The WISDOM Study: Women Informed to Screen Depending on Measures of risk

Clinicaltrials.gov identifier:
NCT02620852 (https://clinicaltrials.gov/show/NCT02620852)

The study is being conducted by researchers at the University of California and at Sanford Health in the Midwest. Contact Information: by phone at 855-729-2844 or by email.

About the Study

The goal of the Wisdom Study is to determine if breast cancer screening can be made better by personalizing each woman’s mammogram schedule, compared to the current one-size-fits-all, annual approach. The Wisdom Study is designed to end the confusion about when to start and how often to have a ~~mammogram~~. For more information, visit the WISDOM Study website.

Type of Study

This Wisdom Study is a preference-tolerant randomized controlled trial. This means that there are two study participation options: randomization or self-selection. If a woman elects to be randomized, she will be randomly assigned to either a personalized screening schedule or an annual screening schedule. If a woman prefers to choose her own screening schedule, she may choose to participate in either the personalized or annual screening group.

What the Study Entails

Participants in the personalized arm
- These women will be asked to submit saliva samples for genetic testing of 9 genes associated with increased breast cancer risk.
- A genetic testing kit will be mailed to the participant’s home address.
- In conjunction with their results from the genetic test, other risk factors like family history, breast density, and previous breast biopsies will be used to determine a woman’s risk for breast cancer according to the Breast Cancer Surveillance Consortium (BCSC) model.
- Their risk results will shape their screening schedule:
  - The high risk women will receive alternating mammograms and MRI’s once every six months starting at age 40
  - The lowest risk women will receive once every other year after age 50 for the women at lowest risk.
- These screenings can occur at the clinic of choice for the participants. Women with concerning mutations will be contacted by a genetic counselor to further explain and inform women of their risk. This consultation is done over the phone and before a woman receives any results with concerning mutations.
Women in the annual screening arm do not receive genetic testing. These women will simply get one mammogram a year at the clinic of their choice.

Participants in both groups will then be asked to complete annual follow-up surveys in the years to come about changes in their breast health.

Details on the Enrollment Process

Participation is done completely online by signing up at wisdomstudy.org. There is no need to come to a participating center as the study can be completed at home. By joining the study, every woman will gain a better understanding of her personalized breast cancer risk, but also help us chart the way forward for breast cancer screening and prevention.

Stepwise process:

Visit www.wisdomstudy.org to learn more about the study
To participate: click Join Now
You will be prompted to complete an Eligibility Survey
- If you are confirmed eligible, you will be prompted to create a Portal Password. This along with the email address you providing when completing the Eligibility Survey will serve as your login credentials for your personal Wisdom portal. This web portal is where you will login to view your unique study related information.
Complete Intake Survey
Select a Study Group
Review the Consent and HIPAA forms
If you decide that you would like to participate, complete the Consent and HIPAA forms by signing the forms via DocuSign.
Complete the following surveys:
- Insurance Survey*
- Breast Health Questionnaire
- Well-being Survey
If you are randomized to the personalized arm or self-select the personalized arm, a genetics (saliva) test will be mailed to you at your home address with instructions on how to complete.

*Some insurance companies have partnered with the Wisdom Study and are covering the genetics test as part of their covered services. Please note that no individual woman will be billed for the genetics test. It will be covered by participating insurers or by the study.

Study Lead Investigator

Laura Esserman, MD MBA: University of California San Francisco

This Study is Open To:

This Study is Not Open To:

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.

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