Trial document




drksid header

  DRKS00018079

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

GLIOPT

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00018079
  •   2019/09/03
  •   [---]*
  •   yes
  •   Approved
  •   191/2019/B02 , Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C71.9 -  Malignant neoplasm: Brain, unspecified
  •   Patients with malignant gliomas (initial diagnosis and relapse in ambulatory)
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   intervention: assessment psychosocial stress in the doctor's consultation
  •   Control: assessment of psychosocial stress in the questionnaire
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

psychosocial care

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • other 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/10/31
  •   616
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Non-fulfillment of inclusion criteria, abscence of inform consense

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Tübingen
    • Hoppe-Seyler-Straße 3
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum TübingenOberärztin, Fachärztin für Neurochirurgie, UMM
    • Ms.  PD Dr. med.  Mirjam  Renovanz 
    • Hoppe-Seyler-Straße 3
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Tübingen
    • Ms.  M.Sc.  Melina  Hippler 
    • Hoppe-Seyler-Straße 3
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Gemeinsamer Bundesausschuss (G-BA Innovationsfonds)
    • Gutenbergstraße 13
    • 10596  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Prüfprotokoll
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.