Trial document




This trial has been registered retrospectively.
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  DRKS00013627

Trial Description

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Title

Dignity Therapy in Germany: A pilot study to evaluate feasibility, acceptability and cultural adaption,of a short term psychotherapeutic intervention in palliative medicine.

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Trial Acronym

WZT

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URL of the Trial

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Brief Summary in Lay Language

Against the background of ongoing public debates about dignity, assisted suicide and physician-assisted suicide, this study deals with dignity therapy. Dignity therapy was developed by H.M. Chochinov (Manitoba, Kanada) based on research results to the topic of “desire to die”.
Dignity therapy is a short-term intervention to improve dignity and to relief existential suffering at the end of life.
Base of dignity-therapy is a semi structured interview with patients. This interview will handed out to a predetermined relative in form of a document, e.g a book. In this study the interview protocoll will be translated into German and tested afterwards.

Dignity therapy is a form of Biography work, which is distinguished by three factors.
1) Generativity, through the creation of a outlasting document for next of kin
2) Elaboration of the essence of patients personality
3) Respectful and appreciating attitude of the practitioner.

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Brief Summary in Scientific Language

Dignity Therapy (DT) is a short-term intervention to reduce psychological suffering at end-of-life care. Its strength lies in the evidenced based development and investigation. The basis of the intervention is a semi-structured question protocol.
Aim of this study is to investigate the feasibility of DT at German palliative care units (PCU), the acceptability and adaption of a German version of the DT question protocol.
To achieve 360° feedback, health care professionals (HCP) participated in cognitive interviews and conducted DT interviews are examined. Patients and relatives provide quantitative (feedback questionnaires) and qualitative data (cognitive interviews) in this clinical multicenter mixed-methods-study.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013627
  •   2017/12/22
  •   [---]*
  •   yes
  •   Approved
  •   837.082.15 (9850), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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

  •   Patients with a terminal illness
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Interventions/Observational Groups

  •   10 health care professionals which are unfamiliar with DT will be asked to evaluate the interview protocol and the feedback questionnaire.

    Patients that met inclusion criteria and are willing to participate receive the short-term intervention Dignity Therapy.
    During Dignity Therapy an interview will be conducted that serves as a basis for a document which will be handed out to a relative who was designated in advance.
    Afterwards patients and relatives are asked to give feedback.
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Characteristics

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

Aim of this study is to test the feasibility of DT in Germany as well as acceptability and cultural adaption of the question protocol. Furthermore to assess the subjective benefit of this psychological short-term intervention.

The translation of the Interview protocol is followed by a comprehensive content validation including expert panels and survey of patients.
Information given by 10 health care professionals will be analysed through content analysis (qualitative analysis). Furthermore it will be assessed how often which question of the semi-structured Interview was asked (quantitative analysis)

Subjective Evaluation of DT will be assessed by patients and relatives through a feedback questionnaire. Quantitative analysis will be applied. The aim is to include 30 patients and 30 relatives in the study.

The amount of patients that met inclusion criteria and were willing to participate, the number of patients, that participated the whole DT process and the amount of patients that answered the feedback questionnaire will be stated.
The amount of relatives that answered feedback questionnaire will be stated. This data will indicate the feasibility of DT in Germany.

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Secondary Outcome

To provide a German interview protocoll for Dignity Therapy.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/06/01
  •   70
  •   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

Patients admitted to either the palliative care ward of the university clinic of Mainz or Würzburg fulfilling the following inclusion criteria will be included in the study:

- Terminal illness with clinically estimated life expectancy from 2 weeks to 12 months.
- Ability to give informed consent
- Sufficient German language skills
- Possible denomination of a relative for feedback questionnaire.

Relatives:
- ≥ 18 years of age
- Ability to give informed consent
- Sufficient German language skills
- Denominated by the patient, regularly contact to the patient, before, during and after DT

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Exclusion Criteria

Patient will be excluded if one/more of following criteria are met:
- Insufficient knowledge of German
- Cognitive impairment
- Estimated life expectancy less than 2 Weeks

Relatives will be excluded if one/more of the following criteria are met:
- High emotional burden so that questionnaire can not be filled out
- Not able to understand and answer questionnaire (cognitive impaired)

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Addresses

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    • Universitätsmedizin Mainz III.Medizinische KlinikInterdisziplinäre Abteilung für Palliativmedizin
    • Mr.  Prof. Dr. med  Martin  Weber 
    • Langenbeckstrasse 1
    • 55131  Mainz
    • Germany
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    • Universitätsklinik WürzburgKlinik und Poliklinik für StrahlentherapieInterdisziplinäres Zentrum Palliativmedizin
    • Ms.  Dr  Elisabeth  Jentschke 
    • Josef-Schneider-Str.11
    • 97080  Würzburg
    • Germany
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    • Unversitätsmedizin MainzIII Med. KlinikInterdisziplinäre Abteilung für Palliativmedizin
    • Ms.  Sandra  Mai 
    • Langenbeckstr.1
    • 55131  Mainz
    • Germany
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    • Unversitätsmedizin MainzIII Med. KlinikInterdisziplinäre Abteilung für Palliativmedizin
    • Ms.  Sandra  Mai 
    • Langenbeckstr.1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin MainzIII.Medizinische KlinikInterdisziplinäre Abteilung für Palliativmedizin
    • Mr.  Prof. Dr. med  Martin  Weber 
    • Langenbeckstrasse 1
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/04/30
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Trial Publications, Results and other Documents

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