Clinical trial: NCT03016403
Section: Confidentiality
Subsections: Who Will See My Research Information?|Information About You That Will Be Seen, Collected, Used And Disclosed In This Study:

The University of Colorado Denver (CU-Denver) and its affiliated hospital(s) have rules to protect information about you. Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect your privacy. This part of the consent form tells you what information about you may be collected in this study and who might see or use it. The institutions involved in this study include:  
University of Colorado Denver Denver Health and Hospital Authority National Jewish Hospital University of Colorado Cancer Center Saint Mary's Hospital and Medical Center (St. Mary's)
We cannot do this study without your permission to see, use and give out your information. You do not have to give us this permission. If you do not, then you may not join this study. We will see, use and disclose your information only as described in this form and in our Notice of Privacy Practices; however, people outside CU-Denver and its affiliate hospitals may not be covered by this obligation. We will do everything we can to maintain the confidentiality of your personal information but confidentiality cannot be guaranteed. The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose your information at any time by writing to the study's Principal Investigator (PI), Dr. Evelinn Borrayo at the address listed below or via e-mail at Evelinn.Borrayo@UCDenver.edu. If you do cancel your permission to use and disclose your information, your part in this study will end and no further information about you will be collected. Your cancellation would not affect information already collected in this study.  
Evelinn A. Borrayo, PhD 1380 Lawrence Street Suite 1100 Denver, CO 80204-2059 We will do everything we can to keep your records confidential; however, this cannot be guaranteed. Records that identify you, including a signed consent form such as this, may be viewed by the following people:  
Federal agencies that oversee human subject research. People at the Colorado Multiple Institutional Review Board (COMIRB).  
The study's doctors and his/her team of researchers.  
PCORI, who is the organization paying for this research study.  
Officials at the University of Colorado Denver, who are in charge of making sure that we follow all of the rules for research.
We will audio-record your Counseling sessions for supervision of the Counselor to ensure proper clinical practices but your name will not be disclosed to the supervisor. We might also talk about this research study at meetings. We might also print the results of this research study in relevant journals. But we will always keep the names of the research participants, like you, private. You have the right to request access to your personal health information from the Investigator. This authorization does not expire. However, you may withdraw this authorization for use and disclosure of your personal health information by providing written request to the Investigator. If you withdraw this authorization, the institution, the Investigator, the research staff, and the

- Name and Demographic Information (age, sex, ethnicity, address, phone number, etc.) - Portions of your previous and current Medical Records that are relevant to this study, including but not limited to Diagnosis(es), History and Physical, laboratory or tissue studies, radiology studies, procedure results
- Research Visit and Counseling Session(s) records (e.g., audio-recordings of sessions) - Psychological and mental health surveys - Alcoholism, Alcohol or Drug abuse - Records of referrals made to specialized mental health services
Clinical trial: NCT03016403
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Possible Discomforts Or Risks?|What Are The Possible Benefits Of The Study?|Injury And Compensation And  Form

Discomforts you may experience from the study could be feeling emotional due to the interview questions. However, this is unlikely since the questions asked are not about sensitive topics. In case you feel distressed, support services are available. You can call the toll-free phone number of the Cancer Information and Counseling Line (CICL) at 1-800-525-3777. In addition, participants who feel distress or discomfort when they complete our survey can be connected to Dr. Kristin Kilbourn, who is part of our research team and is a licensed Clinical Psychologist.

LC and HNC patients and their caregivers often suffer from a lot of stress and emotional distress while patients' undergo an intense and harsh cancer treatment. However, the usual care they receive for their distress is limited and mostly offered when patients are in crisis. Thus, an important benefit of the study is that it will compare these usual care practices to a creative and new kind of "counseling program in steps" Counseling will be offered in steps matched to the individual's feelings of distress (mild, moderate, or severe). It will seek to improve their feelings, and will allow them to potentially cope better and reduce stress among other benefits.

You should inform your care provider(s) if you decide to participate in this research study. If you have questions about anything related to the research study, you may call Dr. Borrayo at (970) 988-2201 and/or your private physician. Dr. Borrayo should be informed about any injury you experience while you take part in this study. If you are hurt by this research, we will give you medical care if you want it, but you will have to pay for the care that is needed. Who do I call if I have **questions?**
The researcher leading this study is Dr. Evelinn A. Borrayo. You may ask any questions you have now but if you have questions, concerns, or complaints later, you may call her at (970) 988-2201. You will be given a copy of this form, please keep it for future reference. If you have questions about your rights as a participant in this study, call Dr. Borrayo or you can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055.
Clinical trial: NCT03016403
Section: Procedures
Subsections: What Happens If I Join This Study?

If you join this study, you will complete an initial survey with information about yourself. We will use this information to determine if you meet the criteria to be assigned to a clinical trial. If you do not meet criteria, you will remain in the study but you will not be assigned. Those in the clinical trial will be randomly assigned to either the stepped-care *program* or to the usual *care* at your hospital (to be *enhanced* with information about local and national mental health resources). If you are in the stepped-care *program*, we will ask about your feelings via the initial survey. You will receive counseling in "steps" that match if you feel mild, moderate, or severe anxiety or depression. You will answer another survey about your feelings again at 6 weeks, 3 months, and 6 months. You will be moved to the next counseling step if your feelings remain or are worse. If at any time you or your Counselor thinks that your anxiety or depression is getting worse, we will give you another survey to determine if you need to (a) move up a step for more services or (b) refer you out to specialized services. Participants receiving usual *care* who feel more anxiety or depression at 6 weeks, 3 months, or 6 months will be referred to specialized mental health services at your hospital or to local community mental health services depending on availability.  
COMIRB APPROVED For Use 07-Dec-2018 05-Mar-2019
Clinical trial: NCT03016403
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

This study will evaluate how useful a mental health counseling program (a *stepped-care* program) is compared to usual *care* for mental health at your hospital. The *stepped-care* program aims to help LC and HNC patients and their caregivers to better manage stress and emotions, such as feeling anxious or depressed, while the patient undergoes cancer treatment.
Clinical trial: NCT03016403
Section: Voluntary Participation
Subsections: Will I Be Paid For Being In The Study?|Is My Participation Voluntary?|Agreement To Be In This Study

You will be paid $25 each time you answer our surveys. If you complete the initial survey you will receive $25. If you are assigned to the clinical trial and answer 3 additional surveys at 6 weeks, 3 months, and 6 months and will be paid another $75 for your participation in this study.

Taking part in this study is voluntary. You have the right to choose not to take part in this study. If you choose to take part, you have the right to stop at any time. If you refuse or decide to withdraw later, you will not lose any benefits or rights to which you are entitled.

I have read this form about the study or it was read to me. I understand the possible risks and benefits of this study. I know that being in this study is voluntary. I choose to be in this study, and I will get a copy of this consent form.  
  
  
  
Consent form explained by: Date: Print Name: