Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma
NCT06468176, Not applicable, Recruiting, Institut du Cancer de Montpellier - Val d'Aurelle
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma | ClinicalTrials.gov |
| NCT number | NCT06468176 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 187 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Institut du Cancer de Montpellier - Val d'Aurelle | ClinicalTrials.gov |
| Conditions | Glioma, Malignant | ClinicalTrials.gov |
| Interventions | Cognitive Behavioral Therapy (CBT) neuropsychologist | ClinicalTrials.gov |
| First posted | 2024-06-21 | ClinicalTrials.gov |
| Last updated | 2025-12-19 | ClinicalTrials.gov |
Registered outcomes 25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Score in the Perceived Cognitive Impairment (PCI) subscale of Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) questionnaire | 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 | ClinicalTrials.gov |
| Secondary | Score in the PCI subscale of FACT-Cog questionnaire | 6, 12 and 18 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. | ClinicalTrials.gov |
| Secondary | Score in the " Comments from the others " subscale of the FACT-Cog | At baseline, 4, 6, 12 and 18 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 including comments from other (4 items). This subscale is rated on 5-point Likert-type scale (from 0 = "Never" to 4 = "Several times a day"). A higher score represents better cognitive functioning or quality of life. | ClinicalTrials.gov |
| Secondary | Score in the " Cognitive abilities perceived by the patient " subscale of the FACT-Cog | At baseline, 4 months, 6 months, 12 months, 18 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 including cognitive abilities perceived by the patient (9 items). An intensity 5-point Likert-type scale (from 0 "Not at all" to 4 "Very much") is used to rate perceived cognitive abilities. A higher score represents better cognitive functioning or quality of life. | ClinicalTrials.gov |
| Secondary | Score in the " Impact on quality of life " subscale of the FACT-Cog | At baseline, 4 months, 6 months, 12 months, 18 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 including impact on quality of life (4 items). An intensity 5-point Likert-type scale (from 0 "Not at all" to 4 "Very much") is used to rate the impact on quality of life. A higher score represents better cognitive functioning or quality of life. | ClinicalTrials.gov |
| Secondary | FACT-Cog cognitive complaints questionnaire and the main neurocognitive domains | At baseline, 4 months and 12 months | Correlations between scores on the 4 subscales of the FACT-Cog cognitive complaints questionnaire and the main neurocognitive domains (score on global functioning, executive functions, language, working memory, processing speed and social cognition). | ClinicalTrials.gov |
| Secondary | 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 | The Prospective and Retrospective Memory Questionnaire (PRMQ) is one of the most commonly used scales to assess both retrospective memory (RM) and prospective memory (PM) complaints. The PRMQ is a 16-item, self-report measure of prospective and retrospective failures in everyday life. 8 items enquire about PM and 8 enquire about RM. The items were also designed to contain an equal number of items concerned with either self-cued memory or environmentally-cued memory, and with short-term versus long-term memory. | ClinicalTrials.gov |
| Secondary | Difference in score on psychopathological distress via Hospital Anxiety and Depression Scale (HADS) | At baseline, 4 months, 6 months, 12 months, 18 months | The HADS is a 14 items questionnaire: 7 items related to anxiety and 7 items related to depression scored on a scale. Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a depression score (HADS-D), or can be added to produce a total score corresponding to emotional distress (HADS-T). Each item is rated on a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), for a total score ranging from 0-21 for each subscale. The entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress | ClinicalTrials.gov |
| Secondary | 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 | Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. | ClinicalTrials.gov |
| Secondary | 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 | This EORTC brain cancer specific questionnaire is intended to supplement the QLQ-C30. The QLQ-BN20 contains 20 items organized into four scales (three items each: future uncertainty, visual disorder, motor dysfunction, and communication deficit), and seven single items (headaches, seizures, drowsiness, hair loss, itchy skin, weakness of legs, and bladder control). All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms. | ClinicalTrials.gov |
| Secondary | Difference in score on fatigue via Multidimensional Fatigue Inventory (MFI-20) | At baseline, 4 months, 6 months, 12 months, 18 months | The MFI-20 is a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. The patient positions himself on a 5-point scale, according to the fatigue he felt the days before the assessment. The " strongly agree " position is worth 5 points, and the " strongly disagree " position is worth 1 point. The score is calculated by adding up the points on the scale. The higher is the score, the more severe is the the fatigue. | ClinicalTrials.gov |
| Secondary | Compliance of intervention | 4 months | Patient adherence to the intervention defined as completion of at least 25 hours of the digital program out of the recommended 40 hours (calculated automatically by the software), and completion of the 3 neuropsycho-oncology (tele)consultations | ClinicalTrials.gov |
| Secondary | Difference in score on neurocognitive test via Montreal Cognitive Assessment (MoCA) | At baseline and 4 and 12 months, respectively | Lasting 10 to 15 minutes, the test assesses mild to moderate cognitive dysfunction, evaluating the following functions: attention, concentration, executive functions, memory, language, visuo-constructive abilities, abstraction skills, calculation, orientation. | ClinicalTrials.gov |
| Secondary | 2 scores on the Prospective and Retrospective Memory Questionnaire (PRMQ) and the main cognitive domains | At baseline, 4 months and 12 months | Correlations between the 2 scores on the PRMQ and the main cognitive domains (score for global functioning, executive functions, language, working memory, processing speed and social cognition) | ClinicalTrials.gov |
| Secondary | Proportion of patients returning to work | At baseline, 4 months, 6 months, 12 months, 18 months | Proportion of patients returning to work or increasing their working hours | ClinicalTrials.gov |
| Secondary | Difference in score on depression via Beck Depression Inventory II (BDI-II) | At baseline, 4 months, 6 months, 12 months, 18 months | The Beck Depression Inventory is used to detect depression and its severity. It is a self-assessment test with 21-items and 4 types of response. These range from 0 to 3 and describe the extent to which we identify the reality described. 0 means not identifying at all and 3 describes a fact which identify almost 100%. Four basic categories are established according to the results obtained : 0-13 = low depression, 14-19 = mild depression, 20-28 = moderate depression and 29-63 = severe depression. | ClinicalTrials.gov |
| Secondary | Difference in score on anxiety via State-Trait Anxiety Inventory (STAI-Y) | At baseline, 4 months, 6 months, 12 months, 18 months | The STAI-Y is a test designed to assess momentary and habitual anxiety. It comprises 2 scales of 20 items each: anxiety-state scale assesses the feelings of apprehension, tension, nervousness and concerns that the subject feels at the time of the consultation. It is an indicator of transient changes in anxiety caused by therapeutic or aversive situations. The anxiety-trait scale assesses the feelings of apprehension, tension, nervousness and concerns that the subject usually experiences. The purpose of this scale is to identify anxiety as a stable disposition. It thus forms the starting point for therapeutic action. The STAI-Y is also used to study the effect of anxiety on memory, learning performance or adjustment to stressful situations | ClinicalTrials.gov |
| Secondary | 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 | The Brief Irritability Test is a brief, reliable, and valid self-report measure of irritability with 5-items. The answers are rated from never to always. | ClinicalTrials.gov |
| Secondary | Difference in score on insomnia via Insomnia Severity Index (ISI) | At baseline, 4 months, 6 months, 12 months, 18 months | The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The usual recall period is the "last month" and the dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). | ClinicalTrials.gov |
| Secondary | Difference in score on cognitive abilities index via Wechsler Adult Intelligent Scale (WAIS-IV) | At Baseline, 4 months, 12 months | This test assesses cognitive abilities across various domains. It comprises 10 core subtests that yield four factor index scores (i.e., Verbal Comprehension: measures language use and long-term memory, Perceptual Reasoning: assesses logical reasoning and visual-spatial abilities, Working Memory: evaluates short-term memory, and Processing Speed: gauges processing speed) as well as the full-scale IQ. There are also five supplemental subtests that can be used as an alternative to the core subtests. In the FREEDOME study, the following sub-tests will be used: * Digit Symbol Substitution Test * Code test * Verbal Digit-span test * Arithmetic | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 41064168 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 10
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Delayed Recall Module | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Recognition Memory Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)