Frequently Asked Questions • Wisdom

Frequently Asked Questions

About the study

What is the WISDOM Study?
What are the benefits of participating in the WISDOM Study?
Why is the WISDOM Study needed?
Who is conducting this study?
Who is funding the WISDOM study?

Participation

How can I participate in the WISDOM Study?
Are there any costs for participating in the study?
Will I be paid for taking part in this study?
What is informed consent?
How do I consent to join WISDOM?
Are there other forms to sign?
What is expected of me if I participate?

How it works

How does the WISDOM Study work?
What is Routine Annual Screening?
What is Personalized Screening?
Why should I choose to be randomized?
Will my healthcare provider know I am in the WISDOM Study?
When I am due for my mammogram, will the WISDOM Study Team order my mammogram?
How do I get my health records and mammograms to the study team?
Will my information be secure? Who will see it?
I have questions, how do I reach the Mammosphere team?
What factors will you use to determine my breast cancer risk?
What if I move or change where I receive my care during the study?
How will the WISDOM Study contact me?
What if I usually get my mammograms somewhere else? (Not at a UC Medical Center or Sanford Health Center)
What happens if I find a lump or experience another breast symptom?
What happens if my personal/family history changes once I’m assigned to a study group?
What if my insurance changes while I am in the study?

Genetic Testing

Who provides genetic testing?
What genetic information are you testing?
Does the Annual group have access to genetic testing?
How long will it take to get my results?
What type of results can I expect?
Can I be discriminated against by insurance companies if I should test positive for a gene mutation?
Will my genetic test results become part of my medical record?

About the study

What is the WISDOM Study?

The WISDOM Study is designed to end the confusion about breast cancer screening. By comparing two safe and accepted screening recommendations, we will determine the best screening guidelines for ourselves, our sisters, our daughters, and future generations of women. Together, we will discover the best way forward.

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What are the benefits of participating in the WISDOM Study?

By participating in this study, you will help us determine how to best screen every woman. You will have access to the latest information on breast health provided from a source you can trust. You may also have access to advanced genetic testing that is currently not routinely available. Most advances that have been made in breast cancer risk reduction, diagnosis, and treatment of breast cancer are due to participation of women like you in studies like this. By participating you are joining a community of 100,000 women who will end the confusion for yourself, other women, and future generations of women.

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Why is the WISDOM Study needed?

There is a lot of confusion about when and how often a woman should get a mammogram. Breast cancer experts don’t all agree. The WISDOM Study hopes to provide clarification on which method is safer and more effective for women: routine yearly screening or personalized screening.
The study aims to determine how to best screen every woman and learn the best way to use mammograms to catch breast cancer while reducing the number of false alarms and biopsies for women without breast cancer. This study will compare routine yearly and personalized screening.

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Who is conducting this study?

The Athena Breast Health Network (“Athena”) is conducting this study. Athena is a group of breast cancer experts, health care providers, researchers, and patient advocates at five University of California Medical Centers (UC Davis, UC Irvine, UC Los Angeles, UC San Diego, UC San Francisco) and the Sanford Health System in North and South Dakota, Iowa, and Minnesota. For more information on Athena, visit our website at www.athenacarenetwork.org. The WISDOM Study is leveraging the power of Athena’s collaborative network to reach a wide and diverse group of women to participate in the study.

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Who is funding the WISDOM study?

This study has been funded by the Patient-Centered Outcomes Research Institute (PCORI), the Robert Wood Johnson Foundation, and private donations from people like you.

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Participation

How can I participate in the WISDOM Study?

You can join the WISDOM Study if this describes you:

  • You are a female, age 40-74
  • You have never been diagnosed with breast cancer or ductal carcinoma in situ (DCIS)
  • You have not had both breasts surgically removed (prophylactic double mastectomy)

  • AND you fit one of the following criteria:

  • You receive healthcare anywhere in California
  • You live in South Dakota, Iowa, Minnesota, or North Dakota and receive healthcare at a Sanford Health location

  • Please note, additional study regions will open later in 2018

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    Are there any costs for participating in the study?

    The WISDOM Study services are provided at no cost to you. This includes the risk assessment, genetic testing, and Breast Health Specialist consultations. We are partnering with insurance companies to cover these costs. If your insurance provider is participating, they will be billed and will cover the costs of the study services described above.
    WISDOM does not cover the routine screening that you receive as part of your care. This includes breast imaging (mammograms, MRI Scans, or ultrasounds), breast procedures, or any other standard of care tests. Insurance coverage and co-pays for breast imaging will not change as a result of study participation.
    Please contact your care facility before your next screening appointment to confirm your out-of-pocket cost as it can vary depending on the facility and whether that facility or provider is deemed a preferred-provider by your insurance company.
    If your insurance does not cover MRI screening, please contact us. The study team will provide a Letter of Medical Necessity. Simply provide this Letter to your provider and ask that they can request MRI coverage for you. Please do not hesitate to contact us if we can provide further guidance by calling us at 855-729-2844 or email us at info@wisdomstudy.org

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    Will I be paid for taking part in this study?

