Effects of Risk Presentation Format and Frequently Asked Questions on Breast Cancer Risk Skepticism
2 other identifiers
interventional
3,000
1 country
1
Brief Summary
The purpose of this study is to find out whether the way a breast cancer risk estimate is presented affects how women feel about their risk and whether they believe the estimate is accurate for them. Women aged 39-74 will complete an online survey in which they receive a personalized breast cancer risk estimate using the Breast Cancer Risk Assessment Tool (BCRAT). The study includes two experiments. In the first experiment, women are randomly assigned to receive their estimate in different formats: some will see their risk over 5 years, 10 years, or a lifetime, and some will see their risk expressed out of 100 women or out of 1,000 women. In the second experiment, women receive their estimate and then have the opportunity to read answers to frequently asked questions about how breast cancer risk is calculated and what the estimate means. In both experiments, women are asked whether they believe the estimate reflects their true risk. Both experiments are conducted online through a national survey panel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Sep 2026
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2026
CompletedFirst Posted
Study publicly available on registry
August 28, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
Study Completion
Last participant's last visit for all outcomes
April 1, 2027
August 28, 2026
August 1, 2026
5 months
August 18, 2026
August 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Risk Skepticism
Participants' perception of their Gail model risk estimate is trichotomized into three categories: Underestimator (believed risk is lower than estimate), Agreer (believed risk equals estimate), and Overestimator (believed risk is higher than estimate).
Day 1
Risk Perception
This measure includes two Likert scale questions assessing the perceived likelihood of developing cancer and the level of worry about getting cancer.
Day 1
Study Arms (6)
5 Year Risk AND N-in-100 Presentation
EXPERIMENTAL10 Year Risk AND N-in-100 Presentation
EXPERIMENTALLifetime Risk AND N-in-100 Presentation
EXPERIMENTAL5 Year Risk AND N-in-1000 Presentation
EXPERIMENTAL10 Year Risk AND N-in-1000 Presentation
EXPERIMENTALLifetime Risk AND N-in-1000 Presentation
EXPERIMENTALInterventions
Participants receive a personalized breast cancer risk estimate generated by the Gail Model. The format of the estimate varies by random assignment across two dimensions: temporal framing (5-year, 10-year, or lifetime risk) and denominator (risk expressed out of 100 women or out of 1,000 women). All other elements of the risk presentation are held constant across conditions.
Participants receive a personalized breast cancer risk estimate generated by the Gail Model and then view an interactive FAQ document. The FAQ document was developed from qualitative interviews with women who had previously rejected their risk estimates and addresses common questions about how breast cancer risk is calculated, what factors the model does and does not include, what different risk levels mean, and how to discuss results with a physician. FAQ items are displayed as expandable questions; participants click to reveal answers. All participants receive the same FAQ document.
Eligibility Criteria
You may qualify if:
- Female sex
- Age 39-74 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision)
- English literacy
You may not qualify if:
- \. Prior diagnosis of
- breast cancer
- Ductal carcinoma in situ (DCIS)
- Lobular carcinoma in situ (LCIS)
- Known BRCA1/2 gene mutation
- Cowan syndrome
- Li-Fraumeni syndrome
- Having received previous chest radiation for treatment of Hodgkin's lymphoma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura D Scherer, PhD
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2026
First Posted
August 28, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
August 28, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- IPD and supporting information will be made available when the first manuscript is submitted to a journal for review.
- Access Criteria
- Anyone will be able to access the IPD and supporting information by downloading it from OSF.
The protocol, code books, and data set associated with this study will be shared on the Open Science Framework after ensuring that it is completely anonymized.