Clinical trial: NCT03831100
Section: Alternatives
Subsections: I. Alternatives

Your alternative is to not participate in this study.  
  
Information about you (including your identifiable private information and/or any identifiable biospecimens) may have all of your identifiers removed and used for future research studies or distributed to other researchers for future research without additional informed consent from you or your legally authorized representative.
Clinical trial: NCT03831100
Section: Confidentiality
Subsections: E. Medical Records And/Or **Certificate Of Confidentiality**|L. Authorization To Use **And Disclose (Release) Medical Information**|Notice Of Privacy Practices Musc Organized Health Care Arrangement (Ohca)

This research is covered by a Certificate of Confidentiality from the Federal government. This means that the researchers may not disclose information or biospecimens that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, nor can the information or biospecimens be used as evidence, unless you have consented to this disclosure. Information or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except 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.

As part of this research study, your study doctor and his/her research team will keep records of your participation in this study. The health information MUSC may use or disclose (release) for this research study includes information in your medical record, results of physical exams, medical history, lab tests or certain health information indicating or relating to your condition. Your study doctor and his/her research team will use and disclose (release) your health information to conduct this study. The health information listed above may be used by and/or disclosed (released) to the following, as applicable:
- The sponsor of the study including its agents such as data repositories or contract research organizations monitoring the study;
- Other institutions and investigators participating in the study; - Data Safety Monitoring Boards; - Accrediting agencies; - Clinical staff not involved in the study whom may become involved if it is relevant; - Parents of minor children if less than 16 years old. Parents of children 16 years old or older require authorization from the child; or
- Health insurer or payer in order to secure payment for covered treatment; - Federal and state agencies and MUSC committees having authority over the study such as:
o The Institutional Review Board (IRB) overseeing this study; Committees with quality  
  
improvement responsibilities; Office of Human Research Protections; Food and Drug Administration; National Institutes of Health or Other governmental offices, such as a public health agency or as required by law.  
Those persons who receive your health information may not be required by Federal privacy laws (such as the Privacy Rule) to protect it and may share your information with others without your permission, if permitted by laws governing them. You do not have to sign this consent form. If you choose not to sign, it will not affect your treatment, payment or enrollment in any health plan or affect your eligibility for benefits. However, you will not be allowed to be a participant in this research study.

THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN
GET ACCESSS TO THIS INFORMATION.  PLEASE REVIEW IT CAREFULLY.  
UNDERSTANDING YOUR PROTECTED HEALTH INFORMATION (PHI)
The Medical University of South Carolina and its affiliates (including but not limited to the Medical University Hospital Authority, MUSC Physicians, MUSC Physicians Primary Care, MUSC Health Partners, MUSC Health Alliance, MUSC Strategic Ventures, LLC, and MUSC Strategic Ventures
(MSV) Health, Inc.) participate in a clinically integrated health care setting.  As a result of this clinical integration, these organizations function as an Organized Health Care Arrangement (OHCA) as defined by the Health Insurance Portability and Accountability Act (HIPAA).  For purposes of this notice, the members of the MUSC OHCA are collectively referred to in this document as "MUSC."  We collect, receive, or share this information about your past, present or future health condition to provide health care to you, to receive payment for this health care, or to operate the hospital and/or clinics.  
OUR PLEDGE REGARDING YOUR HEALTH INFORMATION
MUSC is committed to protecting the privacy of health information we create and obtain about you.  This Notice tells you about the ways in which we may use and disclose health information about you.  It also describes your rights and certain obligations we have regarding the use and disclosure of your health information.  We are required by law to: (i) make sure your health information is protected, (ii) give you this Notice describing our legal duties and privacy practices with respect to your health information, and (iii) follow the terms of the Notice that is currently in effect.  
HOW WE MAY USE AND RELEASE YOUR PROTECTED HEALTH INFORMATION (PHI) –
The following uses do NOT require your authorization, except where required by SC law:
A.  
1. For treatment. Your PHI may be discussed by caregivers to determine your plan of care.  For example, the physicians, nurses, medical students and other health care personnel may share PHI in order to coordinate the services you may need.  
2. To obtain payment. We may use and disclose PHI to obtain payment for our services from you, an insurance company or a third party.  For example, we may use the information to send a claim to your insurance company.  
3. For health care operations.  We may use and disclose PHI for hospital and/or clinic operations.  For example, we may use the information to review our treatment and services and to evaluate the performance of our staff in caring for you. 4. Business Associates.  Your medical information could be disclosed to people or companies outside our Health System who provide services.   These companies typically are required to sign special confidentiality agreements before accessing your information.  They are also subject to fines by the federal government if they use/disclosure your information in a way that is not allowed by law.  
5. For public health activities.  We report to public health authorities, as required by law, information regarding births, deaths, various diseases, reactions to medications and medical products.  
6. Victims of abuse, neglect, domestic violence.  Your PHI may be released, as required by law, to the South Carolina Department of Social Services when cases of abuse and neglect are suspected.  
7. Health oversight activities.  We will release information for federal or state audits, civil, administrative or criminal investigations, inspections, licensure or disciplinary actions, as required by law.  
8. Judicial and administrative proceedings. Your PHI may be released in response to a subpoena or court order.  
9. Law enforcement or national security purposes. Your PHI may be released as part of an investigation by law enforcement or for continuum of care when in the custody of law enforcement.  
10. Military and Veterans . If you are a member of the U.S. or foreign armed forces, we may release your medical information as required by military command authorities.  
1. Uses and disclosures about patients who have died.  We may provide medical information to coroners, medical examiners and funeral directors so they may carry out their duties.  
12. For purposes of organ donation.  As required by law, we will notify organ procurement organizations to assist them in organ, eye or tissue donation and transplants 13. Research.  We may use and disclosure your medical information for research purposes.  Most research projects are subject to Institutional Review Board (IRB) approval. The law allows some research to be done using your medical information without requiring your written approval.  
14. To avoid harm.  In order to avoid a serious threat to the health or safety of a person or the public, we may release limited information to law enforcement personnel or persons able to prevent or lessen such harm.  
15. For workers compensation purposes. We may release your PHI to comply with workers compensation laws.  
16. Marketing. We may send you information on the latest treatment, support groups, reunions, and other resources affecting your health.  
17. Fundraising activities.  We may use your PHI to communicate with you to raise funds to support health care services and educational programs we provide to the community. You have the right to opt out of receiving fundraising communications with each solicitation.  
18. Appointment reminders and health-related benefits and services. We may contact you with a reminder that you have an appointment.  
19. Disaster Relief Efforts . We may disclose your medical information to an entity assisting in disaster relief efforts so that your family can be notified about your condition. Note:  incidental uses and disclosures of PHI sometimes occur and are not considered to be a violation of your rights.  Incidental uses or disclosures are by-products of otherwise permitted uses or disclosures which are limited in nature and cannot be reasonably prevented. B. You may object to the following uses of PHI:
1. Inpatient hospital directories.  Unless you tell us not to, we may include your name, location, general condition and religious affiliation in our patient directory so your family, friends and clergy can visit you and know how you are doing
Clinical trial: NCT03831100
Section: Duration of Study Involvement
Subsections: C. Duration

Participation in the study will take 7 visits over a period of 4 months. This will consist of 5 sessions, each lasting 30 minutes to 1 hour. There are no physical risks to you by joining the study. There may or may not be a benefit to undergoing cognitive behavioral therapy to address body image concerns from your cancer and its treatment. It is hoped that the information gained from the study will help improve care for patients with head and neck cancer.
Clinical trial: NCT03831100
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: D. **Risks And Discomforts**

There are no physical risks to you by joining this study. However, there is the possibility you may feel uncomfortable or upset talking about your cancer. You will be encouraged to take your time when answering questions and you may refuse to answer any question at any time during this study. You may withdraw from the study at any time. There is a risk of a loss of confidentiality of your personal information as a result of participation in this study. Measures will be put in place and every effort will be made to protect the confidentiality of your private information. There is also the risk of randomization, which may cause distress. The treatment you receive may prove to be less effective or to have more side effects than the other study treatment.
Clinical trial: NCT03831100
Section: Procedures
Subsections: B. Procedures

If you agree to be in this study, the following will happen:
1. The researchers will check your medical records to gather information about your diagnosis and  
  
treatment.
Clinical trial: NCT03831100
Section: Purpose of Research
Subsections: A. Purpose Of The Research

Please read this consent form carefully and take your time making your decision. As your doctor or study staff discusses this consent form with you, please ask him/her to explain any words or information that you do not clearly understand. You are being asked to participate in this study because you have head and neck cancer that was treated with surgery and have expressed some body image concerns. The purpose of this study is to determine whether cognitive behavioral therapy is an effective treatment for body image concerns in patients with head and neck cancer undergoing surgery. The study involves research. The study is sponsored by the Medical University of South Carolina (MUSC) and Hollings Cancer Center. The investigator in charge of this study is Evan Graboyes, MD. The study is being done at one site: the Medical University of South Carolina. Approximately 48 participants will take part at MUSC. A grant from the National Cancer Institute (NCI) will sponsor this study. Portions of Evan Graboyes' and his research team's salaries will be paid by this grant.
Clinical trial: NCT03831100
Section: Voluntary Participation
Subsections: Volunteers Statement

I have been given a chance to ask questions about this research study. These questions have been answered to my satisfaction. If I have any more questions about my participation in this study or study related injury, I may contact Evan Graboyes, MD at (843) 792-0719. I may contact the Medical University of SC Hospital Medical Director (843) 792-9537 concerning medical treatment. If I have any questions, problems, or concerns, desire further information or wish to offer input, I may contact the Medical University of SC Institutional Review Board for Human Research IRB Manager or the Office of Research Integrity Director at (843) 792-4148. This includes any questions about my rights as a research subject in this study. I agree to participate in this study. I have been given a copy of this form for my own records. If you wish to participate, you should sign below.  
| _________________________________     | _________________   |      |
|---------------------------------------|---------------------|------|
| Signature of Person Obtaining Consent | Date                |      |
| _________________________________     | _________________   |      |
| Signature of Participant              |                     | Date |
| _________________________________     | ________________    |      |
| Name of Participant                   | Date                |      |  
  
IRB Number: Pro00085204  
  
Date Approved 3/26/2020  
  
Medical University
of South Carolina