Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R37CA254926 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision aid | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Female
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laura Scherer | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39585772 | Background | 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. | |
| 39008858 | Background | 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. |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
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.
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.
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analytic sample was N=495, due to 17 participants excluded for failing 2 attention check questions
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Scherer | University of Colorado | 303-724-5749 | laura.scherer@cuanschutz.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2021 | Aug 6, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2022 | Aug 6, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided
This is a single arm trial with a Decision Aid intervention.
Not provided
Not provided
Not provided
Not provided
| 39917819 | Background | 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. |
| 40107692 | Result | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | 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 5 point Likert scale, with mean scores that range from 1 to 5. Higher mean score reflects more source derogation. | 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. | Posted | Mean | Standard Error | score on a scale | 24 hours |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | 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. | Posted | Count of Participants | Participants | 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
|
|
|
| 0 |
| 495 |
| 0 |
| 495 |
| 0 |
| 495 |
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| never have a mammogram |
|