Changes in Patient Reported Constipation Among Advanced Cancer Patients After Receiving an Educational Intervention
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
If participant agrees to take part in the study, information about them (such as their age, gender, ethnicity, religion, diagnosis, and drugs they are currently taking) will be collected from their medical record.
Participant will also complete 1 questionnaire about constipation. It should take about 1-3 minutes to complete the questionnaire.
After completing the questionnaire, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. Participant will have an equal chance of being in either group.
- If participant is assigned to Group 1, they will watch a short educational video.
- If participant is assigned to Group 2, they will read a fact sheet.
Both the video and the fact sheet describe symptoms of constipation and the importance of regular bowel movements. They should take about 3 minutes each to complete.
After participant has viewed the educational material, they will complete 3 questionnaires about constipation and how helpful they think the video or fact sheet was in educating them about constipation. It should take about 10 minutes total to complete these questionnaires. Participant will watch the video/read the fact sheet and complete the questionnaires in their room at the Supportive Care Clinic.
Length of Study:
Patient's participation on this study will be over after they have completed the last 3 questionnaires.
This is an investigational study.
Up to 200 participants will be enrolled in the study. All will take part at MD Anderson.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Houston, Texas, Estados Unidos, 77030
- University of Texas MD Anderson Cancer Center
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients with diagnosis of advanced cancer, including recurrent, locally advanced, or metastatic cancer
- Age >/= 18 years old
- Patients must be able to understand, read, write, and speak English
- Patients must have no clinical evidence of cognitive impairment as determined by the palliative care physician (Memorial Delirium Assessment Score >/= 7)
- Patients must sign an informed consent
Exclusion Criteria:
- Patients with a diagnosis of inflammatory bowel disease, i.e. Crohn's disease or ulcerative colitis
- Patients with complete or partial bowel obstruction as determined by the palliative care physician
- Patients with a bowel ostomy
Plan de estudios
¿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: Educational Video
Participants complete self-administered numerical rating scale (NRS) constipation questionnaire at baseline.
Participants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements.
Participants then complete three self-administered questionnaires, post-educational material, Modified Rome III questionnaire, and Overall satisfaction of the educational material.
|
Participants complete questionnaires at baseline and after intervention.
Otros nombres:
Participants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements.
|
|
Experimental: Fact Sheet
Participants complete self-administered numerical rating scale (NRS) constipation questionnaire at baseline.
Participants read educational material describing symptoms of constipation and importance of regular bowel movements.
Participants then complete three self-administered questionnaires, post-educational material, Modified Rome III questionnaire, and Overall satisfaction of the educational material.
|
Participants complete questionnaires at baseline and after intervention.
Otros nombres:
Participants read educational material describing symptoms of constipation and importance of regular bowel movements.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient-Reported Perception of Constipation
Periodo de tiempo: 1 day
|
Primary objective is to examine effect of educational intervention on the patient-reported perception of constipation (PRC, by a 0-10 numeric rating score) among advanced cancer patients.
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1 day
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2015-0111
- NCI-2015-00734 (Identificador de registro: NCI CTRP)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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