NCT07228234

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,900

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Nov 2025Nov 2027

Study Start

First participant enrolled

November 6, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Expected
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

6 days

First QC Date

November 11, 2025

Last Update Submit

March 31, 2026

Conditions

Keywords

CommunicationMammography

Outcome Measures

Primary Outcomes (1)

  • Skepticism toward the screening message

    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.

Study Arms (5)

Control condition

EXPERIMENTAL

Participants receive basic information about what mammography screening is

Other: No intervention

Harm/benefit language, survivability information

EXPERIMENTAL

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 happenOther: Breast cancer survivability information

Harm/benefit language, no survivability information

EXPERIMENTAL

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

Outcomes that can happen language, survivability information

EXPERIMENTAL

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 happenOther: Breast cancer survivability information

Outcomes that can happen language, no survivability information

EXPERIMENTAL

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

Interventions

Information about improvements over time in the survivability of breast cancer is provided vs. not

Harm/benefit language, survivability informationOutcomes that can happen language, survivability information

This is the control condition in which only basic information about mammography screening.

Control condition

Information about mortality benefit, false positives and overdiagnosis are referred to throughout the communication as either "harms" and "benefits" or "outcomes that can happen".

Harm/benefit language, no survivability informationHarm/benefit language, survivability informationOutcomes that can happen language, no survivability informationOutcomes that can happen language, survivability information

Eligibility Criteria

Age39 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female, age 39-49

You may not qualify if:

  • No history of breast cancer, no known BRCA1/2 gene mutation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: This is a 2 x 2 +1 randomized factorial design. Participants will be randomly assigned to 1 of 5 experimental conditions, 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2025

First Posted

November 14, 2025

Study Start

November 6, 2025

Primary Completion

November 12, 2025

Study Completion (Estimated)

November 30, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
This information will be made publicly available on the Open Science Framework prior to publishing the a manuscript from these data.
Access Criteria
Anyone will be able to access the IPD via the Open Science Framework.
More information

Locations