Trial document




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  DRKS00010674

Trial Description

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Title

Quality of life in oncology

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Subjective quality of life (QOL) in patients with malignant tumours depends on a number of factors. Beyond impairments due to the disease and it’s treatment, psycho-social factors, physical and mental reserves may play an important part in coping with the disease and resulting QOL.
In this non-interventional observational study we aim to investigate factors prior to a planned treatment start that may influence QOL one year after initiation of the medical intervention.

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Brief Summary in Scientific Language

QOL has gained importance as patient-reported outcome measure and indicator for the quality of care. Especially in patients without a curative treatment option, maintenance or improvement of quality of survival becomes predominant.
QOL does not only depend on the nature of the underlying disease but also concomitant psycho-social factors as has been shown in allogeneic transplant patients.
We aim to perform a non-interventional observational study including oncological patients in an academic teaching hospital. QOL (EORTC QLQ-C30) will be assessed as dependent variable one year after initial medical treatment. Pre-treatment independent variables will include: QOL (EORTC QLQ-C30), anxiety and depression (HADS Score), Hope (HHI-D), social support (MOS social support survey), spirituality (SpREUK), physical symptoms (PSI), coping with the disease (FKV), somatic symptoms, co-morbidities, performance status (Karnofsky Index), resilience (RS-11), treatment related complications and toxicities (Dindo Clavien Index), as well as age, sex and tumour entity.
Primary goal of the trial is to highlight psycho-social, somatic and treatment related factors that are shown relevant in multivariate analyses to influence QOL.
All patients affected by a malignant disease with life expectancy >1 year that are treated according to oncological guidelines and that gave their informed consent will be included. To enable subgroup analyses of the largest oncological entities, the focus will lie on patients with prostate, breast, and colorectal cancer.

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Organizational Data

  •   DRKS00010674
  •   2016/07/05
  •   [---]*
  •   yes
  •   Approved
  •   63/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   Pre-treatment independent variables that will be collected: QOL (EORTC), anxiety and depression (HADS), hope (HHI-D), social support (MOS social support survey), spirituality ( SpREUK), physical symptoms (PSI), coping capabilities (FKV), somatic symptoms (somatic symptoms inventory), co-morbidities (Charlston-Index), performance status (Karnofsky-Index) and resiliene. Dependent variables after one year will include complications and QOL.
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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

Quality of Life (EORTC-QLQ-30) one year after oncological therapy

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2016/09/01
  •   400
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

oncological patients with expected lifetime of one year with oncological therapy acording to Guideline with curative intention

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Exclusion Criteria

inability to work with questionaries

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Addresses

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    • Caritaskrankenhaus Bad Mergentheim
    • Uhlandstrasse 7
    • 97980  Bad Mergentheim
    • Germany
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    • Caritaskrankenhaus Bad Mergentheim
    • Mr.  Prof.Dr.  Peter  Baier 
    • Uhlandstrasse 7
    • 97980  Bad Mergentheim
    • Germany
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    • Caritaskrankenhaus Bad Mergentheim
    • Mr.  Prof.Dr.  Peter  Baier 
    • Uhlandstrasse 7
    • 97980  Bad Mergentheim
    • Germany
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Sources of Monetary or Material Support

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    • Caritaskrankenhaus Bad Mergentheim
    • Mr.  Prof.Dr.  Peter  Baier 
    • Uhlandstrasse 7
    • 97980  Bad Mergentheim
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.