDA) to promote patient-focused drug development (PFDD).1  
During this study, surveys will be deployed to catalog different components of a patient’s 
diagnostic and treatment journey, along with how a lung cancer diagnosis impacts the quality of 
life of those living with lung cancer. Study participants will consent and register for the study 
and complete an initial baseline survey. They will then be followed for 12 months and receive a 
monthly survey (11 surveys in total). The development of the surveys has been guided by input 
from patients, clinicians, FDA experts, and incorporates questions from existing PRO measures.  
Summarized study results will also be posted on LUNGevity’s website. External researchers will 
be able to apply to LUNGevity Foundation to administer additional surveys to study 
participants. They can also apply to have limited access to de-identified data. The study is an 
open-ended longitudinal survey study. Protocol updates and amendments will be submitted to 
the IRB throughout the duration of the project as needed.  
3.0 
Background 
Lung cancer continues to be the number-one cancer killer in the United States and worldwide. 
It is often discovered at later stages of the disease when decisions must be made rapidly, and 
these decisions can be extraordinarily difficult. They are dependent, or should be, on the 
patient’s preferences. With a high overall mortality rate, only 19% alive at the 5-year mark, the 
focus has been on new diagnostics and new therapies to save lives.2 In the last few years, lung 
cancer science has progressed at an unprecedented rate: new categories of therapies for 
patients with lung cancer have become available, including immunotherapies and targeted 
therapies with companion diagnostics, and the application of existing therapies has been 
expanding.  
This progress is especially apparent in certain driver mutation-specific non-small cell lung 
cancer (NSCLC) adenocarcinomas, such as EGFR, ALK, ROS1, BRAF, NTRK, RET, and MET for 
which FDA-approved targeted therapies exist in the first-line setting.3 These targeted agents 
provide higher response rates and a superior quality of life compared to traditional 
chemotherapy. Patients with EGFR- and ALK-positive NSCLC may also have second-line 
treatment options.3 The prescribing preferences for different first-line and second-line 
treatments are currently not known. Furthermore, reasons for treatment discontinuation 
(adverse events, progression, mechanisms of resistance, etc.) are not well documented beyond 
a clinical trial context. In addition, how patients experience their disease in terms of symptoms, 
impacts, outcomes, and quality of life (QoL) throughout their disease progression is unclear. 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
To enhance understanding of the patients’ disease and treatment journey, LUNGevity 
Foundation has developed a mechanism for patients with lung cancer and their caregivers to 
enroll in a patient experience study that will collect longitudinal data to facilitate a more 
rigorous understanding of the diagnostic and treatment journey of people diagnosed with lung 
cancer and to identify determinants of patient experience heterogeneity. 
3.1 
LUNGevity Foundation: 
LUNGevity, one of the nation's largest lung cancer non-profits, is dedicated to changing 
outcomes for people with lung cancer through research, education, and support. LUNGevity 
focuses on research because the link between research spending and improved survival is clear. 
Survival rates have dramatically improved for colorectal, breast, and prostate cancers over the 
last several decades in step with the exponential growth in their research spending. The 
foundation’s goal is to accelerate progress for lung cancer in the same way, in order to 
dramatically improve on the current 19% five-year survival rate. 
To date, LUNGevity has funded 133 research projects at 59 institutions in 23 states. LUNGevity 
research investments focus on early detection, because survival rates rise when lung cancer is 
detected while still localized. LUNGevity also focuses on more effective treatment 
approaches—getting the right treatment to the right patient at the right time to help people 
with lung cancer live longer and better. 
LUNGevity also provides a community of empowerment, support, and hope for everyone 
affected by lung cancer through our extensive educational resources, online peer-to-peer 
support, and in-person survivorship programs, as well as more than 40 grassroots awareness 
and fundraising events held from coast to coast each year.  
LUNGevity’s mission is patient-centric―to provide a voice to the lung cancer patient 
community. 
4.0 
Objectives 
The study objective is to collect longitudinal data that facilitates a more rigorous understanding 
of the treatment experiences and needs of patients with lung cancer―either reported by 
patients or through their caregivers. This research project will catalog different elements of a 
patient’s diagnostic and treatment journey and identify unmet needs of patients with lung 
cancer. This is an international study with an open-ended timeframe. 
The study will collect data to answer the following questions:  
1. What are some of the first-line treatment options prescribed to patients?  
2. What are the reasons for treatment change and second- and subsequent-line 
treatment options (including immunotherapy (I/O) and clinical trials)? 
3. What types of biomarker testing practices were utilized to diagnose the cancer 
and characterize mechanisms of resistance?  

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
4. Are there specific risk factors that can predict the histology of the disease and 
response to specific treatments?  
5. How does a lung cancer diagnosis impact the quality of life of a patient? 
6. Which symptoms, impacts, and outcomes do patients with lung cancer experience 
and how do these change over time (collected through validated patient-reported 
outcome instruments)? 
7. Do patients who have participated in clinical trials have better outcomes than 
those who have not participated in clinical trials? 
 
5.0 
Study Workflow 
A GDPR-compliant workflow for the study is shown below. 
Briefly, 
1. Potential participants will be directed to the study landing page (Attachment 1) through 
various recruitment methods (section 6.3).  

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
2. They will then fill out the Self Registration Form (Attachment 2) 
3. They will then be asked to read the Registration Data Use Agreement and complete the 
Registration Form (Attachment 3) 
4. Following creation of account on the PRO Portal and system determination the cohort 
maximums have not been met (either within the 1200 patients or 300 caregivers), an 
email verification (Attachment 4) will be sent to potential participants.  
5. After account verification, a potential participant will sign the electronic informed consent 
form (eICF) (Attachment 5 and 6) 
6. After a potential participant has consented, they will agree to and sign the Terms of Use 
Agreement and Privacy Policy (Attachment 7 and 8) 
7. The potential participant will complete a brief survey (Attachment 9) to verify that they 
are a lung cancer patient or caregiver as a means to screen out “fraudsters” 
8. At this stage a potential participant is considered a study participant and is able to 
commence participation.  
6.0 
Study subjects 
6.1 
Target population and sample size 
Participation in Project PEER is open to adults within the US and internationally who either 
self-report a lung cancer diagnosis  or receive care at a participating clinic site. PEER is also 
open to any adult caregiver of the above individuals or who self-reports as a caregiver to an 
individual with a lung cancer diagnosis. There is no limit on the number of participants or 
countries included in Project PEER. However, LUNGevity anticipates enrolling a minimum of 
1,500 patients and caregivers. We hope to enroll around 1,200 patients and 300 caregivers. 
LUNGevity will be tracking recruitment and may decide to cap enrollment based on participant 
characteristics.  
6.2 
Inclusion and Exclusion Criteria 
- 
Inclusion criteria: 
• Adults with self-reported lung cancer diagnosis or caregiver of someone with a self-
reported lung cancer diagnosis (patient has to be alive) 
• Ability to read and answer questions in English. 
• Access and ability to use a computer or other internet-connected device. 
- 
Exclusion criteria: 
• Younger than 18. 
• Healthcare providers and healthcare professionals who provide care to lung cancer 
patients except for those who are themselves a patient or a caregiver to a loved one.  

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
• Not able to provide consent. 
Participation in Project PEER does not involve a risk of physical harm; therefore, women of 
childbearing potential will not be tested for pregnancy. The racial, gender, and ethnic 
characteristics of study participants will reflect demographics of patients with lung cancer who 
are seeking information regarding their disease and are potentially interested in participation 
in clinical trials or research studies. No individuals will be excluded from participation in 
Project PEER based on age (if 18 or older), race, ethnicity, or gender. 
6.3 
Recruitment 
For inclusion in PEER, potential participants will be identified either because of attendance at a 
participating clinic site, participation in a market research panel, or by self-report. Regardless of 
how a potential participant is identified, LUNGevity will not have access to medical records.  
All interested participants will be directed to a study landing page (Attachment 1) to learn 
details about study participation. Those interested in participating will be asked to complete a 
brief study registration form that includes a data use agreement (Attachment 3). After 
submission of the registration form, the email provided by the participant will be confirmed and 
an account will be created. At this stage, a participant will be considered enrolled in the study 
and will proceed with signing the electronic informed consent form (eICF).  
The study surveys will be available as an online option only and deployed through the PRO Portal. 
No pen-and-paper version of the survey will be used. Participation in the study is completely 
voluntary. Language used for recruitment is provided in Attachment 10, 11, 27 and 28. 
Self-reporting Participants: Participants that self-report as having lung cancer or as being a 
caregiver of an individual with lung cancer will be recruited by the various methods listed below: 
1. 
Closed Facebook pages maintained by LUNGevity Foundation and other lung cancer 
organizations: A generic link to the study landing page will be posted on closed Facebook groups 
maintained exclusively for patients with lung cancer (or their caregivers).  
2. 
Open Facebook pages and Twitter maintained by LUNGevity Foundation and other lung 
cancer organizations: Links to information about the study will be posted on public social media 
accounts. 
3. 
Newsletters: LUNGevity Foundation and other patient advocacy send regular newsletters 
to their constituents. These newsletters will have a link to the study landing page.  
4. 
Public Meetings: Information about Project PEER might be provided at LUNGevity’s 
International Lung Cancer Survivorship Conferences, public meetings for lung cancer patients and 
caregivers, or other meetings that patients with lung cancer attend. 
5. 
Lung Cancer Europe: Information about Project PEER will be distributed to constituents 
of LuCE. 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
6. 
Market Research Firm (firm)/Specialty Pharmacies: LUNGevity Foundation will work 
with a market research firm and specialty pharmacies to recruit patients and caregivers. The 
firm/specialty pharmacy will recruit these individuals through: a) posting on closed social media 
pages that the firm/specialty pharmacy maintains, b) eblasts and newsletters sent to individuals 
in their network, c) passive postings in offices of health care providers in their network, and d) 
referrals from individuals in their network. Patients and caregivers who learn about Project PEER 
through the firm/specialty pharmacy will contact a member of the firm/specialty pharmacy staff 
to learn more about PEER. If the interested participant meets study eligibility criteria, the 
recruiter will email the person the link to the study website (Attachment 27 and 28). The 
firm/specialty pharmacy will not have access to participants survey responses, and, LUNGevity 
will not have access to the firm/specialty pharmacy’s network data. 
 
7. 
Postcards: Postcards containing information about the study may be distributed through 
LUNGevity partner sites and clinics (Attachment 11). 
 
8. 
Trial websites: LUNGevity will work with websites to include Project PEER as one of the 
research projects listed on their site. People find these websites by performing internet searches. 
These websites allow people to learn about research studies by providing study and contact 
details (which they can use to contact the research team if they choose). The contact details 
provided on the websites will connect people with a member of the LUNGevity research team, 
who will confirm study eligibility of the interested participant and email a link to the study 
website (Attachment 28). 
 
All language for the various outreach methods that we will be using is provided in Attachment 
10, 11, 27 and 28. The links posted will take the participant to a landing page on the LUNGevity 
website that will provide information about Project PEER and where participants can express 
interest in joining.  
Clinic participants: Lung cancer patients receiving care at a participating clinic site and their 
caregivers will be recruited into PEER by a member of the research clinic staff. This staff member 
will review the clinic schedule and medical records (when applicable) to determine potential 
participants eligibility. For all potentially eligible participants, the staff member will inform them 
about PEER. For interested individuals, the staff member will walk the potential participant 
through sign up using the potential participant’s phone to take them to the study landing page 
(i.e., PRO Portal) and have them complete the actions in the above section titled: “All interested 
participants.” The clinic site will not have access to participants survey responses, and, 
LUNGevity will not have access to the clinic site’s patient data. 
 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
6.4 
Consent 
Study participants will sign up for the study and complete surveys through an online platform 
(PRO Portal). No pen-and-paper version of the surveys in the study will be used. Participation in 
the study is completely voluntary, and study participants will be recruited through methods 
described above. Before commencing the baseline survey, all participants will be instructed to 
read and sign the study eICF during the registration process. Study participants will have the 
option to download the signed eICF for their own records. There will be two versions of the eICF 
– one for United States study participants (Attachment 5) and one for non-United States 
participants (Attachment 6). This separation has been done to include GDPR-related information 
in the eICF for non-United States study participants.  
If a study participant withdraws their consent, they will not be contacted further and will not be 
asked to contribute additional data to the study. They will be given the option to share their 
reason for withdrawal (Attachment 12) If invitations when follow-on monthly surveys bounce 
back or if LUNGevity receives notice that the study participant has passed away, LUNGevity will 
withdraw the patient. Their existing survey responses will not be removed from the study but 
any personally identifiable information (PII) will be removed. If a caregiver’s patient passes away 
during the study, the caregiver’s participation is complete following the completion of a close-
out bereavement survey. 
A study FAQ is available for participants once they are registered (Attachment 13). Participants 
will also have access to a Quick Start Guide on the study landing page (Attachment 14) 
7.0 
Study Design and Methods 
7.1 
Financial Incentives 
Study participants will be incentivized minimally to complete all the surveys. It is anticipated that 
a study participant will receive $20 (in the form of an eGift card) every 3 months – a total annual 
incentive amount to not exceed $80 for a total of 12 surveys (1 baseline and 11 follow-up 
surveys). Compensation is dependent on successful completion of all surveys sent out by the 
research team. The schedule of compensation is based on the number of completed surveys. The 
PRO Portal awards “Hearts” (which are a particular type of points) for completion of monthly 
surveys, diary entries, and other information study participants may report directly into the 
system. Hearts are awarded independent of a participant’s specific answers to questions. In 
addition, the number of hearts a study participant receives will vary depending on the scope of 
the data collected. Hearts can be redeemed for cash gift cards (called eGifts) which are 
distributed to them via email. Once every three months, 800 hearts can be redeemed for a $20 
eGift that a participant can choose from a selection of popular merchants. Inactivity for 60 days 
on the PRO Portal will lead to the expiration of 100 hearts. The study-specific rules about 
accumulation of points and eGift redemption limits can be accessed in the PRO Portal by clicking 
on the Rewards tab. If a study participant withdraws from the study early, they can still redeem 
their earned points for eGifts prior to withdrawal; redemption of the points that they have 
accumulated is not contingent upon study completion. If a participant is removed from the study 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
by the Principal Investigator for suspected fraudulent involvement, they will not be able to 
redeem any pending rewards. 
7.2 
Description of study design for study participants 
Patients: Once patients provide informed consent, they will continue with the study baseline 
survey which can be found in Attachment 15. The baseline survey design includes structured 
questions with response options or ratings on a Likert-type scale, as well as the ability to enter 
comments and open-ended text for the structured questions. It is expected to take 45-60 
minutes to complete. The survey has language reminding patients that they may need to check 
their medical records to complete the survey.  
The baseline survey for patients is modular and contains the following sections: 
• 
Module 1 will ask patients about their lung cancer diagnostic journey 
• 
Module 2 will ask patients questions about how a lung cancer diagnosis has impacted 
their quality of life, including questions on hospitalizations and experience with their healthcare 
team.  
• 
Module 3 will include validated PRO instruments that ask patients about their lung cancer 
symptoms, impacts, and outcomes.  
• 
Module 4 will ask patients questions specific to their lung cancer, including questions on 
biomarker testing and different treatment options 
• 
Module 5 will ask patients about their demographic characteristics 
In addition, for patients who enroll between August 2020 and December 2020, we will have a 
COVID-19 specific module (which will be displayed between Modules 4 and 5).  
There will be 11 additional follow-on surveys (one every month after a patient has completed 
the baseline survey) each lasting approximately 10-15 minutes. Patients will receive an email 
invitation when these surveys are ready to be filled out (Attachment 16). The follow-on surveys 
are identical for all the 11 months of follow-up. 
An additional set of COVID-19 vaccine questions will be inserted to learn about vaccination 
patterns and hesitancy (Attachment X of May amendment). For new enrollees to PEER these 
items will be included as part of the Patient Baseline Survey. For current PEER participants, the 
items will be asked as part of their next scheduled monthly questionnaire. If a participant has 
received the vaccine, no additional vaccine questions will be asked. For participants who have 
yet to receive the vaccine, they will be asked items 7 – 10 at 6 months and again at 12 months 
only if they still have not received the vaccine.   
Patients will also have the option to provide additional information by logging on to their account 
and providing information in their eDiary. The eDiary will chart a patient’s compliance with 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
medications with food and weight as well as the option of “checking in”.  This is completely 
optional. A screenshot of the eDiary option is included in Attachments 17A, B, and C. 
The consent process will explicitly discuss the time needed to complete surveys. 
Summary of the different PRO instruments to be used in Module 3 for patients is as follows: 
1. A PRO-CTCAE side-effect question— Please choose the response below that best 
describes the severity of your overall side effects from treatment over the past 
week” (where 0 = none and 4 = very severe) 
2. SAQ items for all-comers, including small cell lung cancer (SCLC) patients to 
understand how SAQ may be applied to the SCLC population 4 
3. EORTC short-form questions on physical/functional/emotional functioning, fatigue, 
and pain5,6  
4. EORTC questionnaire on financial toxicity7 
 
Caregivers:  
Once caregivers provide informed consent, at the beginning of their participation they will be 
asked if the patient they care for is deceased or still alive. 
If during the caregiver’s baseline survey (Attachment 18), they report  that their patient is 
deceased, they will be compensated $20 for their time upon completion of their survey. These 
caregivers will not receive any follow on monthly surveys.   
The baseline survey (Attachment 18) for caregivers is modular and contains the following 
sections: 
• 
Module 1 will ask caregivers about their role in caregiving.  
• 
Module 2 will ask caregivers questions about their patient’s lung cancer diagnostic 
experience   
• 
Module 3 will include caregiver-specific questions on quality of life and coping 
mechanisms as a caregiver (including the CarGOQoL instrument8,9 and the Enriched Social 
Support Instrument10)  
• 
Module 4 will ask caregivers questions specific to their lung cancer, including questions 
on biomarker testing and different treatment options 
• 
Module 5 will ask caregivers about their demographic characteristics 
Caregivers whose patients are alive at the time of study initiation and who have completed the 
baseline survey will also be asked at the start of each follow-on survey if the patient they provide 
care for is still alive. There will be 11 additional follow-on surveys (one every month after a 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
caregiver has completed the baseline survey) each lasting approximately 10-15 minutes. 
Participants will receive an email invitation when these surveys are ready to be filled out 
(Attachment 19 and Attachment 20).  
An additional set of COVID-19 vaccine questions will be inserted to learn about vaccination 
patterns and hesitancy (Attachment X of May amendment). For new enrollees to PEER these 
items will be included as part of the Caregiver Baseline Survey. For current PEER participants, the 
items will be asked as part of their next scheduled monthly questionnaire. If a participant has 
received the vaccine, no additional vaccine questions will be asked. For participants who have 
yet to receive the vaccine, they will be asked items 7 – 10 at 6 months and again at 12 months 
only if they still have not received the vaccine.   
 
If the patient has passed away during the duration of the study, the caregiver will be directed to 
the close-out bereavement survey (Attachment 21).11,12 They will be compensated for their time 
based on the number of follow-on surveys completed. For example, a caregiver who has 
completed 6 of the 12 surveys will be compensated $40 in total. 
The following table summarizes the three potential possibilities of caregiver participation. 
Type of Caregiver 
Participation 
Patient 
deceased 
at 
time 
of 
study 
commencement 
Will only finish baseline survey (Attachment 
18) 
Patient is alive during follow-up 
Will finish baseline (Attachment 18) and 
monthly surveys (Attachment 19 and 20) 
Patient passes away during the follow-up 
period 
Will 
have 
the 
option 
to 
complete 
bereavement survey (Attachment 21), in 
addition to completing baseline baseline 
survey 
(Attachment 
18) 
at 
study 
commencement  
 
7.3 
Reminders 
All participants will receive standard email reminders for activities, such as password changes 
and reminders when surveys are available (Attachment 22). 
7.4 
Participant-facing results 
Aggregate summary results of the study will be posted on the LUNGevity website and will be 
periodically updated as participants join the study and complete more follow-on surveys. 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
The study is an open-ended longitudinal survey study. Protocol extensions will be submitted as 
needed throughout the duration of the study. 
7.5 
Study risks 
All participants: Recruitment and participation in the study itself does not put potential study 
participants at risk.  
Self-report participants not from a market research firm, specialty pharmacy, or trial website: 
There are no privacy concerns associated with recruitment given that all recruitment will be 
conducted through online means and not use any touch-points with patients or their caregivers. 
Self-report participants from a market research firm, specialty pharmacy, or trial website: There 
is minimal risk for privacy concerns. Since: 1) these participants will be recruited by staff that have 
completed the appropriate training for the conduct of research and will recruit participants 
according to this training. 2) The market research firm, specialty pharmacy, and trial website will 
not have access to participants survey responses. 3) LUNGevity will not have access to the market 
research firm, specialty pharmacy, and trial website network data.  
Clinic participants: For patients and caregivers recruited at a clinic site, there is minimal risk for 
privacy concerns. Since: 1) these participants will be recruited by clinic staff that have completed 
the appropriate training for the conduct of research and will recruit participants according to this 
training. 2) The clinic site will not have access to participants survey responses. 3) LUNGevity will 
not have access to the clinic site’s patient data.  
All study participants will be provided a link that directs them to the study surveys. Responses will 
be confidential and only analyzed in aggregate, and personally identifiable information will not be 
shared with outside parties.  
As with all electronic data capture systems, there is a potential risk of breach of confidentiality 
of personal and medical information and the associated privacy of study participants. Such 
risks will be minimized by (1) storing personal identifiable information (e.g., subject names) in 
tables separate from other study information; (2) limiting direct access to information 
contained within the study to trained LUNGevity and EmpiraMed research personnel; (3) de-
identifying any shared data; and (4) the use of a secure, compliant, well-established, and 
proven software application (PRO Portal). 
7.6 
Withdrawal or removal from study 
Withdrawal: If a study participant wishes to withdraw from the study, they may do so by emailing 
the Principal Investigator or by accessing the Forms and Privacy Settings section of their personal 
profile and selecting “withdraw”. They can still redeem their earned points for eGifts before their 
account becomes inactive; redemption of the points that they have accumulated is not 
contingent upon study completion. Their email address and other identifiable information will be 
removed from the database and they will no longer be asked to provide additional data to the 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
study. Data that have already been collected will not be removed from the study. Study 
participants will be given the option to provide a reason for their withdrawal in the PRO Portal.  
(Attachment 12) 
Removal: The Principal Investigator may remove a study participant from the study under the 
following circumstances: 
• LUNGevity Foundation or IRB cancels the study 
• The Principal Investigator thinks that removing a study participant from the study is in 
their best interests 
• A study participant is not responding to the surveys or not following directions given for 
the study. In this case, an email to the study participant notifying them of their non-
compliance will be sent to the registered email address (Attachment 4) 
• The Principal Investigator suspects fraudulent participation in the study (Attachment 23) 
7.7 
Detection of possible fraudulent participation 
 The research team is committed to ensuring the integrity of the data collected, both to respect 
authentic participants from the lung cancer community and to maintain the rigor and robustness 
of the data collected.  To achieve this, they have taken every precaution to deter fraudulent 
participation in Project PEER, such as: 
• Use of CAPTCHA at the time of participant registration 
• Use of a short verification survey (Attachment 9) to confirm whether a participant is a 
person with lung cancer or a caregiver to a person with lung cancer 
• Pacing of study participation incentives every 3 months whereby a participant will receive 
an incentive after completing 3 surveys broken into 4 periods (totally 12 surveys). This is 
described in detail in Section 7.1 
In addition to these precautions, we will flag participants who have registered with duplicate 
emails and/or duplicate usernames as fraudsters. In the event that a participant is identified to 
have duplicate accounts, they will receive the fraudulent participant email (Attachment 23) and 
have the opportunity to rectify the misidentification. A participant will be flagged as fraudulent 
only if they fail to respond to the fraudulent participation email within 7 days of receiving the 
email.  We will also be doing period data quality controls before each incentive is paid out (after 
completion of survey # 3, 6, 9, and 12): 
• Step 1: For all participants, we will be tracking their responses over time and checking for 
inconsistencies such as a large selection of “I do not know” for different questions within 
the same survey and variations in data collected through each monthly survey.  For 
example, baseline and monthly surveys administered to both patients and caregivers have 
common questions. Variations, such as fluctuation in treatment-related and patient or 
caregiver experience data, will be easily identified during data quality control. 
• Step 2: For those participants where such variations and/or inconsistencies are identified, 
we will look at survey para data to identify whether the participants identified in Step 1  

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
finished the survey really quickly – defined as time taken to complete the survey that is 
two standard deviations lower than the mean completion time. This time limit has been 
decided based on previously published research.13 The PRO portal allows researchers to 
access survey para data (mean survey completion time for all participants and individual 
participant completion time for each survey). It is important to note that different survey 
para data time limit values will be used for patients and caregivers, given the different 
lengths of the surveys.  
• Step 3: In the event that a participant is identified through Step 2, they will receive the 
fraudulent participant email (Attachment 23) and have the opportunity to rectify the 
misidentification. A participant will be flagged as fraudulent only if they fail to respond to 
the fraudulent participation email within 7 days of receiving the email.   
Given all the precautions we have taken, we do not anticipate many fraudulent participants. In 
the event that a participant is suspected of being fraudulent, we will deal with each situation on a 
case-by-case basis based on their survey responses and the survey para data.  
8.0 
Data analysis 
All data analysis will be conducted using Excel, SPSS, Stata, R, or another similar software. Data 
will be analyzed using frequencies, cross tabulation, time-series, and regression analysis. All 
analyses will include aggregate results and presented as tables, graphs, or charts. No individual-
level data comparisons will be made. Participants will have access to their individual responses, 
but individual-level responses will not be shared and will not contain personally identifiable 
information.  
Study results will be disseminated at international conferences through presentations and 
posters, and as manuscripts in peer-reviewed journals. Aggregate summary results of the study 
will be posted on the LUNGevity website and will be periodically updated as participants join the 
study and complete more follow-on surveys. Findings will be disseminated to stakeholders, such 
as patients, caregivers, doctors and other healthcare providers, regulatory agencies, and 
pharmaceutical companies.  
Data collected from patients and caregivers will be analyzed separately. As noted above, 
caregivers will be providing anonymous patient-level data in modules 2 and 4 and in the monthly 
surveys. Patient-level data provided through caregivers will be used to categorize caregivers (for 
example, caregivers of non-small cell lung cancer versus small cell lung cancer, caregivers whose 
patients are receiving chemotherapy versus targeted therapy, etc.) to understand how patient-
level factors impact caregiver experience.  
9.0 
Data management and protection 
9.1 
Data management 
Study participants are informed that their personally identifiable information, including name 
and contact information, will not be made public or shared with any outside parties, and they 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
are informed how their de-identified data may be used. Identifiable information will be stored 
separately from study data.  
Only authorized LUNGevity Foundation and affiliate research staff from EmpiraMed will have 
access to all data collected through the survey. Responses will be held in strict confidence and 
will be used only for the purposes of this research study. The results will be reported in 
aggregate form only and such that individuals cannot be identified.  There will be no individual 
participant-level data analysis.  All subsets of study participants for analysis (e.g., breakouts by 
type of cancer, age, etc.) will be based on answers to survey questions voluntarily given by 
participants and will be anonymous, as these answers will not be tied to any personally 
identifying information about the participant.  
If a study participant requests to be removed from the study, their email address and other 
identifiable information will be removed from the database and they will no longer be asked to 
provide additional data to the study. If LUNGevity learns that a patient has died, their personally 
identifiable information will be deleted from the database. Information of caregivers of patients 
who have died will also be removed from the study, and they will not be contacted further. Existing 
data cannot be removed from the study 
9.2 
Data Storage, Security, and Confidentiality 
A state-of-the-art web-based, patient registry platform (EmpiraMed, Maynard, MA) will be 
used for data capture. LUNGevity will track participant enrollment based on entered data via 
the secure web portal.  This data will be used to track enrollment as needed (1,200 patients 
and 300 caregivers).  
HIPAA privacy rules and HIPAA security rules mandate that covered entities have in place 
appropriate policies and procedures to protect the confidentiality and security of protected 
health information. EmpiraMed complies with all HIPAA regulations. Furthermore, 
EmpiraMed complies with the General Data Protection Regulation (EU) 2016/679 ("GDPR"). 
GDPR is a regulation in EU law on data protection and privacy for all individuals within 
the European Union (EU) and the European Economic Area (EEA). It also addresses the export 
of personal data outside the EU and EEA areas.  
In compliance with these regulations, the database security features of EmpiraMed’s PRO 
Portal target multiple levels including the data element (e.g., restricted access to fields), user 
(e.g., password authentication access), application (e.g., role-based access to features, access 
audit trails), and hosting services (e.g., firewall, secure sockets layer). Taken together, these 
features ensure access control, audit control, data integrity, user authentication, and 
transmission security. The research project will be set up in EmpiraMed’s PRO Portal to ensure 
exported datasets are de-identified as defined in the HIPAA privacy regulation [45 C.F.R. 
§164.514 (b)(2)].  
All server requests are transmitted over SSL. All servers have several layers of data and access 
protection:  (1) A dedicated, managed router firewall, (2) A redundant array of independent 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
disk [RAID] Level 5 is used to ensure that data will not be lost if a hard drive fails between back-
ups, (3) A system level back-up is performed nightly and retained for 2 weeks and is stored in 
the data center, (4) a database level back-up is performed every 6 hours and retained for 2 
months and is stored at the data center. 
Participant medical information will be stored electronically within the database. The 
database design is such that participant identifiable information is kept in data tables separate 
from the medical information. 
Access to patient and caregiver information will be restricted to trained research staff from 
LUNGevity Foundation and EmpiraMed.  
Participant information will be stored for an indefinite period of time. If a participant requests to 
be removed from the study, their email address and other identifiable information will be 
removed from the database and they will no longer be asked to provide additional data to the 
study. Existing data will remain in the study database. 
9.3 
Availability of de-identified data to third-party researchers 
External researchers who are interested in analyzing Project PEER data may check the survey and 
variables collected in the study, which will be posted on the website. The posted survey will not 
include any consent language.  
If a researcher expresses a desire to interrogate the data, they will provide a short proposal to 
LUNGevity Foundation, clearing stating: 
a. What is the research question?  
b. How does the research question impact lung cancer? 
c. What survey fields/questions are relevant to the research question? 
Following approval by LUNGevity and members of LUNGevity’s Survivor Advisory Council, the 
researchers will have access to limited, de-identified data in the form of an Excel csv or an SPSS-
compatible file with only specified data fields along with a data dictionary. The transfer of the 
data file will be made through a password-protected Dropbox Business account maintained by 
LUNGevity Foundation or a password-protected Excel csv file sent via encrypted email. Two 
emails will be sent — one with the Excel file and a follow-up email with the password. The data 
will be made available free of cost. Any identifying information such as age (continuous variable) 
will be categorized before data sharing.  
10.0 
Premature closeout of study or study discontinuation 
In case LUNGevity Foundation decides to discontinue the study, the Principal Investigator will 
inform the IRB formally to close the study and also send emails to all registered participants 
informing them of study closeout.  

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
11.0 
Attachments 
Attachment 1_LUNGevity Peer _Landing Page 
Attachment 2_LUNGevity PEER (LC2)_Participant Self-Registration Intake Form 
Attachment 3_LUNGevity_Registration Data Use Agreement 
Attachment 4_LUNGevity PEER (LC2)_Custom Email Content 
Attachment 5_LUNGevity PEER (LC2) eICF 
Attachment 6_LUNGevity PEER (LC2) eICF_EU 
Attachment 7_LUNGevity_Privacy Policy 
Attachment 8_LUNGevity_Terms of Use Agreement 
Attachment 9_LUNGevity PEER (LC2)_PARTICIPANT VERIFICATION survey 
Attachment 10_LUNGevity_Project PEER Recruitment Language 
Attachment 11_LUNGevity_PEER_PostcardRecruitment_July 8_2020 
Attachment 12_LUNGevity PEER (LC2)_Study Withdrawal Reasons 
Attachment 13_LUNGevity PEER (LC2)_FAQ 
Attachment 14_LUNGevity (LC2) Quick Start Guide 
Attachment 15_LUNGevity BASELINE PATIENT survey 
Attachment 16_LUNGevity MONTHLY PATIENT survey 
Attachment 17A_LUNGevity_LC2 Medication with Food 
Attachment 17B_LUNGevity (LC2) eDiary Check-in Screenshots 
Attachment 17C_LUNGevity (LC2) eDiary Weight Screenshots 
Attachment 18_LUNGevity BASELINE CAREGIVER survey 
Attachment 19_LUNGevity CAREGIVER MONTHLY Months 2_4_6_8_10 survey 
Attachment 20_LUNGevity CAREGIVER MONTHLY Months 3_5_7_9_11_12 survey 
Attachment 21_LUNGevity CAREGIVER Bereavement survey 
Attachment 22_LUNGevity PEER (LC2)_Standard Emails 
Attachment 23_LUNGevity_Fraudulent Participation email draft 
Attachment 24_LUNGevity e-Blast 
Attachment 25_LUNGevity Clinic Site Recruitment Script 
Attachment 26_LUNGevity Clinic Site Informational Card 
Attachment 27_LUNGevity Participant Outreach_ Market Research Firm 
Attachment 28_LUNGevity Non-clinic site recruitment script 
 
12.0 
REFERENCES 
1. 
Chalasani M, Vaidya P, Mullin T. Enhancing the incorporation of the patient's voice in drug 
development and evaluation. Res Involv Engagem. 2018;4:10. 
2. 
SEER. Cancer Stat Facts: Lung and Bronchus Cancer. 
https://seer.cancer.gov/statfacts/html/lungb.html. Published 2020. Accessed June 10, 2020. 
3. 
NCCN. NCCN Guidelines Version 6.2020 Non-Small Cell Lung Cancer. 
https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Published 2020. Accessed July 
1, 2020. 

 
 
Longitudinal lung cancer patient experience study 
 CONFIDENTIAL 
April 26, 2023 
4. 
McCarrier KP, Atkinson TM, DeBusk KP, et al. Qualitative Development and Content Validity of 
the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), A Patient-
reported Outcome Instrument. Clin Ther. 2016;38(4):794-810. 
5. 
Bouazza YB, Chiairi I, El Kharbouchi O, et al. Patient-reported outcome measures (PROMs) in the 
management of lung cancer: A systematic review. Lung Cancer. 2017;113:140-151. 
6. 
Pompili C, Koller M, Velikova G, et al. EORTC QLQ-C30 summary score reliably detects changes in 
QoL three months after anatomic lung resection for Non-Small Cell Lung Cancer (NSCLC). Lung 
Cancer. 2018;123:149-154. 
7. 
Koskinen JP, Farkkila N, Sintonen H, Saarto T, Taari K, Roine RP. The association of financial 
difficulties and out-of-pocket payments with health-related quality of life among breast, 
prostate and colorectal cancer patients. Acta Oncol. 2019;58(7):1062-1068. 
8. 
Kaveney SC, Baumstarck K, Minaya-Flores P, et al. Validation of the American version of the 
CareGiver Oncology Quality of Life (CarGOQoL) questionnaire. Health Qual Life Outcomes. 
2016;14:82. 
9. 
Minaya P, Baumstarck K, Berbis J, et al. The CareGiver Oncology Quality of Life questionnaire 
(CarGOQoL): development and validation of an instrument to measure the quality of life of the 
caregivers of patients with cancer. Eur J Cancer. 2012;48(6):904-911. 
10. 
Mitchell PH, Powell L, Blumenthal J, et al. A short social support measure for patients recovering 
from myocardial infarction: the ENRICHD Social Support Inventory. J Cardiopulm Rehabil. 
2003;23(6):398-403. 
11. 
Kramer BJ, Kavanaugh M, Trentham-Dietz A, Walsh M, Yonker JA. Complicated grief symptoms 
in caregivers of persons with lung cancer: the role of family conflict, intrapsychic strains, and 
hospice utilization. Omega (Westport). 2010;62(3):201-220. 
12. 
Bass DM, Bowman K. The transition from caregiving to bereavement: the relationship of care-
related strain and adjustment to death. Gerontologist. 1990;30(1):35-42. 
13. 
Teitcher JE, Bockting WO, Bauermeister JA, Hoefer CJ, Miner MH, Klitzman RL. Detecting, 
preventing, and responding to "fraudsters" in internet research: ethics and tradeoffs. J Law Med 
Ethics. 2015;43(1):116-133.