Efectos del Yoga en la Calidad de Vida de Pacientes con Cáncer de Mama
Effects of Two Different Online Yoga Interventions on the Quality of Life of Breast Cancer Patients Compared With Waiting List - a Three-arm Randomized Controlled Trial
This study investigates the effects of two different online yoga interventions on the health-related quality of life in breast cancer patients. Qualitative and quantitative data will be collected.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In this randomized controlled trial breast cancer patients will be randomized into three treatment arms:
- Intervention group 1 will receive an Iyengar yoga intervention online in a group setting, based on the internationally renowned yoga school of B.K.S. Iyengar, which in the context of this study mainly includes physical and relaxation exercises.
- Intervention group 2 will receive a meditative yoga intervention online including physical and meditation exercises and also ideologically neutral explanations of the ethical aspects of yoga.
- Group 3 consists of a waiting list control group, combined with the offer to participate in a yoga intervention after 6 months.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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State of Berlin
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Berlin, State of Berlin, Alemania, 14109
- Reclutamiento
- Charite University
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Contacto:
- Miriam Roesner
- Número de teléfono: 030 80505 682
- Correo electrónico: m.roesner@immanuel.de
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Investigador principal:
- Andreas Michalsen, Prof.Dr.
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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:
- Histologically confirmed diagnosis of non-metastatic breast cancer (TNM stage I-III) up to 5 years after diagnosis
- Primary therapy completed for at least 3 months
- Limitation of the quality of life due to the cancer (indication of at least 4 out of 10 points on the numerical analogue scale)
- Willingness to participate in the study and signed informed consent.
Exclusion Criteria:
- Current or planned chemotherapy, radiation or surgery
- Severe physical or psychopharmacologically treated psychiatric comorbidity due to which a patient is unable to participate in the study
- Pregnancy/breastfeeding
- Participation in other clinical trials with behavioral, psychological, or complementary medicine interventions
- Immobility or limitation for gymnastic exercise due to orthopedic, neurologic, or other medical cause
- regular meditation practice >2x/month
- regular yoga practice >2x/month
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: Iyengar yoga
Intervention group 1 receives an Iyengar yoga intervention online in a group setting, based on the internationally renowned yoga school of B.K.S. Iyengar, which in the context of this study primarily includes physical and relaxation exercises. |
Iyengar Yoga focuses on the correct alignment of the body while practicing the physical exercises of yoga. Props are used to support the body in finding the right alignment. Relaxation is also part of this intervention. Participiants receive 1x90 min guided yoga class per week for 8 weeks and are encouraged to continue their practice at home daily for at least 30 minutes. |
|
Experimental: Meditative yoga
Intervention group 2 receives an Integrative yoga intervention online including physical and meditation exercises as well as ideologically neutral explanations of the ethical aspects of Yoga. |
Meditative Yoga in the context of this study means practicing the physical exercises of yoga as well as meditation. Additionally, each week one of the yamas/niyamas, which are ethical principles to live by in the Yoga philosophy, will be presented at the beginning of each class and will form the theme of the class. Participants receive 1x90 min guided yoga class per week for 8 weeks and are encouraged to continue their practice at home daily for at least 30 minutes. |
|
Sin intervención: Waitlist Control Group
Group 3 consists of a waitlist control group. Participants will be offered the opportunity to attend a yoga intervention after 4 months. The patients in this waiting list control group are allowed to choose the yoga course after 6 months. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Periodo de tiempo: Date of inclusion (baseline), after 8 weeks
|
Assessing full scale, range 0-40, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Periodo de tiempo: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Assessing full scale, range 0-40, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Functional Assessment of Cancer Therapy: Fatigue (FACIT-F)
Periodo de tiempo: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Assessing full scale, range 0-52, higher score meaning a better outcom |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Perceived Stress Scale (PSS-10)
Periodo de tiempo: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Assessing full scale, range 0-40, lower score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Flourishing Scale (FS-D)
Periodo de tiempo: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Assessing full scale, range 8-56, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Self-Compassion Scale (SCS-D)
Periodo de tiempo: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Mean score of 12 items, range 1-5, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Self-Efficacy Scale (ASKU)
Periodo de tiempo: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Mean score of 3 items, range 1-5, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Sociodemographic measures
Periodo de tiempo: Date of inclusion (baseline)
|
Age, education level, personal income, household income, employment status, job description, marital status, household members, days of sick leave past 3 months |
Date of inclusion (baseline)
|
|
Behavioral questions: cigarettes
Periodo de tiempo: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Number of cigarettes on average per day in the last month |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Behavioral questions: alcohol
Periodo de tiempo: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Number of alcoholic beverages on average per week in the last month |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Expectation question
Periodo de tiempo: Date of inclusion (baseline)
|
expectation of effectiveness of the intervention on a 5-point likert scale, how they expect to handle the intervention on a 5-point likert scale, higher score meaning better outcome |
Date of inclusion (baseline)
|
|
Behavioural question
Periodo de tiempo: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
diet |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Behavioural question 2
Periodo de tiempo: Date of inclusion (baseline)
|
Practice of other mindfulness practices besides Yoga |
Date of inclusion (baseline)
|
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Behavioural question 3
Periodo de tiempo: Date of inclusion (baseline)
|
Yoga styles were practiced before |
Date of inclusion (baseline)
|
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Behavioural question 4
Periodo de tiempo: Date of inclusion (baseline)
|
If and how often yoga is practiced regularly |
Date of inclusion (baseline)
|
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Functional Assessment of Cancer Therapy - General (FACT-G)
Periodo de tiempo: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Assessing full scale, range 0-108, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Yama/Niyama Questionnaire - YaNiQ
Periodo de tiempo: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Assessing full scale, range 0-100, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Hospital Anxiety and Depression Scale (HADS)
Periodo de tiempo: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Assessing full scale, range 0-42, lower score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Qualitative interviews
Periodo de tiempo: 8 weeks after inclusion
|
Qualitative assessment will be carried out in qualitative interviews in 20 patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis. |
8 weeks after inclusion
|
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Heart Rate Variability (HRV)
Periodo de tiempo: Date of inclusion (baseline), after 8 weeks
|
24h measuring by Faros 180 |
Date of inclusion (baseline), after 8 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- YOMA
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.
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