Clinical Trials Education Program for Hispanic Americans
3 de marzo de 2020 actualizado por: Georgia Robins Sadler, University of California, San Diego
Randomized Controlled Clinical Trials Education Program for Hispanic Americans
Hispanic Americans are underrepresented in cancer clinical trials.
The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test education programs designed to reduce barriers and Increase facilitators associated with cancer clinical trials participation for Hispanic Americans. Focus groups were conducted with Hispanic American men and women to obtain culturally-linked attitudes related to clinical trials participation. This information was used to create a prototypic educational program anticipated to increase participation in clinical trials. It was then vetted and honed via additional focus groups.
Simultaneously, a validation study was conducted with Hispanic Americans for a packet of psychosocial instruments that could be used for a subsequent randomized controlled trial to evaluate the impact of the clinical trials education program.
The finalized clinical trials education program was tested via a randomized controlled trial. Participants assigned to the experimental group received the clinical trials education program, while participants in the control arm were administered a comparable, but non-relevant education program. Recruitment to this study has been completed.
Tipo de estudio
Intervencionista
Inscripción (Actual)
1034
Fase
- Fase 3
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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California
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La Jolla, California, Estados Unidos, 92093-0850
- UC San Diego Moores Cancer Center
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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
21 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Self-identified as Hispanic American
- At least 21 years of age
- Sufficiently literate to comprehend written and spoken testing materials in English or Spanish
- Living in southern California
- Mentally competent to complete the informed consenting process
Exclusion Criteria:
-
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: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Cancer Clinical Trials Education Program
Cancer Clinical Trials Education Program is offered to English- and Spanish-speaking Hispanics in the experimental arm.
This program was designed to promote increased clinical trials literacy among Hispanic Americans.
Increased clinical trials knowledge and a better understanding of clinical trials is anticipated to create more positive attitudes, and perceptions about clinical trials among Hispanic Americans.
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Hispanic Americans are underrepresented in cancer clinical trials.
The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.
|
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Comparador de placebos: Neighborhood Watch Education Program
The Neighborhood Watch Program created by the Bureau of Justice Assistance and the National Crime Prevention Council was selected for inclusion in the control arm of this study.
It provided participants with a program of equivalent length and format, as well as an equivalent focus on improving the well-being of Hispanic Americans.
It also provided an opportunity to evaluate the impact of the Neighborhood Watch Program.
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Hispanic Americans are underrepresented in cancer clinical trials.
The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to First Follow-up
Periodo de tiempo: Change from baseline to first follow-up (immediately after receiving intervention)
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To assess the impact of the intervention arm on participants' knowledge, attitudes, and perceptions related to clinical trials, they were asked to complete the same surveys given at baseline during post-intervention immediately after intervention.
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Change from baseline to first follow-up (immediately after receiving intervention)
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Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to Second Follow-up
Periodo de tiempo: Change from baseline to second follow-up (three months after receiving intervention)
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At the three-month follow-up, participants were mailed the final packet of survey instruments to complete and return in a stamped, self-addressed envelope.
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Change from baseline to second follow-up (three months after receiving intervention)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Willingness to Participate in Research
Periodo de tiempo: Two weeks after receiving intervention
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Two weeks after receiving the intervention, participants were mailed an invitation to participate in a different research study by a researcher not previously known to them, to assess whether the intervention influenced behavior related to clinical trials invitations.
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Two weeks after receiving intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Georgia R Sadler, PhD, UC San Diego Moores Cancer Center
- Investigador principal: Vanessa L Malcarne, PhD, San Diego State University
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)
1 de marzo de 2010
Finalización primaria (Actual)
1 de agosto de 2018
Finalización del estudio (Actual)
1 de agosto de 2018
Fechas de registro del estudio
Enviado por primera vez
4 de marzo de 2014
Primero enviado que cumplió con los criterios de control de calidad
6 de marzo de 2014
Publicado por primera vez (Estimar)
11 de marzo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
3 de marzo de 2020
Última verificación
1 de marzo de 2020
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- CCT2525
- NCI R25CA 130869 (Otro identificador: UCSD)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .