Trial document




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  DRKS00005337

Trial Description

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Title

Patient-reported outcomes in the treatment of oncological patients - A multicentred pilot study to select appropriate assessment instruments

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Trial Acronym

PRO-ONKO

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URL of the Trial

https://www.medizin.uni-halle.de/index.php?id=3754&BF=&L=1

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Brief Summary in Lay Language

Background: Cancer patients suffer from numerous symptoms and functionality restrictions resulting from the disease and the therapy. Registering these symptoms and functionality restrictions is the basis for interprofessional communication and optimal therapy management during the course of the illness. However, up to now no systematically extended documentation of symptoms and functionality restrictions reported by the patients themselves has been carried out in everyday nursing procedures (Patient Reported Outcomes, PRO).

Purpose: This project therefore aims at setting up an item pool from the available tools, seen from the point of view of the professional staff concerned and the cancer patients themselves, which will then make PRO effective for clinical decision-making.

Methods: Qualitative, multicentred cross-section survey carried out in cooperation with physicians (surgery, internal medicine, radiation therapy), oncological nursing staff, members of the psychosocial services (psycho-oncologists, welfare workers) and patients diagnosed with various types of tumour, either hospitalized or receiving outpatient treatment.

Expected result: A modular assessment tool that fulfils the requirements of both patients and practitioners

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Brief Summary in Scientific Language

Background: Cancer patients frequently suffer from various symptoms often impairing functional status and quality of life. To enable interdisciplinary supportive care assessment of symptoms should include patients' self-assessment (Patient Reported Outcomes, PRO). To facilitate the implementation of PRO-assessment in daily clinical practice it is important to provide valid and feasible means meeting requirements of health care professionals and patients likewise.
Purpose: This project therefore aims to compile an item pool from available tools, meeting the requirements of health care professionals and patients, in order to facilitate the use of PRO assessment for clinical decision-making.

Methods: Qualitative, multicentre cross-sectional study comprising two stages in cooperation with physicians (surgery, internal medicine, radiation therapy), oncological nursing staff, members of the psychosocial services (psycho-oncologists, welfare workers) and patients diagnosed with various types of cancer, either hospitalized or receiving outpatient treatment.
The first stage comprised interdisciplinary focus groups to define the particular requirements of the participating clinics with respect to PRO and to recommend suitable questionnaires. In the second stage patients completed the recommended questionnaires. In one centre data collection was carried out via tablet PC. The resulting PRO were compared with routine documentation and judged by patients and HCP’s with respect to usefulness for clinical routine.

Expected result: A modular assessment tool that fulfils the requirements of both patients and practitioners

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Organizational Data

  •   DRKS00005337
  •   2013/11/28
  •   [---]*
  •   yes
  •   Approved
  •   2013-79, 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
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Interventions/Observational Groups

  •   Cancer patients, aged >18 Years, heterogenious diagnoses, undergoing in and/ or out-patient treatment complete questionnaires to assess patient reported outcomes(PRO) and evaluate their usefulness and appropriateness.
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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 modular assessment tool that fulfils the requirements of both patients and practitioners to facilitate supportive therapy and symptom management of oncologic patients.

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Secondary Outcome

-

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2014/01/02
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Cancer patients, aged >18 Years, heterogenious diagnoses, undergoing in and/ or out-patient treatment who gave written informed consent.

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Exclusion Criteria

non-sufficient understanding of the German language, cognitive impairments (e.g. dementia) or not able to give informed consent.

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Addresses

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    • Wilhelm-Roux-Förderprogramm der Medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg, Prodekanat Forschung
    • Magdeburgerstr. 8
    • 06112  Halle
    • Germany
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    • Institut für Gesundheits- und Pflegewissenschaft Medizinische Fakultät der Martin-Luther-Universität Halle Wittenberg
    • Ms.  Dr. med.  Heike  Schmidt 
    • Magdeburgerstr. 8
    • 06097  Halle
    • Germany
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    • Institut für Gesundheits- und Pflegewissenschaft, Medizinische Fakultät der Martin-Luther-Universität, Halle-Wittenberg
    • Ms.  Dr. med.  Heike  Schmidt 
    • Magdeburgerstr. 8
    • 06112  Halle
    • Germany
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Sources of Monetary or Material Support

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    • Wilhelm-Roux-Förderprogramm der Medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg
    • Magdeburgerstr. 8
    • 06112  Halle
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/05/31
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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.