Clinical trial: NCT04000581
Section: Confidentiality
Subsections: Confidentiality And Use Of Health Information|Who May See This Information?|What Information May Be Collected, Used And Shared?|Why Will This Information Be Used And/Or Shared?|What Happens To My Health Information After It Is Given To Others?

If you volunteer to take part in this research study, and you sign this document, you give permission to the study doctor and research staff to use or disclose (release) your health information that identifies you and is collected as part of the research study described in this consent. This means that others may know or be able to find out your identity, use your health information and share it with others. We want you to know who may use this information and how they may use it. We also want to tell you about your rights before you agree to take part in the study. If you volunteer to take part in this research study, you consent to the release of your health information from other medical facilities for any moderate to life-threatening or fatal adverse events that occur while on study treatment through 90 days after treatment ends.

Dr. Khurshid Guru and all the members of the study/research team and other health care professionals at Roswell Park  
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Government or Regulating Agencies such as the FDA, DHHS, NCI, NIH or other agencies worldwide Government agencies that must receive reports about certain diseases and conditions Institutional Review Boards or Data Safety and Monitoring Boards at Roswell Park and its affiliates or outside of Roswell Park.

Health information that identifies you and relates to your participation in this study will be collected and created. This may include the following:  
Health information, sometimes known as "Protected Health Information" (PHI) can include your name; address, patient identification number; medical record number; date of birth; photographs; information about your health, including past medical history, treatment, diagnosis, test results and any other information about your health or medical condition; or about payment of charges for medical treatment found in your medical record or other records maintained by Roswell Park.
Information from the procedures used to find out whether you are eligible to take part in this study. This may include physical examinations, blood and urine tests, x-rays and other procedures or tests, and any other information that you may release to us, including information about your health history.  
Information obtained in the course of the study including information about your response to any treatments you receive, information related to study visits and phone calls, physical examinations, blood and urine tests, genomic or genetic tests, x-rays and other procedures or tests, and any other information about your participation in this study.

PHI and other information that may identify you will be used and given out to others to carry out the research study. The sponsor will analyze (test) and evaluate the results of the study. The sponsor, its agents, assigns, government agencies, and others may visit the research site to follow how the study is being done and may review your information for this purpose. This information may be given to the FDA. It may also be shared with other governmental agencies in this country and in other countries. This is done for participant protection and so the sponsor can receive marketing approval for any new products that may result from this research. The information may also be used to meet the reporting needs of the governmental agencies. The results of this research may be published in scientific journals or presented at medical meetings, but your identity will not be disclosed (shared). Your health information may also be stored in a research database or repository. This information may then be used for other research, either de-identified or identified, with or without further IRB review and approval. This information will be kept indefinitely. Page 8 of 10 V.3 Participant Name:
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If you sign this form, the health information collected from you and shared as indicated above, may be re-disclosed to third parties who are not subject to the same laws as those in the United States and may no longer be protected. There is a risk that your information will be given to Date: 02/28/2020 Page 9 of 10 V.3 Participant Name:
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others without your permission; however, the Sponsor also has protections in place to assure the security of your health information.
Clinical trial: NCT04000581
Section: Participant Responsibilities
Subsections: 8. What Are My Responsibilities In This Study?

If you choose to take part in this study you will need to:
- Keep your study appointments. - Tell your doctor about:
o any side effects o if you have been or are currently in another research study.
Clinical trial: NCT04000581
Section: Participant's Rights
Subsections: What If I Decide Not To Give Permission To Use And Give Out My Health Information?|May I Review Or Copy The Information Obtained From Me Or Created About Me?|Authorization

If you refuse to authorize the collection, use and disclosure of your health information as indicated above, you will not be able to be in this research study. Your decision not to sign this authorization or to withdraw from the study will not involve any penalty or loss of benefits to which you are otherwise entitled and will not affect your access to non-research related health care here.

To keep the integrity (truthfulness) of this research study, you will not have the right to review or copy your health information related to this research until the study is complete. At the end of this research study and at your written request, you may have access to your health information. This information is kept in a designated record set, which is a set of data that includes medical information or billing records used in whole or in part by your doctors or other health care providers at Roswell Park to decide about care and treatment. Access to your health information in a designated record set is described in the Notice of Privacy Practices provided to you by Roswell Park. If it is necessary for your care and/or treatment, your health information will be provided to you or your referring or primary care doctor.

As a participant in this study, you agree to allow the use of your health information for research purposes. You understand that your health information will be used/disclosed by Roswell Park as indicated in this document. You understand that you have a right to withdraw your authorization for use of your health information in writing, but the information which has already been used or disclosed before your written withdrawal will continue to be used for research purposes. Finally, you understand your health information that has been disclosed by Roswell Park through this authorization to the study sponsor, government agencies, or others may be further disclosed by them, as the health information will no longer be protected by the federal privacy laws. Page 10 of 10 V.3 Participant Name:
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Clinical trial: NCT04000581
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 6. What Risks And Discomforts Are Involved?|9. What Happens If I Am Injured As A Result Of This Study?

While you take part in this study, you may be at risk of fall. Falls can have a variety of outcomes ranging from no injury or minor injury, to serious injury such as bruises, skin contusion, bone fracture or intracranial bleeding. Falls that not result in physical injury can lead to self-imposed limitation of activity and might decrease your functional ability.

If you believe you have been injured as a direct result of your participation in this research study, notify the Roswell Park Patient Advocate at (716) 845-1365 or the Study Doctor at (716) 8454107. Medical diagnosis and treatment for the injury will be offered, and a determination will be made regarding appropriate billing for the diagnosis and treatment of the injury. A financial counselor can be reached at 716-845-3161 to provide an explanation of coverage and to answer questions you may have regarding study related billing. You do not give up any legal rights by signing this form. You are not prevented from seeking to collect compensation for injury related to malpractice, fault, or blame on the part of those involved in the research.
Clinical trial: NCT04000581
Section: Procedures
Subsections: 3. If I Take Part In This Study, What Tests And Procedures Will I Have Done?|The Following Procedure That You Will Receive As Part Of Your Clinical Research Study Is Considered Research Related: Xsens Motion Tracking. This Procedure Will Be Provided To You At No Cost.

Prior to surgery, you will be given a Godin Leisure-Time Exercise Questionnaire to assess your typical leisure time physical activity. After surgery, in the hospital, you will wear a 3D tracking sensor whenever you move out of the bed. The sensor is used to monitor the participants mobility time and range of movement, from the first day after surgery until you are discharged from the hospital. XSENS is a wireless technology that makes use of sensors. The sensors are applied in a non-invasive manner. There are various configurations of the sensors that can be utilized. The minimum number of sensors needed is 7. They are applied by using Velcro bands. The entire set-up takes about 5-10 minutes. Information will also be collected from your medical record regarding the gastrointestinal symptoms such as nausea, vomiting, passing flatus or stool and any degree of abdominal pain. Chest symptoms including coughing, sputum production, chest pain and fever will be retrieved from your medical record. You will complete a post experiment questionnaire about your experiences and quality of life post discharge. This will be done either over the phone or during one of your standard follow ups.

There are many different types of insurance plans and contracts. It is not possible to tell you in advance the exact amount your insurance will pay and what your financial responsibility will be. If you wish, a financial counselor can meet with you to help answer your questions regarding insurance coverage issues before you decide to participate in this study. A Financial Counselor can be reached at 716-845-3161. There are certain insurance plans that will not cover charges for any care related to an experimental or investigational therapy or study. These plans may deny coverage for even the routine, standard of care medical services you will need to receive during the time you are enrolled in the study. If you have an insurance plan that does not cover participation in a clinical research study, or if you currently have no insurance coverage, a financial counselor can meet with you to provide an estimate of the costs that would be associated with participation in this study. A payment schedule can be developed if needed. A Financial Counselor can be reached at 716-845-3161. A representative from the Patient Access Department can help you obtain authorizations from your insurance carrier when needed. A representative from the Patient Access Department can be reached at 716-845-1049. You and /or your insurance company will be responsible for charges related to the administration of drugs used in this clinical research study and for charges for medications that may be needed to prevent or control side effects. Date: 02/28/2020 Page 5 of 10 V.3 Participant Name:
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If you develop complications or side effects from your participation in this clinical research study, medical treatment will be provided at the usual charge. A financial counselor can be reached at 716-845-3161 to provide an explanation of coverage and to answer questions you may have regarding study related billing.
Clinical trial: NCT04000581
Section: Purpose of Research
Subsections: 1. What Is The Purpose Of This Study?

The purpose of this study is to identify the minimum required level of mobility after inpatient oncologic surgeries to enhance early post-operative recovery and decrease early post-operative complications. This will be assessed objectively using 3D motion tracking technology (XSENS).  
  
  
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Clinical trial: NCT04000581
Section: Withdrawal from Study
Subsections: What Happens If I Want To Withdraw My Authorization?

You may change your mind and revoke (take back) this authorization at any time, except to the extent that Roswell Park has already acted (used or disclosed health information) based on this authorization. To revoke/withdraw this authorization, you must write to the study doctor (name and address is on the first page of this form) and let the doctor know that you are withdrawing your authorization to use and disclose your information. If you should die while enrolled in or after taking part in this study, your health information may be used or disclosed solely for research purposes without getting any added authorization. The results of clinical tests or therapy performed as part of the research may be included in your medical record and will not be removed from the record if you withdraw. If all information that does or can identify you is removed from your health information or biospecimens (such as blood or tissue samples), the remaining information or biospecimens will no longer be subject to this authorization and may be used or disclosed for other purposes, including use for future research studies or distributed to another investigator for future research studies without additional informed consent from you or your legally authorized representative.