JOURNAL ONKOLOGIE – STUDIE

Mind-body Medicine for Patients With Malignant Hematological Diseases

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03735992

Studienbeginn:
September 2017

Letztes Update:
22.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Hematologic Neoplasms, Hematologic Diseases

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Universität Duisburg-Essen

Collaborator:
Robert Bosch Medical Center

Studienleiter

Gustav Dobos, Prof. MD
Study Director
Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen

Kontakt

Holger Cramer, PhD
Kontakt:
Phone: +4971181017860
E-Mail: holger.cramer@med.uni-tuebingen.de» Kontaktdaten anzeigen

Heidemarie Haller, PhD
Kontakt:
Phone: +4920172377382
E-Mail: heidemarie.haller@uk-essen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin
70376 Stuttgart
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Walter E. Aulitzky, Prof. MD
E-Mail: walter.aulitzky@rbk.de

Maria M. Winkler
E-Mail: marcela.winkler@rbk.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. General Fatigue (Time Frame - week 12):
Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale

Secondary outcome:

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

Studien-Arme

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.
No Intervention: Wait list
Treatment as usual.

Geprüfte Regime

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.

Quelle: ClinicalTrials.gov

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