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NCT Number: NCT06441474

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Female

Age range

39 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver, Aurora, Colorado, United States

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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 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.

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

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 personal breast cancer risk estimate

Behavioral

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

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 their plans to get a mammogram in the next 12 months. The question is answered on a 5-point will-will not Likert scale.

Other outcomes

  1. Receipt of screening

    Time frame: At 12 month follow-up survey

    Participants are asked if they received a mammogram in the past 12 months following the baseline survey.

  2. Racial demographic of participants

    Time frame: At baseline survey

    Participants are asked about their race and whether or not they are of Hispanic or Latino origin.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Understanding and Addressing Rejection of Personalized Cancer Risk Information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 4, 2024
Registry last updated
May 19, 2026

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

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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.

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