Breast NeoplasmsNCT05327543
Effects of Online Yoga on the Quality of Life of Breast Cancer Patients
A study testing Iyengar Yoga and Meditative Yoga in people with Breast Neoplasms and Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms, Cancer
- What is being tested?
- Iyengar Yoga and Meditative Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteGermany
- Study dates
- 9 May 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charite University
Berlin, State of Berlin, 14109
Miriam Roesner, 030 80505 682, m.roesner@immanuel.de
Andreas Michalsen, Prof.Dr.
About this study
Official title: 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
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.
Read the 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 6 months.
- Conditions
- Breast Neoplasms, Cancer
- Being tested
- Iyengar Yoga, Meditative Yoga
- Keywords
- Yoga
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iyengar YogaBehavioural
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 YogaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Iyengar Yoga |
| 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. Receives: Behavioral: Meditative Yoga |
| 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 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Assessing full scale, range 0-40, higher score meaning a better outcome
Measured: Date of inclusion (baseline), after 8 weeks
Secondary outcomes (17)
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Assessing full scale, range 0-40, higher score meaning a better outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Date of inclusion (baseline)
Behavioral questions: cigarettes
Number of cigarettes on average per day in the last month
Measured: 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
Measured: 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
Measured: Date of inclusion (baseline)
Behavioural question
diet
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Behavioural question 2
Practice of other mindfulness practices besides Yoga
Measured: Date of inclusion (baseline)
Behavioural question 3
Yoga styles were practiced before
Measured: Date of inclusion (baseline)
Behavioural question 4
If and how often yoga is practiced regularly
Measured: Date of inclusion (baseline)
Functional Assessment of Cancer Therapy - General (FACT-G)
Assessing full scale, range 0-108, higher score meaning a better outcome
Measured: 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
Measured: 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
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start9 May 2022
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327543
- Sponsor's protocol ID
- YOMA
- Status last verified
- Sep 2026
- First submitted
- 7 Apr 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05327543
- Acronym / sponsor ID
- YOMA
- Conditions
- Breast Neoplasms, Cancer
- Keywords
- Yoga
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iyengar yoga | Experimental | Behavioral: Iyengar YogaIntervention 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 | Experimental | Behavioral: Meditative YogaIntervention 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 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 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iyengar YogaIyengar 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. | Behavioural | Iyengar yoga |
| Meditative YogaMeditative 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. | Behavioural | Meditative yoga |
Primary outcome
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Time frame: Date of inclusion (baseline), after 8 weeks
Assessing full scale, range 0-40, higher score meaning a better outcome
17 secondary outcomes
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Functional Assessment of Cancer Therapy: Fatigue (FACIT-F)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Perceived Stress Scale (PSS-10)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Flourishing Scale (FS-D)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Self-Compassion Scale (SCS-D)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Self-Efficacy Scale (ASKU)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Sociodemographic measures
Time frame: Date of inclusion (baseline)
Behavioral questions: cigarettes
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Behavioral questions: alcohol
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Expectation question
Time frame: Date of inclusion (baseline)
Behavioural question
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Behavioural question 2
Time frame: Date of inclusion (baseline)
Behavioural question 3
Time frame: Date of inclusion (baseline)
Behavioural question 4
Time frame: Date of inclusion (baseline)
Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Yama/Niyama Questionnaire - YaNiQ
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iyengar Yoga and Meditative Yoga in people with Breast Neoplasms and Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) (time frame: Date of inclusion (baseline), after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.