Clinical trial: NCT04337203
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study?|What Other Choices Are There?

If you agree to take part in this study, there may or may not be direct benefit to you. We hope the information learned from this study will benefit other people in the future. The benefits of participating in this study may be: a personalized health plan and potential increase in motivation for improving your health.

This is not a treatment study. Your alternative is to not participate in this study.  
WHAT ARE THE COSTS?  
There is no cost to you for taking part in this study.
Clinical trial: NCT04337203
Section: Confidentiality
Subsections: Will Your Research Records Be Confidential?|What About My Health Information?

The results of this research study may be presented at scientific or medical meetings or published in scientific journals. Your identity and/or your personal health information will not be disclosed unless it is authorized by you, required by law, or necessary to protect the safety of yourself or others. There is always some risk that even de-identified information might be re-identified. Participant information may be provided to Federal and other regulatory agencies as required. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction. This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or Page 3 of 7 biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects. The Certificate cannot be used to refuse a request for information from personnel of the United States federal or state government agency sponsoring the project that is needed for auditing or program evaluation by the National Institutes of Health which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it. Audio recordings will be stored on a secure server that is password protected and only accessible to study team members. Audio recordings will also be shared securely with a service provider who will transcribe these recordings. We will retain recordings until all data analysis is complete. At that time any research information will either be destroyed or it will be de-identified and kept for an indeterminate period of time. During study activities, you may request that recordings be stopped at any time.

In this research study, any new information we collect from you] and/or [information we get from your medical records or other facilities about your health or behaviors is considered Protected Health Information. The information we will collect for this research study includes: questionnaire information, text message responses, interview information, and some information from your medical record. If this research study involves the diagnosis or treatment of a medical condition, then Protected Health Information collected from you during this study will be placed in your medical record, and may be used to help treat you, arrange payment for your care, or assist with Medical Center operations. We will make every effort to keep your Protected Health Information private. We will store records of your Protected Health Information in a cabinet in a locked office or on a password protected computer. Your personal health information and information that identifies you ("your health information") may be given to others during and after the study. This is for reasons such as to carry out the study, to determine the results of the study, to make sure the study is being done correctly, to provide required reports and to get approval for new products. Some of the people, agencies and businesses that may receive and use your health information are the research sponsor; representatives of the sponsor assisting with the research; investigators at other sites who are assisting with the research; central laboratories, reading centers or analysis centers; the Institutional Review Board; representatives of Wake Forest University Health Sciences and North Carolina Baptist Hospital; representatives from government agencies such as the Food and Drug Administration (FDA) or the Office of Human Research Protections (OHRP), the Department of Health and Human Services (DHHS) and similar agencies in other countries. Monitors, auditors, IRB or other regulatory agencies will be granted direct access to the participant's original medical record for verification of clinical trial procedures or data, without violating confidentiality of the participant and to the extent permitted by other applicable laws. If required by law or court order, we might also have to share your Protected Health Information with a judge, law enforcement officer, government agencies, or others. If your Protected Health Information is shared with any of these groups it may no longer be protected by federal or state privacy rules. Any Protected Health Information collected from you in this study that is maintained in the research records will be kept for at least six years after the study is finished. At that time any research information not already in your medical record will either be destroyed or it will be deidentified. You will not be able to obtain a copy of your Protected Health Information in the research records until all activities in the study are completely finished. You can tell Stephanie Sohl, PhD that you want to take away your permission to use and share  
 your Protected Health Information at any time by sending a letter to this address:  
Stephanie Jean Sohl, Ph.D.  
  
However, if you take away permission to use your Protected Health Information you will not be able to be in the study any longer. We will stop collecting any more information about you, but any information we have already collected can still be used for the purposes of the research study.  
By signing this form you give us permission to use your Protected Health Information for this study. If you choose to participate in this study, your medical record at Wake Forest University Baptist Medical Center will indicate that you are enrolled in a clinical trial. Information about the research and any medications or devices you are being given as a participant may also be included in your medical record. This part of the medical record will only be available to people who have authorized access to your medical record. If you are not a patient at this Medical Center, a medical record will be created for you anyway to ensure that this important information is available to doctors in case of an emergency. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this Web site at any time.
Clinical trial: NCT04337203
Section: Participant's Rights
Subsections: What Are My Rights As A Research Study Participant?

Taking part in this study is voluntary. You may choose not to take part or you may leave the study at any time. Refusing to participate or leaving the study will not result in any penalty or loss of benefits to which you are entitled. If you decide to stop participating in the study we encourage you to talk to the investigators or study staff first to learn about any potential health or safety consequences. The investigators also have the right to stop your participation in the study at any time. This could be because new information becomes available, you had an unexpected reaction, or because the entire study has been stopped. Information that identifies you may be removed from the data or specimens that are collected as part of this study and could be used for future research or shared with others without additional consent. You will be given any new information we become aware of that would affect your willingness to continue to participate in the study. Clinically relevant research results will not be disclosed to  
 you on an individual basis.
Clinical trial: NCT04337203
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks Of The Study?

The risk of harm or discomfort that may happen as a result of taking part in this research study is not expected to be more than in daily life or from routine physical or psychological examinations or tests. You should discuss the risk of being in this study with the study staff. In addition, there is a slight risk of a breach of confidentiality. We will do our best to protect your confidential information. There may be other risks of participating that we cannot predict.  
Taking part in this research study may involve providing information that you consider confidential or private. Efforts, such as coding research records, keeping research records secure and allowing only authorized people to have access to research records, will be made to keep your information safe.
Clinical trial: NCT04337203
Section: Procedures
Subsections: What Is Involved In The Study?

Once you agree to participate and are enrolled, we will ask you to complete two study questionnaires, one at the beginning and one at the end of the study. The questionnaires ask for basic information about you, your health, emotional functioning, and symptoms. Each questionnaire will take approximately 30 minutes or less to complete and will not require any additional clinic visits. We will then invite you to talk on the phone or via videoconference with a health coach about selecting personalized health goals three times to support your survivorship visit. The first will be scheduled after agreeing to participate in the study and the second two will be spaced approximately 3 weeks apart. You will also receive 3 weeks of daily text messages/emails in between the coaching calls (for a total of 6 weeks) to enhance your goal setting experience. Some of these messages will ask you for a brief response. You may be asked to complete an interview at the end of the study either in person or by telephone. As part of this research study, we request that you be audiotaped during the coach calls and follow-up interview. This is being done for quality assurance and to gather feedback about your experience with the program. You may request the recording be stopped at any time during the course of the research study. You can also withdraw your consent to use and disclose the audiotape before it is used. You should also understand that you will not be able to inspect, review, or approve the audiotapes or other media (including articles containing such) before they are used in this study. Please choose one of the following regarding the use and disclosure of the audiotape used in this research study: ____ I would like the audiotapes of me to be destroyed once their use in this study is finished. ____ The audiotapes of me can be kept for use in future studies provided they are kept secure and any future study will be reviewed by an IRB. I understand that I will not be able to inspect, review or approve their future use.  
HOW LONG WILL I BE IN THE STUDY?  
  
You will be in the study for about 8-10 weeks. You can stop participating at any time. If you decide to stop participating in the study we encourage you to talk to the investigators or study staff first.
Clinical trial: NCT04337203
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

The purpose of this research study is to pilot and evaluate your feedback on the SHARE-S coaching and texting support program.  
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?  
Approximately 40 people will take part in this study.
Clinical trial: NCT04337203
Section: Voluntary Participation
Subsections: Will You Be Paid For Participating?

You will be paid up to $100 at the end of the study if you complete all the scheduled assessments. If you withdraw for any reason from the study before completion you will be paid $25 for each assessment completed and $25 if you complete the follow-up interview. To receive payment, you must provide your social security number, name and address so that we can comply with IRS (Internal Revenue Service) reporting requirements. When payments are reported to the IRS we do not let them know what the payment is for, only that you have been paid. If you do not wish to provide this information you can still take part in this study but you will not be paid.