Clinical trial: NCT04743999
Section: Alternatives
Subsections: 7. What Other Options Are There And What Are My Alternatives?

Participation is voluntary. You do not have to participate in this study. Your other choices may include:
- Receiving the standard of care therapy which is combined chemotherapy and radiation, which may include different types of chemotherapy treatments combined with radiation
- Receiving no treatment at all Talk to your doctor and family about your choices before you decide if you will take part in this study.
Clinical trial: NCT04743999
Section: Confidentiality
Subsections: 8. How Will My Personal Information Be Protected?

Research records will not include names, registration numbers, or other information that is likely to allow someone other than the researchers to link the information to you. Your research information will not be made a part of your regular medical record. If the researcher orders any tests, the order and results may become part of your regular medical record. All electronic files containing identifiable information will be password protected on a secure Henry Ford network drive and only the members of the research staff will have access to the passwords. At the conclusion of this study, the researchers may publish their findings. Information will be presented in summary format and you will not be identified in any publications or presentations. The researchers will maintain any data described in this paragraph in accordance with the security provisions of this paragraph until destroyed by the researchers.  
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| INFORMED CONSENT  TO PARTICIPATE IN A  RESEARCH STUDY                                                            | MRN:  NAME:                                                      |
| (HFH IRB form rev: 6/6/2019) PROJECT TITLE: Prospective evaluation of quality of life and treatment-related side |                                                                  |
| APPROVED                                                                                                         |                                                                  |
| 07-January-2022                                                                                                  | effects of women undergoing multimodality treatment for advanced |
| INSTITUTIONAL REVIEW BOARD                                                                                       | stage endometrial carcinoma                                      |  
  
Your identifiable private information may be stripped of identifiers and used for future research studies or distributed to another researcher for future research studies without your additional informed consent. You should also know that the HFHS Institutional Review Board (IRB) and IRB Administration Office may inspect study records as part of its auditing program, but these reviews only focus on the researchers. The IRB is a group of people who review research studies to protect the rights and welfare of research participants.
Clinical trial: NCT04743999
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 9. What If I Get Sick Or I Am Injured?

There is no federal, state, or other program that will compensate you or pay for your medical care if you are injured as a result of participating in this study. You and/or your medical insurance may have to pay for your medical care if you are injured as a result of participating in this study. By signing this consent form, you do not give up any of your legal rights in the event of an injury.
Clinical trial: NCT04743999
Section: Procedures
Subsections: 4. What Will Happen If I Take Part In This Research Study?

If you agree to take part in this study, your participation in this study will last a total of 24 months (2 years). As part of this study, you will undergo combined chemotherapy and RT, which is the standard of care in women who have diagnosed with this disease. You will also be asked to fill-out a questionnaire at regular intervals during your treatment. We will ask you to fill-out this form at baseline, 3, 6, 12, 18 and 24 months after surgery. These forms will be filled out in an outpatient setting. The time expected to fill out each form is between 5-10 minutes. These questionnaires will be filled out at standard follow-up visits, and you will not need to make a special trip to the hospital to complete them. During the study, you will have the following procedures:
- Experimental components: Questionnaire at baseline, 3, 6, 12, 18, and 24 months
- Standard components: Combined RT and chemotherapy, treatment of side effects For some research studies, including the one you are being asked to join, you will be given the results of certain tests that are standard of care including blood tests and follow-up scans to assess your response to therapy and any side effects you may be having.
Clinical trial: NCT04743999
Section: Purpose of Research
Subsections: 3. Why Is This Research Being Done?

You have been asked to take part in a research study because you have been diagnosed with stage III endometrial cancer and will be recommended to undergo both chemotherapy and radiation treatments. The purpose of this Phase II study is to find out what effects (good and/or bad) combined chemotherapy and RT has on you and your quality life, side effect profile, and survival outcomes. A total of 60 people will be enrolled in this study at Henry Ford Health System (HFHS).  
| INFORMED CONSENT  TO PARTICIPATE IN A  RESEARCH STUDY (HFH IRB form rev: 6/6/2019)   |
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| DATE:  MRN:  NAME:   |
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| PROJECT TITLE: Prospective evaluation of quality of life and treatment-related side   |                                                                  |
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| APPROVED                                                                              |                                                                  |
| 07-January-2022                                                                       | effects of women undergoing multimodality treatment for advanced |
| INSTITUTIONAL REVIEW BOARD                                                            | stage endometrial carcinoma                                      |
Clinical trial: NCT04743999
Section: Voluntary Participation
Subsections: 11.Do I Have To Participate In This Study?|Documentation Of Consent

You do not have to be in this study if you do not want to. If you agree to be in the study, but later change your mind, you may drop out at any time. Inform the research staff/study doctor if you are thinking about stopping or decide to stop. There are no penalties or loss of benefits to which you are otherwise entitled if you decide that you do not want to participate. If this happens, you may be asked to return for a visit for safety reasons. You will get the same medical care from HFHS whether or not you participate in this study. You will be told about any significant information that is discovered that could reasonably affect your willingness to continue being in the study. You will be notified of all significant new findings during the course of the study that may affect your willingness to continue. You do not have to answer any question that you do not want to answer.

By signing this form, I agree that I have read and understand this form and that I agree to participate in the research project described above. I have been given enough time and opportunity to ask about the details of the research study and to decide whether or not to participate. Its general purposes, the particulars of my involvement and possible risks and inconveniences have been explained to my satisfaction. I understand that I can withdraw at any time without giving any reason without my medical care or legal rights being affected. My signature also indicates that I have received a copy of this consent form. The researchers in this study might want to ask you to participate in additional studies. In some cases, you might be a good candidate for a particular study because of your health history or genetic information. I am willing to be contacted for future research studies. Please initial below. _____ I agree _____ I refuse I understand that the investigator may use publicly available databases to determine whether I am living, for purposes related to my participation in this study only. Please initial below. _____ I agree _____ I refuse  
| INFORMED CONSENT  TO PARTICIPATE IN A  RESEARCH STUDY (HFH IRB form rev: 6/6/2019)   |
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| DATE:  MRN:  NAME:   |
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| PROJECT TITLE: Prospective evaluation of quality of life and treatment-related side   |                                                                  |
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| APPROVED                                                                              |                                                                  |
| 07-January-2022                                                                       | effects of women undergoing multimodality treatment for advanced |
| INSTITUTIONAL REVIEW BOARD                                                            | stage endometrial carcinoma                                      |  
Signature of Subject Date Time Printed Name of Subject Witness to Signature Date Time Signature of Person Obtaining Consent Date Time Printed Name of Person Obtaining Consent I am unable to read but this consent document has been read and explained to me by ___________________ (name of reader). I volunteer to participate in this research. Signature of Subject/Representative Date Time  
| INFORMED CONSENT  TO PARTICIPATE IN A  RESEARCH STUDY (HFH IRB form rev: 6/6/2019)   |
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| DATE:  MRN:  NAME:   |
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| PROJECT TITLE: Prospective evaluation of quality of life and treatment-related side   |                                                                  |
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| APPROVED                                                                              |                                                                  |
| 07-January-2022                                                                       | effects of women undergoing multimodality treatment for advanced |
| INSTITUTIONAL REVIEW BOARD                                                            | stage endometrial carcinoma                                      |  
  
Printed Name of Subject/Representative (and Relationship if Someone other than the Subject) Witness to Signature Date Time Signature of Person Obtaining Consent Date Time Print Name of Person Obtaining Consent
Clinical trial: NCT04743999
Section: Withdrawal from Study
Subsections: 12.Who Else Can Stop My Participation?

The PI, sponsor, or your doctor can end your participation in the research study at any time. If this happens, you may be asked to return for a visit for safety reasons. Reasons that we may end your participation include poor tolerance to therapy including low blood counts leading to infection or intolerable side effects.