- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07793721
Effects of Risk Presentation Format and Frequently Asked Questions on Breast Cancer Risk Skepticism
26. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
3000
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Laura D Scherer, PhD
- Telefonnummer: 303-724-3278
- E-Mail: laura.scherer@cuanschutz.edu
Studieren Sie die Kontaktsicherung
- Name: Emily A Vidal, MS
- Telefonnummer: 303-724-5426
- E-Mail: emily.a.vidal@cuanschutz.edu
Studienorte
-
-
Colorado
-
Aurora, Colorado, Vereinigte Staaten, 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
-
Hauptermittler:
- Laura D Scherer, PhD
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Fakultätszuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Risk Skepticism
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Laura D Scherer, PhD, University of Colorado, Denver
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. September 2026
Primärer Abschluss (Geschätzt)
1. Februar 2027
Studienabschluss (Geschätzt)
1. April 2027
Studienanmeldedaten
Zuerst eingereicht
18. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
26. August 2026
Zuerst gepostet (Tatsächlich)
28. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
28. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 26-1163
- R01CA279953 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
IPD and supporting information will be made available when the first manuscript is submitted to a journal for review.
IPD-Sharing-Zugriffskriterien
Anyone will be able to access the IPD and supporting information by downloading it from OSF.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ANALYTIC_CODE
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .