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The Influence of TaKeTiNa Music Therapy, Traditional Chinese Acupuncture and Clown Theatrical Performance on Quality of Life and the Therapeutic Process of Patients Undergoing Allogenic Stem Cell Transplantation (TriCAM)

This study is currently recruiting participants.
Verified December 2016 by Ali Behzad, University of Erlangen-Nürnberg Medical School
Sponsor:
ClinicalTrials.gov Identifier:
NCT02976558
First Posted: November 29, 2016
Last Update Posted: December 6, 2016
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.
Information provided by (Responsible Party):
Ali Behzad, University of Erlangen-Nürnberg Medical School
  Purpose
The allogenic stem cell transplantation (aSCT), the only curative approach for many hematological diseases, often leads to severe diseases or chronic conditions, leaving patients with physical disabilities and severe depression and impacting their quality of life in many cases. These consequences are still not adequately addressed by conventional therapies. In this study, the investigators examine the influence of the three complementary medicine methods (CAM) namely acupuncture according to Traditional Chinese Medicine (TCM), music therapy according to the TaKeTiNa method and the psychological disease processing by theatrical clown performance on the quality of life and the therapy process of patients before and after aSCT.

Condition Intervention
Hematological Neoplasm Graft-Versus-Host Disease Depression Stem Cell Transplant Complications Quality of Life Leukemia Behavioral: Clown theatrical Performance Procedure: Acupuncture Behavioral: Music Therapy TaKeTiNa

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Open Randomized Monocentric Two-armed Controlled Clinical Trial in Parallel Groups to Investigate the Influence of Complementary Medicine (CAM) Interventions on Quality of Life and The Treatment Process of Patients Undergoing Allogenic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Ali Behzad, University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Difference in the Quality of Life of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]
    Assessment through FACT-G Questionaire


Secondary Outcome Measures:
  • Difference in development of GvHD of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]
    Assessment through staging of GvHD and required days of hospitalisation

  • Difference in development of fungal infections of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]
    Assessment through required days of hospitalisation and antimycotic therapy

  • Difference in development of bacterial infections of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]
    Assessment through required days of hospitalisation and antibiotic therapy

  • Difference in development of viral infections including CMV and EBV of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]
    Assessment through required days of hospitalisation and antiviral therapy

  • Difference in Depression of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]
    Assessment through HADS-D questionaire

  • Impact of the diagnosis and therapy according to traditional chinese medicine on the difference in development of Infections of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]
    Assessment days of hospitalisation and antiinfective therapy

  • Impact of the diagnosis and therapy according to traditional chinese medicine on the difference in development of GvHD of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]
    Assessment through staging of GvHD and required days of hospitalisation


Estimated Enrollment: 80
Study Start Date: December 2016
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group

Interventions:

Acupuncture, music therapy (TaKeTiNa) and Clown theatrical performance starting before allogenic stem cell transplant until three months after transplantation.

Interventions each twice a week for 4 weeks, then once a week for 4 weeks, then once every two weeks for 4 weeks

Behavioral: Clown theatrical Performance
Other Name: theatre therapy, humour for health
Procedure: Acupuncture
Acupuncture according to Traditional Chinese Medicine
Behavioral: Music Therapy TaKeTiNa
No Intervention: Control Group
control group. No interventions

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • planned allogenic stem cell transplantation
  • patient mentally and intellectually able to understand and sign the form

Exclusion Criteria:

  • Current enrollment in another intervention study
  • clinical diagnosis of depression by HADS-D score plus drug therapy for depression at the time of enrollment
  Contacts and Locations
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): NCT02976558


Locations
Germany
University of Erlangen Nuermberg Medical School Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Ali Behzad, Board Certified MD       ali.behzad@uk-erlangen.de   
Principal Investigator: Ali Behzad, MD         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
  More Information

Publications:

Responsible Party: Ali Behzad, Dr. med., University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT02976558     History of Changes
Other Study ID Numbers: CCS Erlangen 0383
First Submitted: November 21, 2016
First Posted: November 29, 2016
Last Update Posted: December 6, 2016
Last Verified: December 2016

Keywords provided by Ali Behzad, University of Erlangen-Nürnberg Medical School:
CAM
allogenic Stem Cell Transplantation
Graft-Versus-Host Disease
Depression
Quality of Life
Acupuncture
Traditional chinese Medicine
Integrative medicine
Complementary and Alternative Medicine
Music therapy TaKeTiNa
Clown theatrical performance
Humour
Chemotherapy side effects
Psycho neuro immune system
GvHD
PNEIS
CMV
EBV
holistic medicine

Additional relevant MeSH terms:
Depression
Graft vs Host Disease
Hematologic Neoplasms
Behavioral Symptoms
Immune System Diseases
Neoplasms by Site
Neoplasms
Hematologic Diseases