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Effects of Risk Presentation Format and Frequently Asked Questions on Breast Cancer Risk Skepticism

26 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

3000

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • University of Colorado Anschutz Medical Campus
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Laura D Scherer, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  1. Female sex
  2. Age 39-74 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision)
  3. English literacy

Exclusion Criteria:

1. Prior diagnosis of

  1. breast cancer
  2. Ductal carcinoma in situ (DCIS)
  3. Lobular carcinoma in situ (LCIS)
  4. Known BRCA1/2 gene mutation
  5. Cowan syndrome
  6. Li-Fraumeni syndrome
  7. Having received previous chest radiation for treatment of Hodgkin's lymphoma.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 5 Year Risk AND N-in-100 Presentation
Conductual: Risk Presentation Format
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.
Conductual: Frequently Asked Questions Exposure
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
Conductual: Risk Presentation Format
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.
Conductual: Frequently Asked Questions Exposure
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
Conductual: Risk Presentation Format
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.
Conductual: Frequently Asked Questions Exposure
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
Conductual: Risk Presentation Format
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.
Conductual: Frequently Asked Questions Exposure
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
Conductual: Risk Presentation Format
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.
Conductual: Frequently Asked Questions Exposure
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
Conductual: Risk Presentation Format
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.
Conductual: Frequently Asked Questions Exposure
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Risk Skepticism
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Colorado, Denver

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Laura D Scherer, PhD, University of Colorado, Denver

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de febrero de 2027

Finalización del estudio (Estimado)

1 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

18 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de agosto de 2026

Publicado por primera vez (Actual)

28 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 26-1163
  • R01CA279953 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir IPD

IPD and supporting information will be made available when the first manuscript is submitted to a journal for review.

Criterios de acceso compartido de IPD

Anyone will be able to access the IPD and supporting information by downloading it from OSF.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CÓDIGO_ANALÍTICO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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