Breast Cancer Outcomes Disparities Study

(Observational Study)

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Sponsor: Sister2Sister

Protocol Number: UG00021

Principal Investigator: Anthony D. Joseph, Ph.D.

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​Purpose of the Study

 

You are invited to participate in an observational study that aims to investigate disparities in breast cancer care and outcomes. By contributing your electronic health records (EHR) data, you will help us gain insights into diagnostic and treatment journeys, healthcare interactions, and factors contributing to disparities in breast cancer care across various geographic, ethnic, and socioeconomic backgrounds. This study will analyze real-world data to better understand and address inequities in breast cancer care and outcomes.

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Can I participate?

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You are eligible to participate if you meet the following criteria:

• You are a U.S. resident

• You are a woman over the age of 18 (or 20 if in Puerto Rico)

• You have had either of the following:

  • A past or current diagnosis of breast cancer

  • A past experience of a breast cancer scare, where breast cancer was ultimately ruled out.

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What Will Happen During the Study

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If you agree to participate, you will be asked to:

1. Enroll in the Study: You will be asked to electronically sign this informed consent form, enrolling you in the study.

2. Authorize a Connection to your Providers’ Patient Portals: You will be asked to contribute personal information relating to your health history to the study through a platform called Unite. Unite is a no cost online research platform that makes it easy for individuals to centralize and view their medical history data across different providers and share it for research. The Unite platform is integrated with thousands of healthcare provider patient portals (the ones you have used may be called something like MyHealth, MyChart, etc.), enabling you to connect, import, and view your electronic health records (EHR) data from multiple providers in one integrated view. To contribute your medical history data to the study, you will simply use Unite’s search tool to search for the name of the healthcare providers that may have records related to your breast cancer, and follow the on-screen steps to authorize the import-only connection that will allow the Unite platform to import your records.  The process typically takes 30 seconds or less per provider. Once you authorize the connection, the Unite platform will initiate the process of retrieving your records from the provider’s system, which typically completes in about 1 minute. After the import is complete, you will see a screen describing the data that was imported. This data typically includes information relating to:

   • Measurements and assertions (lab data, device measurements, clinical assessment tool scores, etc.)

   • Diagnoses

   • Conditions

   • Problems

   • Procedures

   • Family history

   • Detected issues (drug-drug interactions, duplicate therapies, etc.)

   • Imaging results (x-ray, CT, MRI, etc.)

   • Medications and administrations

   • Responses to questionnaires administered by your health team (social history, patient intake forms, research questionnaires, case report forms, etc.)

   • Records of samples taken

   • Diagnostic reports

   • Allergies

   • Providers and members of care team

   • other information of this kind

3. Ongoing Data Collection: You may be asked to authorize the connection with a given provider to be maintained in the background for up to 1 year so that the system can periodically check for new records and update the data in your Unite account. If the connection with one of your providers has expired, you may be asked to reconnect it so that your Unite data can be refreshed. Throughout the study, you will be able to use your Unite account to view any data that was imported from any providers you have previously connected. You may also be asked to provide additional information or complete questionnaires via the Unite Portal.

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Duration

 

The recruitment phase is estimated to last 12-24 months to reach our target of 1000 participants. Your participation may continue as long as you are willing to contribute EHR data to the study. Data collection and analysis will be ongoing throughout the study.

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Risks

 

The risks associated with participation are minimal. The primary risk is a potential breach of confidentiality, which will be mitigated by our robust data security measures. Additionally, the completion of supplemental questionnaires may involve minor discomfort or inconvenience due to the time required to answer the questions. There may be risks that are unknown.

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New Findings

 

Any new important information that is discovered during the study and which may influence your willingness to continue participation in the study will be provided to you.

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Benefits

 

By participating in this study, you may experience several direct benefits:

• You will have easy access to your health data through the UNITE platform, where you will be able to view your health history data from all of your providers, view graphs and charts of your past health measures over time, and easily reference important information from your records.

• You may gain a clearer understanding of your own health history and the information generated during your past healthcare visits. This may enable you to be a stronger advocate for yourself and help you better navigate your healthcare journey moving forward.

• You will be notified when results of the study are published, and a copy of the published results will be shared with you directly.

• You may feel a sense of satisfaction from contributing to important medical research. Your participation may benefit those diagnosed with breast cancer in the future as well.

 

Costs

 

There will be no cost to you for participating in this research study.

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Compensation

 

You will not receive any monetary compensation for your participation in this study.

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Future Research

 

The data collected in this study may be used for future research studies. These studies may focus on breast cancer or other health conditions, treatments, or outcomes identified in your medical history. The data may be stored and used indefinitely for these purposes. If you choose to withdraw from future research, you may notify the study team at any time. However, any data that has already been de-identified and included in research datasets will not be removed.

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Confidentiality

 

Your data will be secured and kept confidential. Data will be encrypted both in transit and at rest. Data from this study may be used for future research studies, may focus on breast cancer or other health conditions, treatments, or outcomes that are observed in the data collected. We may share de-identified data (data that has been stripped of any information that could reveal the identity of a participant) with third parties with whom we may partner, such as academic research collaborators, commercial life sciences organizations, and health technology providers. Information that could identify you will never be shared without your explicit consent. The data in your Unite account will be stored indefinitely unless and until you delete your Unite account. Regardless of your participation status in the study, the data in your Unite account will be handled according to Unite’s Privacy Policy and Terms of Use. While every effort will be made to protect the confidentiality of your information, absolute confidentiality cannot be guaranteed.

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Voluntary Participation and Withdrawal

 

Your participation in this study is voluntary. You may withdraw from the study at any time without penalty or loss of benefits to which you are otherwise entitled.  You may continue to use your Unite account even after you have withdrawn from the study. Any data collected prior to your withdrawal will remain in the study dataset, and any data that has already been de-identified and included in further research datasets will not be removed. To withdraw, notify the study team through the Unite platform or by email to s2sstudy@unitegenomics.com.

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The Investigator or the sponsor can stop your participation at any time without your consent for the following reasons:

 

• If you fail to follow directions for participating in the study

• If it is discovered that you do not meet the study requirements

• If the study is canceled

• For administrative reasons

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Alternatives to Participation

 

This research study is for research purposes only. The only alternative is to not participate in this study.