The Effects of a Preoperative Exercise Intervention During Neoadjuvant Therapy in Patients With Pancreatic Cancer
Phase: NA
Conditions: Pancreatic Cancer
Sponsor: University of Colorado, Denver

The effects of a preoperative exercise intervention during neoadjuvant therapy in patients with 
pancreatic cancer 
 
NCT02648880 
 
Protocol Version Date July 20, 2016 

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COMIRB Protocol 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490    TELEPHONE:  303-724-1055  Fax:  303-724-0990 
 
 
 
Protocol #: 15-2266 
Project Title: 
The effects of a preoperative exercise intervention during neoadjuvant 
therapy in patients with pancreatic cancer 
 
 
 
Principal Investigator:  Catherine Jankowski, PhD 
Version Date: 7-20-16  
 
 
 
  
 
I. Hypotheses and Specific Aims:   
 
The long-term goal of this investigation is to improve the health status of patients with pancreatic 
and other advanced cancers. The first specific aim will examine the feasibility of implementing a 
preoperative exercise intervention in patients with pancreatic cancer undergoing neoadjuvant 
treatment. Two additional specific aims will test the novel hypothesis that preoperative exercise 
during neoadjuvant treatment will maintain or improve physical fitness and function, and improve 
postoperative outcomes, with potential mediation by positive effects on psychological stress and 
systemic inflammatory status. 
 
AIM 1: To investigate the feasibility of providing a preoperative exercise intervention during 
neoadjuvant therapy in patients with pancreatic cancer. 
Objective: Assess the accrual rate of patients able and willing to participate in a 
preoperative exercise program, as well as the adherence of enrolled patients to the 
preoperative exercise program. Safety will be determined by non-serious and serious 
adverse event rate and type. 
AIM 2: To investigate the effects of preoperative exercise during neoadjuvant therapy on physical 
fitness and function, as well as postoperative hospital length of stay and readmission. 
Hypothesis 1: Preoperative exercise will result in improved or maintained physical fitness 
and function, during and after treatment, compared to a non-exercising control group 
(standard care). 
Hypothesis 2: Preoperative exercise will result in reduced postoperative hospital length of 
stay and occurrence of readmission compared to standard care. 
Exploratory AIM: To investigate how subjective and objective measures of psychological stress and 
systemic inflammatory markers change in response to preoperative exercise during neoadjuvant 
therapy and to determine relationships to postoperative outcomes. 
Hypothesis 1: Measures of psychological stress and systemic inflammatory markers will 
decrease in response to preoperative exercise compared to standard care. 
Hypothesis 2: Preoperative measures of psychological stress and systemic inflammatory 
markers will be positively correlated with postoperative hospital length of stay and 
occurrence of readmission in all participants. 
 
II. Background and Significance:  
 
The Problem: Interventions to improve health status in patients with pancreatic cancer are 
understudied. Health, as defined by the World Health Organization, is “a complete state of physical, 
mental, and social well-being, and not merely the absence of disease or infirmity.” Pancreatic 
cancer is often diagnosed at an advanced stage, which has resulted in a 5-year survival rate of less 
than 5%1. As such, most research has focused on the disease and curative components of 
treatment, and not the overall health status of the individual. Investigations of exercise in cancer 
survivors, an intervention able to address and improve most aspects of health, have specifically 
focused on cancer populations with high survival rates2. Furthermore, advances in the medical 
treatment of pancreatic cancer have increased 5-year survival rate to 10-30% in patients who 

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receive surgery3, making this a growing clinical population in which interventions to improve health 
status are understudied. 
 
The Population: Patients with pancreatic cancer undergoing neoadjuvant therapy. Pancreatic 
cancer is the fourth leading cause of cancer-related death in the United States, resulting in an 
estimated 37,390 deaths in 20124. Neoadjuvant therapy (preoperative chemotherapy and radiation) 
is often prescribed to a subgroup of patients to improve their response to surgery, the best known 
treatment for the disease. This therapy, however, can reduce physical fitness and function, 
decreasing the health status of the patient during and after treatment. Reduced preoperative 
cardiopulmonary fitness may also lead to increased postoperative complications5, resulting in 
further decreases in health status.  
 
The Intervention: A preoperative exercise program during neoadjuvant treatment, which can 
improve patient health status during and after treatment. Preoperative exercise has been shown to 
be safe and effective at improving physical fitness and function, vital components of overall health, 
in patients with other cancer diagnoses undergoing neoadjuvant therapy6, but has not been 
investigated in patients with pancreatic cancer. Therefore, a gap in the research exists surrounding 
interventions to improve health status in the growing clinical population of pancreatic cancer 
survivors. The preoperative neoadjuvant treatment period allows implementation of an exercise 
program likely to maintain or improve cardiovascular fitness and muscular strength, improving 
postoperative outcomes and health status, and improved physical function has also been 
associated with decreases in hospital length of stay and readmission7. Beneficial effects of 
preoperative exercise may be mediated by changes in psychological stress and systemic 
inflammatory markers. Both increased psychological stress and systemic inflammatory markers 
have been associated with accelerated disease progression and worsening health status8,9. Both 
are beneficially affected by exercise9,10, possibly contributing to the overall effects of the exercise 
intervention. Regardless of effects on disease progression, the beneficial psychological effects of 
exercise11 can contribute to improved health status. 
 
Preoperative exercise is a safe intervention in patients with advanced cancer. Exercise programs, 
both pre and postoperative, have been safely implemented in a wide variety of cancer survivors, 
with few to no adverse events reported12. Although no studies of preoperative exercise programs 
for patients with pancreatic cancer have been published, postoperative exercise programs in this 
population have reported no adverse events10,13. A survey of colorectal surgeons agreed that 
suitable preoperative exercise programs pose no risk to elderly colorectal cancer patients14, and a 
systematic review of exercise during neoadjuvant treatment stated that preoperative exercise was 
a safe and feasible intervention6. 
 
III. Preliminary Studies/Progress Report:   
 
No preliminary studies have been carried out examining preoperative exercise in patients with 
pancreatic cancer. The preoperative exercise intervention, however, will be administered through 
the BFitBWell Cancer and Exercise Program at the Anschutz Health and Wellness Center. This 
program has successfully provided individualized exercise interventions to over 100 cancer 
survivors during the past two years. These interventions are led by trained cancer and exercise 
specialists, and have led to consistent improvements in physical fitness, physical function, and 
quality of life. 
 
The BFitBWell program has provided exercise interventions for six patients with pancreatic 
cancer. Pre- and post-program measures of physical fitness were collected in two of these 
patients, both showing improvement. Measures of strength and physical function improved in the 
majority of patients and 4 of 6 patients reported measurable decreases in fatigue. 
 

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Based on discussions with physicians at the University of Colorado Cancer Center, approximately 
100 patients are diagnosed and treated there each year who would be potential participants in the 
proposed study.  
 
IV. Research Methods 
 
A. Outcome Measure(s):   
 
Physical fitness and function outcomes:  
The primary outcome of physical fitness and function will be the 400-meter walk time, which is 
a validated measure of cardiorespiratory fitness and mobility. The test assesses the time it 
takes a participant to independently walk 400 meters15. This test was developed to assess 
functional walking and exercise capacity in older adults, as distance was found to be more 
motivating than time (compared to the 6 minute walk test). This test has been associated with 
the development of cardiovascular disease and functional limitations16, and has been used to 
assess functional walking and exercise capacity in cancer populations17. 
 
Secondary measures of physical fitness and function include: 
 
Lean muscle mass and body composition. This will be assessed utilizing a dual-energy x-ray 
absorptiometry (DXA) scan. This is the gold standard measure of body composition and 
commonly used in studies of exercise interventions in cancer survivors18. The potential 
preservation of lean muscle is an important assessment in this population as improved muscle 
quantity and quality has been associated with improved postoperative outcomes in patients 
with pancreatic cancer undergoing surgery19. 
 
Gait speed is an easily implemented measure linked to a variety of functional outcomes in 
multiple populations20. It will be measured during the middle 4 meters of a 10 meter course 
where participants will be instructed to walk at a normal pace and as quickly, but safely as 
possible. Participants will perform one practice trial and two test trials for each pace, with the 
fastest trial recorded, according to NIH guidelines21. 
 
The Timed Up and Go (TUG) times participants as they rise from a chair, walk 3 meters, turn 
around, and return to the chair and sit22. One practice trial is performed, followed by two test 
trials. The two test trials are averaged for the final time. This is an easily implemented test that 
has shown good sensitivity and specificity for predicting falls in older cancer patients23, as well 
as predicting surgical complications following cardiac and colorectal procedures24. 
 
The Stair Climb Test (SCT) records the time taken to ascend and descend a single flight of 
stairs. It correlates with the TUG25, but as a higher level task, reduces possibilities of a ceiling 
effect during data processing and has been utilized in previous studies of cancer survivors18. 
One trial is performed. 
 
The Single Limb Stance (SLS) test records how long participants can balance on one leg, with 
a cap at 30 seconds. Participants are given two attempts with the best time recorded. This is a 
valid and reliable measure of balance and postural stability26. 
 
The 30 sec Sit-to-Stand (30StS) test is associated with strength and function of the lower 
extremities and records the number of times participants can go from a seated position to a 
standing position in 30 seconds27. It is a valid and reliable test that has been used previously to 
assess strength and function in cancer survivors18. 
 
Grip strength will be assessed on both the dominant and non-dominant hands using grip 
dynamometry. This is a valid and reliable measure28 that has been associated with physical 
function, health, gross strength, and survival in cancer survivors29.  

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Average daily step count (ADSC) will be assessed using pedometers. Pedometers will be 
given to participants for 7-day periods and participants will record their daily step count in a 
paper journal at the end of each day, prior to resetting the pedometer. Participants will also 
record any periods of time that the pedometer was not worn. ADSC will be assessed as 
average step count per day worn. 
 
Postoperative outcomes: 
Hospital length of stay will be collected from medical records and be defined as the number of 
days from surgical admission to hospital discharge. 
 
Hospital readmission will be assessed as whether a patient is rehospitalized in an unplanned 
response to a surgical complication within 30 days of hospital discharge. Planned 
rehospitalizations will not be assessed as a hospital readmission. 
 
Hospital physical function will be assessed using the AM-PAC test of inpatient physical activity 
and basic mobility30. 
 
Questionnaire/Psychological Outcomes Assessment: 
 
Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue 
scale (FACIT-Fatigue), a validate measure of fatigue in cancer survivors31. 
 
Health-related Quality of Life (HRQOL) will be assessed with the Functional Assessment of 
Cancer Therapy-General form (FACT-G)32. This form provides information on the physical, 
social, emotional, and functional well-being of patients with cancer. 
 
Subjective psychological stress will be assessed with the Perceived Stress Scale (PSS)33, 
which assesses perceived stress based on individual and environmental stressful events, 
focusing on experiences in the last month. Depression will be assessed using the Center for 
Epidemiologic Studies Depression Scale (CES-D)34. 
 
Prior physical activity level will be assessed with the Godin Physical Activity Questionnaire. 
This measure is a self-report estimate of leisure physical activity for the prior month. Prior 
physical activity level will be compared between groups and considered as a potential factor to 
control for in statistical analyses. This will only be collected at the first assessment. 
 
Objective Stress Assessment: 
 
Heart rate variability (HRV) will be used as an objective measure of stress, both physiologic 
and psychological. HRV will be assessed in four different conditions. Electrocardiography 
(ECG) will be recorded during a 10 minute baseline period (seated), a 5 minute orthostatic 
challenge (sit-to-stand), a 5 minute cognitive dissonance period (standard Stroop Task), and a 
5 minute cancer-salient dissonance period (cancer-related Stroop Task)35. The standard 
Stroop Task involves naming the color a word is printed in. The words are usually a color word 
(e.g. “Red”, “Blue”) and sometimes do not match the color the word is printed in. The cancer-
related Stroop Task also requires participants to name the color a word is printed in, except 
words will either be neutral words or words related to cancer (e.g. “Malignancy”, “Chemo”). 
Participants will be told prior to performing either task that the tasks are designed to be 
challenging and possibly evoke emotion. The standard Stroop and cancer-related Stroop will 
be performed in a random order between participants, but kept constant across Visits within 
participants, and separated by a 5 min rest period. Both time and frequency domain HRV 
measures will be calculated from the ECG signal for each period offline, quantifying overall 
autonomic tone (assessed by average heart rate and the total spectral power of HRV), 
parasympathetic tone (the high frequency component of HRV), and changes from baseline for 
each condition.  

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Biomarker Assessment: 
 
Systemic markers of inflammatory status will be assessed by measuring pro-inflammatory 
cytokines: serum C-reactive protein, associated with postoperative outcomes in patients with 
pancreatic cancer36, interluekin-6, potentially involved in the development and progression of 
cachexia37, and soluble tumor-necrosis factor receptor 1, a possible indicator of exercise-
induced changes in systemic inflammatory status38, and an anti-inflammatory cytokine, 
interleukin-10, involved in exercise-induced pathways39. Blood samples will be drawn at the 
same time as other blood draws performed as part of standard care at the University of 
Colorado Cancer Center, to reduce patient burden. If these routine blood draws do not occur 
within a one week window of the assessment, blood draws will be performed at the Clinical and 
Translational Research Center on the Anschutz Medical Campus, where all sample analyses 
will be performed. 
 
B. Description of Population to be Enrolled 
 
The potential participant population will be individuals who receive a diagnosis of borderline-
resectable pancreatic cancer (adenocarcinoma), being treated at the University Hospital 
Cancer Center. These inclusion and exclusion criteria will apply to participants in both groups. 
 
Inclusion Criteria: Recent (< 4 week) first diagnosis of a borderline-resectable pancreatic 
adenocarcinoma, assigned to receive neoadjuvant therapy and surgery at University of 
Colorado Cancer Center, physician clearance to participate in exercise program, and age 21-
80 years.  
 
Exclusion Criteria: Any significant comorbid conditions that would interfere with or preclude 
participation in an exercise intervention, including orthopedic conditions such as advanced 
osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute 
orthopedic injuries; advanced rheumatoid arthritis; widespread chronic pain conditions such as 
fibromyalgia; pulmonary conditions such as chronic obstructive pulmonary disease, 
emphysema, interstitial lung disease, use of supplemental oxygen; known cardiovascular 
disease, uncontrolled hypertension, or new cardiac event within the past 6 months. Participants 
with a second cancer diagnosis at the time of enrollment will be excluded. 
 
