Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
Phase: NA
Conditions: Colorectal Cancer, Bladder Cancer, Ovarian Cancer, Cervical Cancer, Uterine Cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center

LINEBERGER COMPREHENSIVE CANCER CENTER 
Health Services Research 
CLINICAL ONCOLOGY RESEARCH PROGRAM 
 
January 24, 2018 
UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
 
LCCC1929: Development of Patient Reported Outcomes-informed Symptom 
Management System (PRISMS; Feasibility) 
 
 
 
Principal Investigator 
Lixin Song, PhD, RN, FAAN 
 
 
 
 
 
 
 
  
Co-Investigator(s) 
 
Matthew Nielsen, MD, MS, FACS 
 
Angela B. Smith, MD, MS 
 
Karyn Stitzenberg, MD, MPH, FACS 
 
Ethan Basch, MD, MSc 
 
 
 
Biostatistician  
 
Xianming Tan, PhD 
 
 
 
Sponsor:  Lineberger Comprehensive Cancer Center 
 
Funding Source: 
 
Version Date:  August 23, 2019 

LINEBERGER COMPREHENSIVE CANCER CENTER 
Health Services Research 
CLINICAL ONCOLOGY RESEARCH PROGRAM 
 
January 24, 2018 
UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
 
LCCC1929:  Development of Patient Reported Outcomes-informed Symptom 
Management System (PRISMS; Feasibility) 
 
 
Principal Investigator 
Lixin Song, PhD, RN, FAAN 
 
 
 
 
 
 
 
 
Signature Page 
 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable U.S. federal 
regulations and ICH guidelines. 
 
Principal Investigator (PI) Name: Lixin Song, PhD, RN  
 
PI Signature: ___________________ 
 
Date: 08/23/19 
 
 
 
Version Date: August 23, 2019 

LCCC 1929 
 
CONFIDENTIAL 
PI: Lixin Song, PhD, RN 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date: 07/24/2019 
 
January 24, 2018 
 
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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 Objective ............................................................................................... 2 
2.2 
Secondary Objectives ......................................................................................... 3 
3.0 
PATIENT ELIGIBILITY .......................................................................................... 3 
3.1 
Inclusion Criteria ................................................................................................. 3 
3.2 
Exclusion Criteria ................................................................................................ 3 
4.0 
STUDY PLAN ........................................................................................................ 3 
4.1 
Schema ............................................................................................................... 3 
4.2 
Duration of Study ................................................................................................ 4 
4.3 
Study Details ....................................................................................................... 4 
4.4 
Expected Risks ................................................................................................... 5 
4.5 
Removal of Patients from Protocol ..................................................................... 5 
5.0 
TIME AND EVENTS TABLE .................................................................................. 5 
5.1 
Time and Events Table ....................................................................................... 5 
6.0 
UNANTICIPATED PROBLEMS ............................................................................. 6 
6.1 
Definition ............................................................................................................. 6 
6.2 
Reporting ............................................................................................................ 6 
7.0 
STATISTICAL CONSIDERATIONS ...................................................................... 6 

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7.1 
Study Design ...................................................................................................... 6 
7.2 
Sample Size and Accrual .................................................................................... 6 
7.3 
Data Analysis Plans ............................................................................................ 7 
7.4 
Data Management/Audit ..................................................................................... 7 
8.0 
STUDY MANAGEMENT ...................................................................................... 10 
8.1 
Institutional Review Board (IRB) Approval and Consent .................................. 10 
8.2 
Required Documentation .................................................................................. 11 
8.3 
Registration Procedures ................................................................................... 11 
8.4 
Adherence to the Protocol ................................................................................ 11 
8.5 
Amendments to the Protocol ............................................................................ 12 
8.6 
Record Retention .............................................................................................. 12 
8.7 
Obligations of Investigators .............................................................................. 13 
9.0 
REFERENCES ..................................................................................................... 13 
10.0 APPENDICES ...................................................................................................... 14 

LCCC 1929 
 
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PI: Lixin Song, PhD, RN 
 
UNIVERSITY OF NORTH CAROLINA 
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1.0 
BACKGROUND AND RATIONALE 
1.1 
Study Synopsis 
In this proof-of-concept study, our multidisciplinary team will conduct a pilot 
randomized clinical trial to test the feasibility of the innovative Patient-Reported 
Outcomes-Informed Symptom Management System (PRISMS) to enhance 
personalized supportive care for cancer patients and caregivers during post-
treatment care transition. PRISMS was formerly known as PROCESS (Patient-
Reported Outcome-Informed Caregiving Education and System Management 
System). We will randomly assign 20 colorectal and bladder cancer (CBC) 
patients who transition from post-ostomy creation hospital care to self-
management at home and their caregivers to either the PRISMS or usual care 
groups (a total of 40 individuals). We will conduct pre- and post-assessments of 
QOL and PRO (symptoms) at baseline upon enrollment and 3 months later. If 
results indicate that PRISMS is feasible and beneficial, we will design and 
conduct a definitive trial to examine the efficacy of PRISMS, a potentially 
scalable intervention that can be disseminated through oncology clinics 
nationwide to enhance post-treatment care for CBC patients with ostomies and 
their caregivers. 
 
1.2 
Background 
The third and fourth most common cancers in the US respectively,1 colorectal 
and bladder cancer (CBC) affects more than 100,000 patients each year.2 CBC 
disproportionately affects older patients, with median age of diagnosis 63 years 
and 75 years for colorectal and bladder cancer, respectively.1 After ostomy 
surgery, a major treatment option,1 patients often encounter significant symptoms 
and complications (e.g., dehydration, infection) and wound care problems.3,4 
These symptoms and complications are associated with reduced quality of life 
(QOL)5-7 and high rates of morbidity and mortality.8,9 Poor symptom management 
is also a primary reason for emergency room visits,10-12 hospital readmission,4,9,13 
and high costs of care for patients with ostomies.4 There has been limited 
research to support cancer patients and caregivers to manage symptoms, 
improve QOL, and reduce preventable hospital visits and their related costs while 
CBC patients transition from in-patient care to post-treatment self-care at home.  
 
To address these issues, our team has developed a web-based mHealth 
symptom and complication monitoring and self-management program for CBC 
patients with ostomies and their family caregivers, known as PRISMS. PRISMS 
is a personalized/customized mHealth program that integrates patient reported-
outcomes (PRO) measures and technology in enhancing program relevance and 
usefulness, and improving human-technology interaction and information 
delivery, all of which predict use of technology-delivered programs.  
 
PRISMS aims to provide monitoring, education, skills training, and social support 
to ameliorate the complex, interrelated symptoms and complications, and 
ultimately, improve QOL. PRISMS includes modules addressing ostomy care, the 
most common complications (e.g., dehydration, skill problems) and related 

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physical and psychosocial symptoms (e.g., fatigue, sleep disturbance, emotional 
distress, and sexual dysfunction), and safe physical activity for speedy recovery 
(while preventing hernia and falls). PRISMS integrates PRO (e.g., fatigue) and 
objective data from wearable devices (smart bottle and smart scale that monitor 
fluid intake and loss) to provide continuous monitoring of patients’ symptoms and 
complications after they are discharged home. PRISMS triages patient care based 
on the monitoring data that indicate severity of their symptoms and complications. 
Patients and caregivers will self-monitor and manage at home for mild and 
moderate symptoms but be referred to professionals (e.g., wound and stoma 
nurse) when the patient experiences severe symptoms or significantly worsened 
symptoms. PRISMS also provides moderated online forum to promote peer 
support among study participants who face similar challenges, as well as “Let’s 
Chat” to facilitate professional support. 
 
1.3 
Purpose and Rationale 
This is a pilot randomized clinical trial (RCT) using mixed methods. We will 
examine the feasibility of PRISMS by conducting a two-armed pre-post pilot RCT 
study and interviews to obtain feedback from participants who use PRISMS. 
Study participants - twenty CBC patients with new ostomies and their caregivers 
(N=20 dyads, i.e., 40 individuals) - will be randomly assigned to either the 
PRISMS or usual care groups.   
 
2.0 
STUDY OBJECTIVES AND ENDPOINTS  
The objective of this pilot randomized clinical trial is to test the feasibility of the 
innovative PRISMS program to enhance personalized supportive care for cancer 
patients and caregivers during care transition. The aims that will help gather 
preliminary data for a larger definitive trial are listed below. The indicators of 
feasibility will include recruitment, enrollment and retention rates as well as 
automatic recorded online activity comprising navigation time, number of logins, 
utilization of program sections, which we will collect the data using administration 
log and study website.  
The study outcome, Quality of life (QOL), will be assessed at T1 and T2 using 
the 27-item Functional Assessment of Chronic Illness Therapy general scale 
(FACT-G).94 We will measure general QOL and physical, social/family, emotional, 
and functional subdomains.95 Caregivers will report QOL using the spouse’s 
version of FACT-G with slightly modified wording.96 We will use the PROMIS 
measures of fatigue, pain, sleep disturbance 97-100 and Cancer Anxiety101 and 
Depression102 to assess patient and caregiver symptom distress at T1 and T2.  
We will also collect participants’ demographics (age, race/ethnicity, income, 
education) and patient treatment information at T1. At T2, we will collect 
quantitative data on participant satisfaction of and comfort with using PRISMS. 
 
2.1 
Primary Objective 
To examine the feasibility of delivering PRISMS to patients and caregivers (as 
assessed by the recruitment, enrollment, and retention rates, and satisfaction 

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with and perceived ease of use of PRISMS).  
 
2.2 
Secondary Objectives  
To estimate the magnitude of benefit of PRISMS. We hypothesize that, 
compared with the patients receiving usual care, the PRISMS users will report (1) 
greater improvement in their primary outcomes of QOL (overall, physical, 
emotional, and social QOL); and (2) fewer post-treatment care services related to 
stoma complications (e.g., ER visits, readmission, use of healthcare providers) 
from between T1 and T2.  
 
3.0 
PATIENT ELIGIBILITY 
3.1 
Inclusion Criteria 
Patients must (1) have been surgically treated for bladder or colorectal cancer; 
(2) have a newly created ostomy within the past 4 weeks, and (3) have a 
caregiver who is willing to participate in the study. The caregiver must (1) be 18 
years and older, (2) be identified as the primary caregiver by the patient. We will 
also recruit 3-5 providers who provide direct post-surgical care to CBC patients to 
provide feedback on the PRISMS. Providers, patients and caregivers will be 
recruited from the LCCC urologic (GU) and gastrointestinal (GI) oncology in- and 
out-patient units. 
3.2 
Exclusion Criteria 
Patients and their caregivers will be excluded if they are unable to read, speak, 
or understand English. Have other cancer excluding non-melanomatous skin 
cancer or have cognitive impairment.   
 
4.0 
STUDY PLAN 
4.1 
Schema 
We will recruit patients and caregiver dyads based on procedures used 
successfully in the past.83,93 After PRC and Institutional Review Board (IRB) 
approval, we will inform the health care providers working at the GU and GI units 
and obtain their permission to display the flyers of our PRISMS study (with our 
contact information) on the information board at the units.  
 
A research team member will meet the patients who express interest in the 
PRISMS study by calling the research office or informing the professionals on the 
UNC LCCC in-patient GU or GI unit prior to their discharge home. The research 
team will provide study information, answer questions, screen the patient and 
caregiver for eligibility and willingness to participate, obtain informed consent, 
and collect baseline (T1) data (demographics, QOL, and symptom distress). The 
coordinator will then schedule a home visit to install PRISMS within 48 hours of 
discharge and train participants to use the study devices. Patients and caregivers 

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will use the PRISMS for 3 months—the period of time that patients have the 
highest risk for complications and related ER visits and readmission. Participants 
will be instructed to synchronize their devices daily. Participants will be contacted 
via telephone and email after 3 months to conduct the follow-up interview (T2) 
and collect the devices.   
4.2 
Duration of Study 
The study will be conducted for 3 months among CBC patients and caregivers.  
There will be a survey at the beginning and end of the 3 months. The providers 
will be in the study one time for about 30-45 minutes to complete an interview. 
4.3 
Study Details 
The coordinator will meet the patients who express interest in the PRISMS study 
by calling the research office or informing the professionals the GU or GI units 
prior to their discharge home. (Note: However, the clinician Co-Is and the PI will 
meet I early September to explore the possibility and procedure of enrolling 
potential participants prior to surgery. Once we have the details we will modify 
the study protocol immediately.) The coordinator will provide study information, 
answer questions, screen the patient and caregiver for eligibility and willingness 
to participate, obtain informed consent, and collect baseline (T1) data 
(demographics, QOL, and symptom distress). The coordinator will then schedule 
a home visit to install the PRISMS within 48 hours of discharge and train 
participants to use the study devices. Patients and caregivers will use the 
PRISMS for 3 months—the period of time that patients have the highest risk for 
complications and related ER visits and readmission. Participants will be 
instructed to synchronize their devices daily. Participants will be contacted via 
telephone and email after 3 months to conduct the follow-up interview (T2) and 
collect the devices. 
 
Our project coordinator will identify potentially eligible patients and caregivers 
and introduce to them the PRISMS study and answer any questions they may 
have via in-person meeting (before discharge) and via telephone (after 
discharge). Potentially eligible patients and caregivers will be provided study 
brochures and introductions, written or telephone informed consent (whichever is 
the most convenient for participants) will be obtained from all patients and their 
caregivers prior to any research activities. After informed consent, patients and 
caregivers will complete their baseline assessment of quality of life and symptom 
distress. The project coordinator will then schedule for a home visit to install the 
study devices within 48 hours after patient discharge. The coordinator will teach 
participants how to use the devices and synchronize data daily. Patients and 
caregivers will then be encouraged to use PRISMS as scheduled. The 
standardized schedule is twice a day for 3 days, then daily for two weeks, and 
finally weekly for the rest of the study.  But the assessment schedule can be 
reset if new symptoms and complications appear or existing symptoms and 
complications worsen. That is, if the patient experiences severe symptoms, 
participants will be automatically directed to use PRISMS more often. The 
synchronization between the iPAD and wearable devices (Fitbit, smart scale, and 
smart bottle) is designed to be a 1-click process to ease PRISMS use for elderly 
participants because colorectal and bladder cancer disproportionately influence 
older people.  

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6.0 
UNANTICIPATED PROBLEMS 
6.1 
Definition 
This study involves minimal risk to the participants. 
 
As defined by UNC’s IRB, unanticipated problems involving risks to study 
subjects 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 pilot randomized clinical trial (RCT) using mixed methods. We will 
conduct a two-armed pre-post pilot RCT study and interviews to obtain feedback 
from participants who use PRISMS. Study participants - twenty CBC patients 
with new ostomies and their caregivers (N=20 dyads, i.e., 40 individuals) - will be 
randomly assigned to either the PRISMS or usual care groups. 
7.2 
Sample Size and Accrual 
We plan to recruit 20 patients with recent ostomy (within 4 weeks) and their 
caregiver (with a total of 20 patient-caregiver dyads and 40 individuals) and 3-5 
health care providers. Based on previous experiences, we anticipate we will 
achieve data saturation among these participants.  We claim such a study as 
Screening 
x 
 
 
 
