A Phase III Randomized Study Comparing the Effects of a Personalized Exercise Program (PEP) Against No Intervention in Patients With Stage I-IIIa Primary Non-Small Cell Lung Cancer or Secondary Lung Cancer Undergoing Surgical Resection
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer, Secondary Lung Cancer
Sponsor: University of Utah

Protocol name: Precision Exercise Prescription Randomized Clinical Trial 
Version Date: 9/11/2017 
Principal Investigator: Cornelia Ulrich, MS, PhD 
 
 
 
A Phase III Randomized Study Comparing the Effects of a 
Personalized Exercise Program (PEP) Against No Intervention in 
Patients with Stage I-IIIa Primary Non-Small Cell Lung Cancer or 
Secondary Lung Cancer Undergoing Surgical Resection 
Trial ID: HCI104671/IRB# 104671 
NCT # TBD 
HCI-17-PopSci-15 
 
 
 
Principal Investigators 
Cornelia Ulrich, MS, PhD (contact PI) 
Huntsman Cancer Institute, University of Utah 
2000 Circle of Hope, Room 4165 
Salt Lake City, Utah, 84112 
Phone: 801-213-5716 
Email: neli.ulrich@hci.utah.edu  
 
Thomas Varghese, MD, MS 
University of Utah School of Medicine 
30 North 1900 East, #3C127 SOM 
Salt Lake City, Utah, 84132 
Phone: 801-581-5311 
Email: thomas.varghese@hsc.utah.edu 
 
Paul LaStayo, PhD, PT 
University of Utah Division of Physical Therapy 
520 Wakara Way, Suite 302-14 
Salt Lake City, Utah, 84108 
Phone: 801-581-7419 
Email: paul.lastayo@hsc.utah.edu 
 
Sub-investigator(s) 
 
 
 
 
 
 
 
David Wetter, PhD 
University of Utah Department of Population Health Sciences 
383 Colorow Drive, Room 361 
Salt Lake City, Utah, 84108 
Phone: 801-213-6178 
Email: david.wetter@hci.utah.edu 
 
 

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
Version Date: 9/11/2017 
Principal Investigator: Cornelia Ulrich, MS, PhD 
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Sub-investigator(s) 
Rachel Hess, MD, MS 
University of Utah Department of Internal Medicine 
Williams Building Room 1N411, 295 Chipeta Way 
Salt Lake City, UT 84101 
Phone: 801-587-1697 
Email: rachel.hess@hsc.utah.edu 
 
Jaewhan Kim, PhD 
University of Utah Department of Family and Preventive Medicine 
375 Chipeta Way, Suite A 
Salt Lake City, Utah, 84108 
Phone: 801-587-3027 
Email: jaewhan.kim@utah.edu 
 
Kenneth Boucher, PhD 
Huntsman Cancer Institute, University of Utah 
2000 Circle of Hope Room 3161 
Salt Lake City, Utah, 84112 
Phone: 801-585-5357 
Email: ken.boucher@hci.utah.edu 
 
Historical Protocol Versions 
Version 1: 9/11/2017 

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
Version Date: 9/11/2017 
Principal Investigator: Cornelia Ulrich, MS, PhD 
Page 3 of 44 
TABLE OF CONTENTS 
Page 
Contents 
LIST OF ABBREVIATIONS ............................................................................................. 5 
PROTOCOL SIGNATURE ................................................................................................ 7 
STUDY SUMMARY.......................................................................................................... 8 
SCHEMA .......................................................................................................................... 10 
1 
OBJECTIVES ........................................................................................................... 11 
1.1 
Primary Objective .............................................................................................. 11 
1.2 
Secondary Objectives ......................................................................................... 11 
1.3 
Exploratory Objectives ....................................................................................... 11 
2 
BACKGROUND ...................................................................................................... 12 
2.1 
Lung Cancer: A Major Public Health and Clinical Challenge ........................... 12 
2.2 
Functional Outcomes After Surgery .................................................................. 13 
2.3 
Exercise Training in Oncological Patients ......................................................... 13 
2.4 
Physical Functioning (AM-PAC Scores) Among Lung Cancer Patients at HCI 14 
2.5 
Rationale for Conducting the Study ................................................................... 14 
2.6 
Rationale for the PEP Intervention Design ........................................................ 15 
2.7 
PEP Study Pilot .................................................................................................. 16 
3 
STUDY DESIGN...................................................................................................... 17 
3.1 
Description ......................................................................................................... 17 
3.2 
Number of Patients ............................................................................................. 17 
3.3 
Number of Study Centers ................................................................................... 17 
3.4 
Duration .............................................................................................................. 17 
4 
ELIGIBILITY CRITERIA........................................................................................ 18 
4.1 
Inclusion Criteria ................................................................................................ 18 
4.2 
Exclusion Criteria ............................................................................................... 18 
5 
INTERVENTION ..................................................................................................... 19 
5.1 
Control Group .................................................................................................... 19 
5.2 
Intervention Group ............................................................................................. 19 
6 
SCHEDULE OF EVENTS ....................................................................................... 21 
7 
QUESTIONNAIRES ................................................................................................ 22 
8 
STUDY PROCEDURES .......................................................................................... 25 
8.1 
Pre-Surgery Clinic Visit ..................................................................................... 25 
8.2 
In the Weeks Leading to Surgery (Outpatient) .................................................. 25 
8.3 
Pre-Anesthesia Visit ........................................................................................... 25 
8.4 
Inpatient Stay...................................................................................................... 26 
8.5 
Hospital Discharge Visit .................................................................................... 26 
8.6 
During the Follow-Up (Outpatient).................................................................... 26 
8.7 
Follow-Up Clinic Visits (2 and 6 Months Post-Surgery). .................................. 26 
9 
CRITERIA FOR EVALUATION OF ENDPOINTS ............................................... 27 
9.1 
Physical Function Performance .......................................................................... 27 
9.2 
Patient Reported Outcomes ................................................................................ 27 

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9.3 
Respiratory Function Status ............................................................................... 27 
9.4 
Exploratory Objectives ....................................................................................... 27 
10 STATISTICAL CONSIDERATIONS...................................................................... 28 
10.1 
Randomization ................................................................................................... 28 
10.2 
Outcomes, Power, and Sample Size Considerations .......................................... 28 
10.3 
Primary Endpoint Analysis ................................................................................ 28 
10.4 
Other Endpoint Analyses ................................................................................... 28 
11 REGISTRATION GUIDELINES ............................................................................. 29 
12 DATA SUBMISSION SCHEDULE ........................................................................ 29 
13 SPECIAL INSTRUCTIONS .................................................................................... 30 
13.1 
Correlative Studies ............................................................................................. 30 
14 ETHICAL AND REGULATORY CONSIDERATIONS ........................................ 30 
14.1 
Informed Consent ............................................................................................... 30 
14.2 
Institutional Review ........................................................................................... 30 
14.3 
Data and Safety Monitoring Plan ....................................................................... 30 
14.4 
Adverse Events / Serious Adverse Events ......................................................... 31 
14.5 
SAE Reporting Requirements ............................................................................ 31 
14.6 
Protocol Amendments ........................................................................................ 32 
14.7 
Protocol Deviations ............................................................................................ 32 
14.8 
FDA Annual Reporting ...................................................................................... 33 
14.9 
Clinical Trials Data Bank ................................................................................... 33 
15 BIBLIOGRAPHY ..................................................................................................... 34 
APPENDIX 1 - AM-PAC Basic Mobility Outpatient Form and Conversion Table ........ 41 
APPENDIX 2 - AM-PAC Basic Mobility Staging and Expected Performance ............... 44 
 
 
 

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Principal Investigator: Cornelia Ulrich, MS, PhD 
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LIST OF ABBREVIATIONS 
Abbreviation or Term1 
Definition/Explanation 
6MW 
Six Minute Walk  
AE 
Adverse Event OR Aerobic Exercise (contextual) 
AM-PAC 
Boston University Activity Measure for Post-Acute Care 
BMI 
Body Mass Index 
BP 
Blood Pressure 
BREQ-3 
Behavioral Regulation in Exercise Questionnaire 3 
COPD 
Chronic Obstructive Pulmonary Disease 
CRC 
Clinical Research Coordinator 
CRF 
Case report form 
CTCAE 
Common Toxicity Criteria for Adverse Events 
eCRF 
Electronic case report form 
ERV 
Expiratory Reserve Volume 
FACT-L 
Functional Assessment of Cancer Therapy-Lung 
FDA 
Food and Drug Administration 
FEV1 
Forced Expiratory Volume in 1 second 
GCP 
Good Clinical Practice 
HAPA 
Health Action Process Approach 
HR 
Heart rate 
hr 
Hour or hours 
i.e. 
Id est (that is) 
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
IRV 
Inspiratory Reserve Volume 
LOC 
Locus of Control 
MFI 
Multidimensional Fatigue Inventory 
MI 
Motivational Interviewing 
NCCN 
National Comprehensive Cancer Network 
NSCLC 
Non-Small Cell Lung Cancer 
PEF 
Peak Expiratory Flow 
PEP 
Personalized Exercise Program 

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Principal Investigator: Cornelia Ulrich, MS, PhD 
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Abbreviation or Term1 
Definition/Explanation 
PRO 
Patient Reported Outcomes 
PROMIS 
Patient Reported Outcomes Measurement Information System 
PSQI 
Pittsburgh Sleep Quality Index 
PT 
Physical Therapy / Therapist (contextual) 
RCT 
Randomized Clinical Trial 
RE 
Resistance Exercises 
SAE 
Serious Adverse Event 
SD 
Standard deviation 
SPPB 
Short Physical Performance Battery  
SOC 
Standard Of Care 
UUHS 
U of Utah Healthcare system 
VC 
Vital capacity 
VDO 
Value Driven Outcomes 
 
 
 

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
Version Date: 9/11/2017 
Principal Investigator: Cornelia Ulrich, MS, PhD 
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PROTOCOL SIGNATURE 
 
I confirm that I have read this protocol, and I will conduct the study as outlined herein and 
according to the ethical principles stated in the latest version of the Declaration of Helsinki, 
the applicable ICH guidelines for good clinical practice, and the applicable laws and 
regulations of the federal government. I will promptly submit the protocol to the IRB for 
review and approval. Once the protocol has been approved by the IRB, I understand that 
any modifications made during the course of the study must first be approved by the IRB 
prior to implementation except when such modification is made to remove an immediate 
hazard to the subject. 
I will provide copies of the protocol and all pertinent information to all individuals 
responsible to me who assist in the conduct of this study. I will discuss this material with 
them to ensure that they are fully informed regarding the study treatment, the conduct of 
the study, and the obligations of confidentiality. 
Note: This document is signed electronically through submission and approval by the 
Principal Investigator in the University of Utah IRB Electronic Research Integrity and 
Compliance Administration (ERICA) system. 
 

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
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Principal Investigator: Cornelia Ulrich, MS, PhD 
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STUDY SUMMARY 
Title 
A Phase III Randomized Study Comparing the Effects of a 
Personalized Exercise Program (PEP) Against Standard of Care 
(No Intervention) in Patients with Stage I-IIIa Non-Small Cell 
Primary Lung or Secondary Lung Cancer Undergoing Surgical 
Resection 
Short Title 
PEP Intervention Study Randomized Clinical Trial 
Protocol Number 
104671 
IND 
IND exempt 
NCT number 
TBD 
Phase 
3 
Design 
Randomized two-arm clinical trial comparing a personalized 
exercise program (Intervention Arm – Group 1) to the standard 
of care (Control Arm – Group 2: no exercise program) in patients 
with lung cancer (primary stage I-IIIa or secondary) 
Study Duration 
4 years 
Study Center(s) 
Single center - Huntsman Cancer Institute 
Objectives 
Primary: 
Evaluate the improvement in mobility performance via the 6 
Minute Walk (6MW) test 
Secondary: 
1. Evaluate the improvement in strength, endurance, and balance 
via the Short Physical Performance Battery (SPPB) test. 
2. Evaluate the improvement in respiratory function status via 
spirometry measurements. 
3. Gather patient-reported outcomes regarding disease specific 
symptoms, multidimensional fatigue, common mental health 
issues, and hypothesized treatment mechanisms, via 
questionnaires  
Number of Subjects 
Randomized clinical trial: 200 (approximately 106 men and 94 
women), and 300 approached (anticipated recruitment rate 65%) 
Diagnosis and Main 
Eligibility Criteria 
Inclusion: 
 Male or female subject aged ≥ 18 years. 
 Diagnosis of primary lung cancer stage I, II, or IIIa OR 
secondary lung cancer.  
 Disease amenable to surgical resection to be performed at the 
Huntsman Cancer Hospital in the opinion of the treating 
surgeon. 
 Patients must be able to follow directions and complete 
questionnaires and exercise diaries in English.   
 Patients must agree to be randomly assigned to either 
Intervention or Control Group.   

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Exclusion: 
 Contraindications for entry into an exercise training program 
(unstable angina, uncontrolled hypertension [systolic > 200, 
diastolic > 100], orthostatic hypotension [> 20 mm fall in 
systolic], moderate or serve aortic stenosis, uncontrolled 
arrhythmia, uncontrolled congestive heart failure, third degree 
heart block, pericarditis, myocarditis, pulmonary/systemic 
embolism within the past 6 months, thrombophlebitis, ST 
displacement > 3 mm at rest, history of cardiac arrest. 
 Patient is morbidly obese (BMI > 40 kg/m2) or anorexic (BMI 
< 17.5 kg/m2). 
 Abnormalities on screening physical exam judged by study 
physicians 
or 
physical 
therapist 
to 
contra-indicate 
participation in exercise program compliance. 
 Alcohol or drug abuse as judged by study physicians.  
 Significant mental or emotional problems that would interfere 
with study participation (assessed by NCCN Distress 
Thermometer). 
Study Product, 
Dose, Route, 
Regimen and 
Duration 
A personalized exercise regimen based on a patient’s AM-PAC 
score and performed in the outpatient setting starting 2 to 4 
weeks pre-surgery, inpatient for the duration of the hospital stay, 
and outpatient 6 months post-surgery.  
Statistical 
Methodology 
Primary analysis 
Power calculations are based on the group effect in an analysis 
of covariance for the 6MW test at 8 weeks, with baseline 6MW 
test as covariate. The planned sample size (n = 200) allows for a 
25% dropout rate leaving at least 150 subjects evaluable for the 
primary endpoint. The hypothesis is that the difference in the 
6MW distance between the study arms (Intervention vs. Control) 
will be ≥ 39.95 m. This effect size stems from a meta-analysis 
where 4 weeks of post-surgery exercise training provided a 39.95 
increase in the 6MW distance in NSCLC patients. Consistent 
with Arbane, SD = 100 m and correlation = 0.5 between repeated 
6MW test measurements on the same subject are assumed. 
Power to detect the treatment effect was estimated by simulation 
(in R) of an analysis of covariance model with 6MW test at 2 
months post-surgery as outcome, treatment group as primary 
predictor and pretreatment 6MW test as covariate. Pre and post 
6MW test was assumed to be bivariate normally distributed. 
Secondary analyses 
See section 10 for details. 
 
 

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SCHEMA 
 
 
 

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
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Principal Investigator: Cornelia Ulrich, MS, PhD 
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1 OBJECTIVES 
This study is designed to establish whether participation in a personalized exercise program 
during the pre- and post-operative setting can positively affect physical performance, 
cardiorespiratory fitness, quality of life, clinical outcomes (hospital length-of stay and 
readmission rate, complications), and treatment related costs in patients undergoing 
surgery for the treatment of stage I-IIIa NSCLC as well as secondary lung cancer when 
compared to the current standard of care (no exercise program). 
1.1 Primary Objective 
1.1.1 Evaluate the improvement in mobility performance. 
Primary Endpoint: Six Minute Walk (6MW) distance. 
1.2 Secondary Objectives  
1.2.1 Evaluate the improvement in strength, endurance, and balance. 
Secondary Endpoint #1: Short Physical Performance Battery (SPPB) test 
scores 
1.2.2 Gather patient-reported outcomes regarding disease specific symptoms, 
multidimensional fatigue, common mental health issues, and hypothesized 
treatment mechanisms and evaluate differences between arms. 
Secondary Endpoint #2: results from PROMIS, FACT-L (Functional 
Assessment of Cancer Therapy-Lung), FACIT-F (Chronic Illness Fatigue 
Scale), PSQI (Pittsburgh Sleep Quality Index), and BREQ-3 (Behavioral 
Regulation in Exercise Questionnaire 3) questionnaires.  
1.2.3 Evaluate the improvement in respiratory function status.  
Secondary Endpoint #3: spirometry measurements (FEV1, PEF, VC, IRV, 
ERV).  
Further secondary endpoints to be explored include self-efficacy, social support, 
disease-related symptoms (e.g., pain shortness of breath), activities of daily life, 
personal habits, emotions, demographics, background information, and living 
conditions. 
1.3 Exploratory Objectives 
1.3.1 Evaluate changes in biomarker levels. 
Exploratory Endpoint #1: potential prognostic or mechanistic biomarkers, 
such as inflammatory biomarkers, in serum, plasma, and buffy coat.  
1.3.2 Evaluate the rate of complications. 
Exploratory Endpoint #2: rate of occurrence of pulmonary, cardiac, and 
other complications requiring treatment (e.g., liver dysfunction, gastric ulcer, 

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wound infection, colitis, depression), readmissions and deaths within the first 
30 days after discharge. 
1.3.3 Measure the length of stay post-surgical resection. 
Exploratory Endpoint #3: time from surgery to discharge obtained from 
clinical databases. 
1.3.4 Evaluate costs and utilization from admission to discharge, from discharge to 2 
months follow-up, and from 2 to 6 months follow-up. 
Exploratory Endpoint #4: total cost of care and utilization for each of the three 
periods collected through the UUHS VDO, the Utah APCD, daily electronic 
diaries, and time-line follow-back. 
2 BACKGROUND 
2.1 Lung Cancer: A Major Public Health and Clinical Challenge 
The incidence and prevalence of lung cancer has risen dramatically. In 1953, primary 
lung cancer became the most common cause of cancer death in men, while the same 
occurred for women in 1985 in the United States.1 Worldwide, lung cancer is one of 
the most commonly diagnosed cancer types and also the leading cause of death in men.1 
Among the most aggressive cancers, lung cancer causes more deaths than the next three 
most lethal common cancers combined.1 The lungs are the most common site for 
metastatic disease (secondary lung cancers), which are identified in 30-55% of 
metastatic cancer patients.2  
Non-small cell lung cancer (NSCLC) accounts for the majority of primary lung cancer 
(~ 85%). Stage I disease (small lesion, no spread in lymph nodes) and stage II disease 
(larger lesion, no spread in lymph nodes and involvement of structures such as the chest 
wall or diaphragm, or involvement of hilar lymph nodes) make up about a third of 
patients with NSCLC.1 Treatment options for lung cancer depend on histology, stage, 
and patient-specific factors. Randomized clinical trials have established surgical 
resection of a single lobe of the lung, or lobectomy, as the treatment of choice for 
operable lung cancer patients in stage I and II,1 improving survival to up to 75%.1,2 For 
those patients with stage IIIa disease (involvement of ipsilateral mediastinal lymph 
nodes), surgical resection plays a role after chemoradiation therapy, provided no further 
spread of disease has occurred, and patients remain medically operable. The lung is 
also a common site for metastatic spread from other primary cancers (most common: 
breast, colon, sarcoma and melanoma). Experience with surgical resection of secondary 
lung cancers (pulmonary metastasectomy), once the primary cancer has been 
controlled, has confirmed that resection can substantially prolong survival and 
potentially cure some patients.3-8 In 2015, lung cancer accounted for $13.4 billion in 
costs out of a total expense of cancer care of $147.5 billion.9 Lung cancer patients often 
experience multidimensional impairments affecting quality-of-life (QoL) during their 
course of disease.10 Impairments result from both symptoms of the disease and 
comorbidities, as well as side effects of treatment. Interventions aimed at minimizing 
morbidity would have a significant impact on public and population health. 

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2.2 Functional Outcomes after Surgery 
Surgical resection is the treatment of choice for primary lung cancer patients with stage 
I to IIIa lung cancer, as it offers the best chance for cure. The goal of surgical resection 
for lung cancer patients is excision of one or more lobes of the lung that are affected 
by cancer. For secondary lung cancers, this goal is complete removal of the lesion with 
adequate margins. Lung cancer patients suffer substantial functional decline and 
reduced activity levels following surgical lung resection.11-13 There is a significant 
deterioration in six minute walk (6MW) distance at five days post-operatively 
compared with pre-operatively (average of 337m vs. 467m).11 Lung resection is 
associated with an immediate 12% reduction in exercise tolerance and 18% reduction 
in pulmonary function.12 Lung resection also has an impact on post-surgery health-
related QoL14-16 and causes persistent pain following surgical treatment for up to 33% 
of patients.17 The postsurgical period is associated with a 20-40% reduction in 
physiological and functional capacity, particularly in the elderly with comorbidities, 
who may never return to pre-surgery levels of function.18-20 Additionally, poor pre-
surgery physical performance has been shown to increase the risk of mortality,21 post-
surgery complications, and prolonged functional recovery.22 Thus, the pre-operative 
and post-operative periods are ideal periods to intervene. Enhancing functional 
capacity 2-4 weeks prior to a lung resection is feasible and motivates the patient to 
continue with physical activities and exercises post-operatively, which is essential for 
optimizing outcomes 
2.3 Exercise Training in Oncological Patients 
Exercise intervention studies prior to, during and after cancer treatment consistently 
show beneficial effects for various physical and psychosocial outcomes.23-33 The 
American College of Sports Medicine Roundtable on Exercise Guidelines for Cancer 
Survivors concluded that exercise training is safe during and after cancer treatments 
and results in improved physical function, QoL, and cancer-related fatigue in multiple 
cancer survivor groups.24 It has been shown that exercise interventions can ameliorate 
or reverse cancer treatment-induced impairment of physical function and QoL, such as 
cancer-related fatigue and pain.24-37 
Several non-randomized intervention studies and ten randomized controlled trials have 
demonstrated positive effects of pre- or post-surgical exercise intervention in lung 
cancer patients.11,38-59 In a review, Crandall et al. concluded that compared to usual 
care, exercise interventions among lung cancer patients both pre- and post-surgery are 
associated with improved cardiopulmonary exercise capacity and muscle strength, and 
reduced fatigue, post-operative complications and hospital length of stay.60 Despite this 
consistent and convincing evidence, implementation of exercise programs in clinical 
practice for patients with lung cancer is still low, perhaps due to unacceptable financial 
and resource demands on the patient and the health care system (e.g., center-based 
exercise). There are further gaps in the evidence base: Although the majority of 
exercise studies have demonstrated positive impact, only a small Turkish trial has 
covered the continuum from pre-surgery to the survivorship period,49 and none have 
used a highly standardized, yet patient-tailored approach. Most of the exercise studies 
in lung cancer patients have been developed outside of the United States, and there are 
currently only two American trials recruiting patients, both of which differ substantially 

