C71.9
Conditions
Interventions
Group 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 we
Sponsors
Universität zu Köln
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the quality of life after 6 months compared to the beginning of proactive early specialized palliative care. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactCharlotte Nettekoven
Zentrum für PalliativmedizinUniversitätsklinikum Köln
Outcome results
None listed