Trial document




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  DRKS00010251

Trial Description

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Title

Interviews with proxies regarding decision making in accordance with cancer patients will.

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Trial Acronym

InSuReD - study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Purpose and Background:
Due to severe illness patients often neither are able to speak out their will nor to decide medical or nursing issues.
In case of being named in a health care proxy confidants like relatives or friends may be in charge of making decisions in alleged patients will.
In this study there will be interviews with vocational guardians or empowered confidants (such as family members, partners, friends, acquaintances), given that there is a bond of trust between agent and a cancer patient for whom they were to make a medical or nursing decision as surrogates within the last year.
These personal, manual guided interviews reach out to expose positive as well as negative experiences when coming to such a decision as explained beforehand, and furthermore what kind of support the agent would have wished for.
Objective: figuring out potential to improve professional support for agents in decisionmaking in accordance with patients will.

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Brief Summary in Scientific Language

Qualitative data collected by personal, guideline based interviews of empowered agents who made a medical or nursing decision representing the cancer patients will.
This study will be conducted within six months.

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Organizational Data

  •   DRKS00010251
  •   2016/04/18
  •   [---]*
  •   yes
  •   Approved
  •   047/16, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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

  •   C00-C97 -  Malignant neoplasms
  •   Lost capacity for consent, cancer
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Interventions/Observational Groups

  •   Qualitative study - Guided Interview with surrogates of cancer patients who already had to made a decicion (allged patient wills)
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Characteristics

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

expectations and experiences

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Secondary Outcome

positive and negative experiences

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2016/04/30
  •   15
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Vocational guardians responsible for a cancer patient who they personally know or confidants empowered by the patient (health care proxy).
At least one medical or nursing decision made by the agent within the last year is premised.

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Exclusion Criteria

Lack of linguistic and/or intellectual possibility to understand or respond to given questions (estimated by interviewer).
Vocational guardians not knowing the patient personally.
Respecting patient does not have a cancerous disease.
Agent's consent to take part in this study is not recorded in writing.
Agent was not to make a decision as a surrogate yet.

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Addresses

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    • Center for Integrated Oncology (CIO) Bonn
    • Sigmund-Freud-Str. 25
    • 53127   Bonn
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Institut für Hausarztmedizin am Universitätsklinikum Bonn
    • Ms.  Rieke  Schnakenberg 
    • Siegmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Institut für Hausarztmedizin am Universitätsklinikum Bonn
    • Ms.  Rieke  Schnakenberg 
    • Siegmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Center for Integrated Oncology (CIO) Köln-Bonn
    • Mr.  Prof. Dr. med.  Klaus  Weckbecker 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/02/12
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Trial Publications, Results and other Documents

  •   1. Jox RJ, Heßler H-J, Borasio GD. End-of-life decisions, powers of attorney, and advance directives. Nervenarzt 2008; 79:729-739. 2. Bundesärztekammer. Umgang mit Vorsorgevollmacht und Patientenverfügung in der ärztlichen Praxis; Dtsch Arztebl 2013:110(33-34);A1580-85. 3. L. H. Nicholas et al. Regional variation in the association between advance directives and end-of-life medicare expenditures. JAMA 306 (2011) 13, 1447–1453. 4. Shalowitz DI, Garrett-Mayer E, Wendler D. The accuracy of Surrogate Decision Makers – A systematic Review. Arch Intern Med. 2006;166:493-497. 5. Ranganathan A, Gunnarsson O, Casarett D. Palliative care and advance care planning for patients with advanced malignancies. Ann Palliat Med. 2014 Jul;3(3):144-6. doi: 10.3978/j.issn.2224-5820.2014.07.04. 6. McMahan R, Knight SJ, Fried TR, Sudore RL. Advance Care planning beyond advance directives: Perspectives from patients & surrogates. Journal of Pain & Symptom Management (2013);46(3):355-65.
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* This entry means the parameter is not applicable or has not been set.