Mind-body Medicine for Patients With Malignant Hematological Diseases

Study Overview
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Brief Summary
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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.

Official Title
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Mind-body Medicine as a Supportive Strategy for Patients With Malignant Hematological Diseases: a Randomized Controlled Trial

Conditions
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Hematologic Neoplasms

Intervention / Treatment
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* Behavioral: Mind-body medicine group program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with malignant hematological diseases in complete remission after primary chemotherapy and/or radiation Physical and mental ability to attent 8 of 11 group units Exclusion Criteria: Chemotherapy, radiation, or rehabilitation programm during the study period Pregnancy Participation in other studies with behavioral interventions during the study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind-body medicine group program<br>Patients recieve an 11-week mind-body medicine group program including elements of mindfullness based stress reduction (MBSR), yoga, and education + treatment as usual. | Behavioral: Mind-body medicine group program<br>* 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.<br>|
| No Intervention: Wait list<br>Treatment as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Fatigue | Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Fatigue | Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale | week 24 | 
| Physical Fatigue | Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Hematologic Neoplasms, Supportive Therapy, Mind-body medicine, Complementary and alternative medicine