Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes
Phase: NA
Conditions: Thoracic Surgery
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 #3 
LCCC 1945: Improving Quality of Life after Thoracic Surgery using Patient Reported 
Outcomes 
AMENDMENT INCORPORATES (check all that apply): 
_x_ Editorial, administrative changes 
___ Scientific changes  
___ Therapy changes  
___ Eligibility Changes  
AMENDMENT RATIONALE AND SUMMARY: 
The purpose of this modification is to change the planned closeout for the study due to low survey 
completion rates and negative preliminary findings related to long-term QOL outcomes. Affected 
participants will be notified of this change by email. We plan to discontinue 2-year follow-up for 
those currently active in the study.  
List of updates to the protocol: 
Section 4.1 
Updated to reflect that some patients will have a shortened participation period due 
to early discontinuation of study procedures.  
Section 4.2 
Updated to reflect that some patients will have a shortened participation period due 
to early discontinuation of study procedures. 
THE ATTACHED VERSION DATED October 05, 2023 INCORPORATES THE ABOVE 
REVISIONS 
ATTACH TO THE FRONT OF EVERY COPY OF PROTOCOL 
LCCC 1945: IMPROVING QUALITY OF LIFE AFTER THORACIC SURGERY 
USING PATIENT REPORTED OUTCOMES: 
Principal Investigator 

LINEBERGER COMPREHENSIVE CANCER CENTER 
CLINICAL ONCOLOGY RESEARCH PROGRAM 
UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Health Services Research 
 
 
Gita Mody, MD, MPH 
3040 Burnett-Womack Building 
Campus Box 7065 
Chapel Hill, NC 27599-7065 
Phone: (984) 966-3382 
Fax: (919) 966-3475 
Email:gita_mody@med.unc.edu 
 
 
Co-Investigator(s) 
Ethan Basch, MD, MSc 
Antonia Bennett, PhD 
Benjamin E. Haithcock, MD 
Jason M. Long, MD, MPH 
Lauren Hill, DNP 
 
 
Biostatistician 
Allison Deal 
Mian Wang  
 
 
Sponsor:  Lineberger Comprehensive Cancer Center 
 
 
Funding Source: Thoracic Surgery Foundation (completed), American College of 
Surgeons and Lineberger Comprehensive Cancer Center 
 
 
Version Date: 10/05/2023 
 
 
 
 
 
 
 
 

LCCC 1945 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL 
UNIVERSITY OF NORTH CAROLINA 
October 05, 2023 
 
1 
 
LCCC 1945: IMPROVING QUALITY OF LIFE AFTER THORACIC SURGERY 
USING PATIENT REPORTED OUTCOMES: 
 
 
Principal Investigator 
Gita Mody, MD, MPH 
3040 Burnett-Womack Building 
Campus Box 7065 
Chapel Hill, NC 27599-7065 
Phone: (984) 966-3382 
Fax: (919) 966-3475 
Email: gita_mody@ med.unc.edu  
 
 
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: Gita Mody, MD 
 
PI Signature: _________________ 
 
Date:______________ 
 
 
 
Version Date: 10/05/2023 

LCCC 1945 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL 
UNIVERSITY OF NORTH CAROLINA 
October 05, 2023 
 
2 
 
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 .........................................................3 
2.1 
Primary Objective..................................................................................................3 
2.2 
Secondary Objectives ............................................................................................3 
3.0 
PATIENT ELIGIBILITY ......................................................................................4 
3.1 
Inclusion Criteria ...................................................................................................4 
3.2 
Exclusion Criteria ..................................................................................................4 
4.0 
STUDY PLAN .........................................................................................................5 
4.1 
Schema ..................................................................................................................5 
4.2 
Duration of Study ..................................................................................................6 
4.3 
Study Details .........................................................................................................6 
4.4 
Expected Risks ......................................................................................................9 
4.5 
Removal of Patients from Protocol .....................................................................11 
5.0 
TIME AND EVENTS TABLE .............................................................................10 
5.1 
Time and Events Table ........................................................................................10 
6.0 
UNANTICIPATED PROBLEMS .......................................................................11 
6.1 
Definition ............................................................................................................11 
6.2 
Reporting .............................................................................................................11 
7.0 
STATISTICAL CONSIDERATIONS ................................................................11 

LCCC 1945 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL 
UNIVERSITY OF NORTH CAROLINA 
October 05, 2023 
 
3 
 
7.1 
Study Design .......................................................................................................11 
7.2 
Sample Size and Accrual ....................................................................................12 
7.3 
Data Analysis Plans .............................................................................................14 
7.4 
Data Management/Audit .....................................................................................16 
8.0 
STUDY MANAGEMENT ....................................................................................17 
8.1 
Institutional Review Board (IRB) Approval and Consent ..................................17 
8.2 
Required Documentation.....................................................................................17 
8.3 
Registration Procedures.......................................................................................17 
8.4 
Adherence to the Protocol ...................................................................................17 
8.5 
Amendments to the Protocol ...............................................................................17 
8.6 
Record Retention .................................................................................................17 
8.7 
Obligations of Investigators ................................................................................19 
9.0 
REFERENCES ......................................................................................................20 
10.0 APPENDICES .......................................................................................................21 

LCCC 1945 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL 
UNIVERSITY OF NORTH CAROLINA 
October 05, 2023 
4 
 
 
 
 
1.0 
BACKGROUND AND RATIONALE 
1.1 
Study Synopsis 
In this feasibility study, up to 140 patients undergoing elective thoracic surgery 
will be randomized to one of two arms to complete PRO (patient reported 
outcome) symptom monitoring. The two arms are 1) active symptom monitoring 
and 2) passive symptom monitoring. The participants randomized to active 
symptom monitoring will have alerts sent to their clinicians when their PRO 
symptom scores exceed baseline discharge day scores (when discharge day scores 
are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are 
reported. Participants randomized to the passive PRO monitoring arm will 
complete the same PROs as participants in the active monitoring arm, but will not 
have alerts sent to their clinician. 
 
