Promoting Informed Choice for Breast Cancer Screening

March 6, 2026 updated by: University of Colorado, Denver

Understanding Affective Processing of Scientific Evidence to Promote Informed Choice for Breast Cancer Screening

Identify the prevalence and predictors of reactance, self-exemption, disbelief, source derogation in reaction to evidence about mammography benefits and harms, and consequences for decision-making and trust.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, the goal is to identify the prevalence and predictors of reactance, self-exemption, disbelief, and source derogation in reaction to evidence about mammography benefits and harms, and consequences for decision-making and trust. Research has not yet systematically identified the proportion of women who respond negatively (vs. positively) to evidence about the benefits and harms of mammography screening, or attempted to explain these responses by examining theory-driven predictors. The Investigator will develop and conduct a probability-based nationally representative survey in which mammography evidence is communicated using current best practices in risk communication. The Investigators will identify theory-driven predictors of negative and positive responses to that evidence, and identify consequences of these responses for screening decision-making and trust.

Study Type

Interventional

Enrollment (Actual)

637

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Study Population

Women age 39-49 in the United States.

Description

Inclusion Criteria:

  • Female
  • Between 39-49 years of age
  • No history of breast cancer
  • No known BRCA 1/2 mutation

Exclusion Criteria:

  • Non-English or Spanish Speaking
  • Persons unable to provide informed consent (e.g. sever dementia or cognitive disability or illiterate
  • History of breast cancer
  • Known BRCA 1/2 mutation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Women age 39-49 in the United States
The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
Behavioral: Decision aid
Mammography screening decision aid for women in their 40s with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening Intentions
Time Frame: 24 hours
Intentions to engage in mammography screening. Options will include: 1. I am planning to start/continue having regular mammograms this year. 2. I am planning to wait until I'm older but before age 50 to have my first/next mammogram. 3. I am planning to wait until I am 50 to have my first/next mammogram. 4. I am not planning to have a mammogram in the future at any age
24 hours
Reactance
Time Frame: 24 hours
In response to mammography evidence, feeling that the information is manipulative or biased. 4 questions total, each on a 7 point Likert scale, with mean scores that range from 1 to 5. Higher mean scores reflect greater reactance.
24 hours
Disbelief
Time Frame: 24 hours
In response to mammography evidence, feeling that the evidence is not accurate or believable. 4 questions total, each on a 5 point Likert scale, with mean scores that range from 1 to 5. Higher mean score reflects more disbelief in the information.
24 hours
Source Derogation
Time Frame: 24 hours
In response to mammography evidence, feeling that the source of the evidence is not trustworthy or competent. 4 questions total, each on a 5 point Likert scale, with mean scores that range from 1 to 5. Higher mean score reflects more source derogation.
24 hours
Self Exemption
Time Frame: 24 hours
Feeling that mammography evidence is not relevant to oneself.34 questions total, each on a 5 point Likert scale, with mean scores that range from 1 to 5. Higher mean scores indicate greater belief that the information is not self relevant.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical Mistrust Scale (Eaton et al., 2015)
Time Frame: 24 hours
6 question scale that assesses mistrust in healthcare providers. Calculated as mean trust (range 1-low trust to 5-high trust). Assessed both pre and post receipt of screening decision aid to evaluate change
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Laura Scherer, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2022

Primary Completion (Actual)

May 7, 2022

Study Completion (Actual)

May 7, 2022

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

May 13, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-1866.cc
  • R37CA254926 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified survey data will be shared using the Open Science Framework. These data will be shared with reviewers and editors prior to publication of main results. After publication of main results, deidentified data will be made available publicly.

IPD Sharing Time Frame

All elements of the study except data will be shared immediately. Survey data will be shared with reviewers and editors prior to publication of main study results. Survey data will be shared publicly after publication of main study results.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Study Data/Documents

  1. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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