Effects of Online Yoga on the Quality of Life of Breast Cancer Patients
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
1 other identifier
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2022
CompletedFirst Posted
Study publicly available on registry
April 14, 2022
CompletedStudy Start
First participant enrolled
May 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
February 18, 2025
February 1, 2025
4.1 years
April 7, 2022
February 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (17)
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
- +12 more secondary outcomes
Other Outcomes (2)
Qualitative interviews
8 weeks after inclusion
Heart Rate Variability (HRV)
Date of inclusion (baseline), after 8 weeks
Study Arms (3)
Iyengar yoga
EXPERIMENTALIntervention 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.
Meditative yoga
EXPERIMENTALIntervention 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.
Waitlist Control Group
NO INTERVENTIONGroup 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charite University
Berlin, State of Berlin, 14109, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Andreas Michalsen
Study Record Dates
First Submitted
April 7, 2022
First Posted
April 14, 2022
Study Start
May 9, 2022
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 18, 2025
Record last verified: 2025-02