Clinical trial: NCT03227744
Section: Alternatives
Subsections: Alternatives

You may choose to not participate in this research study. If you wish to seek treatment for any feelings of anxiety related to your prostate cancer diagnosis, you should speak with your Urologist, or one of the other study doctors, and they may provide a referral for you to speak with a mental health care professional separate from this study.
Clinical trial: NCT03227744
Section: Confidentiality
Subsections: Confidentiality|Authorization To Use Your Health Information For Research Purposes|What Personal Information Will Be Used Or Disclosed?|Who May Use Or Disclose The Information?|Who May Receive Or Use The Information?|Will Access To My Medical Record Be Limited During The Study?

This section of the consent form describes how your information in this research study will be used, shared and safeguarded in relation to this study. Your information will only be used in accordance with this authorization/informed consent form and as required or allowed by law. Please read it carefully before signing it.

The federal privacy regulations, Health Insurance Portability and Accountability Act (HIPAA) requires that we get your permission to use personal identifiable health information about you that is either created by or used in connection with this research study. This permission is called an Authorization. The personal identifiable health information (PHI) we will use includes the entire research record and supporting information from your medical records, results of laboratory tests, and both clinical and research observations made during your participation in the research.

Your identity will be kept as confidential as possible as required by law. Except as required by law, you will not be identified by name, social security number, address, telephone number, or any other direct identifier.

Your research records may be disclosed outside of Winthrop University Hospital, but in this case, you will be identified only by a unique code number. Information about the code will be kept in a secure location and access limited to only research study personnel. However, the Department of Behavioral Health or Department V.2  2 Patient Initials:_______________________
of Urology may further release information resulting from this study. Please be aware that once your protected health information is disclosed to a person or organization that is not covered by the federal medical Privacy Rule (HIPPA), the information is no longer protected by the Privacy Rule and may be subject to re-disclosure.  
The results of this research study may be presented at scientific or medical meetings or published in scientific journals. However, your identity will not be disclosed.

Organizations that may request to inspect and/or copy your research and medical records for quality assurance and data analysis include groups such as: The Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), regulatory agencies in other countries, and to Winthrop University Hospital.  
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: all study information is stored on a password protected computer which is connected to a protected network. Access to the folder where study information is stored is restricted to research personnel only.

While the study is ongoing, the Investigator or Winthrop University Hospital may refuse to permit you to access your personal identifiable health information obtained in the course of the study. However, you will have access to this health information following the completion of this study.
Clinical trial: NCT03227744
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Possible Risks Or Discomforts Involved|If You Are Having Thoughts About Harming Yourself Or Others At Any Time, Please Call And Notify Your Doctor Or Call 911 Immediately. Benefits|Research-Related Injury

Your participation in this study may involve risks. The potential risks of this study are discomfort with answering some of the questions in the questionnaires regarding your feelings of anxiety or your urinary symptoms. You do not have to answer all of the questions if you are not comfortable, but it may impact your eligibility to participate in the study. There is the potential for accidental disclosure of your personal health information, but this risk is very low, as all information is stored in a locked computer with restricted access.

It is unknown whether you will receive any benefits from participating in this study. It is our aim to reduce any anxiety related to your prostate cancer diagnosis, and if you are assigned to the group therapy, you may receive some benefit in reducing your feelings of anxiety or worry.

If as a result of your participation you experience physical injury from known or unknown risks of the research procedures as described, immediate medical care and treatment, including hospitalization, if necessary, will be available. No funds have been set aside for compensation; therefore you will be responsible for the costs of such medical treatment, either, directly or through your medical insurance and/or other forms of medical coverage.  
V.2  3 Patient Initials:_______________________
Clinical trial: NCT03227744
Section: Procedures
Subsections: Study Procedures

If you decide to take part in this study you will be asked to complete three validated questionnaires which will ask you questions about your anxiety surrounding your diagnosis of prostate cancer, your feelings of anxiety in general and your ability to function in your day to day activities. The questionnaires should take approximately 5-10 minutes to complete. After you complete these questionnaires, the investigator will determine if you are eligible to participate in this study. If you are eligible to participate, you will be randomly assigned to either attend 12 once-weekly 1 hour group therapy sessions with a licensed psychologist, or not. Whether you are assigned or not assigned to weekly group sessions, you will follow up with your Urologist as directed.
Clinical trial: NCT03227744
Section: Purpose of Research
Subsections: Background And Purpose Of This Study

