Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 187
- 试验地点
- 10
- 主要终点
- Score in the Perceived Cognitive Impairment (PCI) subscale of Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) questionnaire
研究概览
简要总结
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.
详细描述
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 and/or have significant limitations (e.g. 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 patient's human therapeutic alliance for adherence to a program. Moreover, certain psychopathological variables (e.g. anxiety, depression) have a significant impact on both neurocognitive abilities and complaints, justifying the intervention of a neuropsychologist specialized in oncology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old, no age limit;
- •Histo-molecular diagnosis of grade 2 or 3 diffuse glioma according to World Health Organization (WHO) Classification 2016, regardless of oncological treatments previously received;
- •Patient in satisfactory general condition for the study, defined by a WHO performance index ≤ 2 (ECOG-Performance Status (PS) ≤ 2);
- •Neurosurgical excision (excluding biopsy) performed ≥ 12 months previously;
- •In the case of oncological treatment, patient who has completed his sessions (radiotherapy, chemotherapy) for ≥ 6 months;
- •Patient presenting a cognitive complaint defined as a response rated at least "Fairly" to at least one of the 2 items (n°20 and 25) assessing cognitive complaint in the EORTC QLQ-C30 questionnaire (i.e., defined as a score on the "Cognitive Functioning" scale ≤ 66.67);
- •Fluent in French;
- •Affiliation to the French Social Security System;
- •Possible regular use of a digital tool with Internet access;
- •Signature of informed consent prior to any study procedure.
排除标准
- •Visual or auditory deficit not corrected to normal and/or preventing use of computer tools (i.e., homonymous lateral hemianopia is not a criterion for non-inclusion) ;
- •Concurrent participation in a study with cognition as primary endpoint (e.g., "POLCA", " POLO " clinical trials) ;
- •Legal incapacity or physical, psychological, social or geographical conditions preventing the patient from signing the consent form or completing the study ;
- •Unstable or uncontrolled psychiatric syndrome (i.e., psychotropic treatments are not a criterion for non-inclusion if doses are stable) ;
- •Known severe cognitive impairment (e.g., neurodegenerative disease, sequelae of head trauma, etc.) or defined by a score ≤ 20 on the MoCA test or impacting the ability to use digital tools at home ;
- •Oncological treatment (radiotherapy and/or chemotherapy and/or surgery) planned within 4 months of inclusion. Targeted anti-Isocitrate DeHydrogenase (IDH) therapies are authorized.
结局指标
主要结局
Score in the Perceived Cognitive Impairment (PCI) subscale of Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) questionnaire
时间窗: 4 months
The FACT-Cog is a self-assessment questionnaire to estimate memory, attention, concentration, language, and thinking abilities of patients before, during, and after chemotherapy. This questionnaire, composed of 37 items consists of four subscales: cognitive impairments perceived by the patient (20 items), comments from others (4 items), cognitive abilities perceived by the patient (9items), and impact on quality of life (4 items). The Perceived Cognitive Impairments and the Comments from Others subscales are rated on 5-point Likert-type scale (from 0 = "Never" to 4 = "Several times a day"). An intensity 5-point Likert-type scale (from 0 "Not at all" to 4 "Very much") is used to rate perceived cognitive abilities and the impact on quality of life. For all subscales, a higher score represents better cognitive functioning or quality of life
次要结局
- Score in the " Comments from the others " subscale of the FACT-Cog(At baseline, 4, 6, 12 and 18 months)
- Difference in score on quality of life questionnaire Quality of Life Questionnaire - Core (30EORTC QLQ-C30)(At baseline, 4 months, 6 months, 12 months, 18 months)
- Score in the " Cognitive abilities perceived by the patient " subscale of the FACT-Cog(At baseline, 4 months, 6 months, 12 months, 18 months)
- FACT-Cog cognitive complaints questionnaire and the main neurocognitive domains(At baseline, 4 months and 12 months)
- Score in the 2 scales of Prospective and Retrospective Memory Questionnaire (PRMQ) for patient and family caregiver(At baseline, 4 months, 6 months, 12 months, 18 months)
- 2 scores on the Prospective and Retrospective Memory Questionnaire (PRMQ) and the main cognitive domains(At baseline, 4 months and 12 months)
- Difference in score on anxiety via State-Trait Anxiety Inventory (STAI-Y)(At baseline, 4 months, 6 months, 12 months, 18 months)
- Difference in score on irritability via Brief Irritability Test (BIT) for patient and family caregiver(At baseline, 4 months, 6 months, 12 months, 18 months)
- Difference in score on insomnia via Insomnia Severity Index (ISI)(At baseline, 4 months, 6 months, 12 months, 18 months)
- Difference in score on verbal learning and memory via Hopkins Verbal Learning Test (HVLT)(At Baseline, 4 months, 12 months)
- Difference in score on psychopathological distress via Hospital Anxiety and Depression Scale (HADS)(At baseline, 4 months, 6 months, 12 months, 18 months)
- Difference in score on neurocognitive test via Montreal Cognitive Assessment (MoCA)(At baseline and 4 and 12 months, respectively)
- Difference in score on verbal fluency via verbal fluency test(At Baseline, 4 months, 12 months)
- Score in the PCI subscale of FACT-Cog questionnaire(6, 12 and 18 months)
- Score in the " Impact on quality of life " subscale of the FACT-Cog(At baseline, 4 months, 6 months, 12 months, 18 months)
- Difference in score on quality of life questionnaire Quality of Life Questionnaire - Brain Neoplasm (EORTC QLQ-BN20)(At baseline, 4 months, 6 months, 12 months, 18 months)
- Difference in score on fatigue via Multidimensional Fatigue Inventory (MFI-20)(At baseline, 4 months, 6 months, 12 months, 18 months)
- Compliance of intervention(4 months)
- Proportion of patients returning to work(At baseline, 4 months, 6 months, 12 months, 18 months)
- Difference in score on depression via Beck Depression Inventory II (BDI-II)(At baseline, 4 months, 6 months, 12 months, 18 months)
- Difference in score on Theory of Mind via Reading the Mind in the Eyes Test (RMET)(At Baseline, 4 months, 12 months)
- Difference in score on cognitive abilities index via Wechsler Adult Intelligent Scale (WAIS-IV)(At Baseline, 4 months, 12 months)
- Difference in score on processing speed and executive function via Stroop Delis-Kaplan test(At Baseline, 4 months, 12 months)
- Difference in score on visual attention via Trail Making Test (TMT)(At Baseline, 4 months, 12 months)