Clinical trial: NCT03538587
Section: Alternatives
Subsections: Alternative Approaches Or Treatments What Other Choices Do I Have If I Do Not Take Part In This Study?

You have the option to not participate in this study. You may still participate in any other supportive therapies offered by NIH or elsewhere. If you choose not to participate, it will not affect your medical care or participation in any other research study at NIH.
Clinical trial: NCT03538587
Section: Confidentiality
Subsections: Confidentiality Protections Provided In This Study Will Your **Medical Information Be Kept Private?**|Certificate Of Confidentiality|Privacy Act

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:
- The NIH and other government agencies, like the Food and Drug Administration (FDA),
which are involved in keeping research safe for people.  
File in Section 4: Protocol Consent (1) Version Date: 12/13/2021 Page 5 of 8  
- National Institutes of Health Intramural Institutional Review Board
- The St. Baldrick's Foundation who have provided us support through a grant.  
When results of an NIH research study are reported in medical journals or at scientific meetings, the people who take part are not named and identified. In most cases, the NIH will not release any information about your research involvement without your written permission. However, if you sign a release of information form, for example, for an insurance company, the NIH will give the insurance company information from your medical record. This information might affect (either favorably or unfavorably) the willingness of the insurance company to sell you insurance. If we share your specimens or data with other researchers, in most circumstances we will remove your identifiers before sharing your specimens or data. You should be aware that there is a slight possibility that someone could figure out the information is about you. Further, the information collected for this study is protected by NIH under a Certificate of Confidentiality and the Privacy Act.

To help us protect your privacy, the NIH Intramural Program has received a Certificate of Confidentiality (Certificate). With this certificate, researchers may not release or use data or information about you except in certain circumstances. NIH researchers must not share information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if requested by a court. The Certificate does not protect your information when it:  
1. is disclosed to people connected with the research, for example, information may be used for auditing or program evaluation internally by the NIH; or 2. is required to be disclosed by Federal, State, or local laws, for example, when information must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA);
3. is for other research; 4. is disclosed with your consent.
The Certificate does not prevent you from voluntarily releasing information about yourself or your involvement in this research. The Certificate will not be used to prevent disclosure to state or local authorities of harm to self or others including, for example, child abuse and neglect, and by signing below you consent to those disclosures. Other permissions for release may be made by signing NIH forms, such as the Notice and Acknowledgement of Information Practices consent.

The Federal Privacy Act generally protects the confidentiality of your NIH medical records we collect under the authority of the Public Health Service Act. In some cases, the Privacy Act protections differ from the Certificate of Confidentiality. For example, sometimes the Privacy Act allows release of information from your medical record without your permission, for example, if File in Section 4: Protocol Consent (1) Version Date: 12/13/2021 Page 6 of 8 it is requested by Congress. Information may also be released for certain research purposes with due consideration and protection, to those engaged by the agency for research purposes, to certain federal and state agencies, for HIV partner notification, for infectious disease or abuse or neglect reporting, to tumor registries, for quality assessment and medical audits, or when the NIH is involved in a lawsuit. However, NIH will only release information from your medical record if it is permitted by both the Certificate of Confidentiality and the Privacy Act.
Clinical trial: NCT03538587
Section: Duration of Study Involvement
Subsections: During The Study

Once you sign the consent document you will be asked to complete 8 questionnaires and your parent/caregiver will be asked to complete 6 questionnaires before starting this program. The questionnaires take about 20 minutes to complete for youth and 20 minutes for caregivers. The questionnaires will collect information about the following areas:
1. Emotional wellbeing (including mood, stress, and anxiety) 2. Physical wellbeing (including sleep, pain, and fatigue)  
3. Quality of life (including things like friendships, school, activities, health) 4. Mindfulness (including how much you pay attention to the present moment)
Also, we will ask you for permission to collect data from your medical record if you receive treatment at an outside institution. We will have them send us your records for review, so we can gather additional information about your medical condition. Once you complete these questionnaires for the first time, we will have our Registration Office "randomize" you to one of two groups:
1. Mindfulness Group or  
2. Standard Care group
"Randomize" means to assign you to one of these two groups by chance, similar to flipping a coin. We cannot predict which group you will be assigned to. People who are randomize to the Standard of Care group will have the opportunity to later participate in the mindfulness program. Standard Care Group Participants in the standard care group will receive information with general recommendations for coping with cancer. The information is designed to benefit both youth and caregivers and will be briefly reviewed with you with the research team following completion of the baseline questionnaires. Supportive check-in sessions lasting about 10 minutes will be scheduled one-week and three-weeks after starting the protocol, during which any questions or concerns about coping or emotional wellbeing can be addressed. These may be done over the phone. Mindfulness Group Within one week of completing baseline questionnaires, participants assigned to participate in the mindfulness intervention will attend an in-person training session with members of the research team ("mindfulness coaches"). The participant will meet with one member of the research team for an initial training session, while the parent participant will have a training session at the same time with the second member of the research team. The initial in-person session will last approximately 90 minutes, and we will teach you about mindfulness, practice mindfulness exercises, and discuss options for at-home practice. The parent and participant will come together for the final 20 to 30 minutes of the training session. If you do not have access to a device with audio and internet capability, an iPod can be loaned to you for the duration of the intervention. The research team will provide you with a self-addressed pre-paid envelope in which to return the iPod at the end of the study, or it can be returned in-person if convenient. After completing the in-person session, participants will be asked to practice mindfulness exercises four out of seven days per week, though daily practice is encouraged, for an 8-week period. Weekly text messages (or emails) will be sent to ask you how many days you practiced. One week and three weeks after the in-person session, participants will check in with their coach (either in-person or via video chat) to troubleshoot any difficulties and make adjustments to the practice routine. Check-ins will last approximately 30 minutes. 8-Week Follow-up Everyone will be asked to complete follow-up questionnaires about 8 weeks after starting the study. This will include the same questionnaires completed at baseline, and for participants in the
Clinical trial: NCT03538587
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation What Side Effects Or Risks Can I Expect From Being In This Study?|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

The time commitment for the in-person session and completion of the questionnaires is the primary burden of participation. In addition, some individuals experience stress related to talking about difficult things, such as cancer diagnosis and treatment.

The primary aim of this study is to see if mindfulness has potential as a coping tool for patients with similar health conditions. In addition, this study will examine whether there are any benefits to this type of intervention for patients with high-grade or high-risk cancers. We do not know if you will receive personal benefit from taking part in this study. The potential benefits could include reductions in stress, improved coping, and emotional wellbeing. We also hope that the knowledge gained from this study may help others in the future who have cancer.
Clinical trial: NCT03538587
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study? Before You Begin The Study

A treatment team member referred you to this study. To make sure you meet the requirements for taking part in this study we will talk to your medical doctor. We will also make sure you have access to the internet and equipment that will allow you to do the protocol activities.
Clinical trial: NCT03538587
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

The primary purpose of this study is to learn whether a type of coping tool called mindfulness is feasible and acceptable for pediatric patients with high-grade or high-risk cancers and their caregivers. Mindfulness is a practice that teaches people to focus on the present moment with an open mind. This study will see whether children, adolescents, and young adults with high-grade or high-risk cancers are able to carry out mindfulness practices during their cancer treatment and aims to learn more about what aspects of this intervention were helpful. This study will also assess whether mindfulness can help emotional and physical wellbeing of patients and their caregivers.
Clinical trial: NCT03538587
Section: Voluntary Participation
Subsections: It Is Your Choice To Take Part In The Study|Why Are You Being Asked To Take Part In This Study?

You may choose not to take part in this study for any reason. If you join this study, you may change your mind and stop participating in the study at any time and for any reason. In either case, you will not lose any benefits to which you are otherwise entitled. However, to be seen at the NIH, you must be taking part in a study or are being considered for a study. If you do choose to leave the study, please inform your study team to ensure a safe withdrawal from the research.

You have been diagnosed with a high-grade or high-risk cancer and you and/or your caregiver indicated to a treatment team member that this study would be of interest to you. HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? We expect that about 40 participants will complete this study, including 20 caregivers and 20 patients. DESCRIPTION OF RESEARCH STUDY
Clinical trial: NCT03538587
Section: Withdrawal from Study
Subsections: Stopping Participation

The study doctor may decide to stop your therapy for the following reasons:
- you have completed the study follow-up period
- you become too sick to continue participation File in Section 4: Protocol Consent (1) Version Date: 12/13/2021 Page 4 of 8
- you are in in need of additional support due to a mental health condition
- if he/she believes that it is in your best interest In this case, you will be informed of the reason therapy is being stopped. You can stop taking part in this study at any time. However, if you decide to stop taking part in the study, we would like you to talk to the study investigator first.