Promoting Informed Choice for Breast Cancer Screening: A Longitudinal Study

NCT05838417 | Completed DMC

• 2 other identifiers: 22-0957.ccR37CA254926
• Study Type: interventional
• Target: 499
• Locations: 1 country
• Sites: 2

Brief Summary

All participants will read a decision aid (DA) communicating evidence about mammography screening benefits and harms. Participants' evaluations of that evidence will be assessed, along with their screening intentions and receipt of screening. Participants will be sent 3 surveys via email and a final brief survey conducted by email or phone. The four surveys will be collected 1) upon enrollment and prior to the primary care appointment; 2) following the primary care appointment; 3) 3 months after enrollment; 4) 1 year after enrollment. The final 2 surveys will offer an increased incentive to increase retention rates.

Conditions

Breast Cancer

Keywords

No known BCRA 1/2 gene mutation; Mammogram; Breast Cancer Screening

Outcome Measures

Primary Outcomes (4)

• REDS (Reactance, self-Exemption, Disbelief and Source derogation) reactions to mammography benefits

  Reactance, self-Exemption, Disbelief and Source derogation in reaction to evidence about mammography benefits. This is a multi-item measure (3-4 questions per subscale) and assessed on a 1 (strongly disagree) to 5 (strongly agree) Likert scale. Averages will be computed to create for scores (corresponding to each sub scale), with a maximum score of 5 and minimum score of 1.

  12 months

• REDS (Reactance, self-Exemption, Disbelief and Source derogation) reactions to mammography harms

  Reactance, self-Exemption, Disbelief and Source derogation in reaction to evidence about mammography harms (over diagnosis and false positive results). This is a multi-item measure (3-4 questions per subscale) and assessed on a 1 (strongly disagree) to 5 (strongly agree) Likert scale. Averages will be computed to create for scores (corresponding to each sub scale), with a maximum score of 5 and minimum score of 1. Reactions to over diagnosis and false positives will be assessed separately.

  12 months

• Screening intentions question

  This is a single item question in which participants will indicated their intentions to initiate regular screening with mammograms, using a 4 category response: 1. screen now, 2. wait until they are older but before age 50, 3. wait until age 50, or 4. do not intend to screen in the future at any age

  12 months

• Number of participants who receive screening in the study period

  We will use medical records to identify whether the participant has received screening in the 12-month study period

  12 months

Secondary Outcomes (6)

• Change in breast cancer screening knowledge from pre- to post-decision aid

  12 months

• Whether the participant had a conversation with their doctor about screening

  12 months

• Change in medical mistrust from pre- to post-decision aid

  12 months

• Perceptions of breast cancer risk

  12 months

• Emotional responses to the decision aid

  12 months

Study Arms (1)

Cohort-1

EXPERIMENTAL

Individuals who identify as female at birth age 39-49 without a prior breast cancer diagnosis (including DCIS or LCIS) or known BCRA1/2 gene mutations.

Behavioral: REDS survey

Interventions

REDS survey BEHAVIORAL

R - Reactance, E - self-Exemption, D - Disbelief, S - Source derogation

Cohort-1

Eligibility Criteria

• Age: 39 Years - 49 Years
• Gender Eligibility Details: Identify as female at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals who identify as female at birth
• Ages 39-49 years old (inclusive) at the time of consent
• English literacy
• Internet access
• No prior diagnosis of breast cancer, ductal carcinoma in situ (DCIS, also known as "stage zero breast cancer"), or lobular carcinoma in situ
• No known BCRA1/2 gene mutation

You may not qualify if:

• Individuals who identify other than female at birth
• Individuals who are currently pregnant
• Individuals \< 39 years old or 50 years old and \> at the time of consent
• Lack English literacy
• Lack of internet access
• Prior diagnosis of breast cancer, ductal carcinoma in situ (DCIS, also known as "stage zero breast cancer"), or lobular carcinoma in situ
• Known BCRA1/2 gene mutation
• Decisionally Challenged Individuals
• Prisoners or those on alternative sentencing or probation

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Laura Scherer

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: May 1, 2023
• Study Start: November 22, 2022
• Primary Completion: April 28, 2025
• Study Completion: November 30, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)