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

Phase 3

Completed

Conditions: C71.9
Brain, unspecified

Registration Number: DRKS00016066

Lead Sponsor: niversität zu Köln

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 231

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.