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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Neoplasms
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Andreas Michalsen
Prof. Dr. Andreas Michalsen
Charite University, Berlin, Germany
Eligibility Criteria
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
Outcomes
Primary Outcomes
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Time Frame: Date of inclusion (baseline), after 8 weeks
Assessing full scale, range 0-40, higher score meaning a better outcome
Secondary Outcomes
- Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Functional Assessment of Cancer Therapy: Fatigue (FACIT-F)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Perceived Stress Scale (PSS-10)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Flourishing Scale (FS-D)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Self-Compassion Scale (SCS-D)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Self-Efficacy Scale (ASKU)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Sociodemographic measures(Date of inclusion (baseline))
- Behavioral questions: cigarettes(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Behavioral questions: alcohol(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Expectation question(Date of inclusion (baseline))
- Behavioural question(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Behavioural question 2(Date of inclusion (baseline))
- Behavioural question 3(Date of inclusion (baseline))
- Behavioural question 4(Date of inclusion (baseline))
- Functional Assessment of Cancer Therapy - General (FACT-G)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Yama/Niyama Questionnaire - YaNiQ(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Hospital Anxiety and Depression Scale (HADS)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)