Project Summary

PCORI has identified the need for large studies that look at real-life questions faced by diverse patients, caregivers, and clinicians. To address this need, PCORI launched the Pragmatic Clinical Studies initiative in 2014. Pragmatic clinical studies allow for larger-scale studies with longer timelines to compare the benefits and harms of two or more approaches known to be effective for preventing, diagnosing, treating, or managing a disease or symptom. They focus on everyday care for a wide range of patients. This research project is one of the studies PCORI awarded as part of this program.

COVID-19-Related Project Enhancement

How people view potential risks of a health problem, such as breast cancer, may affect whether they follow guidance for screening. Similarly, how people view the risks for COVID-19 may affect whether they follow public health recommendations.

With this enhancement, the research team wants to learn about the relationship between people’s views about risks and whether they follow health recommendations. The study will focus on breast cancer screening and COVID-19. The team will look at what factors:

  • Affect how people perceive risks for COVID-19 and breast cancer
  • Influence how people make decisions in response to health recommendations

The results will inform ways to encourage people to follow health guidance.

Enhancement Award Amount: $375,736

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

For women and their doctors, deciding what age to start screening for breast cancer with mammograms, which use x-rays, can be a hard decision. Groups like the American Cancer Society and U.S. Preventive Services Task Force have different guidance about whether these exams should start at age 40 or 50. They also disagree about whether women should get these exams every year or less often. Women have different levels of risk for breast cancer. This risk includes a woman’s personal history, family history, and genetics. A screening schedule based on age may not be the best way to screen for breast cancer.

Overscreening for breast cancer can lead to false alarms, with women getting testing or treatment that doesn’t improve their health or could make them worry for no reason. Because of these potential downsides, women who have a low risk for breast cancer may decide they want to get mammograms less often. In contrast, women who have a higher risk may decide they want to get screening more often. Or, they may want to take other steps to reduce their chances of developing cancer at all.

In this study, researchers are testing two types of screening schedules: one based on a woman’s risks and one based on age. They want to find out

  • If the risk-based screening schedule helps decrease false alarms that lead to unneeded tests or treatments
  • How women feel about using a risk-based screening schedule
  • If the type of schedule affects how much women worry about breast cancer
  • Whether women who learn that they are at high risk take other steps to reduce their chances of getting cancer
  • How well each screening schedule detects cancer

Who can this research help?

Results from this research can help women and their doctors make decisions about how often women should get screening for breast cancer based on their risk level and their personal preferences.

What is the research team doing?

The research team is recruiting 100,000 women ages 40 to 74 who are receiving breast cancer screening at clinics in California and at Sanford Health in the Midwest. Women are assigned by chance to one of two screening schedules.

  • Screening based on age: Half of the women receive an annual mammogram and fill out a health survey. Based on their survey answers and results from the first mammogram, researchers identify an elevated risk group. This smaller group has the option to talk with a breast health specialist and can choose a more frequent schedule if they wish. The other women will get a mammogram every year.
  • Screening based on risk: The other half of the women have their breast cancer risk assessed. Risk is based on medical history (for instance, if they have ever smoked or had any previous breast biopsies, and their age at their first menstrual period), family history, and genetic testing. These women complete a health survey and provide a saliva sample for genetic testing. Based on the results, they get advice from a breast health specialist about when to start getting screened, how often, and when to stop.

To find out how many women in the study are diagnosed with advanced breast cancer or have a biopsy for breast cancer during the five years after they join the study, the research team uses medical records. The team also looks at how many women

  • Stick to the screening schedule they were assigned
  • Choose risk-based screening even if they were assigned an age-based screening
  • Take medicine to reduce their risk for breast cancer
  • Get called back for more testing
  • Are diagnosed with cancer between their scheduled screenings
  • Are diagnosed with cancer at any time
  • Are diagnosed with cancer even though they were very low risk
  • Receive treatment for breast cancer

Women in the study also take surveys to help the research team understand how worried they feel about getting breast cancer and how happy they are with the screening decisions they have made.

The research team is workings with patients, their families, and primary care providers to plan this study, as well as with breast cancer advocacy organizations, insurance companies, and government agencies.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial plus self-selection study arm
Population Women ages 40 to 74 years in participating regions who are receiving breast cancer screenings and who have never been diagnosed with breast cancer or ductal carcinoma in-situ (DCIS)
Interventions/
Comparators
  • Age-based breast cancer screening
  • Risk-based breast cancer screening
Outcomes

Primary: late-stage cancer, biopsy rate

Secondary: rate of late-stage cancers, interval cancers rate, rate of systemic therapy, mammogram recall rate, breast biopsy rate, DCIS rate, chemoprevention uptake rate, choice of risk-based versus annual screening in self-assigned cohort, adherence to assigned screening schedule, breast cancer anxiety, decisional regret, ultra-low risk cancer rate

Timeframe 5-year follow-up for primary outcomes after enrollment

Journal Articles

More About This Research

PCORI Blog

Taking the Confusion out of Breast Cancer Screening 
In a PCORI blog post, Study Principal Investigator Laura Esserman and patient partner Diane Heditsian discuss the study's goal to compare different approaches for scheduling mammograms.

Study Website

https://www.thewisdomstudy.org/
University of California San Francisco

Videos

No Two Patients Should Be Treated the Same (right)
Laura Esserman says that patients’ unique backgrounds, circumstances, and values should be considered before doctors choose a treatment.

A Look Ahead: Breast Cancer Screening in 5 Years
Laura Esserman describes her hopes for breast cancer screening practices to provide better outcomes for women.

Project Information

Laura J. Esserman, MD, MBA
University of California, San Francisco
$19,384,746

Key Dates

68 months
February 2015
October 2023
2015

Study Registration Information

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PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care.

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Last updated: February 4, 2021