Breast Cancer
Conditions
Keywords
Breast Cancer Screening
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.
Detailed 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.
Interventions
BEHAVIORALDecision 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.
Sponsors
University of Colorado, Denver
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This is a single arm trial with a Decision Aid intervention.
Eligibility
Sex/Gender
FEMALE
Age
39 Years to 49 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reactance | 24 hours | 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. |
| Disbelief | 24 hours | 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. |
| Source Derogation | 24 hours | 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. |
| Self Exemption | 24 hours | 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. |
| Screening Intentions | 24 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medical Mistrust Scale (Eaton et al., 2015) | 24 hours | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaura Scherer
University of Colorado, Denver
Participant flow
Recruitment details
Data were collected from January to April 2022 through the online survey research panel Ipsos KnowledgePanel. A total of 637 participants were identified for the survey, but 22 did not meet eligibility criteria, 103 did not complete the survey, and 17 were excluded for failing 2 attention check questions, resulting in a final analytic sample of 495 participants.
Participants by arm
| Arm | Count |
|---|---|
| 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: 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. | 495 |
| Total | 495 |
Baseline characteristics
| Characteristic | Women Age 39-49 in the United States |
|---|---|
| Age, Continuous | 43.9 years STANDARD_DEVIATION 3.2 |
| Race/Ethnicity, Customized Hispanic | 70 Participants |
| Race/Ethnicity, Customized non-hispanic >2 races | 20 Participants |
| Race/Ethnicity, Customized non-hispanic Black | 53 Participants |
| Race/Ethnicity, Customized non-hispanic other race | 25 Participants |
| Race/Ethnicity, Customized Non-hispanic white | 327 Participants |
| Sex: Female, Male Female | 495 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 495 |
| other Total, other adverse events | 0 / 495 |
| serious Total, serious adverse events | 0 / 495 |
Outcome results
Primary
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.
Time frame: 24 hours
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Women Age 39-49 in the United States | Disbelief | Response to screening benefits | 2.06 Score on a scale | Standard Deviation 0.61 |
| Women Age 39-49 in the United States | Disbelief | Response to false positives | 2.32 Score on a scale | Standard Deviation 0.63 |
| Women Age 39-49 in the United States | Disbelief | Response to overdiagnosis | 2.41 Score on a scale | Standard Deviation 0.68 |
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 5. Higher mean scores reflect greater reactance.
Time frame: 24 hours
Population: The group is women aged 39-49 in the United States with no history of breast cancer or known BRCA1/2 mutation, 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Women Age 39-49 in the United States | Reactance | Response to screening benefits | 2.28 score on a scale | Standard Deviation 0.71 |
| Women Age 39-49 in the United States | Reactance | Response to false positives | 2.45 score on a scale | Standard Deviation 0.75 |
| Women Age 39-49 in the United States | Reactance | Response to overdiagnosis | 2.55 score on a scale | Standard Deviation 0.8 |
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
Time frame: 24 hours
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Women Age 39-49 in the United States | Screening Intentions | Have regular mammograms at current age | 286 Participants |
| Women Age 39-49 in the United States | Screening Intentions | Wait until older but before age 50 | 100 Participants |
| Women Age 39-49 in the United States | Screening Intentions | Wait until age 50 | 88 Participants |
| Women Age 39-49 in the United States | Screening Intentions | never have a mammogram | 21 Participants |
Primary
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.
Time frame: 24 hours
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Women Age 39-49 in the United States | Self Exemption | Response to screening benefits | 2.20 score on a scale | Standard Deviation 0.7 |
| Women Age 39-49 in the United States | Self Exemption | Response to false positives | 2.21 score on a scale | Standard Deviation 0.71 |
| Women Age 39-49 in the United States | Self Exemption | Response to overdiagnosis | 2.32 score on a scale | Standard Deviation 0.72 |
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 5 point Likert scale, with mean scores that range from 1 to 5. Higher mean score reflects more source derogation.
Time frame: 24 hours
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Age 39-49 in the United States | Source Derogation | 2.56 score on a scale | Standard Error 0.09 |
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
Time frame: 24 hours
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Women Age 39-49 in the United States | Medical Mistrust Scale (Eaton et al., 2015) | Pre-DA trust | 3.11 score on a scale | Standard Deviation 0.69 |
| Women Age 39-49 in the United States | Medical Mistrust Scale (Eaton et al., 2015) | Post-DA trust | 3.02 score on a scale | Standard Deviation 0.65 |