- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03735992
Mind-body Medicine for Patients With Malignant Hematological Diseases
November 21, 2023 updated by: Holger Cramer, Universität Duisburg-Essen
Mind-body Medicine as a Supportive Strategy for Patients With Malignant Hematological Diseases: a Randomized Controlled Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
94
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Heidemarie Haller, PhD
- Phone Number: +4920172377382
- Email: heidemarie.haller@uk-essen.de
Study Contact Backup
- Name: Holger Cramer, PhD
- Phone Number: +4971181017860
- Email: holger.cramer@med.uni-tuebingen.de
Study Locations
-
-
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Stuttgart, Germany, 70376
- Recruiting
- Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin
-
Contact:
- Walter E. Aulitzky, Prof. MD
- Email: walter.aulitzky@rbk.de
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Contact:
- Maria M. Winkler
- Email: marcela.winkler@rbk.de
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
No Intervention: Wait list
Treatment as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Fatigue
Time Frame: week 12
|
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
|
week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Fatigue
Time Frame: week 24
|
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale
|
week 24
|
Physical Fatigue
Time Frame: week 12
|
Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale
|
week 12
|
Physical Fatigue
Time Frame: week 24
|
Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale
|
week 24
|
Reduced Activity
Time Frame: week 12
|
Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale
|
week 12
|
Reduced Activity
Time Frame: week 24
|
Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale
|
week 24
|
Reduced Motivation
Time Frame: week 12
|
Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale
|
week 12
|
Reduced Motivation
Time Frame: week 24
|
Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale
|
week 24
|
Mental Fatigue
Time Frame: week 12
|
Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale
|
week 12
|
Mental Fatigue
Time Frame: week 24
|
Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale
|
week 24
|
Qaulity of life
Time Frame: week 12
|
Functional Assessment of Cancer Therapy - General (FACT-G)
|
week 12
|
Qaulity of life
Time Frame: week 24
|
Functional Assessment of Cancer Therapy - General (FACT-G)
|
week 24
|
Depression
Time Frame: week 12
|
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
|
week 12
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Depression
Time Frame: week 24
|
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
|
week 24
|
Anxiety
Time Frame: week 12
|
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
|
week 12
|
Anxiety
Time Frame: week 24
|
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
|
week 24
|
Stress
Time Frame: week 12
|
Perceived Stress Scale (PSS)
|
week 12
|
Stress
Time Frame: week 24
|
Perceived Stress Scale (PSS)
|
week 24
|
Sleep
Time Frame: week 12
|
Pittsburgh Sleep Quality Index (PSQI)
|
week 12
|
Sleep
Time Frame: week 24
|
Pittsburgh Sleep Quality Index (PSQI)
|
week 24
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Physical activity
Time Frame: week 12
|
Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)
|
week 12
|
Physical activity
Time Frame: week 24
|
Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)
|
week 24
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Fatigability
Time Frame: week 12
|
30-Second Chair Stand Test
|
week 12
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Fatigability
Time Frame: week 24
|
30-Second Chair Stand Test
|
week 24
|
Adverse Events
Time Frame: week 12
|
Number of patients with adverse events
|
week 12
|
Adverse Events
Time Frame: week 24
|
Number of patients with adverse events
|
week 24
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Expectation
Time Frame: week 0
|
Visual Analogue Scale (VAS)
|
week 0
|
Treatment Satisfaction
Time Frame: week 12
|
Client Satisfaction Questionnaire (CSQ)
|
week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Gustav Dobos, Prof. MD, Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2017
Primary Completion (Estimated)
July 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
November 7, 2018
First Submitted That Met QC Criteria
November 7, 2018
First Posted (Actual)
November 8, 2018
Study Record Updates
Last Update Posted (Actual)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 21, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBK02-17-00424
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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