Skip to main content
OpenTrials
Completed

NCT Number: NCT06975085

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Female

Age range

39 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Black or African American race

Exclusion criteria

  • 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.

Treatment and study plan

Presentation of a personal breast cancer risk estimate

Behavioral

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.

Primary outcomes

  1. Risk rejection as measured by a numeric estimate

    Time frame: at baseline survey

    Participants 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.

  2. Risk-concordant information seeking

    Time frame: at baseline survey

    Participants 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.

  3. Screening intentions

    Time frame: at baseline survey

    Participants are asked: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.