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: * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
138
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.
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.
Charite University
Berlin, State of Berlin, Germany
RECRUITINGFunctional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Assessing full scale, range 0-40, higher score meaning a better outcome
Time frame: Date of inclusion (baseline), after 8 weeks
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Assessing full scale, range 0-40, higher score meaning a better outcome
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Functional Assessment of Cancer Therapy: Fatigue (FACIT-F)
Assessing full scale, range 0-52, higher score meaning a better outcom
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
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Sociodemographic measures
Age, education level, personal income, household income, employment status, job description, marital status, household members, days of sick leave past 3 months
Time frame: Date of inclusion (baseline)
Behavioral questions: cigarettes
Number of cigarettes on average per day in the last month
Time frame: 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
Time frame: 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
Time frame: Date of inclusion (baseline)
Behavioural question
diet
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Behavioural question 2
Practice of other mindfulness practices besides Yoga
Time frame: Date of inclusion (baseline)
Behavioural question 3
Yoga styles were practiced before
Time frame: Date of inclusion (baseline)
Behavioural question 4
If and how often yoga is practiced regularly
Time frame: Date of inclusion (baseline)
Functional Assessment of Cancer Therapy - General (FACT-G)
Assessing full scale, range 0-108, higher score meaning a better outcome
Time frame: 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
Time frame: 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
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks