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

NCT ID: NCT06441474

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-02

Study Completion Date

2028-04-02

Brief Summary

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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

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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.

Conditions

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Breast Cancer Female

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Breast cancer risk

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

Group Type OTHER

Presentation of personal breast cancer risk estimate

Intervention Type BEHAVIORAL

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

Interventions

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Presentation of personal breast cancer risk estimate

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

39 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Scherer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Erika Waters, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University at St. Louis

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status RECRUITING

Washington University in St. Louis

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Damilola Jolaoso, MSc

Role: CONTACT

303-724-2504

Michelle Eggers

Role: CONTACT

Other Identifiers

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1R01CA279953-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-0345.cc

Identifier Type: -

Identifier Source: org_study_id

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