Precoce Medical Care by the Mobil Support for Patients With Glioblastoma

Glioblastoma Clinical Trial

— GLIOSUPPORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04516733
• Other study ID #: PROICM 2018-04 GLI
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: February 15, 2022

Study information

• Verified date: March 2022
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 15, 2022
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Other:
• supportive care
visit with supportiv unit and neuropsychologue every 3 months

Locations

Country	Name	City	State
France	ICM Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (10)

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clin — View Citation

Batchelor TT, Mulholland P, Neyns B, Nabors LB, Campone M, Wick A, Mason W, Mikkelsen T, Phuphanich S, Ashby LS, Degroot J, Gattamaneni R, Cher L, Rosenthal M, Payer F, Jürgensmeier JM, Jain RK, Sorensen AG, Xu J, Liu Q, van den Bent M. Phase III randomiz — View Citation

Brown PD, Ballman KV, Rummans TA, Maurer MJ, Sloan JA, Boeve BF, Gupta L, Tang-Wai DF, Arusell RM, Clark MM, Buckner JC. Prospective study of quality of life in adults with newly diagnosed high-grade gliomas. J Neurooncol. 2006 Feb;76(3):283-91. — View Citation

Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. — View Citation

Chinot OL, Wick W, Mason W, Henriksson R, Saran F, Nishikawa R, Carpentier AF, Hoang-Xuan K, Kavan P, Cernea D, Brandes AA, Hilton M, Abrey L, Cloughesy T. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb — View Citation

Darlix A, Zouaoui S, Rigau V, Bessaoud F, Figarella-Branger D, Mathieu-Daudé H, Trétarre B, Bauchet F, Duffau H, Taillandier L, Bauchet L. Epidemiology for primary brain tumors: a nationwide population-based study. J Neurooncol. 2017 Feb;131(3):525-546. d — View Citation

Flechl B, Ackerl M, Sax C, Dieckmann K, Crevenna R, Gaiger A, Widhalm G, Preusser M, Marosi C. Neurocognitive and sociodemographic functioning of glioblastoma long-term survivors. J Neurooncol. 2012 Sep;109(2):331-9. doi: 10.1007/s11060-012-0897-1. Epub 2 — View Citation

Flechl B, Sax C, Ackerl M, Crevenna R, Woehrer A, Hainfellner J, Preusser M, Widhalm G, Kiesel B, Lütgendorf-Caucig C, Dieckmann K, Steffal C, Marosi C, Hassler MR. The course of quality of life and neurocognition in newly diagnosed patients with glioblas — View Citation

Gilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, Colman H, Chakravarti A, Pugh S, Won M, Jeraj R, Brown PD, Jaeckle KA, Schiff D, Stieber VW, Brachman DG, Werner-Wasik M, Tremont-Lukats IW, Sulman EP, Aldape KD, Curran WJ Jr, Me — View Citation

Gilbert MR. Antiangiogenic Therapy for Glioblastoma: Complex Biology and Complicated Results. J Clin Oncol. 2016 May 10;34(14):1567-9. doi: 10.1200/JCO.2016.66.5364. Epub 2016 Mar 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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