Executive and Socio-cognitive Functions in Survivors of Primary Brain Tumor: Impact on Patients' Quality of Life
NCT ID: NCT02693405
Last Updated: 2018-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2016-02-29
2018-09-30
Brief Summary
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The most serious challenge survivors of brain tumors face may be cognitive dysfunction. One especially important cognitive domain is executive functioning, which refers to essential factors such as problem-solving, goal-directed behavior and the ability to maintain stable interpersonal relationships (Lezak et al., 2004). Despite the potential impact of executive impairments on behavioral regulation and quality of life, few studies were conducted with survivors of PBT specifically for the assessment of executive functioning. Another fundamental neuro-cognitive domain is social cognition, which refers to the ability to understand the intentions and beliefs of others (Frith \& Singer, 2008). Social cognitive deficits are expected to impair autonomy and relationships, but scarce attention has been devoted to the study of social cognition in survivors of PBT and no study has attempted to compare socio-cognitive data and measures of health-related quality of life. It is noteworthy that executive function and socio-cognitive skills improve throughout childhood and adolescence, and improvements in these skills have frequently been attributed to maturation of the brain, especially the prefrontal cortex (e.g., Tamnes et al., 2010). This suggests a greater impact of the disease and its treatment on these functions in children/adolescents.
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Detailed Description
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Second, the investigators will compare the neuropsychological scores for cognitive and socio-cognitive tasks to health related quality of life (HRQOL) data (composite scores and by domains). Comparisons of neuropsychological and HRQOL scores will be performed between the two populations (children / adolescents and adults).
Third, the investigators will compare the data from the two age groups for the aforementioned variables (cognitive and behavioral executive assessments, cognitive and affective TOM). The proximity of the tasks should provide valid elements of comparison. The investigators will compare the questionnaires in auto-and hetero-evaluation for each HRQOL scales, and also for executive behavioral questionnaires.
Finally, to evaluate the investigators will compare the HRQOL patients/relatives' data to measure the potential impact of the disease on HRQOL of relatives of PBT survivors and the potential link between these data.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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child and adult survivors of brain tumor
Executive functions and social cognition will be assessed using cognitive (Stroop task, Modified Card Sorting Task, Digit spans) and behavioral (BRIEF for childrens and BRIEF-A for adults) tests.
Quality of life will be assessed by questionaires (SF-36, QLQC30-BN20 for adults and Peds-Ql for childrens)
Executive functions
measures of executive functioning with tasks
social cognition
measures of socio-cognitive functioning with tasks
quality of life
measures of quality of life with questionnaires
healthy controls
Executive functions and social cognition will be assessed using cognitive (Stroop task, Modified Card Sorting Task, Digit spans) and behavioral (BRIEF for childrens and BRIEF-A for adults) tests.
Quality of life will be assessed by questionaires (SF-36, QLQC30-BN20 for adults and Peds-Ql for childrens)
Executive functions
measures of executive functioning with tasks
social cognition
measures of socio-cognitive functioning with tasks
quality of life
measures of quality of life with questionnaires
Interventions
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Executive functions
measures of executive functioning with tasks
social cognition
measures of socio-cognitive functioning with tasks
quality of life
measures of quality of life with questionnaires
Eligibility Criteria
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Inclusion Criteria
* Children/adolescents and adults who have been treated by chemotherapy and/or radiotherapy and/or neurosurgery, subsequent to the diagnosis of a primary brain tumor
* The end of treatment must be comprised between 2 and 5 years at the time of the assessment, as argued above.
Exclusion Criteria
* Language or praxis deficits inconsistent with the achievement of the tasks
* Neurological disease other than PBT
* secondary brain tumor
* Psychiatric history (consultation with a psychiatrist of the University Hospital if doubt)
* Insufficient French language proficiency
8 Years
59 Years
ALL
Yes
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Jeremy Besnard, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Angers
Locations
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CHU Angers
Angers, , France
Countries
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Central Contacts
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Facility Contacts
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Didier Le Gall
Role: primary
References
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Frith CD, Singer T. The role of social cognition in decision making. Philos Trans R Soc Lond B Biol Sci. 2008 Dec 12;363(1511):3875-86. doi: 10.1098/rstb.2008.0156.
Landier W, Bhatia S. Cancer survivorship: a pediatric perspective. Oncologist. 2008 Nov;13(11):1181-92. doi: 10.1634/theoncologist.2008-0104. Epub 2008 Nov 5.
Lezak, M.D., Howieson, D.B., & Loring, D.W. (2004). Neuropsychological Assessment. New York, NY: Oxford University Press.
Panigrahy A, Bluml S. Neuroimaging of pediatric brain tumors: from basic to advanced magnetic resonance imaging (MRI). J Child Neurol. 2009 Nov;24(11):1343-65. doi: 10.1177/0883073809342129.
Tamnes CK, Ostby Y, Walhovd KB, Westlye LT, Due-Tonnessen P, Fjell AM. Neuroanatomical correlates of executive functions in children and adolescents: a magnetic resonance imaging (MRI) study of cortical thickness. Neuropsychologia. 2010 Jul;48(9):2496-508. doi: 10.1016/j.neuropsychologia.2010.04.024. Epub 2010 Apr 29.
Caissie A, Nguyen J, Chen E, Zhang L, Sahgal A, Clemons M, Kerba M, Arnalot PF, Danjoux C, Tsao M, Barnes E, Holden L, Danielson B, Chow E. Quality of life in patients with brain metastases using the EORTC QLQ-BN20+2 and QLQ-C15-PAL. Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):1238-45. doi: 10.1016/j.ijrobp.2011.09.025. Epub 2011 Dec 13.
Pulenzas N, Khan L, Tsao M, Zhang L, Lechner B, Thavarajah N, Barnes E, Danjoux C, Holden L, Lauzon N, Sheehan P, Bedard G, Chow E. Fatigue scores in patients with brain metastases receiving whole brain radiotherapy. Support Care Cancer. 2014 Jul;22(7):1757-63. doi: 10.1007/s00520-014-2140-4. Epub 2014 Feb 9.
Samson, D. (2012). Neuropsychologie de la théorie de l'esprit chez l'adulte : Etat de l'art et implications cliniques. In P. Allain, G. Aubin & D. L. Gall (Eds.), Cognition sociale et neuropsychologie (pp. 47-63). Marseille: Solal
Stone VE, Baron-Cohen S, Knight RT. Frontal lobe contributions to theory of mind. J Cogn Neurosci. 1998 Sep;10(5):640-56. doi: 10.1162/089892998562942.
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Cantisano N, Menei P, Roualdes V, Seizeur R, Allain P, Le Gall D, Roy A, Dinomais M, Laurent A, Besnard J. Relationships between executive functioning and health-related quality of life in adult survivors of brain tumor and matched healthy controls. J Clin Exp Neuropsychol. 2021 Dec;43(10):980-990. doi: 10.1080/13803395.2022.2040432. Epub 2022 Mar 1.
Other Identifiers
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CHU-P2015-06
Identifier Type: -
Identifier Source: org_study_id
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