Feasibility and Acceptability of Remote Monitoring of Lung Cancer Patient-Reported Outcomes Using Moovcare®
Phase: NA
Conditions: Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms, Cancer of Lung
Sponsor: UNC Lineberger Comprehensive Cancer Center

LINEBERGER COMPREHENSIVE CANCER CENTER 
CLINICAL ONCOLOGY RESEARCH PROGRAM 
UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Health Services Research 
 
PROTOCOL AMENDMENT #4 
FEASIBILITY AND ACCEPTABILITY OF REMOTE MONITORING OF LUNG 
CANCER PATIENT-REPORTED OUTCOMES USING MOOVCARE® 
AMENDMENT INCORPORATES (check all that apply): 
x    Editorial, administrative changes 
x  Scientific changes 
x    Therapy changes 
x  Eligibility Changes 
AMENDMENT RATIONALE AND SUMMARY: 
The purpose of this amendment is to update secondary and exploratory endpoints and make 
administrative changes. The sponsor has asked for these changes.  
The following changes have been made to the protocol: 
Section 1.1 
Updated target population and study participation duration 
Section 2.0 
Updated secondary and exploratory endpoints 
Section 4.1 
Updated study schema, changed study participation duration, updated 
timepoints for patient and provider satisfaction surveys 
Section 4.2 
Updated study duration, enrollment period, and accrual goal 
Section 4.3 
Updated unattended alerts escalation process, and outcome surveys 
timepoints 
Section 5.1 
Updated time and event table to reflect the change in the study participation 
duration and updated survey frequency 
Section 7.1 
Clarified primary objective 
Section 7.2 
Updated sample size and accrual duration 
Section 7.3 
Updated post-baseline assessment time point under supplemental analysis to 
remove the time points after 6 months.  
Section 7.5 
Updated language on AE and SAE collection and reporting and updated 
unattended alerts escalation process 
THE ATTACHED VERSION DATED APRIL 19, 2022 INCORPORATES THE ABOVE 
REVISIONS 
ATTACH TO THE FRONT OF EVERY COPY OF THE PROTOCOL 

CONFIDENTIAL 
UNIVERSITY OF NORTH CAROLINA 
                                        April 19, 2022 
LCCC 2050 
PI: Gita Mody, MD, MPH 
 
 
TABLE OF CONTENTS 
1.0 
BACKGROUND AND RATIONALE .................................................................... 1 
1.1 
Study Synopsis .......................................................................................................... 1 
1.2 
Background .............................................................................................................. 1 
1.3 
Purpose and Rationale ............................................................................................. 2 
2.0 
STUDY OBJECTIVES AND ENDPOINTS .......................................................... 2 
2.1 
Primary Objectives .................................................................................................. 2 
2.2 
Secondary Objectives............................................................................................... 2 
2.2.1 Secondary Endpoints will be: .................................................................................. 3 
2.2.2 Exploratory endpoints will be: ............................................................................... 3 
3.0 
PATIENT ELIGIBILITY ....................................................................................... 3 
3.1 
Inclusion Criteria ..................................................................................................... 3 
3.2 
Exclusion Criteria .................................................................................................... 4 
4.0 
Study plan ................................................................................................................. 4 
4.1 
Schema ...................................................................................................................... 4 
4.2 
Duration of Study ..................................................................................................... 5 
4.3 
Study Details ............................................................................................................. 5 
4.4 
Expected Risks.......................................................................................................... 9 
4.5 
Removal of Patients from Protocol ....................................................................... 10 

CONFIDENTIAL 
UNIVERSITY OF NORTH CAROLINA 
                                        April 19, 2022 
LCCC 2050 
PI: Gita Mody, MD, MPH 
 
 
5.0 
TIME AND EVENTS TABLE .............................................................................. 10 
5.1 
Time and Events Table .......................................................................................... 10 
6.0 
UNANTICIPATED PROBLEMS ......................................................................... 11 
6.1 
Definition ................................................................................................................ 12 
6.2 
Reporting ................................................................................................................ 12 
7.0 
STATISTICAL CONSIDERATIONS ................................................................. 12 
7.1 
Study Design ........................................................................................................... 12 
7.2 
Sample Size and Accrual ....................................................................................... 12 
7.3 
Data Analysis Plans ................................................................................................ 13 
7.4 
Data Management/Audit ....................................................................................... 13 
Adverse events (AEs) and serious AE collection and reporting: .................................. 14 
8.0 
STUDY MANAGEMENT ..................................................................................... 15 
8.1 
Institutional Review Board (IRB) Approval and Consent ................................. 15 
8.2 
Required Documentation ...................................................................................... 15 
8.3 
Registration Procedures ........................................................................................ 15 
8.4 
Adherence to the Protocol ..................................................................................... 16 
8.4.1 Emergency Modifications ...................................................................................... 16 
8.4.2 Single Patient/Subject Exceptions ........................................................................ 16 
8.4.3 Other Protocol Deviations/Violations ................................................................... 16 

CONFIDENTIAL 
UNIVERSITY OF NORTH CAROLINA 
                                        April 19, 2022 
LCCC 2050 
PI: Gita Mody, MD, MPH 
 
 
8.5 
Amendments to the Protocol ................................................................................. 17 
8.6 
Record Retention .................................................................................................... 17 
8.7 
Obligations of Investigators .................................................................................. 18 
9.0 
REFERENCES ....................................................................................................... 18 
10.0 
APPENDICES (See Attached) .............................................................................. 19 
 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
1 
 
 
 
1.0 
BACKGROUND AND RATIONALE 
1.1 
Study Synopsis 
This single site study is being conducted to evaluate the feasibility and 
acceptability of monitoring lung cancer patients’ disease- and therapy-related 
symptoms remotely with electronic patient-reported outcome (ePRO) surveys. Up 
to 50 patients undergoing treatment and/or surveillance for new or existing 
diagnoses of lung cancer at the University of North Carolina’s Lineberger 
Comprehensive Cancer Center will be prospectively enrolled to the use of the 
mobile medical application Moovcare® for 6 months. Moovcare® automatically 
delivers ePRO surveys on common symptoms experienced by lung cancer 
patients. Results are stored in a secure web-based portal for provider review. 
Concerning survey responses are reported to a designated provider via an email 
alert. 
 
This study will evaluate and report on: patient adherence with surveys, patient   
and provider satisfaction with Moovcare®, quality of life, and survival during the 
study period. 
 
1.2 
Background 
In the United States, lung cancer was the third most commonly diagnosed cancer 
(>200,000 cases) and the leading cause of cancer death (>140,000 fatalities) in 
2019.1,2 While the majority of lung cancer patients are at an advanced stage at 
presentation and survival is still less than 20% at 5 years,1 increasing numbers of 
patients are living longer due to advances in chemotherapy and immunotherapy 
regimens. Lung cancer patients are highly symptomatic due to the tumor itself 
and the side effects of multimodal therapy.3 Therefore, strategies for systematic 
outpatient symptom monitoring that lead to earlier clinician management before 
symptoms become severe and lead to emergency department visits, 
hospitalizations, or other complications are anticipated to be clinically meaningful 
in this group. 
 
Electronic patient-reported outcome (ePRO) surveys can be used to monitor 
symptoms related to disease and treatment remotely in ambulatory patients. ePRO 
monitoring systems automatically deliver surveys that capture symptoms directly 
from patients and alert providers in real-time to concerning responses above 
predetermined symptom severity thresholds. ePRO monitoring has been shown to 
result in improvement of routine clinical care in the oncology population. In a 
large randomized controlled trial of advanced cancer patients, ePRO monitoring 
was associated with reduced emergency department (ED) visits and hospital 
readmissions, improved quality of life (QOL) and patient satisfaction, and 
increased overall survival, findings supported by other studies.4-7 
 
Moovcare® is a web-mediated ePRO survey delivery and monitoring system 
designed for the detection of recurrent lung cancer. Patients are automatically 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
2 
 
 
 
reminded through emails to complete weekly surveys on symptoms common to 
lung cancer patients. Providers are notified for concerning changes in symptoms 
based on a previously validated algorithm predictive of lung cancer recurrence.8 
In prior studies, lung cancer recurrence in patients with advanced lung cancer was 
detected earlier and survival was improved in patients using Moovcare®. 8,9 
1.3 Purpose and Rationale 
The purpose of this study is to demonstrate the feasibility and acceptability of 
using Moovcare® to monitor symptoms related to complications of treatment 
(surgery, radiotherapy, and/or chemotherapy) and disease recurrence in American 
lung cancer patients as well as to provide preliminary data to inform future 
controlled studies on the association of ePRO monitoring with clinical and quality 
of life outcomes. 
 
The study of the implementation of mobile health information technology (HIT), 
such as Moovcare®, in diverse patient populations and settings is important to 
identify and solve barriers to uptake. This study will endeavor to show feasibility 
of ePRO HIT in patients receiving care at the University of North Carolina 
(UNC), a large public, academic hospital setting. In a separate UNC study 
looking at the feasibility and impact of ePRO monitoring for the initial 90 days 
after discharge from thoracic surgery (including lung resection for cancer),  
initial study experience suggests ePRO use is likely to be feasible in other 
patients with   intrathoracic pathology including lung cancer patients. Evaluating 
compliance with longitudinal ePRO monitoring throughout the treatment and 
surveillance periods of lung cancer patients will allow protocols for use in 
multidisciplinary care to be developed. 
 
2.0 
STUDY OBJECTIVES AND ENDPOINTS 
2.1 
Primary Objectives 
 
2.1.1 The primary objective of the study is to evaluate the feasibility of self-reporting 
symptoms by lung cancer patients using Moovcare®. Feasibility will be defined 
as the mean of assigned weekly ePRO surveys completed per patient. 
 
2.1.2 The primary endpoint will be: 
 
1. ePRO survey completion rate: the mean percentage of surveys completed 
per patient by 6 months or coming off study per protocol if sooner. 
 
2.2 
Secondary Objectives 
  
The secondary objectives of the study will be to evaluate the acceptability of Moovcare® 
(through patient and provider satisfaction surveys) and estimate the overall survival and 
change in the quality of life in patients using Moovcare®.    
 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
4 
 
 
3.2 
Exclusion Criteria 
 
All participants meeting any of the following exclusion criteria at baseline will be 
excluded from study participation: 
 
3.2.1 Dementia, altered mental status, or any psychiatric condition that would 
prohibit the understanding or rendering of informed consent or completing study 
procedures 
3.2.2 Current participation in other PRO monitoring trials 
3.3.3 Inability to read and speak English 
3.3.4 Current incarceration 
 
4.0 
Study plan 
4.1 
Schema 
 
This is a single site nonrandomized feasibility study of approximately 50 
participants on  treatment and/or surveillance for new or existing diagnoses of lung 
cancer who will be assigned to a single-arm involving monitoring of their patient-
reported outcomes using a mobile medical application. The study population will 
include patients with a diagnosis of lung cancer undergoing outpatient treatment or 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
5 
 
 
surveillance at UNC. Patients will be recruited from the Multidisciplinary Thoracic 
Oncology Program (MTOP) clinics at UNC over 10-12 months and undergo ePRO 
monitoring for 6 months or until criteria for coming off study are met, whichever 
comes first. Study procedures include monitoring of patient symptoms using 
automated weekly PRO surveys delivered by Moovcare® and assessment of 
outcomes including quality of life at baseline and 3-month intervals, as well as 
patient satisfaction at 6 months using the UNC REDCap electronic survey delivery 
software platform. Other clinical outcomes including   health care utilization, 
recurrence, and survival will be abstracted at any time after enrollment from the 
medical record into the UNC REDCap database. Provider satisfaction will be 
assessed via electronic survey after the study has been open to enrollment for at 
least 6 months. 
 
4.2 
Duration of Study 
 
This study will last for approximately 2 years. Training of providers will take 
place prior to enrollment starts. Approximately 50 participants will be enrolled 
over 1 year. Each participants’ participation in the study will last   up to 6 months 
or until the patient comes off-study due to transition to hospice, death, or 
withdrawal from the study. Study analysis of participant data will take place 
throughout the study duration and at the conclusion. 
 
4.3 
Study Details 
 
Overview 
The study involves two types of repeating surveys: weekly PRO surveys 
delivered by e-mail via Moovcare® and periodic outcomes surveys delivered 
by e-mail via the UNC REDCap platform, a secure web-based server, or 
collected on paper in the clinic. PRO responses are managed by providers 
through a combination of reports graphically displaying responses over time 
and e-mail    alerts about concerning levels or combinations of symptoms. 
Provider response to ePRO reports and alerts may lead to earlier or different 
management than routine clinical care and so potentially impact health care 
utilization and clinical outcomes. For all surveys (Moovcare® PRO and 
REDCap outcome surveys), participants’ caregivers (family, friends) may 
assist with completion in any way the participant chooses. The study 
coordinator may also provide technical assistance. 
 
Screening, Recruitment, and Enrollment 
Potentially eligible patients will be identified from the review of the visit reason 
from the thoracic oncology providers’ Epic clinic schedules. Patients who have 
appointments for outpatient care at Multidisciplinary Thoracic Oncology Program 
(postoperative clinic visit, any radiation, or oncology visit) will be considered. To 
identify potentially eligible patients, the study coordinator can review clinical 
documentation such as the patient’s chart in the electronic medical record, 
clinical schedules, or ask clinical staff about potential eligible patients through a 
limited HIPAA waiver from the IRB. Providers will also be approached by the 
study coordinator to identify any other patients with lung cancer. 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
6 
 
 
 
Identified patients will be entered into a screening log. Providers will be asked to 
verify a clinical diagnosis of lung cancer. For surgical patients, lack of enrollment 
in concurrent LCCC protocol #1945 will be verified   with the assigned study 
coordinator. Patients meeting the eligibility criteria on the initial screening will 
be approached in person, by telephone by the study coordinator to verify the 
remainder of the eligibility criteria and invite the patient to the study. Interested 
patients will undergo informed consent procedures. An IRB-approved study team 
member will approach the patient to discuss study procedures, benefits, risks and 
obtain informed consent prior to any study procedures. Patients who agree to 
participate will review and sign the informed consent form after the study is 
explained and questions have been answered.  
 
Patients who are found to be ineligible during screening due to lack of email, 
phone number, or English language or those potentially eligible during screening 
but found to be ineligible after contact will be excluded from the study. The 
reasons for exclusion as well as basic demographics available in the EMR (e.g. 
race, ethnicity, age, gender, education level if available) will be collected in 
REDCap. 
 
For patients who are eligible but refuse enrollment, reasons for refusal, as well as 
basic demographics available in the EMR (e.g. race, ethnicity, age, gender, 
education level if available) will also be collected within REDCap.  
 
Moovcare® Registration and Use 
After enrollment, participants will be registered and receive a log-in ID for the 
Moovcare® website. Participants will be trained by the study coordinator on 
the purpose of ePRO monitoring and how to log in and self-report PROs using 
the Moovcare® application. Participants will be instructed that any time a 
severe or worsening symptom is reported, their care team will be alerted but 
that the alert will only be received during business hours. If there is a severe 
symptom warranting attention outside of business hours, participants will be 
instructed to contact the care team directly or visit the emergency room. 
Participants should be informed that this system cannot be counted on as the 
sole means of communicating problems to their care team, and that any time a 
concerning symptom occurs, they should consider contacting a health care 
provider or calling 911 as they would do if participating in the study. 
 
The Moovcare® survey system asks questions about common symptoms lung 
cancer patients experience, specifically about loss of weight, loss of appetite, 
dyspnea, depression, cough, pain, fever, hemoptysis, subcutaneous nodules, 
dysphonia, and superior vena cava syndrome. 
 
The Moovcare® application will notify the patient via email on a weekly basis 
during daytime hours to complete a scheduled symptom survey within 24 hours. If 
the patient does not complete the scheduled Moovcare® survey by the deadline, the 
system will generate e-mail reminders. If the survey is not completed after 48-72 
hours, the study coordinator may also contact patients for a reminder. Participants 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
7 
 
 
will have the option to report symptoms via Moovcare® more often as needed. 
 
Before study initiation, the study coordinator will train all providers on the 
MTOP team on use of the Moovcare® portal, intended use of ePROs for 
symptom monitoring and management, and logging on and viewing ePRO 
results in the portal between and during clinic visits. Providers will also be 
trained on the need to document management of ePRO symptoms in the 
regular medical record (i.e. Epic) per service routine.  
 
Provider Alerts and Reports 
Members of the MTOP care team(s) will be assigned to each participant within 
the Moovcare® portal. ePRO survey symptoms that are severe and/or meet the 
Moovcare® algorithm for lung cancer recurrence prediction will generate an 
email alert to a designated clinical care team member. Any free text addressing 
“other” symptoms will also generate an email alert. The care team will follow 
their usual protocols for management of symptoms which may include calling 
patient for more information or to manage the issue, scheduling an appointment or 
testing, and/or referring to the emergency room amongst other management 
strategies. At any time, the MTOP care team members can review an assigned 
participant’s record to determine whether an alert is present and to review the 
prior ePRO symptom survey responses. If the providers did not view the alert in 
48 hours, patients will get a message to contact their health care provider. The 
unattended alerts will also be escalated to the research coordinator who will 
communicate it with the clinical team. The study coordinator will have access to 
all enrolled participants’ Moovcare® records to facilitate review of results. 
 
Outcome Surveys 
At enrollment, all participants will be trained by the study coordinator how to 
use the UNC REDCap online system to complete outcomes surveys for the trial. 
The outcomes surveys will be completed by all participants at baseline; HRQOL 
will be reassessed at months 3, 6/off-study (+/- 4 weeks each) and patient 
satisfaction at 6 months/off-study (+/-4 weeks). Participants will be given a 
choice to complete from home electronically, or if necessary, in clinic at 
otherwise scheduled routine follow-up visits which occur at least every 3 months 
or via phone call (with the study coordinator entering the data after participant 
paper completion into REDCap). For home electronic completion, the outcomes 
surveys will be sent when due by email via REDCap. The REDCap will send 
automatic reminders for incomplete surveys. If the patient does not self-complete 
this information, the study coordinator also has the option to call or email them 
to collect the information and then enter it into REDCap. If the patient goes off 
study  prior to week 26, the study coordinator will contact the patient as soon as 
possible to get the off-study surveys completed. 
 
The patient outcomes surveys include: 
• Participant Demographics Form: This form asks participants about 
their baseline information including full name and date of birth and 
will be administered at the time of  enrollment. 
• Quality of Life Questionnaires: Health-related quality of life will be 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
8 
 
 
assessed by items from the European Organisation for Research and 
Treatment of Cancer Quality of Life Questionnaire Comprehensive 30 
(EORTC-QLQ-C30) and Quality of Life Questionnaire Lung Cancer 13 
module (EORTC-QLQ-LC13), which will be administered to each 
patient participant at baseline, months 3, 6/off- study (+/- 4 weeks 
each). The EORTC is a well-established and frequently used 
questionnaire that includes a 5-item physical functioning domain, 
individual symptom items including symptoms specific to lung cancer 
patients, and a composite quality of life score. 
• Patient Satisfaction Survey: The patient satisfaction survey will be 
administered to each participant at baseline and 6 months of participation 
(+/- 4 weeks). The satisfaction questions are from the Consumer 
Assessment of Healthcare Providers and Systems (CAHPS) survey system, 
which is maintained by the Agency for Healthcare Research and Quality 
(AHRQ), to support and promote the assessment of consumers' experiences 
with health care, and from the “Patient-Centered Communication in Cancer 
Care” short form and validated instrument (PCC- CA-6). No total score is 
calculated, but individual items will be summarized and reported. 
 
Chart Abstraction Form 
The study coordinator will abstract information from the medical chart 
and/or touch base with the clinical team caring for participants to assess 
clinical outcomes including if the patient has died, been hospitalized or 
admitted to the emergency department or urgent care, or had recurrence, 
progression, or death at any time after enrollment and at off study. This form 
will collect relevant medical information, including dates and diagnoses 
related to ER visits and  hospitalizations, prescription of selective supportive 
medications, dates of changes and/or discontinuation of cancer treatments, 
and initiation of hospice services. 
 
