- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07793721
Effects of Risk Presentation Format and Frequently Asked Questions on Breast Cancer Risk Skepticism
keskiviikko 26. elokuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Ehdot
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
3000
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Laura D Scherer, PhD
- Puhelinnumero: 303-724-3278
- Sähköposti: laura.scherer@cuanschutz.edu
Tutki yhteystietojen varmuuskopiointi
- Nimi: Emily A Vidal, MS
- Puhelinnumero: 303-724-5426
- Sähköposti: emily.a.vidal@cuanschutz.edu
Opiskelupaikat
-
-
Colorado
-
Aurora, Colorado, Yhdysvallat, 80045
- University of Colorado Anschutz Medical Campus
-
Ottaa yhteyttä:
- Kate Noonan, MSW
- Puhelinnumero: 303-618-2181
- Sähköposti: KATE.NOONAN@CUANSCHUTZ.EDU
-
Ottaa yhteyttä:
- Laura D Scherer, PhD
- Puhelinnumero: 303-724-3278
- Sähköposti: laura.scherer@cuanschutz.edu
-
Päätutkija:
- Laura D Scherer, PhD
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Joo
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Tehtävätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Risk Skepticism
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Laura D Scherer, PhD, University of Colorado, Denver
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Tiistai 1. syyskuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Maanantai 1. helmikuuta 2027
Opintojen valmistuminen (Arvioitu)
Torstai 1. huhtikuuta 2027
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 18. elokuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 26. elokuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Perjantai 28. elokuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 28. elokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 26. elokuuta 2026
Viimeksi vahvistettu
Lauantai 1. elokuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 26-1163
- R01CA279953 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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-jaon aikakehys
IPD and supporting information will be made available when the first manuscript is submitted to a journal for review.
IPD-jaon käyttöoikeuskriteerit
Anyone will be able to access the IPD and supporting information by downloading it from OSF.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ANALYTIC_CODE
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .