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Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information: Administrative Supplement Study

Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information in Women

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06975085
Enrollment
781
Registered
2025-05-16
Start date
2025-04-16
Completion date
2025-04-30
Last updated
2026-09-15

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

Conditions

Breast Cancer Female

Keywords

breast cancer risk, risk perceptions, screening intentions

Brief summary

The Understanding and Addressing Rejection of Personalized Cancer Risk Information study is a longitudinal study conducted to understand the nature of phenomenon of personalized cancer risk rejection in the context of mammography screening.

Detailed description

The Understanding and Addressing Rejection of Personalized Cancer Risk Information study seeks to understand the nature of the phenomenon of personalized cancer risk rejection in the context of mammography screening by testing hypotheses about why women reject their risk estimate and the influence of rejection on screening intentions. The Breast Cancer Risk Assessment Tool (BCRAT) will be used to asses participant's breast cancer risk. This model is designed to estimate breast cancer risk in women 35-84, and uses the following predictors: 1) age, 2) age at first menstrual period, 3) age at first live birth, 4) first-degree relatives with breast cancer, 5) previous breast biopsy with atypical hyperplasia, and 6) race/ethnicity. Participants will be required to complete a survey in which they receive their BCRAT model risk estimate and respond to that risk estimate.

Interventions

BEHAVIORALPresentation of a personal breast cancer risk estimate

Participants answer questions that are used to calculate their personal breast cancer risk using the Gail Model. This risk estimate is presented to participants using written text and an icon array.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
39 Years to 74 Years
Healthy volunteers
No

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 4. Black or African American race

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
Number of Participants Who Rejected the Cancer Risk Estimateat baseline surveyParticipants are asked whether they agree or disagree with their Gail Model risk estimate. Risk rejection was defined as disagreement the estimate. An open text box allows them to write the risk number that they believe is accurate for them.
Risk-concordant Information Seekingat baseline surveyParticipants will be given the opportunity to get more information about breast cancer screening, and will be given response options to receive information for women at lower than average risk, higher than average risk, or women with risk that is "about the same as a typical woman". Concordance is measured by agreement between the participants' actual risk estimate and the option that they choose.
Screening Intentionsat baseline surveyScreening intentions were measured on a 5-point Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will. Higher scores indicate greater intention.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLaura D Scherer, PhD

University of Colorado, Denver

PRINCIPAL_INVESTIGATORErika Waters, PhD

Washington University School of Medicine

Participant flow

Recruitment details

Participants were recruited to this one-time online survey using Dynata, an online survey panel

Pre-assignment details

There were 836 participants who were eligible to take the survey based on screener questions and began the survey. 781 participants met eligibility criteria and were included in the enrollment population.

Baseline characteristics

Characteristic
Age, Continuous55.8 Years
STANDARD_DEVIATION 9.63
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
781 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Sex: Female, Male
Female
781 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026