Provider Satisfaction Survey 
The amount of staff effort for PRO-related activities will be assessed based 
on data completed by the MTOP nurses and physicians involved in 
managing PRO data. The provider satisfaction survey will be completed at 
least 6 months from the time the initial participant is enrolled. The study 
coordinator will ask the providers to complete the form on paper and then 
immediately upload the results into REDCap or directly enter survey results 
into REDCap by tablet or computer emailed survey link. The provider 
survey satisfaction may be repeated during the study duration particularly if 
changes to the Moovcare® interface or protocol are made. 
 
Off-Study Timing and Procedures 
Participants are asked to remain on the study completing surveys for 6 months 
(26 weekly ePROs), or until they go off-study prior to that time. An “Off-study 
form” requiring information to be abstracted from the participant’s medical 
record will be completed by the study coordinator when the participant goes off 
study (+ 4-week window for form completion). Consultation with MTOP 
physician or nurse may be necessary for clarifications of some of the questions in 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
9 
 
 
this form. For example, this form includes information about reasons and timing 
for the reasons for going off-study. In addition, the final chart abstraction form 
will also be completed (see above) when going off study. In addition, if a patient 
goes off study early for any reason other than death, the coordinator will attempt 
to contact the patient to complete the final Outcomes Questionnaires (including: 
“Patient Quality of Life” and “Patient Satisfaction”) as soon as possible. 
Some of the reasons for patients going off-study include: 
• 
Completion of 6 months (26 weeks) of participation 
• 
Initiation of hospice 
• 
Death 
• 
Moved to a different practice for lung cancer care 
• 
Voluntary disenrollment 
• 
Lost to follow-up 
• 
Removal by principal investigator 
 
Incentives 
Participants will be informed at the time of recruitment they will be given a $25 
incentive for participation (at enrollment in the Moovcare® portal). 
 
4.4 
Expected Risks 
 
Expected risks for this study are likely minimal and involve psychosocial harms 
such as emotional distress or embarrassment related to survey questions and 
breach of confidentiality. Survey questions are similar to questions used in the 
clinical setting and therefore are unlikely to cause harm. However, should a 
patient experience emotional distress stemming from these questions, a 
psychology consult through the Lineberger Comprehensive Cancer Support 
Program will be obtained. Risk of confidentiality breach will be minimized in 
several ways as detailed below: 
 
1. Moovcare® is a web-mediated algorithm where patients enter symptom data 
through a password-secure web platform. Enrolled participants are given a 
unique password to log on to the site so only they, a caregiver with whom 
they share the password, and their assigned clinical care team can access 
their PRO data. Other study data including outcomes questionnaires and 
chart abstraction forms will be collected through the University of North 
Carolina (UNC) REDCap web-based platform for secure survey 
administration. 
2. The REDCap system is a secure, HIPAA-compliant web-based application 
to support distributed data collection governed by standard University, 
School of Medicine, and Federal information security policies and standards. 
The REDCap application is hosted and monitored on a secure server located 
within the UNC CTSA-funded NC TraCS Institute’s Bioinformatics Core. 
Access to the REDCap database for this study will be restricted to 
authorized research team members as needed to perform their job functions. 
Research staff who access the REDCap system will use a unique user ID 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
10 
 
 
provided by the Bioinformatics Core. Each time research staff access 
REDCap, a unique username and password (login) is required, and REDCap 
maintains an audit trail of all activity. 
3. Strict confidentiality will be maintained. Hard-copy research data will be 
minimal and stored in locked, secure areas accessible only by the study 
team. Research data will be maintained in separate charts and identified by 
ID number only when possible. A master list connecting names and ID 
numbers will be kept in a separate, secure location. Only IRB-approved 
members of the research team will have access to secured files and will be 
educated regarding the protection of patients’ rights to confidentiality. At 
study completion, when the database has been declared to be complete and 
accurate, the database will be locked. 
4. Data transmitted between the server and end-users are encrypted using SSL, 
and all databases are encrypted. Only study team members will have access 
to data stored in REDCap, and they will use their UNC ONYEN to gain 
access. Research team members will be instructed to keep all participant 
data and patient participation confidential. 
5. Approaching patients about enrollment in the clinic poses a risk to privacy. 
We anticipate this risk to be low. To avoid threats of coercion, providers 
will be educated but not directly involved with recruitment of patients. 
 
4.5 Removal of Patients from Protocol 
Patients will be removed from the study if: 
• they experience significant emotional distress in response to mobile 
remote monitoring 
• they indicate that they no longer wish to participate 
 
5.0 
TIME AND EVENTS TABLE 
5.1 
Time and Events Table 
The study procedures by each study timepoint are detailed below: 
Enrollment/Baseline Visit 
At this time, the following procedures will be performed: 
 
• In person/telephone recruitment and consent 
• Registration and training on Moovcare® 
• Patient Demographic Form 
• 
Quality Life Surveys and Patient satisfaction survey (if in person 
recruitment and/or enrollment, the participant will complete their baseline  
survey assessment in a private area of the clinic with study coordinator 
assistance) 
 
              Weekly (0-6 months as needed) 
At this time, the following procedures will be performed: 
 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
11 
 
 
• Moovcare® ePRO symptom survey 
Month 3, 6/off study 
At this time, the following procedures will be performed: 
 
• Patient Quality of Life Survey 
Month 6/off study 
At this time, the following procedures will be performed: 
 
• 
Patient Satisfaction Survey 
 
Medical chart abstraction will be conducted at any time after enrollment and at off 
study.  
 
Schedule of Activities: 
 
 
 
 
 
Survey Frequency and Duration: 
 
Survey 
Frequency 
Completion Time 
Patient Satisfaction Survey 
2 
3 minutes 
EORTC QLQ-C30 survey 
3 
10 minutes 
EORTC QLQ-LC13 survey 
3 
4 minutes 
Weekly Symptom Survey 
26 
7 minutes 
Patient – Initiated Symptom Survey 
As needed 
7 minutes 
 
6.0 
UNANTICIPATED PROBLEMS 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
12 
 
 
6.1 
Definition 
As defined by UNC’s IRB, unanticipated problems involving risks to study 
subjects or others (UPIRSO) refers to any incident, experience, or outcome that: 
• 
Is unexpected (in terms of nature, severity, or frequency) given (a) the 
research procedures that are described in the protocol-related 
documents, such as the IRB-approved research protocol and informed 
consent document; and (b) the characteristics of the subject population 
being studied;Is related or possibly related to a subject’s participation 
in the research; and 
• 
Suggests that the research places subjects or others at a greater risk of 
harm (including physical, psychological, economic, or social harm) related 
to the research than was previously known or recognized. 
 
6.2 
Reporting 
Any UPIRSO that occurs during the conduct of this study and that meets all three 
criteria listed in 6.1 must be reported to the UNC IRB using the IRB’s web-based 
reporting system. 
 
7.0 
STATISTICAL CONSIDERATIONS 
7.1 
Study Design 
This is a nonrandomized, single-center, interventional study. The project will 
prospectively enroll eligible lung cancer patients undergoing outpatient treatments 
to a single arm entailing monitoring with weekly patient-reported outcomes 
surveys linked to automated provider reporting. Outcomes will be measured 
serially over the course of the study using surveys and chart abstraction. 
 
The primary objective of this study is to evaluate feasibility, acceptability, and 
adherence with survey completion at the patient level. Secondary objectives 
include estimating the overall survival and change in quality of life in patients 
using Moovcare®. 
 
7.2 
Sample Size and Accrual 
The primary objective is to estimate the percentage of available surveys 
completed by eligible, enrolled patients. Based on other PRO studies including at 
UNC, approximately 80% of assigned surveys are completed per patient.  
 
The Multidisciplinary Thoracic Oncology Program (MTOP) at the UNC 
Lineberger Comprehensive Cancer Center sees a patient population representation 
of the state of North Carolina including approximately 20% African American 
and 60% female patients. An estimated 600 patients with lung cancer diagnoses 
are seen each year. Based on other studies on PROs at UNC institutions, it is 
estimated that 50% of patients meeting screening criteria will be otherwise 
eligible and enroll., It will take an anticipated 12 months to enroll the target of 50 
patients.  

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
14 
 
 
data will be entered into the REDCap database via web-based administration. 
Abstracted medical record data also will be entered into a REDCap study-specific 
database. Moovcare® employs a secure database that is password protected. 
The REDCap system is a secure, HIPAA-compliant web-based application to 
support distributed data collection governed by standard University, School of 
Medicine, and Federal information security policies and standards. The REDCap 
application is hosted and monitored on a secure server located within the UNC 
CTSA-funded NC TraCS Institute’s Bioinformatics Core. Access to the REDCap 
database for this study will be restricted to authorized research team members as 
needed to perform their job functions. Research staff who access the REDCap 
system will use a unique user ID provided by the Bioinformatics Core. Each time 
research staff access REDCap, a unique username and password (login) is 
required, and REDCap maintains an audit trail of all activity. Data transmitted 
between the server and end-users are encrypted using SSL, and all databases are 
encrypted. 
 
Adverse events (AEs) and serious AE collection and reporting: 
Adverse events (AEs) will be defined as any untoward or unexpected events or 
outcomes related or possibly related to a subject’s participation in the ePROs. 
AEs will include any breach in confidentiality or embarrassment with reporting 
PRO symptoms and physical functioning. Delays in management of reported 
symptoms or complications and readmissions related to the patient’s underlying 
condition or operative care will not be considered an adverse event related to the 
study as patients will be informed that any concerning symptoms or other issue 
may require calling the clinic or after-hours phone number (provided via the 
software system) or presentation to the emergency room, consistent with standard 
of care. 
 
Serious AEs are not anticipated in patients related to undergoing use of the ePRO 
survey system or by participating in surveys for feedback on the ePRO system 
given the minimal risks of the study procedures. Similarly, serious AEs are not 
anticipated in providers completing surveys about their experience using the 
Moovcare® application portal. 
 
AEs will be elicited in the free text portion of the ePRO survey. Any AEs and 
serious AEs will be reported to the UNC IRB using the IRB’s web-based 
reporting system and per protocol. 
 
The Principal Investigator is responsible for continuous monitoring of patient 
safety in this trial with periodic reporting to the Data and Safety Monitoring 
Committee (DSMC) as required.  The unattended alerts will be escalated to 
the research coordinator who will communicate it with the clinical team. 
Reports of aggregate PRO responses will be provided by the statistician 
monthly for review at team meetings. 
 
Meetings/teleconferences will be held at a frequency dependent on study accrual, 
and in consultation with the study Biostatistician. At these meetings, the research 
team will discuss all issues relevant to study progress, including enrollment, 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
15 
 
 
safety, regulatory, data collection, etc. and the team will produce summaries or 
minutes of these meetings. These summaries will be available for inspection when 
requested by any of the regulatory bodies charged with the safety of human 
subjects and the integrity of data including, but not limited to, the oversight 
(Office of Human Research Ethics (OHRE) Biomedical IRB, the Oncology 
Protocol Review Committee (PRC) or DSMC). 
 
8.0 
STUDY MANAGEMENT 
8.1 
Institutional Review Board (IRB) Approval and Consent 
It is expected that the IRB will have the proper representation and function in 
accordance with federally mandated regulations. The IRB should approve the 
consent form and protocol. 
 
In obtaining and documenting informed consent, the investigator should comply 
with the applicable regulatory requirement(s) and should adhere to Good Clinical 
Practice (GCP) and to ethical principles that have their origin in the Declaration 
of Helsinki. 
 
Before recruitment and enrollment onto this study, the patient will be given a full 
explanation of the study and will be given the opportunity to review the consent 
form. Each consent form must include all the relevant elements currently required 
by the FDA Regulations and local or state regulations. Once this essential 
information has been provided to the patient and the investigator is assured that 
the patient understands the implications of participating in the study, the patient 
will be asked to give consent to participate in the study by signing or agreeing to 
verbally an IRB-approved consent form. 
 
Prior to a patient’s participation in the trial, the written informed consent form 
should be signed and personally dated by the patient and by the person who 
conducted the informed consent discussion. In cases when written informed 
consent cannot be obtained, telephone consent will be obtained, and a copy of 
the consent sent to the participant. 
 
8.2 
Required Documentation 
Before the study can be initiated at any site, the following documentation must be 
provided to the Office of Clinical & Translational Research (OCTR) at the 
University of North Carolina. 
• A copy of the official IRB approval letter for the protocol  
• A copy of the IRB-approved consent form 
8.3 
Registration Procedures 
All subjects must be registered with the Lineberger Comprehensive Cancer 
Center, and entered into the web based clinical research platform, Oncore®. 
Patient enrollment will also be documented a password   protected excel spread 
sheet stored on a shared drive managed by Lineberger Comprehensive Cancer 
Center’s encrypted server. 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
16 
 
 
 
8.4 
Adherence to the Protocol 
Except for an emergency situation in which proper care for the protection, safety, 
and well-being of the study patient requires alternative treatment, the study shall 
be conducted exactly as described in the approved protocol. 
 
8.4.1 Emergency Modifications 
UNC investigators may implement a deviation from, or a change of, the protocol 
to eliminate an immediate hazard(s) to trial subjects without prior UNC IRB 
approval. 
 
For any such emergency modification implemented, a UNC IRB modification 
form must be completed by UNC Research Personnel within five (5) business 
days of making the change. 
 
8.4.2 Single Patient/Subject Exceptions 
Eligibility single subject exceptions are not permitted for Lineberger 
Comprehensive Cancer Center Investigator Initiated Trials under any 
circumstances. Other types of single subject exceptions may be allowed if proper 
regulatory review has been completed in accordance with Lineberger 
Comprehensive Cancer Center’s Single Subject Exceptions Policy. 
 
8.4.3 Other Protocol Deviations/Violations 
According to UNC’s IRB, a protocol deviation is any unplanned variance from an 
IRB approved protocol that: 
• Is generally noted or recognized after it occurs 
• Has no substantive effect on the risks to research participants 
• Has no substantive effect on the scientific integrity of the research plan 
or the value of the data collected 
• Did not result from willful or knowing misconduct on the part of the 
investigator(s). 
An unplanned protocol variance is considered a violation if the variance meets 
any of the following criteria: 
• Has harmed or increased the risk of harm to one or more research 
participants. 
• Has damaged the scientific integrity of the data collected for the study. 
• Results from willful or knowing misconduct on the part of the 
investigator(s). 
• Demonstrates serious or continuing noncompliance with federal 
regulations, State laws, or University policies. 
 
If a deviation or violation occurs, please follow the guidelines below: 
 
Protocol Deviations: UNC personnel will record the deviation in OnCore® (or 
other appropriate database set up for the study), and report to any sponsor or data 
and safety monitoring committee in accordance with their policies. Deviations 
should be summarized and reported to the IRB at the time of continuing review. 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
17 
 
 
Participant-initiated changes from recommended symptom monitoring schedule 
(ie- non-adherence) will not be considered protocol deviations. A protocol 
deviation would only be recorded if the staff and its systems (i.e. Moovcare® or 
REDCap) did not initiate/reach out to patients to administer the appropriate 
surveys or deliver appropriate alerts. Provider not viewing/managing the alert is 
not considered a deviation. 
 
Events will be documented in OnCore, but not reported to the IRB unless it is 
due to a related AE or SAE. UNC personnel will record the deviation in 
OnCore®, and report to any sponsor or data and safety monitoring committee in 
accordance with their policies.   
 
Protocol Violations: Violations should be reported by UNC personnel within one 
(1) week of the investigator becoming aware of the event using the same IRB 
online mechanism used to report UPIRSO. 
 
Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO): 
Any events that meet the criteria for “Unanticipated Problems” as defined by 
UNC’s IRB (see section 6.1) must be reported by the Study Coordinator using the 
IRB’s web-based reporting system. 
8.5 
Amendments to the Protocol 
Should amendments to the protocol be required, the amendments will be 
originated and documented by the Principal Investigator at UNC. It should also 
be noted that when an amendment to the protocol substantially alters the study 
design or the potential risk to the patient, a revised consent form might be 
required. 
 
The written amendment, and if required the amended consent form, must be sent 
to UNC’s IRB for approval prior to implementation. 
 
8.6 
Record Retention 
Study documentation includes all Case Report Forms, data correction forms or 
queries, source documents, Sponsor-Investigator correspondence, monitoring 
logs/letters, and regulatory documents (e.g., protocol and amendments, IRB 
correspondence and approval, signed patient consent forms). Source 
documents include all recordings of observations or notations of clinical 
activities and all reports and records necessary for the evaluation and 
reconstruction of the clinical research study. 
 
Government agency regulations and directives require that all study 
documentation pertaining to the conduct of a clinical trial must be retained by the 
study investigator. In the case of a study with a drug seeking regulatory approval 
and marketing, these documents shall be retained for at least two years after the 
last approval of marketing application in an International Conference on 
Harmonization (ICH) region. In all other cases, study documents should be kept 
on file until three years after the completion and final study report of this 
investigational study. 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
18 
 
 
 
8.7 
Obligations of Investigators 
The Principal Investigator is responsible for the conduct of the clinical trial at the 
site in accordance with Title 21 of the Code of Federal Regulations and/or the 
Declaration of Helsinki. The Principal Investigator is responsible for personally 
overseeing the treatment of all study patients. The Principal Investigator must 
assure that all study site personnel, including sub-investigators and other study 
staff members, adhere to the study protocol and all FDA/GCP/NCI regulations 
and guidelines regarding clinical trials both during and after study completion. 
 
The Principal Investigator at each institution or site will be responsible for 
assuring that all the required data will be collected and entered onto the Case 
Report Forms. Periodically, monitoring visits will be conducted and the Principal 
Investigator will provide access to his/her original records to permit verification 
of proper entry of data. At the completion of the study, all case report forms will 
be reviewed by the Principal Investigator and will require his/her final signature 
to verify the accuracy of the data. 
 
9.0 
REFERENCES 
1. 
Noone AM HN, Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich 
Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). . Cancer 
Stat Facts: Lung and Bronchus Cancer, SEER Cancer Statistics Review. 
https://seer.cancer.gov/statfacts/html/lungb.html. Accessed2020. 
2. 
CDC. Leading Cancer Cases and Deaths, Male and Female, 2016. 
https://gis.cdc.gov/Cancer/USCS/DataViz.html. Accessed. 
3. 
Rivera MP, Mody GN, Weiner A. Lung Cancer: Treatment. In: Nadel Ma, 
ed. Textbook of Respiratory Medicine.2020. 
4. 
Basch E, Barbera L, Kerrigan CL, Velikova G. Implementation of Patient- 
Reported Outcomes in Routine Medical Care. Am Soc Clin Oncol Educ 
Book. 2018;38:122-134. 
5. 
Kotronoulas G, Kearney N, Maguire R, et al. What is the value of the 
routine use of patient-reported outcome measures toward improvement of 
patient outcomes, processes of care, and health service outcomes in cancer 
care? A systematic review of controlled trials. J Clin Oncol. 
2014;32(14):1480-1501. 
6. 
Basch E, Deal AM, Dueck AC, et al. Overall Survival Results of a Trial 
Assessing Patient-Reported Outcomes for Symptom Monitoring During 
Routine Cancer Treatment. Jama. 2017;318(2):197-198. 
7. 
Basch E, Deal AM, Kris MG, et al. Symptom Monitoring With Patient- 
Reported Outcomes During Routine Cancer Treatment: A Randomized 
Controlled Trial. J Clin Oncol. 2016;34(6):557-565. 
8. 
Denis F, Lethrosne C, Pourel N, et al. Randomized Trial Comparing a 
Web-Mediated Follow-up With Routine Surveillance in Lung Cancer 
Patients. J Natl Cancer Inst. 2017;109(9). 
9. 
Denis F, Yossi S, Septans AL, et al. Improving Survival in Patients 
Treated for a Lung Cancer Using Self-Evaluated Symptoms Reported 
Through a Web Application. Am J Clin Oncol. 2017;40(5):464-469. 
 

LCCC 2050 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL
UNIVERSITY OF NORTH CAROLINA
April 19, 2022
19 
 
 
10.0 APPENDICES (See Attached) 
• Screen shots of Moovcare® interface 
• Participant Demographics Form 
• Quality of Life Surveys: EORTC QLQ-30 & EORTC QLQ LC-13 
• Patient satisfaction survey 
• Provider satisfaction survey