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Decision Support for Chemoprevention

4 de noviembre de 2026 actualizado por: Rita Kukafka, Columbia University

Integrating Breast Cancer and Cardiovascular Disease Risk to Explore Decision-Making for Chemoprevention Among Women at High Risk for Breast Cancer

The purpose of this study is to find out whether electronic tools that provide information and reminders to people at high risk for breast cancer and their healthcare providers can increase the use of medications, such as tamoxifen, that may help lower the risk of developing breast cancer. The study will also look at how these tools can be successfully used as part of routine medical care.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This randomized controlled trial will evaluate whether the web-based RealRisks decision aid, combined with standard educational materials, increases breast cancer chemoprevention uptake among women at high risk for breast cancer compared with standard educational materials alone. The intervention incorporates individualized breast cancer and cardiovascular disease risk information to support informed decision-making regarding chemoprevention. The primary endpoint is chemoprevention uptake at 12 months. Secondary outcomes include medication beliefs, breast cancer risk perceptions, informed choice, and decision conflict.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

240

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

    • New York
      • New York, New York, Estados Unidos, 10032
        • Reclutamiento
        • Columbia University Irving Medical Center
        • Contacto:
        • Contacto:
          • Número de teléfono: 212-342-5162

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

40 años a 79 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  1. Women, age 40-79 years (ages which overlap for the BCSC and ASCVD risk calculators)

  2. High-risk for breast cancer based upon any of the following criteria:

    • Histologically-confirmed atypical hyperplasia or lobular carcinoma in situ
    • At least a 3% breast cancer risk at 5 years or 5% risk at 10 years or 20% lifetime risk according to one of the following breast cancer risk models: Breast Cancer Surveillance Consortium risk calculator V3 (https://tools.bcsc-scc.ucdavis.edu/BC5yearRisk/#calculator), Gail Breast Cancer Risk Assessment Tool (https://bcrisktool.cancer.gov/calculator.html), Tyrer-Cuzick model V8 (https://ibis-risk-calculator.magview.com), or BOADICEA canrisk model (https://www.canrisk.org)
    • Known carriers of germline pathogenic/likely pathogenic variant in the following breast cancer predisposition genes (ATM, BRCA2, CHEK2, or PALB2)
    • Prior chest wall irradiation before age 30 years
  3. English- or Spanish-speaking

  4. Has a clinician affiliated with NYP/CUIMC

  5. Able to provide written, verbal or online informed consent

Exclusion Criteria:

  • Patients who have a prior history of invasive breast cancer or ductal carcinoma in situ are ineligible to participate.

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control

Standard educational materials regarding breast cancer chemoprevention.

Experimental: Intervention

Standard educational materials plus access to the RealRisks web-based decision aid. RealRisks provides personalized breast cancer and ASCVD risk assessment, educational modules, and individualized action planning.

Behavioral/Educational Material

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Chemoprevention Uptake
Periodo de tiempo: 12 months after randomization

The primary outcome is to compare the uptake of breast cancer chemoprevention with selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs) at 12 months among women at high-risk for breast cancer assigned to standard educational materials alone or combined with the web-based decision aid, RealRisks. Assessed by EHR log and self-report

12 months after randomization

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Beliefs about medication
Periodo de tiempo: Baseline, 6 months, 12 months

Beliefs in Medication Questionnaire (BMQ)adapted for use in chemoprevention decision-making. The BMQ includes the Necessity scale (10 items that assess how patients perceive their personal need for chemoprevention for reducing BC risk, maintaining their health, and preventing illness), the Concerns scale (10 items measuring concerns about potential adverse effects of chemoprevention). Participants rate the extent to which they agree with each item on a scale (scored 1- 5). The total score for each scale is computed by adding the scores for each scale item together and dividing by the number of items.

Baseline, 6 months, 12 months
Perceived Breast Cancer Risk
Periodo de tiempo: Baseline, 6 months, and 12 months

3 items of absolute estimate, comparative risk assessed on a 3-point Likert scale, and numeric 10-year risk of breast cancer on a scale of 0 to 100%

Baseline, 6 months, and 12 months
Perceived Cardiovascular Disease Risk
Periodo de tiempo: Baseline, 6-months and 12-months

3 items of absolute estimate, comparative risk assessed on a 3-point Likert scale, and numeric 10-year risk of cardiovascular disease on a scale of 0 to 100%.

Baseline, 6-months and 12-months
Accuracy of Perceived Breast Cancer Risk
Periodo de tiempo: Baseline, 6 months, and 12 months

Difference between perceived numeric risk estimate and actual 10-year risk of breast cancer risk according to the BCSC risk calculator; Categorized as accurate if the difference between subjective and objective risk estimates are ≤5% in either direction, underestimate if >5% below objective risk, and overestimate if >5% above objective risk

Baseline, 6 months, and 12 months
Accuracy of Perceived Cardiovascular Disease Risk
Periodo de tiempo: Baseline, 6-month, and 12-month

Difference between perceived numeric risk estimate and actual 10-year risk of Cardiovascular Disease Risk according to the 2013 ACA/AHA ASCVD risk calculator; Categorized as accurate if the difference between subjective and objective risk estimates are ≤5% in either direction, underestimate if >5% below objective risk, and overestimate if >5% above objective risk

Baseline, 6-month, and 12-month
Informed Choice
Periodo de tiempo: Baseline, 6 months, and 12 months

This measure combines the chemoprevention knowledge scale, an attitudes scale, and chemoprevention decision. Informed choice defined as 1) those who have an adequate knowledge score, a positive attitude towards chemoprevention, and decide to take chemoprevention; 2) those who have an adequate knowledge score, a negative attitude towards chemoprevention, and decide not to take chemoprevention.

Baseline, 6 months, and 12 months
Decision Conflict
Periodo de tiempo: Baseline, 6 months, and 12 months

Score on the 10-item Decision Conflict Scale assessing uncertainty and conflict related to decisions about chemoprevention uptake. Items are rated using three response categories: Yes (0), Unsure (2), and No (4). Scores are summed, divided by 10, and multiplied by 25. Final scores range from 0 to 100, with higher scores indicating greater conflict and lower scores indicating less conflict.

Baseline, 6 months, and 12 months
Intention or decision about chemoprevention uptake
Periodo de tiempo: Baseline, 6 months, and 12 months

Behavioral intentions to take chemoprevention measured using 'Given what you know right now, how likely do you think you are to take a breast cancer prevention drug in the next year?' (1 = 'not at all likely,' to 5 = 'extremely likely').

Baseline, 6 months, and 12 months
Factors influencing intention about chemoprevention
Periodo de tiempo: Baseline, 6 months, and 12 months

Survey item to rank the main factors influencing a patient's decision about chemoprevention: 1) Personalized risk information; 2) polypharmacy for CVD or other comorbidities; 3) Provider recommendation; 4) RealRisks DA; 5) Other:____

Baseline, 6 months, and 12 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Perceived usefulness of RealRisks
Periodo de tiempo: 6 months and 12 months

Preparation for Decision Making scale. 10-items assesses a patients perception of how useful a DA or decision support intervention is in preparing the respondent to communicate with their provider at a consultation making a health decision.

6 months and 12 months
Acceptability of RealRisks
Periodo de tiempo: 6 months and 12 months

Ottawa 10-item Acceptability questionnaire includes questions evaluating comprehensibility, sufficiency of information, and overall suitability of the DA for decision making.

6 months and 12 months

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Rita Kukafka, DrPH, MA, Columbia University

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 (Actual)

7 de octubre de 2026

Finalización primaria (Estimado)

1 de septiembre de 2028

Finalización del estudio (Estimado)

1 de septiembre de 2028

Fechas de registro del estudio

Enviado por primera vez

1 de octubre de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de octubre de 2026

Publicado por primera vez (Actual)

27 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

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

4 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • AAAV2148
  • 5R01CA293927-03 (Subvención/contrato del NIH de EE. UU.)

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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