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

Primary Purpose

Breast Neoplasms, Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Iyengar Yoga
Meditative Yoga
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms focused on measuring Yoga

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Charite UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Iyengar yoga

Meditative yoga

Waitlist Control Group

Arm Description

Intervention group 1 receives an Iyengar yoga intervention 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.

Intervention group 2 receives an Integrative yoga intervention including physical and meditation exercises as well as ideologically neutral explanations of the ethical aspects of Yoga.

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.

Outcomes

Primary Outcome Measures

Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Assessing full scale, range 0-40, higher score meaning a better outcome

Secondary Outcome Measures

Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Assessing full scale, range 0-40, higher score meaning a better outcome
Functional Assessment of Cancer Therapy: Fatigue (FACIT-F)
Assessing full scale, range 0-52, higher score meaning a better outcom
Perceived Stress Scale (PSS-10)
Assessing full scale, range 0-40, lower score meaning a better outcome
Flourishing Scale (FS-D)
Assessing full scale, range 8-56, higher score meaning a better outcome
Self-Compassion Scale (SCS-D)
Mean score of 12 items, range 1-5, higher score meaning a better outcome
Self-Efficacy Scale (ASKU)
Mean score of 3 items, range 1-5, higher score meaning a better outcome
Sociodemographic measures
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
Number of cigarettes on average per day in the last month
Behavioral questions: alcohol
Number of alcoholic beverages on average per week in the last month
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
Behavioural question
diet
Behavioural question 2
Practice of other mindfulness practices besides Yoga
Behavioural question 3
Yoga styles were practiced before
Behavioural question 4
If and how often yoga is practiced regularly
Functional Assessment of Cancer Therapy - General (FACT-G)
Assessing full scale, range 0-108, higher score meaning a better outcome
Yama/Niyama Questionnaire - YaNiQ
Assessing full scale, range 0-100, higher score meaning a better outcome
Hospital Anxiety and Depression Scale (HADS)
Assessing full scale, range 0-42, lower score meaning a better outcome

Full Information

First Posted
April 7, 2022
Last Updated
August 25, 2023
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05327543
Brief Title
Effects of Yoga on the Quality of Life of Breast Cancer Patients
Official Title
Effects of Two Different Yoga Interventions on the Quality of Life of Breast Cancer Patients Compared With Waiting List - a Three-arm Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This Study investigates the effects of two different 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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Cancer
Keywords
Yoga

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iyengar yoga
Arm Type
Experimental
Arm Description
Intervention group 1 receives an Iyengar yoga intervention 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.
Arm Title
Meditative yoga
Arm Type
Experimental
Arm Description
Intervention group 2 receives an Integrative yoga intervention including physical and meditation exercises as well as ideologically neutral explanations of the ethical aspects of Yoga.
Arm Title
Waitlist Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Iyengar Yoga
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Meditative Yoga
Intervention Description
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 Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Description
Assessing full scale, range 0-40, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks
Secondary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Description
Assessing full scale, range 0-40, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Functional Assessment of Cancer Therapy: Fatigue (FACIT-F)
Description
Assessing full scale, range 0-52, higher score meaning a better outcom
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Perceived Stress Scale (PSS-10)
Description
Assessing full scale, range 0-40, lower score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Flourishing Scale (FS-D)
Description
Assessing full scale, range 8-56, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Self-Compassion Scale (SCS-D)
Description
Mean score of 12 items, range 1-5, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Self-Efficacy Scale (ASKU)
Description
Mean score of 3 items, range 1-5, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Sociodemographic measures
Description
Age, education level, personal income, household income, employment status, job description, marital status, household members, days of sick leave past 3 months
Time Frame
Date of inclusion (baseline)
Title
Behavioral questions: cigarettes
Description
Number of cigarettes on average per day in the last month
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Behavioral questions: alcohol
Description
Number of alcoholic beverages on average per week in the last month
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Expectation question
Description
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
Time Frame
Date of inclusion (baseline)
Title
Behavioural question
Description
diet
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Behavioural question 2
Description
Practice of other mindfulness practices besides Yoga
Time Frame
Date of inclusion (baseline)
Title
Behavioural question 3
Description
Yoga styles were practiced before
Time Frame
Date of inclusion (baseline)
Title
Behavioural question 4
Description
If and how often yoga is practiced regularly
Time Frame
Date of inclusion (baseline)
Title
Functional Assessment of Cancer Therapy - General (FACT-G)
Description
Assessing full scale, range 0-108, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Yama/Niyama Questionnaire - YaNiQ
Description
Assessing full scale, range 0-100, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Assessing full scale, range 0-42, lower score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Other Pre-specified Outcome Measures:
Title
Qualitative interviews
Description
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 inclusion
Title
Heart Rate Variability (HRV)
Description
24h measuring by Faros 180
Time Frame
Date of inclusion (baseline), after 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Charite University
City
Berlin
ZIP/Postal Code
14109
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Roesner
Phone
030 80505 682
Email
m.roesner@immanuel.de
First Name & Middle Initial & Last Name & Degree
Andreas Michalsen, Prof.Dr.

12. IPD Sharing Statement

Learn more about this trial

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

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