    You will not be paid for taking part in this study.

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    What is informed consent?

    Informed consent is a voluntary agreement to participate in research. The purpose of the informed consent process is to provide you with more information about the study purpose, procedures, and risks and benefits. This information will help you decide if you want to participate. We encourage you to contact us if you have any questions while reviewing the informed consent.
    Once you review the informed consent document and your questions are answered, you can choose to participate by signing the consent form electronically. This indicates to us that you agree to participate. Please know that research is always voluntary and you may withdraw at any time.
    To view the WISDOM Study consent form, click here.

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    How do I consent to join WISDOM?

    1. Watch the ‘About the Study’ video and decide what study group is right for you: randomized or self-selected
    2. Review the list of forms you will need to sign as part of the consent process (Consent, HIPAA, medical release form)
    3. Clicking ‘Next’ will take you to a DocuSign window that will show you the consent form. You must click the box indicating that you agree to use DocuSign. From here, you can review the consent form and decide whether you’d like to participate. If you agree, you will click the signature box and an electronic signature will appear. Click ‘submit’ and your electronic signature will be saved.

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    Are there other forms to sign?

    After your signature is saved on the consent form, you will see a second form, called the HIPAA form. This is a standard form that is used in routine clinical care as well as research studies. HIPAA stands for Health Insurance Portability and Accountability Act and is also known as the Privacy Rule. It is meant to protect patients from inappropriate disclosure of their protected health information.
    Finally, you will be asked to complete a ‘Release of Health Information’ form. We ask that you fill in the name of the facility of your last mammogram and/or breast exam. This allows us to obtain your previous results from your local health center. Your breast health information, including your breast density, is an important factor that helps us better determine your breast cancer risk. Your signature on both the consent and HIPAA documents is required in order for you to participate in the study. If you have any questions while reviewing the forms, please feel free to contact us at info@WISDOMstudy.org or 855-729-2844

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    What is expected of me if I participate?

    If you are in the Routine Annual Screening group: 

    1. You will answer several questionnaires. We will ask you questions about your health history.
    2. We will encourage you to have an initial screening mammogram, or return for your next mammogram one year from the date of your most recent mammogram.
    3. If our team believes you are at higher than average risk for breast cancer, you will receive a copy of your detailed risk report. You will be offered the opportunity to discuss your risk with a Breast Health Specialist over the phone. A Breast Health Specialist is an individual who has specialized training in breast cancer risk assessment and genetics. Your Specialist may recommend follow-up activities, such as more frequent screening, or suggest ideas about how you may lower your risk for breast cancer.
    4. We will ask you to complete follow-up questionnaires every year to see if there are any changes to your family cancer history, personal history and health status.
    If you are in the Personalized Screening group:

    1. You will complete a series of questionnaires and provide a saliva sample to look for inherited (genetic) risk factors for breast cancer. This test will include 9 genes (including BRCA1 and BRCA2), and a collection of single nucleotide polymorphisms, or SNPS, that have been associated with risk of breast cancer. Please see the FAQs on genetic testing for further detail.
    2. You will receive a screening recommendation that is based on the results of your answers to the questionnaire, your mammographic breast density, and your genetic testing results. This screening recommendation letter indicates when you should return for your next mammogram based on whether you are at higher than average, average, or lower than average risk of developing breast cancer. You could be asked to return in 6 months, 1 year, 2 years, or recommended to wait until you turn 50 to start screening (if you are not 50 already).
    3. If you are determined to be at elevated risk, you will receive a call from a Breast Health Specialist. S(he) may make recommendations about how you may reduce your risk for breast cancer.
    4. We will ask you to complete follow-up questionnaires every year to see if there are any changes to your family cancer history, personal history and health status.

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    How it works

    How does the WISDOM Study work?

    The WISDOM Study is designed to end the confusion about how often women should be screened for breast cancer. If you join, you will decide if you want to be randomized to a screening schedule or select your own screening schedule. All WISDOM Study participants will receive one of the currently approved screening guidelines. You will have the peace of mind knowing that your own personal health history is being considered whatever your recommendation. As a WISDOM Study participant, you will have a personal evaluation to determine your screening recommendation based on your answers to the health history questionnaire (and your mammogram report if you have had one). You will also receive information about how to prevent breast cancer and keep healthy.
    An important aspect of the WISDOM Study is an ongoing review of your breast health history and current exams by our clinical team in order to detect any changes in your breast tissue. As part of WISDOM, you have the option to have a personal Mammosphere account for a digital tool called Mammosphere. You will use Mammosphere to electronically request your breast health records from your doctor and share those records with the study team. Simple and secure.

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    What is Routine Annual Screening?

    Routine Annual (or every year) screening is the practice of having a mammogram every year starting at age 40. This is the current guideline that many healthcare providers and patients follow. It is recommended by various medical professional groups such as the American Congress of Obstetricians and Gynecologists and the American College of Radiology.

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    What is Personalized Screening?

    Personalized screening is the practice of having a mammogram on a schedule that is based on a woman’s personal risk factors for breast cancer. This is a new approach to screening that we are evaluating in the WISDOM Study. The personalized screening approach expands upon the guidelines recommended by the United States Preventive Services Task Force. These guidelines recommend that women get a mammogram every other year starting at the age of 50, and that women under 50 discuss with their healthcare provider as to when to start screening.

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    Why should I choose to be randomized?

    Scientists agree that randomization is the very best way to compare two options. The women who agree to be randomly assigned to a group will be supporting generation of new scientific evidence that will end mammogram screening confusion. WISDOM asks that you follow our screening schedule for at least five years in the hopes of clarifying for everyone which method is best.

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    Will my healthcare provider know I am in the WISDOM Study?

    If your healthcare provider is within the University of California or Sanford Health systems, they may be notified of your study participation by a direct email, notation in your electronic health record, or direct outreach. If you receive care at a different facility, all the information will be available to you on your secure WISDOM portal. You are welcome to download the material and discuss it with your healthcare providers. For those women in the personalized arm that have a positive gene mutation, we will directly contact your local physician to ensure results are communicated and appropriate follow-up is in place.

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    When I am due for my mammogram, will the WISDOM Study Team order my mammogram?

    The WISDOM Study team will not order your mammogram. When you are due for your mammogram, please contact your Primary Care Provider to request a mammogram referral.

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    How do I get my health records and mammograms to the study team?

    To help make participation in WISDOM simple and secure, WISDOM has partnered with an application called Mammosphere; a digital health application designed to help women advocate for your own breast health and quality of care by giving you access and control of your entire breast health history and records.
    As part of WISDOM, you have the option to have a personal Mammosphere account and will use this tool to digitally and securely request your breast health records from providers and share those records with the study team.
    Once registered, it’s as easy as 1, 2, 3:

    1. REQUEST: From the Mammosphere homepage, select “Request your exams” and follow the instructions to digitally request your mammogram images and reports.
    2. SHARE: Mammosphere will notify you via email once your record request has been fulfilled. Log into your Mammosphere account to view your records and fill out the brief “Share your exams” form. Select the exams you want to share and find the “WISDOM Study” in the facility list. Done!
    3. UPDATE: Any time you receive a mammogram and report in the future, simply log into Mammosphere to request the exam from you provider, and share that exam with the WISDOM Study team with just a few clicks.

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    Will my information be secure? Who will see it?

    Your security and privacy is important. When you share your WISDOM as part of the study, you are sharing with physicians and a research team that is part of the top breast health network in the country. We are committed to the security of your information.
    As part of WISDOM, you have the option to have a personal Mammosphere account and will use this tool to electronically and securely request and share your breast health records with the WISDOM Study team. Simple. Scientific. Secure.

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    I have questions, how do I reach the Mammosphere team?

    There are a couple of ways to get in touch with the Mammosphere team:

    1. By email: support@mammosphere.com
    2. By phone: 1 844-626-6617

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    What factors will you use to determine my breast cancer risk?

    Decades of research have provided us with a better understanding of breast cancer biology and the factors that contribute to breast cancer risk. This Wisdom study will give us the opportunity to use what we now know to find the safest and most effective breast screening program for all women. We will be looking at the following to determine your breast cancer risk regardless of which group you are in (Annual or Personalized):

    • Your Age
    • Your race/ethnicity
    • Your family history of breast cancer
    • Your history of benign (non-cancer) breast issues
    • Your breast density (how fibrous and glandular your breast tissue is, which can be seen on your mammogram)
    If you are in the Personalized group, these additional factors will be included in your breast cancer risk assessment:
    • Your genes (inherited gene mutations that have been linked to breast cancer risk)

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    What if I move or change where I receive my care during the study?

    We currently can follow women living anywhere in California, or the Midwestern states where Sanford Health Network operates. If you move during the study, please update your contact information on your secure WISDOM portal, and contact your study coordinator if you are moving out of state at info@WISDOMstudy.org or 855-729-2844

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    How will the WISDOM Study contact me?

    We will primarily communicate with you by email. We will send you reminders to complete study steps, notify you when your results are ready, and send you updates from the study team. We may also contact you by phone or text, so we ask that you provide your phone number. We will not use your contact information for purposes outside of WISDOM Study communications, and will not sell your information to any third parties.

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    What if I usually get my mammograms somewhere else? (Not at a UC Medical Center or Sanford Health Center)

    During the consent process, we ask that you sign a medical release form which allows us to request your mammogram and other follow up records.

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    What happens if I find a lump or experience another breast symptom?

    If you discover a breast lump or other breast symptom, please contact your Primary Care Provider who will evaluate the area and recommend appropriate next steps. Please do not put off getting a mammogram to evaluate a symptom due to your involvement in the WISDOM Study.

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    What happens if my personal/family history changes once I’m assigned to a study group?

    As a WISDOM participant, we ask that you complete a yearly questionnaire to keep us updated. If your risk should change based on changes in your personal health or family history, we will reassign you to the appropriate risk group.

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    What if my insurance changes while I am in the study?

    Changes to your insurance do not affect your participation in the trial, but please keep us informed within your secure participant WISDOM portal.

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    Genetic Testing

    Who provides genetic testing?

    Color Genomics provides the genetic testing for the WISDOM Study. They will mail you a saliva kit to collect your saliva sample along with a return box and shipping label to mail back to the lab. Color Genomics will look for genetic clues, and return the results to the WISDOM Study team to give to you. The Color test used in WISDOM will only test for genes linked to breast cancer risk and does not test other genes in the standard commercial Color test.

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    What genetic information are you testing?

    The WISDOM Study is looking at nine genes associated with breast cancer risk. These nine genes are:

  • BRCA1
  • BRCA2
  • ATM
  • P53
  • PTEN
  • CHEK2
  • CDH1
  • PALB2
  • STK11
  • In addition, the WISDOM Study is looking at over 100 single nucleotide polymorphisms (SNPs), which are small changes in the genes that individually do not mean much, but collectively can increase or decrease a woman’s breast cancer risk. In most cases, the SNP score itself will not place a woman into a higher risk category.

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    Does the Annual group have access to genetic testing?

    The Annual Screening group will not receive genetic testing through the WISDOM Study. If desired, women in the annual group can purchase the genetic test outside of the study at www.color.com

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    How long will it take to get my results?

    Color's emphasis is on providing you with the highest quality results possible, and that means giving individual attention to every sample. The average turnaround time is currently 4-10 weeks from the day your sample is received at the laboratory, but the actual time will be subject to the data associated with each unique sample. Color will notify you via email each step of the way: when your kit has shipped, when you've successfully activated it, when your sample has arrived back at the lab, and when your results are ready.

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    What type of results can I expect?

    As a part of the study, a number of genes will be tested to see if you have a genetic mutation that is associated with increased breast cancer risk. It is possible that as new genes related to cancer risk are discovered, they may be added to this list, and we will notify you if changes to your medical care are indicated. We will provide the results of your genetic testing to you as part of the study. A Breast Health Specialist will be available to talk with you about your results and what they mean to your health and to your family members’ health. In addition, Color Genomics will also look for small alterations in all your genes that might contribute to breast cancer risk. Scientists call these minor differences single nucleotide polymorphisms (SNPs). The SNP results will not be returned but will be incorporated into screening recommendations. Please note, only about 1-3% of women test positive for a gene alteration.

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    Can I be discriminated against by insurance companies if I should test positive for a gene mutation?

    No. The Genetics Information Nondiscrimination Act of 2008 (GINA) is a federal law that protects individuals from genetic discrimination in health insurance and employment. The Act prohibits group health plans and health insurers from denying coverage to a healthy individual or charging that person higher premiums based solely on a genetic predisposition to developing a disease in the future. It also bars employers from using individuals’ genetic information when making hiring, firing, job placement, or promotion decisions. For more information about GINA, please click here.

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    Will my genetic test results become part of my medical record?

    If you are seen at a participating health center in the University of California (Athena Breast Health Network), your genetic testing results and study screening recommendations may be entered into your electronic medical record.
    If you have never been seen within the University of California or Sanford Heath Network, your information will be available only to you on your secure WISDOM portal. You may share these results and recommendations with your primary care physician if you wish.

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