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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05327543
• Other study ID #: YOMA
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Charite University	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative interviews	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
Other	Heart Rate Variability (HRV)	24h measuring by Faros 180	Date of inclusion (baseline), after 8 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	Behavioral questions: cigarettes	Number of cigarettes on average per day in the last month	Date of inclusion (baseline), after 8 weeks, after 16 weeks
Secondary	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
Secondary	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)
Secondary	Behavioural question	diet	Date of inclusion (baseline), after 8 weeks, after 16 weeks
Secondary	Behavioural question 2	Practice of other mindfulness practices besides Yoga	Date of inclusion (baseline)
Secondary	Behavioural question 3	Yoga styles were practiced before	Date of inclusion (baseline)
Secondary	Behavioural question 4	If and how often yoga is practiced regularly	Date of inclusion (baseline)
Secondary	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
Secondary	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
Secondary	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