Trial document




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  DRKS00003319

Trial Description

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Title

The Body concept of prostate carcinoma patients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Background: The aim of the study is the construction of a questionnaire which determines uro-oncological patients’ attitudes to their own body. The questionnaire will be tested by psychometric criteria for suitability. By doing this, epidemiological data of patients after radical retropubic prostatectomy (RRPE) will be generated.

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Brief Summary in Scientific Language

Procedure/ methods:
1. study of literature and hypothesis derviation

2. Analysis of 10 interviews (5 (m) prostate ca , 3 (m) bladder ca , 2 (m) kidney ca) for the generation of content areas of the new instrument (Worbs 2010)

3. Sighting of established methods (questionaires and items) for detection of the body concept (construction of the first version of the questionnaire)

4. Development of the questionnaire in two phases
First phase of scale construction: Method according to Thurstone and Chave by questioning 100 prostatectomy patients (RRP 4th week post OI - 12th month post OI), 50 healthy men subjects
Second phase of scale construction: item selection based upon item discrimination coefficient and item difficulty in addition to the questioning of 105 prostatectomy patients in the AHB (4-6th week post OI) an 50 healthy men subjects. Testing of the single-dimensionality of the developed scales by means of factor analysis and the cut-off-value.

5. Validation of the questionnaire with the Multitrait-mulitmethod-method.
To verify the construct validity, narrative interviews are analysed wich were conducted with prostatectomy patients (n=8; 4th week to 12th month after surgery) and healthy men (n=2) before the questionnaire was completed. Correlation of the information won by the interviews and the questionnaire with the Multitrait-multimethod-method (MTMM).

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Organizational Data

  •   DRKS00003319
  •   2012/02/24
  •   [---]*
  •   yes
  •   Approved
  •   2011-89, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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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

  •   In the construction phase of the questionnaire, two healthy men samples and three prostatectomy samples will be interviewed by the questionaire once.

    Construction 1: (Scaling after Thurstone)
    Patient group 1 (n=100; 4th week to 12th month post OI) and Healthy group 1 (n=50)

    Construction 2 (included validation):
    Patient group 2 (n=105; 4-6th week post OI) Patient group 3 (n=24; 8th to 12th month post OI) and Healthy group 2 (n=50)
    1st survey: Item selectivity and Item difficulty
    2nd survey: 14th day after 1st survey (test retest reliability with randomized questionaire)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
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Primary Outcome

Development of a valid questionnaire for the assessment of attitudes of body concept in urological and uro-onkological patients (e.g. prostatectomy patients).

This observational study consists of two phases:

1. Construction of the investigative tools and psychometric check for suitability of the items

2. Generating attitudes of radical retropubic prostatectomy men to thier own body

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2012/10/12
  •   350
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   50   Years
  •   75   Years
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Additional Inclusion Criteria

1. Patient with histologically secured prostate carzinoma
2. OI indication: radical retropubic PE
3. the age of the men is between 50 and under 75 years.
4. readiness for filling out the questionnaires.
5. Declaration of consent of the patients to the participation in interviews.
6. sufficient german knowledge of the patients.

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Exclusion Criteria

1. Compliance lacking of the patients
2. Preceeding therapy interventions, which caused urinary incontinence or Impotenz
3. Preceeding urinary incontinence or Impotenz of other genesis (by trauma tables damages of the
basin ground, motor and sensory urge incontinence, extraurethrale incontinence, errektile
malfunctions)
4. Physical handicaps or mutilating
5. Serious strokes of fate in the last year (e.g. accidents, death of members standing near,
depressions)
6. Formal or contentwise thoughts disturbance
7. Cardiac infarct, heart insufficiency
8. Diabetes Mellitus
9. Neurological problems (Apoplexy, Mb. parkinson, MS)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Martin-Luther-Universität Halle WittenbergInstitut für Gesundheits- und Pflegewissenschaft
    • Mr.  Diplomsportwissenschaftler  Michael   Worbs 
    • Magdeburger Straße 8
    • 06112   Halle (Saale)
    • Germany
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    • Vogtlandklinik Bad Elster Reha-Zentrum Bad Elster
    • Mr.  Prof. Dr. med.  Dirk-Henrik  Zermann 
    • Forststrasse 3
    • 08645  Bad Elster
    • Germany
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    • Helmut Roedler Schule für Physiotherapie Chemnitz gGmbH
    • Mr.  Diplomsportwissenschaftler  Michael   Worbs 
    • Schönherrstr. 8
    • 09131  Chemnitz
    • Germany
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Sources of Monetary or Material Support

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    • MLU Halle Wittenberg Med. Fakultät Institut für Gesundheits- und Pflegewissenschaft
    • Mr.  Diplomsportwissenschaftler  Michael  Worbs 
    • 06112  Halle
    • Germany
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Status

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

  •   Worbs, M. et al. (2015). Scales for Ascertaining the Body Concept of Uro-onkological Patients undergoing Rehabilitation. Phys Rehab Kur Med 2015; 25(02): 90-100. Goeorg Thieme Verlag KG. Stuttgart, New York. DOI: 10.1055/s-0035-1545340
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* This entry means the parameter is not applicable or has not been set.