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

Not Applicable

Recruiting

• Conditions: Breast Neoplasms; Cancer

• Registration Number: NCT05327543
• Lead Sponsor: Charite University, Berlin, Germany

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.

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 4 months.

Study Timeline

• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Study Start: 2022-05-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)	Date of inclusion (baseline), after 8 weeks	Assessing full scale, range 0-40, higher score meaning a better outcome

Secondary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy: Fatigue (FACIT-F)	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
Perceived Stress Scale (PSS-10)	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
Flourishing Scale (FS-D)	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
Self-Compassion Scale (SCS-D)	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
Self-Efficacy Scale (ASKU)	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
Sociodemographic measures	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
Behavioral questions: cigarettes	Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks	Number of cigarettes on average per day in the last month
Behavioral questions: alcohol	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
Behavioural question 2	Date of inclusion (baseline)	Practice of other mindfulness practices besides Yoga
Behavioural question 3	Date of inclusion (baseline)	Yoga styles were practiced before
Functional Assessment of Cancer Therapy - General (FACT-G)	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
Yama/Niyama Questionnaire - YaNiQ	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
Expectation question	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
Behavioural question	Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks	diet
Behavioural question 4	Date of inclusion (baseline)	If and how often yoga is practiced regularly
Hospital Anxiety and Depression Scale (HADS)	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
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)	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

Trial Locations

Locations (1)

Charite University; 🇩🇪 Berlin, Germany