Clinical trial: NCT02297607
Section: Alternatives
Subsections: 6. Other Options

6.1 If I decide not to take part in this study, what other options do I have?  
Your participation in this study is entirely voluntary. The alternative option is not to participate in the study. Your clinical care will not be affected by your decision to participate in this study.
Clinical trial: NCT02297607
Section: Confidentiality
Subsections: 9. Confidentiality Of Subject Records And Authorization To Release Your Protected Health Information|9.2 What Information About Me Could Be Seen By The Researchers Or By Other People? Why? Who Might See It?|9.3 What Happens To Information About Me After The Study Is Over Or If I Cancel My Permission?|9.4 When Does My Permission Expire?

The information below describes how your privacy and the confidentiality of your research records will be protected in this study. 9.1 How will the researchers protect my privacy?  
Your research information will be stored in a locked cabinet and will not be made a part of your regular medical record. However, if the researcher orders any tests or products (such as tube feeding supplements and supplies),
the order may become part of your regular medical record

Signing this form gives the researchers your permission to obtain, use, and share information about you for this study, and is required in order for you to take part in the study. Information about you may be obtained from any hospital, doctor, and other health care provider involved in your care, including:
Hospital/doctor's office records, including test results (X-rays, blood tests, urine tests, etc.)
All records relating to your condition, the treatment you have received, and your response to the treatment Alcohol/substance abuse treatment records Billing information There are many reasons why information about you may be used or seen by the researchers or others during or after this study. Examples include:
The researchers may need the information to make sure you can take part in the study.  
The researchers may need the information to check your test results or look for side effects. University, Food and Drug Administration (FDA), and/or other government officials may need the information to make sure that the study is done in a safe and proper manner.  
Study sponsors or funders, or safety monitors or committees, may need the information to:
o Make sure the study is done safely and properly o Learn more about side effects o Analyze the results of the study Insurance companies or other organizations may need the information in order to pay your medical bills or other costs of your participation in the study.  
The researchers may need to use the information to create a databank of information about your condition or its treatment.  
Information about your study participation may be included in your regular UMHS medical record.  
If you receive any payments for taking part in this study, the University of Michigan accounting department may need your name, address, social security number, payment amount, and related information for tax reporting purposes.  
Federal or State law may require the study team to give information to government agencies. For example, to prevent harm to you or others, or for public health reasons.  
The results of this study could be published in an article, but would not include any information that would let others know who you are. 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.

As a rule, the researchers will not continue to use or disclose information about you, but will keep it secure until it is destroyed. Sometimes, it may be necessary for information about you to continue to be used or disclosed, even after you have canceled your permission or the study is over.  
Examples of reasons for this include:
To avoid losing study results that have already included your information To provide limited information for research, education, or other activities (This information would not include your name, social security number, or anything else that could let others know who you are.)
To help University and government officials make sure that the study was conducted properly As long as your information is kept within the University of Michigan Health System, it is protected by the Health System's privacy policies. For more information about these policies, ask for a copy of the University of Michigan
"Notice of Privacy Practices". This information is also available on the web at http://www.uofmhealth.org/patient+and+visitor+guide/hipaa. Note that once your information has been shared with others as described under Question 9.2, it may no longer be protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Your permission expires at the end of the study, unless you cancel it sooner. You may cancel your permission at any time by writing to the researchers listed in Section 10 "Contact Information" (below).
Clinical trial: NCT02297607
Section: Duration of Study Involvement
Subsections: 4.2 How Much Of My Time Will Be Needed To Take Part In This Study?

Your participation in this study is for six months. After your hospital discharge you will be required to fill out a daily food diary for a period of 1-month. Filing out a food diary will take approximately 1 hour per day. The food diary will be completed at 1-month after your hospital discharge. In addition, you will undergo a brief assessment at 1-month, 3-months and at 6-months after your surgery. These assessments are completed over the phone and will take approximately 10-minutes. You will not need to return to the clinic for the purpose of research after your feeding tube has been removed.
Clinical trial: NCT02297607
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 5. Information About Risks And Benefits|Risks Associated With The Experimental Group:|Risks Associated With The Standard Of Care Group:|5.2 What Happens If I Get Hurt, Become Sick, Or Have Other Problems As A Result Of This Research?

5.1 What risks will I face by taking part in the study? What will the researchers do to protect me against these risks?  
Discomfort associated with being asked personal questions. It is possible that you may feel discomfort by being asked personal questions about your health history. You may refuse to answer any question on the questionnaires for surveys for any reason.  
Confidentiality. There is a risk of the loss of confidentiality about your medical information. We will take all of the following steps to protect your privacy and the confidentiality of your information:
All data will be maintained in a confidential file with tight security precautions.  
Only researchers involved in this study will have access to information.  
Data will never leave the University of Michigan.

Increase in the occurrence of tube feeding or jejunal tube complications. Specifically, these risks include diarrhea, j-tube site infection and weight gain. These risks are infrequent (1-10%). These risks are minor but will be minimized by ensuring adequate instruction of patient self-care and care of jejunal tubes. We will routinely monitor patients for signs and symptoms of tube feeding or jejunal tube infection, diarrhea and weight gain.

Lack of adequate nutrition. This risk is infrequent (1-10%) and poses moderate risk. The study team will minimize this risk by collecting dietary diets and evaluating patients for signs and symptoms of inadequate nutrition.  
Dehydration. This risk is infrequent (1-10%) and poses moderate risk. The study team will minimize this risk by collecting dietary diaries and evaluating patients for signs and symptoms of inadequate nutrition. Failure to Thrive. This risk is rare but serious. The study team will minimize this risk by routinely assessing patient condition.  
Need to restart **tube feeding supplements.** This risk is infrequent (1-10%) and not serious. The study team will reinitiate tube feeding support if patient condition warrants.  
As with any research study, there may be additional risks that are unknown or unexpected.

The researchers have taken steps to minimize the risks of this study. Even so, you may still have problems or side effects, even when the researchers are careful to avoid them. Please tell the researchers listed in Section 10 about any injuries, side effects, or other problems that you have during this study. You should also tell your regular doctors. 5.3 If I take part in this study, can I also participate in other studies? Being in more than one research study at the same time, or even at different times, may increase the risks to you.  
It may also affect the results of the studies. You should not take part in more than one study without approval from the researchers involved in each study.  
5.4 How could I benefit if I take part in this study? How could others benefit?  
You may not receive any personal benefits from being in this study. However, you may benefit from increased nutritional support in first month following your surgery. Future patients may benefit from the research results, which may ultimately lead to improved ability of doctors to treat future surgical patients.  
5.5 Will the researchers tell me if they learn of new information that could change my willingness to stay in this study?  
Yes, the researchers will tell you if they learn of important new information that may change your willingness to stay in this study. If new information is provided to you after you have joined the study, it is possible that you may be asked to sign a new consent form that includes the new information.
Clinical trial: NCT02297607
Section: Purpose of Research
Subsections: 2. Purpose Of This Study 2.1 Study Purpose:

The purpose of this study is to determine the best plan of care for post-operative nutritional support following an esophagectomy. Current esophagectomy patients receive tube feeding in the hospital until they can take adequate nutrition by mouth, which is usually 8 days following surgery or until hospital discharge. However, because the amount of food that patients are able to eat varies, some patients may not be able to consistently eat enough to meet their nutritional needs. If a nutritional deficit becomes severe, it can lead to hospital readmission, dehydration and other complications. Continuing tube feeding via jejunal tube for at least 1 month after surgery may decrease the risks of post-operative complications as a result of adequate nutrition and improve patient outcomes following surgery. This research is being done to determine whether continuing tube feeding support for 1 month following surgery is effective in decreasing post-operative complications and improving quality of life and patient satisfaction.
Clinical trial: NCT02297607
Section: Voluntary Participation
Subsections: 12. Signatures Consent/Assent To Participate In The Research Study

I understand the information printed on this form. I have discussed this study, its risks and potential benefits, and my other choices with _______________________________. My questions so far have been answered. I understand that if I have more questions or concerns about the study or my participation as a research subject, I may contact one of the people listed in Section 10 (above). I understand that I will receive a copy of this form at the time I sign it and later upon request. I
understand that if my ability to consent or assent for myself changes, either I or my legal representative may be asked to re-consent prior to my continued participation in this study. Legal Name: ________________________________________________________________________
Signature: _________________________________________________________________________
Date of Signature (mm/dd/yy): ________________________
For use only if required by sponsor: Date of Birth (mm/dd/yy): ____________________________ ID Number: ________________________________________
Clinical trial: NCT02297607
Section: Withdrawal from Study
Subsections: 4.3 When Will My Participation In The Study Be Over?|7. Ending The Study

Your participation in the study will be completed 6 months after your scheduled surgery, however the study team may wish to contact you at a further date to ask you some additional questions. Any coded data you donate to the University databases will be kept there unless you withdraw your participation.

7.1 If I want to stop participating in the study, what should I do? You are free to leave the study at any time. If you leave the study before it is finished, there will be no penalty to you. You will not lose any benefits to which you may otherwise be entitled. If you choose to tell the researchers why you are leaving the study, your reasons for leaving may be kept as part of the study record. If you decide to leave the study before it is finished, please tell one of the persons listed in Section 10 "Contact Information"
(below).  
7.2 Could there be any harm to me if I decide to leave the study before it is finished?  
Participation in this study is completely voluntary. There are no risks involved in leaving the study early. Patients who randomize to the experimental group will need to return tube feeding pump and unused supplies at the time of study termination. 7.3 Could the researchers take me out of the study even if I want to continue to participate?  
Yes. There are many reasons why the researchers may need to end your participation in the study. Some examples are:
The researcher believes that it is not in your best interest to stay in the study.  
You become ineligible to participate.  
Your condition changes and you need treatment that is not allowed while you are taking part in the study.  
You do not follow instructions from the researchers.  
The study is suspended or canceled.