Clinical trial: NCT04179305
Section: Alternatives
Subsections: What Other Options Are There?

Instead of being in thisstudy, you may choose not to participate in thisresearch study. Participation, discontinuing participation, or lack of participation will not affect your relationship with Weill Cornell Medicine.
Clinical trial: NCT04179305
Section: Confidentiality
Subsections: What About Confidentiality?|Hipaa Authorization To Useor Discloseprotected Health Information For Research Purposes For Using Or Sharing Protected Health Information: If You Decide To Join This Study, Wcmc|Access To Research Records

Efforts will be made to protect your medical records and other personal information to the extent allowed by law. However, we cannot guarantee absolute confidentiality. Records of study participants are stored and kept according to legal requirements and may be part of your medial record. You will not be identified personally in any reports or publications resulting from thisstudy. Organizationsthat may request to inspect and/or copy your research and medical recordsfor quality assurance and data analysisinclude groupssuch as:
o Representatives of Weill Cornell Medical College and New York-Presbyterian Hospital o The Institutional Review Board (IRB) o The Office of Human Research Protection (OHRP) o Department of Health and Human Services and National Institutes of Health o The Food and Drug Administration (FDA) and/or their representatives o National Institutes of Health and/or their representative will have accessto your files.  
By signing this consent form, you authorize access to this confidential information. You also authorize the release of your medical records to Weill Cornell Medical College and NewYork-Presbyterian Hospital by any other hospitals or institutions where you might receive medical care of any kind while you are participating in this study. If information about your participation in this study is stored in a computer, we will take the following precautions to protect it from unauthorized disclosure, tampering, or damage by requiring a unique ID and password to log into the database. We will keep a password-protected spreadsheet with subjects' identifying information that will be stored on the secure WCM shared drive, accessible only by appropriate study personnel. We will keep your identifying information separate from your responses to study questions, and will instead us a unique Study ID number to identify your responses. In addition, only personnel who are associated with the study will have access to the study specific records in the database.

researchers need your permission to use your protected health information. If you give permission, Weill Cornell Medical College (WCMC) and/or New York-Presbyterian Hospital (NYPH) researchers may use your information or share (disclose) information about you for their research that is considered to be protected health information.  
Voluntary **Choice:** The choice to give WCMC and/or NYPH researcher's permission to use or share your protected health information for their research is voluntary. It is completely up to you. No one can force you to give permission. However, you must give permission for WCMC and/or NYPH researchers to use or share your protected health information if you want to participate in the study. If you decline to sign this form, you cannot participate in this study, because the researchers will not be able to obtain and/or use the information they need in order to conduct their research. Refusing to give permission will not affect your ability to get usual treatment, or health care from WCMC and/or NYPH.  
Protected Health Information To Be Used or **Shared:** Government rules require that researchers get your permission (authorization) to use or share your protected health information. Your medical information may be disclosed to authorized public health or government officials for public health activities when required or authorized by law. If you give permission, the researchers could use or share with the entities identified above any protected health information related to this research study from your medical records and from any scan results.  
Other Use and Sharing of Protected Health **Information**: If you give permission, the researchers could also use your protected health information to develop new procedures or commercial products. They could share your protected health information with the study sponsor, the WCMC Institutional Review Board, inspectors who check the research, government agencies and research study staff. The information that may be shared with the sponsor and/or government agencies could include your medical record and your research record related to this study. They may not be considered covered entities under the Privacy Rule and your information would not be subject to protections under the Privacy Rule. You may agree to allow your data, tissue, and/or blood sample(s) to be used for future research either within or outside WCMC and/or NYPH. If information goes to an outside entity then the privacy rule may not apply.  
Confidentiality: Although the researchers may report their findings in scientific journals or meetings, they will not identify you in their reports. Also, the researchers will try to keep your information confidential, but this cannot be guaranteed. The government does not require everyone who might see your information to keep it confidential, so it might not remain private.

During the course of this study, you will have access to see or copy your protected health information as described in this authorization form in accordance with Weill Cornell Medical College (WCMC) and/or New York-Presbyterian Hospital (NYPH) policies. During your participation in this study, you will have access to your research record and any study information that is part of that record.
Clinical trial: NCT04179305
Section: Duration of Study Involvement
Subsections: How Long Will I Be In The Study?

You will be in the research study for up to 12 months You can stop participating at any time. However, if you decide to stop participating in the study, we encourage you to talk to the researcher and your regular doctor first. If you choose to not participate in the study or to leave the study, your regular care will not be affected nor will your relations with WCMC, New York-Presbyterian Hospital, your physicians, or other personnel. In addition, you will not lose any of the benefitsto which you are entitled.
Clinical trial: NCT04179305
Section: Participant's Rights
Subsections: What Are My Rights As A Participant?

Taking part in thisstudy is voluntary. You may choose to not take part in the study or to leave the study at any time. If you choose to not participate in the study or to leave the study, your regular care will not be affected nor will your relations with the Weill Cornell Medical College, New York-Presbyterian Hospital, your physicians, or other personnel. In addition, you will not lose any of the benefitsto which you are entitled.
Clinical trial: NCT04179305
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks Of The Study?|Policy/Procedures For Research Related Injury

There are risksto taking part in any research study. The risks associated with thisstudy are small. There are no risks of physical injury. The interviewer will ask you questions about how you have been coping with your illness and about your mental health (depression, anxiety). You may find yourself becoming emotional when discussing these topics. You have the right to not answer a question orstop the interview at any time. If you experience difficulty answering the questions, please refrain from pushing yourself to the point of discomfort. If you find the interview has upset you and you want to talk with someone, please contact your healthcare team for immediate needs. You may also contact the study Principal Investigator, Dr. Holly Prigerson, Ph.D. at (212) 746-1374 for concernsthat are not urgent. Risksfrom Invasion of Privacy: Given that your personal responses will be gathered by the researchers, there is a risk of loss of confidentiality. Every effort will be made to protect your privacy.

Compensation for wages, time lost, disability or discomfort is not available. You do not give up any of your legal rights by signing this consent form.
Clinical trial: NCT04179305
Section: Procedures
Subsections: What Is Involved In The Study?

Your oncologist will either have been trained or not have been trained in the Oncolo-GIST method. You will receive care as normal. The study involves the same commitment regardless of whether your oncologist is GIST-trained. Your participation in the study will involve two initial interviews:
1. The first interview will take place when you enroll in the study and will take approximately 25 minutes.  
2. The second interview will take place after you have an imaging scan and discussthe results with your oncologist, within one week of the appointment. It will take approximately 20 minutes.  
We may ask you to complete two additional surveys in the future. These would also take place after you have an imaging scan and discuss the results with your oncologist. Each of these surveys would take approximately 20 minutes. You can choose whether to do the surveys at home on the computer (via a secure internet link); over the phone; or in person (during or after a treatment appointment). The interviews will include questionsthat ask about:  
- Strategies you are using to cope with your illness - Your physical, psychological, and social wellbeing
- How your oncologist explainsscan results and treatment optionsto you
- Your prognosis and intent of the treatment(s) you are receiving
If you become upset or tired during the interviews, the interviewers will ask you if you would like to take a break or reschedule the interview for another time. If you become very upset during or after an interview, we will ask you to speak with your healthcare team or with Dr. Heather Derry, who is a psychologist on the research study team. Dr. Derry can help put you in touch with a mental health professional if you would like to speak with one.  
IRB
Clinical trial: NCT04179305
Section: Purpose of Research
Subsections: Why Is The Study Being Done?

The purpose of this study is to pilot a new informal oncologist training that we call GIST—Giving Information Strategically and Transparently. We hope GIST will help oncologists better communicate information to their patients, and for patients to better understand the details about their prognosis as well as what their options are and what those options mean for their future.
Clinical trial: NCT04179305
Section: Withdrawal from Study
Subsections: Withdrawal By Investigator, Physician, Or Sponsor|Canceling Authorization

The investigators, physicians or sponsors may stop the study or take you out of the study at any time should they judge that it is in your best interest to do so, if you experience a study-related injury, if you need additional or different medication, or if you do not comply with the study plan. They may remove you from the study for various other administrative and medical reasons. They can do this without your consent.

Canceling **Permission:** If you give the WCMC and/or NYPH researchers' permission to use or share your protected health information, you have the right to cancel your permission whenever you want. However, canceling your permission will not apply to information that the researchers have already used or shared. If you wish to cancel your permission, you may do so at any time by writing to: Privacy Officer 1300 York Avenue, Box 303 New York, NY 10065  
IRB