Project Summary

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?

Some types of cancer are hereditary. With hereditary cancers, people may have many family members who had cancer, or they may have a gene mutation that causes cancer. About 1 in 10 people in the United States are at risk of hereditary cancer. People with this risk often get cancer at a young age.

One way for doctors to find out if a patient is at risk for hereditary cancer is to ask about the patient’s family history. In this type of screening, patients answer questions about their health history and the health of their relatives. Doctors can use different methods to get patients’ family history. These methods vary in

  • How accurate they are
  • How easy they are to use
  • How well they work to identify people at risk for hereditary cancer who should have genetic testing and cancer screening
  • How much anxiety about cancer risk people have as a result of talking about their family history

In this study, the research team is looking at three ways to collect family histories to compare their effectiveness.

Who can this research help?

Healthcare systems may be able to use the results when considering the best ways to identify and provide care for patients at risk for hereditary cancer.

What is the research team doing?

The research team is enrolling 18,000 members of a large healthcare system. The team is assigning patients by chance to one of three groups. Patients in the first group receive usual care. In this group, the doctor asks patients about their family history and provides follow-up care as needed.

Patients in both the second and third groups complete an online family history form. In the second group, patients complete a brief version. This version identifies people at highest risk of hereditary breast and colorectal cancer only; it takes about 10 minutes to complete. In the third group, patients complete a detailed, three-generation family history form. This version takes more time but collects more information to guide care. Patients in both the second and third groups receive cancer screening and follow-up care from a genetic counselor as needed.

The research team is looking at how well each screening method identifies patients at risk for hereditary cancer. The team also wants to know about any negative effects, such as anxiety. Finally, the team is looking at health records to see how many patients

  • Successfully report their family history
  • Complete recommended cancer screening
  • Get recommended genetic testing

Patients, advocacy groups, clinicians, and health insurers are providing input on all aspects of the study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 18,000 members of a large healthcare system who are ages 25–75 and have had ≥2 clinical visits in the past 2 years
  • Doctor collects family history and provides follow-up care (usual care)
  • Patient-administered brief online family history form with appropriate follow-up care from clinicians as recommended by guidelines
  • Patient-administered detailed online family history form with appropriate follow-up care from a genetic counselor and clinicians as recommended by guidelines

Primary: high risk of hereditary cancer, anxiety, proportion up-to-date with cancer screening, resource use related to cancer risk

Secondary: number of patients referred to and evaluated by genetic counseling, number of patients who undergo genetic testing, number of patients diagnosed with a hereditary cancer syndrome, number of patients at average or moderate risk of cancer, cancer-related worry, decisional regret, perceived risk of cancer, completed cancer screening tests, screening findings (precancer and cancer), surgeries performed for cancer prevention, complications from screening, genetics consultations, outpatient tests, screening tests

Timeframe Up to 15-month follow-up for primary outcomes

Project Information

Douglas Corley, MD, PhD
Kaiser Foundation Research Institute
System-Level Capture of Family History Data to Assess Risk of Cancer and Provide Longitudinal Care Coordination

Key Dates

August 2018
August 2025

Study Registration Information


Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies 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. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: September 26, 2023