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| Name | Class |
|---|---|
| Robert Bosch Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mind-body medicine group program | Experimental | Patients recieve an 11-week mind-body medicine group program including elements of mindfullness based stress reduction (MBSR), yoga, and education + treatment as usual. |
|
| Wait list | No Intervention | Treatment as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind-body medicine group program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| General Fatigue | Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| General Fatigue | Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale | week 24 |
| Physical Fatigue | Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Expectation | Visual Analogue Scale (VAS) | week 0 |
| Treatment Satisfaction | Client Satisfaction Questionnaire (CSQ) | week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Holger Cramer, PhD | Contact | +4971181017860 | holger.cramer@med.uni-tuebingen.de | |
| Heidemarie Haller, PhD | Contact | +4920172377382 | heidemarie.haller@uk-essen.de |
| Name | Affiliation | Role |
|---|---|---|
| Gustav Dobos, Prof. MD | Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin | Recruiting | Stuttgart | 70376 | Germany |
Upon reasonable request.
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| week 12 |
| Physical Fatigue | Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale | week 24 |
| Reduced Activity | Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale | week 12 |
| Reduced Activity | Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale | week 24 |
| Reduced Motivation | Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale | week 12 |
| Reduced Motivation | Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale | week 24 |
| Mental Fatigue | Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale | week 12 |
| Mental Fatigue | Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale | week 24 |
| Qaulity of life | Functional Assessment of Cancer Therapy - General (FACT-G) | week 12 |
| Qaulity of life | Functional Assessment of Cancer Therapy - General (FACT-G) | week 24 |
| Depression | Hospital Anxiety and Depression Scale - Depression subscale (HADS-D) | week 12 |
| Depression | Hospital Anxiety and Depression Scale - Depression subscale (HADS-D) | week 24 |
| Anxiety | Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) | week 12 |
| Anxiety | Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) | week 24 |
| Stress | Perceived Stress Scale (PSS) | week 12 |
| Stress | Perceived Stress Scale (PSS) | week 24 |
| Sleep | Pittsburgh Sleep Quality Index (PSQI) | week 12 |
| Sleep | Pittsburgh Sleep Quality Index (PSQI) | week 24 |
| Physical activity | Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland) | week 12 |
| Physical activity | Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland) | week 24 |
| Fatigability | 30-Second Chair Stand Test | week 12 |
| Fatigability | 30-Second Chair Stand Test | week 24 |
| Adverse Events | Number of patients with adverse events | week 12 |
| Adverse Events | Number of patients with adverse events | week 24 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |