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Not recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT06441474

Conditions

Breast Cancer Female

Eligibility Criteria

Sex: Female

Age: 39 - 70+

Healthy Volunteers: Not accepted

Interventions

Presentation of personal breast cancer risk estimate

Study Details

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.

Conditions

Breast Cancer Female

Study ID

NCT06441474

Start date

Apr 2, 2025

Status verified date

Feb, 2026

Completion date

Apr 2, 2028

Anticipated

Primary completion date

Apr 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 39 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

750 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Breast cancer risk

All participants receive a personal breast cancer risk estimate using the Gail Model

Interventions

Presentation of personal breast cancer risk estimate

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

Primary outcome measure

  • Risk rejection as measured by a numeric estimate. [ Time Frame: At baseline survey ]
  • Risk-concordant information seeking [ Time Frame: At baseline survey ]
  • Screening intentions [ Time Frame: At baseline survey ]

Central Contacts and Locations

Central contacts

Emily Vidal, MS

303-724-5426Emily.A.Vidal@cuanschutz.edu

Michelle Eggers

meggers@wustl.edu

Locations

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Emily Vidal, MS

303-724-5426emily.a.vidal@cuanschutz.edi

Principal Investigator:

Laura Scherer, PhD

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63130

Principal Investigator:

Erika Waters, PhD, MPH

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Risk rejection
  • Screening behaviour

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-02-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.