Clinical trial: NCT03397160
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study?|What Other Choices Do I Have If I Do Not Take Part In This Study?

There will be no direct benefit to your from participating in this study. However, the information that you provide may help health professionals better understand how patient education materials and decision support aid men with their treatment decisions for prostate cancer.

You are free to choose not to participate in the study. If you decide not to take part in this study, there will be no penalty to you. You will not lose any of your regular benefits, and you can still get your care from our institution the way you usually do.
Clinical trial: NCT03397160
Section: Confidentiality
Subsections: Will Information About Me Be Kept Private?

We will do our best to make sure that the personal information gathered for this study is kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.  
Authorized representatives from the following organizations may review your research data for the purpose of monitoring or managing the conduct of this study: Representatives of the Sponsor the Department of Defense, Department of the Army Military Medical Research.  
Representatives of the University of California.  
Representatives and study staff with the study at your local community-based urology practice.
Clinical trial: NCT03397160
Section: Duration of Study Involvement
Subsections: How Many People Will Take Part In This Study?|How Long Will I Be In The Study?

About 160 men total will take part in this study. All 160 subjects will be enrolled at communitybased urologist practices affiliated with a research network organized by the University of California, San Francisco.

Participation in the study will take a total of about 1-2 hours over a period of one (1) month. The main study period ends after you visit your doctor to discuss and decide about your management of prostate cancer and complete post treatment decision survey.
Clinical trial: NCT03397160
Section: Participant's Rights
Subsections: What Are My Rights If I Take Part In This Study?

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you in any way. You will not lose any of your regular benefits, and you can still get your care from our institution the way you usually do.
Clinical trial: NCT03397160
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can I Expect From Being In The Study?

Possible risks related to the patient education strategies include:  
1. **Confusion regarding decision-making**. Although patient education materials and counseling are always intended to clarify the issues surrounding your decisions, it is possible they could create confusion.  
2. **Anxiety and uncertainty**.  
o Participants may feel some anxiety or discomfort in completing study surveys
- but you may skip any questions that you do not feel comfortable in answering.  
o Participants may feel more anxious and uncertain after reviewing patient education materials or receiving educational counseling.  
3. **Dissatisfaction**. Participants may not like the patient education materials or counseling. 4. **Loss of Privacy**. Although members of the study team are trained in how to protect patient privacy, interactions with study researchers and staff could spread patient information more widely and increase the risk of loss of privacy.  
  
  
5. **Unknown Risks**: Some patient education strategies may have side effects that no one knows about yet. The researchers will let you know if they learn anything that might make you change your mind about participating in the study.  
6. For more information about risks and side effects of participating in this study, please ask one of the researchers.
Clinical trial: NCT03397160
Section: Procedures
Subsections: What Will Happen If I Take Part In This Research Study? If You Agree, The Following Procedures Will Occur:

- First you will be asked to review the informed consent form and if you agree to participate you will be asked to sign this form and return it to the researchers.  
- You will be asked to fill out a paper survey and mail it back, in a postage paid envelope. The survey asks questions about your knowledge of prostate cancer treatment options and about your feelings about the possible outcomes associated with your treatments. If any questions make you feel uncomfortable, you may skip those questions and not give an answer.  
o If you choose, you may be given the option to complete these surveys online.  
- Information will be collected from your medical record for study purposes. Specifically, information about your age; race; prostate specific antigen (PSA) test; biopsy test results (i.e., Gleason grade and number of biopsy cores); prostate size; information from physical exam (such as your height and weight); cancer stage; and the date of your upcoming consultation visit with your urologist.  
- Before you meet your doctor to discuss treatment options, you may be offered the opportunity to review patient education materials or receive counseling, depending on what is being offered at your clinic at the time you schedule your visit. The materials may include print or web-based information, and the counseling may include telephone calls or in-person interviews to help you prepare for your visit. If you receive counseling, you may be advised to review specific educational materials and formulate your questions in a written list for you and your medical care team. A clinic employee or study team member may offer to assist you with these tasks.  
- If you are currently on medications prescribed by your primary care doctor or urologist for your prostate, do not change any medications without checking with your urologist.  
- At the office visit with your urologist, both before and after your meeting with your doctor, you will be asked to fill out surveys that ask again about your knowledge of prostate cancer treatment options, and your feelings about the possible outcomes.  
- After the visit with your urologist but before you start treatment, you will be sent a final set of surveys that ask about your overall health and satisfaction with your cancer treatment you selected. You will also be asked about your interest in completing surveys on diet and lifestyle.  
- Twenty-four participants will be selected for a phone conversation by one of the research team members at UCSF to ask you questions about your study experience. The researcher will make a sound recording of your conversation. After the interview,  
  
someone will type into a computer a transcription of what's on the recording and will remove any mention of names. The sound recording will then be destroyed.  
- At the end of this study you may be asked to participant in another long-term follow up study about prostate cancer outcomes named 'Cancer of the Prostate Strategic Urologic Research Endeavor or *CaPSURE'*. In order to participate in *CaPSURE* you will need to sign a separate consent form to be followed in *CaPSURE*.  
- **Study location**: All these procedures will be done at your home and/or your urologist's practice.
Clinical trial: NCT03397160
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

The purpose of this study is to understand which patient education strategies are most highly associated with informed treatment or management decisions. The U.S. Department of Defense, Department of the Army Military Medical Research is funding this study.
Clinical trial: NCT03397160
Section: Voluntary Participation
Subsections: Consent

You have been given a copy of this consent form to keep. You will be asked to sign a separate form authorizing access, use, creation, or disclosure of health information about you. PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to be in this study, or to withdraw from it at any point without penalty or loss of benefits to which you are otherwise entitled. If you wish to participate in this study, you should sign below.  
  
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Clinical trial: NCT03397160
Section: Withdrawal from Study
Subsections: Can I Stop Being In The Study?

Yes. You can decide to stop at any time. Just tell the study researcher or staff person right away if you wish to stop being in the study. Also, the study researcher may stop you from taking part in this study at any time if he or she believes it is in your best interest, if you do not follow the study rules, or if the study is stopped.