Evaluating Mammography Communication Approaches

March 31, 2026 updated by: University of Colorado, Denver
This is a randomized online experiment testing different methods for communicating about the benefits and harms of breast cancer screening. Participants will be randomly assigned to experimental conditions which vary whether screening outcomes are referred to as "benefits and harms" vs. "outcomes that can happen with screening", and vary the presence or absence of information about improvements in breast cancer survivability. In a control condition, participants receive basic information about what mammography is (which is also information received in all other conditions). Primary outcomes include skepticism toward the information presented, and screening intentions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized online experiment testing different methods for communicating about the benefits and harms of breast cancer screening. Participants will be randomly assigned to 1 of 5 experimental conditions, in a 2 x 2 + 1 factorial design, which vary (1) whether screening outcomes are referred to as "benefits and harms" vs. "outcomes that can happen with screening", and (2) the presence or absence of information about improvements in breast cancer treatment and survivability. In a 5th arm, a control condition, participants receive basic information about what mammography is (which is also information received in all other conditions). Primary outcomes include skepticism toward the information presented, and screening intentions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1900

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female, age 39-49

Exclusion Criteria:

  • No history of breast cancer, no known BRCA1/2 gene 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: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Control condition
Participants receive basic information about what mammography screening is
Other: No intervention
This is the control condition in which only basic information about mammography screening.
Experimental: Harm/benefit language, survivability information
Outcomes of screening are referred to as "harms" and "benefits"; information about breast cancer survivability is included
Other: Harm/benefit language vs. outcomes that can happen
Information about mortality benefit, false positives and overdiagnosis are referred to throughout the communication as either "harms" and "benefits" or "outcomes that can happen".
Other: Breast cancer survivability information
Information about improvements over time in the survivability of breast cancer is provided vs. not
Experimental: Harm/benefit language, no survivability information
Outcomes of screening are referred to as "harms" and "benefits"; information about breast cancer survivability is not included
Other: Harm/benefit language vs. outcomes that can happen
Information about mortality benefit, false positives and overdiagnosis are referred to throughout the communication as either "harms" and "benefits" or "outcomes that can happen".
Experimental: Outcomes that can happen language, survivability information
Outcomes of screening are referred to as "outcomes that can happen"; information about breast cancer survivability is included
Other: Harm/benefit language vs. outcomes that can happen
Information about mortality benefit, false positives and overdiagnosis are referred to throughout the communication as either "harms" and "benefits" or "outcomes that can happen".
Other: Breast cancer survivability information
Information about improvements over time in the survivability of breast cancer is provided vs. not
Experimental: Outcomes that can happen language, no survivability information
Outcomes of screening are referred to as "outcomes that can happen"; information about breast cancer survivability is not included
Other: Harm/benefit language vs. outcomes that can happen
Information about mortality benefit, false positives and overdiagnosis are referred to throughout the communication as either "harms" and "benefits" or "outcomes that can happen".

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Skepticism toward the screening message
Time Frame: Participant experience entails a one-time survey. This outcome is measured in that survey, immediately after participants read information about mammography screening.
Skepticism toward the screening message is assessed using the RED scale, consisting of 11 questions each measured on a 7-point Likert scale
Participant experience entails a one-time survey. This outcome is measured in that survey, immediately after participants read information about mammography screening.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-0635.cc
  • R37CA254926 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Although these data are anonymized, data will be checked for any potentially identifying information. Any such information will be removed from the data prior to data sharing. The full data (sans potential identifiers) will be made publicly available on the Open Science Framework.

IPD Sharing Time Frame

This information will be made publicly available on the Open Science Framework prior to publishing the a manuscript from these data.

IPD Sharing Access Criteria

Anyone will be able to access the IPD via the Open Science Framework.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • 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

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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