NCT05376241

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
637

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

October 24, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 17, 2022

Results QC Date

May 16, 2025

Last Update Submit

March 6, 2026

Conditions

Breast Cancer

Keywords

Breast Cancer Screening

Outcome Measures

Primary Outcomes (5)

  • Reactance

    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

    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

    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

    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

  • Screening Intentions

    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

Secondary Outcomes (1)

  • Medical Mistrust Scale (Eaton et al., 2015)

    24 hours

Study Arms (1)

Women age 39-49 in the United States

EXPERIMENTAL

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

Interventions

Decision aidBEHAVIORAL

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.

Women age 39-49 in the United States

Eligibility Criteria

Age39 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (4)

  • Scherer LD, Lewis CL, Cappella JN, Hersch J, McCaffery K, Tate C, Smyth HL, Mosley B, Morse B, Schapira MM. Skeptical reactions to breast cancer screening benefits and harms: Antecedents, consequences, and implications for screening communication. Health Psychol. 2025 Jun;44(6):608-619. doi: 10.1037/hea0001442. Epub 2024 Nov 25.

    PMID: 39585772BACKGROUND

  • Scherer LD, Lewis CL, McCaffery K, Hersch J, Cappella JN, Tate C, Morse B, Arnett K, Mosley B, Smyth HL, Schapira MM. Mammography Screening Preferences Among Screening-Eligible Women in Their 40s : A National U.S. Survey. Ann Intern Med. 2024 Aug;177(8):1069-1077. doi: 10.7326/M23-3325. Epub 2024 Jul 16.

    PMID: 39008858BACKGROUND

  • Parmet T, Yoder G, Morse B, Cappella J, Schapira M, Lewis C, McCaffery K, Smyth H, Hersch J, Scherer LD. Trust in the healthcare system declines after exposure to information about the harms and benefits of breast cancer screening. J Health Psychol. 2025 Nov;30(13):4091-4097. doi: 10.1177/13591053251315383. Epub 2025 Feb 7.

    PMID: 39917819BACKGROUND

  • Morse B, Parmet T, Yoder G, Tate CE, Lewis CL, McCaffery K, Cappella JN, Hersch J, Schapira MM, Scherer LD. Evaluation of how US women react to a decision aid informing them of the harms and benefits of mammography: a qualitative study. BMJ Open. 2025 Mar 18;15(3):e087997. doi: 10.1136/bmjopen-2024-087997.

    PMID: 40107692RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Laura Scherer
Organization
University of Colorado
laura.scherer@cuanschutz.edu
303-724-5749

Study Officials

  • Laura Scherer

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This is a single arm trial with a Decision Aid intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2022

First Posted

May 17, 2022

Study Start

January 3, 2022

Primary Completion

May 7, 2022

Study Completion

May 7, 2022

Last Updated

March 27, 2026

Results First Posted

October 24, 2025

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
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.
More information

Available IPD Datasets

Individual Participant Data Set Access

Locations

US(1)