Precoce Medical Care by the Mobil Support for Patients With Glioblastoma

NCT04516733 | Completed

• 1 other identifier: PROICM 2018-04 GLI
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Keywords

supportive care; mobil unit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• The recruitment rate (proportion of patients giving consent to participate in the study among eligible patients during screening)

  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)

  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)

  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)

  from date of inclusion visit until an average of 3 months

• Changes over time in patients' quality of life

  from date of inclusion visit until an average of 3 months

Study Arms (1)

single arm

OTHER

patient with glioblastoma

Other: supportive care

Interventions

supportive care OTHER

visit with supportiv unit and neuropsychologue every 3 months

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

ICM Val d'Aurelle

Montpellier, 34298, France

Location

Related 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 clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

  PMID: 8433390 RESULT

• 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, Jurgensmeier JM, Jain RK, Sorensen AG, Xu J, Liu Q, van den Bent M. Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma. J Clin Oncol. 2013 Sep 10;31(26):3212-8. doi: 10.1200/JCO.2012.47.2464. Epub 2013 Aug 12.

  PMID: 23940216 RESULT

• 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. doi: 10.1007/s11060-005-7020-9.

  PMID: 16163448 RESULT

• 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. doi: 10.1200/JCO.1993.11.3.570.

  PMID: 8445433 RESULT

• 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 20;370(8):709-22. doi: 10.1056/NEJMoa1308345.

  PMID: 24552318 RESULT

• Darlix A, Zouaoui S, Rigau V, Bessaoud F, Figarella-Branger D, Mathieu-Daude H, Tretarre 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. doi: 10.1007/s11060-016-2318-3. Epub 2016 Nov 16.

  PMID: 27853959 RESULT

• 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 2012 May 29.

  PMID: 22644537 RESULT

• Flechl B, Sax C, Ackerl M, Crevenna R, Woehrer A, Hainfellner J, Preusser M, Widhalm G, Kiesel B, Lutgendorf-Caucig C, Dieckmann K, Steffal C, Marosi C, Hassler MR. The course of quality of life and neurocognition in newly diagnosed patients with glioblastoma. Radiother Oncol. 2017 Nov;125(2):228-233. doi: 10.1016/j.radonc.2017.07.027. Epub 2017 Aug 8.

  PMID: 28801008 RESULT

• 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. No abstract available.

  PMID: 27001588 RESULT

• 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, Mehta MP. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):699-708. doi: 10.1056/NEJMoa1308573.

  PMID: 24552317 RESULT

MeSH Terms

Conditions

Glioblastoma

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Michel FABBRO, MD

  Institut du Cancer de Montpellier - Val d'Aurelle

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: in addition to oncology care, there will be a care with palliative team and neuropsychological care

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 18, 2020
• Study Start: May 10, 2019
• Primary Completion: September 15, 2020
• Study Completion: February 15, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)