Breast CancerPhase 2NCT05376241
Promoting Informed Choice for Breast Cancer Screening
A Phase 2 study testing Decision aid in people with Breast Cancer, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 39 to 49 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 637 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2022to 7 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Between 39-49 years of age
- No history of breast cancer
- No known BRCA 1/2 mutation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Understanding Affective Processing of Scientific Evidence to Promote Informed Choice for Breast Cancer Screening
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Decision aid
- Keywords
- Breast Cancer Screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 24 hours
Secondary outcomes (1)
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start3 Jan 2022
- Primary completion7 May 2022
- Study completion7 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm trial with a Decision Aid intervention.
- Masking
- None (open label)
- Enrolment
- 637 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Laura Scherer, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376241
- Sponsor's protocol ID
- 20-1866.cc
- Other IDs
- R37CA254926
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2022
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39585772Scherer 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.
PubMed 39008858Parmet 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.
PubMed 39917819Morse 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.
PubMed 40107692
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Affective Processing of Scientific Evidence to Promote Informed Choice for Breast Cancer Screening
- ClinicalTrials.gov ID
- NCT05376241
- Acronym / sponsor ID
- 20-1866.cc
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer Screening
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 637 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 7 May 2022 (actual)
- Study completion
- 7 May 2022 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Posted 24 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm trial with a Decision Aid intervention.
| Arm | Type | Receives |
|---|---|---|
| Women age 39-49 in the United States | Experimental | Behavioral: Decision aidThe 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. |
Who may qualify
- Ages
- 39 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female
- Between 39-49 years of age
- No history of breast cancer
- No known BRCA 1/2 mutation
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aidMammography 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. | Behavioural | Women age 39-49 in the United States |
Primary outcome
Reactance
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
1 secondary outcome
Medical Mistrust Scale (Eaton et al., 2015)
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 39585772Scherer 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.
- Background: PubMed 39008858Scherer 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.
- Background: PubMed 39917819Parmet 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.
- Results publication: PubMed 40107692Morse 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Scherer principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decision aid in people with Breast Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactance (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05376241, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.