- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07793721
Effects of Risk Presentation Format and Frequently Asked Questions on Breast Cancer Risk Skepticism
26 sierpnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
3000
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Laura D Scherer, PhD
- Numer telefonu: 303-724-3278
- E-mail: laura.scherer@cuanschutz.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Emily A Vidal, MS
- Numer telefonu: 303-724-5426
- E-mail: emily.a.vidal@cuanschutz.edu
Lokalizacje studiów
-
-
Colorado
-
Aurora, Colorado, Stany Zjednoczone, 80045
- University of Colorado Anschutz Medical Campus
-
Kontakt:
- Kate Noonan, MSW
- Numer telefonu: 303-618-2181
- E-mail: KATE.NOONAN@CUANSCHUTZ.EDU
-
Kontakt:
- Laura D Scherer, PhD
- Numer telefonu: 303-724-3278
- E-mail: laura.scherer@cuanschutz.edu
-
Główny śledczy:
- Laura D Scherer, PhD
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Risk Skepticism
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Laura D Scherer, PhD, University of Colorado, Denver
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 września 2026
Zakończenie podstawowe (Szacowany)
1 lutego 2027
Ukończenie studiów (Szacowany)
1 kwietnia 2027
Daty rejestracji na studia
Pierwszy przesłany
18 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
26 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
28 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
28 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
26 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 26-1163
- R01CA279953 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
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.
Ramy czasowe udostępniania IPD
IPD and supporting information will be made available when the first manuscript is submitted to a journal for review.
Kryteria dostępu do udostępniania IPD
Anyone will be able to access the IPD and supporting information by downloading it from OSF.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .