Promoting Informed Choice for Breast Cancer Screening

Breast Cancer Clinical Trial

Official title:

Understanding Affective Processing of Scientific Evidence to Promote Informed Choice for Breast Cancer Screening

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05376241
• Other study ID #: 20-1866.cc
• Secondary ID: R01CA254926
• Status: Active, not recruiting
• Start date: August 7, 2020
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 498
• Est. completion date: May 2025
• Est. primary completion date: May 7, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 39 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 7. Higher mean scores reflect greater reactance.	24 hours
Primary	Disbelief	In response to mammography evidence, feeling that the evidence is not accurate or believable. 4 questions total, each on a 7 point Likert scale, with mean scores that range from 1 to 7. Higher mean score reflects more disbelief in the information.	24 hours
Primary	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 7 point Likert scale, with mean scores that range from 1 to 7. Higher mean score reflects more source derogation.	24 hours
Primary	Self exemption	Feeling that mammography evidence is not relevant to oneself.34 questions total, each on a 7 point Likert scale, with mean scores that range from 1 to 7. Higher mean scores indicate greater belief that the information is not self relevant.	24 hours
Primary	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	Medical mistrust scale (Eaton et al., 2015)	6 question scale that assesses mistrust in healthcare providers. Calculated as mean trust (range 1-low trust to 5-high trust). Assessed both pre and post receipt of screening decision aid to evaluate change	24 hours
Secondary	Mammography screening knowledge (adapted from Hersch et al., 2015)	10 items that assess knowledge about mammography benefits and harms such as overdiagnosis; calculated as proportion out of 10 correct. Higher scores reflect greater knowledge; assessed both pre vs. post receipt of screening decision aid	24 hours