The effects of a yoga-based stress reduction program
on fatigue and quality of life
in women with adjuvant chemotherapy for breast cancer
a mono-centre, pragmatic, randomized clinical study.

N/A

The working hypothesis is that women undergoing chemotherapy for breast cancer, who receive a postoperative YBSR program added to the standard treatment will report a lower “fatigue symptom score”, lower psychological stress, higher quality of life, less days in return to work and more patient satisfaction than women who receive standard care alone.

Contact 1 (screening):
In case of adjuvant chemotherapy: 6-9 days after surgery
In case of neoadjuvant chemotherapy: after PA diagnosis
A. Screening;
B. Verbal and written information.
2. Contact 2/ T=0 (intake-baseline):
In case of adjuvant chemotherapy: Within 3 weeks after surgery
In case of neoadjuvant chemotherapy: Within 3 weeks after PA diagnosis
A. Informed consent/ medical history/ demographic data/ stage of breast cancer/ type of surgery/ type of (neo)adjuvant chemotherapy/ other adjuvant therapies/ instruction for measurements and timelines during the study;
B. Questionnaires (online): MFI, FQL, EORTC-QLQ-C30 + EORTC QLQ-BR23, HADS, IES, SOC, PE.

3. Intervention during 12 weeks: (Standard Care + YBSR-program or Standard Care only according to randomisation);
4. Contact 3, T=1 (3 months after start intervention):
A. Questionnaires (online): MFI, FQL, EORTC-QLQ-C30 + EORTC QLQ-BR23, HADS, IES, SOC, PE;
B. Telephone semi-structured interview: Compliance to the intervention, actual therapies, possible adverse events from intervention, return to work, satisfaction with the provided care.
5. Contact 4, T=2 (4 months after start intervention):
A. General well-being, evaluation treatment + actual medication / therapy, possible adverse events from medications and therapies.
6. Contact 5, T=3 (6 months after start intervention):
A. Questionnaires (online): MFI, FQL, EORTC-QLQ-C30 + EORTC QLQ-BR23, HADS, IES, SOC;
B. Telephone semi-structured interview: Actual therapies, possible adverse events from intervention, return to work, satisfaction with the provided care.

Standard Medical Treatment + 12 week Yoga-Based Stress Reduction (YBSR) Program: starts 1-2 weeks before the start of chemotherapy.

Standard Medical Treatment is provided according to the hospital guidelines.



Standard Medical Treatment + 12 week Yoga-Based Stress Reduction (YBSR) Program:

In addition to standard care the YBSR program will be followed once a week for a period of 12 weeks. The YBSR program is an innovative behavioral intervention specifically designed and tailored to address patients’ pain, fatigue, and emotional distress. It is a comprehensive program provided by certified yoga teachers, that systematically integrates a broad spectrum of soft movements, breathing- and relaxation techniques. The physical exercises are designed to create body awareness and help patients to improve flexibility in neck, shoulder, arms and back to regain trust in their body. The meditative breathing- and relaxation exercises are directed to reduce stress and fatigue and increase acceptance and emotional well-being.