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Completed

NCT Number: NCT04516733

Precoce Medical Care by the Mobil Support for Patients With Glioblastoma

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICM Val d'Aurelle

Montpellier, 34298, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supportive Care

Other

visit with supportiv unit and neuropsychologue every 3 months

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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

  8. 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

  9. 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,

  10. 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

  11. 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

  12. 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

  13. 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

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

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

Acronym: GLIOSUPPORT

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Aug 18, 2020
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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