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

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer Female

Treatments: Behavioral: Presentation of personal breast cancer risk estimate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06441474

23-0345.cc

1R01CA279953-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 750 estimated patients

Sex: Female

Ages: 39 to 74 years old

Volunteers: No Healthy Volunteers

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

2. breast cancer

3. Ductal carcinoma in situ (DCIS)

4. Lobular carcinoma in situ (LCIS)

5. Known BRCA1/2 gene mutation

6. Cowan syndrome

7. Li-Fraumeni syndrome

8. Having received previous chest radiation for treatment of Hodgkin's lymphoma.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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750 participants in 1 patient group

Breast cancer risk

Other group

Description:

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

Treatment:

Behavioral: Presentation of personal breast cancer risk estimate