NLM logo

National Information Center on Health Services Research and Health Care Technology (NICHSR)

HSRProj (Health Services Research Projects in Progress)

Information about ongoing health services research and public health projects


System-level capture of family history data to assess risk of cancer and provide longitudinal care coordination
Investigator (PI): Corley, Douglas
Performing Organization (PO): (Current): Kaiser Permanente, Division of Research / (510) 891-3400
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2019
Final Year: 2025
Record Source/Award ID: PCORI/ IHS-2017C3-9211
Funding: Total Award Amount: $6,914,863
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: This research project is in progress. PCORI will post the research findings on the PCORI website 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, and 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? Health care 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 health care 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, and get recommended genetic testing. Patients, advocacy groups, clinicians, and health insurers are providing input on all aspects of the study. Research methods. Design: The study design is a randomized controlled trial. Population: The study population is 18,000 members of a large health care system who are ages 25-75 and have had e2 clinical visits in the past 2 years. Interventions/comparators are (1) a doctor collects family history and provides follow-up care (usual care), (2) patient-administered brief online family history form with appropriate follow-up care from clinicians as recommended by guidelines, and (3) patient-administered detailed online family history form with appropriate follow-up care from a genetic counselor and clinicians as recommended by guidelines. Outcomes: Outcomes are (a) primary: high risk of hereditary cancer, anxiety, proportion up-to-date with cancer screening, and resource use related to cancer risk; and (b) secondary outcomes: 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, and screening tests. The timeframe is up to 15-month follow-up for primary outcomes.
Abstract Archived: About one in ten people in the United States will develop cancer due to a hereditary predisposition. A hereditary predisposition means an increased risk of cancer due to presence of cancer in multiple family members or due to the inheritance of a cancer-causing gene mutation. People susceptible to hereditary cancer are at a very high risk of developing malignancy, often at an early age. Family history collection has been universally recommended as the best way to identify those at risk of hereditary cancer. However, doctors often do not adequately collect and act upon family history information such that as few as 5% of people at risk of hereditary cancer are identified, and as few as half of them receive recommended preventative health care that can lower their chance of developing or dying from cancer. Our study aims to solve this problem and find the best approach for family history collection (to identify individuals at risk of hereditary cancer) and for provision of follow-up care for those at risk. We propose a large (18,000-person), randomized trial to compare three methods to identify individuals at risk of hereditary cancer and provide them with the recommended follow-up care. The trial will take place in a large health system with members who are diverse in their age, race, ethnicity, income, and urban-rural residence. We will compare 1) physician collection of family history information and physician provision of follow-up care (usual care); 2) patient completion of online prediction models that numerically estimate cancer risk based on select family history information, with follow-up care that is coordinated by a genetic counselor and nurse practitioner team; and 3) online patient completion of a detailed three-generation family history (pedigree), along with follow-up care that is coordinated by a genetic counselor and nurse practitioner team. When the study ends (outcomes), we will better understand the strengths and weaknesses of each method and which is best in terms of benefits and harms that are important to patients. We will learn which method is best for identifying people at risk of hereditary cancer, what patients think about each method, how each method impacts follow-up care that can reduce or prevent cancer mortality, how many health care resources are used in each method, and what is needed to spread these interventions to other health systems. Our study uses a patient-centered research design: 1) the compared methods of family history collection and care coordination are the best available; 2) stakeholder partners have been instrumental since study inception. Stakeholders are crucial to conduct of the study and dissemination of study results, through a stakeholder advisory board. The advisory board includes patients, patient advocacy groups, academic researchers and clinicians, community-based providers, national professional societies, individual health care systems and insurance representatives, health care networks, public health agencies, and industry representatives. This advisory board will help to make the study and its results relevant to a wide audience; and 3) this study is focused on questions and outcomes of interest to patients, families, and other health care stakeholders. Identifying and providing appropriate follow-up care to the large number of people (~1:10 Americans) at risk for hereditary cancer is an important health care goal. Patient-Centered Outcomes Research Institute (PCORI), the National Academy of Medicine, and the Cancer Moonshot have all called for improving prevention and early detection of cancer; our study attempts to accomplish this goal.

MeSH Terms:
  • Continuity of Patient Care
  • Data Collection
  • Follow-Up Studies
  • Genetic Predisposition to Disease
  • Health Services Research
  • Humans
  • Internet
  • Mathematical Model
  • Neoplasms /*diagnosis
  • /genetics /*psychology
  • Outcome Assessment (Health Care)
  • Patient-Centered Care
  • Pedigree
  • Randomized Controlled Trials as Topic
  • Risk
  • Rural Population
  • United States
  • Urban Population
Country: United States
State: California
Zip Code: 94612
UI: 20201437
CTgovId: NCT04145388
Project Status: Ongoing
Record History: ('Alternate title: Comparing three ways to identify and provide care to patients at risk for hereditary cancer',) ('2020: Archived abstract to Abstract Archived 1 field and added new abstract.',)