Breast Neoplasms, Cancer
Conditions
Keywords
Yoga
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.
Interventions
BEHAVIORALIyengar 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.
BEHAVIORALMeditative 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.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | Date of inclusion (baseline), after 8 weeks | Assessing full scale, range 0-40, higher score meaning a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | 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 |
| Functional Assessment of Cancer Therapy: Fatigue (FACIT-F) | 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 |
| Perceived Stress Scale (PSS-10) | 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 |
| Flourishing Scale (FS-D) | 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 |
| Self-Compassion Scale (SCS-D) | 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 |
| Self-Efficacy Scale (ASKU) | 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 |
| Sociodemographic measures | 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 |
| Behavioral questions: cigarettes | Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks | Number of cigarettes on average per day in the last month |
| Behavioral questions: alcohol | 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 |
| Yama/Niyama Questionnaire - YaNiQ | 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 |
| Hospital Anxiety and Depression Scale (HADS) | 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 |
| Expectation question | 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 |
| Behavioural question | Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks | diet |
| Behavioural question 2 | Date of inclusion (baseline) | Practice of other mindfulness practices besides Yoga |
| Behavioural question 3 | Date of inclusion (baseline) | Yoga styles were practiced before |
| Behavioural question 4 | Date of inclusion (baseline) | If and how often yoga is practiced regularly |
| Functional Assessment of Cancer Therapy - General (FACT-G) | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Qualitative interviews | 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. |
| Heart Rate Variability (HRV) | Date of inclusion (baseline), after 8 weeks | 24h measuring by Faros 180 |
Countries
Germany
Outcome results
None listed