Precoce Medical Care by the Mobil Support for Patients With Glioblastoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glioblastoma

Intervention / Treatment
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* Other: supportive care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: in addition to oncology care, there will be a care with palliative team and neuropsychological care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single arm<br>patient with glioblastoma | Other: supportive care<br>* visit with supportiv unit and neuropsychologue every 3 months<br>|

What is the study measuring?
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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. | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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); | 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; | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supportive care, mobil unit