Breast CancerNCT07793721
Effects of Risk Presentation Format and Frequently Asked Questions on Breast Cancer Risk Skepticism
A study testing Risk Presentation Format and Frequently Asked Questions Exposure in people with Breast Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to find out whether the way a breast cancer risk estimate is presented affects how women feel about their risk and whether they believe the estimate is accurate for them. Read more about this study
- Who is it for?
- Ages 39 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Risk Presentation Format and Frequently Asked Questions Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female sex
- Age 39-74 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision)
- English literacy
Who cannot join
- 1. Prior diagnosis of
- breast cancer
- Ductal carcinoma in situ (DCIS)
- Lobular carcinoma in situ (LCIS)
- Known BRCA1/2 gene mutation
- Cowan syndrome
- Li-Fraumeni syndrome
- Having received previous chest radiation for treatment of Hodgkin's lymphoma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Laura D Scherer, PhD, 303-724-3278, laura.scherer@cuanschutz.edu
Kate Noonan, MSW, 303-618-2181, KATE.NOONAN@CUANSCHUTZ.EDU
About this study
The purpose of this study is to find out whether the way a breast cancer risk estimate is presented affects how women feel about their risk and whether they believe the estimate is accurate for them. Women aged 39-74 will complete an online survey in which they receive a personalized breast cancer risk estimate using the Breast Cancer Risk Assessment Tool (BCRAT). The study includes two experiments. In the first experiment, women are randomly assigned to receive their estimate in different formats: some will see their risk over 5 years, 10 years, or a lifetime, and some will see their risk expressed out of 100 women or out of 1,000 women. In the second experiment, women receive their estimate and then have the opportunity to read answers to frequently asked questions about how breast cancer risk is calculated and what the estimate means. In both experiments, women are asked whether they believe the estimate reflects their true risk. Both experiments are conducted online through a national survey panel.
- Conditions
- Breast Cancer
- Being tested
- Risk Presentation Format, Frequently Asked Questions Exposure
- Keywords
- breast cancer risk, risk perception, screening intentions
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Presentation FormatBehavioural
Participants receive a personalized breast cancer risk estimate generated by the Gail Model. The format of the estimate varies by random assignment across two dimensions: temporal framing (5-year, 10-year, or lifetime risk) and denominator (risk expressed out of 100 women or out of 1,000 women). All other elements of the risk presentation are held constant across conditions.
Frequently Asked Questions ExposureBehavioural
Participants receive a personalized breast cancer risk estimate generated by the Gail Model and then view an interactive FAQ document. The FAQ document was developed from qualitative interviews with women who had previously rejected their risk estimates and addresses common questions about how breast cancer risk is calculated, what factors the model does and does not include, what different risk levels mean, and how to discuss results with a physician. FAQ items are displayed as expandable questions; participants click to reveal answers. All participants receive the same FAQ document.
| Study group | Role | What they receive |
|---|---|---|
| 5 Year Risk AND N-in-100 Presentation | Experimental | Not described Receives: Behavioral: Risk Presentation Format; Behavioral: Frequently Asked Questions Exposure |
| 10 Year Risk AND N-in-100 Presentation | Experimental | Not described Receives: Behavioral: Risk Presentation Format; Behavioral: Frequently Asked Questions Exposure |
| Lifetime Risk AND N-in-100 Presentation | Experimental | Not described Receives: Behavioral: Risk Presentation Format; Behavioral: Frequently Asked Questions Exposure |
| 5 Year Risk AND N-in-1000 Presentation | Experimental | Not described Receives: Behavioral: Risk Presentation Format; Behavioral: Frequently Asked Questions Exposure |
| 10 Year Risk AND N-in-1000 Presentation | Experimental | Not described Receives: Behavioral: Risk Presentation Format; Behavioral: Frequently Asked Questions Exposure |
| Lifetime Risk AND N-in-1000 Presentation | Experimental | Not described Receives: Behavioral: Risk Presentation Format; Behavioral: Frequently Asked Questions Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Skepticism
Participants' perception of their Gail model risk estimate is trichotomized into three categories: Underestimator (believed risk is lower than estimate), Agreer (believed risk equals estimate), and Overestimator (believed risk is higher than estimate).
Measured: Day 1
Risk Perception
This measure includes two Likert scale questions assessing the perceived likelihood of developing cancer and the level of worry about getting cancer.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
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 D Scherer, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793721
- Sponsor's protocol ID
- 26-1163
- Other IDs
- R01CA279953
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol, code books, and data set associated with this study will be shared on the Open Science Framework after ensuring that it is completely anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Risk Presentation Format and Frequently Asked Questions on Breast Cancer Risk Skepticism
- ClinicalTrials.gov ID
- NCT07793721
- Acronym / sponsor ID
- 26-1163
- Conditions
- Breast Cancer
- Keywords
- breast cancer risk, risk perception, screening intentions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether the way a breast cancer risk estimate is presented affects how women feel about their risk and whether they believe the estimate is accurate for them. Women aged 39-74 will complete an online survey in which they receive a personalized breast cancer risk estimate using the Breast Cancer Risk Assessment Tool (BCRAT). The study includes two experiments. In the first experiment, women are randomly assigned to receive their estimate in different formats: some will see their risk over 5 years, 10 years, or a lifetime, and some will see their risk expressed out of 100 women or out of 1,000 women. In the second experiment, women receive their estimate and then have the opportunity to read answers to frequently asked questions about how breast cancer risk is calculated and what the estimate means. In both experiments, women are asked whether they believe the estimate reflects their true risk. Both experiments are conducted online through a national survey panel.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 5 Year Risk AND N-in-100 Presentation | Experimental | Behavioral: Risk Presentation Format, Behavioral: Frequently Asked Questions Exposure |
| 10 Year Risk AND N-in-100 Presentation | Experimental | Behavioral: Risk Presentation Format, Behavioral: Frequently Asked Questions Exposure |
| Lifetime Risk AND N-in-100 Presentation | Experimental | Behavioral: Risk Presentation Format, Behavioral: Frequently Asked Questions Exposure |
| 5 Year Risk AND N-in-1000 Presentation | Experimental | Behavioral: Risk Presentation Format, Behavioral: Frequently Asked Questions Exposure |
| 10 Year Risk AND N-in-1000 Presentation | Experimental | Behavioral: Risk Presentation Format, Behavioral: Frequently Asked Questions Exposure |
| Lifetime Risk AND N-in-1000 Presentation | Experimental | Behavioral: Risk Presentation Format, Behavioral: Frequently Asked Questions Exposure |
Who may qualify
- Ages
- 39 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female sex
- Age 39-74 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision)
- English literacy
Key exclusion criteria (8 listed)
- 1. Prior diagnosis of
- breast cancer
- Ductal carcinoma in situ (DCIS)
- Lobular carcinoma in situ (LCIS)
- Known BRCA1/2 gene 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 |
|---|---|---|
| Risk Presentation FormatParticipants receive a personalized breast cancer risk estimate generated by the Gail Model. The format of the estimate varies by random assignment across two dimensions: temporal framing (5-year, 10-year, or lifetime risk) and denominator (risk expressed out of 100 women or out of 1,000 women). All other elements of the risk presentation are held constant across conditions. | Behavioural | 10 Year Risk AND N-in-100 Presentation, 10 Year Risk AND N-in-1000 Presentation, 5 Year Risk AND N-in-100 Presentation, 5 Year Risk AND N-in-1000 Presentation, Lifetime Risk AND N-in-100 Presentation, Lifetime Risk AND N-in-1000 Presentation |
| Frequently Asked Questions ExposureParticipants receive a personalized breast cancer risk estimate generated by the Gail Model and then view an interactive FAQ document. The FAQ document was developed from qualitative interviews with women who had previously rejected their risk estimates and addresses common questions about how breast cancer risk is calculated, what factors the model does and does not include, what different risk levels mean, and how to discuss results with a physician. FAQ items are displayed as expandable questions; participants click to reveal answers. All participants receive the same FAQ document. | Behavioural | 10 Year Risk AND N-in-100 Presentation, 10 Year Risk AND N-in-1000 Presentation, 5 Year Risk AND N-in-100 Presentation, 5 Year Risk AND N-in-1000 Presentation, Lifetime Risk AND N-in-100 Presentation, Lifetime Risk AND N-in-1000 Presentation |
Primary outcome
Risk Skepticism
Time frame: Day 1
Participants' perception of their Gail model risk estimate is trichotomized into three categories: Underestimator (believed risk is lower than estimate), Agreer (believed risk equals estimate), and Overestimator (believed risk is higher than estimate).
Risk Perception
Time frame: Day 1
This measure includes two Likert scale questions assessing the perceived likelihood of developing cancer and the level of worry about getting cancer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes. The protocol, code books, and data set associated with this study will be shared on the Open Science Framework after ensuring that it is completely anonymized.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Laura D Scherer, PhD 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 study testing Risk Presentation Format and Frequently Asked Questions Exposure 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 28 Aug 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily A Vidal, MS (303-724-5426, emily.a.vidal@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Skepticism (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2026.