Clinical trial: NCT03645005
Section: Confidentiality
Subsections: What Happens To The Information Collected For The Research?|Hipaa Authorization:

Efforts will be made to limit the use and disclosure of your personal information, including research study and medical records, to people who have a need to review this information. We cannot promise complete secrecy. Organizations that may inspect and copy your information include the IRB and other representatives of this institution, as well as the research staff at UIC that has been approved to conduct this study by the Northwestern IRB. Also if necessary, the information may be looked at by the UIC Office for the Protection of Research Subjects to protect your rights or welfare (for example, to monitor the research or consent process) or if required by law. Any study records that can identify you, such as this informed consent, will be kept confidential. They will be stored separately from your interview under lock and key. Any study records used to collect information about you such as interviews, questionnaires, audio recordings or phone application information will not have any identifiable information and will also be kept under lock and key, or protected by a password. Any information collected will be accessible only to the research staff on this study for purposes of analysis. The data collected via the smartphone will be transmitted using Transport Layer Security (TLS) encryption to prevent eavesdropping and tampering of information and data while it is transmitted directly to the Northwestern sever. At the end of participation, the application will be deleted from your phone, and no other information will be collected. For participants that borrowed a study phone, the application will also be deleted from the phone and the phone will be reset to the factory setting. All information collected by the phone application will be immediately transmitted to CBITs, this application does not save any data to the phone's memory, and it does not collect any data from the phone besides the data entered into the application by you, or through your interaction with the application. Besides the email required for login, no other private health information will be collected by this application or stored by the application. If you do not have an email address, or do not wish to use your personal email, we will create a temporary email address using pseudonyms which will be deleted at the end of the study. The following is a complete list of information that the phone application will collect: - An email addresses - Login events - Questionnaire answers and when the questionnaire form was submitted - Page view events (what page you viewed in the application and when it was viewed) The results of the research study may be published, but your name will not be used or associated with the data at any time.

In order to participate in this study, we need to obtain your health information from you medical providers. Your signature on this consent with HIPAA Authoriation is the means for getting access to that information. We are committed to respect your privacy and to keep your personal information confidential. When choosing to take part in this study, you are giving us the permission to use your personal health information that includes health information in your medical records and information that can identify you. For example, personal health information may include your name, address, phone number or social security number. Your health information we may collect and use for this research includes:
All information in a medical record Results of physical examinations Medical history Lab tests, or certain health information indicating or relating to a particular condition as well diaries and questionnaires Records about medication or drugs Genetic health information: BRCA (BReast CAncer susceptibility) gene testing/results (to assess increased breast cancer risk)
Those persons who get your health information may not be required by Federal privacy laws to protect it. Under the HIPAA Authorization, the following clinical providers may give the researchers information about you: all current and previous health care providers, including but not limited to the Rehabilitation Institute of Chicago (RIC), Northwestern Medical Group (NMG), Northwestern Memorial Hospital (NMH), Northwestern Lake Forest Hospital (NLFH). Once we have the health information listed above, we may share some of this information with the following offices or entities outside of Northwestern University, UIC, and its clinical partners (or affiliates): the Northwestern University Institutional Review Board Office and Office for Research Integrity; the US Office of Research Integrity; the US Office for Human Research Protections; the US Food and Drug Administration. Any research information shared with outside entities will not contain your name, address, telephone or social security number or any other personal identifier unless disclosure of the identifier is necessary for review by such parties or is required by law or University policy [except that such information may be viewed by the Study sponsor and its partners]. During the conduct of the research, the researchers may use or share your health information with the following:  
Authorized members of the Northwestern University workforce, who may need to see your information, such as administrative staff members from the Office for Research, Office for Research Integrity and members of the Institutional Review Board.  
Authorized members of the UIC research team approved by the Northwestern Institutional Review Board (IRB). Also if necessary by the UIC Office for the Protection of Research Subjects to protect your rights or welfare (for example, to monitors the research or consent process) or if required by law.
Clinical trial: NCT03645005
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Page 3 Of 8 Will Being In This Study Help Me In Any Way?|Is There Any Way Being In This Study Could Be Bad For Me?

We cannot promise any benefits to you or others from your taking part in this research. However, you may benefit from the testing of these phone applications as there is some preliminary evidence that health information such as what you will be accessing through the applications can improve quality of life and health related knowledge. Although the main purpose of this study is to assess the usefulness and effectiveness of the phone applications at improving wellbeing and quality of life, based on previous research, it is possible for you to have some benefits. In our previous research, we have found that former cancer patients have reported medium to high satisfaction with learning about healthy living and have reported that they have been able to incorporate the information on healthy living into their everyday routines. Additionally, the information gained from this study may benefit society by providing information to help other patients and health care providers to better assist Latina women to manage their symptoms and to improve their quality of life after their treatment.

Your participation in the three study meetings does not involve any risks other than what you would encounter in daily life. Some of the questions we ask might make you feel some discomfort. If you are uncomfortable, you are free to decline or to skip any questions. If the investigator feels you are experiencing a lot of distress, we will provide you with a referral for psychological support.  
We do not foresee that the use of the application will cause distress, it's meant to increases selfefficacy in communication and coping with emotions, as well as increase knowledge about breast cancer. It contains information only from legitimate sources, and it has been vetted by multiple clinical psychologists and doctors at Northwestern and the University of Illinois at Chicago (UIC). However, the use of the application does not replace your standard of care provided by a doctor. You should inform your physician whenever you make changes to your health regimen. In an emergency, or if you have an urgent medical or mental health issue call 911. If you have less pressing questions regarding the application you can contact us, but note that it could take us up to 72 hours to respond. Finally, there can be risks associated with your individual use of the application. There is a slight risk of loss of confidentiality. While any information in the application is protected, there is some possibility that the use of the application in public could cause loss of confidentiality since those around you could see what you are inputting or looking at within the app. Also, there is a risk if you try to use the smartphone while walking or driving since it could involve injury or accidents. Therefore, you are not permitted to use the application while driving or walking.
Clinical trial: NCT03645005
Section: Procedures
Subsections: What Happens If I Say, "Yes, I Want To Be In This Research"?

If you agree to participate in this study, you will be assigned by random assignment (by chance - like flipping a coin) to one of the two phone applications. You have an equal chance of being assigned to either of the two applications.
Clinical trial: NCT03645005
Section: Purpose of Research
Subsections: Key Information About This Research Study:

The following is a short summary of this study to help you decide whether to be a part of this study. Information that is more detailed is listed later on in this form. The purpose of this study is to compare two health applications. These health applications are delivered via phone and are designed to address the quality of life of Latina women after completing breast cancer treatment. Through this study we aim to 1) test the usefulness and helpfulness of (satisfaction with) the application you are assigned to, and 2) examine the effects of the application you are assigned to on your quality of life and wellbeing. You will be asked to be part of three study meetings: the first meeting is in-person but may also be done over the phone, and the final 2 meetings are over the phone. The first two meetings will last 1 hour each, and the final meeting will last 30 minutes. Additionally, you will participate in an 8-week field trial of the phone application you are assigned to. During your first 6 weeks of participation, we will request that you access your phone application for about 2 hours each week on your own schedule, and during the last 2 weeks, you can use the application at your own discretion. During the first 6 weeks, we will also set up a weekly call that will take about 15 minutes. We expect that you will be in this research study for a total of 8 weeks. There are no significant risks associated with this study. The main benefit is access to health information designed for women diagnosed with breast cancer.
Clinical trial: NCT03645005
Section: Voluntary Participation
Subsections: Why Am I Being Asked To Take Part In This Research Study?

We are asking you to take part in this research study because you are a Hispanic/Latina woman who has completed treatment for breast cancer and meets the study's eligibility criteria.
Clinical trial: NCT03645005
Section: Withdrawal from Study
Subsections: What Happens If I Do Not Want To Be In This Research?|Page 4 Of 8 What Happens If I Say "Yes", But I Change My Mind Later?

Participation in research is voluntary. You can decide to participate or not to participate. You can withdraw from this study at any time. Choosing not to be in this study will not negatively affect your right to any present or future medical treatment.

You can leave the research at any time and it will not be held against you. At any time during your participation, you may decide to withdraw from the study. If you decide to leave the research please tell the research team first. If you decide to leave the research, your regular care will not be affected nor will your relations with Northwestern University, the University of Illinois at Chicago (UIC), your physicians, or other personnel. In addition, you will not lose any of the benefits to which you are entitled. If you withdraw no more information will be collected from you. If you indicate you wish to withdraw, the investigator will ask if the information already collected from you can be used.