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Effects of Risk Presentation Format and Frequently Asked Questions on Breast Cancer Risk Skepticism

Effects of Risk Presentation Format and Frequently Asked Questions on Breast Cancer Risk Skepticism

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07793721
Enrollment
3000
Registered
2026-08-28
Start date
2026-09-01
Completion date
2027-04-01
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer risk, risk perception, screening intentions

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.

Interventions

BEHAVIORALRisk Presentation Format

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.

BEHAVIORALFrequently Asked Questions Exposure

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.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
39 Years to 74 Years
Healthy volunteers
Yes

Inclusion criteria

1. Female sex 2. Age 39-74 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision) 3. English literacy

Exclusion criteria

1\. Prior diagnosis of 1. breast cancer 2. Ductal carcinoma in situ (DCIS) 3. Lobular carcinoma in situ (LCIS) 4. Known BRCA1/2 gene mutation 5. Cowan syndrome 6. Li-Fraumeni syndrome 7. Having received previous chest radiation for treatment of Hodgkin's lymphoma.

Design outcomes

Primary

MeasureTime frameDescription
Risk SkepticismDay 1Participants' 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).
Risk PerceptionDay 1This measure includes two Likert scale questions assessing the perceived likelihood of developing cancer and the level of worry about getting cancer.

Countries

United States

Contacts

CONTACTEmily A Vidal, MS
emily.a.vidal@cuanschutz.edu303-724-5426
CONTACTLaura D Scherer, PhD
laura.scherer@cuanschutz.edu303-724-3278
PRINCIPAL_INVESTIGATORLaura D Scherer, PhD

University of Colorado, Denver

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026