Trial document





This trial has been registered retrospectively.
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  DRKS00003453

Trial Description

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Title

Health-related quality of life, mental distress und somatopsychic symptoms in adult patients with haematological neoplasms

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Trial Acronym

PSY-HAEM-ONC

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Longitudinal studies with health-related quality of life (HRQoL), mental distress and somatopsychic burdens are still underrepresented for patients with haematological malignancies, in particular as routine assessment at treatment-relevant time points from patients’ and physicians’ perspective. Furthermore, there are only few objective tools in clinical oncology up to now to support physicians’ and patients’ understanding of the somatic burdens during cancer treatment and emphasizing patients’ burden perspective in cancer clinical trials. The main purposes of the study are the longitudinal investigation of psycho-oncological outcomes and the research question, if there are associations between the somatic burden of chemotherapy induced adverse events and mental distress outcomes of cancer patients.

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Brief Summary in Scientific Language

Longitudinal studies with health-related quality of life (HRQoL), mental distress and somatopsychic burdens are still underrepresented for patients with haematological malignancies, in particular as routine assessment at treatment-relevant time points from patients’ and physicians’ perspective. Furthermore, there are only few objective tools in clinical oncology up to now to support physicians’ and patients’ understanding of the somatic burdens during cancer treatment and emphasizing patients’ burden perspective in cancer clinical trials. The main purposes of the study are:
1) Development and validation of the Somatic Burden Score as quantitative and objective measurement of somatic burden due to chemotherapy-induceed adverse events (Partial study "SBS-AE")
2) the longitudinal investigation of psycho-oncological outcomes;
3) the research question, if there are associations between the somatic burden of chemotherapy induced adverse events and mental distress outcomes of cancer patients.

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Organizational Data

  •   DRKS00003453
  •   2011/12/27
  •   [---]*
  •   yes
  •   Approved
  •   65/06, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

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

  •   C92.0 -  Acute myeloid leukaemia
  •   C82.2 -  Non-Hodgkin's lymphoma: Large cell, follicular
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Interventions/Observational Groups

  •   Longitudinal assessment of described patient-reported outcomes: T1-at beginning of cancer treatment, T2-interim staging according to the chemotherapy protocol, T3-last discharge after treatment.
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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

a. Validation of the Somatic Burden Score SBS-AE
b. Aspects of mental health and somatopsychic symptoms in patients with haematological malignoms (e.g., general health perception, fatigue) assessed with the Medical Outcomes Study 36-Item Short Form Survey Instrument (SF-36), Patient Health Questionnaire (PHQ-D), Brief COPE and scale of general self-efficacy as longitudinal investigation: T1-at beginning of cancer treatment, T2-interim staging according to the chemotherapy protocol, T3-last discharge after treatment.

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Secondary Outcome

associations between the somatic burden of chemotherapy induced adverse events and mental distress outcomes of cancer patients.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2006/09/01
  •   500
  •   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

ICD-10-C-diagnosis, ECOG < 3

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Exclusion Criteria

palliative treatment, ECOG > 2

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik für Hämatologie und Onkologie
    • Mr.  Michael  Koehler 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Hämatologie und Onkologie
    • Mr.  Michael  Koehler 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Hämatologie und Onkologie
    • Mr.  Michael  Koehler 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Magdeburg
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Koehler M, Toll v. T, Fischer T, Frommer J. Generic health-related quality of life assessment in patients with autologous hematopoietic stem cell transplantation following high-dose chemotherapy. Onkologie 2011; 34 (S6):108. Koehler M, Holzhäuser J, Mohren M, Koenigsmann M, Frommer J. First evaluation of a new tool for assessment of toxicity in patients undergoing inpatient cytotoxic chemotherapy: The Somatic Burden Score. Onkologie 2007; 30 (S3), 114-115.
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* This entry means the parameter is not applicable or has not been set.