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

Recruiting

• Conditions: Breast Cancer Female

• Registration Number: NCT06441474
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The Understanding and Addressing Rejection of Personalized Cancer Risk Information study is a longitudinal observational 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 1) identifying demographic and psychological factors associated with risk rejection and 2) identify how risk rejection influences risk-concordant mammography seeking 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 Gail model risk estimate and respond to that risk estimate. They will then complete a 12-month follow-up survey.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-05-28
• Study First Posted: 2024-06-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-07
• Study Start: 2025-12
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 750

Inclusion Criteria

1. Female sex
2. Age 39-49 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision)
3. English literacy

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Screening intentions	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.
Risk rejection as measured by a numeric estimate.	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.
Receipt of screening	At 12 month follow-up survey	Participants are asked if they received a mammogram in the past 12 months following the baseline survey.
Risk rejection as measured by risk relative to a typical woman their age.	At baseline survey	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: 1. I think my risk is higher than a typical woman my age.; 2. I think my risk is about the same as a typical woman my age.; 3. I think my risk is lower than a typical woman my age.
Risk rejection as measured by a validated believability scale	At baseline survey	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: 1. Overall, how much do you agree or disagree with your personal breast cancer risk estimate?; 2. In my opinion, my personal breast cancer risk estimate was believable.; 3. In my opinion, my personal breast cancer risk estimate was convincing.; 4. In my opinion, my personal breast cancer risk estimate was accurate.; Each question is answered on a 5-point agree-disagree Likert scale.
Risk-concordant information seeking	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 low risk women, high risk women, 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.

Secondary Outcome Measures

Name	Time	Method
Participant score on Objective numeracy	At baseline survey	Adapted from Schwartz \& Woloshin 1997, participants are asked three math questions to assess their understanding of probability. The questions are: 1. Imagine you flip a nickel 1,000 times. What is your best guess about how many times the coin would come up heads?; 2. Imagine that the chance of getting a disease is 1%. If there were 1,000 people, about how many would be expected to get the disease?; 3. Imagine that the chance of getting a disease is 1 in 1,000. What percent of people would be expected to get the disease?
Racial demographic of participants	At baseline survey	Participants are asked about their race and whether or not they are of Hispanic or Latino origin.
Participant score on Subjective numeracy	At baseline survey	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: 1. How good are you at working with fractions?; 2. How good are you at figuring out how much a shirt will cost if it is 25% off?; 3. How often do you find numerical information to be useful?
Participant score on Health literacy	At baseline survey	Adapted from HINTS 4 Cycle 2, participants are asked questions on their perceived confidence in understanding and using health information. These questions are: 1. How confident are you that you could find advice or information about your health if you needed it?; 2. How confident are you about your ability to take good care of your health?; 3. How confident are you about your ability to understand information about your health? Each questions is measured on a 5-point not all confident-completely confident Likert scale.

Trial Locations

Locations (2)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States