Trial document




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  DRKS00014055

Trial Description

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Title

The preparation of cancer patients for further outpatient treatment - assessment of symptom distress of patients in dependency on communication and subjective stress of medical practitioners

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Discharge consultations are supposed to prepare cancer patients optimally for further outpatient treatment and for enabling them to deal better with their disease. A good communication between medical practitioners and patients is important to respond to the patient's needs. In practice medical practitioners are often faced with a high workload, which can be associated with deficits in communication. Moreover especially in discharge management it becomes apparent that there are often care deficits and patients are discharged unprepared. Before developing interventions for the enhancement of discharge consultations the distress of patients shall be investigated in this study. Furthermore it shall be investigated up to what extent the quality of communicated affects distress and if the medical practitioners stress affects the evaluation of communication and the patients' distress.

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Brief Summary in Scientific Language

Discharge consultations are supposed to prepare cancer patients after in-patient stay optimally for further outpatient treatment and for enabling them to deal better with their disease. An effective communication between medical practitioners and patients is necessary. In practice medical practitioners are often faced with a high workload which can be associated with deficits in communication. Moreover especially in discharge management it becomes apparent that there are often care deficits and patients are discharged unprepared. Aim of the study is to investigate how distressed cancer patients are during the discharge process and how patients evaluate the quality of communication in discharge consultations: It shall be investigated up to what extent a good communication during the discharge consultation can lead to a decrease of patients' distress. Furthermore it shall be investigated how much the medical practitioners' distress affects the patients' evaluation of communication. Therefore the patients' symptom distress, anxiety and depressive symptoms are measured before discharge consultation and after discharge. The medical practitioners' distress before the consultation and the patients' evaluation of communication are captured as well. For statical evaluations descriptive analyses, t-tests and linear regressions are conducted. The results serve as generation of knowledge on oncological discharge consultations and associated factors. The knowledge shall serve as groundwork for the development of interventions.

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Organizational Data

  •   DRKS00014055
  •   2018/04/05
  •   [---]*
  •   yes
  •   Approved
  •   52/18, 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
  •   F30-F39 -  Mood [affective] disorders
  •   F40-F48 -  Neurotic, stress-related and somatoform disorders
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Interventions/Observational Groups

  •   Cancer patients in in-patient treatment fill in questionnaires before discharge consultation and after discharge: A modified German version of the Memorial Symptom Assessment Scale (Portenoy et al., 1994, German version: Spichiger et al., 2011) for capturing symptom distress and a modified German version of the Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983, German Version: Herrmann-Lingen, Buss, & Snaith, 2011) for capturing anxiety and depressive symptoms. After discharge consultation, they fill in a modified version of the questionnaire Communication Assessment Tool (Makoul, Krupat, & Chang, 2007, German version: Karger, Wuensch, Bachmann, & Kiessling, in preparation). Medical practitioners that treat the patients answer a visual analogue scale for measuring distress before discharge consultation.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Symptom distress shall be measured with a modified German Version of the Memorial Symptom Assessment Scale (Portenoy et al., 1994, German version: Spichiger et al., 2011). Anxiety and depressive symptoms are captured with the modified German version of the Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983; German version: Herrmann-Lingen, Buss & Snaith, 2011). Symptom distress, anxiety and depressive symptoms are captured before the discharge consultation, after the discharge consultation before discharge and after discharge.

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Secondary Outcome

The progress of symptom distress, anxiety and depressive symptoms between the measurements 1 and 2 shall be ascertained as differences between the times of measurements based on the results of the Memorial Symptom Assessment Scale (Spichiger et al., 2011) and the Hospital Anxiety and Depression Scale (Herrmann-Lingen, Buss & Snaith, 2011).
For capturing the patients' evaluation of communication, a modified German version of the Communication Assessment Tool (Makoul, Krupat, & Chang, 2007, German version) is used. The data is captured after the discharge consultation.
Medical practitioners distress is captured with a visual analogue scale before the discharge consultation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/05/04
  •   100
  •   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

Precondition for participation is that patients are oncological patients during in-patient stay and are imminent to hospital discharge. The participation is only possible, if the patients' Karnofsky score is above 60. Sufficient knowledge in German.

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Exclusion Criteria

If the medical practitioners that treat the participating patients don't participate

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Psychosoziale Krebsberatungsstelle, Tumorzentrum CCCF, Universitätsklinikum Freiburg
    • Mr.  Dr.  Alexander  Wünsch 
    • Haupstraße 5a
    • 79104  Freiburg
    • Germany
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    • Psychosoziale Krebsberatungsstelle, Tumorzentrum CCCF, Universitätsklinikum Freiburg
    • Mr.  Dr.  Alexander  Wünsch 
    • Hauptstraße 5a
    • 79104  Freiburg
    • Germany
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    • Psychosoziale Krebsberatungsstelle, Tumorzentrum CCCF, Universitätsklinikum Freiburg
    • Mr.  Dr.  Alexander  Wünsch 
    • Hauptstraße 5a
    • 79104  Freiburg
    • Germany
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    • Psychosoziale Krebsberatungsstelle, Tumorzentrum CCCF, Universitätsklinikum Freiburg
    • Ms.  Natalie  Röderer 
    • Hauptstraße 5a
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Psychosoziale Krebsberatungsstelle, Tumorzentrum CCCF, Universitätsklinikum Freiburg
    • Mr.  Dr.  Alexander  Wünsch 
    • Haupstraße 5a
    • 79104  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/07/13
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Trial Publications, Results and other Documents

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