Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy
Phase: NA
Conditions: Young Adult, Cancer, Physical Activity
Sponsor: University of Wisconsin, Milwaukee

MCW Protocol No: PRO00027448 
 
Version No. 6 
IND No. 
 
Version Date:  8/16/17 
1 
 
 
 
 
 
 
 
CLINICAL STUDY PROTOCOL 
 
 
 
Fatigue in Young Adults with Cancer 
 
Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving 
Chemotherapy  
 
 
 
Jeanne M. Erickson, PhD, RN, AOCN 
 
 
 
Version Number 6 August 16, 2017 
 
 
 
Proprietary and Confidential 
The information in this document is considered privileged and confidential, and may not 
be disclosed to others except to the extent necessary to obtain Institutional Review 
Board approval and informed consent, or as required by federal and state laws. Persons 
to whom this information is disclosed should be informed that this information is 
privileged and confidential and that it should not be further disclosed. 
 
 
 
 
 

MCW Protocol No: PRO00027448 
 
Version No. 6 
IND No. 
 
Version Date:  8/16/17 
2 
PROTOCOL SIGNATURE PAGE 
Protocol No.: PRO00027448 
Version Date: 3/30/17 
1. I agree to follow this protocol version as approved by the MCW Scientific Review Committee 
(SRC), Institutional Review Board (IRB) and Data Safety Monitoring Committee (DSMC).  
2. I will conduct the study in accordance with applicable IRB requirements, federal regulations, 
and state and local laws to maintain the protection of the rights and welfare of study 
participants.  
3. I certify that I, and the study staff, have received the requisite training to conduct this 
research protocol.  
4. I have read and understand the information in the Investigator’s Brochure (or Manufacturer’s 
Brochure) regarding the risks and potential benefits. I agree to conduct the protocol in 
accordance with Good Clinical Practices (ICH-GCP), the applicable ethical principles, the 
Statement of Investigator (Form FDA 1572) and with local regulatory requirements. In 
accordance with the FDA Modernization Act, I will ensure the registration of the trial on the 
www.clinicaltrials.gov website.  
5. I agree to maintain adequate and accurate records in accordance with IRB policies, Federal, 
state and local laws and regulations. 
 
 
MCW Principal Investigator / Study Chair 
Jeanne M. Erickson 
 
 
Printed Name 
 
 
 
3/30/17 
Signature 
 
Date 
 

MCW Protocol No: PRO00027448 
 
Version No. 6 
IND No. 
 
Version Date:  8/16/17 
3 
Title: Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving 
Chemotherapy 
MCW OnCore® No.: Assigned initially. 
MCW Protocol No.: IRB will assign.   
FDA IND No.: NA 
Principal Investigator/Study 
Chair/Coordinating Center/Sponsor-
Investigator:  
Jeanne M. Erickson, RN, PhD, AOCN 
Assistant Professor 
University of Wisconsin-Milwaukee 
1921 E. Hartford Avenue 
Milwaukee WI  53211 
414-229-6920 
ericksoj@uwm.edu 
IND Sponsor: NA 
 
Sub-investigator/Responsible Investigator:  
Ann Swartz, PhD 
Professor  
Department of Kinesiology 
University of Wisconsin-Milwaukee 
PO Box 413 
Milwaukee, WI  53211 
414-229-4242 
aswartz@uwm.edu 
 
Sub-investigator/Responsible Investigator:  
Melinda Stolley, PhD 
Professor of Medicine 
Director of Prevention and Control 
Medical College of Wisconsin Cancer Center 
8701 Watertown Plank Road 
Milwaukee WI  53226-3548 
414-805-8208 
mstolley@mcw.edu 
Sub-investigator/Responsible Investigator:  
John Charlson, MD 
Associate Professor of Medicine 
Medical College of Wisconsin 
8701 Watertown Plank Road 
Milwaukee, WI  53226-3548 
414-805-8208 
jcharlson@mcw.edu  
OnCore® Contact: 
Name 
Title 
Institution 
Address 
Telephone 
Fax 
Email address 
Sub-investigator/Responsible Investigator:  
Kristin Bingen, PhD 
Associate Professor 
Children’s Hospital of Wisconsin 
Medical College of Wisconsin 
8701 Watertown Plank Road 
Milwaukee, WI  53226-3548 
kbingen@mcw.edu 
 
 
 
Research Coordinator: 
Name:  Nancy Peret, RN 
Title: Research Nurse 
Institution:  Children’s Hospital of Wisconsin 
Address:  9200 W. Wisconsin Ave 
Milwaukee, WI  53226 
Telephone:  414-266-3230 
Email address:  nperet@chw.org  

MCW Protocol No: PRO00027448 
 
Version No. 6 
IND No. 
 
Version Date:  8/16/17 
4 
 
Biostatistician: 
Weiming Ke, PhD 
Researcher/Statistician 
University of Wisconsin-Milwaukee 
1921 E. Hartford Avenue 
Milwaukee WI  53211 
414-229-4011 
ke2@uwm.edu 
 
 
Funding Sponsor:  
Self-Management Science Center 
Rachel Schiffman, PhD, RN, FAAN 
Principal Investigator & Administrative Core 
Director 
University of Wisconsin-Milwaukee 
1921 E. Hartford Avenue 
Milwaukee WI  53211 
414-229-3991 
schiffma@uwm.edu 
 
 
 
 
 

MCW Protocol No: PRO00027448 
 
Version No. 6 
IND No. 
 
Version Date:  8/16/17 
5 
REVISION HISTORY 
Revision history is presented in reverse order so that the information pertaining to the most 
current version of the protocol is presented first in this section. 
Version 6, Version Date 8/16/17 
Version 6 includes a revision to the procedures that include calls or emails to study participants 
to remind them to return the accelerometer promptly after the baseline and post-study periods.   
Version 5, Version Date 3/30/17 
Version 5 includes revisions requested by the Scientific Review Committee on March 14, 2017. 
Version 4, Version Date 10/16/16 
Version 4 reflects wording changes requested during IRB pre-review on October 10, 2016.   
Version 3, Version Date 08/30/16 
Version 3 reflects the inclusion of Children’s Hospital of Wisconsin as a second site for the 
study.  Kristin Bingen, PhD and Nancy Peret, RN were added to the study team.   
Version 2, Version Date 07/26/2016 
Version 2 reflects refinement of study procedures after meeting with study team on July 22, 
2016.  This version will be sent to Dr. James Thomas to request documentation of approvals by 
Faculty Review Committee and Scientific Review Committee as discussed in a meeting on July 
11, 2016.   
Version 1, Version Date 06/23/2016  
This draft was sent to OCCRIC on 6/24/16 as initial notification of the proposed study. 
 
 

MCW Protocol No: PRO00027448 
 
Version No. 6 
IND No. 
 
Version Date:  8/16/17 
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PROTOCOL SUMMARY 
 
Title 
Step-Up Intervention for Self-Management of Fatigue in Young 
Adults Receiving Chemotherapy 
Protocol Number 
 
IND Sponsor 
N/A 
Principal Investigator 
/Study Chair/
Coordinating 
Center/Sponsor-
Investigator 
Jeanne M. Erickson, PhD, RN, AOCN 
Study Sites 
Froedtert Hospital/MCW Cancer Center and Children’s Hospital of 
Wisconsin 
Clinical Trial Phase 
N/A 
Study Disease 
N/A 
Main Eligibility Criteria 
1) Young adults between the ages of 18 and 39 years; 2) have a 
diagnosis of cancer; 3) are within the first 2 months of a 
chemotherapy regimen that will last at least another 3 months; 4) are 
ambulatory without assistance; 5) have written consent from their 
physician to participate; 6) have the ability to understand English; 7) 
have access to a computer and the Internet, 
 
Study Rationale 
Despite decades of research, fatigue remains one of the most 
distressing symptoms and a disabling problem for young adults with 
cancer.  Interventions to increase physical activity have been shown 
to relieve fatigue in patients receiving chemotherapy, but no studies 
have tested a physical activity intervention to improve fatigue in 
young adults receiving chemotherapy.  Young adults with cancer 
acknowledge unmet needs for information and interventions related 
to physical activity, and they have concerns about how and when to 
return to physical activity during treatment.    
Primary Objectives 
To determine the impact of a physical activity intervention on the 
self-management process variables of self-efficacy and self-
regulation and their relationships to physical activity and fatigue 
severity.   
Secondary Objectives 
To determine the preliminary efficacy of a physical activity 

MCW Protocol No: PRO00027448 
 
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intervention on outcomes of physical activity and fatigue severity.   
Endpoints 
Self-efficacy for physical activity 
Self-regulation for physical activity 
Physical activity (steps/day) 
Symptom severity 
Fatigue severity  
Study Design 
A randomized experimental design with an intervention group and a 
usual care group  
Study Agent/
Intervention 
Description 
The physical activity intervention is based on the Individual and 
Family 
Self-Management 
Theory 
(IFSMT) 
and 
includes 
3 
components:  1) education about the benefits of physical activity 
during chemotherapy; 2) guidance and resources to help the young 
adult set physical activity goals during chemotherapy and to self-
monitor progress toward goals with a tracking device; and 3) ongoing 
collaboration with a physical activity coach.   
Number of Subjects 
75 young adults will be recruited.  
Subject Participation 
Duration 
Patients will continue in the study for approximately12 weeks.  
Duration of Follow up 
No follow-up after completion of study measures at 12 weeks 
Estimated Time to 
Complete Enrollment: 
20 months 
Statistical 
Methodology: 
 
Descriptive statistics will be used to describe and summarize the 
context variables related to the sample.  Variables with significant 
patterns of variation will be explored as potential covariates.  Field 
notes from sessions with the coach will be recorded and organized  
Safety Assessments 
The Safety Monitoring Committee of the P20 Center, the Self-
Management Science Center at UWM, will be responsible for 
monitoring the data safety of this pilot project. 
Efficacy Assessments 
NA 
Unique Aspects of this 
Study 
NA 
 
 
 

MCW Protocol No: PRO00027448 
 
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SCHEMA
Consent 
Study staff will complete medical record review 
and randomize participants into 2 groups. 
Study staff will provide participants with 
information about baseline measures, including 
use of accelerometer (Actigraph) x 1 week. 
Visit 1 Enrollment:  Participants will complete 
baseline surveys and wear accelerometer x 1 
k
RANDOMIZATION 
Intervention Arm 
Usual Care Arm 
Visit 2:  The facilitator will provide initial 
education to participants about the benefits of 
physical activity, setting physical activity goals,  
and using a physical activity tracker (Fitbit Flex).    
 
  Visit 2: The facilitator will provide initial 
information to participants about the study and a 
published handout with general guidelines for 
physical activity during cancer treatment.   
Visit 4:  During a regularly scheduled visit for 
chemotherapy, the facilitator will deliver a 30 
minute intervention: 1) review physical activity 
summary, 2) discuss barriers and strategies to 
overcome barriers, and 3) revise physical 
activity goals as needed.  
 
Visit 4:  During a regularly scheduled visit for 
chemotherapy, the facilitator will check in with 
participants to maintain study engagement.   
 
Visit 3:  During a regularly scheduled visit for 
chemotherapy, the facilitator will deliver a 30 
minute intervention: 1) review physical activity 
summary, 2) discuss barriers and strategies to 
overcome barriers, and 3) revise physical 
activity goals as needed.  
Visit 3:  During a regularly scheduled visit for 
chemotherapy, the facilitator will check in with 
participants to maintain study engagement. 
 
Study staff will ensure completion and return of 
accelerometers from participants. Participants 
will receive $25 compensation.   

 
 
 
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Visit 6:  During a regularly scheduled visit for 
chemotherapy, the facilitator will deliver a 30 
minute intervention: 1) review physical activity 
summary, 2) discuss barriers and strategies to 
overcome barriers, and 3) revise physical 
activity goals as needed.  
The facilitator will provide the accelerometer and 
schedule post-study week for participant to wear 
accelerometer (Actigraph). Participants will 
complete post-study measures.  They will be 
invited to keep physical activity tracker (Fitbit).     
Visit 5:  During a regularly scheduled visit for 
chemotherapy, the facilitator will deliver a 30 
minute intervention: 1) review physical activity 
summary, 2) discuss barriers and strategies to 
overcome barriers, and 3) revise physical 
activity goals as needed.  
 
Study staff will ensure completion of 
accelerometer use by all participants and  
completion of post-study measures.  
Participants will receive $25 compensation.  
Visit 5:  During a regularly scheduled visit for 
chemotherapy, the facilitator will check in with 
participants to maintain study engagement. 
 
Visit 6:  During a regularly scheduled visit for 
chemotherapy, the facilitator will check in with 
participants to maintain study engagement.  The 
facilitator will provide the accelerometer and 
schedule post-study week for participant to wear 
accelerometer (Actigraph).  Participants will 
complete post-study measures.   

 
 
 
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Study Calendar 
STUDY CALENDAR  
 
Visit 1 
(EN) 
Visit 
2 
Visit 
3 
Visit 
4 
Visit 
5 
Visit 
6 
All Participants 
Medical Record Review Form 
X 
 
 
 
 
 
Individual and Family Information Form 
X 
 
 
 
 
 
Godin Leisure Time Index 
X 
 
 
 
 
 
Physical Activity Assessment Inventory 
X 
 
 
 
 
X 
Self-regulation Index for Physical Activity 
X 
 
 
 
 
X 
PROMIS-29 (Multiple symptom severity) 
X 
 
 
 
 
X 
PROMIS-Fatigue Short Form  
X 
 
 
 
 
X 
Wear accelerometer (Actigraph) x 1 week 
X 
 
 
 
 
X 
Intervention Group Participants 
The facilitator will provide initial education to participants about the benefits of physical 
activity, setting physical activity goals, and using a physical activity tracker (Fitbit Flex).    
X 
 
 
 
 
 
During regularly scheduled visits for chemotherapy, the facilitator will meet with participants 
to deliver a 30 minute intervention:  1) review physical activity summary, 2) discuss barriers 
and strategies to overcome barriers, and 3) revise physical activity goals as needed.   
 
X 
X 
X 
X 
X 
Physical activity visit summary report 
 
X 
X 
X 
X 
X 
Evaluation of intervention components 
 
 
 
 
 
X 
Usual Care Group Participants 

 
 
 
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STUDY CALENDAR  
The facilitator will provide initial education about the study and a published handout with 
general guidelines for physical activity during cancer treatment.   
X 
 
 
 
 
 
During regularly scheduled visits for chemotherapy, the facilitator will meet with participants 
to maintain engagement in the study and identify any issues related to physical activity or 
participation in the study.     
 
X 
X 
X 
X 
 
Usual care visit summary report 
 
X 
X 
X 
X 
 
 

 
 
 
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TABLE OF CONTENTS 
 
Protocol Signature Page………………………………………………………………………………… 2 
Revision History…………………………………………………………………………………………...5 
Protocol Summary.………………………………………………………………………………………..6 
Schema.…………………………………………………………………………………………………….8 
Study Calendar…………………………………………………………………………………………….10 
Table of Contents………………………………………………………………………………………….12 
Specific Aims……………………………………………………………………………………………....13 
Background………………………………………………………………………………………………...14 
Study Design……………………………………………………………………………………………….16 
Patient Selection…………………………………………………………………………………………...17 
Study Procedures………………………………………………………………………………………….17 
Statistical Analysis…………………………………………………………………………………………19 
Adverse Events…………………………………………………………………………………………….20 
Regulatory Compliance, Ethics, and Study Management…………………………………………….22 
Data Handling and Management………………………………………………………………………...23 
References………………………………………………………………………………………………….25 

 
 
 
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1 SPECIFIC AIMS 
Over 70,000 adolescents and young adults (AYAs) between the ages of 15 and 39 years are 
diagnosed with cancer each year in the United States.1 These young patients have a unique 
cancer profile and frequently face months of therapy, often associated with distressing adverse 
side effects and decreased quality of life. Despite decades of research, fatigue remains one of 
the most distressing symptoms and a “major and disabling problem” for AYAs with cancer.2 
Persistent fatigue is implicated as one cause for the poor physical and emotional health-related 
quality of life outcomes in this young group of patients.3    
 
Like many patients, AYAs receiving chemotherapy get caught in a cycle of cancer-related 
fatigue, which leads to decreased physical activity (PA), which contributes to deconditioning and 
more fatigue.4 An array of interventions designed to increase PA have been shown to relieve 
fatigue in patients with cancer receiving chemotherapy, but most of this evidence emerges from 
studies with middle-aged adults receiving treatment for the most common cancers.  To date, no 
studies have tested a PA intervention to improve fatigue in AYAs receiving chemotherapy.5 
AYAs with cancer acknowledge unmet needs for information and interventions related to PA, 
and AYAs report concerns about how and when to return to PA during and after treatment.6-9  
 
An effective PA intervention, implemented early in the chemotherapy treatment process, is 
needed to prevent the cycle of fatigue and inactivity in AYAs that is associated with negative 
outcomes.4 A multi-strategy intervention that includes components of education, negotiated 
goal-setting, and individualized feedback, can meet this need to enable AYAs to incorporate 
realistic goals to stay physically active on their own.  During treatment, AYAs need to adjust PA 
goals based on their chemotherapy administration schedules and the predictable patterns of 
chemotherapy-related fatigue in order to prevent weeks of decreasing activity.  Most studies 
report that PA is safe and well-tolerated by patients receiving chemotherapy, including patients 
with leukemia and lymphoma, which are common cancers in AYAs.10-12 Patients receiving 
chemotherapy can safely begin a program of low-to moderate-intensity PA on their own.13-15 
Furthermore, home-based approaches may result in better maintenance of PA for AYAs with 
cancer who are in active treatment and who may be unwilling or unable to travel to supervised 
programs at alternate locations.6, 16,17  
 
Self-management is the dynamic process by which individuals integrate strategies to manage 
their disease, including management of treatment-related symptoms, such as fatigue. For 
individuals with a chronic disease, such as cancer, this self-management process will last a 
lifetime, requiring the adoption of healthy lifestyle habits.  The Individual and Family Self-
Management Theory (IFSMT) outlines factors related to the individual’s knowledge and beliefs, 
self-efficacy and self-regulation, which impact the self-management process to improve 
outcomes.18 Self-efficacy is a predictive factor for participating in PA, and promoting AYAs’ self-
efficacy for PA needs to be explored as a strategy to improve self-management of fatigue.19  
 
The purpose of this research is to study a 12-week PA intervention to improve self-management 
of fatigue in AYAs receiving chemotherapy. The intervention will include components of 
education, negotiated collaboration to set individual PA goals during chemotherapy cycles, and 
tools for self-monitoring PA.  The aims of this study are: 
 
1. To determine the impact of the PA intervention on the self-management process variables of 
self-efficacy and self-regulation and their relationships to PA and fatigue severity. 
2. To determine the preliminary efficacy of the PA intervention on outcomes of PA and fatigue 
severity. 

