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| Name | Class |
|---|---|
| Sana-Klinikum Lichtenberg | OTHER |
| Park-Klinik Berlin Weißensee | UNKNOWN |
| Vivantes Klinikum am Urban | UNKNOWN |
| Steffen Lohrer Stiftung |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walking-Group | Active Comparator | Participants in this group walk 45 minutes 3 times a week (plus 15 minutes of warm up and cool-down) in a moderate intensity range (64-76% HRmax). |
|
| Mindfulness and Self-Compassion focussed Walking-Group | Experimental | Participants in this group walk 45 minutes 3 times a week (plus 15 minutes of warm up and cool-down) in a moderate intensity range (64-76% HRmax) and additionally practice mindfulness exercises and self-compassion exercises during the 60 minutes. |
|
| TAU-Group | No Intervention | Participants in this group receive no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness and Self-Compassion focussed exercises during walking training | Behavioral | Mindfulness and Self-Compassion focussed exercises during walking training with moderate intensity |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor specific fatigue symptomatology | Fatigue Assessment Questionnaire (FAQ), minimum value 0, maximum value 60, higher values mean a worse outcome | Change from baseline to 12, 24 and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from baseline to 12, 24 and 52 weeks |
| Self-Compassion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yves L. Steininger, M.Sc. M.Sc. | Contact | +491635820041 | yves.steininger@charite.de | |
| Andreas Ströhle, Prof. | Contact | +4930450517034 | andreas.stroehle@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Ströhle, Prof. | Charite Universitätsmedizin Berlin | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite Universitätsmedizin Berlin | Recruiting | Berlin | 10117 | Germany |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| UNKNOWN |
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| Walking training | Behavioral | Walking training with moderate intensity |
|
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 |
| 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 | 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 | 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 | Change from baseline to 12, 24 and 52 weeks |
| Anxiety | State-Trait Anxiety Inventory (STAI) - Trait Dimension, minimum value 10, maximum value 80 for STAI total score, higher values mean a better outcome | Change from baseline to 12, 24 and 52 weeks |
| Heart rate variability | Polar watch V800 | Change from baseline to 12, 24 and 52 weeks |
| Alpha-Amylase | extraction from saliva measurements | Change from baseline to 12, 24 and 52 weeks |
| cardiac function parameters | Examination by sonography | Change from baseline to 12, 24 and 52 weeks |
| Immune defence | Measurement of leukocytes by blood sampling | Change from baseline to 12, 24 and 52 weeks |
| Sana-Klinikum Lichtenberg, Berlin | Recruiting | Berlin | 10117 | Germany |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |