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

NCT06441474 | Active Not Recruiting

• 2 other identifiers: 23-0345.cc1R01CA279953-01
• Study Type: interventional
• Target: 726
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer Female

Keywords

Risk rejection; Screening behaviour

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Other Outcomes (2)

• Receipt of screening

  At 12 month follow-up survey

• Racial demographic of participants

  At baseline survey

Study Arms (1)

Breast cancer risk

OTHER

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

Behavioral: Presentation of personal breast cancer risk estimate

Interventions

Presentation of personal breast cancer risk estimate BEHAVIORAL

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

Breast cancer risk

Eligibility Criteria

• Age: 39 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female sex
• Age 39-74 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision)
• English literacy

You may not qualify if:

• \. Prior diagnosis of
• breast cancer
• Ductal carcinoma in situ (DCIS)
• Lobular carcinoma in situ (LCIS)
• Known BRCA1/2 gene mutation
• Cowan syndrome
• Li-Fraumeni syndrome
• Having received previous chest radiation for treatment of Hodgkin's lymphoma.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Study Officials

• Laura Scherer, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Erika Waters, PhD

  Washington University at St. Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 4, 2024
• Study Start: April 2, 2025
• Primary Completion (Estimated): April 2, 2027
• Study Completion (Estimated): April 2, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: We will share data and supporting information when we submit the first manuscript for publication.
• Access Criteria: Anyone can access on the Open Science Framework

Locations

US (2)