Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin
Stuttgart, 70376, Germany
Location status: Recruiting
Recruiting
NCT Number: NCT03735992
Mind-body Medicine for Patients With Malignant Hematological Diseases
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Mind-body medicine group program
BehavioralThe 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.
Primary outcomes
-
General Fatigue
Time frame: week 12
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
Secondary outcomes
-
General Fatigue
Time frame: week 24
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
-
Physical Fatigue
Time frame: week 12
Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale
-
Physical Fatigue
Time frame: week 24
Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale
-
Reduced Activity
Time frame: week 12
Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale
-
Reduced Activity
Time frame: week 24
Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale
-
Reduced Motivation
Time frame: week 12
Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale
-
Reduced Motivation
Time frame: week 24
Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale
-
Mental Fatigue
Time frame: week 12
Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale
-
Mental Fatigue
Time frame: week 24
Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale
-
Qaulity of life
Time frame: week 12
Functional Assessment of Cancer Therapy - General (FACT-G)
-
Qaulity of life
Time frame: week 24
Functional Assessment of Cancer Therapy - General (FACT-G)
-
Depression
Time frame: week 12
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
-
Depression
Time frame: week 24
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
-
Anxiety
Time frame: week 12
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
-
Anxiety
Time frame: week 24
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
-
Stress
Time frame: week 12
Perceived Stress Scale (PSS)
-
Stress
Time frame: week 24
Perceived Stress Scale (PSS)
-
Sleep
Time frame: week 12
Pittsburgh Sleep Quality Index (PSQI)
-
Sleep
Time frame: week 24
Pittsburgh Sleep Quality Index (PSQI)
-
Physical activity
Time frame: week 12
Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)
-
Physical activity
Time frame: week 24
Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)
-
Fatigability
Time frame: week 12
30-Second Chair Stand Test
-
Fatigability
Time frame: week 24
30-Second Chair Stand Test
-
Adverse Events
Time frame: week 12
Number of patients with adverse events
-
Adverse Events
Time frame: week 24
Number of patients with adverse events
Other outcomes
-
Treatment Expectation
Time frame: week 0
Visual Analogue Scale (VAS)
-
Treatment Satisfaction
Time frame: week 12
Client Satisfaction Questionnaire (CSQ)
Study contacts
Contact information is provided by the study sponsor or research team.
Heidemarie Haller, PhD
CONTACT
Holger Cramer, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Universität Duisburg-Essen
Other
Collaborators
- Robert Bosch Medical Center
Registry information
Official study title
Mind-body Medicine as a Supportive Strategy for Patients With Malignant Hematological Diseases: a Randomized Controlled Trial
Important dates
- Study start
- 2017
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Nov 8, 2018
- Registry last updated
- Apr 15, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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