- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01727635
The Long-term Effects of Body-mind-spirit Group Therapy
The Long-term Effects of Body-mind-spirit Group Therapy on Close Relationships, Sleeping Quality, Depression, Quality of Life, Meaning of Life, and Saliva Cortisol Responses in Breast Cancer Survivors and Partners
Aims and objectives: This study aims to examine the effects of the body-mind-spirit group therapy on marital close relationships, sleeping quality, depression, quality of life, meaning of life, and salivary cortisol levels in metastatic breast cancer survivors and partners.
Methods: The design adopts the randomized controlled trial (RCT). The metastatic breast cancer survivors will be recruited from outpatient department of surgical at hospital. The partners will be invited to participate in this study through the survivors. The 120 dyad survivors and spouse will be randomly assigned into an experimental group or a control group. Survivors and spouse partners in an experimental group will receive 2 months time body-mind-spirit group therapy while those in a control will receive usual care in the same period of time. The outcome measures include Experiences in close relationships scale, Moss sleeping scale, Short-form 12 health-related quality of life questionnaires, Meaning of life questionnaire, BDI-II depression scale and salivary cortisol levels. Measurement time-points include pre intervention, post intervention (after 8 weekly group therapy), & then 3, 6, 12 months after the end of intervention for the maintenance effect. Univariate analyses will be performed to explore the basic characteristics of participants. The hierarchical linear model will be used to test the hypothesis the improvement is higher in intervention group than the control group in the effects of marital close relationships, sleeping quality, depression, meaning of life, quality of life, and salivary cortisol levels in metastatic breast cancer survivors and partners.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Taipei, Taiwán, 10051
- Department of Nursing, College of Medicine, National Taiwan University
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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:
Inclusion criteria of Survivors:
- breast cancer patients who complete active treatments,
- those who are willing to participate in the research,
- those who currently do not receive any individual or group psychotherapy, AND
- aged between 18 and 65.
Inclusion criteria of Spouse partners:
- partners of breast cancer patient who complete active treatments,
- those who are willing to participate in the research,
- those who currently do not receive any individual or group psychotherapy, AND
- aged between 18 and 65.
Exclusion Criteria:
Exclusion criteria of Survivors:
- diagnosed as both breast cancer and other types of cancers,
- those with adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR
- those who currently use antidepressants.
Exclusion criteria of Survivors:
- diagnosed as adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR
- those who currently use antidepressants.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: counseling
body-mind-spirit group therapy
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8-session therapy
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Diurnal Cortisol patterns
Periodo de tiempo: pre, post, 3months, 6months and 1year after end of treatment
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pre, post, 3months, 6months and 1year after end of treatment
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
The Experiences in Close Relationships-Revised questionnaire
Periodo de tiempo: pre, post, 3months, 6months and 1year after end of treatment
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pre, post, 3months, 6months and 1year after end of treatment
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Beck Depression Inventory
Periodo de tiempo: pre, post, 3months, 6months and 1year after end of treatment
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pre, post, 3months, 6months and 1year after end of treatment
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Quality of life
Periodo de tiempo: pre, post, 3months, 6months and 1year after end of treatment
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pre, post, 3months, 6months and 1year after end of treatment
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MOS sleep scale
Periodo de tiempo: pre, post, 3months, 6months and 1year after end of treatment
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pre, post, 3months, 6months and 1year after end of treatment
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Meaning in Life Questionnaire
Periodo de tiempo: pre, post, 3months, 6months and 1year after end of treatment
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pre, post, 3months, 6months and 1year after end of treatment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Fei Hsiao, PhD, National Taiwan 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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 200909010R
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. .
Ensayos clínicos sobre body-mind-spirit group therapy
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Boston Children's HospitalTerminadoEstrés Psicológico | Problema de aculturaciónEstados Unidos