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Mind-body Medicine for Patients With Malignant Hematological Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03735992
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : May 5, 2021
Sponsor:
Collaborator:
Robert Bosch Medical Center
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Behavioral: Mind-body medicine group program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mind-body Medicine as a Supportive Strategy for Patients With Malignant Hematological Diseases: a Randomized Controlled Trial
Actual Study Start Date : September 6, 2017
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Behavioral: Mind-body medicine group program
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.


Outcome Measures
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Primary Outcome Measures :
  1. General Fatigue [ Time Frame: week 12 ]
    Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale


Secondary Outcome Measures :
  1. General Fatigue [ Time Frame: week 24 ]
    Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale

  2. Physical Fatigue [ Time Frame: week 12 ]
    Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale

  3. Physical Fatigue [ Time Frame: week 24 ]
    Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale

  4. Reduced Activity [ Time Frame: week 12 ]
    Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale

  5. Reduced Activity [ Time Frame: week 24 ]
    Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale

  6. Reduced Motivation [ Time Frame: week 12 ]
    Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale

  7. Reduced Motivation [ Time Frame: week 24 ]
    Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale

  8. Mental Fatigue [ Time Frame: week 12 ]
    Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale

  9. Mental Fatigue [ Time Frame: week 24 ]
    Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale

  10. Qaulity of life [ Time Frame: week 12 ]
    Functional Assessment of Cancer Therapy - General (FACT-G)

  11. Qaulity of life [ Time Frame: week 24 ]
    Functional Assessment of Cancer Therapy - General (FACT-G)

  12. Depression [ Time Frame: week 12 ]
    Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)

  13. Depression [ Time Frame: week 24 ]
    Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)

  14. Anxiety [ Time Frame: week 12 ]
    Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)

  15. Anxiety [ Time Frame: week 24 ]
    Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)

  16. Stress [ Time Frame: week 12 ]
    Perceived Stress Scale (PSS)

  17. Stress [ Time Frame: week 24 ]
    Perceived Stress Scale (PSS)

  18. Sleep [ Time Frame: week 12 ]
    Pittsburgh Sleep Quality Index (PSQI)

  19. Sleep [ Time Frame: week 24 ]
    Pittsburgh Sleep Quality Index (PSQI)

  20. Physical activity [ Time Frame: week 12 ]
    Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)

  21. Physical activity [ Time Frame: week 24 ]
    Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)

  22. Fatigability [ Time Frame: week 12 ]
    30-Second Chair Stand Test

  23. Fatigability [ Time Frame: week 24 ]
    30-Second Chair Stand Test

  24. Adverse Events [ Time Frame: week 12 ]
    Number of patients with adverse events

  25. Adverse Events [ Time Frame: week 24 ]
    Number of patients with adverse events


Other Outcome Measures:
  1. Treatment Expectation [ Time Frame: week 0 ]
    Visual Analogue Scale (VAS)

  2. Treatment Satisfaction [ Time Frame: week 12 ]
    Client Satisfaction Questionnaire (CSQ)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735992


Contacts
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Contact: Holger Cramer, PhD +4920117425015 h.cramer@kem-med.com
Contact: Heidemarie Haller, PhD +4920117425044 h.haller@kem-med.com

Locations
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Germany
Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin Recruiting
Stuttgart, Germany, 70376
Contact: Walter E. Aulitzky, Prof. MD       walter.aulitzky@rbk.de   
Contact: Maria M. Winkler       marcela.winkler@rbk.de   
Sponsors and Collaborators
Universität Duisburg-Essen
Robert Bosch Medical Center
Investigators
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Study Director: Gustav Dobos, Prof. MD Department of Internal and Integrative Medicine | Kliniken Essen-Mitte | Faculty of Medicine | University of Duisburg-Essen
More Information
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Responsible Party: Holger Cramer, Research Director, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT03735992    
Other Study ID Numbers: RBK02-17-00424
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Holger Cramer, Universität Duisburg-Essen:
Hematologic Neoplasms
Supportive Therapy
Fatigue
Mind-body medicine
Complementary and alternative medicine
Additional relevant MeSH terms:
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Hematologic Neoplasms
Hematologic Diseases
Neoplasms
Neoplasms by Site