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in their design. One trial tests a 16-week exercise intervention that starts at least one 
year following the completion of therapy and requires participants to attend three 
supervised sessions per week (NCT 01068210). The other trial provides mindfulness-
based pulmonary rehabilitation prior to surgery for both lung cancer and COPD patients 
(NCT 01682850). There is clearly a need for testing innovative exercise interventions 
in lung cancer patients that can be translated into clinical practice across the entire 
continuum of care. 
2.4 Physical Functioning (AM-PAC Scores) Among Lung Cancer Patients at 
HCI 
The AM-PAC mobility score61 was implemented as the inpatient mobility assessment 
tool in June of 2014 within the University of Utah Health Care system (UUHS) and has 
become a standard mobility measure collected by physical therapists in the University’s 
acute hospitals (see Appendices 1-3). The PEP Study team plans to extend assessments 
to pre-surgery visits for the standardized precision exercise program. As part of a pilot 
study, n = 63 AM-PAC scores were collected at Dr. Varghese’s clinic from lung cancer 
patients during their pre-operative outpatient clinic visit. The average score was 54 ± 
13. Patients were 54% female, with mean age of 61 ± 15 years. Overall 44% of patients 
were categorized as AM-PAC stage 3, indicating that they had difficulty with 
community mobility. Eighteen % had stage 2, indicating that they had difficulty with 
mobility within the home. Patients ranging across mobility stages 2-4 are generally 
capable of performing exercise that will have the greatest likelihood in resulting in 
positive outcomes. The level of physical function of patients in the clinic can vary 
widely, reinforcing the PEP concept of an exercise intervention that is tailored for the 
mobility stage of each patient. No correlations between the AM-PAC score and age, 
sex or cancer stage (all p > 0.05; ǀrǀ < 0.30); some 75 year olds had better function than 
50 year old patients. This suggests that the AM-PAC score is well-suited and sufficient 
to assess physical function, and should be evaluated for appropriate tailoring of exercise 
interventions. 
2.5 Rationale for Conducting the Study 
Studies that have investigated the effect of exercise in lung cancer patients undergoing 
surgery have been center-based and resource intensive, and consequently have not been 
implemented in the clinical setting.65-67 Pre-operatively, effective exercise programs 
lasting 6-12 weeks are not feasible since patients with lung cancer do not want to delay 
surgery. In fact, one randomized controlled trial (RCT)38 was prematurely discontinued 
because neither patients nor providers were willing to delay surgery longer than 4 
weeks. Post-surgery, home-based exercise strategies capable of improving mobility 
and fatigue levels of patients following surgery for lung cancer and colorectal cancer 
45 have been prohibitively expensive because they required supervised visits by a 
nurse.32 In addition, these programs have been “one size fits all,” lacking a personalized 
approach to optimize adherence and efficacy.65-68  
To date, no attempt has been made to test a pragmatic and personalized exercise 
intervention (i.e., face to face visits at clinical contacts, telephone counseling in the 
home, and personalized exercise prescriptions) before and following surgery for 

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patients with lung cancer. Unfortunately, the application of personalized principles of 
exercise in randomized controlled trials with cancer survivors (specifically non-breast 
cancer survivors) is incomplete and inconsistent.69 To establish consistency in the 
exercise prescription while accommodating the exercise to match the patient’s level of 
mobility, a validated basic mobility assessment tool to create modes and dosages of 
exercise that can be implemented across the continuum of the pre- and post-operative 
surgical experience in lung cancer patients. The Activity Measure-Post Acute Care™ 
(AM-PAC) (described in Figure 2) will be used as the basic mobility assessment tool 
that prompts the prescribed exercise mode and dose for the patient. The AM-PAC has 
been developed as a pragmatic measurement system that can be used across care 
settings and a very broad range of impairments, limitations and diagnoses.70 The PEP 
Study’s approach with the use of AM-PAC will address a gap in the care of lung cancer 
patients, i.e., the underutilization of exercise because it is clinically not pragmatic and 
it is not known how and when to implement exercise.71   
2.6 Rationale for the PEP Intervention Design 
Dr. Ulrich’s previous work with the empirically validated MotivAction intervention 
will serve as the foundation for the PEP intervention, which will be adapted for lung 
cancer patients. The Health Action Process Approach (HAPA) describes a general 
framework for self-regulation and behavior change among individuals with chronic 
illness.72-78 The overarching conceptual basis is the social cognitive model 74-76 which 
posits that high levels of both motivation and self-efficacy are necessary for behavior 
change.29 Thus, in the HAPA model, a key element for lasting behavior change is a 
motivational shift that instigates a decision and commitment to change. In the absence 
of such a shift, skill training is viewed as premature.74,79,80 As such, the PEP 
intervention focuses on both enhancing the motivation to achieve and maintain change, 
as well as developing the self-efficacy and skills necessary to do so. Many interventions 
focus largely on either motivation or problem-solving/skills training despite the strong 
theoretical and empirical bases for doing both. When motivation is addressed, the focus 
is typically on initiating a change attempt, with little attention given to the motivation 
to maintain change. Specific components of the PEP intervention include: 
individualized tailoring of the exercise prescription; individualized tailoring of the 
counseling based on motivation and self-efficacy to engage in exercise including the 
use of simple motivational interviewing (MI) 79 techniques (e.g., reflective listening, 
avoiding argumentation; developing discrepancy); identifying barriers to exercising 
and problem-solving solutions; use of goal setting and self-monitoring (including via 
the activity tracker); and, implementing specific strategies for improving self-efficacy 
(e.g., building a series of small achievable goals; practicing specific exercises during 
the face to face visits to increase mastery (see Figure 1).  
In sum, the PEP intervention is a directive but patient-centered approach designed to 
enhance motivation for change, and increase self-efficacy in a non-confrontational 
manner. Several meta-analyses and systematic reviews have supported the efficacy of 
both social cognitive and MI-based interventions for behavior change in general and 
with respect to cancer patients specifically.81-85  

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Figure 1: PEP interventions strategies and mechanisms 
2.7 PEP Study Pilot  
In order to test the feasibility of patient recruitment and study implementation, a pilot 
study was conducted (IRB 91478, The PEP Study: Precision Exercise Prescription 
among lung cancer patients, approved 7/3/2016).  
Between 7/7/2016 and 10/11/2016, n=18 lung cancer patients were recruited into the 
intervention program at their pre-surgery consult with Dr. Varghese. Every eligible 
patient was approached, and all patients approached (100%) agreed to participate in the 
intervention. Their physical function was assessed with 6MW test, SPPB, and AM-
PAC score. The testing and precise exercise prescription was implemented within 
normal clinic workflow and clinic space by a trained physical therapist (Dr. Barnes) 
using existing space in the clinic of Thoracic Surgery. The intervention included 
individually-prescribed exercise modes (mobility, flexibility, callisthenic, aerobic and 
resistance) and dosages (low, moderate, high) tailored to the patient’s AM-PAC 
mobility stage.  
The baseline observed 6MW distance varied from 209-679m with a mean distance of 
467±119m. Normal 6MW distance for healthy 60-69 year olds is 572m for men and 
538m for women. For ten patients, post-operative 6MW distances were obtained prior 
to 10/15 (max. follow-up time 20 post-operative days within the pilot). Compared to 
comparable control patients (for whom 6MW distances at comparable pre- and post-
time points were available) PEP patients maintained their physical function and 
experienced a lesser reduction in 6MW distance (median 6.8% decline in PEP and 
18.7% in controls, see Figure 1). Although this comparison is not based on a 
randomized study, it is notable that the decrease (47m) in 6MW distance in the controls 
exceeded the minimal clinically important distance, despite the time points achieved at 
this point being very early in the intervention process. To date, only one patient has 
dropped out (5.5% drop-out rate).  
A follow-up phone evaluation of the PEP intervention showed that patients planned to 
exercise an average of 4.7 days per week and 93% agreed (86% strongly) that exercise 
should be part of their cancer treatment; 86% also strongly agreed with the statement 
that they believe that the exercise program will have a positive effect on their cancer 
treatment. Several patients noted that they loved being in the program and the effort of 
our team. They emphasized that the exercise intervention helped them immensely with 
recovery from surgery.  

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In conclusion, these preliminary results demonstrate that: (1) our team has successfully 
worked together on the PEP study intervention, generated pilot data, and two scientific 
abstracts;90,91 (2) lung cancer patients differ dramatically in their functional status, 
independent of age, sex and stage, requiring individualized interventions; (3) the PEP 
intervention was feasible within the existing workflow of a high-volume surgical clinic, 
with only the addition of a physical therapist to manage the intervention; (4) the PEP 
intervention is welcomed by patients and appears to show early efficacy; and (5) our 
assumptions for anticipated patient recruitment (65%) and drop-out rates (15%) are 
conservative. Overall, this pilot work sets the base for a successful clinical trial. 
3 STUDY DESIGN 
3.1 Description 
This is a Phase 3 study aimed at investigating the effects of a personalized exercise 
program (PEP) in NSCLC patients (stage I, II, IIIa) and secondary lung cancer patients 
undergoing surgical treatment at the University of Utah and comparing the intervention 
to the current standard of care (no exercise program).  
Eligible patients will be randomized between two arms (1:1 ratio) prior to the surgery 
and will be followed for 6 months post-surgery: 
 An Intervention Arm (referred to in materials as Group 1) which features pre- 
and post-surgery PEP interventions. 
 A Control Arm (referred to in materials as Group 2) which does not include a 
personalized exercise program (the standard of care). Patients randomized to 
the Control Arm will be given the opportunity to participate in a PEP-
intervention session providing exercise counseling after the 6 month assessment 
and will receive a free activity tracker for their participation. 
3.2 Number of Patients 
The target enrollment for the randomized clinical trial is 200 patients (approximately 
106 men and 94 women). It is estimated that 300 patients will be approached about the 
study which will achieve a conservative recruitment rate of 65%.  
3.3 Number of Study Centers 
This study will open at a single center at the Huntsman Cancer Institute.  
3.4 Duration 
Participants will be recruited over the course of 33 months. The estimated total 
duration of the study from the first enrollment to the end of the last 6-months follow-
up is 4 years. 
 
 

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4 ELIGIBILITY CRITERIA 
This eligibility checklist is used to determine patient eligibility and filed with investigator’s 
signature in the patient research chart. 
Patient No. ______________________ 
Patient’s Initials: (L, F, M) _________________ 
4.1 Inclusion Criteria 
Yes/No (Response of “no” = patient ineligible) 
4.1.1 _____ Male or female subject aged ≥ 18 years. 
4.1.2 _____ Diagnosis of primary lung cancer stage I, II, or IIIa OR secondary lung 
cancer.  
4.1.3 _____ Disease amenable to surgical resection in the opinion of the treating 
surgeon. 
4.1.4 _____ Patients must be able to follow directions and complete questionnaires 
and exercise diaries in English.   
4.1.5 _____ Patients must agree to be randomly assigned to either Intervention or 
Control Group.   
4.2 Exclusion Criteria 
Yes/No (Response of “yes” = patient ineligible) 
4.2.1 _____Contraindications for entry into an exercise training program including, 
but not limited to: unstable angina, uncontrolled hypertension (systolic > 200 
mm Hg, diastolic > 100 mm Hg), orthostatic hypotension (> 20 mm Hg fall in 
systolic), moderate or serve aortic stenosis, uncontrolled arrhythmia, 
uncontrolled congestive heart failure, third degree heart block, pericarditis, 
myocarditis, pulmonary/systemic embolism within the past 6 months, 
thrombophlebitis, ST displacement > 3 mm at rest, history of cardiac arrest. 
4.2.2 _____ Patient is morbidly obese (BMI > 40 kg/m2) or anorexic (BMI < 17.5 
kg/m2). 
4.2.3 _____ Abnormalities on screening physical exam judged by study physicians 
or supervising physical therapist to contraindicate participation in exercise 
program compliance. 
4.2.4 _____ Alcohol or drug abuse as judged by study physicians.  
4.2.5 _____ Significant mental or emotional problems that would interfere with study 
participation (assessed by NCCN Distress Thermometer).  
I certify that this patient meets all inclusion and exclusion criteria for enrollment onto 
this study.  
 
______________________________  
_________ _______ 
Investigator Signature  
 
 
 
Date  
Time 

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5 INTERVENTION  
5.1 Control Group 
Patients randomized to the Control Group (Group 2) will not experience any changes 
in the standard of care for lung cancer patients according to their cancer stage. Although 
patients are encouraged to increase walking both in the pre-surgery and post-surgery 
period, there is no formalized pre-surgery exercise program. Upon study completion 
(at the 6 month post-surgery follow-up visit), participants in the Control Group will be 
offered a PEP-intervention session with precision exercise counseling and receive a 
free activity tracker. 
5.2 Intervention Group 
The PEP intervention involves a combination of home-based exercise as well as in-
patient exercise. The exercise modes will include basic transfer and calisthenics 
mobility, aerobic and resistance exercises and will be performed in various postures 
(supine, sitting, standing and walking) with variable challenges (level walking, 
bending, inclines, steps and squatting). 
For patients randomized to the Intervention Group (Group 1), the PEP intervention will 
be personalized, implemented, and modified (based on the patients AM-PAC mobility 
stage) by a licensed physical therapist in face-to-face meetings (~30-40 minutes). An 
exercise education manual, specifically developed for this study, will be used by the 
physical therapist to educate the patients on all aspects of starting and maintaining the 
exercise intervention.  
5.2.1 Inpatient Sessions 
The post-surgery inpatient PEP intervention will be performed under the supervision 
of the physical therapist in accordance with the exercise education manual and the 
patient’s AM-PAC mobility stage. 
5.2.2 Home-Based Exercise 
The outpatient exercises will be performed both pre- and post-surgery and will be done 
at home, the HCI Wellness Center, or a recreational center.  
The study physical therapist will go over (verbally and in writing) the individual 
exercise modes and dosages to be performed at home. Although individually-
prescribed, the exercise mode and dosage will be standardized with respect to the 
patient’s AM-PAC mobility stage (as shown in Figure 2). For example, a patient in 
AM-PAC mobility stage 3 will progress from walking on level surfaces for 10 minutes 
per day at a “somewhat hard” perceived exertion with the ability to talk but not sing 
during walking. The rate of steps/minute will be ~100. Additionally, this patient will 
also perform squatting exercise at the same perceived exertion for short bouts that add 
up to 5 minutes per day. These aerobic and resistance exercises will be progressed to 
20 minutes and 10 minutes per day respectively as they progress to AM-PAC mobility 
stage 4. 

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Patients will be given access to instruction sheets demonstrating exercise modes along 
with exercise tools (e.g., light weights and external resistance bands), tracking 
diary/calendar and activity tracker (see note below) for the home-based exercise 
program.  
Telephone calls or TeleHealth interactions between the participant and the physical 
therapist will take place weekly to answer questions, optimize patient engagement, and 
adjust exercise prescriptions remotely as needed.  
Ongoing monitoring of attitudes and barriers to exercise will occur and strategies for 
encouraging uptake of the exercise intervention will be individually tailored. U of Utah 
TeleHealth capabilities, including video chat, will be used to augment telephone 
communications.  
Note: the activity tracker, a consumer wearable device (e.g., Fitbit Zip Wireless 
Activity Tracker), will be used as a pragmatic motivational and self-monitoring tool to 
improve participant exercise efficacy and home exercise program adherence.86 
 
Figure 2: AM-PAC stages (according to Arbane) and corresponding exercise modes 
and dosages. 
5.2.3 Interruption and Discontinuation 
The PEP intervention is already personalized, implemented, and modified based on an 
individual’s patient characteristics. However, if, at any time during the study a 
participant develops an illness that contraindicates exercise in the opinion of the 
enrolling physician (including but not limited to those described in exclusion criterion 
4.2.1), the patient’s primary care physician will be consulted regarding whether and 
when it would be safe to re-start the exercise program.  
Should any participant develop any condition that would limit their ability to fully 
participate in the prescribed protocol, the participant would be temporarily, or if 
necessary permanently, withdrawn from the study.  
 
 
 
 

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6 SCHEDULE OF EVENTS 
PROCEDURES 
Pre-surgery 
visit 
Before 
surgery 
Pre-anesthesia 
visit 
While 
inpatient 
Discharge 
visit 
During 
follow-up 
Post-surgery 
outpatient visit 
Post-surgery 
outpatient visit 
2-4 weeks  
pre-surgery 
 
  
6 to 10 days 
  
  
2 month 
post-surgery 
6 months 
post-surgery 
Informed consent 
X 
 
 
 
 
 
 
 
Body measurements1 
X 
 
 
  
  
  
  
  
Baseline 
questionnaires7 
X 
 
 
 
 
 
 
 
Eligibility review  
X 
 
 
  
  
  
  
  
Randomization 
X 
 
 
 
 
 
 
 
Follow-up 
questionnaires7 
 
 
 
  
X 
  
X8 
X8 
AM-PAC  
outpatient form 
X 
 
 
  
X 
  
X 
X 
6MW test 
X 
 
  
  
X 
  
X 
X 
Short Physical 
Performance Battery  
X 
 
  
  
X 
  
X 
X 
Correlative blood 
collection 
 
 
X 
  
  
  
X 
  
Saliva sample 
 
 
 
  
  
  
 
X 
Respiratory function 
test 
X2 
 
(X)2 
  
X 
  
X 
X 
† PEP materials 
distribution3 
X 
 
  
  
X 
  
(X6) 
(X6) 
† PEP intervention 
(with PT) 
X 
 
  
 
  
  
X 
X 
† PEP intervention 
(home based) 
 
Daily 
 
 
 
Daily between visits 
† PT assessment + 
activity review  
X4 
 
  
X5 
X6 
 
X6 
X6 
† PT phone call + 
activity review7 
  
Weekly 
  
  
  
Weekly6 
  
  
† 
Only due for patients participating in the PEP intervention 
1. Body measurements will include height, weight, waist and hips measurements. 

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2. Respiratory function test is a standard of care procedure which can be completed at the pre-surgery visit OR the pre-anesthesia visit. 
3. Materials include an exercise packet (with exercise tool), diary/calendar, and activity tracker at baseline and new tracking diary/calendars at the follow-up visits.  
4. There will be no activity review at baseline (no activity started) and during the inpatient stay or at discharge (since the PEP intervention is on hold). 
5. While inpatient the physical therapist will assess the patient (including AM-PAC scoring) as needed depending on the patient’s condition.  
6. Activity review + AM-PAC scoring could lead to an adjustment in exercise mode / dosage as well as the patient being given a new version of the tracking diary. 
7. See details in Section 7.   
8. Not yet included. Will be submitted as an amendment 
7 QUESTIONNAIRES 
Concept/ Instruments 
# of Items 
Baseline 
pre-surgery visit 
Discharge 
1. Exercise 
 
2. Behavioral Regulation in Exercise Questionnaire (BREQ-3) 
24 
 
24 
3. Self-Efficacy (Sallis)  
James F. Sallis et al; The development of self-efficacy scales for 
healthrelated diet and exercise behaviors, Health Education Research, 
Volume 3, Issue 3, 1 September 1988, Pages 283–292 
12 
 
12 
4. Social Support for Exercise (Sallis) 
Sallis JF et al. The development of scales to measure social support for diet 
and exercise behaviors. Prev Med. 1987;16(6):825-36. Epub 1987/11/01. 
PubMed PMID: 3432232. 
13 
 
13 
5. Your health and well-being 
6. FACT-L 
37 
37 
37 
7. Pain scale (1-10) 
2 
2 
2 
8. FACIT-F, chronic illness fatigue scale 
13 
13 
13 
9. Your sleep habits 
10. PSQI (Pittsburgh sleep quality index) 
10 
10 
10 

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11. Activities of daily life 
12. Activities of daily life – from WHI form 155;  
https://www.whi.org/researchers/studydoc/WHI%20Forms/F155%20v1.pdf 
(bottom, page 5) 
7 
7 
 
13. Your Personal Habits 
14. Weight change – from WHI form 34 
https://www.whi.org/researchers/studydoc/WHI%20Forms/F034%20v2.pdf 
(Form F34, WHI, page 4) 
2 
2 
 
15. Physical activity/ exercise, asks about the usual physical activity and 
exercise – from WHI form 155 
https://www.whi.org/researchers/studydoc/WHI%20Forms/F155%20v1.pdf 
(Form F155, WHI, page 4-5) 
3 
3 
 
16. Tobacco history – from David Wetter 
11 
11 
 
17. Your thoughts and feelings 
18. Modified Differential Emotion Scale (mDES), Emotion experience during 
the past 24 hours 
20 
 
20 
19. WHI Emotions during past week – from WHI form 155 
https://www.whi.org/researchers/studydoc/WHI%20Forms/F034%20v2.pdf 
(Form F155, WHI, page 14) 
12 
12 
 
20 Loneliness (Cacioppo) 
Hughes, M. E. et al. (2004). A short scale for measuring loneliness in large 
surveys: Results from two population-based studies. Research on Aging, 
26(6), 655-672. DOI: 10.1177/0164027504268574 
3 
 
3  
21 Your background 
22 Birthday – ColoCare Questionnaire 
1 
1 
 
23 Sex – ColoCare Questionnaire 
1 
1 
 
24 Ethnicity – ColoCare Questionnaire 
3 
3 
 

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25 Education – ColoCare Questionnaire 
1 
1 
 
26 Marital Status – ColoCare Questionnaire 
1 
1 
 
27 Income – ColoCare Questionnaire 
2 
2 
 
28 Weight – ColoCare Questionnaire 
2 
2 
 
29 Height – ColoCare Questionnaire 
1 
1 
 
30 Subjective Social Status Ladders – from David Wetter 
2 
2 
 
31 Your financial situation 
32 Financial Strain– COST Questionnaire 
8 
8 
 
33 Living condition (nursing home, relationship etc.) 
 
34 Living conditions – from WHI questionnaire form 155 
https://www.whi.org/researchers/studydoc/WHI%20Forms/F155%20v1.pdf 
(Form 34, page 6) 
3 
2 
 
35 Others 
36 PROMIS Score (Dimensions)  
CAT  
Part of every clinical visit 

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8 STUDY PROCEDURES 
8.1 Pre-Surgery Clinic Visit 
During their pre-surgery clinic visit (which typically takes place 2-4 weeks prior to 
surgery), all lung cancer patients who are surgical candidates (as determined by the 
surgeon) will be approached about the PEP study. Patients who are interested and 
potentially eligible will undergo the following procedures: 
 Informed consent. 
 Verification of the patient’s eligibility for the study. 
 Randomization. 
 Baseline assessments by physical therapist including: 
o Body measurements (height, weight, waist and hips measurements). 
o Medical history, medication use. 
o AM-PAC mobility score (via the 18 questions AM-PAC outpatient form). 
o 6 Minute Walk Test (6MW) and Short Physical Performance Battery 
(SPPB). 
 Respiratory function tests (spirometry: FEV1, PEF, VC, IRV, ERV). 
 Baseline questionnaires (all patients – details in Section 7).  
Patients randomized to the Intervention arm will also receive the following: 
 Exercise packet (with exercise tool), instruction for access to supplementary 
instructional video, tracking diary/calendar, and activity tracker for the home-
based pre-surgical exercise program. 
 Individual instruction by physical therapist (verbal and written) about the 
individual exercise modes and dosages to be performed at home and first PEP 
intervention. 
8.2 In the Weeks Leading to Surgery (Outpatient) 
During the 2 to 4 weeks before the surgery, patients randomized to the Intervention arm 
will complete a daily PEP intervention as instructed by the physical therapist and record 
their activity on the tracking diary/calendar.  
Weekly telephone calls or TeleHealth interactions (including video chat) between the 
patient and the physical therapist will take place to answer questions and optimize 
patient engagement. Ongoing monitoring of attitudes and barriers to exercise will occur 
and strategies for encouraging uptake of the exercise intervention will be individually 
tailored. 
8.3 Pre-Anesthesia Visit 
At the time of the pre-anesthesia visits the following procedures will be done for all 
patients: 
 Respiratory function tests (spirometry: FEV1, PEF, VC, IRV, ERV) only if they 
were not performed at the pre-surgery visit. 

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 Correlative blood samples collection. 
8.4 Inpatient Stay  
The inpatient stay post-surgery is expected to last from 5 to 10 days and will include 
assessments by the physical therapist for all patients. The frequency of the assessments 
will follow standard of care guidelines and is dependent on the patient’s condition. 
8.5 Hospital Discharge Visit 
The following procedures will be completed at the discharge visit: 
 Assessment by physical therapist including: 
o AM-PAC mobility score (18 questions outpatient form). 
o Education on acute and sub-acute post-operative mobility limitations. 
 6 Minute Walk test (6MWT) and Short Physical Performance Battery (SPPB). 
 Follow-up questionnaires (see section 6 for details). 
 Distribution of tracking diary/calendar. 
Patients randomized to the Intervention arm will also receive the following: 
 Review of home exercises and, if needed, adjustments to the mode/dose of the 
exercise regimen (for patients randomized to the Intervention arm only). 
 Patients randomized to the Intervention arm will also receive the following: 
8.6 During the Follow-Up (Outpatient) 
For patients randomized to the Intervention arm, weekly telephone calls or TeleHealth 
interactions between the participant and the physical therapist will continue as 
described in section 8.3. 
8.7 Follow-Up Clinic Visits (2 and 6 Months Post-Surgery). 
The following procedures will be completed at the follow-up visits scheduled 2 and 6 
months after surgery: 
 Assessment by physical therapist including AM-PAC mobility score (18 
questions outpatient form). 
 6 Minute Walk test (6MW) and Short Physical Performance Battery (SPPB) 
 Respiratory function tests (spirometry: FEV1, PEF, VC, IRV, ERV) 
 Follow-up questionnaires 
 Distribution of tracking diary/calendar  
 Correlative blood samples collection (2 months follow-up only) 
 Saliva samples (6 months follow-up only). 
Patients randomized to the Intervention arm will also receive the following: 
 Review of tracking diary/calendar 
 If needed, adjustments to the mode/dose of the exercise regimen 

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9 CRITERIA FOR EVALUATION OF ENDPOINTS 
9.1 Physical Function Performance 
The primary endpoint associated with the evaluation of improvement in mobility 
performance is the result of the 6MW test (6MW distance). The distance patients can 
walk indoors on a 25 meters level smooth-surfaced track over the course of 6 minutes 
will be measured at baseline as well as at the time of discharge and at the 2 and 6 
months follow-up. Median distances will be computed for each arm at the various time 
points and the expected post-surgery decline and recovery during follow-up will be 
compared between arms.  
A secondary endpoint associated with the evaluation of improvement in physical 
performance is the result of the short physical performance battery test. The SPPB score 
(ranging from 1 to 12) will be obtained for each patient at the time points described 
above. Medians will be obtained and compared for each arm. 
9.2 Patient Reported Outcomes 
Questionnaires aimed at measuring disease specific symptoms, multidimensional 
fatigue, common mental health issues (i.e., depression, anxiety, and alcohol use), and 
hypothesized treatment mechanisms will be obtained on this study at baseline, at 
discharge, and at the 2 and 6 months follow-up. The effect of the PEP intervention on 
patient reported outcomes will be evaluated by comparison between each arm of the 
study. 
9.3 Respiratory Function Status 
The effect of the PEP intervention on respiratory functional status will be evaluated by 
comparison of the following parameters between each arm of the study: FEV1, PEF, 
VC, IRV, and ERV. These will be measured at baseline, discharge, and at the 2 and 6 
months follow-up. 
9.4 Exploratory Objectives 
Data gathered from all patients who received the PEP intervention and pertaining to the 
quality of the intervention, participation in the intervention, and attitudes toward 
exercise (obtained via questionnaires) will be analyzed. 
Additionally, the effects of the PEP intervention on the following will be evaluated by 
comparison between each arm of the study: 
 Rate of complications (pulmonary and cardiac events, other complications 
requiring treatment [e.g., liver dysfunction, gastric ulcer, wound infection, 
colitis, depression], readmissions, and deaths within the first 30 days after 
discharge). 
 Length of stay post-surgical intervention.  
Finally, the effects of the PEP intervention on the following will be evaluated by 
comparison between each arm of the study: 

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 Total cost of care and utilization (obtained through the UUHS VDO, the Utah 
APCD, daily electronic diaries, and time-line follow-back) 
 Levels of potential prognostic or mechanistic biomarkers such as inflammatory 
biomarkers, in serum, plasma, and buffy coat. 
10 STATISTICAL CONSIDERATIONS 
10.1 Randomization 
Randomization will have a uniform 1:1 allocation ratio with block sizes of 8. The 
random allocation sequence will be stratified by pre-treatment AM-PAC stage only; 
based on primary data (as described in section 2.4), the AM-PAC stage is sufficient to 
assess physical function.  
10.2 Outcomes, Power, and Sample Size Considerations 
Objectives and endpoints are described in Section 1. Covariates used in sensitivity or 
mediation analysis of the objectives will be age, gender, baseline smoking status, 
primary or secondary lung cancer, neoadjuvant treatment, tumor stage, baseline level 
of outcome, pain, sleep. 
Power calculations are based on the group effect in an analysis of covariance for the 
6MW test at 8 weeks, with baseline 6MW test as covariate. The planned sample size 
(n = 200) allows for a 25% dropout rate (the main reasons for drop outs observed during 
the pilot study was found to be complications or poor health status preventing follow-
up visits as well as distance to study site), leaving at least 150 subjects evaluable for 
the primary endpoint. The hypothesis is that the difference in the 6MW distance 
between the study arms (Intervention vs. Control) will be ≥ 39.95 m. This effect size 
stems from a meta-analysis where 4 weeks of post-surgery exercise training provided 
a 39.95 increase in the 6MW distance in NSCLC patients.87 Consistent with Arbane,11 
SD = 100 m and correlation = 0.5 between repeated 6MW test measurements on the 
same subject are assumed. Power to detect the treatment effect was estimated by 
simulation (in R) of an analysis of covariance model with 6MW test at 2 months post-
surgery as outcome, treatment group as primary predictor and pretreatment 6MW test 
as covariate. Pre and post 6MW test was assumed to be bivariate normally distributed. 
10.3 Primary Endpoint Analysis 
Analyses will include all patients that are evaluable for our primary endpoint (expected 
at least n=150). The primary outcome will be the group effect for an analysis of 
covariance model with 6MW test at 2 months post-surgery as outcome and 
pretreatment 6MW test as covariate, tested at the nominal two-sided 0.05 significance 
level. A sensitivity analysis will be performed with additional adjustment variables 
(listed as covariates in Section 10.1). Missing data will be handled using multivariate 
imputation by chained equations 88 as implemented in the R package “mice”. 
10.4 Other Endpoint Analyses 
The approach to testing for group differences for each continuous outcome (e.g., quality 
of life and fatigue summary scales, pulmonary function, length of stay after surgical 

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resection, cost) will be to test for the group effect in an analysis of covariance model 
with adjustment for covariates listed in Section 10.1 as well as baseline values of the 
outcome variable when available.  
The proportion of patients who continue to smoke post-surgery is expected to be too 
small to include as a reliable adjustment variable or outcome (~ 5%).89 Former smokers 
will be tested at the 6 month clinic visit to assess smoking recidivism (saliva). A 
separate descriptive analysis will be performed in the subset of smokers.  
An analogous approach will be used for endpoints coded as binary variables 
(complications, readmission) using logistic regression models instead of analysis of 
covariance models. If diagnostics plots show significant deviation from model 
assumptions, then a separate sensitivity analysis will be performed using appropriate 
robust regression methods such as those available in the “robustbase” package in R. 
The study design provides 96% power to detect a 10 point increase in FACT-L in the 
Intervention Group compared to the Control Group, similar to the effect of aerobic 
training on FACT-L reported in Jones.46 
For estimation of mediation, mixed effects regression analysis will be performed with 
random slope and intercept for each participant and unstructured covariance matrix. 
The direct and indirect effects of the intervention will be examined. Indirect effects 
analysis can provide important information about underlying mechanisms (e.g. 
treatments could achieve the same outcome via different mechanisms). Particular 
attention will be paid to the potential mediating/moderating effects of pain and self-
efficacy. For indirect effects analyses, sensitivity analyses will be conducted to 
examine the robustness of effects under different assumptions regarding missing data. 
Gender-specific effects of the intervention will also be investigated. 
11 REGISTRATION GUIDELINES 
Patients must meet all of the eligibility requirements listed in Section 5 prior to 
registration.   
Patients must not have any study procedures or begin protocol treatment prior to 
registration. 
To register eligible patients on study, complete a Clinical Trials Office Patient Registration 
Form and submit to: CTORegistrations@hci.utah.edu. 
Randomization to the Intervention or Control Arm will be done at the time of enrollment 
by the enrolling coordinator using OnCore (the Clinical Trials Office’s electronic clinical 
research management system).  
12 DATA SUBMISSION SCHEDULE 
The Case Report Forms (CRFs) for this study are a set of electronic forms for each patient 
that provides a record of the data generated according to the protocol. CRFs should be 
created prior to the study being initiated and updated (if applicable) when amendments to 
the protocol are IRB approved. Data capture should be restricted to endpoints and relevant 

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patient information required for planned manuscripts. These forms will be completed on 
an on-going basis during the study. The medical records will be source of verification of 
the data. During the study, the CRFs will be monitored for completeness, accuracy, 
legibility and attention to detail by a member of the Research Compliance Office. The 
CRFs will be completed by the Investigator or a member of the study team as listed on the 
Delegation of Duties Log. The data will be reviewed no less than annually by the Data and 
Safety Monitoring Committee. The Investigator will allow the Data and Safety Monitoring 
Committee or Research Compliance Office personnel access to the patient source 
documents, clinical supplies dispensing and storage area, and study documentation for the 
above-mentioned purpose. The Investigator further agrees to assist the site visitors in their 
activities. 
13 SPECIAL INSTRUCTIONS  
13.1 Correlative Studies 
13.1.1 Blood  
Correlative blood samples will be taken at the pre-operative visit as well as at the 2 
months post-surgery visit.  
One 10mL red top tube and one 10mL EDTA tube will be collected at each visit. Serum, 
plasma and buffy coat will be stored for future analysis. 
13.1.2 Saliva 
Patients will be asked to collect a saliva sample at 6 months follow-up.  
14 ETHICAL AND REGULATORY CONSIDERATIONS 
14.1 Informed Consent  
Informed consent will be obtained from all research participants prior to performing 
any study procedures using the most recent IRB approved version.  
14.2 Institutional Review 
This study will be approved by the Institutional Review Board of University of Utah. 
14.3  Data and Safety Monitoring Plan 
A Data and Safety Monitoring Committee (DSMC) is established at Huntsman Cancer 
Institute (HCI) and approved by the NCI to assure the well-being of patients enrolled 
in Investigator Initiated Trials that do not have an outside monitoring review. Roles 
and responsibilities of the DSMC are set forth in the NCI approved plan. The activities 
of this committee include a quarterly review of adverse events including SAEs, 
important medical events, significant revisions or amendments to the protocol, and 
approval of cohort/dose escalations. If the DSMC and/or the PI have concerns about 
unexpected safety issues, the study will be stopped and will not be resumed until the 

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
Version Date: 9/11/2017 
Principal Investigator: Cornelia Ulrich, MS, PhD 
Page 31 of 44 
issues are resolved. The DSMC also reviews and approves audit reports generated by 
the Research Compliance Office.  
14.4 Adverse Events / Serious Adverse Events 
An adverse event is the appearance or worsening of any undesirable sign, symptom, or 
medical condition occurring after starting the study drug even if the event is not 
considered to be related to study drug. For the purposes of this study, the terms toxicity 
and adverse event are used interchangeably. Medical conditions/diseases present before 
starting study drug are only considered adverse events if they worsen after starting the 
PEP regimen. Abnormal test results constitute adverse events only if they induce 
clinical signs or symptoms, are considered clinically significant, or require therapy. 
For this low-risk study, information about a subset of adverse events of interest will be 
collected, recorded and followed as appropriate. This subset includes all injuries, 
events, and conditions which could be related to the PEP intervention and require 
medical attention. 
The occurrence of adverse events should be sought by non-directive questioning of the 
patient at each visit or phone contact during the study. Adverse events also may be 
detected when they are volunteered by the patient during or between visits or through 
physical examination or other assessments. As far as possible, each adverse event 
should be evaluated to determine: 
1. Its severity grade based on CTCAE v.4 (grade 1-5). 
2. Its relationship to the PEP intervention (definite, probable, possible, unlikely, 
not related). 
3. Its duration (start and end dates or if continuing at final exam). 
4. Action taken (no action taken; PEP intervention adjusted, temporarily 
interrupted, permanently discontinued due to this adverse event; concomitant 
medication taken; 
non-drug therapy 
given; 
hospitalization/prolonged 
hospitalization). 
5. Whether it constitutes an SAE. 
All adverse events will be treated appropriately. Such treatment may include changes 
in the intervention (as described in Figure 2). Once an adverse event is detected, it 
should be followed until its resolution, and assessment should be made at each visit (or 
more frequently, if necessary) of any changes in severity, the suspected relationship to 
the PEP regimen, the interventions required to treat it, and the outcome. 
14.5 SAE Reporting Requirements 
SAEs must be reported to the DSMC as well as the IRB and the FDA (when applicable) 
according to the requirements described below: 
The Investigator (or a properly delegated study team member) must complete a 
MedWatch 3500A form and submit it to the Research Compliance Office 
(compliance@hci.utah.edu) as soon as possible, but no later than 10 business days of 
first knowledge or notification of the event (5 business days for fatal or life threatening 
event). 

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
Version Date: 9/11/2017 
Principal Investigator: Cornelia Ulrich, MS, PhD 
Page 32 of 44 
14.5.1 DSMC Notifications 
Upon receipt of the MedWatch 3500A, an HCI Ressearch Compliance Officer will 
process and submit the form to the proper DSMC member as necessary for this study.  
The RCO will summarize and present all reported SAEs according to the Data and 
Safety Monitoring Plan at the quarterly DSMC meeting. 
14.5.2 IRB Notifications 
Events meeting the University of Utah IRB reporting requirements (described at 
(https://irb.utah.edu) will be submitted by the Investigator (or a properly delegated 
study team member) through the IRB’s electronic reporting system (ERICA) within 10 
working days. 
14.5.3 FDA Notifications 
Adverse events occurring during the course of a clinical study that meet the following 
criteria will be promptly reported to the FDA: 
 Serious 
 Unexpected 
 Definitely, probably, or possibly related to the intervention 
Fatal or life-threatening events which meet the criteria above will be reported within 7 
calendar days after first knowledge of the event by the investigator; followed by as 
complete a report as possible within 8 additional calendar days. 
All other events that meet the criteria above will be reported within 15 calendar days 
after first knowledge of the event by the investigator. 
Prior to submission to the FDA, the RCO will review the MedWatch report for 
completeness, accuracy and applicability to the regulatory reporting requirements. The 
MedWatch report will then be submitted to the FDA through the voluntary reporting 
method by the Regulatory Coordinator. 
14.6 Protocol Amendments 
Any amendments or administrative changes in the research protocol during the period, 
for which the IRB approval has already been given, will not be initiated without 
submission of an amendment for IRB review and approval.    
These requirements for approval will in no way prevent any immediate action from 
being taken by the investigator in the interests of preserving the safety of all patients 
included in the trial. 
14.7 Protocol Deviations 
A protocol deviation (or violation) is any departure from the defined procedures and 
treatment plans as outlined in the protocol version submitted and previously approved 
by the IRB. Protocol deviations have the potential to place participants at risk and can 
also undermine the scientific integrity of the study thus jeopardizing the justification 
for the research.  Protocol deviations are unplanned and unintentional events.  

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
Version Date: 9/11/2017 
Principal Investigator: Cornelia Ulrich, MS, PhD 
Page 33 of 44 
Because some protocol deviations pose no conceivable threat to participant safety or 
scientific integrity, reporting is left to the discretion of the PI within the context of the 
guidelines below. The IRB requires the prompt reporting of protocol deviations 
which are: 
 
Exceptions to eligibility criteria. 
 
Intended to eliminate apparent immediate hazard to a research participant, 
or  
 
Harmful (caused harm to participants or others, or place them at increased 
risk of harm - including physical, psychological, economic, or social 
harm), or  
 
Possible serious or continued noncompliance 
14.8 FDA Annual Reporting  
This study is IND exempt therefore there are no annual reporting requirements to the 
FDA.   
14.9 Clinical Trials Data Bank  
The study will be registered on http://clinicaltrials.gov and the NCI CTRP (Clinical 
Trials Reporting Program) by the Clinical Trials Office. 
 
 

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
Version Date: 9/11/2017 
Principal Investigator: Cornelia Ulrich, MS, PhD 
Page 34 of 44 
15 BIBLIOGRAPHY 
 
1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016;66(1):7-30. 
doi: 10.3322/caac.21332. PubMed PMID: 26742998. 
2. Schwartz 
D. 
Secondary 
Lung 
Tumors2014 
10.28.2016. 
Available 
from: 
http://emedicine.medscape.com/article/426820-overview. 
3. Pastorino U, Buyse M, Friedel G, Ginsberg RJ, Girard P, Goldstraw P, Johnston M, 
McCormack P, Pass H, Putnam JB, Jr. Long-term results of lung metastasectomy: prognostic 
analyses based on 5206 cases. J Thorac Cardiovasc Surg. 1997;113(1):37-49. Epub 
1997/01/01. PubMed PMID: 9011700. 
4. Hornbech K, Ravn J, Steinbruchel DA. Outcome after pulmonary metastasectomy: analysis of 
5 years consecutive surgical resections 2002-2006. J Thorac Oncol. 2011;6(10):1733-40. Epub 
2011/08/27. doi: 10.1097/JTO.0b013e3182287da2. PubMed PMID: 21869715. 
5. Younes RN, Fares AL, Gross JL. Pulmonary metastasectomy: a multivariate analysis of 440 
patients undergoing complete resection. Interact Cardiovasc Thorac Surg. 2012;14(2):156-61. 
Epub 2011/12/14. doi: 10.1093/icvts/ivr076. PubMed PMID: 22159255; PubMed Central 
PMCID: PMCPmc3279984. 
6. Larsen KR, Svendsen UG, Milman N, Brenoe J, Petersen BN. Cardiopulmonary function at 
rest and during exercise after resection for bronchial carcinoma. Ann Thorac Surg. 
1997;64(4):960-4. Epub 1997/11/14. PubMed PMID: 9354509. 
7. Casiraghi M, De Pas T, Maisonneuve P, Brambilla D, Ciprandi B, Galetta D, Borri A, Gasparri 
R, Petrella F, Tessitore A, Guarize J, Donghi SM, Veronesi G, Solli P, Spaggiari L. A 10-year 
single-center experience on 708 lung metastasectomies: the evidence of the "international 
registry 
of 
lung 
metastases". 
J 
Thorac 
Oncol. 
2011;6(8):1373-8. 
doi: 
10.1097/JTO.0b013e3182208e58. PubMed PMID: 21642869. 
8. Baser S, Shannon VR, Eapen GA, Jimenez CA, Onn A, Keus L, Lin E, Morice RC. Pulmonary 
dysfunction as a major cause of inoperability among patients with non-small-cell lung cancer. 
Clin Lung Cancer. 2006;7(5):344-9. Epub 2006/04/28. doi: 10.3816/CLC.2006.n.017. PubMed 
PMID: 16640807. 
9. Institute USNIohNC. Cancer Trends Progress Report - Financial Burden of Cancer Care 2015 
[10.28.2016]. Available from: http://www.progressreport.cancer.gov/after/economic_burden. 
10. Johnsen AT, Petersen MA, Pedersen L, Groenvold M. Symptoms and problems in a nationally 
representative sample of advanced cancer patients. Palliat Med. 2009;23(6):491-501. Epub 
2009/05/16. doi: 10.1177/0269216309105400. PubMed PMID: 19443525. 
11. Arbane G, Tropman D, Jackson D, Garrod R. Evaluation of an early exercise intervention after 
thoracotomy for non-small cell lung cancer (NSCLC), effects on quality of life, muscle strength 
and exercise tolerance: randomised controlled trial. Lung Cancer. 2011;71(2):229-34. Epub 
2010/06/15. doi: 10.1016/j.lungcan.2010.04.025. PubMed PMID: 20541832. 
12. Brunelli A, Belardinelli R, Refai M, Salati M, Socci L, Pompili C, Sabbatini A. Peak oxygen 
consumption during cardiopulmonary exercise test improves risk stratification in candidates to 
major lung resection. Chest. 2009;135(5):1260-7. Epub 2008/11/26. doi: 10.1378/chest.08-
2059. PubMed PMID: 19029436. 
13. Jones LW, Eves ND, Haykowsky M, Freedland SJ, Mackey JR. Exercise intolerance in cancer 
and the role of exercise therapy to reverse dysfunction. Lancet Oncol. 2009;10(6):598-605. 
Epub 2009/06/02. doi: 10.1016/s1470-2045(09)70031-2. PubMed PMID: 19482248. 
14. Pompili C, Brunelli A, Xiume F, Refai M, Salati M, Sabbatini A. Predictors of postoperative 
decline in quality of life after major lung resections. Eur J Cardiothorac Surg. 2011;39(5):732-
7. Epub 2010/10/12. doi: 10.1016/j.ejcts.2010.08.046. PubMed PMID: 20926306. 
15. Celli BR. Chronic respiratory failure after lung resection: the role of pulmonary rehabilitation. 
Thorac Surg Clin. 2004;14(3):417-28. Epub 2004/09/24. doi: 10.1016/s1547-4127(04)00017-
9. PubMed PMID: 15382772. 

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
Version Date: 9/11/2017 
Principal Investigator: Cornelia Ulrich, MS, PhD 
Page 35 of 44 
16. Pelletier C, Lapointe L, LeBlanc P. Effects of lung resection on pulmonary function and 
exercise capacity. Thorax. 1990;45(7):497-502. Epub 1990/07/01. PubMed PMID: 2396230; 
PubMed Central PMCID: PMCPmc462576. 
17. Wildgaard K, Ravn J, Nikolajsen L, Jakobsen E, Jensen TS, Kehlet H. Consequences of 
persistent pain after lung cancer surgery: a nationwide questionnaire study. Acta Anaesthesiol 
Scand. 2011;55(1):60-8. Epub 2010/11/17. doi: 10.1111/j.1399-6576.2010.02357.x. PubMed 
PMID: 21077845. 
18. Christensen T, Bendix T, Kehlet H. Fatigue and cardiorespiratory function following 
abdominal surgery. Br J Surg. 1982;69(7):417-9. Epub 1982/07/01. PubMed PMID: 7104617. 
19. Thomas DR, Ritchie CS. Preoperative assessment of older adults. J Am Geriatr Soc. 
1995;43(7):811-21. Epub 1995/07/01. PubMed PMID: 7602039. 
20. Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, Newhouse JP, Weiler 
PC, Hiatt HH. Incidence of adverse events and negligence in hospitalized patients. Results of 
the Harvard Medical Practice Study I. N Engl J Med. 1991;324(6):370-6. Epub 1991/02/07. 
doi: 10.1056/nejm199102073240604. PubMed PMID: 1987460. 
21. Wilson RJ, Davies S, Yates D, Redman J, Stone M. Impaired functional capacity is associated 
with all-cause mortality after major elective intra-abdominal surgery. Br J Anaesth. 
2010;105(3):297-303. Epub 2010/06/25. doi: 10.1093/bja/aeq128. PubMed PMID: 20573634. 
22. Lawrence VA, Hazuda HP, Cornell JE, Pederson T, Bradshaw PT, Mulrow CD, Page CP. 
Functional independence after major abdominal surgery in the elderly. J Am Coll Surg. 
2004;199(5):762-72. Epub 2004/10/27. doi: 10.1016/j.jamcollsurg.2004.05.280. PubMed 
PMID: 15501119. 
23. Sebio Garcia R, Yanez Brage MI, Gimenez Moolhuyzen E, Granger CL, Denehy L. Functional 
and postoperative outcomes after preoperative exercise training in patients with lung cancer: a 
systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2016;23(3):486-97. 
Epub 2016/05/27. doi: 10.1093/icvts/ivw152. PubMed PMID: 27226400. 
24. Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin 
ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL. 
American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. 
Med 
Sci 
Sports 
Exerc. 
2010;42(7):1409-26. 
Epub 
2010/06/19. 
doi: 
10.1249/MSS.0b013e3181e0c112 
00005768-201007000-00023 
[pii]. 
PubMed 
PMID: 
20559064. 
25. Rock CL, Flatt SW, Byers TE, Colditz GA, Demark-Wahnefried W, Ganz PA, Wolin KY, 
Elias A, Krontiras H, Liu J, Naughton M, Pakiz B, Parker BA, Sedjo RL, Wyatt H. Results of 
the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: 
a behavioral weight loss intervention in overweight or obese breast cancer survivors. J Clin 
Oncol. 2015;33(28):3169-76. Epub 2015/08/19. doi: 10.1200/jco.2015.61.1095. PubMed 
PMID: 26282657; PubMed Central PMCID: PMCPmc4582146. 
26. Morey MC, Blair CK, Sloane R, Cohen HJ, Snyder DC, Demark-Wahnefried W. Group 
trajectory analysis helps to identify older cancer survivors who benefit from distance-based 
lifestyle 
interventions. 
Cancer. 
2015;121(24):4433-40. 
Epub 
2015/10/30. 
doi: 
10.1002/cncr.29684. PubMed PMID: 26512712; PubMed Central PMCID: PMCPmc4670587. 
27. Kenzik KM, Morey MC, Cohen HJ, Sloane R, Demark-Wahnefried W. Symptoms, weight loss, 
and physical function in a lifestyle intervention study of older cancer survivors. J Geriatr Oncol. 
2015;6(6):424-32. Epub 2015/09/13. doi: 10.1016/j.jgo.2015.08.004. PubMed PMID: 
26362355; PubMed Central PMCID: PMCPmc4662250. 
28. Demark-Wahnefried W, Rogers LQ, Alfano CM, Thomson CA, Courneya KS, Meyerhardt JA, 
Stout NL, Kvale E, Ganzer H, Ligibel JA. Practical clinical interventions for diet, physical 
activity, and weight control in cancer survivors. CA Cancer J Clin. 2015;65(3):167-89. Epub 
2015/02/17. doi: 10.3322/caac.21265. PubMed PMID: 25683894. 

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
Version Date: 9/11/2017 
Principal Investigator: Cornelia Ulrich, MS, PhD 
Page 36 of 44 
29. Demark-Wahnefried W, Colditz GA, Rock CL, Sedjo RL, Liu J, Wolin KY, Krontiras H, Byers 
T, Pakiz B, Parker BA, Naughton M, Elias A, Ganz PA. Quality of life outcomes from the 
Exercise and Nutrition Enhance Recovery and Good Health for You (ENERGY)-randomized 
weight loss trial among breast cancer survivors. Breast Cancer Res Treat. 2015;154(2):329-37. 
Epub 2015/11/01. doi: 10.1007/s10549-015-3627-5. PubMed PMID: 26518022; PubMed 
Central PMCID: PMCPMC4654570. 
30. Denlinger CS, Ligibel JA, Are M, Baker KS, Demark-Wahnefried W, Dizon D, Friedman DL, 
Goldman M, Jones L, King A, Ku GH, Kvale E, Langbaum TS, Leonardi-Warren K, McCabe 
MS, Melisko M, Montoya JG, Mooney K, Morgan MA, Moslehi JJ, O'Connor T, Overholser 
L, Paskett ED, Peppercorn J, Raza M, Rodriguez MA, Syrjala KL, Urba SG, Wakabayashi MT, 
Zee P, McMillian NR, Freedman-Cass DA. Survivorship: healthy lifestyles, version 2.2014. J 
Natl Compr Canc Netw. 2014;12(9):1222-37. Epub 2014/09/06. PubMed PMID: 25190692; 
PubMed Central PMCID: PMCPmc4465248. 
31. Jones LW. Precision oncology framework for investigation of exercise as treatment for cancer. 
J Clin Oncol. 2015;33(35):4134-7. Epub 2015/10/16. doi: 10.1200/jco.2015.62.7687. PubMed 
PMID: 26460301. 
32. Hoffman AJ, Brintnall RA, von Eye A, Jones LW, Alderink G, Patzelt LH, Brown JK. Home-
based exercise: promising rehabilitation for symptom relief, improved functional status and 
quality of life for post-surgical lung cancer patients. J Thorac Dis. 2014;6(6):632-40. Epub 
2014/07/01. doi: 10.3978/j.issn.2072-1439.2014.06.08. PubMed PMID: 24976984; PubMed 
Central PMCID: PMCPmc4073408. 
33. Jones LW, Alfano CM. Exercise-oncology research: past, present, and future. Acta Oncol. 
2013;52(2):195-215. Epub 2012/12/19. doi: 10.3109/0284186x.2012.742564. PubMed PMID: 
23244677. 
34. Horneber M, Fischer I, Dimeo F, Ruffer JU, Weis J. Cancer-related fatigue: epidemiology, 
pathogenesis, diagnosis, and treatment. Dtsch Arztebl Int. 2012;109(9):161-71; quiz 72. Epub 
2012/03/31. doi: 10.3238/arztebl.2012.0161. PubMed PMID: 22461866; PubMed Central 
PMCID: PMCPmc3314239. 
35. Thomas ML, Elliott JE, Rao SM, Fahey KF, Paul SM, Miaskowski C. A randomized, clinical 
trial of education or motivational-interviewing-based coaching compared to usual care to 
improve cancer pain management. Oncol Nurs Forum. 2012;39(1):39-49. Epub 2011/12/29. 
doi: 10.1188/12.onf.39-49. PubMed PMID: 22201654. 
36. Price A, Goodwin L, Rayner L, Shaw E, Hansford P, Sykes N, Monroe B, Higginson I, Hotopf 
M, Lee W. Illness perceptions, adjustment to illness, and depression in a palliative care 
population. J Pain Symptom Manage. 2012;43(5):819-32. Epub 2012/01/31. doi: 
10.1016/j.jpainsymman.2011.05.013. PubMed PMID: 22285286. 
37. Steindorf K, Schmidt ME, Klassen O, Ulrich CM, Oelmann J, Habermann N, Beckhove P, 
Owen R, Debus J, Wiskemann J, Potthoff K. Randomized, controlled trial of resistance training 
in breast cancer patients receiving adjuvant radiotherapy: results on cancer-related fatigue and 
quality 
of 
life. 
Ann 
Oncol. 
2014;25(11):2237-43. 
Epub 
2014/08/07. 
doi: 
10.1093/annonc/mdu374. PubMed PMID: 25096607. 
38. Benzo R, Wigle D, Novotny P, Wetzstein M, Nichols F, Shen RK, Cassivi S, Deschamps C. 
Preoperative pulmonary rehabilitation before lung cancer resection: results from two 
randomized 
studies. 
Lung 
Cancer. 
2011;74(3):441-5. 
Epub 
2011/06/15. 
doi: 
10.1016/j.lungcan.2011.05.011. PubMed PMID: 21663994; PubMed Central PMCID: 
PMC3191236. 
39. Bobbio A, Chetta A, Ampollini L, Primomo GL, Internullo E, Carbognani P, Rusca M, Olivieri 
D. Preoperative pulmonary rehabilitation in patients undergoing lung resection for non-small 
cell lung cancer. Eur J Cardiothorac Surg. 2008;33(1):95-8. Epub 2007/11/17. doi: 
10.1016/j.ejcts.2007.10.003. PubMed PMID: 18006327. 

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
Version Date: 9/11/2017 
Principal Investigator: Cornelia Ulrich, MS, PhD 
Page 37 of 44 
40. Cesario A, Ferri L, Galetta D, Cardaci V, Biscione G, Pasqua F, Piraino A, Bonassi S, Russo 
P, Sterzi S, Margaritora S, Granone P. Pre-operative pulmonary rehabilitation and surgery for 
lung 
cancer. 
Lung 
Cancer. 
2007;57(1):118-9. 
Epub 
2007/05/04. 
doi: 
10.1016/j.lungcan.2007.03.022. PubMed PMID: 17475363. 
41. Cesario A, Ferri L, Galetta D, Pasqua F, Bonassi S, Clini E, Biscione G, Cardaci V, di Toro S, 
Zarzana A, Margaritora S, Piraino A, Russo P, Sterzi S, Granone P. Post-operative respiratory 
rehabilitation after lung resection for non-small cell lung cancer. Lung Cancer. 2007;57(2):175-
80. Epub 2007/04/20. doi: 10.1016/j.lungcan.2007.02.017. PubMed PMID: 17442449. 
42. Coats V, Maltais F, Simard S, Frechette E, Tremblay L, Ribeiro F, Saey D. Feasibility and 
effectiveness of a home-based exercise training program before lung resection surgery. Can 
Respir J. 2013;20(2):e10-6. Epub 2013/04/26. PubMed PMID: 23616972; PubMed Central 
PMCID: PMC3630051. 
43. Divisi D, Di Francesco C, Di Leonardo G, Crisci R. Preoperative pulmonary rehabilitation in 
patients with lung cancer and chronic obstructive pulmonary disease. Eur J Cardiothorac Surg. 
2013;43(2):293-6. Epub 2012/05/17. doi: 10.1093/ejcts/ezs257. PubMed PMID: 22588033. 
44. Granger CL, Chao C, McDonald CF, Berney S, Denehy L. Safety and feasibility of an exercise 
intervention for patients following lung resection: a pilot randomized controlled trial. Integr 
Cancer Ther. 2013;12(3):213-24. Epub 2012/07/18. doi: 10.1177/1534735412450461. 
PubMed PMID: 22801943. 
45. Hoffman AJ, Brintnall RA, Brown JK, Eye A, Jones LW, Alderink G, Ritz-Holland D, Enter 
M, Patzelt LH, Vanotteren GM. Too sick not to exercise: using a 6-week, home-based exercise 
intervention for cancer-related fatigue self-management for postsurgical non-small cell lung 
cancer 
patients. 
Cancer 
Nurs. 
2013;36(3):175-88. 
Epub 
2012/10/12. 
doi: 
10.1097/NCC.0b013e31826c7763. PubMed PMID: 23051872. 
46. Jones LW, Eves ND, Peterson BL, Garst J, Crawford J, West MJ, Mabe S, Harpole D, Kraus 
WE, Douglas PS. Safety and feasibility of aerobic training on cardiopulmonary function and 
quality of life in postsurgical nonsmall cell lung cancer patients: a pilot study. Cancer. 
2008;113(12):3430-9. Epub 2008/11/07. doi: 10.1002/cncr.23967. PubMed PMID: 18988290. 
47. Jones LW, Peddle CJ, Eves ND, Haykowsky MJ, Courneya KS, Mackey JR, Joy AA, Kumar 
V, Winton TW, Reiman T. Effects of presurgical exercise training on cardiorespiratory fitness 
among patients undergoing thoracic surgery for malignant lung lesions. Cancer. 
2007;110(3):590-8. Epub 2007/06/22. doi: 10.1002/cncr.22830. PubMed PMID: 17582629. 
48. Peddle-McIntyre CJ, Bell G, Fenton D, McCargar L, Courneya KS. Feasibility and preliminary 
efficacy of progressive resistance exercise training in lung cancer survivors. Lung Cancer. 
2012;75(1):126-32. Epub 2011/07/01. doi: 10.1016/j.lungcan.2011.05.026. PubMed PMID: 
21715041. 
49. Pehlivan E, Turna A, Gurses A, Gurses HN. The effects of preoperative short-term intense 
physical therapy in lung cancer patients: a randomized controlled trial. Ann Thorac Cardiovasc 
Surg. 2011;17(5):461-8. Epub 2011/09/02. PubMed PMID: 21881371. 
50. Riesenberg H, Lubbe AS. In-patient rehabilitation of lung cancer patients--a prospective study. 
Support Care Cancer. 2010;18(7):877-82. Epub 2009/08/29. doi: 10.1007/s00520-009-0727-y. 
PubMed PMID: 19714371. 
51. Sekine Y, Chiyo M, Iwata T, Yasufuku K, Furukawa S, Amada Y, Iyoda A, Shibuya K, Iizasa 
T, Fujisawa T. Perioperative rehabilitation and physiotherapy for lung cancer patients with 
chronic obstructive pulmonary disease. Jpn J Thorac Cardiovasc Surg. 2005;53(5):237-43. 
Epub 2005/06/15. doi: 10.1007/s11748-005-0032-8. PubMed PMID: 15952314. 
52. Spruit MA, Janssen PP, Willemsen SC, Hochstenbag MM, Wouters EF. Exercise capacity 
before and after an 8-week multidisciplinary inpatient rehabilitation program in lung cancer 
patients: a pilot study. Lung Cancer. 2006;52(2):257-60. Epub 2006/03/15. doi: 
10.1016/j.lungcan.2006.01.003. PubMed PMID: 16529844. 

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
Version Date: 9/11/2017 
Principal Investigator: Cornelia Ulrich, MS, PhD 
Page 38 of 44 
53. Stigt JA, Uil SM, van Riesen SJ, Simons FJ, Denekamp M, Shahin GM, Groen HJ. A 
randomized controlled trial of postthoracotomy pulmonary rehabilitation in patients with 
resectable lung cancer. J Thorac Oncol. 2013;8(2):214-21. Epub 2012/12/15. doi: 
10.1097/JTO.0b013e318279d52a. PubMed PMID: 23238118. 
54. Wall LM. Changes in hope and power in lung cancer patients who exercise. Nurs Sci Q. 
2000;13(3):234-42. PubMed PMID: 11847803. 
55. Chang NW, Lin KC, Lee SC, Chan JY, Lee YH, Wang KY. Effects of an early postoperative 
walking exercise programme on health status in lung cancer patients recovering from lung 
lobectomy. 
J 
Clin 
Nurs. 
2014;23(23-24):3391-402. 
Epub 
2014/03/22. 
doi: 
10.1111/jocn.12584. PubMed PMID: 24646333. 
56. Edvardsen E, Skjonsberg OH, Holme I, Nordsletten L, Borchsenius F, Anderssen SA. High-
intensity training following lung cancer surgery: a randomised controlled trial. Thorax. 
2015;70(3):244-50. Epub 2014/10/18. doi: 10.1136/thoraxjnl-2014-205944. PubMed PMID: 
25323620. 
57. Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Randomised controlled trial on the effectiveness 
of home-based walking exercise on anxiety, depression and cancer-related symptoms in 
patients with lung cancer. Br J Cancer. 2015;112(3):438-45. Epub 2014/12/10. doi: 
10.1038/bjc.2014.612. 
PubMed 
PMID: 
25490525; 
PubMed 
Central 
PMCID: 
PMCPmc4453645. 
58. Gao K, Yu PM, Su JH, He CQ, Liu LX, Zhou YB, Pu Q, Che GW. Cardiopulmonary exercise 
testing screening and pre-operative pulmonary rehabilitation reduce postoperative 
complications and improve fast-track recovery after lung cancer surgery: A study for 342 cases. 
Thorac Cancer. 2015;6(4):443-9. Epub 2015/08/15. doi: 10.1111/1759-7714.12199. PubMed 
PMID: 26273399; PubMed Central PMCID: PMC4511322. 
59. Pouwels S, Fiddelaers J, Teijink JA, Woorst JF, Siebenga J, Smeenk FW. Preoperative exercise 
therapy in lung surgery patients: a systematic review. Respir Med. 2015. Epub 2015/08/26. doi: 
10.1016/j.rmed.2015.08.009. PubMed PMID: 26303337. 
60. Crandall K, Maguire R, Campbell A, Kearney N. Exercise intervention for patients surgically 
treated for Non-Small Cell Lung Cancer (NSCLC): a systematic review. Surg Oncol. 
2014;23(1):17-30. Epub 2014/02/18. doi: 10.1016/j.suronc.2014.01.001. PubMed PMID: 
24529937. 
61. Jette DU, Stilphen M, Ranganathan VK, Passek SD, Frost FS, Jette AM. Validity of the AM-
PAC "6-Clicks" inpatient daily activity and basic mobility short forms. Phys Ther. 
2014;94(3):379-91. Epub 2013/11/16. doi: 10.2522/ptj.20130199. PubMed PMID: 24231229. 
62. Tao W, Haley SM, Coster WJ, Ni P, Jette AM. An exploratory analysis of functional staging 
using an item response theory approach. Arch Phys Med Rehabil. 2008;89(6):1046-53. Epub 
2008/05/28. doi: 10.1016/j.apmr.2007.11.036. PubMed PMID: 18503798; PubMed Central 
PMCID: PMCPmc2677141. 
63. Jette AM, Haley SM, Tao W, Ni P, Moed R, Meyers D, Zurek M. Prospective evaluation of 
the AM-PAC-CAT in outpatient rehabilitation settings. Phys Ther. 2007;87(4):385-98. Epub 
2007/02/22. doi: 10.2522/ptj.20060121. PubMed PMID: 17311888. 
64. Weiss CO, Fried LP, Bandeen-Roche K. Exploring the hierarchy of mobility performance in 
high-functioning older women. J Gerontol A Biol Sci Med Sci. 2007;62(2):167-73. Epub 
2007/03/07. PubMed PMID: 17339641; PubMed Central PMCID: PMCPmc2788919. 
65. Adamsen L, Stage M, Laursen J, Rorth M, Quist M. Exercise and relaxation intervention for 
patients with advanced lung cancer: a qualitative feasibility study. Scand J Med Sci Sports. 
2012;22(6):804-15. Epub 2011/05/24. doi: 10.1111/j.1600-0838.2011.01323.x. PubMed 
PMID: 21599754. 
66. Oldervoll LM, Loge JH, Lydersen S, Paltiel H, Asp MB, Nygaard UV, Oredalen E, Frantzen 
TL, Lesteberg I, Amundsen L, Hjermstad MJ, Haugen DF, Paulsen O, Kaasa S. Physical 
exercise for cancer patients with advanced disease: a randomized controlled trial. Oncologist. 

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
Version Date: 9/11/2017 
Principal Investigator: Cornelia Ulrich, MS, PhD 
Page 39 of 44 
2011;16(11):1649-57. Epub 2011/09/29. doi: 10.1634/theoncologist.2011-0133. PubMed 
PMID: 21948693; PubMed Central PMCID: PMCPmc3233301. 
67. Quist M, Rorth M, Langer S, Jones LW, Laursen JH, Pappot H, Christensen KB, Adamsen L. 
Safety and feasibility of a combined exercise intervention for inoperable lung cancer patients 
undergoing chemotherapy: a pilot study. Lung Cancer. 2012;75(2):203-8. Epub 2011/08/06. 
doi: 10.1016/j.lungcan.2011.07.006. PubMed PMID: 21816503. 
68. Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. 
Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010;97(8):1187-
97. Epub 2010/07/06. doi: 10.1002/bjs.7102. PubMed PMID: 20602503. 
69. Winters-Stone KM, Neil SE, Campbell KL. Attention to principles of exercise training: a 
review of exercise studies for survivors of cancers other than breast. Br J Sports Med. 
2014;48(12):987-95. Epub 2013/01/08. doi: 10.1136/bjsports-2012-091732. PubMed PMID: 
23293010. 
70. Haley SM, Andres PL, Coster WJ, Kosinski M, Ni P, Jette AM. Short-form activity measure 
for post-acute care. Arch Phys Med Rehabil. 2004;85(4):649-60. Epub 2004/04/15. PubMed 
PMID: 15083443. 
71. Bade BC, Thomas DD, Scott JB, Silvestri GA. Increasing physical activity and exercise in lung 
cancer: reviewing safety, benefits, and application. J Thorac Oncol. 2015;10(6):861-71. Epub 
2015/04/02. doi: 10.1097/jto.0000000000000536. PubMed PMID: 25831230. 
72. Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons 
with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil 
Psychol. 2011;56(3):161-70. Epub 2011/07/20. doi: 10.1037/a0024509. PubMed PMID: 
21767036. 
73. Schwarzer R. Models of health behaviour change: intention as mediator or stage as moderator? 
Psychol Health. 2008;23(3):259-63. Epub 2008/04/01. doi: 10.1080/08870440801889476. 
PubMed PMID: 25160477. 
74. Marlatt GA, Donovan DM. Relapse prevention: maintanance strategies in the treatment of 
addictive behaviors. New York, NY: Guliford Press; 2005. 
75. Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004;31(2):143-
64. Epub 2004/04/20. doi: 10.1177/1090198104263660. PubMed PMID: 15090118. 
76. Marlatt GA, Gordon JR. Relapse prevention: maintenance strategies in the treatment of 
addictive behaviors. . New York, NY: Guilford Press; 1985. 
77. Kadden RM. Behavioral and cognitive-behavioral treatments for alcoholism: research 
opportunities. Addict Behav. 2001;26(4):489-507. Epub 2001/07/18. PubMed PMID: 
11456073. 
78. Schwarzer R, Sniehotter F, Lippke S, Luszczynska A, Scholz U, Schüz B. On the assessment 
and analysis of variables in the health action process approach: conducting an investigation. 
Berlin: Freie Universitaet Berlin. 2003. 
79. Miller W, Rollnick S. Motivational Interviewing. Third Edition. Helping People Change. New 
York. NY: Guilford Press; 2014. 
80. Rollnick S, Miller W. What is motivational interviewing? Behavioral and Cognitive 
Psychotherapy. 1995;23. 
81. Rubak S, Sandbaek A, Lauritzen T, Christensen B. Motivational interviewing: a systematic 
review and meta-analysis. Br J Gen Pract. 2005;55(513):305-12. Epub 2005/04/14. PubMed 
PMID: 15826439; PubMed Central PMCID: PMCPmc1463134. 
82. Burke BL, Arkowitz H, Menchola M. The efficacy of motivational interviewing: a meta-
analysis of controlled clinical trials. J Consult Clin Psychol. 2003;71(5):843-61. Epub 
2003/10/01. doi: 10.1037/0022-006x.71.5.843. PubMed PMID: 14516234. 
83. Martins RK, McNeil DW. Review of Motivational Interviewing in promoting health behaviors. 
Clin Psychol Rev. 2009;29(4):283-93. Epub 2009/03/31. doi: 10.1016/j.cpr.2009.02.001. 
PubMed PMID: 19328605. 

Protocol name: Precision Exercise Prescription Randomized Clinical Trial  
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84. Spencer JC, Wheeler SB. A systematic review of Motivational Interviewing interventions in 
cancer patients and survivors. Patient Educ Couns. 2016;99(7):1099-105. Epub 2016/02/18. 
doi: 10.1016/j.pec.2016.02.003. PubMed PMID: 26879805. 
85. Stacey FG, James EL, Chapman K, Courneya KS, Lubans DR. A systematic review and meta-
analysis of social cognitive theory-based physical activity and/or nutrition behavior change 
interventions for cancer survivors. J Cancer Surviv. 2015;9(2):305-38. Epub 2014/11/30. doi: 
10.1007/s11764-014-0413-z. PubMed PMID: 25432633; PubMed Central PMCID: 
PMCPmc4441740. 
86. Bice MR, Ball JW, McClaran S. Technology and physical activity motivation. International 
Journal 
of 
Sport 
and 
Exercise 
Psychology. 
2016;14(4):295-304. 
doi: 
10.1080/1612197X.2015.1025811. 
87. Ni HJ, Pudasaini B, Yuan XT, Li HF, Shi L, Yuan P. Exercise Training for Patients Pre- and 
Postsurgically Treated for Non-Small Cell Lung Cancer: A Systematic Review and Meta-
analysis. Integr Cancer Ther. 2016. Epub 2016/05/07. doi: 10.1177/1534735416645180. 
PubMed PMID: 27151583. 
88. Little RJA, D.B. R. Statistical analysis with missing data,. 2nd ed. New York: John Wiley & 
Sons; 2002. 
89. Simmons VN, Litvin EB, Jacobsen PB, Patel RD, McCaffrey JC, Oliver JA, Sutton SK, 
Brandon TH. Predictors of smoking relapse in patients with thoracic cancer or head and neck 
cancer. Cancer. 2013;119(7):1420-7. doi: 10.1002/cncr.27880. PubMed PMID: 23280005; 
PubMed Central PMCID: PMCPMC3604135. 
90. Barnes C, Ulrich C, Varghese T, Marcus R, Finlayson S, Boucher K, Himbert C, Baker J, 
Delphan M, LaStayo P. Implementation of a precise pre- and post-operative exercise 
intervention in patients with lung cancer. Utah Physical Therapy Association 2016 Fall 
Concference; 10/29/2016; Salt Lake City, Utah, USA2016. 
91. Barnes C, Ulrich C, LaStayo P, Marcus R, Finlayson S, Boucher K, Himbert C, Baker J, 
Delphan M, Varghese T. Implementation of a precise pre- and post-operative exercise 
intervention in patients with lung cancer. American Association for Thoracic Surgery; 
4/29/2017; Boston, MA, USA2017. 
 
 
 

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APPENDIX 1 - AM-PAC Basic Mobility Outpatient Form and Conversion Table 
 
 
 

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APPENDIX 2 - AM-PAC Basic Mobility Staging and Expected Performance