Trial document




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  DRKS00007607

Trial Description

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Title

The Multimorbid Geriatric Cancer Patient – Therapy and Quality of Life
A Multicenter Study to Develop, Modulate and Pilot-test a Patient-centered Interdisciplinary Care Concept for Geriatric Oncology Patients

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Trial Acronym

PIVOG

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URL of the Trial

http://www.medizin.uni-halle.de/index.php?id=4401&L=1%20%27

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Brief Summary in Lay Language

Elder Cancer patients often suffer from multiple comorbidities. Physical and cognitive functioning can differ significantly. Therefore, a comprehensive geriatric assessment (CGA) is recommended to identify relevant risk factors in order to administer optimized cancer specific therapy. This study aims to integrate medical and patient reported outcomes to administer a comprehensive treatment during hospitalization and after care.

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Brief Summary in Scientific Language

Elder Cancer patients often suffer from multiple comorbidities. Physical and cognitive functioning can differ significantly. Therefore, a comprehensive geriatric assessment (CGA) is recommended to identify relevant risk factors in order to administer optimized cancer specific therapy. The complex intervention of this study aims to integrate medical, biological and patient reported outcomes to administer individualized cancer and supportive therapies during hispitalization and after care.

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Organizational Data

  •   DRKS00007607
  •   2014/12/09
  •   [---]*
  •   yes
  •   Approved
  •   2014-115, 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

  •   oncologic diseases in geriatric patients
  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   In addition to standardized medical assessments according to clinical guidelines comprehensive geriatric assessment, bilogical age (AGE-Reader) and patient reported quality of life will be taken into account for treatment planning. 6 months telephone after care by specialized nurse.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

HRQoL (health-related quality of life) (EORTC QLQ-C30, ELD14) 6 months after dismissal from hospital (t3 Follow-up) in comparison to admission (t1). Presumed clinical relevand difference of 10 pts. of the scale from 0/100.

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Secondary Outcome

6 months after dismissal (t3) number and reason of readmissions (during follow-up), overall and disease specific survival, patient satisfaction (7 questions likert scale)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/11/28
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Oncologic patients 70 years and older receiving in-patient or out-patient treatment with at least one comorbidity and/or one functional impairment regarding ADL, with written informed consent given by patients and, if necessary, their legal custodian.

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Exclusion Criteria

unsufficient language proficiency, severe psychiatric comorbidity or severe dementia that preclude answering questionnaires

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Addresses

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    • Wilhelm-Roux-Förderprogramm der Medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg, Prodekanat Forschung
    • 06112  Halle
    • Germany
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    • Institut für Gesundheits- und Pflegewissenschaft, Medizinische Fakultät der MLU Halle-Wittenberg
    • Ms.  Dr.  Heike  Schmidt 
    • Magdeburgerstr. 8
    • 06112  Halle
    • Germany
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    • Institut für Gesundheits- und Pflegewissenschaft, Medizinische Fakultät der MLU Halle-Wittenberg
    • Ms.  Dr.  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, Prodekanat Forschung
    • Magdeburgerstr, 8
    • 06112  Halle
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/01/19
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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.