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

Understanding and Addressing Rejection of Personalized Cancer Risk Information

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06441474
Enrollment
726
Registered
2024-06-04
Start date
2025-04-02
Completion date
2028-04-02
Last updated
2026-05-19

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

Conditions

Breast Cancer Female

Keywords

Risk rejection, Screening behaviour

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 1) identifying demographic and psychological factors associated with risk rejection and 2) identify how risk rejection influences risk-concordant mammography screening behavior. The study will test a priori theory-derived hypotheses about the precursors of risk rejection and the influence of rejection on real-life screening decision making. 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 the baseline survey in which they receive their BCRAT model risk estimate and respond to that risk estimate. They will then complete a 12-month follow-up survey.

Interventions

BEHAVIORALPresentation of personal breast cancer risk estimate

All participants will be presented with their personal breast cancer risk estimate, calculated using the Gail Model

Sponsors

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

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 rejection as measured by a numeric estimate.At baseline surveyParticipants are asked whether they agree or disagree with their Gail Model risk 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 surveyParticipants are asked their plans to get a mammogram in the next 12 months. The question is answered on a 5-point will-will not Likert scale.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLaura Scherer, PhD

University of Colorado, Denver

PRINCIPAL_INVESTIGATORErika Waters, PhD

Washington University at St. Louis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026