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

February 14, 2025 updated by: Andreas Michalsen, Charite University, Berlin, Germany

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14109
        • Recruiting
        • Charite University
        • Contact:
        • Contact:
          • Andreas Michalsen, Prof.Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waitlist Control Group
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 4 months.
Experimental: Iyengar yoga
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.
Behavioral: Iyengar Yoga
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.
Experimental: Meditative yoga
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.
Behavioral: Meditative Yoga
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Date of inclusion (baseline), after 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Date of inclusion (baseline)
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
Date of inclusion (baseline)
Behavioural question 2
Time Frame: Date of inclusion (baseline)
Practice of other mindfulness practices besides Yoga
Date of inclusion (baseline)
Behavioural question 3
Time Frame: Date of inclusion (baseline)
Yoga styles were practiced before
Date of inclusion (baseline)
Behavioural question 4
Time Frame: Date of inclusion (baseline)
If and how often yoga is practiced regularly
Date of inclusion (baseline)
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
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
Assessing full scale, range 0-52, higher score meaning a better outcom
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
Assessing full scale, range 0-40, lower score meaning a better outcome
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
Assessing full scale, range 8-56, higher score meaning a better outcome
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
Mean score of 12 items, range 1-5, higher score meaning a better outcome
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
Mean score of 3 items, range 1-5, higher score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
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
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
Number of alcoholic beverages on average per week in the last month
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
Behavioural question
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
diet
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
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
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
Assessing full scale, range 0-100, higher score meaning a better outcome
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
Assessing full scale, range 0-42, lower score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks after inclusion
Heart Rate Variability (HRV)
Time Frame: Date of inclusion (baseline), after 8 weeks
24h measuring by Faros 180
Date of inclusion (baseline), after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOMA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe