Trial document




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  DRKS00018811

Trial Description

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Title

Development of a question prompt list for patients with metastasised lung cancer in Germany

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Trial Acronym

Projekt QPL

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to develop a communication aid called question prompt list (QPL). Question prompt lists are lists of example questions, that patients might want to ask during consultation and that should help them to answer outstanding issues and address difficult issues. The first step will be to interview 20-30 patients and relatives to assess the current state of communication with the doctors and the need for a QPL and to identify possible questions and topics for such a QPL. Afterwards we will develop from the results of the interviews, if necessary, a QPL and evaluate it with the help of Telefon interviews with patients and relatives.
The second step will be to discuss the QPL in a focusgroup with doctors and nursing staff.
The third step will be to evaluate the QPL with the help of questionnaires for patients.

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Brief Summary in Scientific Language

The aim of this study is to develop a communication aid called question prompt list (QPL). Question prompt lists are lists of example questions, that patients might want to ask during consultation and that should help them to answer outstanding issues and address difficult issues. The first step will be to interview 20-30 patients and relatives to assess the current state of communication with the doctors and the need for a QPL and to identify possible questions and topics for such a QPL. Afterwards we will develop from the results of the interviews, if necessary, a QPL and evaluate it with the help of Telefon interviews with patients and relatives.
The second step will be to discuss the QPL in a focusgroup with doctors and nursing staff.
The third step will be to evaluate the QPL with the help of questionnaires for patients.

Additionally a Scoping Review with the topic "Methods for developing a Question Prompt List" is planned to give background information to the 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

  •   DRKS00018811
  •   2019/10/28
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  •   yes
  •   Approved
  •   S-313/2019, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   lung cancer
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Interviews with patients/relatives to assess the current state of communication and develop a question prompt list
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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
  •   N/A
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Primary Outcome

Need for and development of a question prompt list.
The primary outcome is raised by individual interviews and focus groups in the period from November 2019 to March 2020.

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/11/22
  •   60
  •   Monocenter 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:
- patients with metastasised lung cancer in the Thoraxklinik Heidelberg gGmbH
- Diagnosis at least 2 months ago
- atvleast one consultation about current state of disease in the last 2 month
- good German knowledge.

Relatives:
- relatives of a patient with metastasised lung cancer in the Thoraxklinik Heidelberg gGmbH
- regular contact with patient and doctor during the last year
- good German knowledge.

Doctors/nursing staff:
- doctors/nursing staff working in oncology department of Thoraxklinik Heidelberg gGmbH
- good German knowledge.

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Exclusion Criteria

Patients: diagnosis less than 2 months ago or no consultation about current state of disease, other patients than previously described, Age <18 years, no capacity for consent.

Relatives: relatives of other than the previously described patients, no contact to patient or doctor during the last year, Age <18 years, no capacity of consent.

Doctor/nursing staff: Trainees/interns, guest students, nursing students, <3 months work in Thoraxklinik Heidelberg gGmbH.

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Addresses

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    • Thoraxklinik Heidelberg gGmbH
    • Röntgenstraße 1
    • 69126  Heidelberg
    • Germany
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    • Thoraxklinik Heidelberg gGmbH
    • Ms.  cand. med.  Tamara  Schulte-Vieting 
    • Röntgenstraße 1
    • 69126  Heidelberg
    • Germany
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    • Thoraklinik Heidelberg gGmbH
    • Ms.  Tamara  Schulte-Vieting 
    • Röntgenstraße 1
    • 69126  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Thoraxklinik Heidelberg gGmbH
    • Röntgenstraße 1
    • 69126  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Ethikvotum
  •   Prüfbericht
  •   Scoping Review Protocol
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