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NCT Number: NCT05327543

Effects of Online Yoga on the Quality of Life of Breast Cancer Patients

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Charite University

Berlin, State of Berlin, 14109, Germany

Location status: Recruiting

Location contact

Andreas Michalsen, Prof.Dr.

PRINCIPAL_INVESTIGATOR

Miriam Roesner

CONTACT

[email protected]

030 80505 682

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iyengar Yoga

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

    Time frame: 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

  2. Functional Assessment of Cancer Therapy: Fatigue (FACIT-F)

    Time frame: 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

  3. Perceived Stress Scale (PSS-10)

    Time frame: 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

  4. Flourishing Scale (FS-D)

    Time frame: 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

  5. Self-Compassion Scale (SCS-D)

    Time frame: 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

  6. Self-Efficacy Scale (ASKU)

    Time frame: 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

  7. Sociodemographic measures

    Time frame: 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

  8. Behavioral questions: cigarettes

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

    Number of cigarettes on average per day in the last month

  9. Behavioral questions: alcohol

    Time frame: 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

  10. Expectation question

    Time frame: 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

  11. Behavioural question

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

    diet

  12. Behavioural question 2

    Time frame: Date of inclusion (baseline)

    Practice of other mindfulness practices besides Yoga

  13. Behavioural question 3

    Time frame: Date of inclusion (baseline)

    Yoga styles were practiced before

  14. Behavioural question 4

    Time frame: Date of inclusion (baseline)

    If and how often yoga is practiced regularly

  15. Functional Assessment of Cancer Therapy - General (FACT-G)

    Time frame: 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

  16. Yama/Niyama Questionnaire - YaNiQ

    Time frame: 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

  17. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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

Other outcomes

  1. Qualitative interviews

    Time frame: 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.

  2. Heart Rate Variability (HRV)

    Time frame: Date of inclusion (baseline), after 8 weeks

    24h measuring by Faros 180

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2022
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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