The purpose of this study is to determine if treating disease-related anxiety improves quality of life and delays radical elective treatment of prostate cancer. We will also be monitoring symptom progression and remission during and after treatment. Approximately 48 patients from Winthrop University Hospital are expected to take part in this study.
Clinical trial: NCT03227744
Section: Voluntary Participation
Subsections: Voluntary Participation And Withdrawal From Study|Consent To Participate

Your participation in this study is voluntary. You may refuse to participate or you may withdraw from the study at any time during the duration of the study without penalty or loss of any care and without affecting your future medical care at Winthrop University Hospital. You have the right to refuse to sign this Authorization/Consent form and refuse to take part in this research study. If you choose not to authorize the use and disclosure of your personal identifiable health information (PHI) or to take part in this research study, any standard medical care and any other benefits which you would normally receive as a patient at Winthrop University Hospital will not be affected. If you withdraw from participating in this study, you may also want to withdraw your authorization for us to use your personal identifiable health information. If you do decide to withdraw, we ask that you contact **Dr. Aaron Pinkhasov** in writing and let him know that you are withdrawing your authorization for the use and disclosure of your identifiable health information. Dr.Pinkhasov's mailing address is Department of Behavioral Health Winthrop University Hospital 222 Station Plaza North, Suite 350A
Mineola, NY 11501 However, even after you have requested that we no longer use your personal identifiable health information, we may have to continue to use the information that has been collected prior to your withdrawal in order to ensure the research study can be completed as necessary. We are unable to take back anything we have already done or any information we have already shared with your permission. We may continue using and sharing the information obtained prior to your withdrawal if it is necessary for the soundness of the overall research. Should it be decided that it is not in the best interest of the study or your health to continue in this study or if you have been unable to follow the study doctor's instructions, your participation in this study may be terminated by the sponsor or the study doctor. At that time we may ask your permission to continue using any identifiable health information that has already been collected as part of the study prior to your withdrawal. However, as stated earlier, we may continue to use the information that has been collected prior to your withdrawal in order to ensure the research study can be completed as necessary. The following reason may be given as reasons to end your participation in this study:
If you develop a side effect or medical condition that may place you at risk of further complications by continuing your participation or if you need a medicine not allowed on this study; V.2  4 Patient Initials:_______________________  
If you are unable to perform required procedures as instructed; If you are unable to keep your scheduled appointments; If the study is cancelled by the sponsor or by the FDA;
For other administrative reasons
It is important that you remember to send your request to withdraw your authorization for us to use your individually identifiable health information in writing to **Dr. Aaron Pinkhasov**. If you do not send us this request in writing we may continue to use your identifiable health information that was collected up until your withdrawal from the research study.

You have read this page and the preceding 5 pages of this consent form. In addition, the study doctor has explained to you the procedures in this study and the potential risks and side effects. You have been given the opportunity to ask questions about this study. You are aware that if you decide not to participate or to withdraw your consent, this will not affect any further treatment at this study site or any treatment by the study doctor. You voluntarily consent to participate in this study. You will receive a copy of this signed and dated consent form. You have not waived any of your legal rights by signing this consent form. A description of this clinical trial will be available on **www.clinicaltrials.gov**, as required by US 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 website at any time.  
| ______________________________________________________________________________ Participant's Signature Printed Name Date _________________________________________________________ ________________ Printed Name of Investigator Conducting Consent Discussion Date  _________________________________________________________ ________________ Signature of Investigator Conducting Consent Discussion Date _________________________________________________ ________________ Printed Name of Person who obtained consent signature Date (If different from above) _________________________________________________ _________________ Signature of Person who obtained consent signature Date (If different from above)   |
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Clinical trial: NCT03227744
Section: Withdrawal from Study
Subsections: If I Sign, Can I Revoke It Or Withdraw From The Research Later?

If you decide to participate in this study, your Authorization allowing us to use and disclose your identifiable health information will expire at the end of the research study, unless you withdraw your authorization sooner. You always have the right to withdraw your Authorization by putting your request in writing to Dr. Aaron Pinkhasov as stated below in the "*Voluntary Participation and Withdrawal from* Study" section of this form. If you withdraw your Authorization, you will also be removed from the study, but you will continue to receive any standard medical care and any other benefits to which you would normally receive as a patient at Winthrop University Hospital. However, if you do not send us this request in writing we may continue to use your personal identifiable health information that was collected up until your withdrawal from the research study to maintain the integrity of the study.