Trial document

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DRKS-ID: 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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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

DRKS-ID: DRKS00016066
Date of Registration in DRKS: 2019/04/29
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 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

ICD10: C71.9 - Malignant neoplasm: Brain, unspecified

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Interventions/Observational Groups

Arm 1: 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.
Arm 2: 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

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: assessor
Control: Active control (effective treament of control group)
Purpose: Supportive care
Assignment: Parallel
Phase: III
Off-label Drug use: 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

DE: Germany

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Locations of Recruitment

University Medical Center Klinik für Allgemeine Neurochirurgie der Uniklinik Köln sowie das MVZ Neurochirurgie der Uniklinik Köln, Köln
University Medical Center Sektion Klinische Neuroonkologie der Klinik und Poliklinik der Neurologie am Universitätsklinikum Bonn und Klinik für Neurochirurgie, Bonn
University Medical Center Klinik für Neurochirurgie, RWTH Aachen
University Medical Center Neurochirurgische Klinik und Poliklinik der LMU, München
University Medical Center Klinik für Neurochirurgie im Neurozentrum des Universitätsklinikums Freiburg, Freiburg im Breisgau
University Medical Center Universitätsklinikum Düsseldorf Klinik für Neurochirurgie , Düsseldorf

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2019/05/10
Target Sample Size: 214
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- Universität zu Köln
- Albertus-Magnus-Platz
- 50923 Köln
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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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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- Telephone: 0049 0221 478 3368
- Fax: [---]*
- E-mail: heidrun.golla at uk-koeln.de
- URL: [---]*
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Contact for Public Queries
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- Zentrum für PalliativmedizinUniversitätsklinikum Köln
- Ms. Dr. rer. nat. Charlotte Nettekoven
- Kerpener Straße 62
- 50937 Köln
- Germany
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- Telephone: 0049 (0)221 478 32050
- Fax: 0049 (0)221 478 82825
- E-mail: charlotte.nettekoven at uk-koeln.de
- URL: [---]*
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Bundesministerium für Bildung und Forschung Dienstsitz Bonn
- Heinemannstr. 2
- 53175 Bonn
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.bmbf.de
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Status

Recruitment Status: Recruiting complete, follow-up continuing
Reason, if "Recruitment stopped after recruiting started" or "Recruiting withdrawn before recruting started": [---]*
Reason, if Reason for Recruiting Stop "Other": [---]*
Study Closing (LPLV): [---]*
Number of Participants in Germany after Recruiting complete: 218
Total Number of Participants (all Sites worldwide) after Recruiting complete: 218

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Trial Publications, Results and other Documents

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