Trial document




drksid header

  DRKS00011046

Trial Description

start of 1:1-Block title

Title

Validation of the german transplation of the disease-specific health-related Quality of life questionnaire (THYCA-QoL) for thyroid cancer survivors.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

THYCA- QoL

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http:///

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In this study, the THYCA-QoL (disease-specific health-related Quality of life questionnaire for thyroid cancer survivors) is going to be translated from Dutch to German. After that, thyroid cancer survivors are going to be examined via cognitive interviews for the following aspects: comprehensibility of the items, how acceptable the items are, identification of misunderstandings or inconsistencies and their correction. The validation of the THYCA-QoLis ensured through the validation of the known questionnaire SF 36, PHQ-D and two QoL questionnaires (UQ QoL and QoL thyroid questionnaire). The aim is to develop a german questionnaire to explore the different dimensions of life quality of thyroid cancer survivors. Through this, it is possible to assess the life quality of the patient, but also the effects of the aftercare. In the long turn, this leads to a treatment improvement and an increase of the patient`s life quality

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The worldwide occurrence of thyroid cancer increases, while the rate of mortality is stabile (in 2007 the survivor rate in the first five years was 97%). Thyroid cancer diseases are accompanied by physical and psychological longterm-diseases. Thus, regular, intensive aftercare is necessary. Husson, Haak, Oranje, Mols, Reemst and van de Poll-Franse describe, that patients, who survived thyroid cancer, declare to have a lower life quality in comparison to the normal population. The disease-specific, health-related quality of life questionnaire for thyroid cancer survivors includes the physical, emotional, social and cognitive perceptions of the patient regarding to his own functions. Through this, it is possible to assess the subjective evaluations of the patient´s life quality and the aftercare -especially tailored to thyroid cancer survivors. Until now, this questionnaire was not available in German, but it was already translated from Dutch into other languages. Through the regulary application of the THYCA-QoL in Germany, it is possible to increase the Quality of the aftercare for thyroid cancer patients.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011046
  •   2016/09/06
  •   [---]*
  •   yes
  •   Approved
  •   16-254, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C73 -  Malignant neoplasm of thyroid gland
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   In this study, the THYCA-QoL is going to be translated from Dutch to German. After that, thyroid cancer survivors are going to be examined via cognitive interviews for the following aspects: comprehensibility of the items, how acceptable the items are, identification of misunderstandings or inconsistencies and their correction. For this, ten cognitive interviews are done with thyroid cancer patients. The Duration of the tests is approximately 50 minutes.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Thyroid cancer survivors are going to be examined via cognitive interviews for the following aspects: comprehensibility of the items, how acceptable the items are, identification of misunderstandings or inconsistencies and their correction. The validation of the THYCA-QoL is ensured through the validation of the known questionnaire SF 36, PHQ-D and two QoL questionnaires (UQ QoL and QoL thyroid questionnaire). This happens at only one time point, on which the researcher goes to the nuclear medical ward and asks the patients to join the study. If the patient agrees to the conditions of the study, a individual appointment is made to do the cognitive pre-test.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

none

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/09/23
  •   120
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

1.) patients, that are treated in the nuclear medicine of the Uniklinik Köln
2.) the participants must have German as mother tongue or must be equipped with adequate german language skills inkl. adequate comprehension of the German language and the capability to read.
3.) min. 18 years old
4.) informed consent is written down (happens after the participants get Information over the study)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

1.) under 18 years
2.) non-elective patients, on whom it was impossible to do a pre-stationary survey, because of organisational difficulties)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Psychosomatik und Psychotherapie der Uniklinik Köln
    • Mr.  Dr.  Frank  Vitinius 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Uniklinik Köln, Klinik und Poliklinik für Nuklearmedizin
    • Ms.  Dr. med.  Christina  Schneider 
    • 50937  Köln
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Klinik und Poliklinik für Nuklearmedizin, Universitätsklinikum Köln
    • Mr.  Markus  Dietlein 
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Klinik für Psychosomatik und Psychotherapie der Uniklinik Köln
    • Mr.  Dr.  Frank  Vitinius 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Uniklinik Köln, Klinik und Poliklinik für Nuklearmedizin
    • Ms.  Dr. med.  Christina  Schneider 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Psychosomatik und Psychotherapie der Uniklinik Köln
    • Mr.  Dr.  Frank  Vitinius 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.