Randomized, Controlled Trial of an Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients
Phase: NA
Conditions: Breast Cancer
Sponsor: Karen Wonders

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 1 of 16 
Revised: September 30, 2017 
 
PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized 
Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
PRINCIPAL INVESTIGATOR: 
Name: Karen Wonders 
Department: Research 
Telephone Number: 937-477-8213 
Email Address Karen.wonders@mapletreecanceralliance.org 
VERSION NUMBER/DATE: 
Version 2.0 
17 January 2020 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
17JAN2020 
Added new method of recruitment (Interest 
Flyer) 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 2 of 16 
Revised: September 30, 2017 
Table of Contents 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives* .............................................................................................................. 4 
3.0 
Background* ............................................................................................................ 4 
4.0 
Study Endpoints* ..................................................................................................... 4 
5.0 
Study Intervention/Investigational Agent ................................................................ 6 
6.0 
Procedures Involved*............................................................................................... 6 
7.0 
Data and Specimen Banking* .................................................................................. 7 
8.0 
Sharing of Results with Subjects* ........................................................................... 7 
9.0 
Study Timelines* ..................................................................................................... 7 
10.0 Inclusion and Exclusion Criteria* ............................................................................ 7 
11.0 Vulnerable Populations* .......................................................................................... 7 
12.0 Local Number of Subjects ....................................................................................... 8 
13.0 Recruitment Methods ............................................................................................... 8 
14.0 Withdrawal of Subjects* .......................................................................................... 8 
15.0 Risks to Subjects* .................................................................................................... 8 
16.0 Potential Benefits to Subjects* ................................................................................ 9 
17.0 Data Management* and Confidentiality .................................................................. 9 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* .......................... 9 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 10 
20.0 Compensation for Research-Related Injury ........................................................... 10 
21.0 Economic Burden to Subjects ................................................................................ 10 
22.0 Consent Process ..................................................................................................... 10 
23.0 Process to Document Consent in Writing .............................................................. 10 
24.0 Setting .................................................................................................................... 10 
25.0 Resources Available............................................................................................... 11 
26.0 Multi-Site Research* ............................................................................................. 11 
 
 
 

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 3 of 16 
Revised: September 30, 2017 
1.0 
Study Summary 
 
Study Title 
Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer 
Patients 
Study Design 
Randomized, controlled trial 
Primary Objective 
The primary objective is to test the effect of an 
individualized exercise oncology program on healthcare 
utilization, 30-day hospital readmission, pain, and cancer 
treatment tolerance.  
Secondary 
Objective(s) 
The secondary objective is to examine the feasibility of an 
individualized exercise oncology program via adherence and 
attrition rates. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Individualized Exercise Oncology Program 
IND/IDE #  
N/A 
Study Population 
Female patients age 18+ newly diagnosed with stage 0, 1 or 
2 breast cancer. 
Sample Size 
70 
Study Duration for 
individual 
participants 
12 weeks 
Study Specific 
Abbreviations/ 
Definitions  
N/A 
 
 

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 4 of 16 
Revised: September 30, 2017 
2.0 
Objectives* 
 
The primary objective is to test the effect of an individualized exercise oncology program 
on healthcare utilization, 30-day hospital readmission, pain, and cancer treatment 
tolerance.  
H1: Among women newly diagnosed with stage 0, 1 or 2 breast cancer, those 
enrolled in an individualized exercise oncology program will have fewer 
emergency room (ER) visits, fewer hospital encounters, fewer 30-day hospital 
readmissions, fewer breaks in cancer treatment, less pain, and better cancer 
treatment tolerance than those in the control group over 3 months.  
The secondary objective is to examine the feasibility of an individualized exercise 
oncology program via adherence and attrition rates. 
H2: Among women newly diagnosed with stage 0, 1 or 2 breast cancer and 
enrolled in an individualized exercise oncology program, adherence to scheduled 
exercise sessions will average 70% or more, and program attrition will average 
70% or less over 3 months. 
3.0 
Background* 
 
In 2018, it was estimated that there were 1.7 million new cancer diagnoses in the 
U.S.1 For all types of cancer, mortality rates are on the decline1, and patients are 
living longer with the chronic and late effects of treatment. This often results in 
costly hospital readmissions and emergency department (ED) visits, leading to 
increased costs, lowered health outcomes, and lengthened stays for patients.2  
 
Several meta-analyses report that exercise interventions are beneficial for patients 
undergoing cancer treatment, in that they reduce symptom severity3 and improve 
cancer-related fatigue4-6, cardiac function7, muscle weakness8, and overall quality 
of life9. Yet, it still remains that less than 5% of patients are ever referred to an 
exercise oncology program during treatment10. Therefore, economic evaluations 
of exercise oncology are warranted, in attempt to evaluate the integration of 
exercise oncology as a standard part of clinical practice.  
 
Maple Tree Cancer Alliance11 has developed an oncology exercise program, 
which results in improved health outcomes, and also cost-saving for facilities and 
payers. Our retrospective data demonstrated that individualized exercise during 
cancer treatment significantly reduced ED visits, 30-day readmissions, and length 
of hospital stays12 resulting in a payer benefit of $3,000/patient over the first 6 
months of enrollment into the Maple Tree Exercise Oncology program2.  As a 
follow up to this research, the purpose of the present study is to prospectively 
analyze the cost savings of an individualized exercise oncology program when 
under a rigorous, randomized, controlled design. We hypothesize that 

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 5 of 16 
Revised: September 30, 2017 
individualized exercise training during cancer treatment will improve treatment 
outcome, lending to a decrease in healthcare-related expenditure. 
 
4.0 
Study Endpoints* 
 
Primary Study Endpoints: 
• Total number of missed fractions, determined via EMR 
• A break in cancer treatment, defined as missing ≥3 fractions due to patient 
condition, determined via EMR 
• ER visits, as determined via EMR 
• Inpatient and outpatient hospital encounters, as determined via EMR 
• Hospital readmission for the same presenting issue, as determined via EMR 
• Hospital length of stay (if hospitalized), as determined via EMR 
• Cancer treatment adherence, determined via EMR 
• Medications for cancer treatment symptom management, determined via EMR 
• Cancer treatment-related side effects, determined via EMR 
• Patient-rated pain measured by visual analog scale, as determined via EMR 
• Cancer treatment tolerance, measured by the Eastern Cooperative Oncology 
Group (ECOG) Performance Status score, as determined via EMR 
• Quality of Life, as measured by the McGill Quality of Life Measure, administered 
in-person at weeks 1 and 12 
(http://www.npcrc.org/files/news/mcgill_quality_of_life.pdf) 
 
Secondary Study Endpoints: 
• Exercise session adherence rate among the Exercise Group, collected from the 
Maple Tree Cancer Alliance participant records. 
• Exercise program attrition rate among the Exercise Group, collected from the 
Maple Tree Cancer Alliance participant records. 
 
Safety endpoints are: 
• Objective worsening lymphedema due to physical activity, as determined by 
treating oncologist 
• Pathologic fracture 
• Recommendation to stop physical activity by treating oncologist 
 
Demographic and Baseline Clinical Characteristics: 
• Age, as determined via electronic medical record (EMR) 
• Diagnosis and diagnostic stage, as determined via EMR 
• Diagnosis Date, as determined via EMR 
• Body mass index, as determined by height and weight in EMR 
• Comorbid chronic conditions (hypertension, diabetes, COPD), as 
determined via EMR 
• Race/ethnicity, as determined via EMR 
 
 

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 6 of 16 
Revised: September 30, 2017 
 
5.0 
Study Intervention/Investigational Agent 
 
Exercise Group 
 
The study intervention is a supervised, individualized exercise oncology program 
described in previous literature2,3,12 and provided by Maple Tree Cancer Alliance, a non-
profit organization providing exercise training to individuals with cancer 
(https://www.mapletreecanceralliance.org/). This organization was founded in 2011 and 
currently operates in 9 hospitals serving Ohio and Pennsylvania, offering free exercise 
programs and nutritional guidance to approximately 500 patients annually to help relieve 
side effects related to cancer treatment.  
 
Patients in the supervised, individualized exercise oncology program (Exercise Group) 
will complete a 60-minute exercise session once per week for 12 weeks at Maple Tree 
Cancer Alliance. The exercise sessions will be individualized to the patient’s needs and 
fitness level by a trainer with a bachelor’s degree in exercise science and a national 
certification for exercise oncology. A patient will work with the same trainer throughout 
the study, who will plan the patient’s individualized exercise regimen, and who will 
provide one-on-one supervision for the duration of each 60-minute session. Each 60-
minute session will include cardiovascular, strength, and flexibility training. 
Cardiovascular exercise will be performed on a treadmill. The intensity level for the 
aerobic exercise ranges from 30-45% of the individual’s predicted VO2max, controlled by 
heart monitors (model S810i; Polar Electro) and lasting 30 min. Strength training will 
involve a full body workout, with emphasis on all major muscle groups and employing 
machines, free weights, and resistance tubing. Patients will complete 3 sets of 10 
repetitions for each strength exercise. Flexibility training will involve static stretching of 
all major muscle groups for 15-20 seconds at the completion of each workout.  
 
Control Group 
The control group will receive the current standard of care, which includes a resource 
guide with various options available to the cancer survivor. Within this guide are tips for 
healthy eating and pictures of standard exercises to improve fitness.   
 
 
6.0 
Procedures Involved* 
 
The study design is an open-label, randomized, controlled, parallel-group trial. Women 
age 30-80 with a recent diagnosis of stage 0, 1 or 2 breast cancer who meet inclusion and 
exclusion criteria will be invited to participate. As is typical and customary, a diagnosis 
within the last 12 weeks will be considered a recent diagnosis. Upon study enrollment 
and informed consent, patients will be randomly assigned to the Exercise Group or the 
Control Group. Random assignment will be conducted in blocks of 10 to ensure equal 
groups (See Appendix A). Participants will be enrolled in the study for 12 weeks.  
 
 

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 7 of 16 
Revised: September 30, 2017 
 
7.0 
Data and Specimen Banking* 
 
N/A 
 
8.0 
Sharing of Results with Subjects* 
 
Most study parameters come from the EMR; patients have ready access to these data. The 
information collected outside the EMR includes quality of life (all patients) and exercise 
session adherence rate (Exercise Group). The Exercise Group will also receive reports on 
their cardiovascular, strength, and flexibility assessments. 
 
9.0 
Study Timelines* 
Patient recruitment will begin after IRB approval is obtained. Each patient will be 
enrolled in the study for 12 weeks. Study enrollment is expected to take place 
over approximately 6 months, until 70 patients are enrolled. When 70 patients 
have been enrolled, enrollment will close, and active subjects will be followed for 
the remainder of their 12 week participation. Once all patients have completed the 
study, data will be abstracted from the EMR and analyzed within 12 months. 
10.0 Inclusion and Exclusion Criteria* 
Patients will be selected according to the Consolidated Standard of Reporting 
Trials criteria. Criteria not determined via EMR are determined via the form in 
Appendix B. Inclusion criteria are:  
• Female; determined from electronic medical record 
• Initial stage 0, 1 or 2 breast cancer diagnosis within the past 12 weeks 
determined from electronic medical record 
• Age 30-80; determined from electronic medical record  
• Physician clearance to participate in exercise 
 
Exclusion criteria are: 
• Participation in supervised physical exercise within 6 months prior to 
study enrollment 
• Currently pregnant or planning to become pregnant 
• Non-English speaking 
• Unable to make own medical decisions and/or to follow verbal 
instructions 
 
11.0 Vulnerable Populations* 
N/A 

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 8 of 16 
Revised: September 30, 2017 
 
 
 
 
12.0 Local Number of Subjects 
A total of 70 subjects will be enrolled (35 in each study group). This sample size 
provides 80% power to detect a medium effect size in number of missed treatment 
fractions between study groups. Only subjects who meet eligibility criteria will be 
enrolled.  
 
13.0 Recruitment Methods 
13.1 Eligible patients will be contacted in person when they are at KMC 
or Soin MC for regular appointments. If in-person appointments are 
not convenient times, patients may be contacted by phone by the 
research coordinator. 
13.2 The research coordinator will attend breast tumor conferences to 
identify eligible patients and seek physician approval to approach the 
patients about study participation. 
13.3 A printed Interest Form will be provided to patients in their initial 
Breast Cancer Journey packets and during the Breast Cancer Class.  
13.4 The subjects will not receive compensation for their participation in 
the study. 
14.0 Withdrawal of Subjects* 
 
Any study patient who experiences a safety endpoint under section 4.0, including 
recommendation to stop physical activity by treating oncologist, will be withdrawn from 
the study. Final, non-physical activity measures will be collected on patients who are 
withdrawn.  
 
As Maple Tree provides free services to patients undergoing cancer treatment, a patient 
withdrawn from the study for safety reasons could, at a later date and when it is deemed 
safe by her physician, again receive exercise services at Maple Tree (outside the study 
context). 
 
15.0 Risks to Subjects* 
The risks associated with the study intervention are commensurate with light to 
moderate physical activity, such as muscle soreness. Given the low-impact nature 
of the exercise and the one-on-one supervision during exercise sessions, the risk 
of injury or another adverse outcome is very low. Participants in the Exercise 
Group will have an exercise program individualized to their needs and physical 
abilities, and participants will be closely monitored during exercise sessions. The 

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 9 of 16 
Revised: September 30, 2017 
study will not be blinded; patients and treating physicians will be aware of group 
status and if the treating oncologist recommends the subject stop physical activity, 
the subject will be withdrawn from the study. 
The Exercise Group may incur some travel costs to attend exercise sessions. 
No psychological, social, or legal risks are anticipated.  
16.0 Potential Benefits to Subjects* 
Participants in the exercise intervention may experience reduced pain and relief 
from other effects of cancer treatment, thus reducing breaks in treatment and 
hospital or ER visits. Participants may also experience improved energy and 
mood and may establish a positive behavioral pattern of physical activity that will 
extend beyond the study. 
 
17.0 Data Management* and Confidentiality 
 
Data Management: 
All study parameters from the EMR will be downloaded by an EMR specialist via a 
report, de-identified, and housed in a Microsoft Excel database. Patient forms, including 
consent forms, will be stored in a locked file cabinet at Maple Tree Cancer Alliance. All 
patients will be assigned a Study ID number and a list linking patient names to Study ID 
number will be kept separately from the study data, on a password-protected computer. 
Data from patient forms will be entered into the master Microsoft Excel spreadsheet. 
Only Study ID will be used to identify patients in the spreadsheet. 
 
Data Analysis Plan: 
Data will be analyzed using IBM SPSS Statistics version 25.0. Continuous variables will 
be described using mean, median, standard deviation, and range. Nominal variables will 
be described using frequency and percentage.  
 
Baseline demographic and clinical characteristics will be compared between treatment 
and control groups to establish equivalence; any statistically significant differences 
between study groups will be controlled statistically. Continuous endpoints will be tested 
for normality using Shapiro-Wilk tests. Differences between study groups on continuous 
endpoints will be evaluated using independent samples t-tests for normally distributed 
endpoints and Mann-Whitney U tests for non-normally distributed endpoints. Nominal 
endpoints will be compared between groups using chi-square tests. Alpha will be set to 
.05, two-tailed for all tests. 
 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
 
N/A; The probability of harm or discomfort anticipated in this study are no greater than 
those encountered in daily life or during the performance of routine physical or 
psychological tests.  

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 10 of 16 
Revised: September 30, 2017 
 
 
 
19.0 Provisions to Protect the Privacy Interests of Subjects 
 
Subject identifiers will only be included in the master list linking subjects to their Study 
ID (Appendix C). Subjects in the Control Group will receive standard care, including 
usual privacy standards. Subjects in the Exercise Group will interact with the same trainer 
throughout the study, so that rapport can be developed, putting the subject at ease. All 
exercise activities will be individually tailored to the subject’s needs. 
To access data from the subjects’ electronic medical records, a request will be sent to 
Information Systems (IS).  Once received, identifiers will be replaced with Study ID 
number. 
 
20.0 Compensation for Research-Related Injury 
 
N/A; The study does not involve more than minimal risk. 
 
21.0 Economic Burden to Subjects 
 
Subjects in the Exercise Group may incur costs associated with once weekly travel to 
Maple Tree Cancer Alliance. No other study-related costs to subjects are expected. 
 
22.0 Consent Process 
All patients will be fully informed about the study and will have time to ask 
questions and consider their decision to participate. A research intern for Maple 
Tree Cancer Alliance, Kara Gnau, will provide a written informed consent form to 
eligible patients and meet with them in person to discuss the study in a private 
room at the Kettering Cancer Center or the Soin Cancer Center. Patients will be 
provided with the informed consent form and the intern will go through the 
information in the form with the patient. Patients will be invited to take the form 
home and talk with family and friends before deciding if they would like to 
participate. If patients wish to take some time to make the decision, they may 
inform the intern about their decision to participate or decline participation via 
phone. 
23.0 Process to Document Consent in Writing 
 
Participants will document consent to participate using the consent form in Appendix D. 
 
24.0 Setting 
 
Subjects will be recruited from patient populations at Kettering and Soin Cancer Centers 
and identified through presentation at breast tumor conferences held at these facilities 
(see Section 13.0). For the Exercise Group, exercise will occur at Maple Tree Cancer 

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 11 of 16 
Revised: September 30, 2017 
Alliance as described in Section 5.0. For the Control Group, all research activities will 
entail usual care at standard treatment locations. Treatment decisions for both groups are 
independent of study participation. 
 
25.0 Resources Available 
 
The study team has adequate resources to execute this study in a timely manner. 
 
26.0 Multi-Site Research* 
 
Not applicable. 
 

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 12 of 16 
Revised: September 30, 2017 
References 
 
1. National Institutes of Health: National Cancer Institute.  
https://www.cancer.gov/about- cancer/understanding/statistics. December 2018. 
2. Wonders, K.Y., Wise, R., Ondreka, D., Gratsch, J. (in press). Cost Savings Analysis of 
Individualized Exercise Oncology Programs. Integrative Cancer Therapies. 
3. Wonders KY, Wise R, Ondreka D. Supervised, individualized exercise mitigates 
symptom severity during cancer treatment. J Adeno & Osteo. 2018;3(1):1-5. 
4. Velthuis MJ, Agasi-Idenburg SC, Aufdemkampe G, Wittink HM.The effect of physical 
exercise on cancer-related fatigue during cancer treatment: a meta-analysis of 
randomised controlled trials. Clin Oncol (R Coll Radiol). 2010; 22(3):208-21. 
5. Cramp F, Byron-Daniel J. Exercise for the management of cancer-related fatigue in 
adults. Cochrane Database Syst Rev 2012;(11):CD006145  
6. Fong DY, Ho JW, Hui BP et al. Physical activity for cancer survivors: meta-analysis of 
randomized controlled trials. BMJ 2012;344:e70. 
7. Wonders KY, Reigle BS. Trastuzumab and doxorubicin-related cardiotoxicity and the 
cardioprotective role of exercise. Integrative Cancer Therapies. 2009;8(1): 17-21.  
8. Wonders, KY, Jennings, J, & Smith, K. A comprehensive cancer care plan: Examining 
the role of exercise, nutrition, and emotional support in cancer recovery. Journal of 
Palliative Care and Medicine; 2012;S1:003 
9. Huether K, Abbott L, Cullen L, Cullen L, Gaarde A. Energy through motion: an 
evidence-based exercise program to reduce cancer-related fatigue and improve 
quality of life. Clinical Journal Of Oncology Nursing. 2016;20(3), E60-E70.  
10. Smith SR, Zheng JY. The Intersection of Oncology Prognosis and Cancer 
Rehabilitation. Curr Phys Med Rehabil Rep. 2017;5:46-54. 
11. See https://www.mapletreecanceralliance.org/ 
12. Wonders, K. (2018). Supervised, Individualized Exercise Programs Help Mitigate 
Costs during Cancer Treatment. J Palliat Care Med 8:338. 
 
 

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 13 of 16 
Revised: September 30, 2017 
Appendix A: Randomization Scheme using Block Size of 10 
 
Subject 
Study Group Assignment 
1 
Control 
2 
Exercise 
3 
Exercise 
4 
Exercise 
5 
Control 
6 
Control 
7 
Control 
8 
Control 
9 
Exercise 
10 
Exercise 
11 
Exercise 
12 
Control 
13 
Control 
14 
Control 
15 
Exercise 
16 
Exercise 
17 
Control 
18 
Control 
19 
Exercise 
20 
Exercise 
21 
Control 
22 
Exercise 
23 
Exercise 
24 
Control 
25 
Exercise 
26 
Exercise 
27 
Control 
28 
Control 
29 
Exercise 
30 
Control 
31 
Exercise 
32 
Exercise 
33 
Control 
34 
Control 
35 
Exercise 
36 
Control 
37 
Control 
38 
Exercise 
39 
Exercise 
40 
Control 
41 
Exercise 
42 
Control 

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 14 of 16 
Revised: September 30, 2017 
43 
Exercise 
44 
Exercise 
45 
Exercise 
46 
Control 
47 
Control 
48 
Exercise 
49 
Control 
50 
Control 
51 
Exercise 
52 
Exercise 
53 
Exercise 
54 
Control 
55 
Control 
56 
Control 
57 
Control 
58 
Exercise 
59 
Exercise 
60 
Control 
61 
Control 
62 
Control 
63 
Exercise 
64 
Exercise 
65 
Control 
66 
Exercise 
67 
Control 
68 
Exercise 
69 
Exercise 
70 
Control 
 
 
 
 
 

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise 
Oncology Program for Newly Diagnosed Breast Cancer Patients 
 
Page 15 of 16 
Revised: September 30, 2017 
Appendix B 
Randomized, Controlled Trial of an Individualized Exercise Oncology 
Program 
 
Determination of eligibility (to be completed by Maple Tree Cancer Alliance 
research intern) 
 
Patient Name ____________________________________ 
 
 
 
Is the patient female, as determined from electronic 
medical record? 
 Yes 
 No (Ineligible) 
 
Does the patient have an initial stage 1 or 2 breast 
cancer diagnosis within the past 12 weeks, 
determined from electronic medical record? 
 
 Yes 
 No (Ineligible) 
 
Is the patient age 30-80, determined from electronic 
medical record? 
 Yes 
 No (Ineligible) 
 
Does the patient have documented physician 
clearance to participate in exercise? 
 
 Yes 
 No (Ineligible) 
Has the patient participated in supervised 
physical exercise within the past 6 months? 
 
 Yes (Ineligible) 
 No 
Is the patient currently pregnant or planning to 
become pregnant? 
 
 Yes (Ineligible) 
 No 
Does the patient speak and read English fluently? 
 Yes 
 No (Ineligible) 
 
Is the patient able to make their own medical 
decisions and to follow verbal instructions? 
 
 Yes 
 No (Ineligible) 
 
 

PROTOCOL TITLE: Randomized, Controlled Trial of an Individualized Exercise Oncology Program for Newly Diagnosed Breast 
Cancer Patients 
 
Page 16 of 16 
Revised: September 30, 2017 
Appendix C: Master list linking patients to Study ID and documenting study participation for CONSORT reporting 
 
Patient Last Name 
Patient First Name 
Date Assessed 
for Eligibility 
(mm/dd/yyyy) 
Excluded? 
(Y/N) 
If Excluded, reason (did not 
meet eligibility criteria, 
declined to participate, other) 
Study ID (N/A 
for those 
excluded) 
Random 
Assignment 
(Exercise Group, 
Control Group) 
  
  
  
  
  
1 
  
  
  
  
  
  
2 
  
  
  
  
  
  
3 
  
  
  
  
  
  
4 
  
  
  
  
  
  
5 
  
  
  
  
  
  
6 
  
  
  
  
  
  
7 
  
  
  
  
  
  
8 
  
  
  
  
  
  
9 
  
  
  
  
  
  
10 
  
  
  
  
  
  
etc.