Trial document





This trial has been registered retrospectively.
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  DRKS00000187

Trial Description

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Title

Validation of a German scale for assessing a desire for hastened death

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

If terminally ill patients express the desire for hastened death, for instance through physician assisted suicide or euthanasia, it does not mean that this wish is unchangeable. In fact it is possible to influence this wish by therapeutic interventions over time. Furthermore the desire for hastened death develops and can exist -initially unexpressed- over a longer period. A questionnaire could be used as diagnostic tool and help to detect a desire for hastened death sooner than before so that support faster can be offered. Moreover such questionnaire could be used in surveys to evaluate the effectiveness of therapeutic interventions.
Within this project the -Schedule of Attitudes towards Hastened Death- (SAHD) should be translated and assessed for it`s quality as a first German instrument for this issue. It is an internationally already successfully implemented instrument developed in the USA by palliative health professionals. The questions to be answered in this project are: Can the SAHD-D, the German version, be used without distressing palliative patients? Is it an appropriate instrument for measuring type, severity and process of the desire for hastened death?

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Brief Summary in Scientific Language

If terminally ill patients express the desire for hastened death, for instance through physician assisted suicide or euthanasia, it does not mean that this wish is unchangeable as shows palliative care experience. In fact it is possible to influence this wish by therapeutic interventions over time. Furthermore the desire for hastened death develops and can exist -initially unexpressed- over a longer period.

A validated instrument could be used as diagnostic tool and help to detect a desire for hastened death sooner than before so that support faster can be offered. It furthermore could be used as a new outcome-criterion in controlled effectiveness trials of therapeutic interventions.
Within this projectl the -Schedule of Attitudes towards Hastened Death- (SAHD) should be translated and validated as a first German instrument for this issue. It is an international already successfully implemented instrument developed in the USA by palliative health professionals. Two questions should be answered within this project: Can the SAHD-D, the German version, be used without further distressing palliative patients? Is it an appropriate instrument for measuring type, severity and process of the desire for hastened death?

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Organizational Data

  •   DRKS00000187
  •   2009/10/07
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  •   yes
  •   Approved
  •   06-208, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   VO 497/4-1  (DFG)
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Health Condition or Problem studied

  •   desire for hastened death
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Interventions/Observational Groups

  •   1.Mini-Mental-Status Test
    2.EORTC, EORTC Quality Of Life - Questionnaires - QLQ-C15
    3.Hope, hospice and palliative recording standarddocumentation
    4.SAHD, Schedule of Attitudes toward Hastened Death
    5.HADS-D, Hospital Anxiety and Depression Scale - german version
    6.questionnaire for evaluation of desire for hastened death
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Characteristics

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

First interview 3-5 days after admission and start of palliative medical treatment, containing following questionnaires
1. Mini-Mental-Status Test
2. HADS-D
3. Hope
4. EORTC
5. SAHD
6. Aussenkriterium zur Einschätzung des Todeswunsch

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Secondary Outcome

Second interview 5-7 days following the first interview, containing the following questionnaires, 1. Mini-Mental-Status Test 2. HADS-D 3. Hope 4. EORTC 5. SAHD 6. Questionnaire for evaluation the desire for hastened death

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2007/11/19
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. patient needs palliative medical treatment
2. patient speaks german
3. patients clinical situation enables participation
4. Mini-Mental State Test >= 21 points (german version)
5. patients written or verbal consent

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Exclusion Criteria

1. less than 21 points in Mini-Mental State Test (german version)
2. missing consent of the patient
3. patient is by self-assessment and assessement by others not capable to participate

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Addresses

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    • Zentrum für Palliativmedizin Uniklinik Köln
    • Mr.  Prof. Dr. med.  Raymond  Voltz 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Zentrum für Palliativmedizin, Uniklinik Köln
    • Ms.  Maren  Galushko 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Zentrum für Palliativmedizin, Uniklinik Köln
    • Ms.  Maren  Galushko 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Mr.  Dr.  Tobias  Grimm 
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2009/11/11
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Trial Publications, Results and other Documents

  •   Voltz R, Galushko M, Walisko J, Pfaff H, Nauck F, Radbruch L, Ostgathe C (2009) End-of-life research on patients´ attitudes in Germany: A feasibility study. Supportive Care in Cancer. Online first: DOI 10.1007/s00520-009-0654-y
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* This entry means the parameter is not applicable or has not been set.