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Assessing Psychosocial and Supportive Care Needs in Patients With Gliomas (ERASMUS)

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ClinicalTrials.gov Identifier: NCT02728024
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : May 27, 2016
Sponsor:
Collaborators:
University of Ulm
Klinikum Stuttgart
Information provided by (Responsible Party):
Dr. med. Mirjam Renovanz, Johannes Gutenberg University Mainz

Brief Summary:

The study is undertaken at three German neurosurgical centers (Ulm, Mainz, Stuttgart) between March 2014 and March 2015. Inclusion criteria were age ≥ 18 and ≤ 80, diagnosis of glioma WHO° II-IV, absence of aphasia impairing communication or consent. In an outpatient setting all eligible patients with gliomas were screened for distress (Distress Thermometer (DT)) and their need for psychosocial support (Supportive Care Needs Survey-SF34-G (SCNS)). Simultaneously their HRQoL was assessed (EORTC QLQ-C30+BN-20 Vers. 3).

Patients at different disease stages were asked to fill out the questionnaires. At two study centers patients were asked to complete the questionnaires prior to their appointment with personal instructions in randomly selected cases. At the third study center, they completed the questionnaires after their outpatient appointment with personal aid and instructions. At the time of investigation, patients were at different stages of treatment (chemotherapy, radiation, re-chemotherapy, re-radiation, none, etc.).


Condition or disease Intervention/treatment
Glioma Other: Missing items, Errors in Completion, Difficulties

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Study Type : Observational
Actual Enrollment : 175 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Psychosocial and Supportive Care Needs in Patients With Gliomas
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
A
Complete the questionnaires with personal aid
Other: Missing items, Errors in Completion, Difficulties
B
questionnaires are completed by patients alone
Other: Missing items, Errors in Completion, Difficulties



Primary Outcome Measures :
  1. Number of missing items in questionnaires [ Time Frame: Baseline ]
    Number of missing items per questionnaire


Secondary Outcome Measures :
  1. Definition of discrimination thresholds for glioma patients with and without distress based bon EORTC QLQ-C30 functioning scores. [ Time Frame: Baseline ]
    Unitless PRO measures of SCNS-SF34-G were grouped into categories corresponding to the functioning scales, HRQoL scale and selected symptom scales of the EORTC QLQ-C30/BN20: physical function (physf), role function (rolef), emotional function (emof), cognitive function (cognf), social function (socf), quality of life (GHS), future uncertainty (FU), fatigue, and motor dysfunction). SCNS scores >3 were defined as need for supportive care with the respective issue. Decision thresholds for the corresponding EORTC QLQ functioning scores were determined using receiver operating characteristics.

  2. Definition of discrimination thresholds for glioma patients with and without supportive care needs based on EORTC QLQ-C30 functioning scores. [ Time Frame: Baseline ]
    Items of the problem list of the DT questionnaire were grouped into categories corresponding to the functioning scales, HRQoL scale and selected symptom scales of the EORTC QLQ-C30/BN20: physical function (physf), role function (rolef), emotional function (emof), cognitive function (cognf), social function (socf), quality of life (GHS), future uncertainty (FU), fatigue, and motor dysfunction). Decision thresholds for the corresponding EORTC QLQ functioning scores were determined using receiver operating characteristics. DT >6 was defined significant distress.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Selection criteria for this study were 1) a glial cerebral tumor (astrocytoma, oligoastrocytoma, oligodendroglioma, glioblastoma), as diagnosed by the local neuro- pathologist in the study center; 2) patient is affiliated with the neuro-oncological outpatient center in one of the three study centers; 3) patient is able to understand and respond to the questions; 4) informed consent of the patient.
Criteria

Inclusion criteria:

  • Harboring a glial cerebral tumor (astrocytoma, oligoastrocytoma, oligodendroglioma, glioblastoma), as diagnosed by the local neuro- pathologist in the study Center
  • Patient is affiliated with the neuro-oncological outpatient center in one of the three study Centers
  • Patient is able to understand and respond to the questions
  • Informed consent of the Patient
  • Age >18, <80 years

Exclusion criteria:

  • Absence of inclusion criteria
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Responsible Party: Dr. med. Mirjam Renovanz, MD, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT02728024    
Other Study ID Numbers: ERASMUS
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue