Clinical trial: NCT04205955
Section: Alternatives
Subsections: What Is The Usual Way To Treat Bowel Symptoms From **Rectal Cancer** Treatments?

The usual way for patients to treat bowel symptoms from rectal cancer treatments is over-thecounter medicines. Examples of bowel symptoms are diarrhea, constipation, loss of bowel control, gas, stomach pain, nausea, vomiting, and loss of water in the body. Other ways to improve bowel symptoms are pelvic floor (area just below your stomach) exercises, over-the counter-supplements, and fiber supplements or teas. Sometimes, these different ways are combined to treat bowel symptoms. Patients have been known to change their diet on their own to help ease their symptoms. Your doctor will explain and tell you which treatment(s) may be best for you. These treatments may or may not control bowel symptoms from rectal cancer treatments.
Clinical trial: NCT04205955
Section: Confidentiality
Subsections: Who Will See My Medical Information?

It is very important to us to protect your information. The study doctors will do their best to protect it. The study doctors must help protect your information if there is a court case.  
However, some of your information may be given out by law. If this should happen, the study doctors will do their best to make sure that any information that goes out to others will not tell others who you are. Some of your health information, such as your treatments and medicines you took, will be stored by the study sponsor in a research database. However, your name and information will not be put in the database. If information from this study is given in journals or at scientific meetings, your name and other personal information will not be used. There are groups that may look at your study records. Your health information in the research database also may be shared with these groups. They must also protect your information, unless the law tells them to give it to another group. Some of the groups that may look at your study records are:  
- The study sponsor (SWOG Cancer Research Network) and University of Arizona. - The NCI Central Institutional Review Board (IRB), which is a group of people who review the research with the goal of protecting the people who take part in the study.  
- The NCI and the groups it works with to go over research.  
- The NCI's National Clinical Trials Network and the groups it works with to do research.
In addition to storing data in the study database, data from studies that are publicly funded may also be shared broadly for future research, with protections for your privacy. The goal of this data sharing is to make more research data available that may improve people's health. Your study records may be stored and shared for future use in public databases. However, your name and other personal information will not be used. Some types of future research may include looking at this stored information and information from other patients to see who had side effects across many studies, or comparing new study data with older study data. However, right now we don't know what research may be done in the future using your information. This means that:  
- You will not be asked if you agree to take part in the specific future research studies using your health information.  
- You and your study doctor/nurse will not be told when or what type of research will be done.  
- You will not get reports or other information about any research that is done using your information.
Clinical trial: NCT04205955
Section: Participant Responsibilities
Subsections: 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 study doctor/nurse about:
o all medicines you are taking o if you have been or are taking part right now in another study.  
- Take part in all scheduled phone calls.  
- Fill out all surveys.
Clinical trial: NCT04205955
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks And Benefits Of Taking Part In This Study?|Risks|Benefits|What Risks Can I Expect From Taking Part In This Study?|Possible Side Effects Of Participation|What Happens If I Get Hurt Taking **Part In This Study?**

There are both risks and benefits to taking part in this study. It is important that you think carefully about these as you make your choice.

We want to make sure you know about some key risks. There is more information in the "What risks can I expect from taking part in this study?" section of this document. If you choose to take part in this study, there is a risk that the study (a diet intervention through phone calls) may not be as good as the healthy living information in treating your bowel symptoms. There may be some risks that the study doctors do not know about yet.

There is data that the diet intervention (health coaches helping you manage your diet or change what you eat) may help treat bowel symptoms and improve quality of life in rectal cancer survivors. This study may help the study doctors learn things that may help people in the future.

If you choose to take part in this study, there is a risk that the diet intervention may not be more helpful than the healthy living information. You may also have the following:  
- Be asked questions about things you don't talk about all the time; this may make you feel unhappy.  
- You may become tired or unhappy from the time taken to be on the phone and filling out surveys.  
- Your bowel symptoms may get worse.
There may be some risks that doctors do not yet know about.

If you become tired or unhappy, your health coach and study doctor/nurse will find out how to best take care of this. Your health coach will let your study doctor/nurse know about any emotional problems or worries for your safety. If you tell the coach that you want to hurt yourself, the coach must report this to your study doctor/nurse. Your study doctor/nurse may tell you about support and counseling that you can use. These may include social work, psychology, and others. You or your insurance may have to pay for these services. Your study doctor/nurse will work with you to find the best information, as needed.

If you get hurt while taking part in this study and need treatment, please talk with your study doctor/nurse right away about your choices. The study sponsors will not pay for treatments if you get hurt on the study. Your insurance may not pay for treatments if you get hurt on the study. Ask them if they will pay. If you do not have insurance, you would need to pay for the treatments. If you feel that you got hurt because of a mistake made by the study doctors or others in charge of the study, you have the right to ask for payment, even though you are in a study. Agreeing to take part in this study does not mean you give up these rights.
Clinical trial: NCT04205955
Section: Procedures
Subsections: What Will Happen If I Decide To Take Part In This Study?|What Exams, Tests, And Procedures Are Involved In This Study?

If you decide to take part in this study, you will complete a "run-in" period. The run-in period is a time for you to finish the first set of study activities and make sure you are ready to take part in the study phone calls. This period will last 2-3 weeks. You will be asked to fill out a 3-day food and symptom diary, a 24-hour diet recall, and a bowel symptom survey by telephone. If you finish these activities, you will be randomly picked by a computer to get diet intervention phone calls or the healthy living information phone calls for 17 weeks. You will also get email/text messages (3 messages every week) during the 17-week period based on the group you are picked to be in. If you finish the run-in period and are randomized, you will be in the study for another 26 weeks. Your study doctor/nurse will ask you about your bowel symptoms and quality of life by asking you to fill out surveys at 18 weeks and 26 weeks after you are told which group you are in.

Before you begin the study, your doctor will review your treatments. This helps your doctor decide if it is safe for you to take part in the study. Your study doctor or study staff will also ask you some questions about your bowel symptoms. This is done using 5 questions on how bad your bowel symptoms are. Based on your answers, you can take part in the study if your study doctor finds out that you have bowel symptoms. If you can and decide to join the study, you will be asked to answer a set of surveys. They will take about 15-60 minutes to complete. The surveys include questions about your:  
- Quality of Life (physical, emotional, social, and spiritual)
- How prepared you feel in managing bowel symptoms
- Your reasons for managing bowel symptoms - Emotions or feelings that you might show about managing bowel symptoms. - Your highest education, if you are married, or have a partner, if you changed your diet after your operation, and how long it took for you to feel good about eating after your operation.
After you answer the baseline surveys, study staff will give you a packet to take home. This packet includes a 3-day food and symptom diary, with steps on how to fill out the diary. You will get a phone call from a trained staff member at the University of Arizona in 48 hours of getting the packet. During this phone call, the staff member will:  
- Teach you how to use the food and symptom diary and send it to the University of Arizona team (by mail or email).  
- Ask you about the kind of foods you ate, and how much you ate, in the last 24 hours.  
- Ask you questions about your bowel symptoms.
This call will last about 60 minutes. When the University of Arizona team gets your food and symptom diary, they will go over the diary. If you filled out the diary and sent it back to the University of Arizona team, you will be put, by chance, into Group 1 or Group 2. If you did not fill out and send back the diary, you will not continue with the study. If you do not continue with the study, the University of Arizona team will mail a packet to you with information on healthy living after cancer treatment. At week 18 & week 26 after you find out which group you're in, you will:  
- Get a phone call from a trained staff member at the University of Arizona to answer questions about your bowel symptoms. This call will take 10 minutes.  
- Fill out a packet of surveys at your clinic or hospital. The surveys have some of the same questions that you answered when you first started the study. The surveys will take about 30-60 minutes to answer. The questions in these surveys ask you about your:
o Quality of Life (physical, emotional, social, and spiritual) o How prepared you feel in managing bowel symptoms o Your reasons for managing bowel symptoms o Emotions or feelings that you might show about managing bowel symptoms o How satisfied you are with the phone calls from the health coaches
Clinical trial: NCT04205955
Section: Purpose of Research
Subsections: Overview And Key Information What Am I Being Asked To Do?|Why Is This Study Being Done?|What Is The Purpose Of This Study?

We are asking you to take part in a research study. This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services. We do research studies to try answering questions about how to keep diseases like cancer from happening, to find out if someone has a disease like cancer, and to treat diseases like cancer. We are asking you to take part in this research study because you have bowel symptoms from your rectal cancer treatments.

This study is being done to answer the following question: Can your bowel symptoms from rectal cancer treatments improve by having health coaches help you manage your diet or change what you eat (or "diet intervention")? We are doing this study because we want to find out if diet intervention is better or worse than getting healthy living information from health coaches.

The purpose of this study is to find out if a diet intervention, or changing what you eat, is better or worse than healthy living information to treat bowel symptoms from rectal cancer treatments. Studies have shown that bowel symptoms (such as diarrhea, constipation, lack of bowel control, and more bowel movements) are common after rectal cancer treatments (like surgery, chemotherapy, and/or radiation). Research also shows that bowel symptoms can lead to poor quality of life in patients with rectal cancer. Some patients with rectal cancer treat their bowel symptoms by changing their diet and the type of foods they eat. However, they may have very little support in changing their diet in the right way. Diet interventions that teach patients how to find foods that cause bowel symptoms and change their diets based on the problem foods may help with bowel symptoms and improve quality of life. There are few treatments for bowel symptoms after rectal cancer treatments that have been tested in research. This study will help study doctors find out if the diet intervention is more helpful than the healthy living information in treating bowel symptoms after rectal cancer treatment. To decide if it is more helpful, study doctors will be looking to see if the diet intervention leads to less bowel symptoms compared to healthy living information. There will be about 94 people taking part in this study.
Clinical trial: NCT04205955
Section: Voluntary Participation
Subsections: Taking Part In This Study Is Your Choice.|My Signature Agreeing To Take Part In The Study

You can choose to or not to take part in this study. You can also change your mind at any time. Whatever choice you make, you will not lose your medical care or give up any rights or benefits. This document has important information to help you make your choice. Take time to read it. Talk to your doctor, family, or friends about the risks and benefits of taking part in the study. It is important that you have as much information as you need and that all your questions are answered. See the "Where can I get more information?" section for information on other clinical trials and cancer information.

I have read this consent form, or had it read to me. I have discussed it with the study doctor and my questions have been answered. I will be given a signed and dated copy of this form. I agree to take part in the main study. I also agree to take part in any additional studies where I circled
"yes".
Clinical trial: NCT04205955
Section: Withdrawal from Study
Subsections: What Are My Choices If I Decide Not To Take Part In This Study?|If I Decide To Take Part In This Study, Can I Stop Later?|Are There Other Reasons Why I Might Stop Being In The Study?

- You may choose to have the usual treatment as explained above.  
- You may choose to take part in a different research study, if one is available.

Yes, you can stop taking part in the study at any time. If you choose to stop, let your study doctor/nurse or health coach know as soon as you can. It is important that you stop safely. If you choose to stop, you can decide if you want to let your study doctor know how you are doing. Your study doctor will tell you about new information or changes in the study that may change your health or your choice to continue in the study.

Yes. The study doctor may take you off the study if:  
- Your health changes and the study is no longer best for you. - New information becomes known and the study is no longer best for you. - You do not follow the study rules. - The study is stopped by the National Cancer Institute (NCI), Institutional Review Board
(IRB), or study sponsor (SWOG Cancer Research Network). The study sponsor is the organization that is in charge of the study.
It is important that you understand the information in the informed consent before making your choice. Please read or have someone read this document to you. If there is anything you don't understand, be sure to ask your study doctor/nurse.