Effects of Online Yoga on the Quality of Life of Breast Cancer Patients

Официальное название

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

Обзор

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.

Подробное описание

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 4 months.

Вмешательства

• Поведенческое Iyengar Yoga
  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.
• Поведенческое Meditative 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.

Первичные конечные точки

• Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) [Срок оценки: Date of inclusion (baseline), after 8 weeks]

Вторичные конечные точки (12)

• Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) [Срок оценки: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks]
• Functional Assessment of Cancer Therapy: Fatigue (FACIT-F) [Срок оценки: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks]
• Perceived Stress Scale (PSS-10) [Срок оценки: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks]
• Flourishing Scale (FS-D) [Срок оценки: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks]
• Self-Compassion Scale (SCS-D) [Срок оценки: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks]
• Self-Efficacy Scale (ASKU) [Срок оценки: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks]
• Sociodemographic measures [Срок оценки: Date of inclusion (baseline)]
• Behavioral questions: cigarettes [Срок оценки: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks]
• Behavioral questions: alcohol [Срок оценки: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks]
• Expectation question [Срок оценки: Date of inclusion (baseline)]
• Behavioural question [Срок оценки: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks]
• Behavioural question 2 [Срок оценки: Date of inclusion (baseline)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Германия · 1 центр

• Charite University — Berlin

Идентификаторы

NCT: NCT05327543 · YOMA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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