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

Understanding and Addressing Rejection of Personalized Cancer Risk Information

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Behavioral: Presentation of personal breast cancer risk estimate

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 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.

• Study Type: Interventional
• Enrollment (Actual): 726
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

The study population will be from a community sample and local healthcare systems. Participants will be recruited from a community sample from UCHealth and Washington University in St. Louis Barnes Jewish Healthcare system (BJC). Washington University in St. Louis will also recruit in person and through flyers around the community.

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Breast cancer risk; All participants receive a personal breast cancer risk estimate using the Gail Model	Behavioral: Presentation of personal breast cancer risk estimate; All participants will be presented with their personal breast cancer risk estimate, calculated using the Gail Model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk rejection as measured by a numeric estimate.	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.	At baseline survey
Screening intentions	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.	At baseline survey
Risk-concordant information seeking	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.	At baseline survey

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk rejection as measured by risk relative to a typical woman their age.	Participants are told their breast cancer risk compared to a typical woman their age. They are asked whether they agree or disagree with this information, and are given the following response options: I think my risk is higher than a typical woman my age.; I think my risk is about the same as a typical woman my age.; I think my risk is lower than a typical woman my age.	At baseline survey
Risk rejection as measured by a validated believability scale	4 questions will be asked to assess whether participants find their risk estimate to be believable. Those questions will be averaged to create a summary score. The questions are: Overall, how much do you agree or disagree with your personal breast cancer risk estimate?; In my opinion, my personal breast cancer risk estimate was believable.; In my opinion, my personal breast cancer risk estimate was convincing.; In my opinion, my personal breast cancer risk estimate was accurate. Each question is answered on a 5-point agree-disagree Likert scale.	At baseline survey
Participant score on Subjective numeracy	Based on the McNaughton et al. MDM 2015 study, participants are asked questions to assess how they think about numbers and how this may affect their opinions about their breast cancer risk estimate. These questions are: How good are you at working with fractions?; How good are you at figuring out how much a shirt will cost if it is 25% off?; How often do you find numerical information to be useful?	At baseline survey
Goldilocks Risk Skepticism	Participants are asked whether they think their personal breast cancer risk estimate provided by the Risk Calculator is: '1=Much too low', '2=A little too low', '3=Just right', '4=A little too high', '5=Much too high.' This variable will be treated as continuous in analysis, with values on either end of the range (i.e., closer to 1 or closer to 5) indicating higher risk skepticism.	At baseline survey
Participant score on Risk Comprehension	We will be measuring participants' judgement of risk comparisons by asking two questions on 'Which amount is bigger?' Response options for question 1 are: The participant's breast cancer risk out of 1,000 people; 15 out of 1,000 people; They are the same Response options for question 2 are 1- The participant's cancer risk out of 1,000 2- 6 out of 100 3- They are the same Each item will be scored (binary) for correctness.	At baseline survey

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of screening	Participants are asked if they received a mammogram in the past 12 months following the baseline survey.	At 12 month follow-up survey
Racial demographic of participants	Participants are asked about their race and whether or not they are of Hispanic or Latino origin.	At baseline survey

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Laura Scherer, PhD, University of Colorado, Denver; Principal Investigator: Erika Waters, PhD, Washington University at St. Louis

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2025
• Primary Completion (Estimated): April 2, 2027
• Study Completion (Estimated): April 2, 2028

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Risk rejection; Screening behaviour
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 23-0345.cc; 1R01CA279953-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share di-identified data
• IPD Sharing Time Frame: We will share data and supporting information when we submit the first manuscript for publication.
• IPD Sharing Access Criteria: Anyone can access on the Open Science Framework
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No