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

Study Overview
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Brief Summary
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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.

Detailed Description
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The allogenic stem cell transplantation (aSCT) is still the only curative approach for many hematological diseases. Despite new therapeutic developments in the past few years, the therapy-associated mortality rate is around 20%. Patients develop a Graft versus Host Disease (GvHD) in 30-70% of the cases, some with persistent, severe progression and often complicated by infections. In severe chronic conditions, physical disabilities such as weakness, paralysis, scarred vulnerable skin, and blindness may occur. A significant reduction in the quality of life of these patients including severe depression is the consequence. The demand of patients for supplementary therapy possibilities in the sense of an integrative, complementary medicine is great. There are indications that complementary methods can help improve the quality of life and reduce the associated side effects. However, there are no scientific studies to clarify the efficacy or safety of such therapies in the aSCT. In this project, the investigators examine the influence of three complementary medicine methods, 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. Acupuncture according to TCM is an evidence-based therapy approach with few side effects for many diseases. In the past few years, not only their superiority over placebo treatment, but also the point-specific effect has been shown. Based on the numerous published data on pain, nausea, fatigue and depression, it can be assumed that acupuncture reduces the side effects of drug therapy in aSCT and thus improves the quality of life of patients. According to TCM, the points influence the flow of the energy (referred to as Qi) in the body and stimulate its self-regulation. In addition, each organ system associated to a different emotion. The unimpeded flow of the ongoing arising of emotions and body energies is, according to TCM, a prerequisite for the health of the organism. In TCM, the acupuncture used to stimulate the self-regulation of the body is accompanied by the regular practice of Qi-Gong or Tai-Qi by the patient to achieve the greatest therapeutic effect between the treatments. This additive component can hardly be realized because of the severely restricted general state of the patients. In order to mobilize the energy and emotions, this study also implements two further treatment modalities, which are practiced with the patient and which the patient can practice on a daily basis by himself: TaKeTiNa is a form of music therapy founded by Reinhard Flatischler, in which body, voice and movement are used to develop present consciousness, physical feeling and rhythm skills. It has been used therapeutically for more than 20 years. Furthermore, the processing of arising emotions needs to be facilitated. Patients undergoing an aSCT are exposed to a deeply invasive and debilitating situation for a period of at least four weeks. Characteristics are social isolation through limited visits as well as confinement to a small room, almost complete loss of the privacy and independence through frequent monitoring and lavation necessary during aSCT. Finally the confrontation with the illness, the side effects of the drug treatment and the possible death. Arising emotions can lead to a blockade in the energy flow of the respective organ according to TCM and can cause illness. Therefore, the introduction of six basic gestures from the clown performance according to the Metzler method (KANA-Institut für Koerperprache Freiburg) is intended to give the patient the opportunity to process his emotions in a playful manner in real time or to communicate them directly to another person without words.

Official Title
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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

Conditions
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Hematological Neoplasm, Graft-Versus-Host Disease, Depression, Stem Cell Transplant Complications, Quality of Life, Leukemia

Intervention / Treatment
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* Behavioral: Clown theatrical Performance
* Procedure: Acupuncture
* Behavioral: Music Therapy TaKeTiNa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>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<br> <br> * Other names: theatre therapy, humour for health;Procedure: Acupuncture<br>* Acupuncture according to Traditional Chinese Medicine<br>Behavioral: Music Therapy TaKeTiNa<br> <br> |
| No Intervention: Control Group<br>control group. No interventions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the Quality of Life of the intervention group compared to the control group | Assessment through FACT-G Questionaire | day 1 of study compared to day 90 of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in development of GvHD of the intervention group compared to the control group | Assessment through staging of GvHD and required days of hospitalisation | day 1 of study compared to day 90 of study | 
| Difference in development of fungal infections of the intervention group compared to the control group | Assessment through required days of hospitalisation and antimycotic therapy | day 1 of study compared to day 90 of study | 
| Difference in development of bacterial infections of the intervention group compared to the control group | Assessment through required days of hospitalisation and antibiotic therapy | day 1 of study compared to day 90 of study | 
| Difference in development of viral infections including CMV and EBV of the intervention group compared to the control group | Assessment through required days of hospitalisation and antiviral therapy | day 1 of study compared to day 90 of study | 
| Difference in Depression of the intervention group compared to the control group | Assessment through HADS-D questionaire | day 1 of study compared to day 90 of study | 
| 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 | Assessment days of hospitalisation and antiinfective therapy | day 1 of study compared to day 90 of study | 
| 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 | Assessment through staging of GvHD and required days of hospitalisation | day 1 of study compared to day 90 of study | 
| Impact on the development of hematoma and soft tissue infections that need treatment (2nd Amendment) | Patients in the intervention group receive acupuncture as one of the three treatment modalities. Any development of hematoma on the skin or any soft tissue infection that need either local treatment (cooling agents, medical ointments etc.) or systemic treatment (surgery or systemic antibiotics) will be documented as an event. Total number of hematomas needing treatment and soft tissue infections needing treatment will be compared between intervention and control group | from day 1 of study to day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAM, CMV, 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, EBV, holistic medicine