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

Study Overview
=================
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.

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

Conditions
-----------------
Breast Neoplasms, Cancer

Intervention / Treatment
-----------------
* Behavioral: Iyengar Yoga
* Behavioral: Meditative Yoga


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iyengar yoga<br>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. | Behavioral: Iyengar Yoga<br>* 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.<br>|
| Experimental: Meditative yoga<br>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. | Behavioral: Meditative Yoga<br>* 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.<br>|
| No Intervention: Waitlist Control Group<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | 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 |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | Assessing full scale, range 0-40, higher score meaning a better outcome | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Functional Assessment of Cancer Therapy: Fatigue (FACIT-F) | Assessing full scale, range 0-52, higher score meaning a better outcom | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Perceived Stress Scale (PSS-10) | Assessing full scale, range 0-40, lower score meaning a better outcome | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Flourishing Scale (FS-D) | Assessing full scale, range 8-56, higher score meaning a better outcome | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Self-Compassion Scale (SCS-D) | Mean score of 12 items, range 1-5, higher score meaning a better outcome | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Self-Efficacy Scale (ASKU) | Mean score of 3 items, range 1-5, higher score meaning a better outcome | Date of inclusion (baseline), after 8 weeks, after 16 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 | Date of inclusion (baseline) | 
| Behavioral questions: cigarettes | Number of cigarettes on average per day in the last month | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Behavioral questions: alcohol | Number of alcoholic beverages on average per week in the last month | Date of inclusion (baseline), after 8 weeks, after 16 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 | Date of inclusion (baseline) | 
| Behavioural question | diet | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Behavioural question 2 | Practice of other mindfulness practices besides Yoga | Date of inclusion (baseline) | 
| Behavioural question 3 | Yoga styles were practiced before | Date of inclusion (baseline) | 
| Behavioural question 4 | If and how often yoga is practiced regularly | Date of inclusion (baseline) | 
| Functional Assessment of Cancer Therapy - General (FACT-G) | Assessing full scale, range 0-108, higher score meaning a better outcome | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Yama/Niyama Questionnaire - YaNiQ | Assessing full scale, range 0-100, higher score meaning a better outcome | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Hospital Anxiety and Depression Scale (HADS) | Assessing full scale, range 0-42, lower score meaning a better outcome | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Yoga