The overall goal of this study is to assess whether collecting and monitoring 
patient-reported data is feasible as part of clinical care of thoracic surgery 
patients, and whether these data are useful for clinicians and patients. Among 
these 140 patients, a subset of approximately 40 patients and their 40 caregivers 
will be chosen to complete a semi-structured interview, if willing, to assess 
patient experience with monitoring experience.  
 
1.2 
Background 
Patient-centered outcomes after surgery go beyond traditionally measured 
morbidity and mortality to include QOL [11]. Patients undergoing thoracic 
surgery strongly value communication from their providers about anticipated 
physical functioning post-operatively [12, 13]. Patients who require thoracic 
surgery are older, have comorbidities, and have greater decreases in QOL after 
often morbid treatments compared to other patients [14]. Therefore, 90-day 
readmissions after thoracic surgery remain high at 18%, largely due to 
symptomatic adverse events including post-operative complications and new 
cardiopulmonary diagnoses [4, 15]. While symptom severity and physical 
functioning worsen for up to 6 months after thoracic surgery [16-18], pain and 
QOL do return to baseline by 12 months [19], suggesting a 
window in the first year after surgery during which PROs can be better monitored 
and managed. 
 
In non-surgical populations, management of patient-reported symptoms has been 
extensively linked to improvements in care delivery including readmissions. The 
NIH has developed a PRO version of the Common Terminology Criteria for 
Adverse Events (PRO-CTCAE), which is a validated library assessing the 
presence, frequency, severity, and interference with usual activities of symptoms. 
Responses are provided by patients on a 5-point Likert scale with recall being 
over the prior week [20]. PRO-CTCAE is feasible for use in a variety of patient 
populations [21]. In surgical patients, PROs have been used as clinical outcomes, 
for quality improvement, and as outcomes in comparative effectiveness research 
[22]. In thoracic surgery patients specifically, PRO assessment through weekly 

LCCC 1945 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL 
UNIVERSITY OF NORTH CAROLINA 
October 05, 2023 
5 
 
 
 
telephone surveys has demonstrated symptom improvement; however, items 
assessed were standard cancer-related and one surgical specific symptom. 
Further, only 60% of symptom alerts lead to intervention by clinicians [8]. 
 
Currently, PROs including symptoms and QOL are not routinely collected in 
thoracic surgery patients. Challenges include selecting a comprehensive, sensitive 
instrument, time and knowledge required to administer and analyze responses, 
and integration into existing systems for outcomes measurement [9]. Nonetheless, 
a pilot study integrated empirically selected symptom items from PROMIS with 
the Society of Thoracic Surgeons (STS) National Database [16]. The potential 
value of using PROs in perioperative care is multifaceted and includes shared- 
decision making, increasing patient satisfaction, and prediction and improvement 
of overall outcomes [9]. Further research on effective implementation of thoracic 
surgery specific PRO instruments is required. 
 
1.3 
Purpose and Rationale 
Patients undergoing thoracic surgery report maintaining independent physical 
functioning and quality of life (QOL) are important and influence their treatment 
decisions [1]. Research has shown readmissions, physical debility, and declines in 
QOL are common after thoracic surgery but has not identified solutions to 
improving these problems [2-4]. The rationale of this research is improvement of 
the patient experience and reduction of readmissions through management of 
symptoms after thoracic surgery. 
 
A potential approach to managing symptoms after thoracic surgery is using 
patient-reported outcomes. Assessment of patient-reported symptoms and QOL 
has improved care in a variety of patient populations. Chemotherapy patients 
randomized to complete PRO assessments at home with nursing alerts for 
concerning symptoms had fewer emergency room visits, hospitalizations, and 
better survival [5, 6]. In lung cancer patients, recurrence was detected earlier 
using PRO monitoring [7]. Few studies have been done using PROs to 
improve care in thoracic surgery patients specifically. One trial in this group 
demonstrated postoperative symptom severity decreased using PROs [8]. This 
proposal aims to build on prior experience with symptom self-reporting by 
optimizing a thoracic surgery specific patient-reported symptom survey and 
rigorously testing its implementation. It is a reasonable expectation this patient 
population will complete the surveys, as they are highly vested in their post- 
surgical care. In addition, 2 UNC clinics have integrated PROs successfully, and 
a multitude of UNC research groups with similar patient populations have 
successfully piloted PRO studies. 
 
Specific gaps in knowledge on PRO use in thoracic surgery have been identified 
[9, 10]. Barriers include optimal instruments and timing for PRO collection, 

LCCC 1945 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL 
UNIVERSITY OF NORTH CAROLINA 
October 05, 2023 
6 
 
 
 
 
utility of PRO monitoring to providers and patients, and association of changes in 
PROs with postoperative outcomes. To address these issues, this study will 
evaluate the implementation of PROs for symptom monitoring in thoracic surgery 
patients and to assess how PROs correlate to readmissions and declines in global 
QOL. The overall hypothesis of this study is that PROs can be used to identify 
opportunities for intervention in patients at risk for poor postoperative recovery. 
 
2.0 
STUDY OBJECTIVES AND ENDPOINTS 
2.1 
Primary Objectives 
 
2.1.1 To determine impact of PRO monitoring with symptom alerts compared to 
PRO monitoring without symptom alerts after thoracic surgery on post-operative 
quality of life. 
 
2.1.2 To determine feasibility of 90-day post-operative PRO symptom monitoring 
after thoracic surgery symptom monitoring eliciting a clinician response. 
 
Feasibility is defined as: 
1. 
>50% of participants complete all symptom surveys until 3 months 
post-operatively 
2. 
>50% of symptom alerts generate a clinician response 
 
2.1.3 To determine barriers/facilitators of PRO monitoring after thoracic surgery 
through semi-structured interviews of patients and caregivers. 
 
2.2 
Secondary Objectives 
2.2.1 To determine impact of PRO monitoring with symptom alerts compared to 
PRO monitoring without symptom alerts after thoracic surgery on post-operative 
readmission and mortality rates by analyzing: 
1. 
30-day post-discharge emergency department visit rate 
2. 
90-day post-discharge emergency department visit rate 
3. 
30-day post-discharge readmissions rate 
4. 
90-day post-discharge readmissions rate 
5. 
30-day mortality (percentage) 
6. 
365-day mortality (percentage) 
7. 
Change in 2-year quality of life 
 
2.2.2 To determine feasibility of PRO monitoring after thoracic surgery in regards 
to monitoring long-term quality of life. Feasibility is defined as > 50% of patients 
completing all quality of life surveys at baseline and all follow-up time points. 

LCCC 1945 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL 
UNIVERSITY OF NORTH CAROLINA 
October 05, 2023 
7 
 
 
 
3.0 
PATIENT ELIGIBILITY 
3.1 
Inclusion Criteria 
 
Patients participating in PRO monitoring must meet the following inclusion 
criteria in order to participate in this study: 
 
3.1.1 
18 years or older 
3.1.2 
English speaking 
3.1.3 
Able and willing to complete web-based symptom survey 
3.1.4 
Be presenting for elective inpatient thoracic surgery 
 
Caregivers willing to participate in semi-structured interview must meet the 
following inclusion criteria in order to participate in this study: 
 
3.1.5 
18 years or older 
3.1.6 
English speaking 
3.1.7 
Be a caregiver for a patient who has undergone thoracic surgery and 
enrolled in the PRO portion of the study 
 
3.2 
Exclusion Criteria 
 
All patients meeting any of the following exclusion criteria at baseline will be 
excluded from study participation: 
 
3.2.1 
Not completing planned surgery within 3 months of obtaining 
informed consent 
3.2.2 
Diagnosis of esophageal cancer 
3.2.3 
Inability to read and speak English 
3.2.4 
Presenting for day surgery 
3.2.5 
Presenting for foregut surgery (e.g. paraesophageal hernia repair) 
3.2.6 
Dementia, altered mental status, or any psychiatric condition that would 
prohibit the understanding or rendering of informed consent. 
3.2.7 
Current incarceration 
3.2.8 
Pregnancy 
 
Caregivers meeting any of the following exclusion criteria at baseline will be 
excluded from study participation: 
 
3.2.9 
Inability to read and speak English 

LCCC 1945 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL 
UNIVERSITY OF NORTH CAROLINA 
October 05, 2023 
8 
 
 
 
 
3.2.10 Dementia, altered mental status, or any psychiatric condition that would 
prohibit the understanding or rendering of informed consent. 
3.2.11 Current incarceration 
3.2.12 Not currently providing care for a patient who has undergone thoracic 
surgery and enrolled in the PRO portion of the study 
3.2.13 Receiving extensive medical treatment (e.g., caregivers admitted in the 
intensive care unit) 
 
4.0 
STUDY PLAN 
4.1 
Schema 
Figure 1: Study Schema 
 
 
THORACIC 
SURGERY
Baseline Visit1
Daily Symptom 
Monitoring2
Day 0
Day 15
Weekly 
Symptom 
Monitoring3
Day 90
Day -90
First Follow-up4
Day 120
Day 180
Third Follow-up6
Fourth Follow-up7
FiŌh Follow-up8
Day 365
[Year 1]
Day 545
Day 730
[Year 2]
1BASELINE
Consent
Eligibility Checklist
RandomizaƟon
Demographics
EORTC QLQ30
EORTC LC13
Baseline Symptoms Assessment
PROMIS Physical FuncƟon SF 4a
2DAY 0-14
PostoperaƟve Symptoms 
Assessment (x15)
PROMIS Physical FuncƟon SF 4a
3DAY 15-90
PostoperaƟve Symptoms 
Assessments (x11)
EORTC QLQ30 (x2)
EORTC LC13 (x2)
PaƟent SaƟsfacƟon Survey (x2)
Re-Admission QuesƟonnaire 
(x2)
PROMIS Physical FuncƟon SF 4a
Semi-structured Interviews
begin 
4DAY 120
EORTC QLQ30
EORTC LC13
PaƟent SaƟsfacƟon Survey
Re-Admission QuesƟonnaire
5DAY 180
EORTC QLQ30
EORTC LC13
PaƟent SaƟsfacƟon Survey
Re-Admission QuesƟonnaire
6DAY 365, DAY 545, DAY 730
EORTC QLQ30
EORTC LC13
PaƟent SaƟsfacƟon Survey
Second Follow-
up5

L C C C 1 9 4 5  
PI: Git a M o d y, M D, M P H  
C O N FI D E N TI A L 
U NI V E R SI T Y O F N O R T H C A R O LI N A  
Oct o ber 0 5, 2 0 2 3  
 
 
9  
 
 
 
T his is a ra n d o mize d st u d y of 1 4 0 partici pa nts u n der g oi n g t h oraci c s ur ger y. T he 
pri mar y p ur p ose of t his st u d y is t o e val uate t he i m ple me ntati o n of P R Os f or 
s y m pt o m m o nit ori n g i n t h oracic s ur g er y p atie nts a n d t o assess h o w ma na g e me nt 
of P R Os c orrelat e t o rea d missi o ns a n d decli nes i n gl o bal Q O L. P R Os wil l be 
a d mi nistere d usi n g t he U ni versit y of N ort h Car oli na Patie nt- Re p orte d O utc o mes 
C ore ( P R O C ore) w e b - base d s yste m. P R O C ore mai ntai ns a s ur ve y s yste m f or 
a d mi nisteri n g a n d ma na gi n g s ur ve y re p orti n g.  P R Os will c o nsist of: 
 
 E O R T C Q L Q -C 3 0: a ca n cer -s p ecific s ur ve y usa bl e f or vari o us ca n cers  
 E O R T C Q L Q - L C 1 3: a s ur ve y use d s pecificall y f or l u n g ca ncer p atie nts  
 P R O MI S P h ysical F u ncti o n S F 4a: a s ur ve y us e d t o meas ure p ercei ve d 
p h ysical m o bilit y a n d ca pa bilit y 
 Pre - o per ati ve s y m pt o m s ur ve y 
 P ost- o perati ve s y m pt o m s ur ve y  
 Patie nt Satisfacti o n  s ur ve y 
 Rea d missi o n  s ur ve y 
 
A s u bset of 4 0 patie nts wit h var yi n g p ost o perati ve e x perie n ces a n d t h eir 
care gi v ers will als o  parti ci pate i n a se mi -str u ct ure d i nter vie w t o assess usa bilit y 
a n d feasi bilit y of t he P R O c ollecti o n.  
 
Patie nt ’s acti ve partici p ati o n is a ntici pate d t o last u p t o a p pr o xi matel y 2 years a n d 
3 m o nt hs. S o me patie nts will ha ve a s h orte n e d partici pati o n peri o d d ue t o earl y 
disc o nti n uati o n of st u d y pr oce d ures. 
 
4. 2  
D ur ati o n of St u d y  
 
T his st u d y will last f or a p pr o xi matel y 4 years. U p t o a t otal of  1 4 0 partici p a nts 
will be e nr olle d o ver t w o years. A s u bset of a p pr o xi matel y 4 0 patie nts wit h 
var yi n g p ost o perati ve e x perie nces a n d t heir care gi vers will als o partici pate i n a 
se mi-str uct ure d i nter vi e w f or a t otal accr u al g oal of 1 8 0 partici pa nts. Eac h 
patie nts’ partici pati o n i n t he st u d y will last u p t o 2 years a n d 3 m o nt hs. S o me 
patie nts will ha ve a s h ort e ne d partici p ati o n peri o d d ue t o earl y disc o nti n uati o n of 
st u d y pr oce d ur es. St u d y a nal ysis of partici pa nt d ata will ta ke place t hr o u g h o ut 
t he 4 years.  
 
4. 3  
St u d y  Det ails  
 
Partici pa nts c o m plete electr o nic s ur ve ys t o ass ess t heir baseli ne a n d p ost - 
o perati ve c h ar acteristics, s y m pt o ms, q ualit y of life, a n d healt h o utc o mes. T he 
st u d y c o nsists of a t otal n u m ber of 9 differe nt s ur v e ys. 

10 
LCCC 1945 
PI: Gita Mody, MD, MPH 
CONFIDENTIAL 
UNIVERSITY OF NORTH CAROLINA 
December 3, 2021 
 
 
 
Figure 2: Survey Frequency and Duration 
 
Survey 
Frequency 
Completion Time 
Pre-operative Symptom Survey 
1 
5 minutes 
Patient Demographics 
1 
3 minutes 
PROMIS Physical Function SF 4a Survey 
32 
2 minutes 
EORTC QLQ-LC13 survey 
8 
3 minutes 
EORTC QLQ-C30 survey 
8 
8 minutes 
Patient Satisfaction survey 
7 
3 minutes 
Readmission Patient Survey 
7 
2 minutes 
Post-operative symptom Daily Survey 
15 
7 minutes 
Post-operative symptom Weekly Survey 
11 
7 minutes 
 
 
Enrollment/Baseline Visit 
 
Patients at the multidisciplinary thoracic oncology clinic with plans for thoracic 
surgery will be approached for enrollment based on inclusion/exclusion criteria 
described above. 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. The study team member will also teach the patient how to 
complete the PRO assessment using PRO Core. 
 
At that time, the participant will complete their pre-operative PRO assessment in 
a private area, which will include PRO surveys as well as demographic questions 
such as age, sex, and education. PRO survey responses will be reported using the 
PRO Core database. Paper copies of PRO surveys and source documents will be 
used if PRO Core system is inaccessible. 
 
For patients who are found to be ineligible during screening or those potentially 
eligible during screening but found to be ineligible after contact, reasons for 
ineligibility as well as basic demographics available in the EMR (e.g. race, 
ethnicity, age, gender, education level if available) will be collected in PRO 
Core.    
 
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 PRO Core.  
 
Discharge Day (Day 0) Visit: 
 
On the day of discharge (or the next business day in the case of late or weekend 
discharges), discharge day surveys will be activated in PRO Core by the study 
staff.   
 
A study team member will call or approach participant in their hospital room 
before or after discharge to reorient the participant with PRO Core, if needed. 

1 1  
L C C C 1 9 4 5  
PI: Git a M o d y, M D, M P H  
C O N FI D E N TI A L 
U NI V E R SI T Y O F N O R T H C A R O LI N A  
Dece m ber  3 , 2 0 2 1 
 
 
 
 
Partici pa nt s will be re mi n de d of t he p ost- disc har g e s ur ve y sc h e d ule, hel pe d wit h 
a n y q uesti o ns t he y ma y h a ve, a n d assiste d wit h c o m pleti n g a n y d ue s ur ve ys, if 
nee de d . 
 
