Caregiver Consent

Overview

In this study, we will gather information about the primary and metastatic breast cancer (MBC) experience of your loved one for research purposes. We are asking for your permission, also called consent, for the storage, maintenance, and use of the information you may provide, but we will only share de-identified information about you.

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. This information will be collected from patients living with MBC and/or their caregivers. 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 as a caregiver.

You can change your mind about us storing, maintaining, using, and sharing the data you may provide about the participant or yourself at any time. You may update or change your responses to the surveys, treatment information, and 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, but we will only share de-identified information. You consent:

  • if authorized by your loved one, to answer future surveys on their behalf. These surveys are designed by researchers or other organizations who are seeking additional information about MBC;
  • to be notified if your loved one potentially matches 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 or your loved one may then contact the investigator if desired and authorized by your loved one;
  • that the MBC Alliance may contact you in the future to obtain additional information or to check on the status of your loved one’s health; and
  • that the MBC Alliance may continue to use your de-identified data if your loved one passes away.

Introduction

MBC Connect is sponsored by the Metastatic Breast Cancer Alliance.  MBC Connect is an innovative patient registry that intends to accelerate MBC research by collecting data about medical and non-medical topics, creating a database, and sharing de-identified information with interested parties.

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 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 your loved one with clinical trials that may be of interest and will provide “Insights” that may help you learn more about MBC.

Data Gathering

You will provide data via use of an app (smartphone or tablet; iOS or Android compatible) or via the mbcconnect.org website. Study information may include responses during registration, answers to surveys, and treatment details.

We will share de-identified, non-personal data via open access on a researcher portal. The data will be retained forever unless you change your mind about us storing them.

All data you enter about yourself or your loved one 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 may include responses during registration, answers to five surveys, and any treatment information entered in the treatment profile.

“De-identified” means that all personal information that could be used to identify your loved one or you has been removed. This de-identified data can be viewed in a researcher portal and downloaded by anyone, including patients and caregivers, because this portal is open access. However, no personal information that could identify you or your loved one will be 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.

The data you provide about yourself or your loved one will be retained forever unless you change your mind about us storing them.  If you want your 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 caregiver profile, which includes a template for notifying us by email ([email protected]).

Privacy

We will protect your privacy to the best of our ability. The data you provide are encrypted and stored securely. However, we cannot promise complete privacy protection.

We will protect your privacy to the best of our ability. The data you provide are encrypted and stored securely. However, we cannot promise complete privacy protection.

The data collected are automatically backed up daily. All accounts of all types are protected by strong, user-selected passwords.

Federal Privacy Regulations provide safeguards for privacy, security, and authorized access. Except when required by law, 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.

In certain circumstances, we may be legally required to share the data you provide with federal and state agencies.

Time Commitment

Depending on what your loved one has authorized you to do, you may need about 30-60 minutes to complete the entire study, which includes your loved one’s five surveys and treatment profile. Most surveys are short and could be completed in about 5-10 minutes per survey. Having your loved one’s medical records handy will be especially helpful for completing the treatment profile.

MBC Connect consists of a registration process, five surveys, and a treatment tab. Each survey is expected to take 5-10 minutes to complete. Depending on what your loved one has authorized you to do, each survey can be answered in as many sessions as you need, taking as much time as you need. You may answer all five of your loved one’s 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 loved one’s treatment information can be entered at your own pace and in as many sessions as you need. Providing information about current and past treatments on the treatment tab may take longer because you will be asked to provide information about medications that were taken in the past, and dates or information about your loved one’s tumor(s).  Because you may have to look up that information or ask your loved one for more information, completing treatment information may take more time.

Study Surveys

Depending on what your loved one has authorized you to do, you may first complete a registration and consent process, and then five surveys and a treatment tab will be visible. You can use a smart phone, tablet, and/or website on a computer to do all these steps.

Depending on what your loved one has authorized you to do, after completing registration and providing consent, five surveys and a treatment tab will be visible. 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 may answer on behalf of your loved one 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, when authorized by your loved one, we will ask you to provide information about your loved one’s 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 your loved one has received or is receiving for primary (if applicable) and MBC.  The treatment profile is useful as a record of these treatments that you and your loved one can keep and access.

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 and caregivers.

Finishing all five surveys and the treatment tab completes your initial participation in MBC Connect.

Study Tasks

Depending on what your loved one has authorized you to do, the application will allow you to view or record your loved one’s treatment profile. We request the details of the various treatments for both primary (if applicable) and metastatic breast cancer.

We request information about both primary (if applicable) and metastatic breast cancer. Depending on what your loved one has authorized you to do, the application will allow you to view or record your loved one’s treatment profile. A treatment profile is a record of the treatments your loved one has received or is 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 your loved one is 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 your loved one participated in one or more clinical trials, you will also provide the details about each trial in the treatment tab.

Withdrawal

As a caregiver, you may choose not to be in the study. If you agree to be in the study, you may withdraw from the study at any time. Your decision not to participate or to withdraw from the study will not involve any penalty.

Participation in MBC Connect as a caregiver 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 ([email protected]).  If you withdraw from the study, no new data will be collected from you for study purposes other than data needed to keep track of your withdrawal. Upon withdrawal, data that had been previously entered about you 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.

Risks and Benefits

A risk of being in this study is that your privacy cannot be guaranteed.

There is no direct benefit to you as a caregiver based on your use of MBC Connect.

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 you with your data. If that happened, you could experience stress, anxiety, or embarrassment.

Some of the questions we may ask you as part of this study on behalf of your loved one 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 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 to your loved one
  • Increased understanding of 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 loved one’s survey responses and treatment history as a PDF, which you may choose to share with others outside MBC Connect (doctors, care team, friends and family, etc.)

Future Contact & Other Research

Depending on what your loved one has authorized you to do, in the future, you may be asked to participate in additional studies on behalf of your loved one. You may also be notified about a potential clinical trial match that may interest your loved one.

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, on behalf of your loved one. Depending on what your loved one has authorized you to do, you may be contacted in the future to answer these additional questions.

You may be notified by the application about a potential clinical trial match for your loved one and receive information about the trial and a link to the trial. You or your loved one may then contact the investigator if you wish.

Questions

If you have questions or issues, you can go to mbcconnect.org or send an email to [email protected].

Quorum Review reviewed this study. Quorum Review is a group of people who review research studies to protect the rights and welfare of research participants. Review by Quorum Review does not mean that the study is without risks.  If you have questions about your rights as a caregiver in this study, if you are not able to resolve your concerns with the investigator, if you have a complaint, or if you have general questions about what it means to be in a research registry, you can call Quorum Review or visit the Quorum Review website at www.QuorumReview.com.

Quorum Review is located in Seattle, Washington.

Office hours are 8:00 AM to 5:00 PM Pacific Time, Monday through Friday.

Ask to speak with a Research Participant Liaison at 888-776-9115 (toll free).

For additional information or questions, please contact [email protected] or call (646) 497-2695.