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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.
In this randomized controlled trial breast cancer patients will be randomized into three treatment arms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iyengar yoga | Experimental | 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. |
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| Meditative yoga | Experimental | 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. |
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| Waitlist Control Group | No Intervention | 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 4 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iyengar Yoga | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | Assessing full scale, range 0-40, higher score meaning a better outcome | Date of inclusion (baseline), after 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative interviews | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite University | Recruiting | Berlin | State of Berlin | 14109 | Germany |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Meditative Yoga | Behavioral | 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. |
|
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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | diet | Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks |
| Behavioural question 2 | Practice of other mindfulness practices besides Yoga | Date of inclusion (baseline) |
| Behavioural question 3 | Yoga styles were practiced before | Date of inclusion (baseline) |
| Behavioural question 4 | If and how often yoga is practiced regularly | Date of inclusion (baseline) |
| Functional Assessment of Cancer Therapy - General (FACT-G) | 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 | 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) | 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 |
24h measuring by Faros 180 |
| Date of inclusion (baseline), after 8 weeks |