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

NCT06975085 | Completed Phase 2

• 2 other identifiers: 23-0345R01CA279953
• Study Type: interventional
• Target: 781
• Locations: 1 country
• Sites: 1

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

breast cancer risk; risk perceptions; screening intentions

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: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will

  at baseline survey

Study Arms (1)

Breast cancer risk presentation

OTHER

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

Behavioral: Presentation of a personal breast cancer risk estimate

Interventions

Presentation of a personal breast cancer risk estimate 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.

Breast cancer risk presentation

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
• Black or African American race

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

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

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Study Officials

• Laura D Scherer, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Erika Waters, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 16, 2025
• Study Start: April 16, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: IPD and supporting information will be made available when we submit the first manuscript to a journal for review.
• Access Criteria: Anyone will be able to access the IPD and supporting information by downloading it from OSF.

Locations

US (1)