Clinical trial: NCT03280836
Section: Confidentiality
Subsections: 7. How Will You Protect My Privacy And Confidentiality If I Decide To Take Part In This Research Study?|7A. What Happens To The Information Collected For The Research?|7B. How Will My Identifiable Health Information Be Used?

Your blood tubes will be labeled with your subject ID number, and surveys will be coded with your subject ID number. Your clinical data we obtain will have your name and date of birth on it.

Efforts will be made to limit the use and sharing of your personal research information. In our research files at The Milton S. Hershey Medical Center (HMC) and Penn State College of Medicine (PSU) we will  
include these identifiers your name, address, phone number, email address, date of birth, medical record number, a code number A list that matches your name with your subject ID number will be kept in a locked file in Dr.  
Schmitz's office.  
Your research records will be labeled with subject ID number and will be kept in a safe area in Dr.  
Schmitz's research office.  
Your research samples will be labeled with your subject ID number and will be stored in our freezers in a passcode protected laboratory.  
Results of some of the research-related tests (including but not limited to your echocardiogram following chemotherapy, will be kept in your HMC medical record.
In the event of any publication or presentation resulting from the research, no personally identifiable information will be shared.

If you give your consent, health information that can be traced to you will be collected for this research study. In general, under federal law, health information is private. However, there are exceptions to this rule, and you should know who may be able to see, use, and share your health information for research and why they may need to do so. We will use and disclose your information only as described in this form and in the HMC Privacy Notice.  
The research team may use the following health information:
Past, present, and future medical records New health information from tests, procedures, visits, interviews, or forms filled out as part of this research study.  
The following people/groups may see, use, and share your identifiable health information:
HMC/PSU research staff involved in this study The HMC/PSU Institutional Review Board (IRB), a group of people who review the research study to protect subjects' rights and welfare The HMC/PSU Human Subjects Protection Office The HMC/PSU Research Quality Assurance Office Non-research staff within HMC/PSU who need this information to do their jobs (such as for treatment, payment (billing), or health care operations)
Federal and state agencies (such as the U.S. Food and Drug Administration, the Office for Human Research Protections, the Department of Health and Human Services, the National Institutes of Health (NIH), and other U.S. or foreign government bodies that oversee or review research)
The NRG Oncology Foundation and the National Cancer Institute (NIH) that oversees the data and safety of this research
These groups may also review and/or copy your original PSU/HMC records while looking at the results of the research study. It is possible that some of the other people/groups who receive your health information may not be required by Federal privacy laws to protect your information. We share your information only when we must, and we ask anyone who receives it from us to protect your privacy. Because research is an ongoing process, your permission for the use, storage and sharing of your health information will continue indefinitely.
Clinical trial: NCT03280836
Section: Duration of Study Involvement
Subsections: 6. How Long Will I Take Part In This Research Study?

If you agree to take part, it will take you about 8 months to complete this research study. You will be asked to return to the research site 0-2 times depending on your schedule. We will make every effort to link research activities to clinical visits to limit the requirement to come to the Medical Center specifically for study activities.  
Baseline testing: Exercising testing and the exercise education session (if randomized to exercise group).  
~ 1hr addition for exercise testing (all participants)
~ 1hr addition for exercise education session (*if randomized to exercise group*)  
Final testing: Exercise testing and the exercise education session (if randomized to control group),
echocardiogram (which is only for research and not part of clinical care, if HER2(-)).  
~2 hrs for echocardiogram and exercise testing (all participants)
~1 addition for exercise education session (*if randomized to control group*)
Surveys will be administered while you are at your infusion session. Blood draws will be obtained when you go for clinical laboratory testing.
Clinical trial: NCT03280836
Section: Participant's Rights
Subsections: Your Privacy Rights:|11. What Are My Rights If I Take Part In This Research Study?

You have the right to refuse to sign this form that allows us to use and share your health information for research; however, if you don't sign it, you will not be able to take part in this research study.  
You have the right to withdraw your permission for us to use or share your health information for this research study. If you want to withdraw your permission, you must notify the person in charge of this research study in writing using the address on the front of this form. Once permission is withdrawn, you cannot continue to take part in the study.  
If you withdraw your permission, we will stop collecting health information about you for this study; we may continue to use and share your health information that we already have if it is necessary for safety and scientific soundness of the research study; and we will not be able to take back information that has already been used or shared with others.  
You have the right to see and get a copy of your health information that is used or shared for treatment or for payment. However, you may not be allowed to see or copy certain health information that is a part of this research study. This is only for the period of the study. You will be allowed to see that information when the entire research study is complete.

Taking part in this research study is voluntary.  
You do not have to be in this research.  
If you choose to be in this research, you have the right to stop at any time. If you decide not to be in this research or if you decide to stop at a later date, there will be no penalty or loss of benefits to which you are entitled.
If you stop being in the research, already collected data may not be removed from the study database. You will be asked whether the investigator can collect medical information from your routine medical care. If you agree, this data will be handled the same as research data. If you withdraw completely from the research study, no further information will be collected and your participation will end. You may discontinue taking part at any time without penalty or loss of benefits to which you are otherwise entitled. Dr. Schmitz may take you out of the research study without your permission.  
Some possible reasons for this are: continuing the research would be harmful, you did not follow the instructions of the study doctor, you experience serious side effects.  
If your participation ends early, you may be asked to visit the research doctor for a final visit.
During the course of the research you will be provided with any new information that may affect your health, welfare or your decision to continue participating in this research.
Clinical trial: NCT03280836
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 3. What Are The Risks And Possible Discomforts From Being In This Research Study?|The Known Foreseeable Risks And/Or Discomforts To The Study Participant|4. What Are The Possible Benefits From Being In This Research Study? 4A. What Are The Possible Benefits To Me?|8B. What Happens If I Am Injured As A Result Of Taking Part In This Research Study?

There is a risk of loss of confidentiality if your information or your identity is obtained by someone other than the investigators, but precautions will be taken to prevent this from happening. The confidentiality of your electronic data created by you or by the researchers will be maintained to the degree permitted by the technology used. Absolute confidentiality cannot be guaranteed.

Risks of exercise testing The risk of maximal cardiopulmonary exercise testing is approximately 1 nonfatal event in 10,000 maximal treadmill tests and only 1 fatal cardiac complication in over 70,000 maximal exercise tests. Major complications of exercise testing include death, myocardial infarction (heart attack), arrhythmia (irregular heart beat), fatigue, hemodynamic instability (fluctuations in heart rate, blood pressure, breathing) and orthopedic injury (injury to muscle, tendons, bone, etc). Skin irritation may occur at the sites where electrodes were placed.  
Risks of exercise training The risk of an exercise training induced cardiac event (heart attack, irregular heart beat) is 2 nonfatal cardiac events in 375,000 subject hrs of exercise, or about 1 event per 1.7 million walk/jogging miles, based on a large Dallas, TX physical activity center study. Further risks of the exercise intervention include: muscle pain, muscle strains/sprains, joint pains (such as hip, knee, ankle or foot pain), fatigue, and risk of fall resulting in trauma/fracture.  
Risks of echocardiography There are no serious risks associated with transthoracic echocardiography. It is possible that subjects may experience mild, temporary discomfort from the ultrasound probe being pressed against the chest or from lying down during the additional imaging.  
Risks for surveys There are no medical risks associated with filling out surveys; however a woman may become uncomfortable providing personal information. Any questions that make you uncomfortable can be skipped.  
Risks of standard venipuncture The discomfort associated with removing blood by venipuncture (by needle from a vein) is a slight pinch or pin prick when the sterile needle enters the skin. The risks include mild discomfort and/or a black and blue mark at the site of puncture. Less common risks include a small blood clot, infection or bleeding at the puncture site, and on rare occasions fainting during the procedure. No additional blood draws will be done outside of standard clinical care. If any important new information about the study develops that may affect your health, welfare, or willingness to stay on the study, your study doctor will tell you. You may be asked to sign another consent form at that time.

There is no guarantee that you will benefit from this research. The possible benefits you may experience from this research study include decreasing your risk for cardiovascular disease and increasing your physical fitness.

It is possible that you could develop complications or injuries as a result of being in this research study. If you experience a side effect or injury and emergency medical treatment is required, seek treatment immediately at any medical facility. If you experience a side effect or injury and you believe that emergency treatment is not necessary, you should contact the principal investigator listed on the first page of this consent form as soon as possible and the principal investigator will arrange for medical treatment.  
HMC/PSU compensation for injury There are no plans for HMC/PSU to provide financial compensation or free medical treatment for research-related injury.  
If an injury occurs, medical treatment is available at the usual charge.  
Costs will be charged to your insurance carrier or to you. Some insurance companies may not cover costs associated with research injuries.  
If these costs are not covered by your insurance, they will be your responsibility.
Clinical trial: NCT03280836
Section: Procedures
Subsections: 2. What Will Happen In This Research Study?|What Is The Exercise Intervention:|What Does The Control Group Do:

Allowing us to utilize your breast tissue taken during your clinical biopsy and also your clinical surgical resection. No extra tissue will be taken for research purposes.  
Allowing us to utilize the images taken during your clinical breast MRI procedures. Allowing us to utilize the images taken during your clinical echocardiogram(s).  
Allow us to collect information from your electronic medical record related to your breast cancer diagnosis.  
Allowing us to take 2 extra tubes of blood (about 1 tablespoon) during a routine clinical blood draw before, at the midpoint, and following neoadjuvant chemotherapy. The blood samples will be used to look at various proteins and markers of inflammation.
Completing surveys during your first, midpoint, and final neoadjuvant chemotherapy infusion which are not part of your clinical care. These surveys include:  
o Leisure time exercise activity-to assess how often you are exercising during your free time o Fatigue-to gain a better understanding of impact of fatigue on your daily life o Health-to gain a better understanding of overall health and how well you feel o Work productivity and activity impairment-to assess effect of your health problems on your ability to work and perform regular activities Completing an exercise test before and after neoadjuvant chemotherapy, this is not part of your clinical care.  
Completing an educational session with regard to exercise and safety, which is not part of your clinical care.  
For women with HER2(-) tumors (i.e. not receiving Herceptin therapy): completing an echocardiogram after chemotherapy that is not part of standard of care.  
If randomly assigned to the exercise intervention (there is a 50% chance you could be assigned to the exercise group):
o You will be asked to complete the exercise intervention with 80% or greater adherence.  
If randomly assigned to the control group (there is a 50% chance you could be assigned to the control group):
o We ask that you do not start an exercise program.

-*If you are randomized* to the exercise intervention group, you will receive a three DVDs and an exercise binder prior to your chemotherapy.  
-You will also receive a Polar Heart Rate monitor; the monitor will guide you in attaining the appropriate exercise intensity for you personally.  
-You will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout.  
-You will be instructed to bring the workout logs to your infusion session for review with the staff exercise physiologist. The exercise physiologist will then provide ongoing support and monitoring of adherence in person at infusion sessions and via phone approximately once per week.  
-*You will work towards the goal of 75+ minutes per week of moderate to vigorous exercise.*
-Weeks 1-2:
20 minute sessions 3 days per week, at mild intensity
-Weeks 3-4:
25 minute sessions 3 days per week, at mild intensity
-Weeks 5-11:
25 minute sessions 2 days per week, at mild intensity 25 minute session 1 day per week, at moderate intensity
-Weeks 12-24:
25+ minute sessions 2 days per week, at mild to moderate intensity 25+ minute session 1 day per week, at vigorous intensity

-You will be asked to maintain your usual level of physical activity and not to engage in any new exercise program during the study. We will contact you at infusion sessions or via phone to inquire about your experience and well-being during treatment. -You will receive the DVDs and exercise binder after completing all study activities AND your surgical oncologist has cleared you for exercise following your surgical resection.  
  
icology visit
Version Date: 12/20/18  
What are my responsibilities if I take part in this research? If you take part in this research, your major responsibilities will include:
coming to the scheduled appointments having the required testing & procedures completing the exercise prescribed to you (if randomized to the exercise group)
Clinical trial: NCT03280836
Section: Purpose of Research
Subsections: 1. Why Is This Research Study Being Done?

You are being asked to participate in this research study because you are patient of the Penn State Hershey Medical Center and have decided to undergo neoadjuvant chemotherapy for breast cancer. The primary purpose of this study is to determine whether breast cancer patients can be enrolled, randomly assigned (like a flip of a coin) to a control or exercise group, and comply with 6 months of aerobic (walking/jogging) exercise training. Additionally, we seek to compare changes in clinical blood tests, fitness level, heart function, quality of life, and tumor response (tumor size) in exercisers vs. control. You will be one of 20 patients in this study.
Clinical trial: NCT03280836
Section: Voluntary Participation
Subsections: Signature Of Person Obtaining Informed Consent|Signature Of Person Obtaining Informed Consent|Signature Of Subject|Signature Of Person Obtaining Informed Consent|Signature Of Person Obtaining Informed Consent|Signature Of Person Giving Informed Consent Signature Of Subject

Your signature below means that you have explained the research to the subject or subject representative and have answered any questions he/she has about the research. ______________________________ __________ ______ ________________ Signature of person who explained this research Date Time Printed Name (Only approved investigators for this research may explain the research and obtain informed consent.) Signature of Person Giving Informed Consent and Authorization Before making the decision about being in this research you should have:
Discussed this research study with an investigator, Read the information in this form, and Had the opportunity to ask any questions you may have.  
Your signature below means that you have received this information, have asked the questions you currently have about the research and those questions have been answered. You will receive a copy of the signed and dated form to keep for future reference.

Your signature below means that you have explained the optional part(s) to the research to the subject or subject representative and have answered any questions he/she has about the research.  
______________________________ _________ _____ ________________ Signature of person who explained this research Date Time Printed Name

By signing this consent form, you indicate that you voluntarily choose to be in this research and agree to allow your information to be used and shared as described above.  
___________________________ __________ ______ ________________  
 Signature of Subject Date Time Printed Name

Your signature below means that you have explained the research to the subject or subject representative and have answered any questions he/she has about the research. ______________________________ __________ ______ ________________ Signature of person who explained this research Date Time Printed Name (Only approved investigators for this research may explain the research and obtain informed consent.) Signature of Person Giving Informed Consent and Authorization Before making the decision about being in this research you should have:
Discussed this research study with an investigator, Read the information in this form, and Had the opportunity to ask any questions you may have.  
Your signature below means that you have received this information, have asked the questions you currently have about the research and those questions have been answered. You will receive a copy of the signed and dated form to keep for future reference.

Your signature below means that you have explained the optional part(s) to the research to the subject or subject representative and have answered any questions he/she has about the research.  
______________________________ _________ _____ ________________ Signature of person who explained this research Date Time Printed Name

By signing below, you indicate that you have read the information written above and have indicated your choices for the optional part(s) of the research study.  
| Signature of Subject   | Date   | Time   | Printed Name   |
|------------------------|--------|--------|----------------|