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Glioma patients in ambulatory care - Optimization of psychosocial care in neurooncological patients

Organizational Data

DRKS-ID:
DRKS00018079
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2019-09-03
Last update in DRKS:
2021-10-29
Registration type:
Prospective

Acronym/abbreviation of the study

GLIOPT

URL of the study

No Entry

Brief summary in lay language

Objective: To optimize the assessment of support needs and thus also the care of patients with malignant gliomas in ambulatory treatment.

Brief summary in scientific language

Hypothesis: In a stress assessment conducted directly by attending physicians and in which the physicians talk to the patients, more patients with glioma are correctly recorded and treated than in a questionnaire survey.

Health condition or problem studied

ICD10:
C71.9 - Brain, unspecified
Free text:
Patients with malignant gliomas (initial diagnosis and relapse in ambulatory)
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
intervention: assessment psychosocial stress in the doctor's consultation
Arm 2:
Control: assessment of psychosocial stress in the questionnaire

Endpoints

Primary outcome:
psychosocial care
Secondary outcome:
Percentage of patients for whom psychosocial stress can be measured, duration of physician consultation, time spent on mediation, psychological stress, quality of life, desire for support, transfer to specialized services, direct costs of care, accuracy of screening, evaluation of protocol adherence

Study Design

Purpose:
Supportive care
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Other Institut für Medizinische Biometrie, Epidemiologie und Informatik (IMBEI) Mainz
  • Other Institut für Medizinische Biometrie, Epidemiologie und Informatik (IMBEI) Mainz
  • Medical center Klinik für Neurologie Ludwigsburg
  • University medical center Klinik für Allgemeine Neurochirurgie Köln
  • University medical center Neurochirurgische Klinik Zentrum für Neuroonkologie Düsseldorf
  • University medical center Klinik für Neurochirurgie Berlin
  • University medical center Interdisziplinäre Sektion Neuroonkologie: Zentrum für Neurologie & Klinik für Neurochirurgie Tübingen
  • Medical center Abteilung für Neurochirurgie und Kinderneurochirurgie Trier
  • University medical center Bezirkskrankenhaus GünzburgKlinik für Neurochirurgie Ulm
  • University medical center Neurochirurgische Klinik und Poliklinik Würzburg
  • University medical center Senckenbergisches Institut für NeuroonkologieZentrum der Neurologie und Neurochirurgie Frankfurt a.M.
  • Medical center Katharinenhospital (KH) Neurochirurgische Klinik Stuttgart
  • University medical center Klinik und Poliklinik für Neurochirurgie Leipzig
  • Medical center Neurochirurgische Klinik/Neurologische Klinik München

Recruitment period and number of participants

Planned study start date:
2019-10-01
Actual study start date:
2019-10-31
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
616
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Age > 18 years, Legal capacity, given inform consence, Diagnosis of a primary tumor (glioma), Patient treated in one of the neurooncological consultation hours

Exclusion Criteria

Non-fulfillment of inclusion criteria, abscence of inform consense

Addresses

Primary Sponsor

Universitätsklinikum Tübingen
Hoppe-Seyler-Straße 3
72076 Tübingen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum TübingenOberärztin, Fachärztin für Neurochirurgie, UMM
PD Dr. med. Mirjam Renovanz
Hoppe-Seyler-Straße 3
72076 Tübingen
Germany
Telephone:
07071-29-86746
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universitätsklinikum Tübingen
M.Sc. Melina Hippler
Hoppe-Seyler-Straße 3
72076 Tübingen
Germany
Telephone:
07071-29-86747
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universitätsklinikum TübingenOberärztin, Fachärztin für Neurochirurgie, UMM
PD Dr. med. Mirjam Renovanz
Hoppe-Seyler-Straße 3
72076 Tübingen
Germany
Telephone:
07071-29-86746
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

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.)

Gemeinsamer Bundesausschuss (G-BA Innovationsfonds)
Gutenbergstraße 13
10596 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
https://www.g-ba.de/

Ethics Committee

Address Ethics Committee

Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2019-03-12
Ethics committee number:
191/2019/B02
Vote of the Ethics Committee:
Approved
Date of the vote:
2019-05-14

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
Prüfprotokoll
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry