Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment - An Addendum to NIH R01CA167821 "Early Imaging Detection of Cardiovascular Injury After Cancer"
Phase: NA
Conditions: Cardiac Toxicity, Malignant Neoplasm, Breast Cancer
Sponsor: Wake Forest University Health Sciences

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
 
 
 
Principal Investigator: 
 
W. Gregory Hundley, MD 
 
Departments of Internal Medicine-Cardiology and 
Radiology 
 
Wake Forest University Health Sciences 
1 Medical Center Boulevard 
E-mail address: ghundley@wakehealth.edu or 
greg.hundley@vcuhealth.org 
Phone: (336) 716-0607 or 804-628-6611 
Fax: (336) 716-9188 
 
 
Co-Investigator(s): 
Peter Brubaker, PhD 
 
Health and Exercise Science 
 
Wake Forest University 
 
E-mail address: brubaker@wfu.edu 
 
Phone: (336) 758-4683 
 
Fax: (336) 758-4680 
 
Shannon Mihalko, PhD 
 
Health and Exercise Science 
 
Wake Forest University 
 
E-mail address: mihalksl@wfu.edu 
 
Phone: (336) 758-1945 
 
Fax: (336) 758-4680 
 
Dalane Kitzman, MD 
 
Departments of Internal Medicine-Cardiology 
 
Wake Forest University Health Sciences 
1 Medical Center Boulevard 
E-mail address: dkitzman@wakehealth.edu 
Phone: (336) 716-2227 
Fax: (336) 716-4995 
 
Jennifer Jordan, PhD 
Internal Medicine-Cardiology 
Virginia Commonwealth University 
E-mail address: jhjordan@vcu.edu 
Phone: (804) 628-6239 
 
Steve Rapp, PhD 
Public Health Sciences 
Wake Forest University Health Sciences 
E-mail address: srapp@wakehealth.edu 
Phone: (336) 716-6995 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
 
 
 
Lynn Wagner, Ph.D. 
Public Health Sciences 
Wake Forest University Health Sciences 
E-mail address: lywagner@wakehealth.edu 
(336) 713-1478 
 
Rakhee Vaidya, B.M.M.S. 
Department of Internal Medicine (Onocology) 
Wake Forest Health Sciences 
Email address: ravaidya@wakehealth.edu 
Phone: (336) 716-2774 
 
Biostatistician: 
Ralph D’Agostino, Jr., PhD 
Comprehensive Cancer Center of Wake Forest 
University 
E-mail address: rdagosti@wakehealth.edu 
Phone: (336) 716-9410 
 
 
Study Coordinator: 
 
W. Gregory Hundley, MD 
E-mail address: ghundley@wakehealth.edu 
 
 
 
 
 
Phone: (336) 716-0607 
 
 
Regulatory Contact: 
 
Amy Ladd, PhD 
E-mail address: amy.ladd@vcuhealth.org 
 
 
 
 
 
Phone: (804 )828-2692 
 
 
Participating Institution(s): 
Wake Forest University, VCU Health Sciences 
 
 
Version Date 11/12/2021 
Amended: 
 
 
 
Confidential

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 3 of 114 
 
 
 
 
 
   
Table of Contents 
Schema…………………………………………………………………………………….…..4 
1.0  Introduction and Background…………………………………………………..............5 
2.0  Objectives………………………………………………………………………………....9 
3.0  Study Population…………………………………………………………………..........10 
4.0  Methods…………………………………………………………………………….........10 
4.1   Recruitment Plan……………………………………………………………………….10 
4.2   Registration Procedure………………………………………………….....................11 
4.3   Summary of Study……………………………………………………….....................12 
5.0   Outcome Measures …………………………………………………………............16 
5.1   Primary Outcome……………………………………………………………………….16 
5.2   Secondary Outcomes…………………………………………………………………..17 
6.0   Analytic Plan ……………………………………………………………….…………23 
7.0   Data Management……………………………………………………………………...25 
8.0   Confidentiality and Privacy…………………………………………………................25 
9.0   Data Safety and Monitoring……………………………………………………………25 
10.0 Reporting of Unanticipated Problems, Adverse Events or Deviations……………25 
References…………………………………………………………………………...............27 
Appendix A – Protocol Registration Form………………………………………………….33 
Appendix B – Subject Eligibility Checklist………………………………………………….34 
Appendix C – MRI-CPET Protocol and Encounter Form………………………..............36 
Appendix D – FACT-Fatique Questionnaire……………………………………………….54 
Appendix E – FACT-Lym……………………………………………………………............56 
Appendix F – Self Efficacy forWalking……………………………………………………..61 
Appendix G – SF-36…………………………………………………………………............63 
Appendix H – Giodin Leisure-time Exercise Questionnaire……………………………...68 
Appendix I – Quality of Life Questionnaires………………………………………………..69 
Appendix J – NEUROCOGNITIVE FUNCTION TESTING BOOKLET………………....75 
Appendix K – Body Composition assessments……………………………………...........96 
Appendix L – Physical Activity Program Eval   ……………………………………...........97 
Appendix M – Health Education Prog Eval       ……………………………………..........99 
Appendix N -  The Q-Pro Shared Resource for Qualitative Research Support  
Services……………………………………………………………………….101 
Appendix O – FACT-B Questionnaire……………………………………………………...102 
Appendix P – Home based testing kit instructions………………………………………..106 
 
 
 
 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 4 of 114 
 
 
 
 
 
   
 
 
 
Schema 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3 3 
N=7 
N=14 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 5 of 114 
 
 
 
 
 
   
1.0 
Introduction and Background 
Cardiovascular complications from anthracycline-based chemotherapy (Anth-bC) 
and other potentially cardiotoxic cancer therapies are a leading cause of 
morbidity and mortality for survivors of lymphoma, the 5th most common cancer 
in North America. The objective of this proposal is to gather pilot data for a 
pending NIH R01 submission that will seek to reduce this cancer treatment 
related CV morbidity by performing and testing a pre-chemotherapy, patient-
centered, tailored physical activity intervention (PAI) designed to prevent declines 
in exercise capacity, cardiovascular performance, cognitive function, and quality 
of life in patients receiving Anth-bC and other potentially cardiotoxic cancer 
therapies for lymphoma or breast cancer. The novel features of this proposal 
include:  
1) Initiation of the intervention before and/or during receipt of chemotherapy, 
leveraging results from animal experiments suggesting this strategy reduces 
Anth-bC related cardiac injury;  
2) Incorporation of three modalities of exercise/activity based training: a) tailored 
progressive activity, b) strength training, and c) home-based activities suited 
to one’s individual lifestyle, each facilitated and reinforced objectively using 
activity tracking; 
3) Use of a newly developed magnetic resonance cardiopulmonary exercise 
treadmill test to assess, for the first time, near simultaneously and with high 
accuracy, the factors [e.g., cardiac output (stroke volume x heart rate)] that 
contribute to peak VO2, the gold standard, objective measure of exercise 
capacity. This new information will provide mechanistic insight into how a 
tailored exercise-based physical activity intervention helps preserve exercise 
capacity and reduces fatigue; and 
4) Measurement of cognitive function, thereby helping to unravel the association 
between the impact of exercise training on exercise capacity and cognitive 
function after receipt of Anth-bC or other potentially cardiotoxic cancer 
therapies for lymphoma and stage I-IV breast cancer. 
 
This study is designed to demonstrate feasibility of performing the (PAI) and the 
primary outcome measures before, during and six months after initiating Anth-bC 
or other potentially cardiotoxic cancer therapies for treatment of non- or Hodgkin 
lymphoma and Stages I-IV breast cancer. This study will test the potential for a 
novel (lifestyle) intervention designed to improve exercise capacity, HRQOL and 
cardiac and cognitive dysfunction.  This data will inform the development of the 
R33 phase of the  clinical trial to determine if the (PAI) can reduce exercise 
intolerance in this high-risk population. In addition, cardiac MRI data from 
individuals within this pilot will be compared to cardiac MRI data from individuals 
in the parent study that did not undergo either of the two interventional arms of 
this study. 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 6 of 114 
 
 
 
 
 
   
Anthracycline-based chemotherapy (Anth-bC) or other potentially 
cardiotoxic cancer therapies improves cancer-related survival in non-
Hodgkin lymphoma (NHL) , but Anth-bC or other potentially cardiotoxic 
cancer therapies also can promote left ventricular (LV) dysfunction, 
exercise intolerance, fatigue, reduced health-related quality of life (HRQOL) 
and cognitive impairment threatening observed gains in cancer 
survivorship.1-3 
• Prospective analyses show that ~20% of patients with NHL taking Anth-bC 
experience >10% reductions in LVEF (p<0.0001) and reduction in peak exercise 
capacity (VO2) to <80% of pretreatment values4-6 
• Lymphoma survivors experience marked reductions in HRQOL and often require 
psychosocial support interventions to perform societal activities of daily living. 
Routine exercise enhances both physical and mental HRQOL in survivors of 
lymphoma.6-8  
• Cognitive impairment occurs after receipt of Anth-bC for NHL. Breast cancer 
recipients of doxorubicin experience cognitive dysfunction that improves as 
activity levels increase. 9    
 
In cancer survivors, exercise capacity – a modifiable characteristic that is 
strongly associated with risk of CV events – is reduced after Anth-bC or 
other potentially cardiotoxic cancer therapies can be enhanced through 
exercise training, and is associated with improved QOL and cognitive 
function. 
• Survey data suggest that more physical activity after lymphoma is associated 
with decreased CV events.10  
• In 122 participants who completed treatment for non- or Hodgkin lymphoma, 12 
weeks of supervised exercise training improved peak VO2 relative to those 
provided written materials (p<0.001). Improved peak VO2 correlated with 
improved physical function (p=0.026). 6 
• In meta-analyses of >3,000 individuals with chronic diseases (including 480 
subjects with cancer), low to high intensity exercise interventions were 
associated with enhanced cognitive function, independent of the disease 
process, or the type, frequency or intensity of the exercise regimen). 11  Proof-of-
concept trials reported improved cognitive function (p<0.01) after exercise in 
breast cancer survivors treated with Anth-bC  
• Among 96 breast cancer survivors, aged 58±10 years, 6-month individualized 
exercise interventions (2 to 3 60-minute moderate intensity episodes/week) 
resulted in a 20% improvement in peak VO2, (p=0.04) and a 35% to 50% 
reduction in behaviorally related fatigue (p=0.001) on the Piper Fatigue Scale.12 
 
In NHL patients, the feasibility, timing of initiation, mechanism of benefit, 
and overall utility of a tailored/progressive physical activity intervention for 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 7 of 114 
 
 
 
 
 
   
preserving peak VO2 during Anth-bC or other potentially cardiotoxic cancer 
therapies is unknown. 
• Among 301 women being treated for breast cancer (either 90 or 180 minutes per 
week of non-tailored moderate-intensity continuous exercise at 75% predicted 
peak VO2) did not prevent decline in peak VO2 after completion of breast cancer 
treatment. 13 
• In addition, pilot data presented in Section 3.C.1. indicate that lymphoma 
survivors do not desire a rigid “exercise” program during receipt of Anth-bC.  
They are however very interested in a program that encourages activity, is 
tailored to their capabilities, and initiates early during their cancer treatment.14   
• Interestingly, in 20 individuals randomized to 12 weeks of 3 individualized/tailored 
bicycle exercise, varying from 60% to 100% of maximum exercise capacity, peak 
VO2 increased by 2.6+3.7 ml/min/kg, versus a 1.5+2.2 ml/min/Kg decline in those 
not exercising.15 
• In male Sprague-Dawley rats, 10 weeks of exercise preconditioning on motorized 
treadmills or voluntary running wheels attenuated LV dysfunction 5 and 10 days 
after doxorubicin treatment; when continued through chronic administration of 
doxorubicin, it prevented 4-week post-treatment-related declines in LV 
performance.2-4 A single bout of exercise 24 hr before doxorubicin protected 
against cardiac dysfunction.1  
• How tailored exercise training preserves exercise capacity – via preservation of 
cardiac function and/or peripheral A-VO2 difference,– is unknown.  As shown in 
Figure 1, exercise capacity is related to two components; 16 most studies have 
focused on the adverse effects of Anth-bC on LV stroke volume (a contributor to 
exercise- associated cardiac output).  However, postmenopausal women before, 
during, and after treatment for breast cancer had decreased peak VO2 but not 
necessarily a marked decrease in exercise-associated cardiac output.17  These 
findings challenge the conventional paradigm that all exercise intolerance after 
Anth-bC or other potentially cardiotoxic cancer therapies is related solely to 
cardiac injury, and raise important considerations for new targets of activity-
based interventions to improve exercise capacity.  

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 8 of 114 
 
 
 
 
 
   
We desire to propose a clinical trial to test the hypothesis that a patient-
centric tailored exercise-based physical activity intervention (PAI)  initiated 
before and continued 
throughout Anth-bC 
treatment  or other 
potentially cardiotoxic 
cancer therapies will 
attenuate LV and 
cognitive dysfunction, 
and preserve HRQOL, 
reduce fatigue and 
maintain peak exercise 
capacity and 6-min 
WD.  (Figure 2). This 
study would be 
significant because it addresses several important premises: 
1) Exercise intolerance and LV dysfunction are important causes of morbidity and 
mortality in patients with NHL who receive Anth-bC.1-3 
2) Animal data suggest that exercise before anthracyclines reduces LV dysfunction 
18-20 If this premise were true in human subjects, patients with NHL may be 
directed to purposely avoid sedentary behavior during receipt of Anth-bC – a true 
paradigm shift in the management of these individuals.  
3) The benefits of activity-based interventions on exercise capacity may extend 
beyond the heart. 17  Existing surveillance recommendations to prevent CV 
events focus primarily on serial measures of “cardiotoxicity”, including LV ejection 
fraction, and global longitudinal strain.  These strategies miss the potential 
adverse effects of Anth-bC on peripheral arterial and skeletal muscle function. 
Importantly, this study will evaluate the differential effects of Anth-bC or other 
potentially cardiotoxic cancer therapies on components of peak VO2. 
4) Activity based interventions may improve cognitive function in conjunction with 
increases in exercise capacity during cancer treatment. 7 
5) NHLBI and NCI mandates: a) the NHLBI goal to improve understanding of 
clinical mechanisms of CV disease and thereby enable better prevention, 
diagnosis and treatment;21 and b) the NCI’s commitment to determine actionable 
strategies to reduce morbidity and mortality in patients with cancer.22 
 
However prior to submitting this application, we need to conduct a pilot open 
label intervention to determine the feasibility of conducting such a proposal.  Our 
pilot will be innovative in that: 
• We are developing a novel integrated, comprehensive program for 
promoting cardiac health and preventing CV events in NHL patients. 
This program addresses multiple challenges for lymphoma patients to 
combat exercise intolerance by enabling patients to perform both goal-

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 9 of 114 
 
 
 
 
 
   
directed structured aerobic exercise and home-based physical activity 
after accounting for factors related to their cancer treatment (e.g., anemia, 
dehydration). 
• The study will incorporate new, advanced, rapid, and highly 
reproducible MRI combined with cardiopulmonary exercise testing 
(CPET) testing results to ascertain primary and secondary study 
aims with much smaller sample sizes than would be needed with 
other modalities. Combining advanced MRI measures with the exercise 
variables will provide mechanistic insights into how increasing activity 
affects the heart versus peripheral factors associated with arteriovenous 
O2 differences, impacting exercise capacity in lymphoma patients. 
• This is the first study to test whether initiating exercise-based physical 
activity before and/or during Anth-bC therapy or other potentially 
cardiotoxic cancer therapies can enhance exercise capacity and/or 
preserve LV function in NHL patients. Our results could challenge 
existing clinical practice regarding exercise & physical activity 
recommendations for lymphoma patients and stage I-IV breast 
cancer before they begin cancer treatment. 
2.0 
Objectives  
 
2.1 
Primary Objective  
To provide critical participant enrollment data necessary to accomplish the 
R01 submission, including: 
2.1.1 Feasibility of screening, enrolling, and randomizing  21 Non or 
Hodgkin lymphoma and stage I-IV breast cancer patients including 
the reasons for failed randomization,  
2.1.2 Identification of barriers for participating in, or adhering to the 
Patient ES-AI and the Healthy Living Control Group. 
 
2.2 
Secondary Objective  
In these 21 patients, at study initiation then 3 and 6 months after initiating 
Anth-bC or other potentially cardiotoxic cancer therapies to assess the 
ability to ascertain: peak exercise cardiac output, calculated A-V O2 
difference and VO2, and pre- exercise measures of LV & cognitive 
function, HRQOL, six-minute walk distance (6min WD) and fatigue.  
Ascertainment of the LV function and HRQOL will be attempted in a 
manner similar to ascertainment of these variables from 47 individuals 
with lymphoma in the parent study. 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 10 of 114 
 
 
 
 
 
   
3.0 
Study Population 
Inclusion Criteria: We will enroll 21 eligible and consenting men and women aged 
18- 85 years with non- or Hodgkin lymphoma or I-IV stage Breast Cancer 
patients23-28 that expect to receive an anthracycline based chemotherapeutic 
regimen or other potentially cardiotoxic cancer therapies (e.g. chemotherapy 
regimens  [anthracyclines, trastuzumab]), immuno-therapies (immune checkpoint 
inhibitors [ICI’s]) or radiation (within 8 weeks of completion).29-31 Potential 
enrollees will need the capacity to walk at least 2 city blocks on a flat surface. 
English-speaking participants only will be enrolled. Stage IV breast cancer 
participants must have a 2 year survival prognosis and approval from their 
physician. 
 
Exclusion criteria: The following are relative contraindications and can be 
considered by the medical director of the study: Uncontrolled hypertension 
(systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg), a 
recent history of alcohol or drug abuse, inflammatory conditions such as lupus or 
inflammatory bowel disease, or another medical condition that might compromise 
safety or successful completion.  Other exclusions include those with 
contraindications to MRI such as ferromagnetic cerebral aneurysm clips or other 
intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices 
or other implanted electronic devices. unstable angina; inability to exercise on a 
treadmill or stationary cycle; significant ventricular arrhythmias (>20 PVCs/min 
due to gating difficulty); atrial fibrillation with uncontrolled ventricular response; 
acute myocardial infarction within 28 days; moving within 12 mos. of enrollment.  
 
Rationale for selecting patient population: Patients with lymphoma or stage I-IV 
breast cancer were included  because their disease is potentially curable and 
therefore late CV effects of treatment are relevant. These individuals experience 
rates of CV morbidity and mortality that can exceed their cancer-related mortality.  
We will recruit all study participants from within the Wake Forest Comprehensive 
Cancer Center. 
4.0 
Methods 
 
4.1 Recruitment Plan 
Study team members will screen and recruit WFUCCC patients via medical 
record review and will attempt to contact these potential subjects via telephone 
for screening of eligibility. Permission is required from the attending 
Hematology/Oncology Physician/Fellow before potential subjects are contacted 
by a study team member. Interested persons will be asked a series of 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 11 of 114 
 
 
 
 
 
   
questions through a telephone interview to determine if they will qualify for the 
study. We are requesting a "limited" waiver of HIPAA authorization to identify 
subjects via Medical Records Review; and the Cancer Center 
screening/recruiting process. We are requesting further use of our "limited" 
waiver of HIPAA authorization to identify subjects via Medical Records Review 
using patient visit schedules from the following Wake Forest Baptist Health 
departments and clinics: a) Nuclear Medicine/P.E.T. Department, b) Cardiac 
Ultrasound and Stress Testing, c) Breast Care Services at Medical Plaza- 
Clemmons, c) Hematology and Oncology clinics located on the main campus 
and in Clemmons, Lexington, Statesville, Mount Airy, Elkin and Lenoir NC.  
 
4.2  Registration Procedures 
All patients entered on any CCCWFU trial, whether treatment, companion, or 
cancer control trial, must be linked to the protocol in EPIC within 24 hours of 
Informed Consent. Patients must be registered prior to the initiation of 
treatment.   
 
We will perform the following steps in order to ensure prompt registration of 
each patient: 
 
1. Complete the Eligibility Checklist (Appendix B) 
2. Complete the Protocol Registration Form (Appendix A) 
3. Alert the Cancer Center registrar by phone, and then send the signed 
Informed Consent Form, Eligibility Checklist and Protocol Registration 
Form to the registrar, either by fax or e-mail. 
 
Contact Information: 
Protocol Registrar PHONE (336) 713-6767 
Protocol Registrar FAX (336) 713-6772 
Protocol Registrar E-MAIL (registra@wakehealth.edu) 
            
*Protocol Registration is open from 8:30 AM - 4:00 PM, Monday-
Friday. 
 
4. Fax/e-mail ALL eligibility source documents with registration. Patients 
will not be registered without all required supporting documents. 
Note: If labs were performed at an outside institution, provide a printout of the 
results. Ensure that the most recent lab values are sent. 
 
To complete the registration process, the Registrar will:   
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 12 of 114 
 
 
 
 
 
   
• assign a patient study number 
• register the patient on the study 
 
4.3  Summary of Study  
 
 
Interventions Participants will be randomized into 1 of 2 arms. Study 
participants in arm 1 will 
receive the PAI during cancer 
treatment. In arm 2, 
participants will participate in 
the Healthy Living instruction 
group. Those randomized to 
each arm will undergo the 
MRI exam and CPET testing 
within 5 weeks of initiating 
treatment and then at 3 & 6 
months (Figure 5). If there are 
restrictions to in person 
testing or if participants prefer, 
MRIs and CPETs may be 
omitted. All individuals in the 
PAI will participate in 
qualitative assessments of the 
physical activity intervention using our QPRO program as described in the 
Resources Section of the document.   
 
 
 
Patient-centric pre-chemotherapy tailored physical activity intervention 
(Arm 1) 
The PAI for this study is based on our experience with PAI in breast cancer 
patients during active treatment32 with anthracyclines, findings from our recent 
Figure 5: Study Intervention timeline: Dark triangle signifies 
testing for MRI-CPET, 6 minWD, HRQOL, QPRO, Cognition, 
Fatigue 
3 
N=14 
N=7 
(N=21) 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 13 of 114 
 
 
 
 
 
   
focus group with lymphoma patients, as well as previously reported successful 
exercise/PA interventions in breast, prostate, leukemia, and lymphoma 
patients. The exercise intervention component of our PAI will be initiated at the 
Health and Exercise Science Clinical Research Center near the Reynolda 
Campus of Wake Forest University, Wake Forest Baptist Health Sticht Center 
or in Cardiac Rehabilitation Facilities and under the direct supervision of a 
master’s level clinical exercise physiologist. Three center-based PAI sessions 
will be offered each week (M,W,F). They will have the ability to participate in 
one to two training sessions per week at one of these centers and 1-2 sessions 
per week at home (the 4th level of our multi-level intervention). Each PAI 
session will consist of a slow (15min) aerobic warm-up; followed by 20 minutes 
of strength training; 15 minutes of progressive intensity aerobic exercise (AE); 
and 10 minutes of cool-down by stretching/toning with elastic bands similar to 
those recommended by the American Cancer Society (Figure 7).33   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Home based activities will be offered if participants are unable to travel to 
the exercise center. The exercises will be constructed similarly to the 
center-based exercise and tailored to their access to equipment and 
symptoms. The study interventionist will work with participants to create 
an exercise session and find creative ways to complete different types of 
exercises. Exercises could include, but are not limited to, over ground 
walking, body weight exercises, or use of resistance bands. 
The mode of activity for the center-based AE sessions will be over-ground 
walking and/or stationary cycling that is prescribed based on the “non-linear 
approach” described by Jones at al.34,35 This approach adheres to the principle 
of progressive intensity and is designed to increase exercise capacity outcomes 
(peak VO2 peak and 6min walk distance), yet also permit individual “tailoring” 
based on each participant’s daily perceived level of fatigue and 
disease/treatment related symptoms. Specifically, in “non-linear” prescriptions, 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 14 of 114 
 
 
 
 
 
   
the AE sessions are sequenced such that the physiological “stimulus” is 
progressively modified with regard to the intensity and duration and in 
conjunction with appropriate rest and recovery sessions in order to optimize 
physiological adaptations. The goal for the moderate – 45-60 minute AE 
sessions per week is to progress the intensity from 50% to 75% of VO2peak by 
the end of the 6 month progressive tailored intervention.36 Strength training will 
initiate at similar thresholds for core and peripheral skeletal muscles in that 
50% of maximal resistance exercises at 5-8 repetitions per muscle group will 
occur at the initial visits and then progress to 70% of maximum resistance with 
the same number of repetitions toward the 6 month completion of the study. 
The CPET will be re-assessed after 3 months of treatment to re-calculate the 
AE intensity level to ensure continual increase in the physiological stimulus. 
During AE sessions, intensity and safety will be stressed and when at the 
cardiac rehabilitation facilities be continuously assessed via heart rate while 
blood pressure at the beginning, middle, and end of each session. Participants 
will be encouraged to accumulate 150 minutes (~30 minutes day) of light-
moderate intensity PA per week outside the program facility. Daily and weekly 
targets for PA will be self-monitored by the participant and validated weekly by 
the intervention staff from wrist-worn Fitbit and Actigraph activity monitors. 
Increasing lifestyle physical activity is an important supplement to the 1-2 
day/wk center-based AE and provides flexibility to the participant’s schedule 
and disease/treatment related side effects. 37 
 
To enhance safety, each subject will be instructed to participate at an 
individually prescribed level of exertion, report any symptoms or problems 
during PA, and to rest as needed. The interventionist will take time to 
communicate with participants during the center-based AE sessions to 
determine whether PA prescriptions are appropriate, to ask how participants 
are feeling, and to answer questions regarding the PA prescription. 
 
Adherence, Retention & Barriers to Patient PAI.  All interventionists will 
receive training and ongoing supervision from Dr. Mihalko in validated 
behavioral techniques developed from social cognitive theory (SCT) to enhance 
intervention adherence.  SCT provides a strong conceptual framework for 
understanding the pathway from physical activity to health outcomes, with self-
efficacy identified as a consistent outcome of physical activity with strong 
potential for modification. Techniques include frequent contact during the 
intervention; positive feedback; incentives to reach attendance and 
performance goals; establishing personal commitment to the project; promoting 
a sense of community via study logo and incentives; and targeted mechanisms 
for behavioral adherence, including self-efficacy, outcome expectations, and 
self-regulatory skills. From the outset, the importance of regular attendance will 
be emphasized. Adherence data will be reviewed regularly to identify any 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
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participants who need additional reminders and/or counseling, and gain insight 
to difficulty with participation in PAI. Interventionists first meet with each 
participant to discuss expectations and negotiate participant goals. 
Interventionists then use a flexible “toolbox” approach to tailor interventions to 
each participant’s needs. Using a social problem-solving framework, a problem 
is identified (e.g., fatigue), and a solution is found (e.g., negotiate alternate time 
when energy is higher) and tested for a specific period of time (e.g., 2 
sessions). Participants have input on options that are selected. If the solution 
effectively resolves the problem, the strategy is continued until consistent 
behavior change is observed. If the solution is unsuccessful, a new option for 
solving the problem is selected (e.g., decrease intensity of physical 
movements) and tested. Collectively, these strategies will increase social 
cognitive mechanisms for regular participation and enhanced adherence in both 
groups. Our team has had remarkable success with this approach, exceeding 
study goals for adherence and retention in several federally-funded trials of 
physical movement-based interventions in adults with chronic disease, e.g., 
cancer. 
 
 
Healthy Living Control Group (Arm 2)  
Those participants randomized to the control arm will come to a centralized 
meeting location or receive an invitation for an online meeting to participate in 
organized health workshops. Each session will last 60 minutes and match the 
number of visits to the rehab centers for the PAI in a 1:1 fashion with 2 
sessions offered per month on Reynolda Campus and remaining sessions over 
the telephone over the 6 months. (Table 4). Make up sessions either in person 
or over the telephone will be offered for those participants who have to miss a 
group session. It is the objective of this HLI intervention to match participant 
contact with the PAI. 
 
 
Session Content: Introduction and Review past material (10 mins); Interactive 
Healthy Living Presentation (30 mins); Short instructor-led program of upper 
body stretching exercises (10 mins); Wrap-Up & discussion of next Workshop 
(10 mins). The topic list is shown Table 5. The purpose of the “Healthy Living” 
study arm is to control for attention from study staff and social interaction in the 
intervention group. The design of the control group was informed by the 
following principles; 1) to positively impact recruitment, participant interest in 
participation, and on-going adherence to the healthy living arm of study; 2) to 
have a comparison group that does not directly influence the primary outcome; 
and 3) to provide a program that would offer benefit to the study participant. 
There is no evidence to suggest that health education alone will impact physical 
activity participation or exercise capacity. In addition, the decision to use a once 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
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per week schedule was based on careful review of science, adherence, and 
expense considerations and the request to match the number of interventions 
in the HLI group with the once per week minimum cardiac rehabilitation center 
visits received by the PAI participants. Note that participants will receive 
referrals to exercise facilities at study completion (Table 4).   
 
The Healthy Living presentations will be interactive and will provide useful 
information on such topics as proper nutrition, management of stress, and 
sleep practices (Table 5). Experts (we have used from prior studies across a 
broad range of relevant topics will be brought in to give guest lectures over the 
course of the 6 months. Participants will be asked to complete homework 
assignments, review past topics, and engage in small group discussions as a 
means to increase active involvement in this study arm. The final component 
of the workshop, the upper body stretching component, was chosen to be part 
of the control arm to enhance adherence to this arm of the study. Specifically, 
this “placebo exercise” activity will serve to increase the benefit perceived by 
the participants of the workshops without directly affecting the study outcomes. 
 
All individuals in the HLI will participate in qualitative assessments using our 
QPRO program as described in the Resources Section of the document.   
 
5.0 
Outcome Measures 
5.1 
Primary Outcome 
5.1.1 The primary outcome will be feasibility. The data gathered will be 
used to inform the development of a larger future study. Feasibility 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
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in this study will be defined as follows: the proportion of patients 
who agree to participate in the intervention.  Among patients who 
agree to participate the proportion that are able to complete the 
intervention and document barriers to participation.   
 
5.1.2 For all patients – both in the active and control groups, we will 
determine the proportion who are able to have the baseline and 
follow-up assessments of measures of interest (cardiovascular 
imaging, exercise measures (peak VO2 and 6 min walk distance). 
5.2 
Secondary Outcomes 
5.2.1 In the 21 patients, the following outcomes will be assessed at the 
first visit and then 3 and 6 months after initiating Anth-bC or other 
potentially cardiotoxic cancer therapies; to assess the ability to 
ascertain: peak exercise cardiac output, calculated A-V O2 
difference and VO2, and pre- exercise measures of LV & cognitive 
function, HRQOL, six-minute walk distance (6minWD) and fatigue 
 
Detailed descriptions of these outcomes are below. 
 
 
 
 
Measurements and quality control 
 
MRI Variables. We will measure LV volumes (including LV stroke volume and 
heart rate to determine exercise associated cardiac output), EF because a) 
these values deteriorate shortly after cancer treatment,19 b) influence exercise 
capacity,16,38,39 and c) are used clinically to guide medical therapy to reduce CV 
events.16,32,40,41 MRI has been selected as the primary assessment of cardiac 
and vascular function because of a) its reliability (>98% acquired valuable 
subjects within the Jackson Heart Study),42 b) its reproducibility (>98% for 
repeated measures in pilot data from cancer participants),22 c) its accuracy 
(ability to detect informative changes indicative of prognosis regarding both the 
cardiac and vascular systems), d) its translational capability (existing large 
NHLBI efforts to assess CV disease from which cross-sectional comparisons 
with the data set can be made),43-45 and e) the low variance and inter-observer 
variability for technologists to acquire reliable data relative to other imaging 
modalities such as transthoracic echocardiography, which is highly technologist 
dependent and exhibits high variance. 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
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Our images will be acquired and analyzed according to previously published 
techniques (for which Dr. Hundley has extensive experience)32,46,47 using 
techniques from other NIH funded initiatives. Briefly, the individual will be 
escorted into the scanner to allow researchers to collect resting CMR images 
(Figure 7). Upon completion, the participant then will perform a CPET, 
according to the Bruce or Modified Bruce protocol. When the individual 
indicated they were at their maximal capacity the test will be terminated and the 
subject will be immediately escorted quickly back into the scanner to collect 
immediate post exercise CMR measures.  In our pilot data and in our 
publications, all post-exercise CMR data are initiated 20 seconds after exercise 
completes and acquisitions are completed within 50 seconds of leaving the 
treadmill. After the post exercise CMR is completed, the individual will be 
monitored to ensure that HR falls to <100 bpm during which recovery LV wall 
motion assessments will be made.  All images will be acquired using the 
Siemens 1.5 Tesla Avanto scanner located in the Cardiovascular Imaging 
Center (Reynolds Tower, Wake Forest Health Sciences, Winston-Salem, North 
Carolina).  
 
The CMR protocol is performed according to prior techniques48-50 & includes a 
series of white blood steady-state free precession cine images acquired in the 
short-axis plane to cover the entire left ventricle (LV) using a 5 to 10 second 
real-time, cardiac-gated, free breathing acquisitions with the following 
parameters: 6-10 slices of 8 mm thickness and 2 mm gap spanning the entire 
LV, a 128x72 matrix, a 340 x 255 mm field of view, 72 views per segment with 
view sharing, and echo spacing of 2.1 ms, resulting in a temporal resolution of 
46 ms and voxel size of 2.6 x 2.6 x 8 mm.  From these images, LV end-diastolic 
(LVEDV) and end-systolic (LVESV) volumes will be determined for calculation 
of the LV ejection fraction and stroke volume. Identical sets of volumetric 
images were acquired pre-exercise and post-exercise (<30 sec from maximal 
exercise stress test). 
 
All images will be processed offline by an image analyst blinded to study group 
using Medis software (Leiden, Netherlands). For each slice of the cine stack 
obtained, pre- and post-exercise, the endocardial border of the myocardium will 
be contoured to determine the area of the LV blood pool at both end-systole 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
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and end-diastole. Using Simpson’s rule, the areas will then be summed 
together and multiplied by the slice volume plus slice gap to determine LVEDV 
and LVESV.51 Ventricular volumes and cardiac output will be indexed to the 
subject’s body surface area and expressed as mL/m2 or L/min/m2. Brachial 
artery blood pressure (BP) and heart rate (HR) will be recorded during 
volumetric image acquisition. Cardiac output will be calculated from the LV 
stroke volume multiplied by the HR during CMR acquisition. For quality control, 
A complete double reading on 15% of the CMR cases will be performed for 
quality control purposes. The reader variability results will be reported at 3-
month intervals or if a change in personnel could affect image analysis and 
interpretation. Any scans with irregularities will be subjected to expert review. 
Like other studies conducted over the past 7 years, these images will also be 
used for data interpretation and for education purposes.  
 
Maximal (peak VO2) and (6-minute walk) exercise capacity outcomes. In 
this study, measures of both maximal (peak V02)22,33,34,52-56 and sub-maximal 
(6-minute walk) exercise capacity will be obtained. Peak V02 is selected as the 
primary outcome measure because it is the most reproducible measures of 
exercise capacity and integrates the physiologic response to exercise. 22,33,34,52-
56. It provides an objective threshold of disability and a metric that forecasts 
adverse cardiac prognosis as well as a parameter that can be utilized to modify 
medical regimens to reduce the likelihood of morbidity and mortality. 22,33,34,52-56  
It is feasible in large multi-center studies, it is reproducible and standardized. It 
is semi-automated and is relatively inexpensive to perform. Our team of 
investigators has extensive experience with using peak V02 as a primary 
measure. 22,33,34,53,54 Amongst 3 studies for which our team serves as the core 
lab, the reproducibility and variance of the measure in elderly individuals (>65 
years old) or those with evidence of congestive HF ranges from 7% to 12% in 
repeated measures. 22,33,34,52-56 We will also perform a 6-minute walk, widely 
used in trials of physical function interventions, measurement that is relatively 
easy to administer and quite feasible and provides a very accurate assessment 
of sub-maximal exercise capacity. Similar to peak V02, the 6-minute walk is an 
independent predictor of CV mortality. Its acquisition will allow cross 
comparisons of data from this cohort with other large NHLBI sponsored multi-
center initiatives. Our investigative team has utilized the 6-minute walk as an 
outcome measure in studies of exercise interventions in individuals treated for 
cancer.57,58  
The 6-minute walk will be administered by trained study personnel using a long, 
enclosed corridor with a cone placed at each end of the course. Participants will 
be allowed to use any mobility aids they traditionally use. Participants will be 
instructed to walk from end to end at their own pace while attempting to cover 
as much ground as possible in the six minutes. 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
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Cardiopulmonary Exercise Test as part of the MRI acquisition 
After obtaining resting CMR images, the participant will perform a CPET on the 
treadmill following the Bruce or Modified Bruce protocol, based on current 
fitness level (Figure 7). Speed and grade of the treadmill will be increased 
gradually every three minutes until the participant reaches volitional fatigue.  
Throughout the CPET, ECG, rate of perceived exertion (RPE) and BP will be 
monitored regularly, and expired air will be collected continuously through a 
one-way breathing mask to determine VO2 peak and other cardiopulmonary 
measures.  
The metabolic system used to collect the expired gases will be calibrated, 
according to the manufactures specifications, before each test.  During the 
CPET, a 12-lead ECG will be continuously monitored and printed at the end of 
each 3-minute stage. Any arrhythmias or ST-segment changes that occurred 
will be documented. Blood pressure and RPE will be taken during the last 
minute of each stage and recorded. Oxygen uptake and respiratory 
equivalence ratio (RER) will be monitored continuously throughout exercise. 
The goal for each subject will be to exceed an RER of 1.05 indicating maximal 
effort. Throughout the CPET, the staff will maintain constant communication 
with the participant to determine when the participant is at their final 30 seconds 
of exercise.  At this point, the staff will complete a peak exercise 12-lead ECG, 
disconnect the electrodes, and transfer the participant to the CMR scanner. The 
test will be discontinued if the participant has complaints of angina or ST-
segment depression >1.5 mV, or if the staff decides to terminate the test in 
accordance with established test termination criteria.53-55 
 Following the CPET a report is generated including a time-down report (30 
second averaged) of VO2 (ml/kg/min), VO2 (L/min), VCO2, METS, RER, VE, 
RR, FEO2, FECO2  and a plot for ventilatory threshold (VAT) determination. 
Heart rate will be determined from the ECG tracings. 
 
Fatigue and health-related quality of life questionnaires. The Functional 
Assessment of Cancer Therapy–Fatigue scale (FACT-fatigue) will be used to 
assess fatigue.59 The FACT-fatigue scale is 13-item scale that has been widely 
used in many studies to assess cancer related fatigue. The 42-item Functional 
Assessment of Cancer Treatment-Lymphoma (FACT-Lym) and the 37-item 
FACT-B questionnaires will be used to assess disease-specific HRQOL. The 
FACT-Lym and FACT-B measures are composed of the FACT-General which 
assesses four primary HRQOL domains: physical well-being (PWB), social 
well-being (SWB), and emotional well-being (EWB); and an additional sub-
scale that measures patient concerns related to lymphoma or breast cancer 
(e.g., pain, fever, swelling, fatigue, and loss of appetite). The MOS 36-item 
Short Form Health Survey (SF-36) will also be used as a general measure of 
health status. The SF-36 is perhaps the most widely used measure of health 
status and includes domains of vitality and physical function. A 6-item measure 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
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of self-efficacy for exercise will be used to assess confidence in walking at a 
moderately fast pace for increments of 10 to 60 minutes.  
 
Cognitive function. Based on studies of chemotherapy and cognition, cardio-
function and cognition and statin therapy and cognition, we propose a battery of 
validated neurocognitive measures (Hopkins Verbal Learning Test-Revised, 
Digit Span-Backward, Controlled Oral Word Association and Trail Making Test).  
These tests will evaluate verbal memory, attention/concentration, working 
memory, language, psychomotor speed, processing speed, and executive 
functions, according to standardized procedures utilized currently in multiple 
studies by Stephen Rapp, PhD, including one with Dr. Hundley 
(RO1HL118740). Additionally, key patient reported outcomes (cognitive 
symptoms, fatigue, mood, pain, social and physical functioning and sleep) will 
be assessed. Following standardized procedures used in other studies by this 
research team, staff will be trained in the administration of all questionnaires. 
Each questionnaire will be self-administered and then reviewed by a study 
interviewer for completeness before being uploaded into the Oncore database.   
A study team member will be trained to administer and scoring of all cognitive 
tests following standardized procedures used in other studies of cognition and 
cancer conducted by members of this research team. 
 
Participants will be given the option to complete these questionnaires 
electronically at their convenience prior to their research visits using a 
link to the secure web application REDCap.   
 
Alternatively, if in person testing is either restricted or participants prefer, we would like 
to be able to carry out a limited battery of physical tests that can be safely completed in 
the home. In addition to the self-reported data that will be collected via REDCap (as per 
protocol) we are planning to send a sanitized container with the following contents (see 
Appendix P): 
1. 
Detailed instruction packet for completing the test battery, including: 
a. Balance test 
b. Grip strength test 
c. 6-minute walk test 
d. Chair stand test 
2. 
A smartphone that is not connected to the internet or cellular service, but which 
contains software for administering a balance assessment. 
3. 
A grip strength dynamometer for measuring upper body strength 
4. 
The previously approved Actigraph device for assessing physical activity patterns 
over a 7-10-day period.  

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
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5. 
A 15-meter length of rope to mark out the course for a 6-minute walk test and 4-
meter walk test. 
6. 
A return shipping label to use to return the exercise kit to the research team after 
completion of home based testing  
Once participants have received the box containing the equipment for completing a 
short battery of tests designed to measure some of the outcomes in the original 
procedures, we will identify a time for them to complete the tests. During the initial 
exercise testing and program initiation (home or supervised) we will teach participants 
how to use rating of perceived exertion (RPE) and how it relates to intensity (heart rate 
response, dyspnea). Given the focus on home-based programming, we also emphasize 
the importance of monitoring their daily symptoms and response to previous exercise 
sessions. Any concerns can be communicated to the intervention staff prior to starting 
exercise. Additionally, the study team has access to and will regularly monitor the heart 
rate and sleep data of participants in order to track their status continuously. To begin 
the testing session, we will contact the patients via video conferencing software and go 
over the instructions for completing the tests. For the balance test, the chair stand test 
and the walking tests, the study participant, the spouse/partner, and the study team will 
confirm that all tests can be completed in a safe area that is free of obstructions and 
that the ground is even/level. This will be done to minimize the possibility of injury. The 
first goal is to familiarize the participants with the smartphone, so they can operate the 
app for testing balance, and access and use the video camera for recording the tests. At 
this time, we will ask the participants spouse/partner to also familiarize themselves with 
the toolkit as they will be asked to take a series of short videos as the participant 
completes the tests. For security purposes this device is not connected to the internet 
so there is a reduced chance the material will be compromised. Instead, videos taken 
will be downloaded from the device once it is received by the PI.  
We will then proceed to guide the participant through the instructions, clarifying any 
queries they may have. We will require the participant to identify a safe, flat space in 
their home where they can complete the balance test. As the balance test completes 
the participant is given immediate feedback based on their results as to their fall risk. 
The study assessors will verify the participant can safely perform the rest of the tests. 
This first test (a validated tool to assess fall risk in elderly MS patients) will help us to 
determine whether our participants are safe to complete tests in their home.  
We will then ask the participant to identify a standard dining-room type chair (approx. 
17-19” seat height), from which they can perform the chair stand tests. Via video 
conference the study assessors will verify the participant can safely stand from seated. 
We will then ask the participant to set up the 15 meters course in a passage way in their 
home (if available) or on a flat surface on or near their property (e.g. drive way). Once 
the set-up is complete we will let the participant and spouse/partner complete the tests. 
We will be available to consult during this time, but to minimize distraction will not 
interfere. 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
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The chair stands (time taken to stand 5 times from seated and amount of chair stands 
completed in 30 seconds) will be filmed in order to determine accurately the parameters 
of the test.  
 
Next the 4m walk will be performed by walking the first 4 meters of the 15m course at a 
usual pace.  This test will be repeated (and filmed 3 times).  
 
The participant will now be encouraged to take a short break.  
Finally, the 6-minute walk test will be completed (and filmed) with the participant walking 
as many laps of the 15- meter course as they can in 6 minutes. Using the video, we will 
use pre-marked guides to determine accurately the number of laps and distance 
covered during the test. During this test the participant will also wear a pulse oximeter to 
track pulse and oxygen saturation. 
 
While the tests are encouraged, safety is of paramount importance and should the 
participant feel they wish to stop the test at any time they may do so.  
 
There is a slight burden of using the technology to complete these tests, though all our 
participants are required to have a smart phone in order to sync their tracking devices 
regularly and we do not expect the level of expertise needed here is more than already 
required. Included in the instructions are links to short video clips demonstrating the 
procedures for clarity. 
 
The participants may contact us at any time throughout the procedures. 
 
Once testing is complete will ask the participants to send back the locked container 
using a pre-addressed shipping label. This can be picked up by the shipper if the 
participant does not feel safe. Finally, upon receipt of the materials all equipment will be 
sanitized with medical grade cleaners. 
 
 
 
Blood testing.  With each study visit, serum hemoglobin/hematocrit will be 
obtained to assess for the presence of anemia, and serum chemistries will be 
obtained to assess serum creatinine to identify renal dysfunction.  Additionally, 
at baseline,3 & 6 months, blood will be obtained for long-term storage of serum 
and plasma for future studies.  Planned studies include assessments of 
markers of inflammation and CV injury. 
 
Database management 
All data management activities will be accomplished through a secure web-
based Oncore application managed and administered by the CCCWFUHS (see 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
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Resources – Dr. D’Agostino, Jr.). This system allows flexibility in processing 
data management tasks, including the ability to register participants and verify 
eligibility criteria before randomization, provide the randomization assignment, 
and allow real-time monitoring and reporting of accrual, retention, and 
intervention adherence.  
 
6.0         Analytic Plan 
 
 
We will enroll 21 patients with 14 in the PAI and 7 in HLI.  The goal of this study is to 
determine feasibility and preliminary efficacy data.  We now describe these 
measurements. 
 
Feasibility: 
We will determine the proportion of patients who agree to participate in the intervention.  
Next, among patients who agree to participate we will determine what proportion are 
able to complete the intervention and document barriers to participation.  For all patients 
– both in the active and control groups, we will determine the proportion who are able to 
have the baseline and follow-up assessments of measures of interest (cardiovascular 
imaging, exercise measures (peak VO2 and 6 min walk distance).   
 
In addition, for the patients receiving the active intervention we will assess the change in 
outcomes of interest to determine preliminary efficacy estimates.  The control patients 
will also provide some preliminary efficacy assessments.   
 
With 21 patients we can estimate a 95% exact confidence interval (using the Clopper-
Pearson method) for the proportion of patients who have measurements taken with a 
width of 0.578 (i.e., from 0.211 to 0.789 if the observed proportion is 0.5 – most 
conservative assumption).   
 
For estimating the outcomes of interest, a 95% confidence interval will extend +/- 0.769 
standard deviation if there are 8 patients in the active group, +/- 0.635 if the sample size 
is 12 and +/- 0.554 SDs if the sample size is 15. 
 
A number of assessments will be made on the patients enrolled.  These include 
measures of peak exercise cardiac output, calculated A-V O2 difference and VO2, and 
pre- exercise measures of LV & cognitive function, HRQOL, six-minute walk distance 
(6minWD) and fatigue.  For each of these measures we will calculate descriptive 
statistics in order to get some preliminary data concerning the mean values and 
variability of these measures.  We will also obtain mean and variability values of the 
MRI cardiac function and HRQOL data from the 47 lymphoma patients in the parent 
study that did not undergo the two arms of the intervention as noted in this pilot 
addendum. This information will be helpful for designing a future clinical trial. 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
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Accrual: 
It is anticipated that at least 1 patient a month will be accrued so that the total time of 
enrollment should be no more than 1.5 year.   
 
Study Length: 
Two years 
 
 
7.0 
Data Management 
 
 
Informed consent document 
WISER/OnCore/PIC/Hundley 
Research Server/Research Chart 
Protocol registration form 
ORIS/Hundley Research 
Server/Research Chart 
Quality of Life Questionnaires 
REDCap 
MRI and CPET data 
Hundley Research Server 
Self-Efficacy for Walking 
REDCap 
FACT-Lym  
REDCap 
Neuro-Cognitive Measures 
REDCap 
8.0 
Confidentiality and Privacy 
 
Confidentiality will be protected by collecting only information needed to assess 
study outcomes, minimizing to the fullest extent possible the collection of any 
information that could directly identify subjects, and maintaining all study information in 
a secure manner. To help ensure subject privacy and confidentiality, only a unique 
study identifier will appear on the data collection form. Any collected patient identifying 
information corresponding to the unique study identifier will be maintained on a linkage 
file, store separately from the data. The linkage file will be kept secure, with access 
limited to designated study personnel. Following data collection subject identifying 
information will be destroyed (state the anticipated time the data will be destroyed, e.g. 
three years after closure of the study, and the method of destruction), consistent with 
data validation and study design, producing an anonymous analytical data set. Data 
access will be limited to study staff. Data and records will be kept locked and secured, 
with any computer data password protected. No reference to any individual participant 
will appear in reports, presentations, or publications that may arise from the study. 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
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9.0 
Data Safety and Monitoring 
 
The principal investigator will be responsible for the overall monitoring of the data 
and safety of study participants. The principal investigator will be assisted by other 
members of the study staff. 
 
10.0 Reporting of Unanticipated Problems, Adverse Events or 
Deviations 
 
Any unanticipated problems, serious and unexpected adverse events, deviations 
or protocol changes will be promptly reported by the principal investigator or designated 
member of the research team to the IRB and sponsor or appropriate government 
agency if appropriate. 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
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lifestyle behavioral factors associated with health-related quality of life in long-
term survivors of non-Hodgkin lymphoma?. Cancer. 2015;121(18):3343-51.  
PMID: 26036473 
8. Spector DJ, Noonan D, Mayer DK, Benecha H, Zimmerman S, Smith SK. Are 
lifestyle behavioral factors associated with health-related quality of life in long-
term survivors of non-Hodgkin lymphoma?. Cancer. 2015;121(18):3343-51.  
PMID: 26036473 
9. Hsieh CC, Sprod LK, Hydock DS, Carter SD, Hayward R,Schneider CM. Effects 
of a supervisedexercise intervention on recovery from treatment regimens in 
breast cancer survivors. Oncol NursForum 2008;35(6):909-15. 
10. Jones LW, Liu Q, Armstrong GT, et al. Exercise and risk of major cardiovascular 
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25311213. 
11. Cai H, Li G, Hua S, Liu Y, Chen L. Effect of exercise on cognitive function in 
chronic disease patients: a meta-analysis and systematic review of randomized 
controlled trials. Clin Interv Aging. 2017;12:773-783.  PMID: 28546744. 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 28 of 114 
 
 
 
 
 
   
12. Courneya KS, Mckenzie DC, Mackey JR, et al. Effects of exercise dose and type 
during breast cancer chemotherapy: multicenter randomized trial. J Natl Cancer 
Inst. 2013;105(23):1821-32.  PMID: 24151326. 
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Cardiovasc Imaging 2013 [epub ahead of print]; 
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McKelvie RS, Kraus WE, Forman DE, Kao AJ, Whellan DJ, O'Connor 
CM,Russell SD. Reproducibility of peak oxygen uptake and other 
cardiopulmonary exercise testing parameters in patients with heart failure (from 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 29 of 114 
 
 
 
 
 
   
the Heart Failure and A Controlled Trial Investigating Outcomes of exercise 
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Sep;46(9):1744-51. doi: 10.1249/MSS.0000000000000297. 
28. Figueira ACC, Cortinhas A, Soares JP, Leitão JC, Ferreira RP, Duarte JA. 
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30. Rosa GM, Gigli L, Tagliasacchi I, Di Iorio C, Carbone F, Nencioni A, Montecucco 
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33. Anderson RT, Kimmick GG, Mccoy TP, et al. A randomized trial of exercise on 
well-being and function following breast cancer surgery: the RESTORE trial. J 
Cancer Surviv. 2012;6(2):172-81.  PMID: 22160629 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
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34. Courneya KS, Mckenzie DC, Mackey JR, et al. Effects of exercise dose and type 
during breast cancer chemotherapy: multicenter randomized trial. J Natl Cancer 
Inst. 2013;105(23):1821-32.  PMID: 24151326. 
35. Jones LW, Hornsby WE, Freedland SJ, et al. Effects of nonlinear aerobic training 
on erectile dysfunction and cardiovascular function following radical 
prostatectomy for clinically localized prostate cancer. Eur Urol. 2014;65(5):852-5.  
PMID: 24315706. 
36. De backer IC, Schep G, Hoogeveen A, Vreugdenhil G, Kester AD, Van breda E. 
Exercise testing and training in a cancer rehabilitation program: the advantage of 
the steep ramp test. Arch Phys Med Rehabil. 2007;88(5):610-6.  PMID: 
17466730 
37. Newman AB, Dodson JA, Church TS, et al. Cardiovascular Events in a Physical 
Activity Intervention Compared With a Successful Aging Intervention: The LIFE 
Study Randomized Trial. JAMA Cardiol. 2016;1(5):568-74. PMID: 27439082 
38. Hundley WG, Kitzman DW, Morgan TM, Hamilton CA, Darty SN, Stewart KP, Herrington 
DM, Link 
KM,Little WC. Cardiac cycle-dependent changes in aortic area and distensibility 
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patients with isolated diastolic heart failure and correlate with exercise 
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magnetic resonance imaging in patients > or =60 years of age to systolic heart 
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41. Jones AL, Barlow M, Barrett-Lee PJ, Canney PA, Gilmour IM, Robb SD, 
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42. Chotenimitkhun R, Hamilton CA, Jeffries N, Harman JL, Taylor H, Carr 
JJ,Hundley WG. Abstract 8579:Age Related Change in Aortic Stiffness in the 
Thoracic and Abdominal Aorta Among AfricanAmericans: The Jackson Heart 
Study. Circulation 2011;124(21 Supplement):A8579. 
43. Edvardsen T, Rosen BD, Pan L, Jerosch-Herold M, Lai S, Hundley WG, Sinha S, 
Kronmal RA,Bluemke DA,Lima JA. Regional diastolic dysfunction in individuals 
with left ventricular hypertrophymeasured by tagged magnetic resonance 
imaging--the Multi-Ethnic Study of Atherosclerosis (MESA). Am Heart J 
2006;151(1):109-14. 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
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44. Heckbert SR, Post W, Pearson GD, Arnett DK, Gomes AS, Jerosch-Herold M, 
Hundley WG, Lima JA,Bluemke DA. Traditional cardiovascular risk factors in 
relation to left ventricular mass, volume, and systolic function by cardiac 
magnetic resonance imaging: the Multiethnic Study of Atherosclerosis. J Am Coll 
Cardiol 2006;48(11):2285-92. 
45. Herrington DM, Brown WV, Mosca L, Davis W, Eggleston B, Hundley WG,Raines 
J. Relationship between arterial stiffness and subclinical aortic atherosclerosis. 
Circulation 2004;110(4):432-7. 
46. Drafts BC, Twomley KM, D'Agostino R, Jr., Lawrence J, Avis N, Ellis LR, Thohan 
V, Jordan J, Melin SA, Torti FM, Little WC, Hamilton CA,Hundley WG. Low to 
moderate dose anthracycline-based chemotherapy is associated with early 
noninvasive imaging evidence of subclinical cardiovascular disease. JACC 
Cardiovasc Imaging 2013 [epub ahead of print]; PMID: 23643285 
47. Little WC, Zile MR, Kitzman DW, Hundley WG, O'Brien TX,Degroof RC. The 
effect of alagebrium chloride (ALT-711), a novel glucose cross-link breaker, in 
the treatment of elderly patients with diastolic heart failure. J Card Fail 
2005;11(3):191-5. PMID: 15812746 
 
48. Larson AM, Brubaker PH, Jordan J, Hundley G. Stroke Volume and Cardiac 
Output Response to Maximal Exercise is Attenuated in Anthracycline Treated 
Cancer Survivors. Medicine & Science in Sports & Exercise. 2017 May; 49:332-
333. doi:10.1249/01.mss.0000517781.71931.6a. 
49. Sukpraphrute B, Drafts BC, Rerkpattanapipat P, Morgan TM, Kirkman PM, Ntim 
WO, Hamilton CA, Cockrum RL, Hundley WG. Prognostic Utility of 
Cardiovascular Magnetic Resonance Upright Maximal Treadmill Exercise 
Testing. J Cardiovasc Magn Reson. 2015 Nov 25;17:103. doi: 10.1186/s12968-
015-0208-z. PMID: 26608545 PMCID: 466078 
50. Rerkpattanapipat P, Gandhi SK, Darty SN, Williams RT, Davis AD, Mazur W, 
Clark HP, Little WC, Link KM, Hamilton CA, Hundley WG. Feasibility to detect 
severe coronary artery stenoses with upright treadmill exercise magnetic 
resonance imaging. Am J Cardiol. 2003 Sep 1;92(5):603-6 
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LL,Flamm SD. Screening adult survivors of childhood cancer for cardiomyopathy: 
Comparison of echocardiography and cardiac magnetic resonance imaging. J 
Clin Oncol 2012;30(23):2876-84 
52. Scott JM, Haykowsky MJ, Eggebeen J, Morgan TM, Brubaker PH,Kitzman DW. 
Reliability of peak exercise testing in patients with heart failure with preserved 
ejection fraction. Am J Cardiol 2012;110(12):1809-13. 
53. Anderson RT, Kimmick GG, Mccoy TP, et al. A randomized trial of exercise on 
well-being and function following breast cancer surgery: the RESTORE trial. J 
Cancer Surviv. 2012;6(2):175-83.  PMID: 22160629. 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
Protocol version date 11/12/2021  
 
 
Page 32 of 114 
 
 
 
 
 
   
54. Kass DA, Kitzman DW,Alvarez GE. The restoration of chronotropic competence 
in heart failure patients with normal ejection fraction (RESET) study: rationale 
and design. J Card Fail 2010;16(1):17-24. 
55. Little WC, Zile MR, Kitzman DW, Hundley WG, O'Brien TX,Degroof RC. The 
effect of alagebrium chloride (ALT-711), a novel glucose cross-link breaker, in 
the treatment of elderly patients with diastolic heart failure. J Card Fail 
2005;11(3):191-5. 
56. Marburger CT, Brubaker PH, Pollock WE, Morgan TM,Kitzman DW. 
Reproducibility of cardiopulmonary exercise testing in elderly patients with 
congestive heart failure. Am J Cardiol 1998;82(7):905-9. 
57. Forman DE, Fleg JL, Kitzman DW, Brawner CA, Swank AM, McKelvie RS, Clare 
RM, Ellis SJ, Dunlap ME,Bittner V. Six-min walk test provides prognostic utility 
comparable to cardiopulmonary exercise testing in ambulatory outpatients with 
systolic heart failure. J Am Coll Cardiol 2012;60(25):2653-61. PMID: 23177293 
58. Guyatt GH, Sullivan MJ, Thompson PJ, Fallen EL, Pugsley SO, Taylor 
DW,Berman LB. The 6-minute walk: A new measure of exercise capacity in 
patients with chronic heart failure. Can Med Assoc J 1985;132(8):919-23. PMID: 
3978515 
 
59. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. 
Conceptual framework and item selection. Med Care. 1992;30(6):473-83. 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Wake Forest Baptist Comprehensive Cancer Center 
CCCWFU# 99112 
 
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Appendix A – Protocol Registration Form 
 
DEMOGRAPHICS 
Patient: Last Name: _____________________ First Name: ___________________________ 
MRN:          ___ ___ ___ ___ ___ ___ ___ ___ DOB (mm/dd/yy): ___ ___ / ___ ___ / ___ ___ 
ZIPCODE:  ___ ___ ___ ___ ___ 
 
 
SEX:   
 ¨ Male     ¨ Female 
Ethnicity (choose one):   ¨ Hispanic 
¨Non-Hispanic 
Race (choose all that 
apply): 
¨ WHITE           ¨BLACK           ¨ ASIAN 
¨ PACIFIC ISLANDER                ¨ NATIVE AMERICAN 
Height:   ___ ___.___ inches 
Weight: ___ ___ ___.___lbs.(actual) 
Surface Area: ___ ___.___m2   
 
Primary Diagnosis: ____________________________________________________________ 
Date of Diagnosis: ___ ___ /___ ___/___ ___ 
 
Performance Status: ___ ___ ___   ¨ ECOG  ¨ Karnofsky 
 
Protocol Registrar can be contact by calling 336-713-6767 between 8:30 AM and 4:00 PM, Monday – Friday. 
 
Completed Eligibility Checklist and Protocol Registration Form must be hand delivered, faxed or e-mailed to 
the registrar at 336-7136772 or registra@wakehealth.edu. 
PROTOCOL INFORMATION 
Date of Registration: 
___ ___ / ___ ___ / ___ ___ 
MD Name (last) : 
______________________       
Date protocol treatment started: 
___ ___ / ___ ___ / ___ ___ 
Informed written consent: 
(consent must be signed prior to 
registration) 
¨ YES  ¨ NO 
 
Date Consent Signed: 
___ ___ / ___ ___ / ___ ___ 
 
PID # (to be assigned by ORIS): 
___ ___ ___ ___ ___ ___ ___ ___ 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
 
Protocol version date 03/16/2020  
 
 
 
  Page 34 of 114 
 
Appendix B – Subject Eligibility Checklist 
IRB Protocol No.  
CCCWFU Protocol No. 
Study Title:  Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early 
Imaging Detection of CV Injury after Cancer” 
Principal Investigator:  Dr. W. Gregory Hundley 
 
Inclusion Criteria 
(as outlined in study protocol) 
Criteria 
is met 
Criteria is 
NOT met 
Source Used to Confirm * 
(Please document dates and lab results) 
Male or Female 
 
□ 
□ 
WakeOne 
Aged 18-85 years 
□ 
□ 
WakeOne 
Stage I-IV Lymphoma (Hodgkin or non-Hodgkin) 
or stage I-IV breast cancer 
 
□ 
□ 
WakeOne 
Expect to receive an anthracycline based 
chemotherapeutic regimen or other potentially 
cardiotoxic cancer therapies 
□ 
□ 
WakeOne 
Capacity to walk at least 2 city blocks on a flat 
surface 
 
□ 
□ 
WakeOne 
Expected survival beyond 6 months 
□ 
□ 
WakeOne 
Exclusion Criteria 
(as outlined in study protocol) 
Criteria 
NOT 
present 
Criteria is 
present 
Source Used to Confirm * 
(Please document dates and lab results) 
Contraindication for MRI 
□ 
□ 
WakeOne 
Contraindications for exercise training or  testing 
□ 
□ 
WakeOne 
Inability to exercise on treadmill or stationary 
cycle 
□ 
□ 
WakeOne 
Claustrophobia 
□ 
□ 
WakeOne 
Unstable angina  
□ 
□ 
WakeOne 
Pregnant 
□ 
□ 
WakeOne 
Inability to provide informed consent 
□ 
□ 
WakeOne 
 
This subject is      
 eligible /  ineligible     for participation in this study. 
ORIS Assigned PID: ___ ___ ___ ___ ___ ___ ___ ___ 
 
 
 
 
 
 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 35 
 
Signature of research professional confirming eligibility:_______________________  
Date: ___ ___ / ___ ___ / ___ ___ 
Signature of Principal Investigator confirming eligibility:_______________________  
Date: ___ ___ / ___ ___ / ___ ___ 
* Examples of source documents include clinic note, pathology report, laboratory results, etc. When listing 
the source, specifically state which document in the medical record was used to assess eligibility. Also 
include the date on the document. Example: “Pathology report, 01/01/14” or “Clinic note, 01/01/14” 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 36 
 
  APPENDIX C: MRI-CPET Protocol and Encounter Form 
 
CPET Stress Cardiovascular MRI  
Procedure Guidelines 
 
 
Non-Contrast Exam 
 
 
 
Abbreviations:  
  
BH:   Breath hold   
 
CMRI:  Cardiovascular magnetic resonance imaging  
 
CPET: Cardio-Pulmonary Exercise Test 
 
ECG:   Electrocardiography  
 
GRE:   Gradient recalled echo  
 
LAO:  Left anterior oblique 
 
IR:  Inversion recovery  
 
NBH:  Non breath hold  
 
PSIR:   Phase sensitive inversion recovery  
 
SSFP:   Steady state free precession  
 
TSE:   Turbo spin echo  
 
VLA:  Ventricular long axis  
 
 
 
 
 
Study image and completion form transfer note to MRI Technologist: 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 37 
 
Immediately upon completion of the study, technologists should submit images to the MRI 
Reading Center at Wake Forest via the CTP node on the scanner. From that PC, participants’ 
images will be automatically encrypted and transmitted to the MRI core lab for further analysis. 
The encryption schema used is https, the standard for secure website transactions, used by 
banks and e-commerce worldwide. Additionally, technologists should burn a CD to give to the 
Study Coordinator for secured storage.  Data should also be stored on the local PACS system. 
MRI technologists should fill-out the MRI completion form and give to the Study Coordinator for 
transmission to the MRI Reading Center.  
 
*Please place the following information in the Patient Registration Window before 
the exam begins: 
 
- Place with the study ID number (PID) in the MRN Field. 
- Place the acrostic in the Patient Name Field.   
- These should be given to you by the Study Coordinator.   
 
 
 
General Overview   
 
This is a cardiovascular MR exam that acquires baseline imaging (pre-exercise stress test) with 
a peak CPET test performed in the MRI facility. Patients are escorted from the CPET test to the 
MRI table with auto-scanning enabled for MRI measures of post-exercise stress test beginning 
<20 seconds after peak exercise.  Recovery LV cines are acquired after the heart rate has 
normalized to ensure no wall motion abnormalities were induced with stress testing.  
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 38 
 
MRI Protocol – List of Sequences 
 
***BASELINE (Pre-Exercise)*** 
Localizers 
 
3 PLANE LOC BH 
2CH LOC FB 
SAX LOC FB 
4CH LOC FB 
LAO SCOUT FB 
ABD LOC 
Body Composition  
 
T1 AX ABDOMEN FAT (L2-L4) 
Axial Phase Contrast 
 
BASELINE AX Aorta Arch 2D PHASE CONTRAST 
 
 
BASELINE AX Aorta Bifur 2D PHASE CONTRAST 
Fast Cines 
BASELINE_SAX_CINE_RT (GATED)  
(Slices to cover the entire LV) 
***POST CPET EXERCISE *** 
Fast Cines  
EXERCISE_SAX_CINE_RT (GATED)  
(Slices to cover the entire LV) 
Axial Phase Contrast 
 
exercise AX Aorta Arch 2D PHASE CONTRAST  
 
 
exercise AX Aorta Bifur 2D PHASE CONTRAST 
***RECOVERY*** 
Fast Cines 
RECOVERY_SAX_RT (GATED) 
(Slices to cover the entire LV) 
 
 
 
 
 
 
 
 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 39 
 
Participant Preparation   
 
1. Complete the MRI safety screening form required at your institution.  All participants 
must be screened for MRI safety/compatibility.  
 
2. Request participant use the rest room before the study.  
 
3. Breath-holding is done at resting lung volume for the entire protocol.    
 
a. Test breath-holding.  The participant is required to be able to hold their 
breath for 15 seconds at resting lung volume twice in order to participate in 
the protocol.   
  
b. Inform and train participant on breath-holding, example:  “Breath in … Let your 
air out until you are comfortable, and stop breathing.”   
 
4. Make sure that the connectors for cardiac coils and ECG are in place.  
 
5. Remember to place nonferromagnetic brachial blood pressure cuff on participant’s arm 
prior to beginning the MRI scans. This is needed to record blood pressures during 
certain sequences as marked on the encounter form. 
 
Thoroughly clean the ECG contact area with alcohol swabs. With participant supine on 
the table, attach ECG electrodes to his/her chest according to your MRI manufacturer 
suggestions.  
 
 
Image Acquisition 
 
MRI encounter form  
Complete the MRI encounter form during each scan and complete the notes regarding 
sedation/completion of study. The encounter form is included in the last page of this 
appendix. 
 
It is recommended that this form is completed in real-time during the study to ensure no 
sequences are skipped and the blood pressures and heart rates are recorded as necessary. 
 
 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 40 
 
Series Name:  
 
_3_PLANE_SCOUT 
Series Description:  
3 Plane Localizer 
Notes:  
 
 
Steady-state free precession scout images 
 
Series Prescription Details 
 
Series Rx Notes 
Prescribe series from: 
Localize the heart at the 
isocenter.   
Orientation: 
three orthogonal planes (axial, 
coronal and sagittal) 
Number of Slices 
At least three slices per plane (at 
least 9 image 
Breath-holding: 
Yes, resting lung volume 
 
Sample Images 
 
 
 
  

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 41 
 
Series Name:  
2CH LOC FB 
Series Description: White-blood 2 Chamber localizer; Pseudovertical long-axis localizer 
Notes: 
This is a bright-blood steady-state free precession, one slice (non-cine) 
image. 
Series Prescription Details 
 
Series Rx Notes 
Sample Series Rx 
Prescribe series from: 
Plan this on the axial scout 
view (_3_PLANE_SCOUT) 
with the largest volume of 
heart, from the base 
(middle of the mitral valve) 
to apex of the LV, on the 
axial scouts.   
 
Orientation: 
Oblique 
Number of Slices 
1 
Breath-holding: 
No 
 
Sample Image 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
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R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 42 
 
Series Name:  
SAX LOC FB 
 
Series Description: White-blood short-axis localizers  
Notes: 
These are a bright-blood steady-state free precession, non-cine images 
covering the whole heart from great arteries to the apex. Data acquisition 
at the diastolic phase.  
 
Series Prescription Details 
 
Series Rx Notes 
Sample Series Rx 
Prescribe series from: 
2CH_LOC cross-
referenced with 
4CH_LOC  
 
 
Orientation: 
Oblique 
Number of Slices 
12 
Breath-holding: 
No 
Sample Images 
 
Series Name:  
4CH LOC FB 
12 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 43 
 
Series Description: White-blood 4 Chamber localizer; horizontal long-axis localizer 
Notes: 
This is a bright-blood steady-state free precession, one slice (non-cine) 
image. 
Series Prescription Details 
 
Series Rx Notes 
Sample Series Rx 
Prescribe series from: 
Plan this on the axial scout 
view (_3_PLANE_SCOUT) 
with the largest volume of 
heart, from the base (middle 
of the mitral valve) to apex of 
the LV, on the axial scouts.  
Cross-reference with 2CH 
Scout 
 
 
Orientation: 
Oblique 
Number of Slices 
1 
Breath-holding: 
No 
 
Sample Image 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 44 
 
Series Name:  
LAO_SCOUT_FB 
Series Description: Aorta candy cane localizer, free-breathing 
Notes: 
This localizer is a left anterior oblique in the candy cane plane of the 
thoracic aorta.  This multi-slice localizer will be used for planning the aorta 
phase contrast images.   
Series Prescription Details 
 
Series Rx Notes 
Sample Series Rx 
Prescribe series from: 
_3_PLANE_SCOUT axial 
image with ascending and 
descending aorta 
 
Orientation: 
Left anterior oblique; plane 
center slice through 
ascending and descending 
aorta 
Number of Slices 
6-8 
Breath-holding: 
No 
Sample Image(s) 
 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 45 
 
Series Name:  
ABD_LOC 
Series Description: Abdominal Localizer 
Notes: 
Perform multi-plane abdominal localizer (coronal and sagittal); Siemens 
sequence name = tfi2d1_84. A coronal plane that appreciates the aorta 
bifurcation will be used in planning future series.  A sagittal plan that 
appreciates L2-L4 will be used in planning future series. 
 
Series Prescription Details 
 
Series Rx Notes 
Prescribe series from: 
_3_PLANE_SCOUT  
Orientation: 
Coronal and Sagittal 
Number of Slices 
3-5 sagittal slices; 8-10 coronal slices 
Breath-holding: 
Yes 
 
Image Parameters 
Image Parameter 
Value 
Slice Thickness  
5mm 
Slice Gap  
5 mm 
TR 
260 
TE  
1.08 
Number of Phase 
Encodings  
143 
Percent Sampling  
75 % 
Percent Phase FOV  
100% 
Pixel Bandwidth  
1132 
Matrix  
192 x 144 
Flip Angle  
65 degrees 
 
Sample Images: 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 46 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 47 
 
Series Name:  
T1_AX_ABDOMEN_FAT 
Series Description: T1 weighted turbo spin-echo sequence acquired with 3 evenly spaced 
axial slices with 1st and 3rd centered at L2 and L4. 
Notes: 
To assess visceral fat, a series of images will be acquired to assess 
visceral fat volume.  Open up FOV to encompass all of the abdomen. 
 
Series Prescription Details 
 
Series Rx Notes 
Sample Series Rx 
Prescribe series from: 
Sagittal plane on ABD_LOC  
 
Orientation: 
Axial 
Number of Slices 
3 - evenly spaced axial slices 
with 1st and 3rd centered at 
L2 and L4. 
Breath-holding: 
Yes 
 
Image Parameters 
Image Parameter 
Value 
FOV 
Open to encompass all of the abdomen 
Slice thickness (mm) 
5mm 
Slice gap (mm) 
Variable – change distance factor as necessary 
TR 
800 ms 
TE 
36 ms 
Flip angle (degrees) 
180 
Matrix 
256 * 256 
Acceleration factor 
2 
Bandwidth 
305 Hz/Px 
Turbo factor 
11 
Echo trains per slice 
13 
Gating 
ECG triggering 
 
Sample Image(s) 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 48 
 
 
Series Name:  
AX Aorta Arch 2D PHASE CONTRAST 
 
 
 
AX Aorta Bifur 2D PHASE CONTRAST 
Series Description: Free breathing, 2D Phase Contrast images of the aorta in 2 planes: the 
ascending-descending aorta at the level of the arch and at the level of 2 
cm above the bifurcation. 
Notes: 
Phase-contrast gradient-echo images will be acquired in axial planes for 
determination of aortic stiffness. Measures of distensibility and pulse 
wave velocity will be performed on the phase-contrast images. Roughly 
30 phases should be acquired.  This is performed at  baseline and 
again post-exercise (following LV Cine stack). 
 
Series Prescription Details - AX Aorta Arch 2D PHASE CONTRAST 
 
Series Rx Notes 
Sample Series Rx 
Prescribe series 
from: 
Prescribe off of the 
LAO_SCOUT_FB images and 
select the slice with the best view 
of the aorta candy cane.  
Prescribe an oblique plane 
running perpendicular through 
the ascending and descending 
aorta as shown on the right. 
 
Orientation: 
Axial; oblique 
Number of Slices 
1 
Breath-holding: 
No 
 
Series Prescription Details - AX Aorta Bifur 2D PHASE CONTRAST 
 
Series Rx Notes 
Sample Series Rx 
Prescribe series 
from: 
Prescribe off of the ABD_LOC 
images and select the slice with 
the best view of the aortIc 
bifurcation.  Prescribe a plane 
running perpendicular through 
the aorta at the level 2 cm 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 49 
 
superior to the bifurcation as 
shown on the right. 
 
Orientation: 
Axial 
Number of Slices 
1 
Breath-holding: 
No 
 
Ph Con Image Parameters 
Image Parameter 
Siemens 
GE 
Philips 
Coil 
Body Matrix 
Gore Full 
Cardiac 
Plane 
Oblique 
Oblique 
Axial 
Field of View 
360 
360 
360 
Repetition Time (TR; 
ms) 
12.0 
12.0 
12.0 
Echo Time (TE; ms) 
3.14 
Min 
2.8 
Flip Angle (degrees) 
15 
30 
12 
Averages 
1 
 
1 
BW 
389 
31.25 
477.8 
NEX 
 
1.00 
1 
Gated 
Cardiac 
Cardiac (auto # 
phases, TrigWin 10) 
Retrospective 
Sequence type 
Phase-contrast GRE 
Phase-contrast GRE 
2D FFE 
Axial Velocity 
encoding direction  
Through-plane 
Through-plane 
Through-plane 
Parasagital Velocity 
encoding direction  
Head-Foot or  
Superior-Inferior 
Head-Foot or  
Superior-Inferior 
Head-Foot or 
Superior-Inferior 
Slice Thickness 
6 mm 
6 
6 
Distance Factor 
20% (1.2m) 
 
 
Segments 
6 
 
 
Matrix 
128 x 128 
128 x 128 
128x128 
Phase FOV 
100% 
1.00 
100% 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 50 
 
Phase encode 
direction 
A-P 
A-P 
A-P 
Phases 
20 
20 
20 
PSD 
 
Vasc PC (Fast 2D 
Phase Contrast 
 
Options 
 
Gat, Seq, Fast 
 
Flow Comp 
 
Off 
Yes 
Gap 
 
0 
0 
VPS 
 
2 (adjust per patient’s 
heart rate for ~30 
phases) 
 
Frequency 
 
S/I 
 
Grad Mode 
 
Whole 
Default 
VENC 
Start with 200, may 
increase if aliasing  
200 
200 
Vascular Screen 
 
Venc: 200, Collapse: 
off, Recon: Ph Diff, 
Flow Analysis: on, Flow 
Dir: Slice, Additional 
Images: Obl S/I 
 
User CV Screen 
 
All set to zero 
Turn off Complex 
Difference 
Ph Con Sample Image(s) 
 
Resulting magnitude (top row) and velocity maps (bottom row) images 
  
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 51 
 
 
 
Series Name: 
SAX_CINE_RT (GATED) – Performed at baseline, post exercise, and 
recovery 
Series Description: Fast short axis cine stack encompassing LV with ECG gating 
Notes: 
** Record BP and HR during acquisition ** 
This is real-time, cardiac triggered, free-breathing cine stack acquired in 
the SAX plane with minimum of 20 phases, covering the whole heart from 
the atria to apex. Temporal resolution should be <40 ms. Cine short axis 
images should be obtained at baseline, immediately following exercise, 
and when heart rate recovers to <100 bpm.  
Parallel imaging (e.g. ASSET, SENSE, or GRAPPA) with an acceleration 
factor of 2 to reduce acquisition time (optional).   Flip angle should be set 
at the largest possible (usually 45-70º).  The last apical slice should 
locate within the myocardium such that the slices could cover left atrium 
as much as possible.  
 
Series Prescription Details 
 
Series Rx Notes 
Sample Series Rx 
Prescribe series from: 
4 Ch Loc and SAX Loc.  
Orientation: 
SAX Oblique 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma 
and Breast Cancer Patients Undergoing Treatment – An addendum to NIH 
R01CA167821 “Early Imaging Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU- #99112) 
. 
 
 
 
 
pg. 52 
 
Number of Slices 
As needed to cover 
apex to atria with slice 
thickness = 8 mm and 
slice gap = 2mm. 
 
Breath-holding: 
No 
 
  
 
 
 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 53 of 114 
 
CPET Stress MRI Encounter Form 
WFSM PROTOCOL NON-CONTRASTTRANSFER images to the STYX and WEBPAX 
      Date of scan:  ______________        
      Tech:  ____________________ 
      Time:  ____________________ 
      Visit #:  ___________________ 
      Height:_____inches     Weight:_____lb 
 
 
 
***BASELINE*** 
Series# 
Record INVIVO 
BP/HR(MRITech) 
INVIVO STRIP 
HR (Nurse) 
Localizers 
 
BP:____/____ 
HR: ______ 
 
HR: ______ 
3 PLANE LOC BH 
 
 
 
2CH LOC FB 
 
 
 
SAX LOC FB 
 
 
 
4CH LOC FB 
 
 
 
LAO SCOUT FB 
 
 
 
ABD LOC 
 
 
 
Body Composition  
 
 
 
 
T1 AX ABDOMEN FAT (L2-L4) 
 
 
 
Axial Phase Contrast 
 
 
 
BASELINE AX Aorta Arch 2D PHASE CONTRAST 
 
 
BP:____/____ 
HR: ______ 
 
BASELINE AX Aorta Bifur 2D PHASE CONTRAST 
 
 
 
Fast Cines 
 
 
 
BASELINE_SAX_CINE_RT (GATED)  
(Slices to cover the entire LV) 
 
BP:____/____ 
HR: ______ 
 
*HR: ______ 
***POST CPET EXERCISE *** 
 
 
 
Fast Cines  
(Run INVIVO STRIP when Participant is positioned on MRI table) 
 
 
*HR: ______ 
EXERCISE_SAX_CINE_RT (GATED)  
(Slices to cover the entire LV) 
 
BP:____/____ 
HR: ______ 
 
*HR: ______ 
Axial Phase Contrast 
 
 
 
Exercise AX Aorta Arch 2D PHASE CONTRAST  
 
 
BP:____/____ 
HR: ______ 
 
Exercise AX Aorta Bifur 2D PHASE CONTRAST 
 
 
 
***RECOVERY*** 
 
 
 
Fast Cines 
 
 
 
RECOVERY_SAX_RT (GATED) 
(Slices to cover the entire LV) 
 
BP:____/____ 
HR: ______ 
 
*HR: ______ 
Participant Name/MRN and Study ID / Label 
Here 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 54 of 114 
 
Appendix D – FACT-Fatigue Questionnaire 
 
Please circle or mark one number per line to indicate your response as it applies to the past 7 days. 
 
 
 
ADDITIONAL CONCERNS 
 
Not 
at all 
A little 
bit 
Some-
what 
Quite 
a bit 
Very 
much 
 
HI7 
I feel fatigued
......................................................................................... 
0 
1 
2 
3 
4 
HI12 
I feel weak all over
 ....................................................................................... 
0 
1 
2 
3 
4 
An1 
I feel listless (“washed out”)
 ....................................................................................... 
0 
1 
2 
3 
4 
cfquAn
2 
I feel tired
 ....................................................................................... 
0 
1 
2 
3 
4 
An3 
I have trouble starting things because I am tired
 ....................................................................................... 
0 
1 
2 
3 
4 
An4 
I have trouble finishing things because I am tired
 ....................................................................................... 
0 
1 
2 
3 
4 
An5 
I have energy
 ....................................................................................... 
0 
1 
2 
3 
4 
An7 
I am able to do my usual activities
 ....................................................................................... 
0 
1 
2 
3 
4 
An8 
I need to sleep during the day
 ....................................................................................... 
0 
1 
2 
3 
4 
An12 
I am too tired to eat
 ....................................................................................... 
0 
1 
2 
3 
4 
An14 
I need help doing my usual activities
 ....................................................................................... 
0 
1 
2 
3 
4 
An15 
I am frustrated by being too tired to do the things I want 
to do
 ....................................................................................... 
 
0 
 
1 
 
2 
 
3 
 
4 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 55 of 114 
 
An16 
I have to limit my social activity because I am tired
 ....................................................................................... 
0 
1 
2 
3 
4 
 
 
 
 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 56 of 114 
 
Appendix E – FACT-Lym  
 
Have you ever been diagnosed with Lymphoma?  
 
Yes  /   No 
If the participant responds “No,” continue to the next questionnaire.  
 
Below is a list of statements that other people with your illness have said are important. 
Please circle or mark one number per line to indicate your response as it applies to 
the past 7 days. 
 
 
 
 
 
PHYSICAL WELL-BEING 
 
Not 
at all 
A little 
bit 
Som
e-
what 
Quite
a bit 
Very 
much 
GP1 
I have a lack of energy
 ................................................................................ 
0 
1 
2 
3 
4 
GP2 
I have nausea
 ................................................................................ 
0 
1 
2 
3 
4 
GP3 
Because of my physical condition, I have trouble 
meeting the needs of my family
 ................................................................................ 
 
0 
 
1 
 
2 
 
3 
 
4 
GP4 
I have pain
 ................................................................................ 
0 
1 
2 
3 
4 
GP5 
I am bothered by side effects of treatment
 ................................................................................ 
0 
1 
2 
3 
4 
GP6 
I feel ill
 ................................................................................ 
0 
1 
2 
3 
4 
GP7 
I am forced to spend time in bed
 ................................................................................ 
0 
1 
2 
3 
4 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 57 of 114 
 
 
 
 
 
SOCIAL/FAMILY WELL-BEING 
 
Not 
at all 
A little 
bit 
Som
e-
what 
Quite
a bit 
Very 
much 
 
GS1 
I feel close to my friends
 ................................................................................ 
0 
1 
2 
3 
4 
GS2 
I get emotional support from my family
 ................................................................................ 
0 
1 
2 
3 
4 
GS3 
I get support from my friends
 ................................................................................ 
0 
1 
2 
3 
4 
GS4 
My family has accepted my illness
 ................................................................................ 
0 
1 
2 
3 
4 
GS5 
I am satisfied with family communication about my 
illness
 ................................................................................ 
 
0 
 
1 
 
2 
 
3 
 
4 
GS6 
I feel close to my partner (or the person who is my 
main support)
 ................................................................................ 
 
0 
 
1 
 
2 
 
3 
 
4 
Q1 
Regardless of your current level of sexual activity, 
please answer the following question. If you prefer not 
to answer it, please mark this box           and go to the 
next section
 
 
 
 
 
GS7 
I am satisfied with my sex life
 ................................................................................  
0 
1 
2 
3 
4 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 58 of 114 
 
Please circle or mark one number per line to indicate your response as it applies to 
the past 7 days. 
 
 
 
EMOTIONAL WELL-BEING 
Not 
at all 
A little 
bit 
Som
e-
what 
Quite
a bit 
Very 
much 
 
GE1 
I feel sad
 ................................................................................. 
0 
1 
2 
3 
4 
GE2 
I am satisfied with how I am coping with my illness
 ................................................................................. 
0 
1 
2 
3 
4 
GE3 
I am losing hope in the fight against my illness
 ................................................................................. 
0 
1 
2 
3 
4 
GE4 
I feel nervous
 ................................................................................. 
0 
1 
2 
3 
4 
GE5 
I worry about dying
 ................................................................................. 
0 
1 
2 
3 
4 
GE6 
I worry that my condition will get worse
0 
1 
2 
3 
4 
 
 
 
FUNCTIONAL WELL-BEING 
 
Not 
at all 
A little 
bit 
Som
e-
what 
Quite
a bit 
Very 
much 
 
GF1 
I am able to work (include work at home)
 ................................................................................. 
0 
1 
2 
3 
4 
GF2 
My work (include work at home) is fulfilling
 ................................................................................. 
0 
1 
2 
3 
4 
GF3 
I am able to enjoy life
 ................................................................................. 
0 
1 
2 
3 
4 
GF4 
I have accepted my illness
 ................................................................................. 
0 
1 
2 
3 
4 
GF5 
I am sleeping well
 ................................................................................. 
0 
1 
2 
3 
4 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 59 of 114 
 
GF6 
I am enjoying the things I usually do for fun
 ................................................................................. 
0 
1 
2 
3 
4 
GF7 
I am content with the quality of my life right now
 ................................................................................. 
0 
1 
2 
3 
4 
 
Please circle or mark one number per line to indicate your response as it applies to 
the past 7 days. 
 
 
 
ADDITIONAL CONCERNS 
 
Not 
at all 
A little 
bit 
Som
e-
what 
Quite 
a bit 
Very 
much 
P2 
I have certain parts of my body where I experience 
pain
0 
1 
2 
3 
4 
LEU1 
I am bothered by lumps or swelling in certain parts 
of my body (e.g., neck, armpits, orgroin)
 
0 
 
1 
 
2 
 
3 
 
4 
BRM3 
I am bothered by fevers (episodes of high body 
temperature)
 
0 
 
1 
 
2 
 
3 
 
4 
ES3 
I have night sweats
 ................................................................................. 
0 
1 
2 
3 
4 
LYM1 
I am bothered by itching
0 
1 
2 
3 
4 
LYM2 
I have trouble sleeping at night
 ................................................................................. 
0 
1 
2 
3 
4 
BMT6 
6
I get tired easily
 ................................................................................. 
0 
1 
2 
3 
4 
C2 
I am losing weight
 ................................................................................. 
0 
1 
2 
3 
4 
Ga1 
I have a loss of appetite
 ................................................................................. 
0 
1 
2 
3 
4 
HI8 
I have trouble concentrating
 ................................................................................. 
0 
1 
2 
3 
4 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 60 of 114 
 
N3 
I worry about getting infections
 ................................................................................. 
0 
1 
2 
3 
4 
LEU6 
I worry that I might get new symptoms of my illness
 ................................................................................. 
0 
1 
2 
3 
4 
LEU7 
I feel isolated from others because of my illness or 
treatment
0 
1 
2 
3 
4 
BRM9 
I have emotional ups and downs
 ................................................................................. 
0 
1 
2 
3 
4 
LEU4 
Because of my illness, I have difficulty planning for 
the future
 ................................................................................. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 61 of 114 
 
Appendix F - Self Efficacy for Walking 
 
 
Please indicate below how confident you are that you can successfully carry out each of the 
activities listed below. 
I BELIEVE THAT I CAN WALK: 
 
1. For 10 minutes at a moderately fast pace without stopping 
 
0% 
10%  20%  30%  40%  50%  60%  70%  80%  90%  100% 
 
NOT AT ALL 
 
 
 
MODERATELY  
  
 
 
HIGHLY 
CONFIDENT 
CONFIDENT 
 
CONFIDENT 
 
2. For 20 minutes at a moderately fast pace without stopping 
 
0% 
10%  20%  30%  40%  50%  60%  70%  80%  90%  100% 
 
NOT AT ALL 
 
 
 
MODERATELY  
  
 
 
HIGHLY 
CONFIDENT 
CONFIDENT 
 
CONFIDENT 
 
3. For 30 minutes at a moderately fast pace without stopping 
 
0% 
10%  20%  30%  40%  50%  60%  70%  80%  90%  100% 
 
NOT AT ALL 
 
 
 
MODERATELY  
 
 
 HIGHLY 
 
CONFIDENT 
 
 
          CONFIDENT 
 
 
        CONFIDENT 
 
4. For 40 minutes at a moderately fast pace without stopping 
 
0% 
10%  20%  30%  40%  50%  60%  70%  80%  90%  100% 
 
NOT AT ALL 
 
 
 
MODERATELY  
  
 
 
HIGHLY 
CONFIDENT 
 
 
 
CONFIDENT                                       
 
CONFIDENT 
 
5. For 50 minutes at a moderately fast pace without stopping 
 
0% 
10%  20%  30%  40%  50%  60%  70%  80%  90%  100% 
 
NOT AT ALL 
 
 
 
MODERATELY  
  
 
 
HIGHLY 
CONFIDENT 
CONFIDENT                                       
CONFIDENT 
 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Page 62 of 114 
 
 
6. For 60 minutes at a moderately fast pace without stopping 
 
0% 
10%  20%  30%  40%  50%  60%  70%  80%  90%  100% 
   NOT AT ALL  
 
 
MODERATELY 
 
  
         
HIGHLY 
 CONFIDENT 
CONFIDENT 
 CONFIDENT 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RESTORE 
FORM 16 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Appendix G – SF-36 (RAND) 
Choose one option for each questionnaire item. 
1. In general, would you say your health is: 
1 - Excellent  
2 - Very good  
3 - Good  
4 - Fair  
5 - Poor  
 
2. Compared to one year ago, how would you rate your health in general now? 
1 - Much better now than one year ago  
2 - Somewhat better now than one year ago  
3 - About the same  
4 - Somewhat worse now than one year ago  
5 - Much worse now than one year ago 
 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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The following items are about activities you might do during a typical day. Does your health now limit you 
in these activities? If so, how much? 
  
Yes, limited 
a lot  
Yes, limited a 
little  
No, not 
limited at all  
3. Vigorous activities, such as running, lifting heavy objects, 
participating in strenuous sports 
1   
2  
3  
4. Moderate activities, such as moving a table, pushing a 
vacuum cleaner, bowling, or playing golf 
1  
2  
3  
5. Lifting or carrying groceries 
1  
2  
3  
6. Climbing several flights of stairs 
1  
2  
3  
7. Climbing one flight of stairs 
1  
2  
3  
8. Bending, kneeling, or stooping 
1  
2  
3  
9. Walking more than a mile 
1  
2  
3  
10. Walking several blocks 
1  
2  
3  
11. Walking one block 
1  
2  
3  
12. Bathing or dressing yourself 
1  
2  
3  
 
 
During the past 4 weeks, have you had any of the following problems with your work or other regular daily 
activities as a result of your physical health? 
  
Yes  No  
13. Cut down the amount of time you spent on work or other activities 
1 
2 
14. Accomplished less than you would like 
1 
2 
15. Were limited in the kind of work or other activities 
1 
2 
16. Had difficulty performing the work or other activities (for example, it took extra effort) 
1 
2 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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During the past 4 weeks, have you had any of the following problems with your work or other regular daily 
activities as a result of any emotional problems (such as feeling depressed or anxious)? 
  
Yes  No  
17. Cut down the amount of time you spent on work or other activities 
1 
2 
18. Accomplished less than you would like 
1 
2 
19. Didn't do work or other activities as carefully as usual 
1 
2 
20. During the past 4 weeks, to what extent has your physical health or emotional problems interfered with 
your normal social activities with family, friends, neighbors, or groups? 
1 - Not at all  
2 - Slightly  
3 - Moderately  
4 - Quite a bit  
5 - Extremely  
21. How much bodily pain have you had during the past 4 weeks? 
1 - None  
2 - Very mild  
3 - Mild  
4 - Moderate  
5 - Severe  
6 - Very severe  
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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22. During the past 4 weeks, how much did pain interfere with your normal work (including both work 
outside the home and housework)? 
1 - Not at all  
2 - A little bit  
3 - Moderately  
4 - Quite a bit  
5 - Extremely  
These questions are about how you feel and how things have been with you during the past 4 weeks. For 
each question, please give the one answer that comes closest to the way you have been feeling. 
How much of the time during the past 4 weeks... 
  
All of 
the time  
Most of 
the time  
A good bit 
of the time  
Some of 
the time  
A little of 
the time  
None of 
the time  
23. Did you feel full of pep? 
1  
2  
3  
4  
5  
6  
24. Have you been a very nervous 
person? 
1  
2  
3  
4  
5  
6  
25. Have you felt so down in the dumps 
that nothing could cheer you up? 
1  
2  
3  
4  
5  
6  
26. Have you felt calm and peaceful? 
1  
2  
3  
4  
5  
6  
27. Did you have a lot of energy? 
1  
2  
3  
4  
5  
6  
28. Have you felt downhearted and blue? 
1  
2  
3  
4  
5  
6  
29. Did you feel worn out? 
1  
2  
3  
4  
5  
6  
30. Have you been a happy person? 
1  
2  
3  
4  
5  
6  
31. Did you feel tired? 
1  
2  
3  
4  
5  
6  
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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32. During the past 4 weeks, how much of the time has your physical health or emotional problems 
interfered with your social activities (like visiting with friends, relatives, etc.)? 
1 - All of the time  
2 - Most of the time  
3 - Some of the time  
4 - A little of the time  
5 - None of the time  
How TRUE or FALSE is each of the following statements for you. 
  
Definitely 
true  
Mostly 
true  
Don't 
know  
Mostly 
false  
Definitely 
false  
33. I seem to get sick a little easier than other 
people 
1  
2  
3  
4  
5  
34. I am as healthy as anybody I know 
1  
2  
3  
4  
5  
35. I expect my health to get worse 
1  
2  
3  
4  
5  
36. My health is excellent 
1  
2  
3  
4  
5  
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Appendix H – Godin Leisure-time Exercise Questionnaire 
1. During a typical 7-Day period (a week), how many times on the average do you do the following kinds of 
exercise for more than 15 minutes during your free time (write on each line the appropriate number): 
 
 
 
 
 
 
 
 
 
 
Times Per Week 
a) Strenuous Exercise  
 (HEART BEATS RAPIDLY)  
 
 
 
   
             ____________ 
 
 
 (e.g., running, jogging, hockey, football, soccer,  
squash, basketball, cross country skiing, judo,  
roller skating, vigorous swimming,  
vigorous long distance bicycling)  
 
 
b) Moderate Exercise  
 
 
 
 
 
 
_____________ 
 (NOT EXHAUSTING)  
 
 (e.g., fast walking, baseball, tennis, easy bicycling,  
volleyball, badminton, easy swimming, alpine skiing,  
 popular and folk dancing) 
 
 
c) Mild Exercise 
 
 
 
 
 
 
 
 _____________ 
(MINIMAL EFFORT)   
 
 (e.g., yoga, archery, fishing from river bank, bowling,  
horseshoes, golf, snow-mobiling, easy walking 
 
 
 2. During a typical 7-Day period (a week), in your leisure time, how often do you engage in any regular 
activity long enough to work up a sweat (heart beats rapidly)?  
 
  
 1.  Often _______ 
 
2. Sometimes  _______ 
 
3. Rarely/Never _______ 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Appendix I: Quality of Life Questionnaires 
 
This page is not to be given to the patient. 
General Instructions: 
 
Examiner: Now I have several questionnaires I would like you to complete on your own. 
Each has instructions that are easy. I cannot interpret the items for you but I can read them 
to you if you cannot read them yourself.  There is no time limit with these so take your time 
and read each item carefully.  
 
Let’s start (Give pages 25 – 30 to the patient for completion on their own).   
 
Do not interpret questions or words. If a patient asks for clarification remind them that you cannot 
assist and they are to do the best they can.  Questionnaires included in this booklet are: 
 
PROMIS Applied Cognition – General Concerns – Short Form 4a (4 items)  
 
PROMIS Applied Cognition – Abilities – Short Form 4a (4 items)  
 
PROMIS Fatigue – Short Form 4a (4 items)  
 
PROMIS Mood – Emotional Distress - Anger – Short Form 5a (5 items)  
                    Emotional Distress - Anxiety – Short Form 4a (4 items)  
 
        Emotional Distress - Depression – Short Form 4a (4 items)  
  
               PROMIS Pain Intensity - Short Form 3a (3 items) 
 
 PROMIS Pain Interference - Short Form 4a (4 items) 
 
              PROMIS Sleep Disturbance - Short Form 4a (4 items) 
 
              PROMIS Physical Function - Short Form 4a (4 items) 
 
              PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a (4 items)   
 
 
  
 
 
 
 
 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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PROMIS Applied Cognition – General Concerns – Short Form 4a (4 items) 
 
 
PROMIS Applied Cognition – Abilities – Short Form 4a (4 items) 
 
  
 
 
__ Month  Visit   
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Page 71 of 114 
 
 
PROMIS Fatigue – Short Form 4a (4 items) 
 
 
 
 
 
PROMIS Mood – Emotional Distress - Anger – Short Form 5a (5 items) 
 
 
 
__ Month  Visit   
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 
 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Emotional Distress - Anxiety – Short Form 4a (4 items)  
 
         
 
 
 
 
 
 
Emotional Distress - Depression – Short Form 4a (4 items) 
 
 
 
 
 
 
 
__ Month  Visit   
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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PROMIS Pain Intensity - Short Form 3a (3 items)
 
PROMIS Pain Interference - Short Form 4a (4 items) 
 
 
 
 
 
 
 
 
 
 
 
__ Month  Visit   
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Page 74 of 114 
 
 
PROMIS Physical Function - Short Form 4a (4 items) 
 
PROMIS Sleep Disturbance - Short Form 4a (4 items) 
 
PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a (4 items) 
 
__ Month  Visit   
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Appendix J: NEUROCOGNITIVE FUNCTION TESTING BOOKLET 
 
Preparing for Testing: 
• Test in a comfortable and quiet place. Distractions will affect patient’s performance 
• Arrange your materials so the patient cannot see this document. A tilted clipboard works 
well.  
• Patient should be seated comfortably and directly in front of you.  
• Have all the equipment ready before you begin. 
 
Creating Rapport: 
• Use a friendly manner of speech. 
• You may encourage patients by saying simple phrases (“You are doing fine”) but be 
careful not to signal correct or incorrect responses to test items. If a patient asks you if a 
response is correct say, “I cannot give you feedback, so just do the best you can,” 
• If the patient needs a break be sure it is not done during the HVLT-R Immediate Recall, Trail 
Making Test, or between words in the Controlled Oral Word Association Test. It is always 
better to suggest they use the bathroom before testing begins. 
• Should a patient appear distressed or nervous about their performance offer only a general 
encouragement such as, “You are doing fine” and remind them not to worry about 
mistakes.  
 
General Guidelines: 
• Speak clearly and slowly. Enunciate. You are not allowed to repeat instructions for most 
tests so you must get it right the first time. Take your time to explain the tests. 
• Read exactly what is written in this document. Do not invent instructions or modify them. 
Read what is there. 
• Never make a statement like, “Oh, this one is hard” as it could affect performance. 
• Familiarize yourself with the procedure before testing. If you are rusty, pre-read this form 
and remove the rust. It will help to read the instructions out loud to yourself or someone else 
before you administer the battery.   
 
Introducing the test battery:  
 
Examiner: “Thank you for agreeing to participate in this study……Other patients could 
benefit from your efforts…….If you are ready, let’s get started…….I am going to have you do 
a series of tasks that challenge your memory and other thinking abilities.  You will not get 
every item correct, so don’t worry about it.  Just relax and do the best you can on each and 
every one. I will instruct you before each task so you will know what to do.  Some of the 
tasks will be timed so you will have to do them as quickly as you can. I will alert you about 
the timed tasks.  Shall we get started now?” 
 
Administer the tests in the following order to every patient 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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1.  HOPKINS VERBAL LEARNING TEST - REVISED (HVLT-R) 
This test has three parts and two alternate forms: 
 
Part A - Free Recall:  Complete the three learning trials first 
 
Part A – Free Recall: Trial 1  
 
Examiner: “I am going to read a list of words to you. Listen carefully, because when I am 
through, I’d like you to tell me as many of the words as you can remember. You can tell 
them to me in any order. Are you ready?” 
• 
Read the words at the rate of one word every 2 seconds.   
 
Examiner: “OK. Now tell me as many of those words as you can remember.” 
• 
Check off the words the patient recalls on the form. 
• 
If a word is said that is not in the list (referred to as an, “intrusion”), do not write that word on 
the form and say nothing to the patient about the word not being on the list. 
• 
There is no time limit for each recall trial.  However, if the patient does not produce any words 
for 10-15 seconds, ask the patient if he/she can remember any more words. 
• 
If not, move on to trial 2. Later, you can record the number of words that were correctly 
repeated on the summary form. 
 
Part A – Free Recall: Trial 2  
 
Examiner:  “Now we are going to try it again. I am going to read the same list of words to 
you. Listen carefully, and tell me as many of the words as you can remember, in any order, 
including the words you told me the first time.”  
• 
Read the words at the rate of one word every 2 seconds.   
• 
Check off the words the patient recalls on the form. 
• 
If a word is said that is not in the list (an “intrusion”), do not write that word on the form and 
say nothing to the patient about the word not being on the list. 
• 
There is no time limit for each recall trial.  However, if the patient does not produce any words 
for 10-15 seconds, ask the patient if he/she can remember any more words. 
• 
If not, move on to trial 3. Later, you can record the number of words that were correctly 
repeated on the summary form. 
Part A – Free Recall: Trial 3 
Examiner:  “I am going to read the list one more time. As before, I’d like you to tell me as 
many of the words as you can remember, in any order, including all the words you’ve 
already told me.” 
• 
Read the words at the rate of one word every 2 seconds.   
• 
Check off the words the patient recalls on the form. 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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• 
If a word is said that is not in the list (an “intrusion”), do not write that word on the form and 
say nothing to the patient about the word not being on the list. 
• 
There is no time limit for each recall trial.  However, if the patient does not produce any words 
for 10-15 seconds, ask the patient if he/she can remember any more words. 
• 
Do not tell the respondent that recall of the words will be tested later. 
 
HOPKINS VERBAL LEARNING TEST  
FREE RECALL (TRIALS 1-3) 
 
 
PART A – FREE RECALL: 
For each trial, mark the box next to each word 
The patient accurately recalls for each trial. 
 
Trial 1 
Trial 2 
Trial 3 
 
            LION 
 
¨ 
 
¨ 
 
¨ 
 
            EMERALD 
 
¨ 
 
¨ 
 
¨ 
 
            HORSE 
 
¨ 
 
¨ 
 
¨ 
 
            TENT 
 
¨ 
 
¨ 
 
¨ 
 
            SAPPHIRE 
 
¨ 
 
¨ 
 
¨ 
 
            HOTEL 
 
¨ 
 
¨ 
 
¨ 
 
            CAVE 
 
¨ 
 
¨ 
 
¨ 
 
            OPAL 
 
¨ 
 
¨ 
 
¨ 
 
            TIGER 
 
¨ 
 
¨ 
 
¨ 
 
            PEARL 
 
¨ 
 
¨ 
 
¨ 
 
            COW 
 
¨ 
 
¨ 
 
¨ 
       
            HUT 
 
¨ 
 
¨ 
 
¨ 
 
Adapted and reproduced by special permission of the publisher, Psychological Assessment Resources, Inc. 16204 North Florida 
Avenue, Lutz, Florida 33549, from the Hopkins Verbal Learning Test-Revised by Jason Brandt, PhD and Ralph H.B. Benedict, PhD, 
Copyright 1991, 1998, 2001 by PAR, Inc. Further reproduction is prohibited without permission from PAR, I 
 
 
__ Month   
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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2.  TRAIL MAKING TEST – Parts A & B [Timed Test] 
 
Part A – Sample:  The Sample for Part A must be completed/attempted by each patient at 
every assessment.  Place the Sample A worksheet flat on the table, directly in front of the 
patient (the bottom of the worksheet should be approximately six inches from the edge of 
the table).  Give the patient a black pen and say: 
 
Examiner: “On this page (point) are some numbers. Begin at number 1 (point to 1) and draw 
a line from 1 to 2 (point to 2), 2 to 3 (point to 3), 3 to 4 (point to 4), and so on, in order, until 
you reach the end (point to the circle marked END).  Draw the lines as fast as you can. 
Ready, begin.” 
 
If the patient completes Sample A correctly, and in a manner demonstrating that s/he understands 
what to do, proceed immediately to Test A. If the patient makes a mistake on Sample A, point out 
the error and explain it. 
The following explanations of mistakes serve as illustrations: 
 
• “This is where you start (point to number 1)”  
• “You skipped this circle (point to the circle omitted)” 
• “You should go from number 1 to 2, 2 to 3, and so on, until you reach the circle marked 
END” 
 
If it is clear that the patient intended to touch a circle but missed it, do not count it as an omission.  
Remind the patient, however, to be sure to touch the circles.  If the patient still cannot complete 
Sample A, take his/her hand and guide him/her through the trail using the opposite end of the pen, 
lightly touching the worksheet to avoid making marks on the copy. Then say:  
 
Examiner: “Remember, begin at number 1 (point to 1) and draw a line from 1 to 2 (point to 
2), 2 to 3 (point to 3), 3 to 4 (point to 4) and so on, in order, until you reach the circle marked 
END (point). Do not skip around, but go from one number to the next in proper order. 
Remember to work as fast as you can. Ready, begin.” 
 
If the patient does not succeed, or it becomes evident that s/he cannot do the task, DISCONTINUE 
testing and indicate the corresponding reason on the Trail Making Data Sheet.  If the patient 
completes Sample A correctly and appears to understand what to do, proceed immediately to Part 
A. 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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                                                             Trailmaking - Part A Sample  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
__ Month   
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Page 80 of 114 
 
 
 
Trailmaking - Part A – Test:  
 
 After the patient has completed Sample A, place the Part A test worksheet directly in front of the 
patient and say: 
 
Examiner: “Good! Let’s try the next one. On this page are numbers from 1 to 25. Do this the 
same way. Begin at number 1 (point) and draw a line from 1 to 2 (point to 2), 2 to 3 (point to 
3), 3 to 4 (point to 4) and so on, in order, until you reach the circle marked END (point). Do 
not skip around, but go from one number to the next in proper order. Remember to work as 
fast as you can. Ready, begin.”  
 
• Start timing as soon as the instruction is given to “begin” 
• Watch closely in order to catch any errors as soon as they are made.  If the patient makes 
an error, call it to his/her attention immediately and have him/her proceed from the point the 
mistake occurred 
• The patient must complete the test in 5 minutes or less 
• DO NOT STOP TIMING UNTIL HE/SHE REACHES THE CIRCLE MARKED “END” 
• If the patient does not complete the test within 5 minutes terminate the testing.  The test can 
also be discontinued if the patient is extremely confused and is unable to perform the task.  
Collect the worksheet and complete the Trail Making Data Sheet indicating the reason the 
test was terminated and the number of last correct circle reached on the test.  
• If the patient successfully completes the test collect the worksheet and record the time to 
completion on the Trail Making Data Sheet in minutes and seconds.  Then say, “That’s fine.  
Now we’ll try another one.” 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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__ Month   
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Page 82 of 114 
 
Trailmaking - Part B – Sample:  The Sample for Part B must be completed/attempted by each 
patient at every assessment.  Place the Sample B worksheet flat on the table, directly in front of the 
patient (the bottom of the worksheet should be approximately six inches from the edge of the table) 
and say: 
 
Examiner:  “On this page (point) are some numbers and letters. Begin at number 1 (point to 
1) and draw a line from 1 to A (point), A to 2 (point to 2), 2 to B (point to B), B to 3 (point to 3), 
3 to C (point to C) and so on, in order, until you reach the end (point to the circle marked 
END). Remember, first you have a number (point to 1), then a letter (point to A), then a number 
(point to 2), then a letter (point to B), and so on. Draw the lines as fast as you can. Ready, 
begin.” 
 
If the patient completes Sample B correctly, and in a manner demonstrating that s/he understands 
what to do, proceed immediately to Part B. If the patient makes a mistake on Sample B, point out 
the error and explain it. 
 
The following explanations of mistakes serve as illustrations: 
 
• “You started with the wrong circle. This is where you start (point to number 1)” 
• “You skipped this circle (point to the circle omitted)”  
• “You should go from number 1 (point) to A (point), A to 2 (point to 2), 2 to B (point to 
B), B to 3 (point to 3) and so on, until you reach the circle marked END (point)” 
 
If it is clear the patient intended to touch a circle but missed it, do not count it as an omission.  
Remind the patient, however, to be sure to touch the circles. If the patient still cannot complete 
Sample B, take their hand and guide them through the trail using the opposite end of the pen, 
lightly touching the worksheet to avoid making marks on the copy. Then say:  
 
Examiner:  “Now you try it. Remember, begin at number 1 (point to 1) and draw a line from 1 
to A (point to A), A to 2 (point to 2), 2 to B (point to B), B to 3 (point to 3) and so on, in order, 
until you reach the circle marked END (point). Ready, begin.” 
 
If the patient does not succeed or it becomes evident that s/he cannot do the task, DISCONTINUE 
testing and indicate the corresponding reason on the Trail Making Data Sheet.  If the patient 
completes Sample B correctly and appears to understand what to do, proceed immediately to Part 
B. 
                                      
 
 
 
 
                                            
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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 Trailmaking - Part B Sample 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Trailmaking – Part B - Test:   
__ Month Visit   
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 84 of 114 
 
After the patient has completed Sample B, place the Part B Worksheet directly in front of the 
patient and say: 
 
Examiner: “Good! Let’s try the next one. On this page are both numbers and letters. Do this 
the same way. Begin at number 1 (point) and draw a line from 1 to A (point to A), A to 2 
(point to 2), 2 to B (point to B), B to 3 (point to 3), 3 to C (point to C) and so on, in order, until 
you reach the circle marked END (point). Remember, first you have a number (point to 1), 
then a letter (point to A), then a number (point to 2), then a letter (point to B), and so on. Do 
not skip around, but go from one circle to the next in the proper order. Draw the lines as 
fast as you can. Ready, begin.”   
 
• Start timing as soon as the instruction is given to “begin” 
• Watch closely in order to catch any errors as soon as they are made.  If the patient makes 
an error, call it to his/her attention immediately and have him/her proceed from the point the 
mistake occurred.  “You were correct up to here (point to last correct circle). Start here 
and continue as quickly as you can.” 
• The patient must complete the test in 5 minutes or less. (Do not tell patient). 
• DO NOT STOP TIMING UNTIL HE/SHE REACHES THE CIRCLE MARKED “END” 
• Collect the worksheet and record the time to completion on the Trail Making Data Sheet in 
minutes and seconds 
• If the patient does not complete the test within 5 minutes terminate the testing. (Say: “That’s 
fine. We will need to move on to the next task”) The test can also be discontinued if the 
patient is extremely confused and is unable to perform the task.  Collect the worksheet and 
complete the Trail Making Data Sheet indicating the reason the test was terminated and the 
last correct number or letter reached on the test.  
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 85 of 114 
 
 
__ Month  
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 86 of 114 
 
TRAIL MAKING TEST DATA SHEET (PART A & B) 
 
 
Maximum time allotted for each part is 5 minutes (300 seconds) 
 
PART A 
 
Total time:                           _____________ minutes   _________ seconds 
 
Highest circle connected:   _____________ 
 
Number of errors:                _____________ 
 
 
PART B 
 
Total time:                          ____________  minutes    _________ seconds 
 
Highest circle connected:   ____________ 
 
Number of errors:               ____________ 
 
                
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
__ Month   
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 87 of 114 
 
 
4.  CONTROLLED ORAL WORD ASSOCIATION TEST (COWA) [Timed Test] 
 
This test has three parts (letters). 
 
Examiner:  “I am going to say a letter of the alphabet, and I want you to say as quickly as 
you can all of the words that you can think of that begin with that letter.  You may say any 
words at all, except proper names such as the names of people or places.  So you would 
not say ‘Rochester’ or ‘Robert’.  Also, do not use the same word again with a different 
ending, such as ‘Eat,’ and ‘Eating.’ 
 
“For example, if I say ‘S,’ you could say ‘son’, ‘sit,’ ‘shoe,’ or ‘slow.’  Can you think of other words 
beginning with the letter ‘s’?” 
 
• Wait for the patient to give a word.  If it is a correct response, say “good”, and ask for another 
word beginning with the letter “s”.  If a second appropriate word is given, proceed to the test 
itself. 
• If the patient gives an inappropriate word on either occasion, correct the patient, and repeat 
the instructions.  If the patient then succeeds, proceed to the test. 
• If the patient fails to respond, repeat the instruction.  If it becomes clear that the patient does 
not understand the instructions or cannot associate, stop the procedure, and indicate the 
reason(s) on the scoring sheet. 
• If the patient has succeeded in giving two appropriate words beginning with the demonstration 
letter, say: 
 
Examiner: “That is fine.  Now I am going to give you another letter and again you say all of 
the words beginning with that letter that you can think of.  Remember, no names of people or 
places, just ordinary words.  Also, if you should draw a blank, I want you to keep on trying 
until the time limit is up and I say STOP.” 
 
“You will have a minute for each letter.  The first letter is ‘___’” (see scoring sheet). 
 
**Allow exactly one minute for each letter** 
 
• If the patient discontinues before the end of the time period, encourage him/her to try to think 
of more words. 
• If he/she is silent for 15 seconds, repeat the basic instruction and the letter (e.g., “Tell me all 
the words you can think of that begin with a “c”). 
• No extension on the time limit is made in the event that instructions are repeated. 
• Continue the evaluation with the remaining two letters, allowing one minute for each. 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 88 of 114 
 
Examiner: Remember, no names of people or places, just ordinary words.  Also, if you should 
draw a blank, I want you to keep on trying until the time limit is up and I say STOP.  You will have 
a minute for each letter. “The next letter is ‘___’” (see scoring sheet). 
 
 
Recording and Scoring: 
 
• The record sheet provides lines on which the patient’s responses can be entered (e.g., write 
in the word that is said by the patient).  If his/her speed of word production is too fast to permit 
verbatim recording, a “+” should be entered to indicate a correct response and try to write an 
abbreviated version. When time permits complete the abbreviation.  
• Incorrect responses either should not be recorded or, if recorded, should be struck through 
with a line. 
• If the patient provides more responses than there are lines on the record sheet, write in the 
margins. 
• Count all the correct responses. The number of correct words should be indicated below 
each column on the recording sheet and on the summary data form that is sent to the 
CCCWFU. 
 
 
Comments on scoring: 
 
• Note:  It can be helpful for the first several patients and for patients known to be fast with their 
word production to tape record the session for transcription at a later time. 
• The instructions include a specific prohibition against giving proper names or different forms 
of the same word. Therefore, inflections of the same word (e.g., eat-eating; mouse-mice; 
loose-loosely; ran-run-runs) are not considered correct responses.  
• Patients often give both a verb and a word derived from the verb or adjective (e.g., fun-funny; 
sad-sadness).  These are not considered correct responses. On the other hand, if the word 
refers to a specific object (e.g., foot-footstool; hang-hanger), it would be counted as a correct 
answer. 
• Many words have two or more meanings (e.g., foot; can; catch; hand).  A repetition of the 
word is acceptable IF the patient definitely indicates the alternative meaning to you. 
• Slang terms are OK if they are in general use. 
•  Foreign words (for example, pasta; passé; lasagna) can be counted as correct if they can be 
considered part of that relevant language, the criterion being their listing in a standard 
dictionary of that language. All incorrect and repeated responses MUST be crossed out with 
one single line, initialed and dated. Additionally, all duplicate entries that have been verified 
to have different meanings must be marked “ok”, initialed and dated. Refer to the descriptions 
above for guidelines for acceptability. Add the total number of correct responses in each 
column and input the totals where indicated on the COWA worksheet.  
• If the test is discontinued or omitted, please mark this on the bottom of the test form and 
indicate the reason. 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 89 of 114 
 
CONTROLLED ORAL WORD ASSOCIATION TEST (COWA) 
 
“C”                                            “F”                                              “L” 
 
_________________________      ________________________    ______________________ 
 
_________________________      ________________________    ______________________ 
 
_________________________      ________________________    ______________________ 
 
_________________________      ________________________    ______________________ 
 
_________________________      ________________________    ______________________ 
 
_________________________      ________________________    ______________________ 
 
_________________________      ________________________    ______________________ 
 
_________________________      ________________________    ______________________ 
 
_________________________      ________________________    ______________________ 
 
_________________________      ________________________    ______________________ 
 
_________________________      ________________________    ______________________ 
 
_________________________      ________________________    ______________________ 
 
_________________________      ________________________    ______________________ 
 
_________________________      ________________________    ______________________ 
 
_________________________      ________________________    ______________________ 
 
 
“C” Total: ________________      “F” total: ________________    “L” Total: _____________ 
 
Adapted and reproduced by special permission of the publisher, Psychological Assessment Resources, Inc. 16204 North Florida 
Avenue, Lutz, Florida 33549, from the Multilingual Aphasia Examination by Arthur L. Benton, PhD, Kerry de S. Hamsher, PhD, and 
Abigail Sivan, PhD, Copyright 1978 by PAR, Inc. Further reproduction is prohibited without permission from PAR, Inc. 
 
 
 
 
 
 
__ Month   
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 90 of 114 
 
4.  DIGIT SPAN 4.  Digit Span Test 
 
Digits Backward 
• 
Administer the digit spans in order 
• 
Do not repeat a span once read. 
• 
Administer both spans of the same length regardless of how the participant performs. 
• 
Say the digits at a rate of 1 digit about every 1 sec. 
• 
Use a monotonic voice; without inflections at the end   
 
Examiner:  “Now I am going to say some numbers, but this time when I stop I want you say them backwards.  
For example, if I say 7-1-9, what would you say?” 
• 
If the participant responds correctly (9-1-7), say, That’s right,” and proceed to Item 1.  
• 
If the participant fails the example, say: “No, you would say 9-1-7.  I said 7-1-9, so to say it backwards you 
would say 9-1-7.  Now try these numbers. Remember, you are to say them backwards 3-4-8.” 
• 
Whether the participant succeeds or fails with the second example (3-4-8), proceed to Item 1. Give no help on 
this second example or any of the items that follow. 
• 
Discontinue after failure on both trials of any item. 
 
Scoring:  Each span is scored ‘0’ or ‘1’. Give 1 point if the participant passes the trial; and no points if the participant 
fails the trial.  Only discontinue test when participant has failed both trials of the same span length (e.g., 5a. and 5b.). 
DIGIT SPAN TEST--- BACKWARD 
 
Item 
Digit span 
Score (0 or 1) 
1a. 
1b. 
2 – 4 
 
5 – 7 
 
2a. 
2b. 
6 – 2 – 9 
 
4 – 1 – 5 
 
3a. 
3b. 
3 – 2 – 7 – 9 
 
4 – 9 – 6 – 8 
 
4a. 
4b. 
1 – 5 – 2 – 8 – 6 
 
6 – 1 – 8 – 4 – 3 
 
5a. 
5b. 
5 – 3 – 9 – 4 – 1 – 8 
 
7 – 2 – 4 – 8 – 5 – 6 
 
6a. 
6b. 
8 – 1 – 2 – 9 – 3 – 6 – 5 
 
4 – 7 – 3 – 9 – 1 – 2 – 8 
 
7a. 
7b. 
9 – 4 – 3 – 7 – 6 – 2 – 5 – 8 
 
7 – 2 – 8 – 1 – 9 – 6 – 5 – 3 
 
 
Wechsler Adult Intelligence Scale-Third Edition. Copyright © 1997 by Harcourt Assessment, Inc. Reproduced with permission. All rights reserved. 
 
 
 
 
 
__ Month   
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 91 of 114 
 
5.  HOPKINS VERBAL LEARNING TEST - REVISED (HVLT- R) 
 
 
Part B – Delayed Recall 
 
• 
DO NOT READ THE WORD LIST AGAIN. 
 
• 
HVLT-R ‘Part B – Delayed Recall’ should be administered approximately 20 minutes after 
Part A of the HVLT-R.   
 
Examiner:  “Do you remember that list of words you tried to learn before? Tell me as many 
of those words as you can remember.” 
 
• Check the box on the corresponding line of the HVLT-R worksheet for each word the patient 
accurately recalls. 
• 
If a word is said that is not in the list (referred to as an, “intrusion”), do not write that word on 
the form and say nothing to the patient about the word not being on the list. 
• 
There is no time limit for each recall trial.  However, if the patient does not produce any words 
for 10-15 seconds, ask the patient if he/she can remember any more words. 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 92 of 114 
 
HOPKINS VERBAL LEARNING TEST (F1)--PART B 
 
DELAYED RECALL 
 
DO NOT READ WORD LIST 
 
Check words correctly recalled 
 
 
Delayed 
Recall 
 
            LION 
 
¨ 
 
            EMERALD 
 
¨ 
 
            HORSE 
 
¨ 
 
            TENT 
 
¨ 
 
            SAPPHIRE 
 
¨ 
 
            HOTEL 
 
¨ 
 
            CAVE 
 
¨ 
 
            OPAL 
 
¨ 
 
            TIGER 
 
¨ 
 
            PEARL 
 
¨ 
 
            COW 
 
¨ 
       
            HUT 
 
¨ 
 
Adapted and reproduced by special permission of the publisher, Psychological Assessment Resources, Inc. 16204 North Florida 
Avenue, Lutz, Florida 33549, from the Hopkins Verbal Learning Test-Revised by Jason Brandt, PhD and Ralph H.B. Benedict, PhD, 
Copyright 1991, 1998, 2001 by PAR, Inc. Further reproduction is prohibited without permission from PAR, Inc. 
 
 
 
 
 
 
__ Month 
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 93 of 114 
 
Part C – HVLT-R Delayed Recognition 
 
 
Examiner:  “Now I’m going to read a longer list of words to you. Some of them are words 
from the original list, and some are not. After I read each word, I’d like you to say “Yes” if it 
was on the original list or “No” if it was not.  Was [word] on the list?” 
 
• Read the words from the top of the columns down. 
• Check either the “Y” (Yes) or “N” (No) box next to each word to indicate the patient’s response. 
• Guessing is allowed. 
• If the test is discontinued or omitted, please mark this on the bottom of the test form and 
indicate the reason.  

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 94 of 114 
 
  
HOPKINS VERBAL LEARNING TEST (F1)--PART C 
 
DELAYED RECOGNITION 
 
 
Check either “Y” or “N” for each word  
 
 
 
Y 
N 
 
Y 
N 
 
HORSE 
 
¨ 
 
¨ 
 
balloon 
 
¨ 
 
¨ 
 
house* 
 
¨ 
 
¨ 
 
boat 
 
¨ 
 
¨ 
 
HUT 
 
¨ 
 
¨ 
 
dog* 
 
¨ 
 
¨ 
 
TENT 
 
¨ 
 
¨ 
 
HOTEL 
 
¨ 
 
¨ 
 
ruby* 
 
¨ 
 
¨ 
 
coffee 
 
¨ 
 
¨ 
 
OPAL 
 
¨ 
 
¨ 
 
scarf 
 
¨ 
 
¨ 
 
EMERALD 
 
¨ 
 
¨ 
 
apartment* 
 
¨ 
 
¨ 
 
Mountain 
 
¨ 
 
¨ 
 
COW 
 
¨ 
 
¨ 
 
CAVE 
 
¨ 
 
¨ 
 
LION 
 
¨ 
 
¨ 
 
TIGER 
 
¨ 
 
¨ 
 
PEARL 
 
¨ 
 
¨ 
 
SAPPHIRE 
 
¨ 
 
¨ 
 
penny 
 
¨ 
 
¨ 
 
cat* 
 
¨ 
 
¨ 
 
diamond* 
 
¨ 
 
¨ 
 
Adapted and reproduced by special permission of the publisher, Psychological Assessment Resources, Inc. 16204 North Florida 
Avenue, Lutz, Florida 33549, from the Hopkins Verbal Learning Test-Revised by Jason Brandt, PhD and Ralph H.B. Benedict, PhD, 
Copyright 1991, 1998, 2001 by PAR, Inc. Further reproduction is prohibited without permission from PAR, Inc. 
 
 
 
_ Month 
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 95 of 114 
 
DATA SUMMARY SHEET 
 
 
1.  HVLT-R – Immediate Recall  
 
(TO BE SCORED AT COORDINATING CTR) 
 
2. Trail Making Test 
 
Part A  
 
Time:  _____ min.  ____ sec 
 
Highest circle connected:  ______ 
 
Errors: _____________ 
 
Part B 
 
Time:   ____ min   ____sec 
 
Highest circle connected:  ______ 
 
Errors: _____________ 
 
3.  Controlled Oral Word Association Test 
 
Letter 1 Word Total _____ 
 
Letter 2 Word Total _____ 
 
Letter 3 Word Total _____ 
 
4. Digit Span  
 
(TO BE SCORED AT COORDINATING CTR) 
 
 
 
 
5.  HVLT-R Delayed & Recognition 
                                                                                             
(TO BE SCORED AT COORDINATING CTR)       
 
 
 
 
__ Month  
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 96 of 114 
 
Appendix K 
: Body Composition assessments 
 
Directions for Measuring Waist Circumference 
 
 
• Patient should be instructed to not hold their breath. 
 
• The measuring tape should be secure but not tight. 
 
• The area being measured can be found by placing the hands on the waist and moving them 
downward until the top curve of the hip bone can be felt. 
 
• Place the tape measure around the top of the hip curve and wrap around at the level of the 
belly button. (This may not be the same level as the top of the pants.) 
 
 
Record this measurement in inches below: 
 
         _________ inches 
 
• Record height and weight: 
________height (inches) __________weight (kg) 
 
 
 
 
Peripheral Edema Evaluation 
 
Does the patient have peripheral edema?       Yes     /      No 
 
 
 
 
 
 
 
 
__ Month  
 
Site: 
Date: 
Patient Initials: 
Patient ID: 
CRA: 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 97 of 114 
 
 
Appendix L:  Physical Activity Program Evaluation 
 
Please circle the number below that best describes your feeling about each statement. 
 
PART I. 
 
1. I liked the physical activity program overall. 
0 
Not At All 
1 
A Little Bit 
2 
Somewhat 
3 
Quite A Bit 
4 
Very Much 
 
 
 
 
 
2. The physical activity program was helpful to me. 
0 
Not At All 
1 
A Little Bit 
2 
Somewhat 
3 
Quite A Bit 
4 
Very Much 
 
 
 
 
 
3. I plan to continue to practice physical activity. 
0 
Not At All 
1 
A Little Bit 
2 
Somewhat 
3 
Quite A Bit 
4 
Very Much 
 
 
 
 
 
4. I plan to start or continue to practice another type of physical activity. 
0 
Not At All 
1 
A Little Bit 
2 
Somewhat 
3 
Quite A Bit 
4 
Very Much 
 
 
 
 
 
5. The physical activity program had an impact on my physical function. 
0 
Not At All 
1 
A Little Bit 
2 
Somewhat 
3 
Quite A Bit 
4 
Very Much 
 
 
 
 
 
6. The physical activity program had an impact on my mental health. 
0 
Not At All 
1 
A Little Bit 
2 
Somewhat 
3 
Quite A Bit 
4 
Very Much 
 
 
 
 
 
7. The interventionist made physical activity enjoyable. 
0 
Not At All 
1 
A Little Bit 
2 
Somewhat 
3 
Quite A Bit 
4 
Very Much 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 98 of 114 
 
PART II. 
 
1. What did you like best about participating in this study and the physical activity 
program? 
 
 
 
 
2. What did you like least about participating in this study and the physical activity 
program? 
 
 
 
 
3. What did you learn from participating in the physical activity program? 
 
 
 
 
4. What other suggestions would you make to improve this program? 
 
 
 
 
5. Please share any other thoughts and comments about your participation in the 
physical activity program. (Feel free to use additional space below or on the back 
of this page if you would like.) 
 
 
 
 
6. May we contact you about participating in future studies? 
Yes 
If yes, E-mail  
No 
Phone  
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 99 of 114 
 
 
 
Appendix M:  Health Education Program Evaluation 
 
Please circle the number below that best describes your feeling about each statement. 
 
PART I. 
 
8. I liked the educational program overall. 
0 
Not At All 
1 
A Little Bit 
2 
Somewhat 
3 
Quite A Bit 
4 
Very Much 
 
 
 
 
 
9. The educational program was helpful to me. 
0 
Not At All 
1 
A Little Bit 
2 
Somewhat 
3 
Quite A Bit 
4 
Very Much 
 
 
 
 
 
10. I plan to continue to practice what I learned. 
0 
Not At All 
1 
A Little Bit 
2 
Somewhat 
3 
Quite A Bit 
4 
Very Much 
 
 
 
 
 
11. The educational program was a valuable use of my time. 
0 
Not At All 
1 
A Little Bit 
2 
Somewhat 
3 
Quite A Bit 
4 
Very Much 
 
 
 
 
 
 
 
 
 
 
12. The interventionist made learning about health enjoyable. 
0 
Not At All 
1 
A Little Bit 
2 
Somewhat 
3 
Quite A Bit 
4 
Very Much 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 100 of 114 
 
PART II. 
 
1. What did you like best about participating in this study and the health education 
program? 
 
 
 
 
2. What did you like least about participating in this study and the health education 
program? 
 
 
 
 
3. What did you learn from participating in the education program? 
 
 
 
 
4. What other suggestions would you make to improve this program? 
 
 
 
 
5. Please share any other thoughts and comments about your participation in the 
health education program. (Feel free to use additional space below or on the back 
of this page if you would like.) 
 
 
 
 
6. May we contact you about participating in future studies? 
Yes 
If yes, E-mail  
No 
Phone  
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 101 of 114 
 
 
 
 
APPENDIX N: THE Q-PRO SHARED RESOURCE FOR QUALITATIVE 
RESEARCH SUPPORT SERVICES 
 
QPRO offers the following services: 
 
• Community-based study recruitment and engagement 
 
• Qualitative research methodological expertise and infrastructure 
 
• Patient-reported outcomes measurement consultation 
 
We will utilize the Q-PRO Shared Resource to provide methodological expertise for qualitative 
research. This expertise applies to all areas of qualitative inquiry including the design and 
selection of methods, selection and recruitment of study sample, data collection, management of 
textual data, and data analysis. Additionally, Q-PRO offers assistance with proposal writing as it 
pertains to qualitative methodology, progress report and presentation development, manuscript 
development, and team- specific training and mentoring in collecting and analyzing qualitative 
data. Q-PRO also provides support facilitating the dissemination of research findings to the 
community. 
 
Personnel 
 
The Q-PRO Developing Shared Resource is co-directed by two faculty members and staffed by a 
Senior Research Associate and a full-time Program Manager. Q-PRO co-directors engage other 
qualified faculty on a per-project basis when external expertise is needed. The co- directors were 
chosen to lead this developing shared resource based on complementary areas 
 
Q-PRO Developing Shared Resource services are provided through the CCCWFUHS and are 
housed in the Department of Social Sciences and Health Policy. For this study, the QPRO 
resources will be available to Dr. Lucas for evaluating participant feedback to identify issues with 
the exercise mediated physical activity intervention. 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
. 
Page 102 of 114 
 
Appendix O – FACT-B questionnaire 
 
Have you ever been diagnosed with breast Cancer?  Yes  /   No 
If the participant responds “No,” continue to the next questionnaire.  
 
Below is a list of statements that other people with your illness have said are important. Please circle or 
mark one number per line to indicate your response as it applies to the past 7 days. 
 
 
PHYSICAL WELL-BEING 
 
Not 
at all 
A little 
bit 
Som
e-
what 
Quite
a bit 
Very 
much 
GP1 
I have a lack of energy
 ................................................................................ 
0 
1 
2 
3 
4 
GP2 
I have nausea
 ................................................................................ 
0 
1 
2 
3 
4 
GP3 
Because of my physical condition, I have trouble 
meeting the needs of my family
 ................................................................................ 
 
0 
 
1 
 
2 
 
3 
 
4 
GP4 
I have pain
 ................................................................................ 
0 
1 
2 
3 
4 
GP5 
I am bothered by side effects of treatment
 ................................................................................ 
0 
1 
2 
3 
4 
GP6 
I feel ill
 ................................................................................ 
0 
1 
2 
3 
4 
GP7 
I am forced to spend time in bed
0 
1 
2 
3 
4 
 
 
SOCIAL/FAMILY WELL-BEING 
 
Not 
at all 
A little 
bit 
Som
e-
what 
Quite
a bit 
Very 
much 
GS1 
I feel close to my friends
 ................................................................................ 
0 
1 
2 
3 
4 
GS2 
I get emotional support from my family
 ................................................................................ 
0 
1 
2 
3 
4 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Please circle or mark one number per line to indicate your response as it applies to the past 7 days. 
 
 
 
EMOTIONAL WELL-BEING 
Not 
at all 
A little 
bit 
Som
e-
what 
Quite
a bit 
Very 
much 
GE1 
I feel sad
 ................................................................................. 
0 
1 
2 
3 
4 
GE2 
I am satisfied with how I am coping with my illness
 ................................................................................. 
0 
1 
2 
3 
4 
GE3 
I am losing hope in the fight against my illness
 ................................................................................. 
0 
1 
2 
3 
4 
GE4 
I feel nervous
 ................................................................................. 
0 
1 
2 
3 
4 
GE5 
I worry about dying
 ................................................................................. 
0 
1 
2 
3 
4 
GE6 
I worry that my condition will get worse
0 
1 
2 
3 
4 
 
GS3 
I get support from my friends
 ................................................................................ 
0 
1 
2 
3 
4 
GS4 
My family has accepted my illness
 ................................................................................ 
0 
1 
2 
3 
4 
GS5 
I am satisfied with family communication about my 
illness
 ................................................................................ 
 
0 
 
1 
 
2 
 
3 
 
4 
GS6 
I feel close to my partner (or the person who is my 
main support)
 ................................................................................ 
 
0 
 
1 
 
2 
 
3 
 
4 
Q1 
Regardless of your current level of sexual activity, 
please answer the following question. If you prefer not 
to answer it, please mark this box           and go to the 
next section
 
 
 
 
 
GS7 
I am satisfied with my sex life
0 
1 
2 
3 
4 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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FUNCTIONAL WELL-BEING 
 
Not 
at all 
A little 
bit 
Som
e-
what 
Quite
a bit 
Very 
much 
 
GF1 
I am able to work (include work at home)
 ................................................................................. 
0 
1 
2 
3 
4 
GF2 
My work (include work at home) is fulfilling
 ................................................................................. 
0 
1 
2 
3 
4 
GF3 
I am able to enjoy life
 ................................................................................. 
0 
1 
2 
3 
4 
GF4 
I have accepted my illness
 ................................................................................. 
0 
1 
2 
3 
4 
GF5 
I am sleeping well
 ................................................................................. 
0 
1 
2 
3 
4 
GF6 
I am enjoying the things I usually do for fun
 ................................................................................. 
0 
1 
2 
3 
4 
GF7 
I am content with the quality of my life right now
0 
1 
2 
3 
4 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Please circle or mark one number per line to indicate your response as it applies to the past 7 days. 
 
 
 
ADDITIONAL CONCERNS 
 
Not 
at all 
A little 
bit 
Som
e-
what 
Quite
a bit 
Very 
much 
B1 
I have been short of breath
 ................................................................................. 
0 
1 
2 
3 
4 
B2 
I am self-conscious about the way I dress
 ................................................................................. 
0 
1 
2 
3 
4 
B3 
One or both of my arms are swollen or tender
 ................................................................................. 
0 
1 
2 
3 
4 
B4 
I feel sexually attractive
 ................................................................................. 
0 
1 
2 
3 
4 
B5 
I am bothered by hair loss
 ................................................................................. 
0 
1 
2 
3 
4 
B6 
I worry that other members of my family might 
someday get the same illness I have
 ................................................................................. 
 
0 
 
1 
 
2 
 
3 
 
4 
B7 
I worry about the effect of stress on my illness
 ................................................................................. 
0 
1 
2 
3 
4 
B8 
I am bothered by a change in weight
 ................................................................................. 
0 
1 
2 
3 
4 
B9 
I am able to feel like a woman
0 
1 
2 
3 
4 
P2 
I have certain parts of my body where I experience 
pain
 ................................................................................. 
0 
1 
2 
3 
4 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Appendix P – PALS Home-Based Testing Kit 
 
 
PALS Home-Based Testing Kit  
 
 
This document contains both instructions for the participant who will perform the tests, and for the 
testing assistant who will use the camera app on the Samsung Android device to film each of the 
tests for scoring purposes.  
Participant Instructions 
To begin with, please check the package you received to make sure it contains the following items. 
 
Package Contents 
1. Instruction booklet (can also be emailed beforehand). 
2. 1 x Android device. 
3. 1 x Camry Grip strength dynamometer. 
4. 1 x 15m length rope (marked in 1m increments). 
5. 2 x weighted markers for securing ends of 15m rope. 
 
Other Equipment Needed 
6. A flat area of the home without obstructions to complete balance tests. The back of a chair, 
a table, or a shelf at about hip height is recommended if you need to catch your balance. 
7. A flat area for set-up and completion of the 4-meter and 6-minute walk test (15-20 meters/ 
50-70 feet). 
8. Standard dining room-type chair for chair stand test (17-19” in height). 
9. Your own smartphone device with the following app installed 6WT (IOS) or 
(Android). 
 
Important Notes:  
 
10. Before you begin, please be aware that participant safety is more important than any 
test outcome. Please let the research team know about any conditions including 
fatigue and concerns related to balance that may make the completion of some of the 
following exercise tests unsafe. 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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11. Please have the person who is helping you to conduct these tests, become familiar 
with the Android device. Specifically, they will need to be able to operate the 
camera/video app found on the home screen. 
12. We would like you to complete all the tests in one attempt. The total time taken to 
complete the full battery of tests should be between 40-60 minutes. 
13. One of the walking tests will be completed at a usual walking pace (4m walk), while 
the other is done as fast as you can without running (6MWT). 
14. Please complete the following tests in the stated order. It is important to be 
adequately recovered for the start of each test. 
 
Test Order 
1. Balance tests - Steady App (If your balance test results show you have a low risk for a fall 
[≤40/100], you may continue to the rest of the tests.) 
2. 4-meter walk test. 
3. Chair stand test. (You may rest after this test, until such time as you feel you have 
regained your breath and can talk normally.) 
4. Grip strength test. 
5. 6-minute walk test. 
 
 
Balance Test - Steady App Instructions 
The Steady App is designed to evaluate your balance and determine your fall 
risk before continuing with the rest of the physical tests. The App can be found 
on the Home screen of the Samsung device you received in your package.  
 
Find a firm, safe, flat area to complete the balance tests. A room with a table or 
shelf at about hip height can be used for support should you feel it may be 
necessary to catch your balance. You may also stand behind the chair you will 
use for some of the remaining tests. Do not do this test on a soft surface like 
grass, or a thick carpet. 
 
1. Open the Steady App  
2. When prompted, 
insert your test subject number (if not sure ask 
the research team) 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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3. Follow the audio instructions on the device as it talks you through 4 
separate balance tests, each taking approximately 30 seconds to 
complete. 
4. When the tests have finished, you will be provided with a fall risk score. 
If 
your score is ≤40, you may continue with the rest of the tests.  
 
General Testing Assistant Instructions 
 
Once the participant has completed the balance tests using the Steady app, if low 
risk for a fall, they will then perform the remaining physical tests. The Camera 
app, located on the home screen of the Samsung Android device will be used to 
film the participant completing each test.  
 
The position you will stand in is slightly different for filming each test so check the 
specific instructions for each test section before you start. 
 
With the Camera app open, you will see a smaller red dot to the left of 
the large white dot in a bar across the bottom of the screen. This is how 
you will start the video. 
 
1. To film the participant performing each test, make sure both you and they are ready to 
begin.  
2. Hold the phone in the vertical position. Make sure you can clearly see the participant in the 
frame of the camera before starting the test. 
3. Start with your finger on the red dot and release the button as you start to count down “3, 2, 
1, GO”. You will begin each test that you film with the same instructions for consistency. 
Note: Do not press the button as you say GO as there will be a 
slight delay at the start of the video and it is important to 
capture the beginning of the test. 
4. To end the test, press the white dot (with a smaller black 
square) in the middle of the bar across the bottom of the 
screen. 
5. Before you perform any of the tests, practice filming a few short clips. 
 
 
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Set up for the 4-meter walk, chair stand, grip strength, and 6-minute walk tests 
First, find a level unobstructed area to complete the 6-minute walk test. This can be a driveway, the 
edge of the road/street outside your home (if not too busy), an open parking area (ideally towards 
the perimeter, where it is not too busy). The space chosen should be safe and firm. Do not 
complete this test on a soft, uneven surface like a lawn or a busy sidewalk where you will be 
interrupted. 
 
1. Hook the loops at the ends of the 15m rope onto the 
weighted markers in the test kit.  
2. Place the weighted anchors (marked with orange 
crosses) in a straight line until the slack is removed 
from the rope. Be careful to not overstretch the rope. 
3. Place a chair perpendicular (at a right angle) to the 
marker at the end of the walking course (close to 
position A). Make sure the chair does not obstruct the 
walking course. You will use this same chair for the sit-to stand tests (chair stands) and to 
provide you with somewhere to sit should you become fatigued or should you need a break 
during the walking test.  
4. You will also perform the grip strength tests while seated in this chair.  
 
 
4-meter Walk Test 
The test will require you to walk at a usual pace for a distance of 4 meters. You will complete 2 sets 
(repeats) of this test. 
 
Testing Assistant Position and Instructions 
As the person filming the test you will want to stand in line with the end 
marker the participant will walk towards. This will be opposite position A. 
From this vantage point, you will follow the participant until they walk past 
the marker at the end of the rope.  
 
To film the test: 
 
5. Open the camera app on the Samsung device.  
6. Make sure the participant is fully viewable in the frame of the screen.  
7. Ask the participant to slowly walk towards the marker at the end of the rope and make sure 
you can follow them through the 4m course. 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Page 110 of 114 
 
8. When you are ready, have the participant start with their toes just behind the 4th mark 
(position B) from the end of the rope.  
9. Remind the participant to walk at a normal/usual pace and to not stop or slow down before 
reaching the end of the rope. 
10. Place your finger on the red dot and release as you start to say “3, 2, 1, GO”. 
11. Repeat the test. 
12. Open the gallery app on the phone and make sure both tests are filmed. 
 
Participant Instructions 
Start with the toes of your feet placed at position B, in line with the 4th mark from the end of the 
rope (4 meters) facing the marker at position A. 
 
 
 
 
 
 
When 
both the 
participant and the person who is videoing the test are ready, have the person filming, start the test 
with “3, 2, 1, GO.” On GO walk towards and past position A, in line with the marker at the end of 
the rope. Walk at a normal pace and do not stop or slow down before reaching the end of the rope. 
Return to the starting position (Position B) and repeat the test for a second time. 
 
 
Chair Stand Test 
The goal of this test is to complete as many chair stands as possible in 30 seconds, but be sure to 
stand up completely and return to a seated position with a straight spine each time. See images 
below for the start and stop positions of each chair stand. 
        
 
Start   
 
    Stop 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Testing Assistant Position and Instructions. 
As the person filming the test you will want to stand perpendicular to the participant so you have 
the same view as in the picture above. From this vantage point, you will film the participant for 
approximately 35 seconds (this allows for the capture of the exact position of the participant at 30 
seconds after the test starts).  
 
To film the test: 
 
1. Open the camera app on the Samsung device.  
2. Make sure the participant is fully viewable in the frame of the screen.  
3. Ask the participant to slowly stand up from seated and make sure they have correct form. 
4. When you are ready, have the participant start with their arms crossed and hands placed on 
their shoulders.  
5. Remind the participant to stand upright completely before returning to the seated position. 
6. Place your finger on the red dot and release as you start to say “3, 2, 1, GO”. 
7. After 35 seconds press the white dot and say “STOP” loudly to end the test. 
8. Open the gallery app on the phone and make sure the test was filmed. 
 
Participant Instructions 
1. Start seated toward the front edge of the chair with your feet shoulder-width and positioned 
behind your knees, and arms folded across your chest (see start stop positions in picture 
above).  
2. You may complete one practice trial, and ask for any corrective feedback as necessary. 
3. When both the participant and the person who is videoing the test are ready, have the 
person filming, start the test with “3, 2, 1, GO.” After they say ‘GO,’ you will stand all the way 
up, and return to the original seated position.  
4. Repeat the stands as many times as you can until you hear the assistant say STOP! 
5. You may stop the test early if you become very tired or short of breath during the repeated 
chair stands. 
6. End your test by returning to the seated position. 
 
 
Grip Strength Test 
The goal of this test is to measure your upper body strength. 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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Testing Assistant Instructions 
It is not necessary to film or photograph this test. 
 
Participant Instructions  
1. To begin with, turn on the device. 
2. Find the user-number you have been designated by pressing the 
up or down arrows and press start. (check with research team 
contact if you are unsure of your number). 
3. Start in the seated position, with your feet hip-width apart, ankles 
vertically below your knees (see picture at right).  
4. Sit upright with the shoulders vertically over your hips. The elbow 
should be tucked in at the side, falling on a line approximately 
halfway between your shoulder and your hips.  
5. Bend the elbow to 90 degrees so your forearm is parallel to the 
tops of the thighs.  
6. Hold the grip dynamometer in your dominant hand, so that your 
thumb is pointing directly up towards the sky. The screen of the device should be facing 
away from the palm of your hand. 
7. When you are ready, squeeze the grip handles as tightly as you can, maintaining the 
position you started in. Repeat 3 times, recording the value for each test. 
8. You may rest for up to 1 minute between each of the 3 attempts. 
9. Switch to the other arm and repeat 3 times. 
 
6-minute walk test 
 
The goal of this test is to walk as fast, but safely, as you can without running for a period of 6 
minutes.  
 
Testing Assistant Position and Instructions 
As the person filming the test you will want to stand in line with the midpoint of the rope about 6-8 
feet back from the rope. From this vantage point, you can follow the participant as they walk 
alongside the rope and around the markers at each end.  
 
To film the test: 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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1. Open the camera app on the Samsung device.  
2. Have the participant start with their toes in line with a marker at the end of the rope (position 
A) facing the other end of the rope.  
3. Make sure the participant is fully viewable in the frame of the screen.  
4. Practice starting the test with “3, 2, 1, GO”, filming as the participant slowly walks one length 
of the course. 
5. Open the gallery app and make sure you are capturing the video accurately as they move 
around the course. 
6. Open the Camera app and remind the participant to walk as fast a pace as possible without 
running and to not stop or slow down before you ask them to STOP. 
7. Place your finger on the red dot and release as you start to say “3, 2, 1, GO”. 
8. You may tell the participant each minute that has passed. 
9. Film the test for 6 minutes and a few seconds (approximately 5 seconds), waiting for the 
participant to complete the length of the course they are on before telling them to stop. 
10. Open the gallery app on the phone and make sure the test was filmed. 
 
Participant Instructions 
1. Start with your feet placed at position A on the diagram facing the opposite marker.  
2. Find the 6WT App on your own device and open it to the screenshot to the 
right.  
3. When the participant and person who is videoing the test are ready, have 
the person filming start the test with “3, 2, 1, GO.” On GO start the test on 
your own device (press the play icon) and place it into your pocket. It will 
automatically stop when the test is over.  
4. Walk as fast but as safely as possible towards and around the marker at 
the end of the rope.  
5. Continue walking until the person filming the test says STOP.  
 

Improving Exercise Capacity with a Tailored Physical Activity Intervention in Lymphoma and Breast 
Cancer Patients Undergoing Treatment – An addendum to NIH R01CA167821 “Early Imaging 
Detection of CV Injury after Cancer” 
Comprehensive Cancer Center of Wake Forest University (CCCWFU - #99112) 
 
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You have completed you tests, well done. If you are tired or unsteady on your feet take a few 
moments to rest. If you are thirsty make sure to hydrate following your tests.