- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03899441
Multimedia Aid Gynecologic Counseling and Consent
10 de agosto de 2020 actualizado por: UNC Lineberger Comprehensive Cancer Center
Does Multimedia Perioperative Teaching Improve Patient Experience in the Treatment of Endometrial Cancer
This is an interventional trial to introduce two short animated videos into preoperative counseling/consent and to compare patient comprehension and satisfaction with a multimedia approach compared to standard of care currently.
The investigators anticipate that patients will retain more information about their surgery and peri-operative care and will be more satisfied with a multimedia approach.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The investigators plan a pilot study where patients will be randomized to receiving standard consent and teaching prior to their planned surgery for endometrial cancer or standard consent and multimedia video aid with targeted teaching.
This video will be an adjunct to the standard consent process and supplement the pre and post-operative teaching that is currently not formalized.
The primary outcome is patient satisfaction.
The secondary outcomes include patient understanding and physician satisfaction.
The investigators hypothesize that patients will be more satisfied when their consent for surgery is done in conjunction with this multimedia aid.
Tipo de estudio
Intervencionista
Inscripción (Actual)
87
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
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- Univeristy of North Carolina at Chapel Hill
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- English-speaking
- Has diagnosis of endometrial cancer
- Planned minimally invasive surgical treatment with hysterectomy and sentinel lymph node biopsy
Exclusion Criteria:
- Non-English speaking
- Pregnant
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control
Patients in the control arm will have pre-operative teaching from their physician and sign consent for surgery, as is the current standard of care at the investigators' institution.
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Experimental: Video arm
Patients in the intervention arm will watch two short animated video about minimally-invasive endometrial cancer surgery followed by focused pre-operative teaching from their physician.
They will then sign consent for surgery.
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Two short animated videos - one that reviews minimally-invasive surgery and sentinel lymph node mapping and biopsy for endometrial cancer treatment.
This video as reviews possible complications.
The second video reviews peri-operative instructions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient satisfaction
Periodo de tiempo: 1 day (assessed at first visit)
|
Patient satisfaction with the clinic visit (either new patient visit where they are consented for surgery or a pre-operative visit).
Patient satisfaction will be measured using two survey tools: a single question to assess global satisfaction with the clinic visit (on a scale from 1-10) and an 8 question validated satisfaction survey (Client Satisfaction Questionnaire-8 or CSQ-8).
Patient satisfaction will be compared between the control and intervention groups.
For the single question satisfaction question, answers are on a scale from 1-10, the higher numbers indicating higher satisfaction.
The CSQ8 survey contains 8 questions that all have answers ranging from 1 to 4, with higher numbers indicating higher satisfaction.
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1 day (assessed at first visit)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient comprehension
Periodo de tiempo: 6-8 weeks (assessed at 3 time points - first clinic visit, inpatient at time of surgery, and at follow-up visit 4-6 weeks after surgery)
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Patient comprehension (of the surgery, its complication, and peri-operative instructions) will be measured using a 9 question survey developed by the study investigators.
This survey was developed to assess patient understanding on key information reviewed either in the study videos or by physicians during pre-operative counseling.
Patient comprehension will be assessed at three different time points (using the same survey) to compare comprehension immediately after watching the video or undergoing standard physician counseling and again during the patient's hospital stay and at the follow-up visit.
Comprehension scores will be compared between the control and intervention groups.
The comprehension surveys questions will all be awarded points for correct answers, with higher answers indicating more comprehension of topics relating to the surgery.
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6-8 weeks (assessed at 3 time points - first clinic visit, inpatient at time of surgery, and at follow-up visit 4-6 weeks after surgery)
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Physician satisfaction
Periodo de tiempo: 1 day (assessed at first visit)
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Physician satisfaction with new patient or pre-operative visit.
Physician satisfaction will be measured using a single question to assess global satisfaction with the clinic visit (on a scale from 1-10, with higher numbers indicating higher satisfaction).
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1 day (assessed at first visit)
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Visit length
Periodo de tiempo: 1 day (assessed during first visit)
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Time of new patient or pre-operative visit.
The length of visits will be recorded (from the time the physician first enters the patient room until the visit is complete and the patient is leaving the clinic room).
Appointment times will be compared between the control and intervention group, for pre-operative visits and new patient visits.
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1 day (assessed during first visit)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Katherine Tucker, MD, UNC Hospital
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)
1 de octubre de 2018
Finalización primaria (Actual)
1 de abril de 2020
Finalización del estudio (Actual)
1 de abril de 2020
Fechas de registro del estudio
Enviado por primera vez
1 de marzo de 2019
Primero enviado que cumplió con los criterios de control de calidad
29 de marzo de 2019
Publicado por primera vez (Actual)
2 de abril de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de agosto de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
10 de agosto de 2020
Última verificación
1 de agosto de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LCCC 1821
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
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. .