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.
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 |
|
| 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 |
COVID-19-Related Study
Relationship between Perceived Risk and Preventive Health Behaviors during the COVID-19 Pandemic -- The WISDOM Study
Results Summary
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
What was this COVID-19 study about?
People’s beliefs about their risk for certain health problems may affect their choices. During the COVID-19 pandemic, people weighed their risk of getting COVID-19 with the risk of not getting preventive care for health problems like breast cancer.
In this project, the research team did two studies:
- Study 1 looked at whether beliefs about COVID-19 and breast cancer risks were related to canceled health visits. The study also looked at whether people’s traits, such as age, were related to behaviors that increased the risk of getting COVID-19, such as being in large groups or not socially distancing.
- Study 2 looked at whether people’s traits were related to choices they made about their health care and their mental health. Mental health included feeling depressed, anxious, tolerant of being uncertain or lonely, stressed, and avoiding problems.
What were the results?
Study 1. Women who thought their risk for getting COVID-19 was high were more likely to have anxiety than women who thought their risk was low. Women who thought their risk was high or low didn’t differ in canceled doctor visits or cancer screenings.
Beliefs about their risk for breast cancer or worry about breast cancer didn’t change over time.
Women who were White, young, or had less education were more likely to engage in COVID-19 risk behaviors. Women with serious health problems were less likely to engage in COVID-19 risk behaviors.
Study 2. Adults with serious health problems were more likely to cancel doctor visits and cancer screenings.
Women reported more anxiety than men. Adults were more likely to have anxiety if they believed they were at high risk for getting COVID-19.
Adults were more likely to have depression and anxiety if they:
- Were young adults
- Couldn’t stand feeling uncertain and lonely
- Avoided problems as a way to cope
- Were stressed from COVID-19 restrictions
- Worried about COVID-19
Adults were also more likely to have depression if they had COVID-19.
Who was in the study?
Study 1 included 13,002 women with scheduled doctor visits or cancer screening at clinics across the United States. Of these, 84 percent were White, 4 percent were Asian, 2 percent were Black or African American, 4 percent were more than one race, and 6 percent were another race or didn’t report their race. Also, 73 percent were ages 40–64.
Study 2 included 74,340 adults living in the United States. Of these, 63 percent were White, 7 percent were Asian, 11 percent were Black, and 3 percent were another race; 15 percent were Hispanic. Also, 52 percent were women, and 34 percent were ages 45–64.
What did the research team do?
Study 1. The research team surveyed women four times in 2020. Patients, patient advocates, and doctors helped design the study.
Study 2. The research team surveyed adults five times from 2020 to 2021.
What were the limits of the study?
Surveys occurred during the first year of the pandemic. Results may have differed after the first year.
How can people use the results?
Doctors can use the results when considering how people’s beliefs about risk affect their care.
Professional Abstract
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
Background
Perception of risk is an important factor in health decision making. Questions remain about how perceptions of risk and preventive health behaviors changed during the COVID-19 pandemic.
Objective
(1) To examine the relationship between a person’s perception of risk for COVID-19 and their risk behaviors for COVID-19; (2) To identify patient characteristics associated with perceptions of risk for COVID-19 and breast cancer; (3) To identify patient characteristics that influence behaviors in response to health recommendations for COVID-19 and breast cancer
Study Design
| Design Element | Description |
|---|---|
| Design | Prospective cohort study |
| Population | WISDOM data set: 13,002 women ages 40–74 participating in the PCORI WISDOM Pragmatic Trial PCORI national data set: 74,340 adults ages 18 and older participating in the PCORI National Survey |
| Outcomes | WISDOM data set: canceled medical visits, including general visits or cancer screening, by patient or clinician; risk behaviors for COVID-19 such as being in large gatherings, not socially distancing, leaving home for nonessential items, and returning to normal activities; anxiety; breast cancer worry; perceived breast cancer risk PCORI national data set: canceled medical visits, including general visits or cancer screening; anxiety; depression; coping behaviors; tolerance of uncertainty and loneliness; COVID-19 restriction stress; COVID-19 worry |
| Data Collection Timeframe | WISDOM data set: Four survey waves: May 10–June 15, 2020; July 11–August 21, 2020; October 1–7, 2020; and December 4–16, 2020 PCORI national data set: Five survey waves: May 10–June 15, 2020; July 11–August 21, 2020; October 1–7, 2020; December 4–16, 2020; and April 8–22, 2021 |
This prospective study examined the relationship between perception of risk for either COVID-19 or breast cancer and corresponding preventive health behaviors.
Using two data sets, researchers administered surveys in multiple waves from 2020 to 2021. They then examined the association between risk perception and behaviors.
The WISDOM data set included 13,002 women with scheduled medical visits, including general visits or cancer screening, at clinics in the United States. Of these, 84% were White, 4% were Asian, 2% were Black or African American, 6% were another race or did not report their race, and 4% were more than one race. Also, 73% were ages 40–64. Patients, patient advocates, and clinicians helped design the study.
The PCORI national data set included 74,340 adults living in the United States. Of these, 63% were White, 11% were Black, 7% were Asian, and 3% were another race; 15% were Hispanic. Also, 52% were female, and 34% were ages 45–64.
Results
WISDOM. Across all survey waves, women with higher perceived risk for COVID-19 had higher anxiety. The percentage of medical visits a clinician or participant canceled did not differ by level of perceived risk for COVID-19.
Perceived risk for breast cancer and breast cancer worry did not change significantly across survey waves.
Women who were White, young, or had less education were more likely to engage in COVID-19 risk behaviors. Women with serious health problems were less likely to engage in COVID-19 risk behaviors.
PCORI National. Across the first four waves, adults with serious health problems were more likely to cancel medical visits.
Adults were more likely to have anxiety if they believed they were at a higher risk for COVID-19. Across all waves, women reported more anxiety than men.
Adults were more likely to have depression and anxiety if they:
- Were young adults
- Had lower tolerance for uncertainty and loneliness
- Had stress from COVID-19 restrictions
- Worried about COVID-19
- Used avoidance coping behaviors
Adults were also more likely to have depression if they had COVID-19.
Limitations
Surveys occurred during the first year of the pandemic. Results may differ at later times.
Conclusions and Relevance
In this study, perception of risk for breast cancer and COVID-19 did not influence preventive behaviors. Participants with serious health problems were less likely to engage in behaviors that increased their risk for COVID-19 and were more likely to cancel medical visits. Participants with higher perceived risk for COVID-19 had higher levels of anxiety and were more likely to have depression if they had COVID-19.
Peer Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers requested more information about how the researchers handled missing information in the surveys, and why they chose to delete a respondent’s survey if some answers were missing. The researchers stated that they did impute some data, such as household income, but did not impute data for other dependent or independent variables. The original study and this COVID-19-focused enhancement study used listwise deletion to remove respondents who had not answered all survey questions.
- The reviewers asked the researchers to expand the report in a number of areas, especially in the description of the original study from which this COVID-19-focused project stemmed, which focused on breast cancer screening. In addition, the reviewers asked for more information on how stakeholders were engaged in the research study development and how the researchers elicited stakeholder feedback for this study. The section on patient and stakeholder engagement described opportunities the researchers took to describe their project at various events but did not provide information on exactly how stakeholder feedback affected the study design, methods and interpretation.
- The reviewers noted that the study sample of respondents did not match the U.S. population, with an overrepresentation of White respondents and underrepresentation of respondents identifying as Latino or Hispanic. The researchers pointed out their description of the sampling process showed that their sample from the national survey was close to the U.S. population. In the sample of women from the parent research project, there was limited racial and ethnic diversity. The parent study improved ethnic and racial representation in their sample later, after the cohort for this enhancement study was recruited.
Final Enhancement Report
View this COVID-19 study's final enhancement report.
DOI - Digital Object Identifier: 10.25302/05.2023.PCS.140210749_C19