- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01108016
Expanding Rural Access: Distance Delivery of Support Groups (Main Study)
The study will answer two questions about women with breast cancer in rural communities:
- Will they find this support group format utilizing videoconferencing acceptable and rewarding?
- Will they report a greater sense of emotional and informational support, and less depression and traumatic stress, than the control groups of women who wait to participate until after the first groups have ended?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Stanford, California, Estados Unidos, 94305
- Stanford University School of Medicine
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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:To be eligible to participate, a woman must meet all of the following criteria:
- be a resident of one of nine rural counties in northeastern California (Modoc, Plumas, Siskiyou, Shasta, Lassen, Trinity, Sierra, Nevada, and Tehama),
- be able to travel to a rural health facility included in the Northern Sierra Rural Health Network to participate in videoconferencing meetings;
- be able to speak and read English well enough to be able to read, discuss, and comprehend the consent form;
- be 21 years of age or older;
- have been diagnosed with breast cancer by a physician; and
- who (in the judgment of the Local Coordinator) is not unduly distressed or otherwise not able to participate effectively in a support group.
Women will be included with any stage of breast cancer as our pilot study demonstrated that in these rural communities, women wanted to include women with any stage of breast cancer in their groups. Also, our pilot study results showed that it worked fine to include women regardless of the period elapsing since they received their diagnosis, as our pilot study results showed that some women with a long period of time elapsing since receiving their diagnosis were still in need of a source of social support for coping with having had this experience and felt that they had a lot of help to offer women who had more recently received a breast cancer diagnosis. The 9 counties were selected because they are among the most remote counties in California, yet they have strong primary care systems in place, and most patients receive specialty care in-state, as opposed to out-of-state. Every effort will be made to include women of ethnic minority groups.
The support group facilitator, community advisory board (CAB) members, and the local community coordinators will also be recruited for the interviews, with informed consent, identified by having played one of these roles for this study.
Exclusion Criteria:Potential participants who do not meet all of the inclusion criteria listed above will be excluded.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Intensity and frequency of posttraumatic stress symptoms in the past month as assessed by total score on the Posttraumatic Check List - Specific version (PCL-S) for breast cancer.
Periodo de tiempo: after 8 weeks of the immediate group sessions
|
after 8 weeks of the immediate group sessions
|
|
Intensity and frequency of depression symptoms in the past week as assessed by total score on the Center for Epidemiological Studies Depression scale (CES-D)
Periodo de tiempo: after 8 weeks of the immediate group sessions
|
after 8 weeks of the immediate group sessions
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Intensity and frequency of emotional control as assessed by the total score on the Courtauld Emotional Control Scale (CECS),
Periodo de tiempo: after 8 weeks of the immediate group sessions
|
after 8 weeks of the immediate group sessions
|
|
Level of self-efficacy for coping with breast cancer as assessed by the total score on the Cancer Behavior Inventory (CBI).
Periodo de tiempo: after 8 weeks of the immediate group sessions
|
after 8 weeks of the immediate group sessions
|
|
Satisfaction with social support as assessed by the total satisfaction score on the UCLA Social Support Inventory.
Periodo de tiempo: after 8 weeks of the immediate group sessions
|
after 8 weeks of the immediate group sessions
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Cheryl Koopman, Stanford University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SU-03012010-5082
- BRSADJ0019
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. .