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Mejora de la comunicación centrada en el paciente en el cáncer de mama a través de intervenciones de pacientes y proveedores (SHARES)

26 de octubre de 2026 actualizado por: Alliance for Clinical Trials in Oncology

Mejora de la comunicación centrada en el paciente en el cáncer de mama: un RCT de un sistema de compromiso de decisión compartida (SHARES)

This trial studies the effectiveness of two interventions on patient reported outcomes of patient centered communication and decision making about breast cancer treatment. The first intervention consists of enhancements to an existing patient-facing breast cancer treatment decision tool called iCanDecide that supports the management of worry, distress, and anxiety as compared to an existing tool. The second intervention consists of a clinician dashboard that populates information after patients view either website regarding any ongoing issues or concerns.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

The primary and key secondary objectives of the study:

PRIMARY OBJECTIVES:

I. To demonstrate that the enhanced iCanDecide (iCanDecide-emotional support enhancement [ESE]) intervention is more effective than the standard version (iCanDecide-standard [S]) resulting in higher patient knowledge about locoregional treatment risks and benefits.

II. To demonstrate that the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient knowledge about locoregional treatment risks and benefits.

SECONDARY OBJECTIVES:

I. To demonstrate that the enhanced iCanDecide (iCanDecide-ESE) intervention is more effective than the standard version (iCanDecide-S), resulting in higher patient-reported breast cancer self-efficacy and lower patient reported cancer worry.

II. To demonstrate that the activation of the clinician dashboard (CDB) is more effective than not using a CDB, resulting in higher patient-reported breast cancer self-efficacy and lower patient reported cancer worry.

OUTLINE: This study is a multi-level trial of SHaDES that has two interventions in a factorial or crossed design: 1) an individually randomized patient-level randomized controlled trial (RCT) to evaluate the standard version (iCanDecide-S) vs. a version with innovative emotional support enhancements (iCanDecide-ESE), and 2) a clinic-level stepped-wedge cluster randomized trial to test a Clinician Dashboard (CDB). Twenty-five surgical practices will be recruited for participation. Practices will be randomized to the timing of the CDB intervention, with some practices initiating the CDB intervention right away, while others may initiate the CDB later or perhaps be randomized to "no CDB" period. Clinicians will be asked to use the CDB beginning in the time period to which their practice was randomized and continuing to the end of the study. After registration, clinicians are followed up at 9 and 18 months. After a patient is registered, the patient will be randomized to one of two arms:

ARM I: Patients utilize the iCanDecide - ESE website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.

ARM II: Patients utilize the iCanDecide - S website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.

After study registration, patients are followed up at 4-5 weeks and 9 months.

Patients will be enrolled at participating clinics during the full duration of the study and all enrolled patients will receive a version of the decision support tool (iCanDecide-S; iCanDecide-ESE). These patient-level activities are not influenced by the timing of the practice-level randomization to the CDB.

Tipo de estudio

Intervencionista

Inscripción (Actual)

614

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.

Ubicaciones de estudio

    • California
      • Vallejo, California, Estados Unidos, 94589
        • Kaiser Permanente-Vallejo
    • Delaware
      • Newark, Delaware, Estados Unidos, 19713
        • Helen F Graham Cancer Center
      • Rehoboth Beach, Delaware, Estados Unidos, 19971
        • Beebe Health Campus
    • Georgia
      • Savannah, Georgia, Estados Unidos, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96819
        • Kaiser Permanente Moanalua Medical Center
    • Illinois
      • Mount Vernon, Illinois, Estados Unidos, 62864
        • SSM Health Good Samaritan
    • Maine
      • Scarborough, Maine, Estados Unidos, 04074
        • Maine Medical Center- Scarborough Campus
    • Michigan
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Kalamazoo, Michigan, Estados Unidos, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Estados Unidos, 49048
        • Ascension Borgess Hospital
    • New York
      • Mount Kisco, New York, Estados Unidos, 10549
        • Northern Westchester Hospital
      • New York, New York, Estados Unidos, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • The Bronx, New York, Estados Unidos, 10461
        • Montefiore Medical Center-Einstein Campus
    • North Carolina
      • Greensboro, North Carolina, Estados Unidos, 27403
        • Novant Health Breast Surgery - Greensboro
    • North Dakota
      • Bismarck, North Dakota, Estados Unidos, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, Estados Unidos, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Chillicothe, Ohio, Estados Unidos, 45601
        • Adena Regional Medical Center
      • Westerville, Ohio, Estados Unidos, 43081
        • Saint Ann's Hospital
      • Zanesville, Ohio, Estados Unidos, 43701
        • Genesis Healthcare System Cancer Care Center
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38120
        • Baptist Memorial Hospital for Women
    • Wisconsin
      • Appleton, Wisconsin, Estados Unidos, 54911
        • ThedaCare Regional Cancer Center
      • Eau Claire, Wisconsin, Estados Unidos, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Grafton, Wisconsin, Estados Unidos, 53024
        • Aurora Cancer Care-Grafton
      • La Crosse, Wisconsin, Estados Unidos, 54601
        • Gundersen Lutheran Medical Center
      • Wausau, Wisconsin, Estados Unidos, 54401
        • Aspirus Regional Cancer Center
      • Wauwatosa, Wisconsin, Estados Unidos, 53226
        • Ascension Medical Group Southeast Wisconsin - Mayfair Road
      • West Allis, Wisconsin, Estados Unidos, 53227
        • Aurora West Allis Medical Center

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • PATIENT ELIGIBILITY
  • Women newly diagnosed with stage 0-III breast cancer. Although men are recommended to undergo surgery to treat breast cancer, male breast cancer is relatively rare and decision making for breast cancer surgery is quite different between men and women
  • Planning breast surgery as a component of their definitive treatment within 5 weeks of registration
  • Receives care from a clinician and at a practice that has consented to participate in the clinician dashboard practice-level intervention. Practices/clinicians will consent initially at the initiation of the study. Patients will then be identified and recruited in those practices. If a practice has more than one clinician doing breast surgery, patients will be recruited from those clinicians who consent (one or more). Patients of clinicians who have not consented will not be eligible
  • Patients must be able to speak English or Spanish with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter)
  • Age 21-84 years
  • CLINICIAN STAKEHOLDER (SURGEONS AND CLINIC STAFF) ELIGIBILITY CRITERIA
  • Clinicians eligible for this study include: breast surgeons and their designee(s) (e.g., physician assistants, nurse practitioners, clinical nurse specialists, or nurses) that participate in the treatment decision-making process. At least one surgical oncologist at a practice must agree to participate and sign consent. S/he may then also identify a nurse, physician assistant (PA) or advanced practice provider (APP) with whom s/he works that is involved in the delivery of the care of the same patients to participate. Henceforth, in this protocol they will be referred to as "clinicians"
  • Clinicians must agree to have their patients recruited for the entire time the study is open at their practice, which will include time periods in which the clinicians will and time periods in which they will not have access to the CDB
  • INSTITUTION ELIGIBILITY:
  • Practices that annually provide surgical care for over 100 patients newly diagnosed with breast cancer are eligible to participate in this study
  • Eligible practices must have at least one surgical oncologist who agrees to participate in the study

Exclusion Criteria:

  • Patients who are visually impaired are not eligible, as they must be able to access the study intervention on a website at home or in clinic and view the decision aid
  • Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
  • Practices currently enrolling to Alliance A231701CD are not eligible to participate in this study

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Arm I: (iCanDecide - ESE)

Patients utilize the iCanDecide - ESE website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.

Ancillary studies

Participate in interview

Undergo surgery

Ancillary studies

Utilize the iCanDecide - ESE website

Comparador activo: Arm II: (iCanDecide - S)

Patients utilize the iCanDecide - S website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.

Ancillary studies

Participate in interview

Undergo surgery

Ancillary studies

Utilize the iCanDecide - S website

Experimental: Clinics 1-5: (CDB)

Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 1-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.

Participate in interview

Ancillary studies

Receive training

Utilize the CDB

Experimental: Clinics 6-8 (CDB)

Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 10-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.

Participate in interview

Ancillary studies

Receive training

Utilize the CDB

Experimental: Clinics 9-11 (CDB)

Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 20-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.

Participate in interview

Ancillary studies

Receive training

Utilize the CDB

Experimental: Clinics 12-14 (CDB)

Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 30-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.

Participate in interview

Ancillary studies

Receive training

Utilize the CDB

Experimental: Clinics 15-17 (CDB)

Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 40-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.

Participate in interview

Ancillary studies

Receive training

Utilize the CDB

Experimental: Clinics 18-20 (CDB)

Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 50-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.

Participate in interview

Ancillary studies

Receive training

Utilize the CDB

Comparador activo: Clinics 21-25 (usual care)

Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and continue to provide breast cancer surgical care per their usual care. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.

Participate in interview

Ancillary studies

Receive training

Utilize usual care

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient Knowledge About Risks and Benefits of Local Regional Treatment
Periodo de tiempo: 5 weeks

Will be defined as the mean percentage of correct answers (range: 0-100%) from a 5-item scale previously developed and pilot tested where higher percentages indicate increased knowledge of treatment risks and benefits of local regional treatment. Because the interventions are fully crossed (with intervention and control patients within both intervention and control practices for every time period), the intervention effect of iCanDecide-E and the intervention effect of the clinician dashboard (CDB) will be obtained from a single linear mixed-effects model for the continuous primary outcome measure patient knowledge.

5 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient Self-efficacy in Dealing With Breast Cancer
Periodo de tiempo: 5 weeks

Will be defined as the composite score obtained from the 11-item (each rated on a 5-point Likert scale: "strongly disagree" to "strongly agree") validated scale designed to assess breast cancer patients' overall feelings of control of their cancer and worry about their cancer (range: 11 to 55); higher scores indicate increased self-efficacy. Because the interventions are fully crossed (with intervention and control patients within both intervention and control practices for every time period), the intervention effect of iCanDecide-E and the intervention effect of the clinician dashboard (CDB) will be obtained from a single linear mixed-effects model for the continuous secondary outcome measure patient self-efficacy.

5 weeks
Patient Cancer Worry
Periodo de tiempo: 5 weeks

Will be defined as the total score obtained from the 8-item (each rated on a 4-point Likert scale: "never" to "almost always") validated Cancer Worry Scale assessing the degree of cancer-related worry (range: 8 to 40); higher scores indicate more frequent worries about cancer. Because the interventions are fully crossed (with intervention and control patients within both intervention and control practices for every time period), the intervention effect of iCanDecide-E and the intervention effect of the clinician dashboard (CDB) will be obtained from a single linear mixed-effects model for the continuous secondary outcome measure patient cancer worry.

5 weeks

Colaboradores e Investigadores

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

Patrocinador

Colaboradores

Investigadores

  • Silla de estudio: Sarah T. Hawley, PhD, MPH, University of Michigan School of Medicine and Public Health

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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)

16 de febrero de 2021

Finalización primaria (Actual)

1 de mayo de 2024

Finalización del estudio (Actual)

12 de julio de 2024

Fechas de registro del estudio

Enviado por primera vez

9 de septiembre de 2020

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2020

Publicado por primera vez (Actual)

16 de septiembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de noviembre de 2026

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

26 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • A231901CD
  • NCI-2020-06176 (Identificador de registro: NCI Clinical Trial Reporting Program)
  • UG1CA189823 (Subvención/contrato del NIH de EE. UU.)
  • R01CA237046 (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. .