Efeitos do Yoga na Qualidade de Vida de Pacientes com Câncer 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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State of Berlin
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Berlin, State of Berlin, Alemanha, 14109
- Recrutamento
- Charite University
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Contato:
- Miriam Roesner
- Número de telefone: 030 80505 682
- E-mail: m.roesner@immanuel.de
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Investigador principal:
- Andreas Michalsen, Prof.Dr.
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
|
Sem intervenção: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Date of inclusion (baseline)
|
Practice of other mindfulness practices besides Yoga |
Date of inclusion (baseline)
|
|
Behavioural question 3
Prazo: Date of inclusion (baseline)
|
Yoga styles were practiced before |
Date of inclusion (baseline)
|
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Behavioural question 4
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Qualitative interviews
Prazo: 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
|
|
Heart Rate Variability (HRV)
Prazo: Date of inclusion (baseline), after 8 weeks
|
24h measuring by Faros 180 |
Date of inclusion (baseline), after 8 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- YOMA
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