Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-01-01 @ 6:23 AM
Study NCT ID:
NCT04516733
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precoce Medical Care by the Mobil Support for Patients With Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-03-04', 'releaseDate': '2025-02-11'}], 'estimatedResultsFirstSubmitDate': '2025-02-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'in addition to oncology care, there will be a care with palliative team and neuropsychological care'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-11', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-14', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'Compliance is defined as the proportion of patients attending three palliative care unit visits (Ve1, Ve2 and Ve3).'}], 'secondaryOutcomes': [{'measure': 'The recruitment rate (proportion of patients giving consent to participate in the study among eligible patients during screening)', 'timeFrame': 'at the inclusion visit', 'description': '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'}, {'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', 'description': 'The proportion of palliative care unit consultations not carried out due to impossibility for the palliative care unit'}, {'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', 'description': 'The proportion of palliative care unit consultations not carried out due to impossibility for the palliative care unit'}, {'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', 'description': 'The proportion of palliative care unit consultations not carried out due to impossibility for the palliative care unit'}, {'measure': "Changes over time in patients' quality of life", 'timeFrame': 'from date of inclusion visit until an average of 3 months', 'description': 'Score of questionnaire (QLQ-C30 (Quality Life Questionnaire)'}, {'measure': "Changes over time in patients' quality of life", 'timeFrame': 'from date of inclusion visit until an average of 3 months', 'description': 'Score of questionnaire BN20 (Brain Cancer Module)'}, {'measure': 'The evolution over time of anxiety and depressive affects in patients', 'timeFrame': 'from date of inclusion visit until an average of 3 months', 'description': 'score of HADS questionnaire (Hospital Anxiety and Depression Scale). \\<9 no significant, between 10 and12 limit and \\> 13 significant'}, {'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', 'description': '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'}, {'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', 'description': 'The percentage of patients for whom advance directives have been written and documented in the medical record,'}, {'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', 'description': 'the percentage of patients for whom the support person has been designated'}, {'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', 'description': 'Percentage of patients receiving specific oncology treatment in the month prior to death'}, {'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', 'description': 'defined as the delay between the date of inclusion and the date of death (any cause) or the date of last update'}, {'measure': 'The proportion of patients diagnosed with glioblastoma that are available for this medical care', 'timeFrame': 'at the inclusion visit', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['supportive care', 'mobil unit'], 'conditions': ['Glioblastoma']}, 'referencesModule': {'references': [{'pmid': '8433390', 'type': 'RESULT', 'citation': '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': '23940216', 'type': 'RESULT', '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, 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': '16163448', 'type': 'RESULT', '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. doi: 10.1007/s11060-005-7020-9.'}, {'pmid': '8445433', 'type': 'RESULT', '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. doi: 10.1200/JCO.1993.11.3.570.'}, {'pmid': '24552318', 'type': 'RESULT', '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 20;370(8):709-22. doi: 10.1056/NEJMoa1308345.'}, {'pmid': '27853959', 'type': 'RESULT', 'citation': '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': '22644537', 'type': 'RESULT', '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 2012 May 29.'}, {'pmid': '28801008', 'type': 'RESULT', 'citation': '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': '27001588', 'type': 'RESULT', '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. No abstract available.'}, {'pmid': '24552317', 'type': 'RESULT', '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, 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.'}]}, 'descriptionModule': {'briefSummary': 'Most patients with glioblastoma have impaired cognitive function, autonomy, and quality of life.\n\nThis 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.\n\nIn this context, and despite the lack of impact on overall survival, improving quality of life becomes a priority objective in recent Phase III trials.\n\nThe 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.', 'detailedDescription': 'glioblastomas are the most common primary malignant tumours of the central nervous system.They represent about 2000 new cases per year in France.\n\nDespite active treatments including surgery, radiotherapy and chemotherapy, patient survival is limited without possible cure.\n\nMost 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.\n\nThis 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient ( ≥ 18 years),\n* Histological diagnosis of Glioblastoma\n* Oncology caret at ICM (regardless of treatment: Stupp protocol, chemotherapy alone, targeted therapy, etc.);\n* Patient consent signed after informed information.\n\nExclusion Criteria:\n\n* Patient unable to consent to the study\n* Major impairment of the general health : performance status OMS =4;\n* Patient not affiliated with a French social security'}, 'identificationModule': {'nctId': 'NCT04516733', 'acronym': 'GLIOSUPPORT', 'briefTitle': 'Precoce Medical Care by the Mobil Support for Patients With Glioblastoma', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'Precoce Medical Care by the Mobil Support for Patients With Glioblastoma Receiving Specific Medical Oncology Treatment', 'orgStudyIdInfo': {'id': 'PROICM 2018-04 GLI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'single arm', 'description': 'patient with glioblastoma', 'interventionNames': ['Other: supportive care']}], 'interventions': [{'name': 'supportive care', 'type': 'OTHER', 'description': 'visit with supportiv unit and neuropsychologue every 3 months', 'armGroupLabels': ['single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "ICM Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Michel FABBRO, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Institut du Cancer de Montpellier - Val d'Aurelle"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-02-11', 'type': 'RELEASE'}, {'date': '2025-03-04', 'type': 'RESET'}], 'unpostedResponsibleParty': "Institut du Cancer de Montpellier - Val d'Aurelle"}}}}