 
 
 
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2 BACKGROUND 
Fatigue in Adolescents and Young Adults (AYAs) with Cancer  
Fatigue is one of the most prevalent and severe symptoms in adolescents and young adults 
(AYAs) with cancer.2 Defined as “a distressing, persistent, subjective sense of physical, 
emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatment 
that is not proportional to recent activity”20 (p1), cancer-related fatigue causes significant 
distress for AYAs and interferes with physical activities, social function, and mood.2, 21 AYAs 
commonly report that fatigue occurs with other troubling symptoms, such as poor sleep, 
nausea, and pain, and within these symptom clusters, fatigue is frequently named as the 
priority symptom.22 AYAs with cancer have shown greater symptom severity, including 
fatigue, than children and older patients. 23, 24 The higher level of fatigue in AYAs may be 
due to their accelerated physical and cognitive growth, hormone-related changes, as well as 
their involvement in multiple activities of this developmental period (school, work, 
relationships, and parenting).3 
 
Cancer-related fatigue is worst during the treatment period.2, 25 During cycles of 
chemotherapy, fatigue levels may follow a predictable and fluctuating pattern of increasing 
in the days after each cycle but improving before the next cycle.2, 26 Studies also show that 
fatigue may be a persistent long-term problem, even for AYAs who have completed 
treatment.2,27,28   
Physical Activity as an Evidence-based Intervention to Manage Fatigue in AYAs  
Major oncology professional organizations recommend physical activity as an evidence-
based intervention to manage fatigue, although most of this evidence comes from studies 
with adults who have the most common cancers, such as breast and prostate cancer. 29 
Diverse PA programs for people with cancer have included aerobic and muscle-
strengthening activities, such as walking, cycling, and yoga, and most programs last 
between 5 and 12 weeks.30-33  
   
No trials have examined a PA intervention with YAs currently receiving treatment, and 
minimal PA studies have been conducted with patients who have the common diagnoses of 
this age group, such as lymphoma, leukemia, sarcoma, and germ cell tumors.  A few PA 
interventions have targeted young adults with cancer who have completed cancer treatment, 
confirming that these patients are interested and able to participate in PA programs, 
especially when recommended by PA experts.34-36    
Many young adults receiving cancer treatment unfortunately get caught in a cycle of cancer-
related fatigue, which leads to decreased PA and physical fitness, which contributes to 
increased severity of fatigue and other symptoms.4 Studies confirm that PA declines in YAs 
during chemotherapy and persists into the years following cancer therapy.7,17,37,38 In addition, 
YA cancer survivors acknowledge unmet needs for information and interventions related to 
PA.6-9  A recent analysis of topics and needs communicated by AYAs with cancer in an 
online forum suggests that YAs are interested in exercise for enjoyment, overall well-being, 
and weight management, but they do have concerns about safety and physical limitations 
and how/when to return to exercise post-treatment.9 AYAs with cancer cite barriers to PA 
similar to a healthy comparison group, such as lack of energy, lack of self-discipline, lack of 
skills, and no companions, but AYA cancer survivors may be less likely to cite ‘lack of time’ 
as a significant barrier.9,17  An effective PA intervention, implemented early in the 

 
 
 
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chemotherapy treatment process, is needed to prevent the cycle of fatigue and inactivity in 
AYAs that is associated with negative outcomes. 
Theoretical Framework 
The Individual and Family Self-Management Theory (IFSMT) will be used as a framework 
for this study.18 This theory proposes three inter-related dimensions of context, process, and 
outcomes related to individuals’ self-management behaviors.  Contextual factors refer to the 
individual and family, the individual’s health status, and the physical and social environment 
which influence self-management.  The process dimension includes knowledge and beliefs, 
behavior-specific self-efficacy and self-regulation, and social facilitation.  Outcome variables 
may be proximal, such as condition-specific self-management behaviors, and/or distal, such 
as quality of life or health care costs.   
 
The IFSMT acknowledges the specific developmental and cancer-related needs of AYAs 
that influence their self-management behaviors.   The intervention in this study (The “Step-
Up” Study) contains three components 
which target the self-management process:  
1) education about the benefits of PA and 
symptom management to improve AYAs’ 
knowledge and beliefs and self-efficacy for 
PA, 2) resources to increase AYAs’ use of 
self-regulation behaviors related to PA, and 
3) ongoing negotiated collaboration with a 
facilitator to promote PA. The impact of the 
intervention on the proximal outcome of 
engagement in PA and on the distal 
outcome of fatigue severity will be 
measured.  (Figure 1).  
 
Innovation 
This study is focused on PA research with 
the understudied group of AYAs with 
cancer.  It is the first study to apply the 
IFSMT as a framework to identify effective interventions to help AYAs increase their PA as a 
strategy to manage fatigue, examining whether improved self-efficacy and self-regulation for 
PA as well as social facilitation will result in desired behavior changes.  The intervention will 
be offered to AYAs who are currently receiving treatment and will be integrated into their 
regularly scheduled visits for chemotherapy administration, an important step to translate 
this evidence-based intervention into practice settings. Finally, since the intervention 
focuses on PA as a self-management behavior, the study will provide evidence about the 
impact of a less intensive and less expensive approach to improving PA, which may be a 
more relevant, meaningful, and feasible PA intervention for all AYAs with cancer.    
 
Preliminary work  
The multidisciplinary team comprises a unique combination of expertise in AYA oncology 
and PA research.  Dr. Erickson is an oncology nurse researcher with over 30 years of 
clinical oncology experience.  She has conducted previous studies that described patterns 
of fatigue during chemotherapy cycles and the negative effects of symptoms such as fatigue 
and sleep-wake disturbances on the daily activities and quality of life of AYAs receiving 
chemotherapy.22, 26, 39 She has also demonstrated the feasibility and acceptability of 
12-week “Step Up” Intervention 
Context 
Risk and Protective Factors 
Process 
The Self-Management Process 
Proximal  
Outcomes 
Distal 
Outcomes 
Individual & Family Self-Management Theory Applied to 
the “Step Up” Intervention for AYAs with Cancer 
 
Condition-Specific Factors 
• 
Health history 
• 
Cancer diagnosis 
• 
Treatment regimen 
 
Physical & Social Environment 
• 
Household characteristics 
 
Individual & Family Factors 
• 
Demographics 
• 
Family characteristics 
• 
PA level before cancer diagnosis 
 
 
 
Knowledge & Beliefs 
• 
Benefits of PA during 
chemotherapy 
• 
Management of symptoms that 
may be barriers to PA 
• 
Self-efficacy for PA 
Self-Regulation Skills & Abilities 
• 
Self-regulation for PA 
• 
Setting goals for PA  
• 
Monitoring PA 
Social Facilitation 
• 
Negotiated collaboration about PA  
 
 
 
 
Individual Self-
Management 
Behaviors 
• 
Engagement in PA 
(steps/day) 
 
 
 
 
 
 
 
 
Health Status 
• 
Fatigue severity 
 
 
 
 
 
 
 
 
 
Figure 1.  Model of PA Intervention.  Adapted from Individual and Family Self-Management Theory, by P. A. Ryan  and K. J. Sawin 
retrieved from www.nursing.uwm.edu/smsc. Copyright 2009, 2014 by Ryan and Sawin.  Adapted with permission. 

 
 
 
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measuring PA and symptoms in AYAs receiving chemotherapy.40 Dr. Stolley is a clinical 
psychologist with expertise in intervention trials related to improving PA and nutrition in 
cancer survivors, including adolescents.  Dr. Swartz has over 15 years of experience as a 
scientific investigator in the areas of physical activity and sedentary behavior assessment.  
Dr. Charlson is a medical oncologist with a clinical focus on the treatment of young adult 
patients with sarcoma and breast cancer. 
 
3 STUDY DESIGN 
 
General description 
The “Step-Up” Study will use a randomized experimental design to examine the preliminary 
efficacy of the physical activity intervention in AYAs who are receiving chemotherapy that 
will last approximately 12 weeks.   
 
Number of Subjects  
Seventy-five AYAs will be recruited from the Froedtert Hospital/Medical College of 
Wisconsin (FH/MCW) Cancer Center and Children’s Hospital of Wisconsin.  
 
Primary Endpoints 
The primary endpoints for the study include self-efficacy for physical activity, self-regulation 
of physical activity fatigue severity, physical activity, and fatigue severity.  
The following table summarizes the proposed instruments for the study: 
  
 
 
 
IFSMT factor 
Variable 
Measure 
Pre 
Post 
Condition-specific: 
Individual 
Demographics, health history, 
diagnosis, treatment regimen  
Medical Record Review Form  
x 
 
Condition-specific: 
Individual and 
family 
Individual, household and family 
characteristics 
Individual and Family Information 
Form  
x 
 
Condition-specific: 
Individual 
Usual amount of PA before diagnosis 
(self-reported) 
Godin Leisure Time Index41 
x 
 
Process: 
Self efficacy  
Self-efficacy for PA 
Physical Activity Assessment 
Inventory42  
x 
x 
Process: 
Goal-setting and 
self-monitoring 
Self-regulation skills and abilities  
Self-Regulation Index for PA43 
x 
x 
Process: 
Negotiated 
collaboration 
Perceptions of the intervention, 
preferred features of the PA tracker 
and facilitator 
Evaluation of Intervention  
(intervention group only) 
 
x 
Proximal outcome: 
PA behaviors 
# days worn, daily and weekly goals, 
daily step counts  
PA and use of PA tracker (Fitbit) 
(intervention group only) 
throughout 
Proximal outcome: 
PA behaviors 
PA (steps/day) 
Blinded accelerometer 
(ActiGraph GTX3+) x 7 days 
x 
x 
Distal outcome: 
Symptom severity 
Intensity of emotional distress, fatigue, 
pain, physical function, sleep 
disturbance, satisfaction with 
participation in social roles  
PROMIS-2944  
x 
x 
Distal outcome: 
Fatigue severity 
Fatigue frequency, duration, intensity 
and impact of fatigue on activities 
PROMIS – Fatigue Short Form44 
x 
x 

 
 
 
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Randomization 
Patients will be randomized into two groups (intervention and usual care) using the Excel 
‘RAND’ function to create a randomization chart forcing 38 into the intervention arm and 37 
into the usual care arm.  
 
Study Timeline 
Primary Completion 
The study will reach primary completion 19 months from the time the study opens to accrual. 
Study Completion 
The study will reach study completion 22 months from the time the study opens to accrual. 
4. PATIENT SELECTION 
Inclusion Criteria 
Patients eligible for the study will be: 
1) between the ages of 18 and 39 years of age;1  
2) have a diagnosis of cancer;  
3) are within the first two months of a chemotherapy regimen that will last at least another 3 
 
months;  
4) are ambulatory without assistance;  
5) have written consent from their physician to participate;  
6) have the ability to understand English;  
7) have access to a computer and the Internet.  
  
The goal of this study is to deliver the intervention as early in the treatment period as 
possible, but we recognize that recruiting and completing baseline measures before 
chemotherapy begins may be a burden to patients and a barrier to recruitment.  The lower 
age limit for AYAs will be set at 18 years rather than 15 years in order to use one set of 
instruments which have been validated only for adults over age 18 years. AYAs with any 
diagnosis of cancer will be included in this exploratory pilot study. 
 
Exclusion Criteria 
Patients will be excluded from enrolling in the study if they have symptoms of uncontrolled 
cardiopulmonary disease, uncontrolled neurological disease, delayed wound healing from 
surgery, a high risk of bone fracture, or pre-existing peripheral neuropathy. Physicians will 
be asked to give written approval to indicate that patients do not have any of these 
contraindications to physical activity.   
5. STUDY PROCEDURES 
Recruitment Process 
A member of the study team will screen clinic schedules at FH/MCW Cancer Center and 
clinic schedules in the Pediatric Hematology/Oncology Clinic to identify every AYA who 
meets the inclusion criteria.  Clinic staff will ask eligible patients if they are willing to speak 

 
 
 
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with a member of the study team about the study. Eligible participants will be given time - 
over days, if necessary and possible - to consider study participation after hearing the 
details of the study. A member of the study team will complete the informed consent process 
with AYAs using an open exchange, reading through the informed consent document 
together, and allowing for assessment of comprehension and discussion of questions and 
concerns.  A member of the study team will obtain written consent from the patient’s primary 
provider to indicate the patients do not have any contraindications to physical activity.   
A signed informed consent form copy will be given to the subject and a copy will be filed in 
the medical record. The original will be kept on file with the study records.  
All patients who are consented will be registered in OnCore®, the MCW Cancer Center 
Clinical Trial Management System. The system is password protected and meets HIPAA 
requirements.  
Study Procedures 
1.  Visit 1 Enrollment 
Following informed consent, a study team member will administer baseline surveys to all 
participants.  Participants will receive instructions about wearing an accelerometer 
(Actigraph) for 1 week and how to return the accelerometer (Actigraph).  
Participants will be asked for their preferred method of contact (email or phone call) to be 
reminded to return the accelerometer after one week of wear.  A study team member will 
contact participants after the one-week period and remind them to return the accelerometer 
promptly in the mailing envelope that was provided.   
Participants will be randomized to the intervention group or the usual care group.   
2.  Visit 2 (next regularly scheduled visit for chemotherapy) 
Intervention group participants will meet with the facilitator, who will provide initial 
education about the benefits of physical activity and strategies to overcome barriers to 
physical activity, help the participants to set physical activity goals based on ability and 
preferences, and educate the participant on using a physical activity tracker (Fitbit Flex).   
Usual care group participants will meet with the facilitator who will provide initial information 
to participants about the study and a published flyer about general guidelines for physical 
activity during treatment.   
3.  Visits 3, 4, 5, 6 (next regularly scheduled visits for chemotherapy – at intervals of 
approximately 3 weeks but may range from every 2-4 weeks based on chemotherapy 
schedule) 
Intervention group participants will meet with the facilitator who will deliver a 30 minute 
intervention:  1) review physical activity summary over the past weeks, 2) identify barriers 
and discuss strategies to overcome barriers to physical activity, and 3) revise physical 
activity goals as needed.  The facilitator will record physical activity data from the tracking 
device (Fitbit Flex), discussion notes about the barriers and strategies, and physical activity 

 
 
 
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goals.  Any experiences or complications that might affect physical activity will be recorded, 
such as hospitalizations.    
Usual care group participants will meet with the facilitator to maintain engagement in the 
study.  The facilitator will record any experiences or complications that might be pertinent to 
the study, such as hospitalizations and enrollment in any activities related to physical 
activity.   
At study visit 6, all participants will complete post-study surveys and will receive 
instructions about wearing an accelerometer (Actigraph) for 1 week and how to return the 
accelerometer (Actigraph).  
A study team member will contact participants after the one-week period and remind them to 
return the accelerometer promptly in the mailing envelope that was provided.   
Following completion of the study, a member of the study team will ensure completion 
and return of accelerometer (Actigraph) use by all participants. All participants will receive 
$25 compensation.  Intervention participants will complete an additional post-study survey to 
evaluate components of the intervention and be invited to keep the physical activity tracker 
(Fitbit Flex).   
6.  STATISTICAL ANALYSIS 
Sample Size 
In an a priori power analysis using a mediation model that includes 4 predictors (intervention 
variable, self-efficacy, self-regulation, and PA), a total sample of 68 participants (34 in each 
group) would be needed to detect a medium-sized effect at a 0.10 significance level with 
80% power.  The power analysis was completed by using an online sample size calculator 
(http://www.danielsoper.com/statcalc/calculator.aspx?id=1) based on the above information.  
Physicians at FH/MCW and CHW saw approximately 300 AYAs with a new cancer 
diagnosis in 2012, and about half of those AYAs received chemotherapy.  Assuming a 50% 
enrollment rate and 10% attrition, 75 AYAs will be recruited from these sites for a final 
sample of 68. 
 
Data Management and Analysis 
Questionnaire data will be collected electronically using REDcap surveys, and 
accelerometer (Actigraph) data will be analyzed using respective software.  For the 
intervention group, weekly PA data will be transcribed from the PA tracker (Fitbit Flex) 
dashboard to REDcap files at each visit.  All REDcap data will be exported to SPSS for 
analysis.  Descriptive statistics will be used to describe and summarize the context variables 
related to the sample.  Variables with significant patterns of variation will be explored as 
potential covariates. Missing values will be identified and reviewed for patterns of 
missingness, and the percentage of missing data will be calculated. If missing data are less 
than 5%, pairwise deletion will be used in data analysis, meaning all available cases will be 
used. If missing data are greater than or equal to 5%, Little’s Chi-square test will be used to 
check if data are missing at random. If missing at random is assumed, multiple imputation 
method will be used. Field notes from sessions with the facilitator related to barriers and 
self-management strategies as well as notes from post-study debriefing interviews will be 
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After all study queries and analyses are completed, the data/PHI will not be destroyed but 
will be archived in a secure long-term storage site in order to keep an accurate record of 
screened and enrolled subjects for the sponsor and potential audit purposes only specific for 
this study. Data/PHI would not be destroyed until permission is granted by the sponsor to 
destroy the records. 
 
Statistical Analyses 
Specific Aim 1: To determine the impact of the PA intervention on the self-management 
process variables of self-efficacy and self-regulation, data analysis will examine differences 
in baseline and post-study measures of self-efficacy and self-regulation for each group.  
Group differences will be compared using t-tests to determine the effect of the intervention 
on these process variables.  A mediation model will be used to describe the relationships of 
self-management process variables (self-efficacy and self-regulation) to PA (steps/day by 
accelerometer) and fatigue severity where self-efficacy and self-regulation are the main 
mediators of the intervention, PA is the second mediator, and fatigue severity is the 
dependent variable. The direct and indirect effect of treatment on PA and fatigue severity 
will be determined by the following steps:45, 46 
 
Step 1. The regression of the fatigue severity on the intervention variable, ignoring the 
mediators, is significant. 
Step 2: The regression of the main mediators on the intervention variable  is significant.  
Step 3: The regression of the second mediator (PA) on the main mediators (self-efficacy and 
self-regulation), controlling for the intervention, is significant.  
Step 4: The regression of the fatigue severity on the second mediator (PA), controlling for 
the main mediators (self-efficacy and self-regulation) and the intervention, is significant.   
Step 5:  The regression of the fatigue severity on the intervention, controlling for the 
mediators, is non-significant and nearly-zero.  In this case, the effect of intervention on 
fatigue severity is indirect through the mediators.  If regression of the fatigue severity on the 
intervention, controlling for the mediators, is still significant, then the effect of treatment on 
fatigue severity is direct.   
 
From the regression models, unstandardized regression coefficients and their standard 
errors will be calculated for the associations between the intervention variable and the 
mediators as well as between the fatigue severity and the mediators. The Sobel test will be 
used to test if the mediation effect is statistically significant.45-49 Data from field notes from 
the intervention group participants will be analyzed using qualitative, inductive content 
analysis procedures to identify themes related to self-efficacy and self-regulation skills. 
 
Specific Aim 2: To determine the preliminary efficacy of the PA intervention on outcome 
variables of PA (steps/day by accelerometer) and fatigue severity, data analysis will 
examine differences in baseline and post-study measures of PA (steps/day by 
accelerometer) and fatigue severity (PROMIS-29 and PROMIS Fatigue scores) for each 
group.   Group differences will then be compared using t-tests to detect the effect of the PA 
intervention on these outcomes.  Direct and indirect effect of the intervention on fatigue 
severity will be studied using the mediation model discussed in Aim 1.  Quantitative data 
about the fidelity of the intervention will be used to estimate the dose of the delivered 
intervention for each participant and to explore whether there was a dosage effect on the 
outcomes. 
 
7.  ADVERSE EVENTS 

 
 
 
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Data and Safety Monitoring Plan 
a.  Monitoring Entity.  The Safety Monitoring Committee of the P20 Center, the Self-
Management Science Center at UWM, will be responsible for monitoring the data safety of 
this pilot project.  The Safety Monitoring Committee includes the Pilot Core Director (M. 
Fendrich), Pilot Core Methods/Content Expert (C. Kovach), and two members independent 
of the P20 Center (C. Huang, Biostatistician, and A. Harley, Community and Behavioral 
Health Promotion).  The P20 Center Director (R. Schiffman) is responsible for submitting 
necessary reports to NINR.   
 
b.  Procedures 
1.  Monitoring study safety.  The Pilot Project Director (J. Erickson) will meet bi-weekly 
with the study team to review study enrollment, compliance with IRB requirements, 
including informed consent, verification of source documents, and compliance with study 
procedures.  The Pilot Project Director will report at the P20 Center Pilot Projects bi-
weekly meetings with the Pilot Core Director any concerns related to study safety 
identified by the project team.  At the point when 10% of the participants are enrolled 
and at random intervals throughout the duration of the study, the Pilot Core Director or 
Methods Expert will review the informed consents for compliance to IRB requirements.  
The Pilot Project Director will provide the necessary study documents for review as 
requested. 
  
2.  Minimizing research-associated risk. This pilot project is anticipated to be minimal 
risk, but potential risks are that participants may experience psychological discomfort or 
distress when reflecting upon their personal experiences about cancer and cancer-
related symptoms and/or physical discomfort, distress, or injury related to following a 
low-intensity physical activity (PA) plan.  The Pilot Project Director (J. Erickson) will 
investigate any research-associated risks that are identified by the study team members 
and will report these concerns to the P20 Center Principal Investigator (R. Schiffman) or 
the Pilot Core Director (M. Fendrich) so that these concerns can be addressed.   
 
The following actions will be outlined in the study procedures to protect against risks: 
  
Psychological discomfort or distress. The facilitator and other members of the study 
team will be educated about how to recognize emotional distress and to make every 
effort to provide psychosocial support when emotional distress is evident. In the event 
that any participant demonstrates or self-reports a high level of distress, a member of the 
study team will conduct a further assessment. With the participant’s consent, the study 
team may inform the participant’s health care provider of the emotional distress in order 
to make adjustments to the care plan or suggest referrals for specialized care. No 
information will be disclosed to another party without the participant’s consent unless 
there is imminent danger to the participant or others. 
 
Physical discomfort, distress, or injury related to following a low-intensity physical activity 
(PA) plan.  According to the American College of Sports Medicine, PA is safe and 
beneficial for patients during cancer treatment, and baseline exercise-testing is not 
required for patients to participate in low- to moderate-intensity PA, such as walking or 
resistance training. We will exclude patients who have contraindications to PA, which 
may include symptoms of uncontrolled cardiopulmonary disease, uncontrolled 
neurological disease, delayed wound healing from surgery, a high risk of bone fracture, 
or preexisting peripheral neuropathy, and we will obtain written approval from the 

 
 
 
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patient’s physician to indicate none of these conditions apply. Patients will receive 
information from the facilitator about PA safety at the start of the study and will be 
advised to set PA goals based on their baseline PA level and to respect their own 
physical limitations. Participants will be reminded to complete ‘pre-exercise’ screening 
every day, and they will be advised not to engage in PA if they have any of the following 
conditions: 1) heart palpitations or chest pain; 2) fever greater than 38o C; 3) shortness 
of breath at rest; 4) new bruises or ongoing bleeding; 5) uncontrolled pain or nausea; 6) 
dizziness. They will be advised not to resume PA until these conditions resolve, and they 
should contact their health care provider about the condition if the problem is new and/or 
severe. PA studies have been safely carried out with patients undergoing intensive 
chemotherapy who have platelet values as low as 20,000/mm3 and leucocytes < 
1.0X109/L, and no studies have shown PA complications related to bleeding or infection.  
At each visit, the facilitator will discuss PA safety with each participant, explore any 
concerns about physical discomfort or distress that may be related to PA, and any new 
symptoms that may be a contraindication to PA. The facilitator will consult with the 
patient’s care providers if there are any concerns about continuing the PA study. 
 
3.  Protecting confidentiality of participant data.  Only study team members will have 
access to participant data. Participant data will be listed using a study ID number, and 
identifiable personal health information (PHI) will be stored separately from other study 
data. Data from surveys, accelerometers (Actigraphs), and PA trackers (Fitbits) and from 
facilitation and interview sessions will be stored on password-protected computers with 
access limited to study personnel. The Pilot Project Director will monitor all project-
related computers and devices used in the study for compliance with data security 
protocols. Data analyses will be conducted without identifiers.  The Pilot Project Director 
will report any data security issues to the P20 Principal Investigator.   
 
c.  Adverse Events and Unanticipated Problems.  This pilot project is identified as 
minimal risk, and adverse events are not expected.  The study team will review study 
activities and participant involvement at each bi-weekly team meeting with attention to 
identification of any unexpected events or problems.  Should an adverse event or 
unanticipated problem occur, the project team will immediately contact the Pilot Project 
Director (J. Erickson), who will contact the P20 Center Principal Investigator (R. Schiffman). 
The PI will assess the event or problem and notify the IRB and NINR, including the plan to 
address the problem. 
 
d.  Multi-site Studies.  This is not a multi-site study.   
 
e.  External Factors.  Before each quarterly meeting with the P20 DSM Team, the Pilot 
Project Director (J. Erickson) and Project Co-Investigators (J. Charlson and M. Stolley) will 
review any changes in practice or policy at Froedtert Hospital/MCW Cancer Center that 
would affect this study.  They will also review any relevant new literature or research that 
would impact the safety of the participants or ethics of the study.  The Pilot Project Director 
will present a summary of these relevant external factors at the quarterly P20 Center 
meetings.   
 
f.  Advanced Plan for Analysis.  An advanced plan for interim and/or futility analysis is not 
planned for this pilot project.   
 

 
 
 
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g.  Subject Complaints.  If a complaint is received by anyone on the study staff, it will be 
discussed with the study staff and will be addressed on a case-by-case basis. The PI will be 
notified of any complaints. Complaints will be reported to the IRB if indicated.  
If the subject has questions about his or her rights as a study subject, wants to report any 
problems or complaints, obtain information about the study or offer input, the subject can 
call the Medical College of Wisconsin/Froedtert Hospital research subject advocate at 414-
955-8844. This information is provided to the subject in their consent.  
The investigator will assess all adverse events and determine reporting requirements to the 
MCWCC Data and Safety Monitoring Committee (DSMC) and MCW’s Institutional Review 
Board.   
8  REGULATORY COMPLIANCE, ETHICS AND STUDY MANAGEMENT 
Ethical Standard and Investigator Compliance 
This study will be conducted in accordance with the ethical principles that have their origin in the 
Declaration of Helsinki as stated in 21 CFR §312.120(c)(4); consistent with GCP and all 
applicable regulatory requirements. 
The principal investigator/study chair) will allow access to all source data and documents for the 
purposes of monitoring, audits, IRB review, and regulatory inspections.  
The study monitor or other authorized representatives of the principal investigator may inspect 
all documents and records required to be maintained by the investigator, including but not 
limited to, medical records (office, clinic, or hospital) and pharmacy records for the subjects in 
this study. The clinical study site will permit access to such records. 
The investigator will conduct the study in compliance with the protocol given approval/favorable 
opinion by the IRB and the appropriate regulatory authority(ies).  
Study Team 
The study team consists of the principal investigator, the clinical research coordinator (CRC), 
the study facilitator, and the research assistant (RA).  The study team will meet with the 
biostatistician, co-investigator, and study consultants as needed while the study is open to 
accrual. 
9  DATA HANDLING AND RECORD KEEPING  
Data Management Responsibilities 
The principal investigator oversees the collection and management of study data. 
The clinical research coordinator (CRC) is responsible for documentation related to the 
recruitment and enrollment of study participants and collection of baseline and post-study 
measures.  The CRC is responsible for registration of study participants in OnCore and for 
completion of study surveys using RedCap.   

 
 
 
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The study facilitator is responsible for documentation of data collected with all participants 
during regular study visits, including documentation of the delivery of the intervention 
components.   
The research assistant (RA) is responsible for analysis of accelerometer (Actigraph) data and 
data entry into RedCap files.   
Only study team members will have access to participant data. Participant data will be listed 
using a study ID number, and identifiable personal health information (PHI) will be stored 
separately from other study data. Data from surveys, accelerometers (Actigraph), and PA 
trackers (Fitbit) and from facilitation and interview sessions will be stored on password-protected 
computers with access limited to study personnel. The Pilot Project Director will monitor all 
project-related computers and devices used in the study for compliance with data security 
protocols. Data analyses will be conducted without identifiers.  The Pilot Project Director will 
report any data security issues to the P20 Principal Investigator.  
The Pilot Project Director (J. Erickson) will meet bi-weekly with the study team to review study 
enrollment, compliance with IRB requirements, including informed consent, verification of 
source documents, and compliance with study procedures.  The Pilot Project Director will report 
at the P20 Center Pilot Projects bi-weekly meetings with the Pilot Core Director any concerns 
related to study safety identified by the project team.  At the point when 10% of the participants 
are enrolled and at random intervals throughout the duration of the study, the Pilot Core Director 
or Methods Expert will review the informed consents for compliance to IRB requirements.  The 
Pilot Project Director will provide the necessary study documents for review as requested. 
The principal investigator will maintain study data for five years.   
The principal investigator will assume ownership of the data, along with the UWM Self-
Management Science Center, and has responsibility for publishing the data. 
 
 

 
 
 
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