This research study is evaluating the effects of two training programs (1. Walking, 2. Mindfulness and Self-compassion focussed Walking) on tumor-specific symptoms of fatigue in women with breast cancer undergoing chemo- and/or radiotherapy.
This randomized research study is evaluating the effects of two training programs (1. Walking, 2. Mindfulness and Self-compassion focussed Walking (MSCW)) on tumor-specific symptoms of fatigue in women with breast cancer undergoing chemo- and/or radiotherapy. The results of both groups are compared with each other and with those of a control group. The MSCW program combines endurance based physical activity in the form of medically controlled walking, as well as standardized, evidence-based mindfulness exercise elements in a training program. The participants of both active groups (Walking and MSCW) practice for 12 weeks, once a week for 60 minutes under the guidance of a trainer in a group and 2 additional times (60 minutes each) independently at home. The purpose of this study is to prevent a sharp decline in quality of life due to fatigue symptoms by participating in the MSCW training program. A total of 135 participants will be included in the study. All participants are followed for 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
135
Mindfulness and Self-Compassion focussed exercises during walking training with moderate intensity
Walking training with moderate intensity
Charite Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGSana-Klinikum Lichtenberg, Berlin
Berlin, Germany
RECRUITINGTumor specific fatigue symptomatology
Fatigue Assessment Questionnaire (FAQ), minimum value 0, maximum value 60, higher values mean a worse outcome
Time frame: Change from baseline to 12, 24 and 52 weeks
Disease-specific quality of life
Functional Assessment of Cancer Therapy - Breastcancer (FACT-B), minimum value 0, maximum value 148 for FACT-B total score, minimum value 0, maximum value 28 for subscores, higher values mean a better outcome
Time frame: Change from baseline to 12, 24 and 52 weeks
Self-Compassion
Self-Compassion Scale German (SCS-D), minimum value 1, maximum value 5 for SCS-D total score, minimum value 1, maximum value 5 for subscores, higher values mean a better outcome
Time frame: Change from baseline to 6, 12, 24 and 52 weeks
Mindfulness
Southampton Mindfulness Questionnaire (SMQ), minimum value 0, maximum value 96 for SMQ total score, minimum value 0, maximum value 24 for subscores, higher values mean a better outcome
Time frame: Change from baseline to 6, 12, 24 and 52 weeks
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS), minimum value 0, maximum value 42 for HADS total score, minimum value 0, maximum value 21 for subscores, higher values mean a worse outcome
Time frame: Change from baseline to 12, 24 and 52 weeks
Stress
Perceived Stress Scale (PSS), minimum value 0, maximum value 40 for PSS total score, higher values mean a worse outcome
Time frame: Change from baseline to 12, 24 and 52 weeks
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Anxiety
State-Trait Anxiety Inventory (STAI) - Trait Dimension, minimum value 10, maximum value 80 for STAI total score, higher values mean a better outcome
Time frame: Change from baseline to 12, 24 and 52 weeks
Heart rate variability
Polar watch V800
Time frame: Change from baseline to 12, 24 and 52 weeks
Alpha-Amylase
extraction from saliva measurements
Time frame: Change from baseline to 12, 24 and 52 weeks
cardiac function parameters
Examination by sonography
Time frame: Change from baseline to 12, 24 and 52 weeks
Immune defence
Measurement of leukocytes by blood sampling
Time frame: Change from baseline to 12, 24 and 52 weeks