Effects of Online Yoga on the Quality of Life of Breast Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorCharite University, Berlin, Germany
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Iyengar Yoga
BehavioralIyengar 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
BehavioralMeditative 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.
Treatment groups
138 Participants
are divided into 3 treatment groupsGroup A: Iyengar yogaExperimental treatment 1 intervention
Group B: Meditative yogaExperimental treatment 1 intervention
Group C: Waitlist Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksOther outcomes
1
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.
Time frame
8 weeks after inclusion2
Heart Rate Variability (HRV)
24h measuring by Faros 180
Time frame
Date of inclusion (baseline), after 8 weeksSponsors and contacts
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Source ClinicalTrials.gov