Sample size estimation: No studies have previously investigated the effects of preoperative 
exercise in patients with pancreatic cancer. In patients with lung cancer, a preoperative 
exercise program reduced hospital length of stay by 4 days compared to usual care40. Based 
on this difference, with a SD of 3, 12 participants would be required in each the experimental 
and control groups (α = 0.05, β = 0.9041). To account for overall attrition, groups will be 
increased by 3 participants each, based on a study of preoperative exercise after neoadjuvant 
treatment in patients with rectal cancer showing an overall attrition of 28%42. A total of 30 
participants (15 per group) will be recruited for this study. 
 
C. Study Design and Research Methods   
 
This is a prospective, non-randomized, parallel group, intervention control trial, patterned on a 
similar pilot study in patients with rectal cancer42. 
 
Recruitment: Participants will be recruited from the University Hospital Cancer Center. Patients 
with a recent diagnosis (< 4 weeks) of pancreatic cancer will be given information on the study 
by their treating physicians and asked if they would be interested in participating. If yes, 
physicians will have patients complete a HIPAA A form to provide study personnel with their 
name. Study personnel will access the patients’ medical records to evaluate the 
inclusion/exclusion criteria. If these criteria are met, research personnel will meet with the 

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potential participant at the University of Colorado Cancer Center to provide information about 
the study. If patients are still interested in participating, the familiarization and possibly first visit 
will be scheduled. Participants will have the option of combining the familiarization session and 
Visit 1. All data collected during screening will be destroyed and recollected after obtaining 
written consent in patients choosing to participate. If the inclusion/exclusion criteria are not met 
after review of the health record, the patient will be contacted and the exclusion decision will be 
explained. 
 
Group Assignment: Volunteers meeting the inclusion and exclusion criteria and willing to 
participate in the exercise intervention will be assigned to the exercise group. The standard of 
care, non-exercise control group will comprise volunteers who meet the inclusion and exclusion 
criteria but are unable to commit to participation in the exercise intervention for practical 
reasons (e.g. barriers in transportation or home location). The use of a non-randomized study 
design is to maximize patients participating in the exercise program to determine accrual rate, 
program adherence, and safety while still allowing a non-exercise control group.  
 
Protocol: 
 
Figure 1 
 
Figure 1 shows the event timeline of the study, with time points of visits and intervention in 
relation to diagnosis and surgery. Written informed consent will be obtained by a study 
investigator during a familiarization period, where participants will have assessments and the 
exercise investigation explained in-depth. There will be four time points for data collection: pre-
intervention (Visit 1), post-intervention and preoperative (Visit 2), 30-day postoperative (data 
retrieved from electronic health record), and follow-up (Visit 3). 
 
Assessments: All assessments will be performed at the Anschutz Health and Wellness Center. 
Participants will also complete the Godin Physical Activity Questionnaire during Visit 1 only. 
The following assessments will be completed at visits 1, 2, and 3.  
 
A total body DXA scan will be performed to determine body composition. The scan takes 
approximately 3 minutes, but 15 minutes is allocated for data entry and positioning the patient.  
  
HRV assessments will be performed prior to functional testing, to avoid the potential impact of 
physical activity on heart rate measures. This assessment will be performed in a private 
examination room and will take approximately 30 min. 
 
Physical fitness and function assessments will then be performed. These assessments will be 
performed in the same order at every assessment, with the most fatigueing assessments 
performed at the end of the session. The order will be: SLS, TUG, grip strength, 30StS, SCT, 
gait speed, 400MWT. All tests will be performed by the same investigator at all time points. 

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This investigator is a licensed physical therapist with experience performing functional tests in 
medically involved or functionally limited populations. A secondary tester, blinded to participant 
group, will be present at all sessions to provide any necessary assistance and insure lack of 
testing bias. Participants will also be given the activity tracker to assess ADSC, with 
instructions on how to use the device and how to return the device in one week. The functional 
assessment period will take approximately 1 hour. 
 
Questionnaire data will be collected using REDCap software. Participants will have two options 
for completing questionnaire data at each assessment: 1) completion of questionnaire data via 
emailed REDCap survey at the Health and Wellness Center via provided computer or tablet, 2) 
completion of printed questionnaires provided at the functional assessment. Data obtained 
from participants completing printed questionnaires will be entered in the REDCap system by 
two study investigators independently to insure accuracy, following which hardcopies will be 
destroyed. 
 
If participants will not receive a standard blood draw as part of their medical care within a one-
week window of the visit, they will be transported to the CTRC where the necessary blood draw 
will be performed. 
 
Thirty days after hospital discharge, the participants’ electronic health record will be reviewed 
to retrieve data about initial hospital length of stay and 30-day unplanned hospital readmission. 
Visit 3 will be performed at approximately 6 weeks post hospital discharge. This is the time at 
which some patients may begin more chemotherapy or radiation treatment (adjuvant therapy), 
and Visit 3 will be performed prior to this to avoid confounding effects of the therapy. 
Exercise Intervention: Participants will start the exercise program within four weeks of their 
diagnosis and decision to undergo neoadjuvant treatment and continue until surgery. 
Participants will continue to receive the standard medical care (described below) provided at 
UCCC. Individual exercise sessions in this program implement a “whole body” approach and 
consist of a 10-min cardiovascular warm-up and 50 minutes of cardiovascular endurance, 
resistance, and flexibility exercises (session components). Typical cardiovascular endurance 
exercises include walking on an indoor track or treadmill, stationary cycling, and stationary 
rowing. Resistance training includes exercises using body weight, free weights, and weight 
machines targeting increased strength of the large upper and lower extremity muscle groups 
and core stability. Flexibility exercises target major muscle groups activated during the 
exercise. Target intensity of exercise will be based on the American College of Sports Medicine 
(ACSM) recommendations for cancer survivors2: 40-85% heart rate reserve for cardiovascular 
endurance exercises; 60-70% one repetition maximum for resistance exercises; and a rate of 
perceived exertion of 12-16 on a 6-20 Borg scale for all activities. 
Exercise Adaptations: Prior to the start of exercise sessions, participants will be questioned on 
significant changes in symptoms or the presence of new symptoms (such as nauseau or 
fever), which will used to modify the exercise session (intensity and components) for that day 
to allow maximum symptom-limited participation. Participants will be encouraged to complete 
three sessions per week for at least eight weeks during neoadjuvant therapy. Exercise 
intensity, components, and time will be recorded for each exercise session to guide the 
exercise specialist in making appropriate exercise adjustments (progression, maintenance, or 
reduction). Exercise programs have been found to be safe in cancer survivors, even during life-
threatening treatments2, but safety has not been investigated specifically in the current 
population. Common risks may include muscular fatigue and soreness, as well as transient 
increases in treatment-related symptoms. Rarer risks include the possibility of injury due to 
unknown bone metastases or acute cardiac events. Intensity and acute changes in symptoms 
will be closely monitored to decrease these risks. 
Participants will schedule their sessions with the exercise specialists administering the 
program, typically taking place between 8AM and 4PM, Monday through Friday, at the 

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Anschutz Center for Health and Wellness. Adherence will be measured as the percent of 
scheduled sessions attended. Exercise sessions will also be individualized to participants on a 
day to day basis, with time and intensity not exceeding that listed above. Prior to the start of 
exercise sessions, participants will be questioned on significant changes in symptoms or 
presence of new symptoms (such as nauseau or fever), which will be used to modify the 
exercise session for that day. Exercise intensity, type, and time will be recorded for each 
exercise session. 
 
Standard Care: Participants in the Standard Care group will receive no exercise intervention, 
but will continue to receive standard follow-ups, treatments and services from their oncology 
team. The services that participants receive as standard care include their medical care, 
symptom control, social worker support, and nutrition. 
 
Participants in all groups will receive $50 reimbursement for each Visit completed, totalling 
$150.00 for all three Visits. 
 
D. Description, Risks and Justification of Procedures and Data Collection Tools: 
 
Risks of exercise and assessments: Certain risks are associated with performing exercise in 
any population, as well as specifically in cancer survivors. The likely risks of exercise include 
muscular fatigue and/or soreness, acute increase in fatigue, joint stiffness or soreness, and 
possible acute increase in treatment- or cancer-related symptoms. The more serious risks 
include fracture associated with unknown bone metastases, development of ventricular 
arrhythmia, myocardial infarction, cardiac arrest, and death. 
 
Justifications and Protection: For adults in the general population and for cancer survivors in 
particular the benefits of exercise training outweigh the risks. Exercise interventions have been 
shown to be safe in multiple cancer survivor populations12. The discomforts of exercise training 
and testing will be explained to the participants. Participants will be informed that they can 
choose to withdraw or not participate in some or all portions of the study at any time for any 
reason. Before, during, and at the conclusion of each exercise training and testing session, 
study personnel will ask participants about new or worsening signs and symptoms. Every 
exercise session will be supervised by qualified study personnel who are versed in exercise 
training for clinical populations and BLS-certified. Exercise intensity and types of exercise will 
be adapted for each individual participant to match their capacity throughout the study. 
Exercise tests and training will be of submaximal intensity. Exercise intensity will be monitored 
by study personnel to decrease likelihood of an acute cardiac event, and participants will be 
monitored for symptoms including chest pain, acute shortness of breath at rest, or dizziness. 
Patients will be instructed to stay well-hydrated, and will be monitored for symptoms of 
dehydration including headache, confusion, tachycardia, significantly increased respiratory 
rate, and changes in skin elasticity. Patients with diabetes will be monitored for symptoms of 
hypoglycemia, encouraged to bring snacks to assessments and exercise sessions, and snacks 
and juice will also be stocked by research personnel. 
 
After providing written informed consent, each participant will be asked to provide clinical 
provider contact information. In the event of an emergency, study personnel will call 9-1-1, 
according to the protocol of the Anschutz Health and Wellness Center and outpatient clinics on 
the AMC. AEDs are available throughout the Wellness Center. The PI will contact the 
designated clinical provider if an emergency arises (after first responders are summoned) or a 
participant exhibits or reports exacerbation of symptoms. In the case of a medical emergency, 
the participant must be cleared for exercise by their clinical provider before resuming exercise 
training or testing. 
 
The risks of the venipuncture are momentary discomfort from the needle stick, excessive 
bleeding, light-headedness with insertion of needle, and infection or hematoma at the site of 

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the blood draw. The risks of hematoma and infection will be minimized by having trained 
clinical personnel perform the procedures using sterile techniques. 
 
The risks of DXA (to assess body composition) involves exposure to ionizing radiation. The 
DXA scans at 3 times during the study involve a total effective radiation exposure of about 3 
mrems. DXA involves <1% of the annual maximum non-therapeutic radiation exposure to the 
whole body recommended by the FDA (5000 mrem/year). This risk is minimized by having 
trained DXA technicians administer the procedure, thereby reducing the likelihood of needing 
repeat assessments.  
 
The risk of the heart rate variability (HRV) testing is a possible brief increase in perceived 
stress and physiologic arousal induced by the cognitive difficulty of the Stroop Task. 
Participants will be warned of this possible increase in stress and arousal. The change will be 
no different than that occurring while performing difficult cognitive tasks on a daily basis. The 
Stroop Task has been previously used to effectively and safely evaluate HRV changes43. The 
ECG electrode adhesive may cause localized skin redness and discomfort. 
 
Confidentiality and privacy: The use of questionnaires and collection of personal medical 
information poses a risk to confidentiality and privacy and may cause embarrassment. 
These risks will be minimized by not including personal identifying information on the forms, 
when possible, and by conducting interviews and collection of personal information in a private 
setting. Direct data entry into a secure website using REDCap software will be coded with a 
unique participant number. 
 
Data Safety and Monitoring: Research personnel will monitor safety concerns on an ongoing 
basis as data is collected and analyzed. The study PI will review the safety of the protocol at 
least monthly and submit an annual report. A medical safety officer (Dr. Kessler), who is not an 
investigator on the study, will review the safety of the study after enrollment of every 10 
participants and submit a report at least annually. Study participants will be informed that they 
can choose to stop the study (exercise intervention or assessments) at any time. If study 
personnel deem that the participant is no longer physically capable of performing the exercise 
intervention or assessments, the participant will be discontinued from the study. The overall 
protocol will be discontinued if the PI, research team, and safety officer agree that participants 
in the exercise group are experiencing significant negative outcomes, not experienced in the 
non-exercise (control) group, attributed to the exercise intervention or testing. 
 
The PI will report all unanticipated problems and adverse events to COMIRB within 5 days of 
occurrence. Unanticipated problems and adverse events are defined as by COMIRB. 
    
E. Potential Scientific Problems:   
Potential Problems and Solutions: Given that no previous studies of preoperative exercise 
programs exist in patients with pancreatic cancer, the power analysis for the current study was 
based on the outcomes of a study of preoperative exercise in patients with lung cancer. It is 
possible that the estimated sample size here will not provide enough power to detect 
differences in postoperative outcomes. Regardless of statistical significance, outcomes from 
this study will provide the basis to allow future studies in this population that are adequately 
powered. Study groups will not be randomized, resulting in a potential selection bias and 
baseline differences. The decision to design the study as a non-randomized trial was made to 
improve recruitment for the target patient population and the short duration of the funding 
period. Analysis of the number of participants who are willing and able to participate in an 
exercise intervention at the AHWC will determine if a randomized trial is feasible and allow a 
better estimate of a realistic enrollment period. We will interpret our enrollment activity as 

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follows: if less than 70% of anticipated enrollment is achieved, we will conclude that additional 
study sites will be needed to enroll sufficient numbers of patients treated with neoadjuvant 
therapy for pancreatic cancer for formal hypothesis testing in a RCT. 
The individualized nature of the exercise program precludes rigorous control of exercise 
components between participants. An individualized exercise program may increase 
adherence and will allow adaptability to acute changes in the patients’ health status due to 
treatment- or disease-related symptoms. The neoadjuvant therapy period will vary between 
participants, resulting in a variable duration of the exercise intervention. The duration of 
exercise must remain variable to avoid deconditioning that would be caused by a long lapse 
between the end of the exercise intervention and surgery. Most patients complete 16 weeks of 
neoadjuvant therapy before surgery, which will result in a typical exercise intervention lasting 
12 weeks. We will record the duration of exercise training and neoadjuvant therapy and test 
these factors as covariates in the analyses of the fitness, function, and stress outcomes. 
 
F. Data Analysis Plan:  
 
The timeline for this protocol is estimated at 2 years. Data collection (participant recruitment 
and intervention) is estimated at 1 - 1.5, after which data will be analyzed and manuscripts 
prepared.  
Data Analysis and Anticipated Outcomes: Groups will be compared on demographic variables 
such as age and gender. Variables that differ significantly will be included in planned analyses 
as covariates. Statistical significance will be defined as α ≤ 0.05, however, results will be 
interpreted cautiously as is warranted for pilot studies44. As we expect to be underpowered to 
test for statistical interactions, multiple tests will be used to assess differences in baseline 
measures, change scores, and postoperative outcomes between groups. Change scores will 
be calculated as the difference between Visit 2 and Visit 1. Groups will be compared using 
non-parametric exact k-sample permutation tests, which are well suited for small sample sizes 
as they do not rely on typical normal-theory methods45.  
Aim 1: The feasibility of implementing this intervention will be assessed by quantifying the 
accrual rate of patients willing and able to participate in the preoperative exercise intervention 
and individual patients’ adherence to the prescribed exercise program (percentage of 
scheduled sessions attended). Safety will be determined by the number of non-serious and 
serious adverse events and relatedness of the events to exercise, as described by COMIRB. 
Aim 2: Hypothesis 1 – Baseline physical fitness and function measures and change scores 
will be compared between groups using exact k-sample permutation tests. We anticipate a 
significant difference in the changes from Visit 1 to Visit 2, with the Exercise group 
demonstrating maintained or improved physical fitness and function compared to the Control 
group, with no differences in baseline measures. A secondary analysis will be used to 
describe the trajectory of changes in physical function from visits 1, 2, and 3. 
Hypothesis 2 – Postoperative outcomes will be compared with exact k-sample permutation 
tests (hospital length of stay) or Fisher’s exact tests (hospital readmission) between the 
Exercise and Control groups. We anticipate the Exercise group to have a significantly lower 
hospital length of stay and occurrence of hospital readmission compared to the Control 
group. 
Exploratory Aim: Hypothesis 1 – Baseline psychological stress and systemic inflammatory 
status measures and change scores will be compared between groups using exact k-sample 
permutation tests. We anticipate a significant difference in change scores, with the Exercise 
group demonstrating decreased (improved) psychological stress and improved systemic 
inflammatory status (decreased CRP, IL-6, sTNFR1 and IIS; increased IL-10) compared to 
the Control group, with no differences in baseline measures. 
Hypothesis 2 – Spearman correlations will be performed between preoperative measures of 
psychological stress and systemic inflammatory status and postoperative variables. We 

Protocol Template 
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CF-146, Effective 7/10/11 
 
anticipate a significant negative correlation between psychological stress and systemic 
inflammatory status and postoperative outcomes, with lower levels of stress and inflammation 
associated with improved outcomes in all participants. 
 
G.  Summarize Knowledge to be Gained:   
 
Aim 1: The feasibility of future, larger scale implementation of the preoperative exercise 
program will be assessed primarily by patient adherence to the program, demonstrating 
patients’ ability and willingness to complete the program. The future study of the intervention 
will be assessed through the measurement of patient accrual, which will provide a reference 
for the necessary time frame of future studies. 
 
Aim 2: The analyses performed in this aim will reveal 1) how a preoperative exercise 
intervention affects physical fitness and physical function prior to and after surgery, and 2) 
whether a preoperative exercise program is associated with improved postoperative 
outcomes in patients with pancreatic cancer undergoing neoadjuvant treatment. These 
analyses will also illustrate typical changes in measures of physical fitness and physical 
function through analysis of the Standard Care group. 
 
Exploratory Aim: The analyses performed in this aim will reveal 1) how a preoperative 
exercise intervention effects subjective and objective measures of psychological stress, 
autonomic function, and systemic inflammation prior to and after surgery, and 2) whether 
these preoperative measures predict postoperative outcomes in patients with pancreatic 
cancer undergoing neoadjuvant treatment. These analyses will also illustrate typical changes 
in measures of physical fitness and physical function through analysis of the Standard Care 
group. Results from this aim may also lead to the development of novel interventions, if 
measures are predictive of outcomes but not adequately changed by exercise. 
 
Outcomes from this study will add to the growing body of literature on the effectiveness of 
preoperative exercise programs in cancer survivors, as well as demonstrate the potential 
effectiveness of an exercise intervention in patients with pancreatic cancer, where there is 
limited evidence. By examining potential mediators in the effectiveness of exercise on 
postoperative outcomes, it allows future studies to tailor exercise program components to 
focus on the mediators most strongly associated with positive outcomes. 
 
 H. References: 
 
1 
Jemal, A. et al. Global cancer statistics. CA Cancer J Clin 61, 69-90, 
doi:10.3322/caac.20107 (2011). 
2 
Schmitz, K. H. et al. American College of Sports Medicine roundtable on exercise 
guidelines for cancer survivors. Medicine and science in sports and exercise 42, 1409-
1426, doi:10.1249/MSS.0b013e3181e0c112 (2010). 
3 
Saif, M. W. Controversies in the adjuvant treatment of pancreatic adenocarcinoma. JOP 8, 
545-552 (2007). 
4 
Siegel, R., Naishadham, D. & Jemal, A. Cancer statistics, 2012. CA Cancer J Clin 62, 10-
29, doi:10.3322/caac.20138 (2012). 
5 
Chandrabalan, V. V. et al. Pre-operative cardiopulmonary exercise testing predicts adverse 
post-operative events and non-progression to adjuvant therapy after major pancreatic 
surgery. HPB (Oxford) 15, 899-907, doi:10.1111/hpb.12060 (2013). 
6 
Loughney, L., West, M. A., Kemp, G. J., Grocott, M. P. & Jack, S. Exercise intervention in 
people with cancer undergoing neoadjuvant cancer treatment and surgery: A systematic 
review. Eur J Surg Oncol, doi:10.1016/j.ejso.2015.09.027 (2015). 
7 
De Buyser, S. L., Petrovic, M., Taes, Y. E., Vetrano, D. L. & Onder, G. A multicomponent 
approach to identify predictors of hospital outcomes in older in-patients: a multicentre, 
observational study. PloS one 9, e115413, doi:10.1371/journal.pone.0115413 (2014). 

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8 
Kim-Fuchs, C. et al. Chronic stress accelerates pancreatic cancer growth and invasion: a 
critical role for beta-adrenergic signaling in the pancreatic microenvironment. Brain, 
behavior, and immunity 40, 40-47, doi:10.1016/j.bbi.2014.02.019 (2014). 
9 
Betof, A. S., Dewhirst, M. W. & Jones, L. W. Effects and potential mechanisms of exercise 
training on cancer progression: a translational perspective. Brain, behavior, and immunity 
30 Suppl, S75-87, doi:10.1016/j.bbi.2012.05.001 (2013). 
10 
Yeo, T. P. et al. A progressive postresection walking program significantly improves fatigue 
and health-related quality of life in pancreas and periampullary cancer patients. J Am Coll 
Surg 214, 463-475; discussion 475-467, doi:10.1016/j.jamcollsurg.2011.12.017 (2012). 
11 
Mishra, S. I. et al. Exercise interventions on health-related quality of life for people with 
cancer during active treatment. The Cochrane database of systematic reviews 8, 
CD008465, doi:10.1002/14651858.CD008465.pub2 (2012). 
12 
Schmitz, K. H. et al. Controlled physical activity trials in cancer survivors: a systematic 
review and meta-analysis. Cancer Epidemiol Biomarkers Prev 14, 1588-1595, 
doi:10.1158/1055-9965.EPI-04-0703 (2005). 
13 
Cormie, P. et al. Exercise as medicine in the management of pancreatic cancer: a case 
study. Medicine and science in sports and exercise 46, 664-670, 
doi:10.1249/MSS.0000000000000160 (2014). 
14 
Boereboom, C. L., Williams, J. P., Leighton, P., Lund, J. N. & Exercise Prehabilitation in 
Colorectal Cancer Delphi Study, G. Forming a consensus opinion on exercise 
prehabilitation in elderly colorectal cancer patients: a Delphi study. Tech Coloproctol 19, 
347-354, doi:10.1007/s10151-015-1317-2 (2015). 
15 
Simonsick, E. M., Montgomery, P. S., Newman, A. B., Bauer, D. C. & Harris, T. Measuring 
fitness in healthy older adults: the Health ABC Long Distance Corridor Walk. J Am Geriatr 
Soc 49, 1544-1548 (2001). 
16 
Newman, A. B. et al. Association of long-distance corridor walk performance with mortality, 
cardiovascular disease, mobility limitation, and disability. JAMA : the journal of the 
American Medical Association 295, 2018-2026, doi:10.1001/jama.295.17.2018 (2006). 
17 
Galvao, D. A. et al. Resistance training and reduction of treatment side effects in prostate 
cancer patients. Medicine and science in sports and exercise 38, 2045-2052, 
doi:10.1249/01.mss.0000233803.48691.8b (2006). 
18 
Nilsen, T. S. et al. Effects of strength training on body composition, physical functioning, 
and quality of life in prostate cancer patients during androgen deprivation therapy. Acta 
Oncol, 1-9, doi:10.3109/0284186X.2015.1037008 (2015). 
19 
Okumura, S. et al. Impact of preoperative quality as well as quantity of skeletal muscle on 
survival after resection of pancreatic cancer. Surgery 157, 1088-1098, 
doi:10.1016/j.surg.2015.02.002 (2015). 
20 
Fritz, S. & Lusardi, M. White paper: "walking speed: the sixth vital sign". J Geriatr Phys 
Ther 32, 46-49 (2009). 
21 
Reuben, D. B. et al. Motor assessment using the NIH Toolbox. Neurology 80, S65-75, 
doi:10.1212/WNL.0b013e3182872e01 (2013). 
22 
Podsiadlo, D. & Richardson, S. The timed "Up & Go": a test of basic functional mobility for 
frail elderly persons. J Am Geriatr Soc 39, 142-148 (1991). 
23 
Overcash, J. A. & Rivera, H. R., Jr. Physical performance evaluation of older cancer 
patients: a preliminary study. Crit Rev Oncol Hematol 68, 233-241, 
doi:10.1016/j.critrevonc.2008.07.001 (2008). 
24 
Robinson, T. N. et al. Slower walking speed forecasts increased postoperative morbidity 
and 1-year mortality across surgical specialties. Ann Surg 258, 582-588; discussion 588-
590, doi:10.1097/SLA.0b013e3182a4e96c (2013). 
25 
Hughes, C., Osman, C. & Woods, A. K. Relationship among performance on stair 
ambulation, functional reach, and timed up and go tests in older adults. Issues on Ageing 
3, 18-22 (1998). 
26 
Potvin, A. R., Syndulko, K., Tourtellotte, W. W., Lemmon, J. A. & Potvin, J. H. Human 
neurologic function and the aging process. J Am Geriatr Soc 28, 1-9 (1980). 

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27 
Jones, C. J., Rikli, R. E. & Beam, W. C. A 30-s chair-stand test as a measure of lower body 
strength in community-residing older adults. Research quarterly for exercise and sport 70, 
113-119, doi:10.1080/02701367.1999.10608028 (1999). 
28 
Trutschnigg, B. et al. Precision and reliability of strength (Jamar vs. Biodex handgrip) and 
body composition (dual-energy X-ray absorptiometry vs. bioimpedance analysis) 
measurements in advanced cancer patients. Appl Physiol Nutr Metab 33, 1232-1239, 
doi:10.1139/H08-122 (2008). 
29 
Kilgour, R. D. et al. Handgrip strength predicts survival and is associated with markers of 
clinical and functional outcomes in advanced cancer patients. Support Care Cancer 21, 
3261-3270, doi:10.1007/s00520-013-1894-4 (2013). 
30 
Jette, D. U. et al. Validity of the AM-PAC "6-Clicks" inpatient daily activity and basic 
mobility short forms. Physical therapy 94, 379-391, doi:10.2522/ptj.20130199 (2014). 
31 
Yellen, S. B., Cella, D. F., Webster, K., Blendowski, C. & Kaplan, E. Measuring fatigue and 
other anemia-related symptoms with the Functional Assessment of Cancer Therapy 
(FACT) measurement system. Journal of pain and symptom management 13, 63-74 
(1997). 
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Brucker, P. S., Yost, K., Cashy, J., Webster, K. & Cella, D. General population and cancer 
patient norms for the Functional Assessment of Cancer Therapy-General (FACT-G). Eval 
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Cohen, S., Kamarck, T. & Mermelstein, R. A global measure of perceived stress. J Health 
Soc Behav 24, 385-396 (1983). 
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Radloff, L. S. The CES-D Scale: A Self-Report Depression Scale for Research in the 
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DiBonaventura, M. D., Erblich, J., Sloan, R. P. & Bovbjerg, D. H. A computerized Stroop 
task to assess cancer-related cognitive biases. Behav Med 36, 37-43, 
doi:10.1080/08964280903521321 (2010). 
36 
Stevens, L. et al. Prognostic significance of pre-operative C-reactive protein and the 
neutrophil-lymphocyte ratio in resectable pancreatic cancer: a systematic review. HPB 
(Oxford) 17, 285-291, doi:10.1111/hpb.12355 (2015). 
37 
Narsale, A. A. & Carson, J. A. Role of interleukin-6 in cachexia: therapeutic implications. 
Curr Opin Support Palliat Care 8, 321-327, doi:10.1097/SPC.0000000000000091 (2014). 
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Perandini, L. A. et al. Inflammatory cytokine kinetics to single bouts of acute moderate and 
intense aerobic exercise in women with active and inactive systemic lupus erythematosus. 
Exercise immunology review 21, 174-185 (2015). 
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Goh, J., Niksirat, N. & Campbell, K. L. Exercise training and immune crosstalk in breast 
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Pehlivan, E., Turna, A., Gurses, A. & Gurses, H. N. The effects of preoperative short-term 
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45 
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education 36, 181-187, doi:10.1152/advan.00072.2012 (2012). 
 

Consent and Authorization Form 
Page 1 of 8
Initials______
Principal Investigator:
Catherine Jankowski, PhD
COMIRB No: 15-2266
Version Date: 3-16-16
Study Title:    Effects of a preoperative exercise intervention during neoadjuvant therapy in 
patients with pancreatic cancer
You are being asked to be in a research study.  This form provides you with information 
about the study. A member of the research team will describe this study to you and 
answer all of your questions. Please read the information below and ask questions 
about anything you don’t understand before deciding whether or not to take part. 
Why is this study being done?
This study plans to learn more about whether the effects of providing a personalized 
exercise program to patients recently diagnosed with pancreatic cancer can improve 
their health and tolerance to cancer treatment. The exercise program will take place 
before surgery, while you are receiving chemotherapy and radiation therapy to 
improve your response to surgery. We anticipate that the exercise program will 
improve your fitness, ability to move, and response to surgery.
You are being asked to be in this research study because you have recently been 
diagnosed with pancreatic cancer and plan on receiving neoadjuvant treatment and 
surgery at the University of Colorado Cancer Center.
Other people in this study
Up to 30 people from your area will participate in the study. This study is not being 
performed in any other locations. 
What happens if I join this study?
If you join the study, you will receive physical fitness and function testing at several 
times (now, before surgery, and 6 weeks after surgery). These tests are performed 
only as a part of this research study and are not typically performed as part of 
standard care. You will need to travel to the Anschutz Health and Wellness Center 
for 1 visit at each assessment time (totaling 3 assessment visits). There will also be 
a familiarization session, which may or may not be combined with the first 
assessment. At the familiarization session, we will go over the study in detail and 
you will fill out an additional questionnaire with demographic and medical history 
information.
There are four components to each assessment: questionnaires, heart rate 
variability testing, functional testing, and body composition testing. 
COMIRB
APPROVED
For Use
31-Mar-2016
08-Mar-2017

Consent and Authorization Form 
Page 2 of 8
Initials______
The questionnaires at each assessment can be filled out in one of two ways: on a 
computer or tablet at the Wellness Center, or on a provided paper copy at the 
Wellness Center. If completed at home (on a device or paper), this must be done 
within one week of the functional testing (and returned to the Center if on paper). It 
will take about 20 minutes to complete the questionnaires.
During heart rate variability testing we will attach small plastic electrodes to the 
center of your chest or over your ribs in order to record your heart beat. We will 
record your heart beat while you are quietly sitting, standing, or performing cognitive 
tasks for 5-10 minute periods of time. The cognitive tasks require you to identify the 
color of words on a screen. Sometimes the words will be different color name, 
random objects, or medical terms related to cancer. These tasks are designed to be 
difficult and evoke some emotion.
During functional assessments, you will perform tasks designed to measure how 
well you can move and perform daily tasks. These include: balancing on one leg, 
rising from a chair and sitting in a chair, gripping a force measuring device as hard 
as possible, going up and down stairs, and walking (short, timed walking in 10 meter 
intervals, and one timed 400 meter [a quarter mile] walk). You will also be given an 
activity monitor that is worn on your upper arm during this session. We will ask you 
to wear this monitor for a week and then return it. It will measure how many steps 
you take each day.
To assess body composition, we will perform up to 3 DEXA scans. There will be 1 
DEXA scan per assessment visit. DEXA is a way of looking inside the body by using 
X-rays. X-rays are a type of radiation. We will pay for these scans, you will not be 
charged.
Finally blood will be drawn either during a routine clinical care or on the medical 
campus on the day of your functional assessment. This will be done to assess the 
inflammatory status in your body. If we do draw blood during the assessment, we will 
need to get about 1 teaspoon of blood from you. We will get blood by putting a 
needle into one of your veins and letting the blood flow into a glass tube. You may 
feel some pain when the needle goes into your vein. A day or two later, you may 
have a small bruise where the needle went under the skin.
As a part of the study, you will join a preoperative exercise program or continue to 
receive standard care if you cannot join the exercise program. The exercise program 
consists of 60-minute sessions with a cancer exercise specialist that is based on a 
“whole-body” approach to exercise. Sessions will include aerobic (walking, treadmill, 
bike, rowing machine), resistance (machines, free weight, and body weight), and 
flexibility (stretching) exercises. You will wear a heart rate monitor and activity 
monitor during these sessions to help monitor the intensity of your exercise. These 
sessions will be scheduled for 2-3 times a week from initiation of the program to your 
date of surgery, and you will be required to travel to the Wellness Center for these 
sessions. Sessions need to be scheduled between 8AM and 4PM.   

Consent and Authorization Form 
Page 3 of 8
Initials______
What are the possible discomforts or risks?
Discomforts you may experience while in this study include muscle fatigue and 
soreness, acute increase in fatigue, or joint stiffness or soreness. These are 
commonly associated with any exercise program and exercise intensity will be 
monitored to decrease these symptoms as much as possible. Any of these 
discomforts may be experienced in response to assessments, as well as exercise 
sessions. It is very important that you inform whoever you are with if you have any 
change in symptoms during assessments and exercise sessions. If getting blood 
drawn as part of the study, you may feel a momentary sharp pain. 
The DEXA scan for measuring your muscle and fat uses x-ray and exposes you to 
radiation. Your natural environment has some radiation in it. Each DEXA scan will 
give you about the same amount of radiation that you would get from your 
environment in 6 days.
The heart rate variability test requires concentration and may cause emotional 
distress. You will be seated at a computer with words presented on the screen. You 
will need to identify either the word or the color of the font the word is printed in as 
they are presented to you. This task is designed to be difficult, possibly resulting in 
distress. Sticky patches will be placed on your chest to measure your heart rate 
activity during the test. The patches may cause redness or soreness of the skin.
Rare risks include:
Exercise testing and assessment: 1) acute cardiovascular event, 2) musculoskeletal 
injury, 3) dehydration, 4) excessive bleeding, and 5) possible fracture due to 
unknown bone metastasis.
Blood draw risks are possible light-headedness with insertion of needle during blood 
draw, and possible infection or bruising at the site of the blood draw.
Careful monitoring of the intensity of exercise sessions as well as any symptoms 
experienced will be done to minimize the occurrence of associated rare risks. When 
a blood draw is performed sterile procedures will be used to minimize the risk of 
infection.
There is a risk that people outside of the research team will see your research 
information.  We will do all that we can to protect your information, but it cannot be 
guaranteed.
You may not be in this study if you are pregnant, the particular treatment or 
procedures involved in the study may involve risks to the embryo or fetus which are 
currently unclear.
The study may include risks that are unknown at this time.

Consent and Authorization Form 
Page 4 of 8
Initials______
Optional Future Research
I give my permission to be contacted with information about future studies conducted in 
the Anschutz Health and Wellness Center for which I may qualify. These studies would 
be related to exercise during and after cancer treatment. I can withdraw my permission 
to be contacted at any time by contacting study personnel either by phone (303-724-
7383), email (catherine.jankowski@ucdenver.edu), or in writing at the address listed 
below for Dr. Catherine Jankowski. Contact for future studies will not occur after one 
year from the date I consent to be in this study.
_______YES
_________NO
_________Initials
I give my permission for my data to be stored in a registry at the Anschutz Health and 
Wellness Center for future use by the study investigators. I can withdraw my permission 
to be contacted at any time by contacting study personnel either by phone (303-724-
7383), email (catherine.jankowski@ucdenver.edu), or in writing at the address listed 
below for Dr. Catherine Jankowski.
1. I give my permission for my data to be kept for use in future research to learn 
more about the effects of exercise during and after cancer treatment.
_______YES
_________NO
_________Initials
2. I give my permission for my data to be used for research about other health 
problems (for example: causes of heart disease, osteoporosis, diabetes).
_______YES
_________NO
_________Initials
What are the possible benefits of the study?
This study is designed for the researcher to learn more about how fitness and 
function change after a diagnosis of pancreatic cancer, and if these can be changed 
with an exercise program.  However, there is no guarantee that your health will 
improve if you join this study.  Also, there could be risks to being in this study, which 
are described above.
Who is paying for this study?
This research is funded by the Anschutz Health and Wellness Center and the 
University of Colorado Cancer Center.
Will I be paid for being in the study?  
You will be paid $50.00 for each assessment visit in this. This will add up to a total of 
$150 if you complete all of the visits. If you leave the study early, or if we have to 

Consent and Authorization Form 
Page 5 of 8
Initials______
take you out of the study, you will be paid only for the visits you have completed. If 
you are in the exercise group, you will not be paid for session attendance, but will 
receive the necessary gym membership and exercise sessions for free.
It is important to know that payments for participation in a study is taxable income. 
Will I have to pay for anything?
It will not cost you anything to be in the study.
Is my participation voluntary?
Taking part in this study is voluntary.  You have the right to choose not to take part in 
this study.  If you choose to take part, you have the right to stop at any time.  If you 
refuse or decide to withdraw later, you will not lose any benefits or rights to which 
you are entitled.  If you leave this study, you will still receive your normal medical 
care. 
Can I be removed from this study? 
The study doctor may decide to stop your participation without your permission if the 
study doctor thinks that being in the study may cause you harm, or for any other 
reason.  
What happens if I am injured or hurt during the study? 
If you have an injury while you are in this study, you should contact the PI, 
Catherine Jankowski, immediately. Her phone number is 303-724-7383. 
We will arrange to get you medical care if you have an injury that is caused by this 
research.  However, you or your insurance company will have to pay for that care. 
Who do I call if I have questions?
The researcher carrying out this study is Dr. Catherine Jankowski. You may ask any 
questions you have now. If you have questions, concerns, or complaints later, you 
may call her at 303-724-7383. You will be given a copy of this form to keep.  
You may have questions about your rights as someone in this study. You can also 
call the responsible Institutional Review Board (COMIRB).  You can call them at 303-
724-1055. 
A description of this clinical trial will be available on http://www.Clinical Trials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. 
At most, the Web site will include a summary of the results. You can search this Web 
site at any time.

Consent and Authorization Form 
Page 6 of 8
Initials______
Who will see my research information?
The University of Colorado Anschutz Medical Campus (UC-AMC) and its affiliated 
hospital(s) have rules to protect information about you.  Federal and state laws 
including the Health Insurance Portability and Accountability Act (HIPAA) also 
protect your privacy.   This part of the consent form tells you what information about 
you may be collected in this study and who might see or use it.  
The institutions involved in this study include:
University of Colorado Anschutz Medical Campus 
University of Colorado Hospital
We cannot do this study without your permission to see, use and give out your 
information.  You do not have to give us this permission.  If you do not, then you may 
not join this study.  
We will see, use and disclose your information only as described in this form and in 
our Notice of Privacy Practices; however, people outside the UC-AMC and its 
affiliate hospitals may not be covered by this obligation.
We will do everything we can to maintain the confidentiality of your personal 
information but confidentiality cannot be guaranteed. 
The use and disclosure of your information has no time limit.  You can cancel your 
permission to use and disclose your information at any time by writing to the study’s 
Principal Investigator (PI), at the name and address listed below.  If you do cancel 
your permission to use and disclose your information, your part in this study will end 
and no further information about you will be collected.  Your cancellation would not 
affect information already collected in this study.  
Catherine Jankowski
University of Colorado College of Nursing
Mail Stop C288-19
13120 East 19th Ave.
Aurora, CO 80045
Both the research records that identify you and the consent form signed by you may 
be looked at by others who have a legal right to see that information, such as:.  

Federal offices such as the Food and Drug Administration (FDA) and the Office 
of Human Research Protections (OHRP) that protect research subjects like you.

People at the Colorado Multiple Institutional Review Board (COMIRB)

The study team.

Officials at the institution where the research is conducted and officials at other 
institutions involved in this study who are in charge of making sure that we follow 
all of the rules for research

Consent and Authorization Form 
Page 7 of 8
Initials______
We might talk about this research study at meetings.  We might also print the results 
of this research study in relevant journals.  But we will always keep the names of the 
research subjects, like you, private. 
You have the right to request access to your personal health information from the 
Investigator. To ensure proper evaluation of test results, your access to these study 
results may not be allowed until after the study is completed..
Information about you that will be seen, collected, used and disclosed in this 
study:

Name and Demographic Information (age, sex, ethnicity, address, phone 
number, etc.

Portions of your previous and current Medical Records that are relevant to this 
study, including but not limited to Diagnosis(es), History and Physical, laboratory or 
tissue studies, radiology studies, procedure results

Research Visit and Research Test records

Psychological and mental health tests

Blood samples and the data with the samples. 
What happens to Data, Tissue, Blood and Specimens that are collected in this 
study?
Scientists at the University of Colorado Denver and the hospitals involved in this 
study work to find the causes and cures of disease.  The data collected from you 
during this study are important to this study and to future research.  If you join this 
study:

The data given by you to the investigators for this research no longer belong to 
you.  

Both the investigators and any sponsor of this research may study your data 
collected from you.

If data are in a form that identifies you, CU-AMC or the hospitals involved in this 
study may use them for future research only with your consent or Institutional 
Review Board (IRB) approval.

Any product or idea created by the researchers working on this study will not 
belong to you.

There is no plan for you to receive any financial benefit from the creation, use or 
sale of such a product or idea. 

Consent and Authorization Form 
Page 8 of 8
Initials______
HIPAA Authorization for Optional Future Contact
In this form, you were given the option to agree to additional, optional research 
procedures.  You must also give us your permission, under HIPAA rules, to use and 
disclose the information collected from these optional procedures, as described 
above.  
If you decline to give us permission to use and disclose your information, you cannot 
take part in these optional procedures, but you can still participate in the main study.  
Please initial next to your choice:
_____ I give permission for my information, from the optional procedures I have agreed 
to above, to be used and disclosed as described in this section.
_____ I do not give permission for my information for any optional procedures to be 
used and disclosed; I understand that I will not participate in any optional 
procedures.
Agreement to be in this study and use my data
I have read this paper about the study or it was read to me.  I understand the possible 
risks and benefits of this study.  I understand and authorize the access, use and 
disclosure of my information as stated in this form.  I know that being in this study is 
voluntary.  I choose to be in this study: I will get a signed and dated copy of this consent 
form.
Signature:
Date:
Print Name:
Consent form explained by:
Date:
Print Name:
Investigator: _______________________________
Date: _______
Investigator must sign within 30 days