Trial document





This trial has been registered retrospectively.
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  DRKS00008193

Trial Description

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Title

Effect of setting up a
SOP Coordination Unit on
the quality, development of new SOPs and cooperation

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Trial Acronym

KOSOP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The working group Standard Operating Procedures (SOP AG) is part of the network oncological centers of excellence of the German Cancer Aid and has the mission to link the SOP activities of centers of excellence with each other. Furthermore, the efforts in this area are to bundle and harmonize where possible. Especially for users outside the CCCs SOPs are an excellent opportunity to learn about the latest medical treatment standards, and innovative methods. The AG SOP is in exchange with the Guidelines program Oncology (OL) of the Association of the Scientific Medical Societies in Germany eV (AWMF), the German Cancer Society (DKG) and the German Cancer Aid eV (VCI), and so far two common areas of interest have already been set: Methodology for the creation of SOPs and Creation of SOPs in rare diseases.
The growing demands to the AG SOP make a central support required. To this end, a coordinating body of the AG SOP should be established to advance these overall goals continuously.
An accompanying scientific evaluation of the effect of such a central facility is entrained to proove the changes in the SOPs in detail. For this purpose, an actual condition survey will be conducted prior to the establishment of the Coordination Unit. The work of the Coordination Office will be documented in the course, and a course of questioning of the CCC coordinators will take place.
In addition, a manual will be prepared as a guideline for establishing SOPs and its use will be tested.

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Brief Summary in Scientific Language


Intervention study with before and after comparison;
Quantitative detection of SOPs before and after Comparison of the use of the coordination office
Quantitative and qualitative detection of the use of the SOP manual

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Organizational Data

  •   DRKS00008193
  •   2015/10/26
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  •   yes
  •   Approved
  •   327/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C00-D48 -  Neoplasms
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Interventions/Observational Groups

  •   Condition survey before and after the establishment of the SOP Coordination Office in all CCC's, occupation of the Coordination Unit SOPs, evaluation of the activities of the Coordination Unit SOPs, leveling survey of all CCC's
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Quality improvement of SOPs
Quantity increasing of SOPs
Comparison of the actual state (2013) number of SOPs (query in all centers) and quality of the SOPs. Query on the number and quality after the establishment of the Coordination Office. Comparison of SOPs from different centers concerning one entity. Creation of quality criteria.
Survey by questionnaire in 2013, 08/2015, 08/2016, 08/2017. Before-after comparison of the quality of the SOPs and the methodology of creation, revision and dissemination.

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Secondary Outcome

Creating an SOP manual
Networking of tumor centers with regard to SOP production and disseminationin cooperation with the Coordination Site SOP.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/08/15
  •   13
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Guideline officer of CCC's

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Exclusion Criteria

Centres that have not signed a cooperation agreement.

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Addresses

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    • Deutsche Krebshilfe (DKH)
    • Buschstr.32
    • 53119  Bonn
    • Germany
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    • Centrum integrierte Onkologie (CIO) Köln Bonn
    • Ms.  Barbara  Starbatty 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    • Universitätsklinik Freiburg
    • Ms.  Martina  Bischoff 
    • Breisacherstr.33
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg
    • Ms.  Martina  Bischoff 
    • Breisacherstr.33
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • DKH
    • Buschstr.32
    • 53119  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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