Clinical trial: NCT03624972
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study? Page 5 Of 6|What Other Choices Do You Have If You Do Not Take Part In This Research Study?

Participating in the study may or may not help you directly. You may learn helpful information through participating but there are no guarantees. If you take part in this study, the information you provide will help inform educational programs for other breast cancer patients and survivors in the future.

You do not have to join this study. Whether you decide to join or not join this study, your care at Fox Chase Cancer Center will not be affected.
Clinical trial: NCT03624972
Section: Confidentiality
Subsections: Will Your Information Be Kept Private?

We will do our best to make sure that the personal information in your medical record will be 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.  
Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include: American Cancer Society The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), involved in keeping research safe for people Fox Chase Cancer Center and its Institutional Review Board A description of this study will be available on *http://www.ClinicalTrials.gov*, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the study and its results. You can search this website at any time. You will be given a separate form to review regarding the steps we will take to guard your privacy as part of your participation in the research study. By electronically signing that additional authorization, you will be providing your consent to use and disclose information described in that form connected with your participation in this research study.
Clinical trial: NCT03624972
Section: Participant's Rights
Subsections: What Are Your Rights If You Take Part In This Research Study?

Taking part in this research study is your choice. You may choose either to take part or not to take part in the research 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 and you will not lose any of your regular benefits. Leaving the study will not affect your medical care if you are a patient here at Fox Chase Cancer Center. You can still get your medical care from our institution. In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by electronically signing this form.
Clinical trial: NCT03624972
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can You Expect From Being In The Research Study?

There is a small risk that you will feel uncomfortable answering survey questions or participating in the program, or that you may get bored during the questionnaire completion. You do not have to answer any question you do not want to answer. We will make every effort to keep the information you provide in this study confidential. However, there is a risk that information about you could become known to people outside of this study. To protect against this, the following steps have been taken:  
All information gathered during this study will be kept in locked cabinets or in electronic databases that are password-protected.  
The study team will delete your name and other information that might identify you or the other participants, to the extent possible.  
All audio recordings will be destroyed when the study is completed or later, if necessary for regulatory compliance.
Clinical trial: NCT03624972
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study?|Audio Record Clinic Visit Communication|Medical Records Review

If you agree to be in this study, you will be asked to do the following:  
Questionnaires: Complete 3 study surveys at different times Be assigned to one of two research study groups in which you will either (1) receive menopausal and sexual health resources or (2) view a brief communication video, described later on (called Starting the Conversation), and receive menopausal and sexual health resources.  
Audio record clinic visit communication: Allow us to audio record (tape) the communication that happens during a visit between you and your breast cancer provider.  
Medical Records Review: Allow us to look at your medical records to record details of your breast cancer and treatment history.
More information about what is involved in taking part in this study is described below.

Regardless of your study group, we will ask to audio record your next clinic visit between you and your breast cancer provider. By electronically signing this consent form, you are consenting to let us audio record your next clinic visit with your breast cancer provider. We will use the audio recording to measure the way you and your provider communicate with each other. This will help us learn about the best ways to enhance patient-provider communication about quality of life topics. The provider visit is part of your standard care. The recording will include the entire length of your visit with your provider. This recording will become a part of your confidential research record - not your medical record - and will not be accessible to anyone other than the members of the research team.

We will record certain aspects of your medical history from your medical records that are relevant to this study. This includes: types and dates of surgery(ies) and treatments, medications, and health status. The information we obtain through your medical record will be noted in a database that is separate from your medical record. Any identifying information will be removed. This information will become a part of your confidential research files.
Clinical trial: NCT03624972
Section: Purpose of Research
Subsections: Why Is This Research Study Being Done?

This research is being done to test whether an educational video-based program is helpful at improving how breast cancer patients communicate with their providers about quality of life topics like menopausal and sexual health. Patients who are being seen in follow-up in the breast cancer clinics may join.
Clinical trial: NCT03624972
Section: Voluntary Participation
Subsections: Consent|Has Been Fully Informed Of All Aspects Of The Research Study.

By signing below, you tell us that you have gotten all of the information you need; that you have received clear answers to your questions, and that you agree to take part in the research study. You will receive a copy of this form. You may also request a copy of the research plan. ___________________________ ________________________ _____________ Signature of Participant Print Name of Participant Date By signing this form the person obtaining consent indicates that the research participant

"Temple Health refers to the health, education and research activities carried out by the affiliates of Temple University Health System, Inc. and by Temple University School of Medicine."  
| ____________________________ _______________________   | ____________         |      |
|--------------------------------------------------------|----------------------|------|
| Signature of Person                                    | Print Name of Person | Date |
| Obtaining Consent                                      | Obtaining Consent    |      |
Clinical trial: NCT03624972
Section: Withdrawal from Study
Subsections: Can You Stop Being In The Research Study?

Your participation is completely voluntary. You can agree to be in the study now and change your mind later.  
If you wish to stop, please tell us right away.  
Leaving this study early will not stop you from getting regular medical care.  
If you leave the study early, Fox Chase may use or give out your health information that it already has if the information is needed for this study or any follow-up activities.