This randomized controlled trial aims to investigate the effectiveness of a mind-body group program as a supprtivemanagement strategy for fatigue in patients with malignant hematological diseases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
94
The group program is mainly based on MBSR. It further integrates elements of the mind-body medicine cancer program of the Benson-Henry Mind/Body Medical Institute at Harvard Medical School which is rooted in psychoneuroendocrinology and focuses on relaxation techniques, exercise, cognitive restructuring, diet, and social support. In addition, naturopathic methods of selfregulation and self-care are incorporated.
Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin
Stuttgart, Germany
RECRUITINGGeneral Fatigue
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
Time frame: week 12
General Fatigue
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
Time frame: week 24
Physical Fatigue
Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale
Time frame: week 12
Physical Fatigue
Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale
Time frame: week 24
Reduced Activity
Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale
Time frame: week 12
Reduced Activity
Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale
Time frame: week 24
Reduced Motivation
Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale
Time frame: week 12
Reduced Motivation
Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale
Time frame: week 24
Mental Fatigue
Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale
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Time frame: week 12
Mental Fatigue
Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale
Time frame: week 24
Qaulity of life
Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: week 12
Qaulity of life
Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: week 24
Depression
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
Time frame: week 12
Depression
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
Time frame: week 24
Anxiety
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time frame: week 12
Anxiety
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time frame: week 24
Stress
Perceived Stress Scale (PSS)
Time frame: week 12
Stress
Perceived Stress Scale (PSS)
Time frame: week 24
Sleep
Pittsburgh Sleep Quality Index (PSQI)
Time frame: week 12
Sleep
Pittsburgh Sleep Quality Index (PSQI)
Time frame: week 24
Physical activity
Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)
Time frame: week 12
Physical activity
Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)
Time frame: week 24
Fatigability
30-Second Chair Stand Test
Time frame: week 12
Fatigability
30-Second Chair Stand Test
Time frame: week 24
Adverse Events
Number of patients with adverse events
Time frame: week 12
Adverse Events
Number of patients with adverse events
Time frame: week 24