Clinical trial NCT04516733: Precoce Medical Care by the Mobil Support for Patients With Glioblastoma
Official title: Precoce Medical Care by the Mobil Support for Patients With Glioblastoma Receiving Specific Medical Oncology Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma
Keywords: supportive care
mobil unit
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: in addition to oncology care, there will be a care with palliative team and neuropsychological care
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess the feasibility in terms of compliance with early medical care in glioblastoma patients by palliative care unit.
timeFrame: from date of inclusion visit until an average of 3 months
Secondary outcomes:
measure: The recruitment rate (proportion of patients giving consent to participate in the study among eligible patients during screening)
timeFrame: at the inclusion visit
measure: Proportion of patients completing all quality of life assessments (QLQ-C30 (Quality Life Questionnaire) at palliative care unit visits (Ve1, Ve2 and Ve3)
timeFrame: from date of inclusion visit until an average of 3 months
measure: Proportion of patients completing all BN20 assessments (Brain Cancer Module) at palliative care unit visits (Ve1, Ve2 and Ve3)
timeFrame: from date of inclusion visit until an average of 3 months
measure: Proportion of patients completing all anxiety assessments (HADS, Hospital Anxiety and Depression Scale) at palliative care unit visits (Ve1, Ve2 and Ve3)
timeFrame: from date of inclusion visit until an average of 3 months
measure: Changes over time in patients' quality of life
timeFrame: from date of inclusion visit until an average of 3 months
measure: Changes over time in patients' quality of life
timeFrame: from date of inclusion visit until an average of 3 months
measure: The evolution over time of anxiety and depressive affects in patients
timeFrame: from date of inclusion visit until an average of 3 months
measure: The evolution over time of neurocognitive performance in patients and the delay before neurocognitive degradation (Mattis DRS scale);
timeFrame: from date of inclusion visit until an average of 3 months
measure: Rate of patients who have written advance directives since the diagnostic announcement;
timeFrame: 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
measure: Rate of patients who have designated a support person since the diagnostic announcement
timeFrame: 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
measure: proportion of patients receiving specific medical oncology treatment in their last month of life
timeFrame: 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
measure: Overall survival
timeFrame: 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
measure: The proportion of patients diagnosed with glioblastoma that are available for this medical care
timeFrame: at the inclusion visit
Other outcomes:
Locations:
city: Montpellier
country: France
facility: ICM Val d'Aurelle
Study officials:
affiliation: Institut du Cancer de Montpellier - Val d'Aurelle
name: Michel FABBRO, MD
role: STUDY_CHAIR
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