Clinical trial: NCT03345420
Section: Alternatives
Subsections: Alternative Procedures

You may choose not to take part in this study and discuss other treatment options and their related benefits and risks with your study doctor.  
Some other things you might do are:
- Use other approved radiation regimens.  
- Use other investigational treatments.  
- Get supportive care.  
- Choose to have no further treatment.
Clinical trial: NCT03345420
Section: Confidentiality
Subsections: Authorization For Use Of Your Protected Health Information

Signing this document means you allow us, the researchers in this study, and other working with us to use some information about your health for this research study.  
This is the information we will use and include **in our research records:**
- Demographic and identifying information like your name, address, telephone number, and email address.  
- Related medical information about you like family medical history, allergies, current and past medications or therapies, information from physical examinations such as blood pressure readings, heart rate, temperature, and lab results.  
- All tests and procedures that will be done in the study How we will protect and share your information:
We will do everything we can to keep you information private, but we cannot guarantee this. The research records will be kept in a secured manner and computer records will be password protected. We may need to disclose information about you as required by law.  
Study information may be stored with other information in your medical record. Other doctors, nurses, and third parties (like insurance companies) may be able to see this information as part of the regular treatment, payment, and health care operations of the hospital.  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S.  
Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.  
In order to conduct this study and make sure it is conducted as described in this form, the research records may be used and reviewed by others who are working with us on this research:
- Members of the research team and University of Utah Health Sciences Center
- The University of Utah Institutional Review Board (IRB), who reviews research involving people to make sure the study protects your rights;
- Government agencies responsible to confirm research accuracy such as the United States Food and Drug Administration (FDA), and the National Cancer Institute (NCI) which is a part of the National Institute of Health (NIH)  
| University of Utah                                                         |
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Treatment Consent Consent Version: 10AUG2018 Previous Version: 08JUN2018 If we share your identifying information with groups outside of the University of Utah Health Sciences Center, the groups may not be required to follow the same federal privacy laws that we follow. They may also share your information again with others not described in this form. During your screening visit and following radiation therapy, photographs (digital images) will be taken of your breasts to document the physical appearance of the breast. If you have a tattoo(s), your tattoo(s)
may be included and visible in the photographs (digital images). Tattoos may be considered unique and identifiable, so the photographs (digital images) of your tattoo(s) may identify you in pictures. However, the photographs will be taken from the neck down and will not include your face.
Clinical trial: NCT03345420
Section: Duration of Study Involvement
Subsections: Treatment Period|Follow-Up|How Long Will I Be In The Study?

If the exams, tests and procedures show that you can be in the study and you choose to take part you will be enrolled and start radiation therapy. This radiation is considered standard of care and would be done even if you were not participating in this study.  
Before you begin radiation, you will have the following procedures done:
- You will complete questionnairesthat ask you some questions about your quality of life and about your breasts and your cancer treatments.  
- Photographic cosmetic assessment. The study doctors want to know how the radiation treatment affects the physical appearance of the breast. This will be done by taking photographs of both breasts before you begin treatment and again 24 months after treatment. The photographs will be taken from the neck down and will not include your face.  
- You will have a CT (Computerized Tomography) scan of the breast that had the cancer to help plan the radiation therapy. This scan is considered standard of care and would be done even if not participating in this study.  
Once you begin radiation therapy on study, you will do the following every week:
- Physical exam if necessary - An evaluation of your ability to perform everyday activities (performance status)
- Evaluation of any side effects
- You will also be asked to complete a diary about your health care expenses. This is optional.
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| University of Utah                                                         |
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- 2-8 weeks after completing radiation therapy:
o Physical exam if necessary o Evaluations of your ability to perform everyday activities (performance status)
o Evaluation of any side effects o You will complete a questionnaire (Health Care Expense Survey) that asks you some questions about your work status and costs of treatment (to help determine cost effectiveness).  
o You will complete questionnaires that ask you some questions about your quality of life and about your breasts and your cancer treatments.  
- 6 months after completing radiation therapy:
o Physical exam if necessary o Evaluations of your ability to perform everyday activities (performance status)
o Evaluation of any side effects o Quality of life and breast questionnaire
- Then at years 1, 2 and 3:
o Physical exam if necessary o Evaluations of your ability to perform everyday activities (performance status)
o Evaluation of any side effects o Quality of life and breast questionnaire (year 2 only) o Photographic cosmetic assessment (year 2 only)

You will be in the study for up to 5 years. The radiation therapy will take approximately 2 weeks to complete. Follow-up visits will be scheduled around 1 month, then 6 months, and then yearly from the end of radiation therapy. After 3 years, you will have completed the study visits; however, the study doctor will continue to review your medical record to check the status of your disease for up to 5 years.
Clinical trial: NCT03345420
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Risks And Side Effects Related To Radiation Therapy: Likely|Reproductive Risks|Other Risks And Inconveniences|Research-Related Injury

These side effects occur in 10% or more of patients:
- Reddening of the skin during treatment and for several weeks following treatment
- Tanning of the skin lasting months and may be permanent
- Slightly smaller breast size or change in the way the breast looks
- Mild thickening or firming of the breast on touch - Tiredness and weakness during treatment and for several weeks following treatment
- Swelling of breast
- Peeling of the skin in the area treated with radiation FOOTER FOR IRB **USE ONLY**
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| University of Utah                                                         |
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| Institutional Review Board Approved 4/5/2023 Expires 4/4/2024 IRB_00103976 |  
  
- Mild pain at the site of radiation treatment requiring over the counter pain relievers Less likely These side effects occur in 3–9% patients:
- Soreness or tightness in muscles of the chest wall under the treated breast - Severe pain at the site of radiation treatment requiring prescription pain relievers - Prominent thickening or firming of the breast on touch  
Rare but serious These side effects are rare but serious, occurring in less than 3% of patients:
- Cough
- Difficulty breathing
- Inflammation of the heart muscle
- Increased risk for heart disease for patients with cancer in the left breast
- Rib fracture
- Risk of developing another cancer

Women who are pregnant or nursing may not take part in this study. Check with your study doctor about what kind of birth control methods to use. Some methods might not be approved for use in this study. If you suspect that you have become pregnant during the trial, you must notify the study doctor immediately.  
Examples of medically acceptable birth control include oral or injectable hormonal contraceptives, medically prescribed IUDs, and double barrier methods, e.g., condom in combination with spermicide.  
If you become pregnant, you will be withdrawn from the study and your pregnancy may be followed.

There are also non-physical risks associated with taking part in this study, such asthe risks associated with a breach of privacy or confidentiality. The risks of such improper disclosure are very small because Huntsman Cancer Institute has adopted strict privacy and confidentiality procedures for this research.

If you are injured from being in this study, medical care is available to you at the University of Utah, as it is to all sick or injured people. The University of Utah has not set aside any money to pay the costs for such care. The University will work with you to address costs from injuries. Costs would be charged to you or your insurance company (if you have insurance), to the study sponsor or other third party (if applicable), to the extent those parties are responsible for paying for medical care you receive. Since this is a research study, some health insurance plans may not pay for the costs. By signing this consent form you are not giving up your right to pursue legal action against any parties involved with this research. The University of Utah is a part of the government. If you are injured in this study, and want to sue the University or the doctors, nurses, students, or other people who work for the University, special laws may apply. The Governmental Immunity Act of Utah is a law that controls when a person needs to bring a claim against the government, and limits the amount of money a person may recover. See sections 63G -7-101 to -904 of the Utah Code.  
| University of Utah                                                         |
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| Institutional Review Board Approved 4/5/2023 Expires 4/4/2024 IRB_00103976 |
Clinical trial: NCT03345420
Section: Procedures
Subsections: Study Treatments|Study Procedures

Once it is decided that you are able to enroll into this study, you will begin study treatment. Within 12 weeks after your last breast conserving surgery (lumpectomy), you will receive radiation therapy to the breast and the area of the lumpectomy. Radiation therapy treatment will be given for 9 days over a twoweek period.

If you decide you will take part in the study and you sign this informed consent form, you will have some screening tests and procedures done to make sure you are eligible to enroll.  
Screening Period
- Medical history and physical exam, including breast exam
- An evaluation of your ability to perform everyday activities (performance status)
- If you are female with the potential of becoming pregnant, you will have a pregnancy test
Clinical trial: NCT03345420
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

You are being asked to take part in this study because you have had breast conserving surgery
(lumpectomy) for breast cancer. Studies have shown that giving radiation therapy to the breast after lumpectomy helps keep cancer from coming back in the breast. Conventional radiation therapy is typically given daily for 5 to 7 weeks. However, recent studies have also shown that the chance of cancer returning in the breast can be the same with a higher daily dose of radiation given to the whole breast in a fewer number of treatments, reducing the number of weeks required for therapy.  
In this study, you will be given radiation therapy at a higher daily dose than what would be given for conventional radiation therapy, and it will be given for a shorter period of time.  
Shortening the treatment length to two weeks could be more convenient and save time and money. It is not known, but it is hoped, that the higher daily dose of radiation to the breast has the same chance or better of preventing the breast cancer returning, be cost effective, and have the same or better patient satisfaction and cosmetic results compared to standard daily doses of radiation. This study will also help researchers learn about how the study treatment affects your quality of life and the feelings you have about how your breast looks after radiation therapy. Quality of life is your physical and emotional wellbeing; you will be given a questionnaire to assess your quality of life.  
The study is being conducted by Dr. Matthew Poppe at Huntsman Cancer Institute of the University of Utah.  
| University of Utah                                                         |
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| Institutional Review Board Approved 4/5/2023 Expires 4/4/2024 IRB_00103976 |
Clinical trial: NCT03345420
Section: Voluntary Participation
Subsections: Voluntary Participation|Consent

Taking part in this research study is voluntary. You may decide not to take part or you may leave the study at any time. Refusal to take part or the decision to withdraw from this study will involve no penalty or loss of benefits to which you are otherwise entitled.  
Tell the study doctor if you are thinking about stopping or decide to stop, as it may be necessary to do certain tests in order to ensure your safety. If you choose not to return for an assessment, we may ask for medical records from your current general practitioner in order to continue to monitor your health.  
If you decide not to continue in the study at any time, your study doctor will arrange for you to receive alternative treatment and any necessary assessments or procedures according to standard of care.

I confirm that I have read this consent and authorization document and have had the opportunity to ask questions. I will be given a signed copy of the consent and authorization form to keep. I agree to take part in this research study and authorize you to use and disclose health information about me for this study, as you have explained in this document.  
________________________
Participant's Name  
| ________________________                                                                             | ____________   | __________   |
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| Participant's Signature                                                                              | Date           | Time         |
| ________________________ Name of Person Obtaining Authorization and Consent ________________________ | ____________   | __________   |
| Signature of Person Obtaining Authorization and Consent                                              | Date           | Time         |
Clinical trial: NCT03345420
Section: Withdrawal from Study
Subsections: Right Of Investigator To Withdraw|What If I Decide Not To Take Part **After I Sign The Consent And Authorization Form?**

Your study doctor may decide to take you off this study at any time without your consent for any of the following reasons:
- if your disease becomes worse and is not responding to the study treatment, - if he or she believes it is in your best interest,
- if you do not follow the study rules,
- if you miss study visits and/or procedures,
- if you have serious side effects,
- if you become pregnant There is also the possibility that the investigator, may close the study before your participation is complete and without prior warning. If any of these events were to happen, your study doctor would assist with arrangements for your continued care as appropriate.

You can tell us anytime that you do not want to be in this study and do not want us to use your health information. You can also tell us in writing. If you change your mind, we will not be able to collect new information about you, and you will be withdrawn from the research study. However, we can continue to use information we have already started to use in our research, as needed to maintain the integrity of the research. This authorization does not have an expiration date.  
You have a right to information used to make decisions about your health care. However, your information from this study will not be available during the study; it will be available after the study is finished.  
| University of Utah                                                         |
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| Institutional Review Board Approved 4/5/2023 Expires 4/4/2024 IRB_00103976 |  
  
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