Clinical trial: NCT04534738
Section: Alternatives
Subsections: Alternatives To Participation

You may seek other nutritional services in addition to or instead of participating in this study regardless of your group assignment. You may choose to not participate in the study without penalty or effects on subsequent medical care.
Clinical trial: NCT04534738
Section: Confidentiality
Subsections: Your Medical Record|Confidentiality Of Records And Authorization To Use And Disclose Information For Research Purposes

As part of this study we will collect some information from your medical record. This will include information such as your age, sex, race, cancer diagnosis, medications you are taking, and the results of any laboratory or diagnostic tests. Information about your study participation and study results may be included in your electronic health record. If you have concerns about this or to obtain more detail, you should discuss this with the study team.  
The study team may be notified if you receive other health care services at University of Rochester Medical Center (URMC) or its affiliates (e.g., visit to the emergency room). In addition, the following individuals may know you participated in research and may see results of testing conducted for this study:
- Staff at the UMRC and its affiliates (e.g., Strong Memorial Hospital, Highland Hospital, URMC
primary care, specialist physician offices) who have a reason to access your electronic health record.  
- Healthcare providers who are involved in your care at a facility that is not part of the URMC and its affiliates and who have reason to access your electronic health record.  
- Individuals who request a copy of information from your health record for activities such as treatment or payment (e.g., medical insurance companies, worker's compensation).

The University of Rochester makes every effort to keep the information collected from you private. In order to do so, access to study files is restricted only to study personnel who need access. Sometimes, however, researchers need to share information that may identify you with people that work for the University, regulators, or the study sponsor. However, if any personal information needs to be shared for these purposes, it will not be made public.  
If you have never received a copy of the URMC and affiliates' Notice of Privacy Practices, please ask the investigator for one.  
- *What information may be used and given to others?*
The study chair will hold your personal and medical information. For example:
o Research records o Records about phone calls and emails made as part of this research o Records about your study visits o Past and present medical records related to the study, including records of external providers that are available via your electronic health record at URMC & affiliates o Results of medical tests (e.g., pregnancy test)
- *Who may use and give out information about you?*
o The study chair and the study staff o URMC and affiliates
- *Your information may be given to:*
o The Department of Health and Human Services o The University of Rochester o The National Institutes of Health, who sponsor this research
- *Why will this information be used and/or given to others?*
o To do the research o To study the results o To see if the research was done correctly o If the results of this study are made public, information that identifies you will not be used.  
- *What if I decide not to give permission to use and give out my health information?*
Then you will not be able to be in this research study.  
- *May I review or copy my information?*
Yes, but only after the research is over.  
- *How long will this permission be valid?*
This permission will last indefinitely. As per policy, all records and databases will be maintained for at least 6 years after the study is complete.  
- *May I cancel my permission to use and disclose information?*
Yes. You may cancel your permission to use and disclose your health information at any time. You do this by sending written notice to the study chair. Upon receiving the written notice, the study team will no longer use or disclose your health information and you will not be able to stay in this study.  
Information that has already been gathered may need to be used and given to others for the validity of the study.  
- *May I withdraw from the study?*
Yes. If you withdraw your permission to be in the study, no new health information identifying you will be gathered after that date. Information that has already been gathered may still be used and given to others.  
- *Is my health information protected after it has been given to others?*
No. There is a risk that your information will be given to others without your permission.
Certificate of Confidentiality To help us further protect your privacy, the investigators have a Certificate of Confidentiality from the Department of Health and Human Services (DHHS). With this Certificate, the investigators cannot be forced (for example, by court subpoena) to disclose or use research information, documents, or samples that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, other proceedings, or be used as evidence. Disclosure will be necessary, however, upon request of DHHS for audit or program evaluation purposes, or to other government agencies related to communicable diseases. You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your consent to receive research information, then the investigator may not use the Certificate to withhold that information. This means that you and your family must also actively protect your own privacy. Finally, you should understand that the investigator is not prevented from taking steps, including reporting to authorities, to prevent serious harm to yourself or others.
Clinical trial: NCT04534738
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Of Participation

