Frequently Asked Questions • Wisdom

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 can discover the best screening guidelines for ourselves, our sisters, our daughters, and future generations of women. Together, we can 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 may also have access to advanced testing and data that is not routinely available, as well as, have access to the latest information on breast health provided from a source you can trust. Most advances that have been made in the prevention, 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 the next generation.

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What is the purpose of the Wisdom study?

The goal of this study is to find the safest and most effective schedule for women to get screened for breast cancer. 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 annual and personalized screening.

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Why is this 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 annual screening or personalized screening.

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Who is conducting this study?

The Athena Breast Health Network 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 (UCD, UCI, UCLA, UCSD, UCSF) and the Sanford Health System, a rural health care system in the Mid-west region of the United States. The Athena Breast Health Network has been working for and with women over the last 5 years and has collected data on more than 85,000 women. For more information on Athena visit our website at www.athenacarenetwork.org

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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.

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Is the Wisdom study part of Athena research?

Yes. The Wisdom study is a way for Athena to harness the power of the collaboration across the network and gather a large set of data which in turn will help us find the best way to screen all women for breast cancer. The goal of Athena is to take what we learn through research and integrate it with your care in a short period of time.

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Participation

How can I participate in the Wisdom study?

You can participate in the study if you are a female between 40 and 74 years old, have never had a breast cancer diagnosis or ductal carcinoma in situ (DCIS) diagnosis, and get your mammogram at a participating facility. (Please check our website for the list of sites that are currently participating in the study). We will confirm that you meet the study criteria, have appropriate health care coverage, and can be in the study. If continuing onto the study, you would complete a health questionnaire and possibly provide a saliva sample.

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Is there any cost or compensation for participating in the trial?

Your insurance provider will be billed and cover all costs of services throughout the study. There is no monetary compensation for participating in the study

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What can I expect once I join the Wisdom Study?

If you are in the Routine Annual Screening group:

  1. You will complete a series of questionnaires, including questions about your health history.
  2. We will encourage you to have an initial screening mammogram, or return for your next mammogram 12 months from the date of your most recent mammogram.
  3. If our team believes you are at higher than average risk for breast cancer, based on your answers to the questionnaire and whether you have dense breasts that are harder to screen, you will receive a copy of your detailed risk report. You will have the opportunity to discuss your risk over the phone with a Breast Health Specialist, an individual who has specialized training in breast cancer risk assessment and genetics. She may recommend follow-up activities, such as more frequent mammogram 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 an increased risk of breast cancer.
  2. You will receive a screening recommendation that is based on the results of your answers to the questionnaire, whether you have dense breasts that are harder to screen, and your genetic testing results. This screening recommendation summary recommends when you should return for your next mammogram based on whether you are at higher than average, average, or lower risk for breast cancer. You could be asked to return in 6 months, 1 year, 2 years, or wait until you turn 50 to start screening (if you are not yet 50 already).
  3. If you are determined to be at elevated risk, you will receive a call from a Breast Health Specialist. She may recommend follow-up activities or suggest ideas 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 works to end the confusion about what is the best way to use the screening mammogram tool. If you are eligible to join, you will fill out some questionnaires, and then you will be randomly assigned into one of two screening groups: Routine Annual Screening group or Personalized Screening group. You will have the option to choose your study group if you do not agree to be assigned to a group. 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. All Wisdom Study participants 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 help keep healthy.

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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 most doctors and patients follow. It is recommended by various medical professional groups such as the American Congress of Obstetricians and Gynecologists, the American College of Radiology, and the American Medical Association.

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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. This is a newer approach to screening that we are evaluating in the Wisdom study. This 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 doctor when to start screening.

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Will my doctor know I am in the Wisdom study?

The doctor that ordered your mammogram will receive a letter indicating that you are in the study. The letter will include your risk of developing breast cancer and our screening recommendations for you. This will be the same information that you will receive, so you will be able to discuss this with your doctor if you wish. If you would like a copy of this risk report sent to another provider, you can let us know that when you come in for your mammogram.

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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 (Routine 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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Genetic Testing

Who provides genetic testing?

Color Genomics will be providing the genetic testing for the Wisdom Study. They will provide you with 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. To learn more, go to https://getcolor.com (Wisdom study will only test for genes linked to breast cancer risk. Wisdom study does not test other genes in the standard Color Genomics panel).

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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 alterations that increase 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 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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