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

Charité University Medicine Berlin

Status: Enrolling

Conditions: Breast Neoplasms; Cancer

Treatments: Behavioral: Iyengar Yoga; Behavioral: Meditative Yoga

Study type: Interventional

Funder types: Other

Identifiers

NCT05327543

YOMA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 3 patient groups

Iyengar yoga

Experimental group

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.

Treatment:

Behavioral: Iyengar Yoga

Meditative yoga

Experimental group

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.

Treatment:

Behavioral: Meditative Yoga

Waitlist Control Group

No Intervention group

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.