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

NCT ID: NCT06975085

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 781 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-16
• Study Completion Date: 2025-04-30

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 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.

Conditions

Breast Cancer Female

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Breast cancer risk presentation

All participants are presented with their personal breast cancer risk, estimated using the Gail Model

Group Type: OTHER

Presentation of a personal breast cancer risk estimate

Intervention Type: 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.

Interventions

Presentation of a personal breast cancer risk estimate

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

4. Black or African American race

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

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura D Scherer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Erika Waters, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

University of Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

R01CA279953

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-0345

Identifier Type: -

Identifier Source: org_study_id