Promoting Informed Choice for Breast Cancer Screening

NCT ID: NCT05376241

Last Updated: 2025-10-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

637 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-07

Study Completion Date

2023-05-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Decision aid

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

39 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Scherer

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 39585772 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39008858 (View on PubMed)

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 Feb 7:13591053251315383. doi: 10.1177/13591053251315383. Online ahead of print.

Reference Type BACKGROUND
PMID: 39917819 (View on PubMed)

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.

Reference Type RESULT
PMID: 40107692 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Study Documents

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Document Type: Individual Participant Data Set

View Document

Other Identifiers

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R37CA254926

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-1866.cc

Identifier Type: -

Identifier Source: org_study_id

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