Trial document





This trial has been registered retrospectively.
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  DRKS00005810

Trial Description

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Title

Comparison between objective and subjective assessment of the
Nutritional status for the identification of malnutrition in patients with
hematological and oncological diseases in ambulant treatment

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to investigate whether a self-assessment of the nutritional status is able to detect malnutrition in oncological and hematological outpatients.
To assess the meaningfulness of the self-assessment, it is compared with various objective diagnostic methods for the detection of malnutrition.
The self-assessment is collected via questionnaire, which is based on an already validated and accepted assessment tool relating to the nutritional status of cancer patients.
Objective diagnostic methods are the determination of the serum proteins albumin, prealbumin and retinol-binding protein as well as the implementation of a bioelectrical impedance analysis for the assessment of body composition.
In addition, the questionnaire is intended to provide information about whether cancer patients are aware or unaware of the risk of malnutrition.

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Brief Summary in Scientific Language

The purpose of this single-center, non-interventional study is to investigate whether a patient-generated self-assessment of the nutritional status is a meaningful indicator of malnutrition in oncological and hematological outpatients.
Therefore, for evaluating the meaningfulness of a self-assessment it will be compared to an objective evaluation of the nutritional status.
To objectively assess the nutritional status, the determination of the serum proteins albumin, prealbumin and retinol-binding protein is used as well as the implementation of a bioelectrical impedance analysis. The patient-generated self-assessment is gathered via questionnaire, which is based on the already validated and accepted assessment tool Scored PG-SGA.
Furthermore, another aim of the study is to provide information about the sensitization of cancer patients regarding the risk of malnutrition and to give information about whether cancer patients have demand for education on this subject.

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Organizational Data

  •   DRKS00005810
  •   2014/02/26
  •   [---]*
  •   yes
  •   Approved
  •   2013-70, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

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Health Condition or Problem studied

  •   C00-D48 -  Neoplasms
  •   D50-D90 -  Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
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Interventions/Observational Groups

  •   The nutritional status is assessed via determination of the serum proteins albumin, prealbumin and retinol-binding protein, bioelectrical impedance analysis for assessing the body composition and via answering a questionnaire which is based on the Scored PG-SGA.
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Characteristics

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

Comparison between objective (single measurement of serum proteins albumin, prealbumin and retinol-binding protein, bioelectrical impedance analysis) and subjective assessment (single completing of a questionnaire which is based on the Scored PG-SGA) of the nutritional status in oncological and hematological outpatients

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Secondary Outcome

Evaluation of the patient's awareness and sensitization for the problem of malnutrition, single data collection via questionnaire;
statement about the practicability of the assessment methods in outpatient setting, according to the judgement of the study coordinator;
statement about the patient's need for information about malnutrition, single data collection via questionnaire

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/10/24
  •   50
  •   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 who are at the beginning or continuation of outpatient chemotherapy in the study site;
age ≥ 18 years;
patient must be able to understand and autonomously answer the complete questionnaire;
dated and signed informed consent of the patient;
patient is able to consent

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Exclusion Criteria

Patients with known drug or alcohol dependency;
patients with severe chronic and / or infectious diseases (liver cirrhosis, hepatitis, rheumatism);
patients with a pacemaker;
patient with a defibrillator;
patients with arm or leg amputation;
patients with HIV / AIDS;
patients on dialysis treatment;
patients in whom an exact size and weight determination is impossible;
patients with impaired thyroid metabolism

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Halle (Saale)
    • Mr.  Dr. med.  Jörn  Rüssel 
    • Ernst-Grube-Str. 40
    • 06097  Halle (Saale)
    • Germany
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    • Universitätsklinikum Halle (Saale)
    • Ms.  B.Sc.  Kristin  Federwisch 
    • Ernst-Grube-Str. 40
    • 06097  Halle (Saale)
    • Germany
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    • Universitätsklinikum Halle (Saale)
    • Mr.  Dr. med.  Jörn  Rüssel 
    • Ernst-Grube-Str. 40
    • 06097  Halle (Saale)
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Halle (Saale), Klinik für Innere Medizin IV, Hämatologie und Onkologie
    • Ernst-Grube-Str. 40
    • 06097  Halle (Saale)
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/02/28
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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.