NCT03735992
Recruiting
N/A
Mind-body Medicine as a Supportive Strategy for Patients With Malignant Hematological Diseases: a Randomized Controlled Trial
ConditionsHematologic Neoplasms
InterventionsMind-body medicine group program
Overview
- Phase
- N/A
- Intervention
- Mind-body medicine group program
- Conditions
- Hematologic Neoplasms
- Sponsor
- Universität Duisburg-Essen
- Enrollment
- 94
- Locations
- 2
- Primary Endpoint
- General Fatigue
- Status
- Recruiting
- Last Updated
- 17 days ago
Overview
Brief Summary
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.
Investigators
Holger Cramer
Research Director
Universität Duisburg-Essen
Eligibility Criteria
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
Arms & Interventions
Mind-body medicine group program
Patients recieve an 11-week mind-body medicine group program including elements of mindfullness based stress reduction (MBSR), yoga, and education + treatment as usual.
Intervention: Mind-body medicine group program
Wait list
Treatment as usual.
Outcomes
Primary Outcomes
General Fatigue
Time Frame: week 12
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
Secondary Outcomes
- Reduced Motivation(week 24)
- Mental Fatigue(week 24)
- Depression(week 24)
- Anxiety(week 24)
- Sleep(week 24)
- General Fatigue(week 24)
- Physical Fatigue(week 24)
- Reduced Activity(week 24)
- Qaulity of life(week 24)
- Adverse Events(week 24)
- Stress(week 24)
- Physical activity(week 24)
- Fatigability(week 24)
- Physical Fatigue(week 12)
- Reduced Activity(week 12)
- Reduced Motivation(week 12)
- Mental Fatigue(week 12)
- Qaulity of life(week 12)
- Depression(week 12)
- Anxiety(week 12)
- Stress(week 12)
- Sleep(week 12)
- Physical activity(week 12)
- Fatigability(week 12)
- Adverse Events(week 12)
Study Sites (2)
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