Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction
10 de junio de 2026 actualizado por: University of California, San Francisco
Evaluating the Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction Patients: Knowledge, Confidence, and Anxiety
This is a prospective, randomized controlled trial evaluating the comparative efficacy of written, video, and combined written and video patient education materials relative to no supplemental education for University of California, San Francisco (UCSF) patients presenting for post-mastectomy breast reconstruction consultation.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
PRIMARY OBJECTIVES:
- Assess baseline knowledge, procedural confidence, and anxiety in patients presenting for breast reconstruction consultation.
- Compare post-intervention outcomes between patients receiving written, video, or combined educational materials relative to no supplemental education.
SECONDARY OBJECTIVES
1. Examine whether the relative efficacy of each modality differs across patient subgroups defined by age, area deprivation index score, and prior health literacy.
OUTLINE:
Participants will be randomized into 1 of 4 groups:
- Written educational intervention
- Video educational intervention
- Combined written and video educational intervention
- No additional educational intervention
Outcome measures are assessed at a single timepoint following participant review of assigned materials and prior to the clinical consultation. Enrolled participants who do not review their assigned educational materials prior to the clinical consultation will be excluded from primary analysis but will be included in secondary intent-to-treat analysis
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
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
- Nombre: Reta Behman, BA
- Número de teléfono: 877-827-3222
- Correo electrónico: Reta.Behman@ucsf.edu
Ubicaciones de estudio
-
-
California
-
San Francisco, California, Estados Unidos, 94143
- Reclutamiento
- University of California, San Francisco
-
Contacto:
- Reta Behnam-Hanona, BA
- Número de teléfono: 877-827-3222
- Correo electrónico: Reta.Behnam@ucsf.edu
-
-
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
No
Descripción
Inclusion Criteria:
- Adults aged 18 or older
- Presenting as a new patient to the UCSF plastic surgery breast reconstruction clinic
- Considering mastectomy, including:
- - Therapeutic mastectomy in the setting of a breast cancer diagnosis
- - Prophylactic mastectomy in the setting of a confirmed high-risk genetic variant
- - Staged procedures, including delayed mastectomy with initial reduction
- Participants who are undecided between lumpectomy and mastectomy
Exclusion Criteria:
- Established patients returning for follow-up, in order to minimize confounding variables of individual surgeon education style on outcome measures
- Participants who are primarily considering lumpectomy or oncoplastic reduction at the time of their visit
- Non-English speakers, as educational materials are currently available in English only
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: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Written Educational Intervention
On the day of consultation prior to meeting with the plastic surgeon, participants will receive a 20-page illustrated brochure covering the full range of reconstructive options and be asked to complete surveys.
Following the appointment, a medical chart review will be conducted.
|
Participants will complete health related questionnaires.
Otros nombres:
20-page illustrated brochure
Otros nombres:
Participants may have data collected from the medical record.
Otros nombres:
|
|
Experimental: Video Educational Intervention
On the day of consultation prior to meeting with the plastic surgeon, participants will receive a five-module video series totaling approximately 20 minutes featuring the senior author and will be asked to complete surveys; expected to take no longer than 10 minutes to complete.
Following the appointment, a medical chart review will be conducted.
|
Participants will complete health related questionnaires.
Otros nombres:
Participants may have data collected from the medical record.
Otros nombres:
Five-module video series
Otros nombres:
|
|
Experimental: Combined Educational Intervention
On the day of consultation prior to meeting with the plastic surgeon, participants in the combined arm will receive both written and video materials and will be asked to complete surveys.
Following the appointment, a medical chart review will be conducted.
|
Participants will complete health related questionnaires.
Otros nombres:
20-page illustrated brochure
Otros nombres:
Participants may have data collected from the medical record.
Otros nombres:
Five-module video series
Otros nombres:
|
|
Otro: No Supplemental Education / Control Arm
On the day of consultation prior to meeting with the plastic surgeon, participants will be asked to complete surveys.
Following the appointment, a medical chart review will be conducted.
|
Participants will complete health related questionnaires.
Otros nombres:
Participants may have data collected from the medical record.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form
Periodo de tiempo: 1 day, during appointment immediately prior to meeting with surgeon
|
STAI is a 20 items instrument for assessing trait anxiety and 20 for state anxiety for a total of 40 items.
State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure."
Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person."
All items are rated on a 4-point scale (e.g., from "1=Almost Never" to 4="Almost Always") with a maximum score range of 40-160 when all 40 items are administered.
Higher scores indicate greater anxiety.
Participants will complete STAI at baseline and during clinic visit with surgeon.
Means, standard deviation, and group differences of the scores with confidence intervals will be reported.
|
1 day, during appointment immediately prior to meeting with surgeon
|
|
Mean scores on the Preparation for Decision Making (PrepDM) Scale -
Periodo de tiempo: 1 day, during appointment immediately prior to meeting with surgeon
|
The PrepDM is a validated 10-item tool that assesses a patient's perception of how well a decision aid or intervention, such as a decision aid, educational material, or clinical consultation, helps a patient feel prepared to make a health decision and discuss it with their practitioner.
It evaluates a patient's perceived readiness across several aspects of decision-making, including understanding available options, recognizing benefits and risks, clarifying personal values, and feeling confident about communicating with healthcare providers.
It uses a 5-point Likert scale (1=Not at all, 5=A great deal), with higher score reflecting greater perceived preparation for decision-making.
Participants will complete PrepDM at baseline and during clinic visit with surgeon.
Means, standard deviation, and group differences of the scores with confidence intervals will be reported.
|
1 day, during appointment immediately prior to meeting with surgeon
|
|
Mean scores on Reconstruction-Specific Knowledge Quiz
Periodo de tiempo: 1 day, during appointment immediately prior to meeting with surgeon
|
Reconstruction-specific knowledge quiz is a 7-item quiz.
It is an author-developed instrument assessing knowledge of the reconstructive options covered in the educational materials, including implant-based reconstruction, autologous reconstruction, Goldilocks reconstruction, and the option of going flat.
Participants will complete Reconstruction-Specific Knowledge Quiz at baseline and during clinic visit with surgeon.
Means, standard deviation, and group differences of the scores with confidence intervals will be reported.
|
1 day, during appointment immediately prior to meeting with surgeon
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Merisa Piper, MD, University of California, San Francisco
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)
6 de junio de 2026
Finalización primaria (Estimado)
31 de marzo de 2028
Finalización del estudio (Estimado)
31 de marzo de 2029
Fechas de registro del estudio
Enviado por primera vez
11 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de mayo de 2026
Publicado por primera vez (Actual)
22 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Comportamiento
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Cumplimiento del paciente
- Aceptación del paciente de la atención médica
- Intervenciones de adherencia
- Adherencia a la medicación
- Educación para la salud
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Recopilación de datos
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Encuestas y cuestionarios
Otros números de identificación del estudio
- 26754
- NCI-2026-03675 (Identificador de registro: NCI Clinical Trials Reporting Program (CTRP))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
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