I n t he cas e t he da y of dis c har ge s ur ve y is n ot o btai ne d (e. g late i n t he d a y 
disc har ges, w ee ke n d disc har ges, a n d p atie nt u na bl e or u n willi n g t o c o m plete a 
s ur ve y), t his will n ot be c o nsi dere d a pr ot oc ol de vi ati o n. 
 
T he st u d y tea m me m ber acti vati n g t he disc har g e da y s ur ve y will  o btai n 
s ur gical i nf or mati o n fr o m E pic, t he s ur ge o n or s ur ger y care t ea m me m ber.  
 
Da y 0 ( Disc h ar ge) t o Da y 1 4 P ost- Disc har ge  
 
At t his ti me t he f oll o wi n g pr oce d ures will be perf or me d:  
 
 Dail y P ost- o perati ve s y m pt o m s ur ve y  
 Dail y P R O MI S P h ysical F u ncti o n S F 4a s ur v e y  
Da y 1 4 ( +/- 7 d a ys) P ost-Disc har ge  
At t his ti me t he f oll o wi n g pr oce d ures will be perf or me d:  
 
 E O R T C Q L Q -L C 1 3  s ur v e y 
 E O R T C Q L Q - C 3 0 s ur ve y 
 Patie nt Satisfacti o n  s ur ve y 
 Rea d missi o n Patie nt  S ur ve y 
 
Da y 1 5 t o Da y 9 0 P ost Disc har ge  
Wee kl y s y m pt o m m o nit ori n g c o m me nces. At t his ti me t he f oll o wi n g pr oce d ures 
will be perf or me d:  
 
 Wee kl y P ost - o per ati ve s y m pt o m s ur ve y 
 Wee kl y P R O MI S P h ysical F u ncti o n S F 4a s ur ve y 
 
Da y 6 0 P ost- Disc har g e ( + 6 0  da ys) 
At t his ti me t he f oll o wi n g pr oce d ures will be perf or me d: 
 
 E O R T C Q L Q -L C 1 3  s ur v e y 
 E O R T C Q L Q - C 3 0 s ur ve y 
 Patie nt Satisfacti o n  s ur ve y 
 Rea d missi o n Patie nt S ur ve y  
Da y 1 2 0 P ost- Disc har g e ( + 6 0  da ys) 
At t his ti me t he f oll o wi n g pr oce d ures will be perf or me d:  
 

1 2  
L C C C 1 9 4 5  
PI: Git a M o d y, M D, M P H  
C O N FI D E N TI A L 
U NI V E R SI T Y O F N O R T H C A R O LI N A  
Dece m ber  3 , 2 0 2 1 
 
 
 
 
 E O R T C Q L Q -L C 1 3  s ur v e y 
 E O R T C Q L Q - C 3 0 s ur ve y 
 P R O MI S P h ysical F u ncti o n S F 4a s ur v e y 
 Patie nt Satisfacti o n  s ur ve y 
 Rea d missi o n Patie nt  S ur ve y 
 
Da y 1 8 0 P ost- Disc har g e ( + 1 8 5 da ys)  
 
At t his ti me t he f oll o wi n g pr oce d ures will be perf or me d:  
 
 E O R T C Q L Q -L C 1 3  s ur v e y 
 E O R T C Q L Q - C 3 0 s ur ve y 
 P R O MI S P h ysical F u ncti o n S F 4a s ur v e y 
 Patie nt Satisfacti o n  s ur ve y 
 Rea d missi o n Patie nt  S ur ve y 
 
Da y 3 6 5 P ost- D isc har g e ( + 1 8 0 da ys) 
At t his ti me t he f oll o wi n g pr oce d ures will be perf or me d:  
 
 E O R T C Q L Q -L C 1 3  s ur v e y 
 E O R T C Q L Q - C 3 0 s ur ve y 
 P R O MI S P h ysical F u ncti o n S F 4a s ur v e y 
 Patie nt Satisfacti o n  s ur ve y 
 
Da y 5 4 5 P ost- D isc har g e ( + 1 8 5 da ys) 
At t his ti me t he f oll o wi n g pr oce d ures will be perf or me d:  
 
 E O R T C Q L Q -L C 1 3  s ur v e y 
 E O R T C Q L Q - C 3 0 s ur ve y 
 P R O MI S P h ysical F u ncti o n S F 4a s ur v e y 
 Patie nt Satisfacti o n  s ur ve y 
 
Da y 7 3 0 P ost- D isc har g e ( + 1 8 5 da ys) 
At t his ti me t he f oll o wi n g pr oce d ures will be perf or me d:  
 
 E O R T C Q L Q -L C 1 3  s ur v e y 
 E O R T C Q L Q - C 3 0 s ur ve y 
 P R O MI S P h ysical F u ncti o n S F 4a s ur v e y 
 Patie nt Satisfacti o n  s ur ve y 
 
Me dical c hart a bstracti o n will be c ollecte d a n y ti m e after e nr o ll me nt t o ca pt ure 

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UNIVERSITY OF NORTH CAROLINA 
December 3, 2021 
 
 
 
clinical events as specified in the protocol.  
 
 
Semi-Structured Interviews 
The PI will identify patients to approach for semi-structured interview. Interviews 
may also be done with selected participants’ caregivers. after the initial 
participant interviews have been completed. The caregiver interview guide, 
sampling frame and timeline will be submitted to the IRB once determined. Semi-
structured participant interviews will initially be conducted between 14-90 days 
post-discharge. Sequential interviews will be conducted with the goal to 
complete10 interview participants in the 14-90 days post-discharge PRO 
monitoring phase. Once complete or if there are no more participants in the 14-90 
days post-discharge phase, the participants will be chosen purposively to capture 
patients with varying postoperative experiences and low PRO survey completion 
rates. Patients who completed the 90-days post-discharge symptom surveys but 
are in long-term follow-up to 12 months post-discharge may also be interviewed 
to increase the sample size as the study nears the end of enrollment, as 
needed.  Interviews will be administered using interview guides and will continue 
until thematic saturation is achieved, which will be defined by no new codes 
being generated to add to the codebook. Semi-structured interview duration is 
dependent on individual participant responses, but the duration is expected to be 
approximately 30-60 minutes. The sample size is anticipated to be approximately 
40 interviews with patients. An additional 40 interviews will be conducted with 
selected participants’ caregivers for those participants who agree to have 
caregivers contacted.  The participants who are asked to be interviewed will 
receive a $20 gift card for their participation after completion of the interview.  
 
4.4 
Expected Risks 
 
Expected risks for this study are likely minimal and involve psychosocial harms 
such as emotional distress or embarrassment related to PRO questions and breach 
of confidentiality. PRO 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. 
 
Study data will be recorded and stored in PRO Core. UNC PRO Core provides a 
secure platform for the electronic administration of surveys and collection of data 
from mobile health devices customized to specific research and clinical care 
applications. PRO Core data are stored in a secure enterprise-level Oracle 
database hosted by UNC Center for Bioinformatics, and web servers are also 
hosted by the UNC Center for Bioinformatics. 
 
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 PRO Core, and they will use their ONYEN to log in. Research team 

1 4  
L C C C 1 9 4 5  
PI: Git a M o d y, M D, M P H  
C O N FI D E N TI A L 
U NI V E R SI T Y O F N O R T H C A R O LI N A  
Dece m ber  3 , 2 0 2 1 
 
 
 
 
me m bers will be i nstr uct e d t o kee p all partici pa nt data a n d patie nt p artici pati o n 
c o nfi de ntial. 
 
A p pr oac hi n g p atie nts a b o ut e nr oll me nt i n t he cli nic p oses a ris k t o pri vac y. We 
a ntici pate t his ris k t o be l o w. I n t he U N C M ulti disci pli nar y T h oracic  
O nc ol o g y Cli nic, researc h tea ms r o uti nel y a p pr oac h patie nts f or e nr oll me nt i n 
cli nical st u dies d uri n g cli nic, eit her prece di n g or s uccee di n g t heir pr o vi der visit. 
T o a v oi d t hreats of c oer ci o n, pr o vi ders will be e d ucate d b ut n ot directl y i n v ol ve d 
wit h recr u it me nt of patie nts. 
 
Se mi -str uct ure d i nter vie ws will be c o n d ucte d b y C H AI C ore researc h assista nt  
a n d/ or st u d y tea m me m b er(s) trai ne d i n q ualitati ve i nter vie ws. S h o ul d 
partici pa nts e x perie nce e m oti o nal distress relate d t o i nter vie w q uesti o ns, a 
ps yc h ol o g y c o ns ult t hr o u g h t he Li ne ber g er C o m pre he nsi ve Ca ncer S u p p ort 
Pr o gra m will be o btai ne d. A u di o files a n d w or d d o c u me nts c o ntai ni n g i nter vie w 
materials will be st ore d o n a sec ure e n cr y pte d ser v er. Rec or d e d i nter vie ws will 
a v oi d usi n g na mes (a n d i nstea d assi g n c o des f or eac h partici p a nt) t o pr otect 
c o nfi de ntialit y. A d diti o nall y, if na mes are i na d verte ntl y use d d uri n g i nter vie ws, 
tra nscri pts will be stri p pe d of partici pa nt na m es. A c o de ke y w hi c h li n ks t he 
partici pa nts i nter vie w c o de t o t heir st u d y I D will be h o use d se paratel y, o n a 
sec ure s er ver. 
 
4. 5  
Re m o v al of P atie nts fr o m Pr ot oc ol 
Patie nts will be re m o ve d fr o m t he st u d y if:  
 t he y e x perie n ce si g nifica nt e m oti o nal distress i n res p o nse t o P R O s ur ve ys 
 t he y i n dicate t hat t he y n o l o n ger wis h t o partici pat e  
 
5. 0  
TI M E A N D E V E N T S  T A B L E 
5. 1  
Ti m e a n d E ve nts  T a ble  
 

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UNIVERSITY OF NORTH CAROLINA 
December 3, 2021 
 
 
 
 
6.0 
UNANTICIPATED PROBLEMS 
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 single center, randomized feasibility study. A total of 140 patients 
undergoing thoracic surgery will be prospectively enrolled and randomized in a 
1:1 ratio. A random block method with blocks of 20 will be utilized to randomize 
participants to one of two arms to complete PRO (patient reported outcome) 
symptom monitoring. The two arms are 1) active symptom monitoring and 2) 
passive symptom monitoring. The participants randomized to active symptom 
monitoring will have alerts sent to their clinicians when their PRO symptom 
scores exceed baselines scores by 2 points or more, or when 'severe' or 'very 
severe' symptoms are reported. Participants randomized to the passive PRO 
monitoring arm will complete the same PROs as participants in the active 
monitoring arm, but will not have alerts sent to their clinician. All participants 
will be administered survey instruments to further assess quality of life including: 
EORTC QLQ30, EORTC LC13, PROMIS Physical Function SF 4a survey SF 4a. 
Additionally, in order to assess the feasibility of the PRO monitoring system, all 
participants will be asked to complete a Patient Satisfaction survey. In addition, a 
subset of 40 participants and 40 caregivers will be chosen to complete a semi- 
structured interview, if willing, to assess patient satisfaction with symptom 
monitoring experience. The subset will be made up of a range of post-operative 
experiences and will be a fair representation of study population, including both 

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UNIVERSITY OF NORTH CAROLINA 
December 3, 2021 
 
 
 
study arms. Participants will be chosen by principal investigator and eligible to 
participate in interview after 14 days of discharge 
 
The primary objectives are to determine 1) impact of PRO monitoring with 
symptom alerts compared to PRO monitoring without symptom alerts after 
thoracic surgery on post-operative quality of life 2) feasibility of 3-month post- 
operative PRO symptom monitoring after thoracic surgery symptom monitoring 
eliciting a clinician response 3) barriers/facilitators of PRO monitoring after 
thoracic surgery through semi-structured interviews of patients. 
 
Secondary objectives include: 1) determining impact of PRO monitoring with 
symptom alerts compared to PRO monitoring without symptom alerts after 
thoracic surgery on post-operative readmission and mortality rates 2) determining 
feasibility of PRO monitoring after thoracic surgery in regards to monitoring 
quality of life. 
 
7.2 
Sample Size and Accrual 
We originally anticipated 100-150 patients to be enrolled per year. A sample size 
of 66 in each group will have 80% power to detect a difference in mean EORTC 
scores of 10.000 assuming that the common standard deviation is 22.900 using two 
group t-test with a 0.050 one-sided significance level. The target sample size was 
140 patients to allow appropriate block randomization in groups of 20. Based on 
enrolling about 140 patients, we would be powered to detect an effect size of 0.437 
(difference in means of 10, common standard deviation of 22.9). Due to slower 
accrual in context of COVID-19, we anticipate enrollment of 100-140 patients 
before funding ends. With 100 patients, we will have 80% power to detect an effect 
size of 0.501 (difference in means of 11.467, common standard deviation of 22.9). 
Power calculations were performed using SAS version 9.4 (SAS Inc., Cary, NC) 
using PROC POWER and a two sample means difference test. 
7.3 
Data Analysis Plans 
 
7.3.1 Aim 1: Impact of PRO monitoring with symptom alerts, compared to PRO 
monitoring without alerts, after thoracic surgery on post-operative quality of life. 
 
Impact will be determined by comparing baseline quality of life to quality of life 
at the following timepoints: Day 14, Day 60, Day 120, Day 180, and Day 365 
post-discharge. QOL will be measured by administering European Organisation 
for Research and Treatment of Cancer’s (EORTC) EORTC QLQ-LC13 and 
EORTC QLQ-C30. These surveys will be scored according to methods described 
in the EORTC scoring manual: https://qol.eortc.org/manual/scoring-manual. 
 
Student’s T and/or Wilcoxon rank sum tests will be used to perform bivariable 
comparisons of EORTC scores at each of the time points (baseline/pre-operative 
and Day 12, Day 60, Day 120, Day 180, and Day 365 post-operative). 
 
Additionally, a linear mixed effect model will be used to assess the average 

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UNIVERSITY OF NORTH CAROLINA 
December 3, 2021 
 
 
 
change in EORTC scores over time amongst both groups, and the difference in 
average trajectory between them, after accounting for repeated measures and 
within- and between- subject variability. Both a random intercept and slope (for 
time) statement will be used, and an unstructured correlation matrix will be 
applied. The random intercept and slope will allow us to assess the impact of 
symptom alerts while allowing for random variation in baseline quality of life and 
trajectories. 
 
If there are convergence issues, simpler correlation structures may be used (e.g. 
independent) or the random slope parameter may be dropped. Dropping the 
random slope parameter will mean we are assuming that there is no/minimal 
individual variation in trajectory across patients. 
 
7.3.2 Aim 2: Determine feasibility of 3-month post-operative PRO symptom 
monitoring with alerts. 
 
The proportion of completed symptom surveys (overall and in each arm) at 3- 
months postoperative will be calculated, as well as the proportion of participants 
who completed all surveys during that time. Chi-square, Student’s T, and 
Wilcoxon rank sum tests will be used to compare patient demographics, study 
arm, and surgery characteristics between those who did and did not complete all 
surveys to attempt to identify predictors of compliance. Multivariable logistic 
regression may also be used. 
 
Similar methods will be used to assess proportion of symptom alerts that generate 
a clinician response. 
 
7.3.3 Aim 3: Identify barriers/facilitators of PRO monitoring through semi- 
structured interviews. 
 
Patient and caregiver interview transcripts will be analyzed as they are collected. 
Transcripts will be coded using in vivo coding methods and a code book will be 
created. Interviews will continue until thematic saturation is achieved, which will 
be defined by no new codes being generated to add to the code book. 
 
7.3.4 Sub-Aim 1: Impact of PRO monitoring with symptom alerts, compared to 
PRO monitoring without symptom alerts, on post-operative readmission and 
mortality rates. 
 
Kaplan Meier curves and Cox proportional hazards regression will be used to 
assess the impact of study treatment arm on 30-day and 90-day emergency 
department (ED) visits, readmissions, and all-cause mortality, as well as 1-year 
all-cause mortality. A linear mixed effect model will be used to assess the change 
in 2-year quality of life (described in Aim 1). 
 
Patients who are lost to follow-up will be censored at their last clinician/study 
interaction. Mortality will be treated as a competing risk for ED visits and 
readmission. This aim will be approached as an intent-to-treat analysis and will 
not require that patients used their PRO monitoring or had symptom alerts sent to 

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UNIVERSITY OF NORTH CAROLINA 
December 3, 2021 
 
 
 
their clinician. 
 
7.3.5 Sub-Aim 2: Determine the feasibility of PRO monitoring for assessing 
quality of life. 
 
Similar methods to Aim 2 will be used. The proportion of completed QOL 
surveys (overall and in each arm) at each time point (baseline/pre-operative and 2- 
weeks, 6-months, 1-year, and 2-year post-operative) will be calculated, as well as 
the proportion of participants who completed all surveys during that time. Chi- 
square, Student’s T, and Wilcoxon rank sum tests will be used to compare patient 
demographics, study arm, and surgery characteristics between those who did and 
did not complete all surveys to attempt to identify predictors of compliance. 
Multivariable logistic regression may also be used. 
 
7.4 
Data Management/Audit 
PRO data will be collected and managed via PRO-Core’s web-based 
administration systems. Satisfaction survey data will also be entered into the 
PRO-Core database via web-based administration. Abstracted medical record data 
will be entered into a PRO-Core study-specific database. PRO-Core employs a 
secure enterprise-level Oracle database managed by the ITS Research Computing 
group at UNC, and web servers are hosted by the UNC Center for Bioinformatics. 
Data transmitted between the server and end-users are encrypted using SSL, and 
all databases are encrypted. 
 
CHAI Core and/or TS-PRO study team member(s) trained in qualitative 
interview will conduct all semi-structured interviews with patient and caregiver 
participants. Each interview will be audio recorded digitally and transcribed 
verbatim. The interview recordings and transcripts will be stored in a study- 
specific password-protected folder. 
 
The Principal Investigator will provide continuous monitoring of patient safety in 
this trial with periodic reporting to the Data and Safety Monitoring Committee 
(DSMC) as required. 
 
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, 
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 the North Carolina TraCS Institute Data 
and Safety Monitoring Board (DSMB). 
 
8.0 
STUDY MANAGEMENT 

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December 3, 2021 
 
 
 
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 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. 
 
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 in a password protected excel spread sheet 
stored on a shared drive managed by Lineberger Comprehensive Cancer Center’s 
encrypted server. 
 
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 

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PI: Gita Mody, MD, MPH 
CONFIDENTIAL 
UNIVERSITY OF NORTH CAROLINA 
December 3, 2021 
 
 
 
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. 
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. PRO Core) did 
not initiate/reach out to patients to administer the appropriate surveys or deliver 
appropriate alerts.   
 
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.   
 

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UNIVERSITY OF NORTH CAROLINA 
December 3, 2021 
 
 
 
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. 
 
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. 
 

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PI: Gita Mody, MD, MPH 
CONFIDENTIAL 
UNIVERSITY OF NORTH CAROLINA 
December 3, 2021 
 
 
 
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. Cykert, S., G. Kissling, and C.J. Hansen, Patient preferences regarding possible 
outcomes of lung resection: what outcomes should preoperative evaluations target? 
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3. Billmeier, S.E., et al., Predictors of nursing home admission, severe functional 
impairment, or death one year after surgery for non-small cell lung cancer. Ann 
Surg, 2013. 257(3): p. 555-63. 
4. Stiles, B.M., et al., Incidence and Factors Associated With Hospital Readmission 
After Pulmonary Lobectomy. Ann Thorac Surg, 2016. 101(2): p. 434-42; 
diacussion 442-3. 
5. Basch, E., et al., Overall Survival Results of a Trial Assessing Patient-Reported 
Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA, 
2017. 318(2): p. 197-198. 
6. Basch, E., et al., Symptom Monitoring With Patient-Reported Outcomes During 
Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol, 2016. 
34(6): p. 557-65. 
7. Denis, F., 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): p. 464-469. 
8. Cleeland, C.S., et al., Automated symptom alerts reduce post-operative symptom 
severity after cancer surgery: a randomized controlled clinical trial. J Clin Oncol, 
2011. 29(8): p. 994-1000. 
9. Pompili, C., et al., Patients reported outcomes in thoracic surgery. J Thorac Dis, 
2018. 10(2): p. 703-706. 
10. Subramanian, M., et al., Patient Reported Outcomes in Cardiothoracic Surgery. 
Ann Thorac Surg, 2018. 
11. Lamas, D.J., et al., Looking beyond Mortality in Transplantation Outcomes. N 
Engl J Med, 2018. 379(20): p. 1889-1891. 
12. Cykert, S., et al., Factors associated with decisions to undergo surgery among 
patients with newly diagnosed early-stage lung cancer. JAMA, 2010. 303(23): p. 
2368-76  
13. Cykert, S. and N. Phifer, Surgical decisions for early stage, non-small cell lung 
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15. Jean, R.A., et al., When good operations go bad: The additive effect of 
comorbidity and post-operative complications on readmission after pulmonary 

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UNIVERSITY OF NORTH CAROLINA 
December 3, 2021 
 
 
 
lobectomy. Surgery, 2018. 164(2): p. 294-299. 
16. Khullar, O.V., et al., Pilot Study to Integrate Patient Reported Outcomes After 
Lung Cancer Operations Into The Society of Thoracic Surgeons Database. Ann 
Thorac Surg, 2017. 104(1): p. 245-253. 
17. Moller, A. and U. Sartipy, Long-term health-related quality of life following 
surgery for lung cancer. Eur J Cardiothorac Surg, 2012. 41(2): p. 362-7. 
18. Rizk, N.P., et al., A prospective trial comparing pain and quality of life 
measures after anatomic lung resection using thoracoscopy or thoracotomy. Ann 
Thorac Surg, 2014. 98(4): p. 1160-6. 
19. Cykert, S., et al., Weighing projections of physical decline in lung cancer 
surgery decisions. Am J Med Sci, 2015. 349(1): p. 61-6. 
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the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer 
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21. Basch, E., et al., Feasibility of Patient Reporting of Symptomatic Adverse 
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10.0 APPENDICES (See Attached) 
• Pre-operative Symptom Survey 
• Participant Demographics Form 
• Refusal/Ineligible demographics from  
• Post-operative Symptom Daily Survey 
• Post-operative Symptom Weekly Survey 
• Quality of Life Surveys: EORTC QLQ30 & EORTC LC13 
• PROMIS Physical Function SF 4a Survey 
• Readmission Patient Survey 
• Patient Satisfaction Survey 
• Caregiver Interview Guide 
• Participant Interview Guide