This randomized controlled trial aims to investigate the effectiveness of a mind body day care clinic program of breast cancer patients undergoing endocrine therapy.
Breast cancer patients undergoing endocrine therapy are often suffering from side effects. This randomized controlled trial analyzes the effects of an 11-week day care clinic group program including mind body medical elements (yoga, relaxation, meditation, education) and acupuncture in breast cancer patients with menopausal symptoms under endocrine therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
Patients recieve an 11-week mind body day care clinic including elements of mindfullness based stress reduction (MBSR), yoga, acupuncture, education
Patients continue usual care by their practitioner
Evang. Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, Germany
Menopausal symptoms
Menopause Rating Scale (MRS)
Time frame: week 11
General health-related quality of life
Functional Assessment of Cancer Therapy - General Questionaire (FACT-G)
Time frame: week 11
Spiritual health-related quality of life
Functional Assessment of Cancer Therapy - Spirutual Subscale (FACT-SP)
Time frame: week 11
Fatigue
Functional Assessment of Cancer Therapy - Fatigue Subscale (FACT-F)
Time frame: week 11
Mental wellbeing
Hospital Anxiety and Depression Scale (HADS)
Time frame: week 11
Stress
Perceived Stress Scale (PSS)
Time frame: week 11
Compliance
Medication Adherence Report Scale (MARS)
Time frame: week 11
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: week 11
Menopausal smptoms
Menopause Rating Scale (MRS)
Time frame: week 23
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Genaeral health-related quality of life
Functional Assessment of Cancer Therapy - General Questionaire (FACT-G)
Time frame: week 23
Spiritual health-related quality of life
Functional Assessment of Cancer Therapy - Spirutual Subscale (FACT-SP)
Time frame: week 23
Fatigue
Functional Assessment of Cancer Therapy - Fatigue Subscale (FACT-F)
Time frame: week 23
Mental wellbeing
Hospital Anxiety and Depression Scale (HADS)
Time frame: week 23
Stress
Perceived Stress Scale (PSS)
Time frame: week 23
Compliance
Medication Adherence Report Scale (MARS)
Time frame: week 23
Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: week 23