Trial document




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  DRKS00007687

Trial Description

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Title

Decision support and process quality in the early detection for prostate cancer – a pilot project in the region of Münster

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Trial Acronym

PSAInForm

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URL of the Trial

http://klinikum.uni-muenster.de/index.php?id=prostatazentrum_studien https://www.uni-marburg.de/aktuelles/news/2014b/0613a

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Brief Summary in Lay Language

The study evaluates the impact of a computer based decision aid for men interested in having a PSA-test for the early detection of prostate cancer as compared to conventional counselling. Primary endpoints are decisional conflict and possible regret.

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Brief Summary in Scientific Language

The study evaluates the impact of a computer based decision aid for men interested in having a PSA-test for the early detection of prostate cancer as compared to conventional counselling. Primary endpoints are decisional conflict and possible regret.

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Organizational Data

  •   DRKS00007687
  •   2015/05/06
  •   [---]*
  •   yes
  •   Approved
  •   72/13, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   conventional counselling + patient bears costs
  •   computer-based decision aid + patient bears costs
  •   conventional counselling + sponsorer bears costs
  •   computer-based decision aid + sponsorer bears costs
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Command variables: satisfaction with counselling, involvement of the patient, possible decision conflicts, feeling of security of the patient and decision for or against a PSA-test

measuring methods: DCS, PEF-9+5, SDM-9, Decicion Regret Scale, SF-12 health-related quality of life

measuring points: before and after the counselling, Follow-Up after 2 weeks and after 6 months

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Secondary Outcome

diagnostic and therapeutic processes after the counselling and/or after the diagnosis prostata cancer

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2015/06/01
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   55   Years
  •   69   Years
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Additional Inclusion Criteria

Practices:
- participation at urologic provision
- regular cancer early detection and health investigations for men
- consulting room with a computer
- willingness to give a result open counselling
- willingness to take part at recruiting-audits

Patients:
- all men between 55 - 69 years, who visit the practice

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Exclusion Criteria

- serious illness which makes a survival of 10 years unlikely
- known prostate cancer
- insufficient knowledge of the german language
- cognitive limitations

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Addresses

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    • Deutsche Krebshilfe e.V.
    • Buschstr. 32
    • 53113  Bonn
    • Germany
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    • Abteilung für Allgemeinmedizin, Präventive und Rehabilitative Medizin, Philipps-Universität Marburg
    • Mr.  Univ.-Prof. Dr. med.  Norbert  Donner-Banzhoff 
    • Karl-von-Frisch-Straße 4
    • 35043  Marburg
    • Germany
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    • Leiter des Prostatazentrums am Universitätsklinikum Münster
    • Mr.  Prof. Dr. med.  Axel  Semjonow 
    • Albert-Schweizer-Campus 1, A1
    • 48149  Münster
    • Germany
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    • Prostatazentrum am Universitätsklinikum Münster
    • Ms.  Dipl.-Betriebsw.  Christiane  Ptok 
    • Niels-Stensen-Str. 12
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Krebshilfe e.V.
    • Buschstr. 32
    • 53113  Bonn
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.