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The Long-term Effects of Body-mind-spirit Group Therapy

12 de noviembre de 2012 actualizado por: National Taiwan University Hospital

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

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

60

Fase

  • Fase 2
  • 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

      • Taipei, Taiwán, 10051
        • Department of Nursing, College of Medicine, National Taiwan University

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 a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Inclusion criteria of Survivors:

  1. breast cancer patients who complete active treatments,
  2. those who are willing to participate in the research,
  3. those who currently do not receive any individual or group psychotherapy, AND
  4. aged between 18 and 65.

Inclusion criteria of Spouse partners:

  1. partners of breast cancer patient who complete active treatments,
  2. those who are willing to participate in the research,
  3. those who currently do not receive any individual or group psychotherapy, AND
  4. aged between 18 and 65.

Exclusion Criteria:

Exclusion criteria of Survivors:

  1. diagnosed as both breast cancer and other types of cancers,
  2. those with adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR
  3. those who currently use antidepressants.

Exclusion criteria of Survivors:

  1. diagnosed as adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR
  2. those who currently use antidepressants.

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: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: counseling
body-mind-spirit group therapy
8-session therapy
Otros nombres:
  • Terapia de grupo

¿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
pre, post, 3months, 6months and 1year after end of treatment

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
pre, post, 3months, 6months and 1year after end of treatment
Beck Depression Inventory
Periodo de tiempo: pre, post, 3months, 6months and 1year after end of treatment
pre, post, 3months, 6months and 1year after end of treatment
Quality of life
Periodo de tiempo: pre, post, 3months, 6months and 1year after end of treatment
pre, post, 3months, 6months and 1year after end of treatment
MOS sleep scale
Periodo de tiempo: pre, post, 3months, 6months and 1year after end of treatment
pre, post, 3months, 6months and 1year after end of treatment
Meaning in Life Questionnaire
Periodo de tiempo: pre, post, 3months, 6months and 1year after end of treatment
pre, post, 3months, 6months and 1year after end of treatment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Fei Hsiao, PhD, National Taiwan University

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

1 de octubre de 2009

Finalización primaria (Actual)

1 de noviembre de 2011

Finalización del estudio (Actual)

1 de noviembre de 2011

Fechas de registro del estudio

Enviado por primera vez

21 de octubre de 2009

Primero enviado que cumplió con los criterios de control de calidad

12 de noviembre de 2012

Publicado por primera vez (Estimar)

16 de noviembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

16 de noviembre de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

12 de noviembre de 2012

Última verificación

1 de noviembre de 2012

Más información

Términos relacionados con este estudio

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. .

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