Trial document





This trial has been registered retrospectively.
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  DRKS00011027

Trial Description

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Title

Integrative Oncology in breast and colorectal cancer - evaluation of a day care program focusing Mind-Body Medicine and Kneipp hydrotherapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Aim of the study is a scientific study of the effect of a day care naturopathic 12 week program with cancer patients at a Berlin hospital

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Brief Summary in Scientific Language

The aim of the study is to evaluate the effect of a naturopathic daily care program by means of a pre / post and group comparison with a waiting list (outcome research)

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Organizational Data

  •   DRKS00011027
  •   2016/08/26
  •   [---]*
  •   no
  •   Approved
  •   EA4/087/13, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   The day care program includes scientifically established individual elements of the health-promoting lifestyle modification, Mind-body medicine, physical therapy, Kneipp therapy and nutritional therapy. It is 12-day interval program for 3 months (1 day/week) with 77 group therapy and consulting hours and 100 hours of homework.
  •   waiting group
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Supportive care
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Exploratory outcome measures:

At the beginning, after the day care program at 3 months and follow-up after 6 months with following study endpoints (with ANOVA / ANCOVA):

Quality of life (FACT-B / -C / -G / WHO-5)
Fatigue (FACIT-F)
Anxiety and depression (HADS).
Mood (POMS)

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/08/13
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   25   Years
  •   75   Years
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Additional Inclusion Criteria

- Manifest breast-, colon- or other cancer in all stages
- Cancer is treated according to medical guidelines conventionally (surgery, radiotherapy, chemotherapy)
- written consent

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Exclusion Criteria

- Terminals disease with restricted mobility
- Cachexia (BMI <20kg / m2)
- Several hours of daily participation is not possible for the patient (physically or mentally)

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Addresses

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    • Deutsches Stiftungszentrum: Margarete Clemens Stiftung
    • 45239  Essen
    • Germany
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    •   [---]*
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    • Immanuel Krankenhaus Berlin
    • Mr.  Prof. Dr.  Andreas  Michalsen 
    • Königstr. 63
    • 14109  Berlin
    • Germany
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    • Immanuel Krankenhaus Berlin
    • Ms.  Miriam  Rösner 
    • Königstr. 63
    • 14109  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Stiftungszentrum (MARGARETE CLEMENS STIFTUNG)
    • 45239  Essen
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/01/30
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Trial Publications, Results and other Documents

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