As with all research studies, there are risks associated with the study activities. We have taken measures to minimize all anticipated risks. Please consider these risks while deciding if you want to participate.  
1. Weight loss due to *adoption of the Mediterranean Diet* This is not a weight loss study. Some studies have documented weight loss upon adoption of the Mediterranean Diet despite not purposefully "cutting calories." We encourage all subjects to eat and drink to satisfy hunger and thirst. However, because many of the foods in the Mediterranean Diet are very filling, and the fact that you are being treated for cancer with chemotherapy, there is a chance that you could lose weight during the study. Slow weight loss will not be considered dangerous (less than approximately 4 pounds or 2 kg per week), especially if you are beginning the study overweight. However, if you experience rapid, unintentional weight loss, as monitored and determined by your oncologist, he or she will advise you on what to do, which may involve withdrawing from the study.  
2. *Gastrointestinal upset* With a change in diet, and especially a large change in diet, you could experience constipation, diarrhea, nausea, heartburn, bloating, or flatulence. These effects usually go away after several days, but you will always has access to the study chair, Dr. Kleckner, as well as a dietitian to discuss how to relieve these effects.  
3. *Emotional distress* If you are assigned to the Mediterranean Diet group, you could become emotionally distressed or overwhelmed by the expectation to consume the food provided to you. However, you are not limited to these foods, and you do not have to eat them. We are providing the food only to help you follow the Mediterranean Diet for our study. We encourage you to cook, eat out with friends and family, etc.  
Our questionnaires contain information that might be distressing or private (e.g., "I am satisfied with family communication about my illness"). You do not have to answer any questions you are not comfortable answering, and you can take a break or stop answering the questionnaires at any time.  
4. *Risks from a blood draw* Bruising, bleeding, and pain could occur where the blood samples are taken. Sometimes, drawing blood causes people to feel lightheaded or even faint. To avoid these risks, all blood will be drawn at the Wilmot Cancer Institute or UR-affiliated labs by trained staff and we will use a port if you have one. Specifically, to minimize the chance of bruising and the slight chance of infection associated with blood collection, the labs employ standardized hospital procedures for blood collection, and use a trained phlebotomist and sterile materials. You will be encouraged to be well-hydrated before and after the blood draw, and to consume food soon after the blood draw.  
5. *Breach of confidentiality* There is always a risk of a breach of confidentiality in which sensitive medical information could become known to persons outside the research team. To avoid leakage of sensitive information, only Dr. Kleckner (the study chair), Ms. Jennifer Reschke (the study coordinator), and any individual designees will have access to the screening log and the file that links your name with your subject number (both will be encrypted); these files will be stored on a password-protected computer in Dr.  
Kleckner's private office. All data files will reference you by a non-identifiable Participant ID and will be stored on Dr. Kleckner's computer and secure servers at URMC. All consent forms will be stored in a locked cabinet also in her office. If Dr. Kleckner shares data with any other researcher for analyses, all data will be deidentified (i.e., will not have name, birthdate, contact information, etc.). Presentation of study findings in the form of posters, presentations, and manuscripts, either in private or public settings, will not have any identifiable information. Dr. Kleckner and all other coinvestigators participate in ethical training in accordance with institutional policies.  
We will share your name, address, and phone number with Project Lean Nation as well as Wegmans Instacart (or local alternative) so that they can deliver meals and other food items to your house. There is a possibility of you receiving mailing advertisements from these companies after your study participation is over. You may opt out of these mailings by contacting these companies directly. No health information will be shared with these companies.
Clinical trial: NCT04534738
Section: Procedures
Subsections: Description Of Study Procedures

If you decide to take part in this study, you will be asked to participate in the following study activities. It is expected that how you feel will change over the course of your chemotherapy treatment, and we would like to see how diet affects these changes. More information regarding each of the activities is provided below.  
At the beginning of the study (baseline):
- Complete questionnaires regarding your symptoms, feelings, and normal diet.  
- Complete a 3-day food log.  
- Provide a blood sample (approximately 3 tablespoons of blood).  
Throughout the study (8 weeks):
- If you are in the Mediterranean Diet group, we will give you information on the Mediterranean Diet, including its principles and components, and help you follow it. We will provide Mediterranean Diet meals for 4 weeks.  
- Record your fatigue level every day on a daily diary.  
At 4 weeks (mid-point):
- Complete questionnaires regarding your symptoms, feelings, and diet.  
- Complete a 3-day food log.  
- Provide a blood sample (approximately 3 tablespoons of blood).  
At 8 weeks (the end of the study):
- Complete questionnaires regarding your symptoms, feelings, and diet.  
- Complete a 3-day food log.  
- Provide a blood sample (approximately 1.5 tablespoons of blood).  
- Participate in an exit interview, telling us what you thought about the study.  
- Those in the usual care group will be provided with the intervention materials and one week of the Mediterranean Diet food.
Questionnaires We will ask you to complete 10 questionnaires that will take approximately 30-45 min to complete. The questionnaires will ask you about your symptoms, feelings, and normal diet, as well as provide us with other relevant information. One of the questionnaires is a 3-day food record that includes everything you eat for 3 days. Many of these questionnaires can be completed online, and they do not have to be completed in one sitting. Alternatively, you can complete paper-based versions. Blood draw We will collect approximately 3 tablespoons of blood at the beginning of the study (week 0) and at the 4week mid-point, and then approximately 1.5 tablespoons at 8 weeks. These collections will be taken in conjunction with your regularly scheduled blood draws (e.g., before your chemotherapy infusion), if possible. This blood will be used to measure features of your metabolism.
Clinical trial: NCT04534738
Section: Purpose of Research
Subsections: Purpose Of Study

Patients and clinical care teams intuitively understand the importance of nutrition in being healthy. However, we don't know how diet during chemotherapy affects the development of cancer-related fatigue. The purpose of this study is to see if people can adopt the Mediterranean Diet plan during chemotherapy, and to test the effects of a Mediterranean Diet plan vs. typical dietary choices during chemotherapy on the development of fatigue.
Clinical trial: NCT04534738
Section: Voluntary Participation
Subsections: Voluntary Participation|Subject Consent

Taking part in this study is voluntary. You are free not to take part or to withdraw at any time, for whatever reason. No matter what decision you make, there will be no penalty or loss of benefit to which you are entitled. In the event that you do withdraw from this study, the information you have already provided will be kept in a confidential manner. If you are a student at University of Rochester or URMC, participation will not affect your class standing or grades. You will not be offered or receive any special consideration if you take part in this research. If you are an employee at University of Rochester, URMC, or its affiliates, taking part in this research is not a part of your duties, and refusing will not affect your job. You will not be offered or receive any special jobrelated consideration if you take part in this research.

I have read (or have had read to me) the contents of this consent form and have been encouraged to ask questions. I have received answers to my questions. I agree to participate in this study. I have received (or will receive) a signed copy of this form for my records and future reference.  
Subject Name (Printed by Subject): _______________________________________________
Signature of Subject: ___________________________________ Date: __________________
Clinical trial: NCT04534738
Section: Withdrawal from Study
Subsections: Exit-Interview|Withdrawing From The Study

At the end of the study, we will "interview" you regarding your participation in the study: what you liked, what you didn't like, etc. You have the option of having your exit-interview audio-taped for research purposes. The recording may be used to make a transcription of your interview (i.e., we will type up the conversation). Your name will not be included in the transcription.

Early Termination: If you decide to withdraw from the study, you will not experience any negative consequences (e.g., to your cancer treatment or care). Circumstances for Dismissal: You may be withdrawn from the study if your disease becomes worse or if your doctor feels that staying in the study is harmful to your health. The study team also holds the discretion to withdraw you from the study if your participation becomes harmful to yourself or others. New Study Information: If we discover any new information that might make you change your mind about continuing in the study, we will relay the information.