Assessing Psychosocial and Supportive Care Needs in Patients With Gliomas

NCT02728024 | Completed

• 1 other identifier: ERASMUS
• Study Type: observational
• Target: 175
• Locations: 0 countries
• Sites: N/A

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.).

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• Number of missing items in questionnaires

  Number of missing items per questionnaire

  Baseline

Secondary Outcomes (2)

• Definition of discrimination thresholds for glioma patients with and without distress based bon EORTC QLQ-C30 functioning scores.

  Baseline

• Definition of discrimination thresholds for glioma patients with and without supportive care needs based on EORTC QLQ-C30 functioning scores.

  Baseline

Study Arms (2)

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

Interventions

Missing items, Errors in Completion, Difficulties OTHER

A; B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• University of Ulm: collaborator
• Klinikum Stuttgart: collaborator

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 5, 2016
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 27, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share