Overview
MBC Connect has three main objectives: 1) to create a database of participant-reported information from people with MBC; 2) to create an open-access researcher portal for the study of de-identified patient data; and 3) to link patients with MBC to researchers conducting clinical trials.
MBC Connect is an application that will collect – via the use of a mobile app (on a smartphone or tablet, iOS and Android compatible) or website – registration data, demographic data, genetic information, disease characteristics, treatment history, quality of life data, and clinical trial experience from patients living with MBC. The data will be collected from responses to surveys and the treatment tab and will be used to advance multiple areas of research into MBC, including both medical and quality of life aspects.
You must be 18 years of age or older to participate.
You may appoint a caregiver to assist you with entering your information. Alternatively, you may appoint a caregiver who can view data that you enter but who cannot make changes on your behalf. If a caregiver enters your information on your behalf, the caregiver must be 18 years of age or older.
You can change your mind about us storing, maintaining, using, and sharing your data at any time. You may update or change your responses to the surveys, your treatment information, and your profile at any time.
We are asking for your permission, also called consent, for the storage, maintenance, and use of identifiable private information for research purposes. You consent:
- to answer future surveys designed by researchers or other organizations who are seeking additional information about MBC. You may change your mind at any time about future contact regarding additional surveys;
- to be notified if you potentially match clinical trials being conducted. You will be notified by the application about the potential matches and will receive a brief message and links to the trials. You may then contact the investigator if you wish. You may change your mind about participating in the clinical trial matching feature at any time;
- that the MBC Alliance may contact you in the future to obtain additional information or to check on the status of your health;
- that the MBC Alliance may contact your caregiver, if you provide the name of this person, regarding the status of your health; and
- that the MBC Alliance may continue to use your de-identified data if you pass away.
Introduction
MBC, which is currently treatable but not curable, is responsible for nearly all 41,070 breast cancer deaths each year in the U.S. Nearly 155,000 women and men are living with MBC in the U.S. today.
Many challenges exist that prevent seamless research into various questions about living with MBC. No national database for MBC outcomes exists anywhere in the world. Prior research information has been stored by the individual investigators and not always widely shared. This prevents access to the information by other researchers. Treatment patterns are not documented systematically. Survival times, treatment responses, and metastatic patterns are not available or are not shared. Data are expensive to extract on a large scale directly from physicians’ offices and medical records. MBC Connect may help overcome some of these obstacles by collecting not only data about medical treatments and disease characteristics regarding MBC but also information about quality of life, lifestyle choices, and other related topics.
MBC Connect is a multi-national registry that does not focus on genetic sequencing. We will not be collecting your electronic health records or biological samples. The registry is sponsored by the MBC Alliance, a consortium made up of nonprofit organizations, pharmaceutical and biotech companies, and individual patient advocates or patients living with MBC. To see a list of MBC Alliance members, go to https://www.mbcalliance.org/about/members. MBC Connect will support MBC patients from the U.S. and four other European countries (the UK, Spain, Portugal, and Sweden).
MBC Connect will also match you with clinical trials that may be of interest and will provide “Insights” that may help you learn more about MBC.
Data Gathering
All data you enter via the app (smartphone or tablet; iOS or Android compatible) or via the mbcconnect.org website will be stored and used for further analysis. Data gathered will include responses during registration, answers to five surveys, and any treatment information entered in your treatment profile.
We will share the de-identified information provided with researchers who visit the researcher portal. Like surveys, all personally identifying information will be removed from the treatment profile before it is shared.
Giving researchers access to a large body of treatment information offers the possibility of discovering patterns of treatment that may result in optimal management of MBC.
Your de-identified data, meaning that all personal health information that could be used to identify you has been removed, can be viewed in a researcher portal and downloaded by anyone, including patients, because this portal is open access.
The study data will be retained forever unless you change your mind about us storing them. If you want your study data deleted so that the information can no longer be used by researchers or viewed on the researcher portal, please use the opt-out feature on the patient profile, which includes a template for notifying us by email (info@MBCconnect.org).
Privacy
We will remove protected health information, which includes personal medical information and demographics, from data that are used outside of the MBC Alliance. Information regarding your personal identity is stored in a different place from your medical information. Any researcher who works with your data will not have access to any of your protected health information that could identify you. Only authorized employees or consultants of the MBC Alliance and Medaptive Health (Medaptive Health is the technology partner of the MBC Alliance) who have received HIPAA training and are certified, and you and your caregiver, will have access to your protected health information. Your data are encrypted, and data collected are automatically backed up daily. All accounts of all types are protected by strong, user-selected passwords.
Any data that identify you will be kept confidential as required by law. Federal Privacy Regulations provide safeguards for privacy, security, and authorized access. Except when required by law or for your care, you will not be identified by name, email address, zip code, or any other direct personal identifier in data disclosed outside of the MBC Alliance. For data you provide about yourself, a unique code number will be generated. The key to the code will be kept securely at the MBC Alliance.
As part of MBC Connect, your de-identified survey answers and treatment information will be available via open access on the researcher portal. In certain circumstances, we may be legally required to share your data with federal and state agencies.
Time Commitment
MBC Connect consists of a registration process, five surveys, and a treatment tab. Each survey is expected to take 5-10 minutes to complete. Each survey can be answered in as many sessions as you need, taking as much time as you need. You may answer all five surveys at once or you may answer them one at a time at your own pace. You will also be able to return to a previously completed survey and change or update your answers. Similarly, your treatment information can be entered at your own pace and in as many sessions as you need. Providing information about your current and past treatments on the treatment tab may take longer because you will be asked to provide information about medications you have taken in the past, and dates or information about your tumor(s). Because you may have to look up that information in your notes or ask your doctor, completing treatment information may take more time.
Study Surveys
After completing registration and providing consent, five surveys and a treatment tab will be available. MBC Connect also includes seven tour (how to) screens that describe how MBC Connect works. The five surveys are entitled: 1) Demographics, 2) Disease history, 3) Quality of life, 4) Genetics, and 5) Clinical trials. The total number of questions you answer will vary depending on your response to each question, because you will sometimes be prompted to answer follow-up questions according to your response. In addition, some questions are optional.
On the treatment tab, we will ask you to provide information about your past and current treatments for primary (if applicable) and MBC. The app will allow you to document and maintain a list of the treatments that you have received or are receiving for primary (if applicable) and MBC. The treatment profile is useful as a record of your treatments that you can keep and access.
Your de-identified data, meaning that all personal identifying information has been removed, will also be shared with researchers. Some survey questions include a free-text answer field that allows you to type in a response using your own words. These free-text field responses will not be shared with researchers, but may be used by the MBC Alliance to provide summary information based on an analysis of free-text field responses entered by many participants.
Finishing all five surveys and the treatment tab completes your initial participation in MBC Connect.
Study Tasks
We request information about both your primary (if applicable) and metastatic breast cancer. A treatment profile is a record of the treatments you have received or are receiving, organized in a timeline. A single line of treatment may consist of medications, surgery, radiation, or other interventions. A completed line of treatment has a start date and an end date. If you are currently receiving a line of treatment, this is indicated by choosing “current” instead of an end date. For a surgical procedure, you will enter the date of the surgery. If you participated in one or more clinical trials, you will also provide the details about each trial in the treatment tab.
Withdrawal
Participation in MBC Connect is entirely up to you. You can withdraw from the study at any point for any reason and you may do so by using the opt-out feature, which includes a template for notifying us by email (info@MBCconnect.org). If you withdraw from the study, no new data about you will be collected for study purposes other than data needed to keep track of your withdrawal. Upon withdrawal, data that had been previously entered will be deleted from our database and will not be used for future analysis. However, any data that have already been downloaded from the researcher portal for study purposes will outlast your withdrawal. Your decision not to participate or to withdraw from the study will not involve any penalty or loss of benefits to which you are entitled, and will not affect your access to health care.
Risks and Benefits
There are no physical risks associated with this study. There is, however, the potential risk of loss of confidentiality. Every effort will be made to keep your information confidential; however, this cannot be guaranteed.
There is a risk that someone outside of the MBC Alliance could link your data with you. If that happened, it is possible that someone could deny you a job or health insurance. Or you could experience stress, anxiety, or embarrassment.
Some of the questions we will ask you as part of this study may make you feel uncomfortable. You may take a break at any time during the study. You may stop your participation in MBC Connect at any time.
The MBC Alliance does not anticipate any discomforts, hazards, or physical, social, legal, or economic risks. There are no provisions for research-related injury compensation from the MBC Alliance or the Breast Cancer Research Foundation, the fiscal sponsor of the MBC Alliance.
We hope that in the future the information learned from this study will benefit other people with MBC. There is no direct benefit to you in terms of improved treatment of your MBC for allowing us to store, maintain, use, or share your data, but there are other indirect benefits, which may include:
- Notification of clinical trials that may be of interest
- Increased understanding of your disease factors in relation to those of the MBC population in general through use of “Insights” provided by MBC Connect
- Satisfaction from providing research data that may help others with MBC in the future
- Increased level of engagement with the research community
- Notification about MBC events such as conferences and webinars, as well as news about MBC
- Enhanced understanding of the medical and psychosocial elements of living with MBC
- Access to de-identified researcher portal data for all MBC Connect participants
- Organization and storage of your survey responses and treatment history as a PDF, which you may choose to share with others outside MBC Connect (your doctors, care team, friends and family, etc.)
- Ability for a caregiver to access MBC Connect on your behalf
Future Contact & Other Research
Some researchers or organizations may want to perform additional studies and will request answers to additional questions beyond those in the initial five surveys and/or treatment tab. You may be contacted in the future to answer these additional questions. Any data obtained at a later time are also de-identified and will be made available on the open access researcher portal. You can also change your mind at any time to opt out of these additional studies.
You may be notified by the application about a potential clinical trial match and receive information about the trial and a link to the trial. You may then contact the investigator if you wish. You may change your mind about participating in the clinical trial matching feature by opting out of this feature.
Whom to Contact About This Study
An institutional review board (IRB) is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, and/or concerns or complaints regarding this research study, contact
North Star Review Board
- via email: info@northstarreviewboard.org
- or call toll free: 877-673-8439