Informed 
Consent 
x 
 
 
x 
Interviews  
x 
 
 
x 
QOL1 
 
x 
x 
 
PRO symptoms 
 
x 
x 
 

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feasible if and only if both (i) recruitment rate (p) and (ii) retention rate (q) are 
large enough. More specifically, this is to test the following hypothesis: H0: p <= 
65% or q <= 65% vs H1: p >= 80% and q >= 80%. We will claim the study 
feasible (high recruitment rate and high retention rate) if we reach 29 or fewer 
patients/dyads to recruit 20 dyads, AND more than 14 (>= 15 out of 20) 
participants remained in the study. This study reaches 76% power at alpha level 
0.10.  In addition, we will estimate the proportion and associated 95% confidence 
interval of patients’ satisfaction with and perceived ease use of PRISMS. With 10 
couples in the PRISMS arm and expected satisfaction rate of 70%, the width of 
the 95% CI will be around 0.58 (0.29 for 1-side width). 
7.3 
Data Analysis Plans 
The feasibility of successful delivery of PRISMS will be measured using 
indicators such as recruitment and retention rates. Analysis of these primary 
indicators are described above.     
 
Appropriate descriptive statistics will be calculated for other indicators of 
feasibility, quality of life; general, and physical, social/family, emotional, and 
functional subdomains, for participants and partners, by time point (T1, T2), and 
by group, and patient’s health care services utilization (e.g., clinic visits, ER 
visits, and readmission) by group.  This sample size (10 in each group) will 
ensure 80% power to detect a large effect size of 1.15 at the one-sided 0.05 
significance level using a two-sample t-test to compare the difference in pre-post 
change (from T1 to T2), or mean level at T2 (if an outcome is only measured at 
T2), of a given outcome between the two intervention groups. 
  
Appropriate exploratory analyses (e.g., trajectory analysis of frequently measured 
PRO outcomes), for the purpose of generating hypotheses, may be conducted. 
  
All analyses will be conducted using an intention-to-treat approach, in which all 
randomized participants will be analyzed according to their assigned group, 
regardless of the extent of intervention actually received. Due to the fact that this 
is an exploratory proof-of-concept study, rather than a confirmatory study, we will 
not adjust for multiplicity when computing the CIs in conducting comparisons. 
Unless otherwise specified, all tests will be one-sided at an alpha level 0.05. All 
analyses will be conducted using SAS 9.4 (SAS Institute Inc., Cary, NC ). 
 
7.4 
Data Management/Audit 
Data will be collected at baseline (T1) and follow-up (T2) surveys and post-exit 
interview by the research assistant assigned to data collection.  We will use 
RedCap to store all of our data. Feasibility of PRISMS will be measured using 
indicators such as recruitment and retention rates, and automatic recorded online 
activity comprising navigation time, number of logins, utilization of program 
sections. We will collect the data using administration log and study website. 
 
7.4.1 Data Management 
Study ID numbers will indicate the identities of subjects, and this information will 
be accessible only to the study investigators. All questionnaires will bear study ID 

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numbers only. Research team staff will conduct all telephone survey sessions in 
a private workstation in a private office designated to the research team. The 
telephone surveys will be recorded and reviewed by the PI, project coordinator, 
research staff at the project office to ensure adherence to the study protocol as 
well as data completeness and accuracy. We will randomly check at least 20% of 
the recordings against completed data for adherence to protocol, data 
completeness, and accuracy. 
 
REDCap online database will be managed by the TraCS Clinical Research Data 
Management Service. NC TraCS is a key initiative of the Biomedical Informatics 
core of the UNC-Chapel Hill CTSA.  The purpose is to provide a system and 
associated support resources, to enable efficient and high-quality collection and 
management of research data that is standards-based in design, development 
and implementation.  Standard features of electronic clinical research data 
management systems are available in the web-based systems provided with the 
service.  These include interactive data entry with real-time field validation, lab 
data imports, audit logs to record database modifications, database integrity 
checks, security (in logins, permissions based on need, and encryption), 
reporting, forms inventory, and exports to common statistical packages for 
analysis. Logging tracks all data entered in REDCap so that it can be traced back 
to the person who entered it.  No data can be changed without showing who has 
made the changes. This allows the study team to ensure there is security and 
integrity of the data collected and submitted, there are controls surrounding this 
aspect.  REDCap also provides for principle investigator to sign off on the data, 
as required in FDA studies.  Although users can modify data based on their 
permissions, they cannot delete the subject or history of that subject.  Requests 
to delete a subject must be made to the REDCap system administrator. Our 
database system provides for secure web-based data entry with the data stored 
on servers that staff at NC TraCS maintain.  The data is encrypted during 
transmission.  The servers are located in a secure campus area with all the 
appropriate physical security measures in place.  The web and database servers 
are monitored by the TraCS IT staff, patched frequently, and scanned by a third-
party vendor to ensure that they are protected against known vulnerabilities.  The 
scanning application is the standard service for the entire campus.  Access is by 
individual user id, and is restricted to the forms and/or functions that the user 
needs to have.  The applications themselves are written using open source tools, 
and have also been scanned by campus security office to ensure that the 
applications also are protected from known exploits.  The data is backed up to 
electronic media on a daily basis.  The electronic media is secured by ITS stored 
in a secure area separate from the servers. 
 
The study website for PRISMS and NCI landing is hosted and maintained by the 
Communication for Health Applications and Interventions (CHAI) of the UNC 
Lineberger Comprehensive Cancer Center. The web activity data of all 
participants will be deidentified (using randomly assigned user IDs) and 
automatically tracked via a built-in feature of the study website. The de-identified 
web activity data from the PRISMS website and the NCI website landing page at 
CHAI will be automatically electronically transferred through SFTP to the 
research office at the School of Nursing on a weekly basis. 
 

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All administrative data (including randomization, referral data) will be centrally 
managed using REDCap at the PI’s research office at the School of Nursing and 
accessed only by the study investigators and research staff. These administrative 
data will be managed separately from the deidentified, password protected, 
encrypted and securely transferred data including surveys and web activity data. 
The PI and project coordinator will examine weekly the accuracy of the data files 
and completeness of the data. 
 
The data collected from this study will help us to design and conduct a definitive 
trial to examine the efficacy of PRISMS, a potentially scalable intervention that 
can be disseminated through oncology clinics nationwide to enhance post-
treatment care for CBC patients with ostomies and their caregivers. All data will 
be deidentified and saved in secure encrypted shared folder on UNC server. All 
identifiable data will be deleted from redcap and other sources following IRB 
instruction and data safety policies. 
 
 
7.4.2. Data Monitoring/Audit.  
This study is of such low risk. With a primary outcome of change in quality of life 
(QOL) between the PRISMS and the usual care control groups, there would not 
be anything significant to provide to the DSMB that might signal a reason for the 
DSMB to stop a study. However, we will implement a data and safety-monitoring 
plan to ensure the safety of participants as well as the validity and integrity of the 
data. The data monitoring plans are as follows: 
 
Oversight for this study will be provided by the PI with input and advice 
from the team. An Adverse Event Monitoring Committee will be formed to 
oversee the conduct of the study. Chaired by the Dr. Song (PI), the committee will 
be comprised of all of the Co-investigators. Dr. Song will chair the committee, 
which will meet as needed to review the activities of the study including 
management, personnel, recruitment, performance, and any emerging problems. 
The research staff will ensure all entry criteria are met prior to the initiation of the 
protocol and all study procedures and reporting of adverse events and 
unanticipated events is performed according to the IRB-approved protocol. Any 
actions taken and associated follow-up activities will be recorded in the study 
database. All intervention-related adverse events will be reported to the PRC and 
IRB within 3-7 days.  The PI and the Adverse Event Monitoring Committee will 
assess the level of risk from adverse events as mild (no interference in usual 
activities); moderate (some interference in usual activities); or severe (usual 
activities were significantly interrupted).  The PI and the Adverse Event 
Monitoring Committee will rate the assessment of attribution to the study as not 
related, unlikely, possible, probable, or definite.  
 
Serious Adverse Event (SAE)/Serious Unanticipated events (SUE) reviewing 
and identifying. The PI will convene weekly meetings with the research staff to 
review project progress, subject accrual, follow-up, and any anticipated or 
unanticipated AEs. The PI and project manager will be responsible for monitoring 
study processes and ensuring that AEs and UEs are reported immediately to the 
Adverse Event Monitoring Committee, the Independent Monitor, the IRB at LCCC 
and UNC-CH.  

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The study Independent Monitor will receive the aggregated progress 
information for reports quarterly compiled by the Adverse Event Monitoring 
Committee to determine if any of the study procedures should be altered or 
stopped. The Adverse Event Monitoring Committee, including 3 nurse scientists, 
a psychologist, 3 physicians, 1 statistician, and all research staff, will review any 
adverse events, safety concerns or problems (e.g., patients’ symptoms of 
distress), appropriateness of strategies of handling these AEs and UEs and 
needed improvement in study procedures, in addition to the assessment of study 
performance related to subject referral, recruitment and retention, protocol 
adherence, and the quality of the data.  
 
(f) SAE/SUE Reporting. 
The PI (Dr. Song), Co-Is, and the research staff will perform continuous 
and close monitoring with prompt reporting of AEs to the LCCC PRC and IRB at 
UNC-CH. The PI, Co-Is and staff will comply with the UNC guidelines for 
reporting AEs that require investigators to report any AEs that are unexpected, 
fatal or life threatening to the IRB using standard forms within 24 hours of the 
incidents. Additionally, the PI will report to the NIH within 24 hours the SAEs and 
actions, if any, taken by investigators or the IRB as a result of the event or its 
continuing review.  
 
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 prior to consenting and enrolling any participants. 
 
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 an 
IRB-approved consent form. 
 
Prior to a patient’s participation in the feasibility study, the written informed 
consent form should be signed and personally dated by the patient and by the 
person who conducted the informed consent discussion. 

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8.2 
Required Documentation 
Before the study can be initiated at any site, the following documentation must be 
provided to the Clinical Protocol Office (CPO) at the University of North Carolina. 
• 
A copy of the official IRB approval letter for the protocol and informed 
consent 
• 
CVs and medical licensure for the principal investigator and any 
associate investigators who will be involved in the study 
• 
A copy of the IRB-approved consent form 
8.3 
Registration Procedures 
Patient enrollment with be captured in RedCap which is password protected. 
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 LCCC 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. 

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• 
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. 
 
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 

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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. 
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 
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Stitzenberg KB, Chang Y, Smith AB, Nielsen ME. Exploring the Burden of 
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Baldwin CM, Grant M, Wendel C, et al. Gender differences in sleep disruption 
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Pittman J, Rawl SM, Schmidt CM, et al. Demographic and clinical factors related 
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Chongpison Y, Hornbrook MC, Harris RB, et al. Self-reported depression and 
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Sheetz KH, Waits SA, Krell RW, et al. Complication Rates of Ostomy Surgery 
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Bell JF, Whitney RL, Reed SC, et al. Systematic Review of Hospital 
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10. 
Kurtz ME, Kurtz JC, Given CW, Given BA. Utilization of services among elderly 
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and survival status. Ethnicity & disease. 2005;15(2 Suppl 2):S17-22. 
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Kurtz ME, Kurtz JC, Given CW, Given B. Predictors of use of health care 
services among elderly lung cancer patients: the first year after diagnosis. 
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Basch E, Jia X, Heller G, et al. Adverse symptom event reporting by patients vs 
clinicians: relationships with clinical outcomes. Journal of the National Cancer 
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Keller DS, Khorgami Z, Swendseid B, Khan S, Delaney CP. Identifying causes 
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2014;28(4):1263-1268. 
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Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research 
in Psychology. 2006; 3(2):77-101. 
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Braun V, Clarke V. What can "thematic analysis" offer health and wellbeing 
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10.0 APPENDICES 
n/a