Precoce Medical Care by the Mobil Support for Patients With Glioblastoma (GLIOSUPPORT)

March 11, 2022 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Precoce Medical Care by the Mobil Support for Patients With Glioblastoma Receiving Specific Medical Oncology Treatment

Most patients with glioblastoma have impaired cognitive function, autonomy, and quality of life.

This clinical situation, combined with a limited life expectancy, makes the preservation of quality of life a major objective, in a supportive environment that respects family integration. This is especially true since there is an established relationship between health-related quality of life, as measured by questionnaires.

In this context, and despite the lack of impact on overall survival, improving quality of life becomes a priority objective in recent Phase III trials.

The feasibility of introducing early accompaniment in GBM should be assessed in the diagnostic and therapeutic announcement environment. In order to measure the expected impact as favorable in the patient and his family, a broad survey of the classic domains of quality of life and more specifically dedicated to neurological symptomatology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

glioblastomas are the most common primary malignant tumours of the central nervous system.They represent about 2000 new cases per year in France.

Despite active treatments including surgery, radiotherapy and chemotherapy, patient survival is limited without possible cure.

Most patients with glioblastoma have impaired cognitive function, autonomy, and quality of life. Exploration of verbal memory in these patients shows that its deterioration is correlated with a more unfavourable prognosis, after adjustment with other usual prognostic factors.

This clinical situation, combined with a limited life expectancy, makes the preservation of quality of life a major objective, in a supportive environment that respects family integration. This is especially true since there is an established relationship between health-related quality of life, as measured by questionnaires.

The feasibility of introducing early accompaniment in GBM should be assessed in the diagnostic and therapeutic announcement environment. In order to measure the expected impact as favorable in the patient and his family, a broad survey of the classic domains of quality of life and more specifically dedicated to neurological symptomatology.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34298
        • ICM Val D'Aurelle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patient ( ≥ 18 years),
  • Histological diagnosis of Glioblastoma
  • Oncology caret at ICM (regardless of treatment: Stupp protocol, chemotherapy alone, targeted therapy, etc.);
  • Patient consent signed after informed information.

Exclusion Criteria:

  • Patient unable to consent to the study
  • Major impairment of the general health : performance status OMS =4;
  • Patient not affiliated with a French social security

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: single arm
patient with glioblastoma
Other: supportive care
visit with supportiv unit and neuropsychologue every 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the feasibility in terms of compliance with early medical care in glioblastoma patients by palliative care unit.
Time Frame: from date of inclusion visit until an average of 3 months
Compliance is defined as the proportion of patients attending three palliative care unit visits (Ve1, Ve2 and Ve3).
from date of inclusion visit until an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The recruitment rate (proportion of patients giving consent to participate in the study among eligible patients during screening)
Time Frame: at the inclusion visit
Participation rate, defined as the proportion of patients who accepted inclusion in the study among all screened patients. Investigator expect an 80% participation rate in this study
at the inclusion visit
Proportion of patients completing all quality of life assessments (QLQ-C30 (Quality Life Questionnaire) at palliative care unit visits (Ve1, Ve2 and Ve3)
Time Frame: from date of inclusion visit until an average of 3 months
The proportion of palliative care unit consultations not carried out due to impossibility for the palliative care unit
from date of inclusion visit until an average of 3 months
Proportion of patients completing all BN20 assessments (Brain Cancer Module) at palliative care unit visits (Ve1, Ve2 and Ve3)
Time Frame: from date of inclusion visit until an average of 3 months
The proportion of palliative care unit consultations not carried out due to impossibility for the palliative care unit
from date of inclusion visit until an average of 3 months
Proportion of patients completing all anxiety assessments (HADS, Hospital Anxiety and Depression Scale) at palliative care unit visits (Ve1, Ve2 and Ve3)
Time Frame: from date of inclusion visit until an average of 3 months
The proportion of palliative care unit consultations not carried out due to impossibility for the palliative care unit
from date of inclusion visit until an average of 3 months
Changes over time in patients' quality of life
Time Frame: from date of inclusion visit until an average of 3 months
Score of questionnaire (QLQ-C30 (Quality Life Questionnaire)
from date of inclusion visit until an average of 3 months
Changes over time in patients' quality of life
Time Frame: from date of inclusion visit until an average of 3 months
Score of questionnaire BN20 (Brain Cancer Module)
from date of inclusion visit until an average of 3 months
The evolution over time of anxiety and depressive affects in patients
Time Frame: from date of inclusion visit until an average of 3 months
score of HADS questionnaire (Hospital Anxiety and Depression Scale). <9 no significant, between 10 and12 limit and > 13 significant
from date of inclusion visit until an average of 3 months
The evolution over time of neurocognitive performance in patients and the delay before neurocognitive degradation (Mattis DRS scale);
Time Frame: from date of inclusion visit until an average of 3 months
Neurocognitive performance of patients assessed by total score and scores at sub-scales of attention, initiation, conceptualization, construction and memory at the Mattis DRS scale
from date of inclusion visit until an average of 3 months
Rate of patients who have written advance directives since the diagnostic announcement;
Time Frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
The percentage of patients for whom advance directives have been written and documented in the medical record,
From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Rate of patients who have designated a support person since the diagnostic announcement
Time Frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
the percentage of patients for whom the support person has been designated
From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
proportion of patients receiving specific medical oncology treatment in their last month of life
Time Frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Percentage of patients receiving specific oncology treatment in the month prior to death
From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival
Time Frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
defined as the delay between the date of inclusion and the date of death (any cause) or the date of last update
From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
The proportion of patients diagnosed with glioblastoma that are available for this medical care
Time Frame: at the inclusion visit
Percentage of patients diagnosed with glioblastoma not care at the center during the inclusion period will be reported, as well as the reasons for not cared at the ICM center
at the inclusion visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Michel FABBRO, MD, Institut Du Cancer de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2019

Primary Completion (Actual)

September 15, 2020

Study Completion (Actual)

February 15, 2022

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 14, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2018-04 GLI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioblastoma

Clinical Trials on supportive care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe