- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07793721
Effects of Risk Presentation Format and Frequently Asked Questions on Breast Cancer Risk Skepticism
26. august 2026 opdateret af: University of Colorado, Denver
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
3000
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Laura D Scherer, PhD
- Telefonnummer: 303-724-3278
- E-mail: laura.scherer@cuanschutz.edu
Undersøgelse Kontakt Backup
- Navn: Emily A Vidal, MS
- Telefonnummer: 303-724-5426
- E-mail: emily.a.vidal@cuanschutz.edu
Studiesteder
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045
- University of Colorado Anschutz Medical Campus
-
Kontakt:
- Kate Noonan, MSW
- Telefonnummer: 303-618-2181
- E-mail: KATE.NOONAN@CUANSCHUTZ.EDU
-
Kontakt:
- Laura D Scherer, PhD
- Telefonnummer: 303-724-3278
- E-mail: laura.scherer@cuanschutz.edu
-
Ledende efterforsker:
- Laura D Scherer, PhD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 5 Year Risk AND N-in-100 Presentation
|
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.
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.
|
|
Eksperimentel: 10 Year Risk AND N-in-100 Presentation
|
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.
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.
|
|
Eksperimentel: Lifetime Risk AND N-in-100 Presentation
|
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.
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.
|
|
Eksperimentel: 5 Year Risk AND N-in-1000 Presentation
|
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.
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.
|
|
Eksperimentel: 10 Year Risk AND N-in-1000 Presentation
|
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.
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.
|
|
Eksperimentel: Lifetime Risk AND N-in-1000 Presentation
|
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.
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk Skepticism
Tidsramme: 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).
|
Day 1
|
|
Risk Perception
Tidsramme: Day 1
|
This measure includes two Likert scale questions assessing the perceived likelihood of developing cancer and the level of worry about getting cancer.
|
Day 1
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Laura D Scherer, PhD, University of Colorado, Denver
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. februar 2027
Studieafslutning (Anslået)
1. april 2027
Datoer for studieregistrering
Først indsendt
18. august 2026
Først indsendt, der opfyldte QC-kriterier
26. august 2026
Først opslået (Faktiske)
28. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26-1163
- R01CA279953 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
IPD and supporting information will be made available when the first manuscript is submitted to a journal for review.
IPD-delingsadgangskriterier
Anyone will be able to access the IPD and supporting information by downloading it from OSF.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .