Trial document




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  DRKS00016066

Trial Description

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Title

Early Palliative Care for Patients with Glioblastoma; a randomized phase lll clinical trial

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Trial Acronym

EPCOG

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URL of the Trial

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Brief Summary in Lay Language

This is a multicenter, randomized, confirmatory, phase III, controlled, clinical parallel group study investigating the effect of early integration of palliative care (EIPC) for patients with glioblastoma disease. The study is conducted by the Center for Palliative Medicine at the University Hospital of Cologne.

Early integration of palliative care (EIPC) in systemic tumor diseases can, among other things, have a positive effect on the quality of life and depressivity of patients, avoid aggressive therapies at the end of life, prolong the lifespan and reduce the burden on relatives/related person (Bakitas et al., 2015; Zimmermann et al., 2014; Temel et al., 2010).

These advantages of EIPC have already been demonstrated for various tumor entities. However, data on the effect of EIPC in patients with glioblastoma (GBM), an extraordinarily malignant brain tumor that can be regarded as a model for rapidly progressive malignant tumors with a wide range of new psychiatric symptoms and psychosocial challenges, do not yet exist.

Therefore, in this study we want to investigate the efficacy of EIPC in GBM patients with very different needs compared to patients with systemic tumor diseases, in medical disciplines (neurooncology, neurosurgery) who are little experienced with palliative medicine and under consideration of feasibility within the German health care system. The study also investigates the effect of EIPC regarding the burden on relatives/related person, which will also be included in this study.

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Brief Summary in Scientific Language

To determine the efficacy of proactive early specialized palliative care in patients with glioblastoma to improve quality of life.

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Organizational Data

  •   DRKS00016066
  •   2019/04/29
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  •   yes
  •   Approved
  •   19-1024, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   C71.9 -  Malignant neoplasm: Brain, unspecified
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Interventions/Observational Groups

  •   Control Group: Patients will receive “optimized” standard care. This includes regular visits to the neurosurgery -in Bonn also to the Neurooncology- outpatient clinic every 3 months (+/- 1 week) with treatment and routine assessment following international standards. In addition, the “optimization” will be that patients’ Quality of Life will regularly be measured using the FACT-Br questionnaire.
  •   Intervention group: in addition to the "optimized" standard care, patients will regularly receive structured contacts (for 12 months) with specialized palliative care, independent of current needs (“proactive”). The intervention will be contducted by a specialized palliative care team consisting of a palliative care physician and a palliative care social worker.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

Change in the quality of life after 6 months compared to the beginning of proactive early specialized palliative care.

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Secondary Outcome

Changes in patients’ Quality of Life measured by the from baseline to 12 months (end of intervention), 18 months, 24 months of follow-up (to evaluate maintenance/sustainability of effect), patients’ palliative care needs, patients’ depression and anxiety, patients’ cognitive impairment, caregiver burden, each outcome measurement being validated and cost-effectiveness from the societal perspective including direct medical and direct non-medical costs.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2019/05/10
  •   214
  •   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

-Patients with newly diagnosed Glioblastoma (histologically confirmed by biopsy or resection) within 4 weeks of diagnosis
-Patients with recurrent Glioblastoma within 4 weeks after diagnosis of relapse
-Eastern Cooperative Oncology Group (ECOG) Scale: 0-2
-Age ≥ 18 years
-ability to understand, read and respond to the German language
-ability to give written consent

Relatives:

-Person (relative or other closely acquainted person) of particular importance to the patient, i.e. living together or in personal contact with the patient at least twice a week. (Caution: Patients may also be included if such a person does not exist.)
-Eastern Cooperative Oncology Group (ECOG) Scale: 0-2
-Age ≥ 18 years
-ability to understand, read and respond to the German language
-ability to give written consent

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Exclusion Criteria

Patients and relatives:

-Refusal to adhere to the study protocol
-legal incapacity
-prolonged use of drugs or alcohol or psychiatric disease which, in the opinion of the investigator, makes the patient or relative unsuitable for participation in the study
-Any dependence on the investigators or employed by the sponsor or investigator.
-legal or official placement in an institution

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Addresses

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    • Universität zu Köln
    • Albertus-Magnus-Platz
    • 50923  Köln
    • Germany
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    • Uniklinik Köln,Zentrum für Palliativmedizin
    • Ms.  PD Dr. med.  Heidrun  Golla 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Zentrum für PalliativmedizinUniversitätsklinikum Köln
    • Ms.  Dr. rer. nat.  Charlotte  Nettekoven 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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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.