Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468176
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-17
Brief Title:
Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma
Sponsor:
Institut du Cancer de Montpellier - Val dAurelle
Organization:
Institut du Cancer de Montpellier - Val dAurelle
Study Overview
Official Title:
Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FREEDOME
Brief Summary:
Diffuse low-grade glioma are rare brain tumors affecting young subjects median age at diagnosis 38 years for grade 2 and 49 years for grade 3 Cognitive symptoms are common in these patients including memory attention and executive function disorders These disorders may have a deleterious impact on patients professional family and social lives and have a negative impact on their quality of life The benefits of cognitive rehabilitation have been demonstrated in other neurological pathologies Furthermore due to limited access to rehabilitation by neuropsychologists some studies have evaluated the impact of digital cognitive rehabilitation programs However it cannot replace human support
Detailed Description:
Diffuse Low-Grade Gliomas DLGG are rare tumors that affect young subjects median age at diagnosis 38 years for grade 2 and 49 for grade 3 Overall survival varies from 5 to 15 years Cognitive symptoms are common in these patients notably impaired memory attention and executive functions For examples in a prospective study conducted by our team 40-53 of patients with grade 2 DLGG starting first-line chemotherapy had a cognitive complaint These findings are in line with a recent meta-analysis based on 11 studies involving 313 glioma patients These cognitive disorders can have a deleterious impact on patients professional family and social lives and have a negative impact on their quality of life The value of cognitive rehabilitation has been demonstrated in other neurological pathologies Randomized controlled trials in DLGG are promising but are ultimately few in number andor have significant limitations eg small number of patients sample heterogeneity questionable matching criteria lack of control group Furthermore due to limited access to rehabilitation by neuropsychologists some studies have evaluated the impact of digital cognitive rehabilitation programs Although this type of tool seems particularly well suited to this young patient population it cannot replace human accompaniment by a neuropsychologist Indeed we know the importance of the patients human therapeutic alliance for adherence to a program Moreover certain psychopathological variables eg anxiety depression have a significant impact on both neurocognitive abilities and complaints justifying the intervention of a neuropsychologist specialized in oncology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None