Trial document




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  DRKS00000296

Trial Description

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Title

Experienced involvement in counselling for prostate cancer

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Trial Acronym

[---]*

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URL of the Trial

http://www.klinikum.uni-heidelberg.de/Urologie-Heidelberg-e-V.113928.0.html

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Brief Summary in Lay Language

Besides evaluating counselling for localized prostate cancer from our patients' point of view, we would like to study feasibility, acceptance and efficiency of a dyadic peer-to-peer support program.

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Brief Summary in Scientific Language

Experienced involvement is a well established idea in psychiatric disease. We would like to transfer this approach to oncology and study the feasibility, acceptance and efficiency of a dyadic peer-to-peer support program for localized prostate cancer. Moreover, we evaluate counselling from our patients' point of view.

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Organizational Data

  •   DRKS00000296
  •   2010/01/05
  •   [---]*
  •   yes
  •   Approved
  •   S-333/2009, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1113-0684 
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Interventional arm: Additional psychosocial support by a former patient.
  •   Control: Routine counselling without additional intervention.
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Health care system
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Subjective satisfaction with decision-making process and with the finally made decison - self-designed questionnaire

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Secondary Outcome

Feasibility of the additional support program - documented interventions || Depression and self efficiency - PHQ-4 (Löwe, Wahl et al. in press); SWE (Schwarzer and Jerusalem 1995) || Objective and subjective coping parameters: degree of informedness, self-assessment of health, subjective quality of life, satisfaction with provided counselling, emotional distress, subjective judgement on objective symptoms - PCI (Schwarzer und Taubert 2002), Emotion thermometer (Mitchell, Baker-Glenn et al. 2009), SF 12 (Ware, Kosinski et al. 1996), ICS male (Bates, Wright et al. 1998) || Personality traits in intervention and control arm: preferences for decision making, self efficiency, need of social support, communication characteristics, social integration - SWE (Schwarzer and Jerusalem 1995), PCI (Schwarzer and Taubert 2002) || Quality of dyadic peer-to-peer support - self-designed questionnaire

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/01/12
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   85   Years
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Additional Inclusion Criteria

Initial diagnosis of localized prostate cancer
Counselling at the Department of Urology, University of Heidelberg
Informed consent

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Exclusion Criteria

Missing informed consent
Prostatectomy is not a valid treatment option
Extension of surgery (e.g. cystectomy)
Locally advanced disease (N+, R2-situation) or systemic disease (M1)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Urologische Universitätsklinik Heidelberg
    • Mr.  Dr. med.  Dr. phil. Johannes  Huber 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Urologische Universitätsklinik Heidelberg
    • Mr.  Dr. med.  Dr. phil. Johannes  Huber 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Urologische Universitätsklinik Heidelberg
    • Mr.  Dr. med.  Dr. phil. Johannes  Huber 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Urologische Universitätsklinik Heidelberg
    • Mr.  Prof. Dr. med.  Markus  Hohenfellner 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2011/12/31
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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.