Behaviors and Mental Disorders

All Conditions

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Quality of Life

All Drugs and Chemicals

Immunomodulating Agents

These participants will a undergo a neurocognitive and psychosocial assessment at baseline, and in follow-up after 6 months and 1 year thereafter. The aim of this group is to measure the extent of psychosocial and cognitive difficulties and health-related quality of life.

The experimental group will undergo profound neuropsychological and psychological assessment before starting the integrative neurocognitive remediation therapy, in addition to the assessment already done at baseline. This group will repeat the testing after completion of the integrative neurocognitive remediation therapy, and 6 months thereafter.

Integrative Neurocognitive Remediation Therapy is a clinical program of 12 weeks (1 day/week) that combines personalized computerized cognitive training and neurocognitive strategy training, with group sessions of adapted physiotherapy, acceptance and commitment therapy (ACT), cognitive behavioral therapy (CBT) and information sessions on cognition, fatigue, nutrition and physical exercise.

Integrative neurocognitive remediation therapy

Nathalie Vanlaer, MSc

Anne Rogiers, MD, PhD

Nathalie Vanlaer, Msc

Bart Neyns, MD, PhD

Since 2010, the field of immunotherapy has grown substantially, leading to a growing population of long-term cancer survivors treated with immunotherapy. Since cancer survivorship in immunotherapy is an emerging field, to date not much is known about psychosocial and neurocognitive survivorship-related issues in advanced cancer survivors treated with immunotherapy. Preliminary findings indicated significant psychosocial and cognitive problems in survivors of advanced melanoma persist after treatment with immunotherapy. The objective for this project is twofold. First, the investigators want to longitudinally identify survival-related problems in survivors of advanced cancer treated with immunotherapy. The second goal is to identify the efficacy of an Integrative Neuro-Cognitive Remediation Therapy (INCRT) program. The investigators will focus on the following outcomes: (1) Psychosocial consequences, such as emotional complaints, fatigue, fear of recurrence, (2) neurocognitive functioning, and (3) health-related quality of life. The INCRT combines personalized computerized cognitive training and neurocognitive strategy training, with group sessions of exercise, mindfulness, Acceptance and Commitment Therapy, and cognitive behavioral therapy.

We will have three cohorts:

* Cohort 1: advanced cancer survivors treated with immunotherapy
* Cohort 2: cancer survivors treated with cancer therapy of any kind (excluded immunotherapy), and who have subjective complaints and/or objective cognitive impairment
* Cohort 3: cancer survivors of a central nervous system (CNS) tumor, who do not have active disease in the CNS, and who have subjective complaints and/or objective cognitive impairment

In the first part of the study, survival-related problems will be evaluated in cohort 1, in a longitudinal manner by means of a semi-structured interview at baseline, various questionnaires and a computerized neuropsychological test battery.

In the second part of the study, patients of cohort 1, 2 and 3 with subjective or objective cognitive dysfunction can follow the INCRT program. The efficacy of the INCRT is evaluated through a pre-INCRT and post-INCRT evaluation. This evaluation consist of several questionnaires and neuropsychological tests. Long-term efficacy will be evaluated by a follow-up evaluation six months after completion of the INCRT program.

We will have three cohorts:

* Cohort 1: advanced cancer survivors treated with immunotherapy
* Cohort 2: cancer survivors treated with cancer therapy of any kind (excluded immunotherapy)
* Cohort 3: cancer survivors of a CNS tumor, who do not have active disease in the CNS

All patients of cohort 1 will receive a psychosocial and neurocognitive assessment at baseline. Patients who do not have cognitive problems or do not have interest in following the integrative neurocognitive remediation therapy program will go into the non-intervention group for follow-up.

Patients of cohort 1, 2 and 3 who have cognitive problems and/or cognitive complaints who want to follow the integrative neurocognitive remediation program will complete a neurocognitive and psychosocial assessment before and immediately after the remediation program. The same assessment will be repeated six months after finishing the therapy program, to investigate the long-term efficacy of the therapy program.

Longitudinal Neurocognitive, Psychosocial and Health-related Quality of Life Assessment in Advanced Cancer Survivors Treated With Immunotherapy and the Efficacy of Integrative Neurocognitive Remediation Therapy

To measure neurocognitive functioning (attention, memory and executive functioning), with the computerized neuropsychological test battery COGBAT. This battery gives an overall degree of objective neurocognitive functioning, in addition to the specific test performance per subtest. The test performance will be measured in raw scores and z-scores. This test battery will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter. Improvement in test performance after the therapy program, compared to baseline, will indicate efficacy of the integrative neurocognitive remediation therapy program.

To measure subjective cognitive functioning as assessed by the Cognitive Failures Questionnaire, values ranging from 0 to 100. Higher values mean more cognitive complaints. This will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter. A cut-off score of 44 will be used to define elevated levels of cognitive complaints, a score higher than 54 indicates severe cognitive complaints. Improvement in subjective cognitive complaints after the therapy program, compared to baseline, will indicate efficacy of the integrative neurocognitive remediation therapy program.

To identify emotional distress, the Hospital Anxiety and Depression Scale will be used, with values ranging from 0 to 42. Higher scores mean more emotional distress. This will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter. A cut-off score of 8 will be used to define elevated levels of emotional distress, a score higher than 10 corresponds to moderate emotional distress, a score higher than 14 corresponds to severe emotional distress.

To identify fatigue, the Fatigue Severity Scale will be used. Mean scores will be calculated, leading to a score between 1 and 7. Higher values indicate more fatigue. This will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter. A cut-off score of 4 will be used to define elevated levels of fatigue.

To identify fear of cancer recurrence, the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). will be used. Values range from 0 to 36 and higher values indicate more fear of cancer recurrence. This will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter. A cut-off score of 13 will be used to define significant fear of cancer recurrence. A score higher than 15 equals clinically significant fear of cancer recurrence, a score higher than 21 equals a pathological fear of cancer recurrence.

To measure health-related quality of life, the EORTC Quality of Life Questionnaire (EORTC-QLQ-C30) will be used. Transformed scores range between 0 and 100, higher scores indicate better health-related quality of life. This will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter. The scores will be compared to the Threshold of Clinical Importance, developed by Giesinger et al. (2020). To evaluate change over time, the changes of at least 10 points are regarded, which are supported to be clinically meaningful changes (Snyder et al., 2014).

To document baseline demographic data, prior disease history, nature of immunotherapy therapy, the investigators will look into the patient medical record and a general questionnaire will be used.

To explore the feasibility of the implementation in a larger scale of this clinical program will be assessed by the care need of the patients and the possibility to implement the therapy program in other hospitals (resources needed, cost of the program for the patient).

Psychological distress will be measured by the sum scores of the Hospital Anxiety and Depression Scale. Subjective cognitive functioning will be measured by the sum scores of the Cognitive Failures Questionnaire. To measure the relation between the two variables, the investigators will conduct a statistical correlation of these outcomes. The outcome will be a correlation coefficient (r).

Psychological distress will be measured by the sum scores of the Hospital Anxiety and Depression Scale. Objective cognitive functioning will be measured by the COGBAT neuropsychological battery. To measure the relation between the two variables, the investigators will conduct a statistical correlation of these outcomes. The outcome will be a correlation coefficient (r).

Subjective cognitive functioning will be measured by the sum scores of the Cognitive Failures Questionnaire. Objective cognitive functioning will be measured by the COGBAT neuropsychological battery. To measure this relation, the investigators will conduct a statistical correlation of these outcomes. The outcome will be a correlation coefficient (r).

This will be assessed through two open questions asked to the patient, more specifically: 1) if the patient has interest in personalized nutritional advice, 2) what the specific nutritional care need is of the patient.

To identify rumination, the Brooding items of the Ruminative Response Scale (RRS) will be used. Values range from 5 to 20, higher values indicate more tendency of 'Brooding', a maladaptive type of rumination. This will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter.

To measure visuo-spatial memory span, with the computerized version of the Corsi Block Tapping Test by the Vienna Test System. The test performance will be measured in raw scores and z-scores. This will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter.

To measure verbal long-term memory measured by the California Verbal Learning Test. This will be tested only in the intervention group, i.e. the patients that will follow the integrative neurocognitive remediation therapy. It will be repeated after completion of the therapy program and six months thereafter. The test performance will be measured in raw scores and z-scores.

To measure information processing speed measured by the WAIS-IV Symbol Search and Coding. This will be tested only in the intervention group, i.e. the patients that will follow the integrative neurocognitive remediation therapy. It will be repeated after completion of the therapy program and six months thereafter. The test performance will be measured in raw scores and Weschler subscale scores. The Weschler subscale scores range from 0-20 and have a mean of 10.

To measure verbal short-term memory by the WAIS-IV Digit Span Forwards. This will be tested only in the intervention group, i.e. the patients that will follow the integrative neurocognitive remediation therapy. It will be repeated after completion of the therapy program and six months thereafter. The test performance will be measured in raw scores and z-scores.

To measure working memory by the WAIS-IV Digit Span Backwards. This will be tested only in the intervention group, i.e. the patients that will follow the integrative neurocognitive remediation therapy. It will be repeated after completion of the therapy program and six months thereafter. The test performance will be measured in raw scores and z-scores.

Anxiety will be measured by the State-Trait Anxiety Inventory. This will be tested only in the intervention group, i.e. the patients that will follow the integrative neurocognitive remediation therapy. It will be repeated after completion of the therapy program and 6 months thereafter. Values range from 20 to 80. Higher values indicate more anxiety. STAI scores classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

Self-esteem will be measured by the Rosenberg Self-Esteem Scale. This will be tested only in the intervention group, i.e. the patients that will follow the integrative neurocognitive remediation therapy. It will be repeated after completion of the therapy program and 6 months thereafter. Values range from 0 to 30. Higher values indicate a higher self-esteem. Scores between 15 and 25 are within normal range; scores below 15 correspond to low self-esteem.

Tendency for procrastination will be measured by the Pure Procrastination Scale. This will be tested only in the intervention group, i.e. the patients that will follow the integrative neurocognitive remediation therapy. It will be repeated after completion of the therapy program and six months thereafter. Values range from 11 to 55. Higher values indicate more tendency for procrastination. A score lower than 28 indicate a low level of procrastination, a score between 28-39 indicate a moderate level of procrastination, and a score higher than 39 indicate a high level of procrastination.

Metacognition will be measured by the Metacognition Questionnaire. This will be tested only in the intervention group, i.e. the patients that will follow the integrative neurocognitive remediation therapy. It will be repeated after completion of the therapy program and six months thereafter. Values range from 30 to 120. Higher values indicate more metacognitive beliefs.

Tendency for perfectionism will be measured by the Frost Multidimensional Perfectionism Scale. This will be tested only in the intervention group, i.e. the patients that will follow the integrative neurocognitive remediation therapy. It will be repeated after completion of the therapy program and six months thereafter. Values range from 35 to 210, higher values indicate more tendency for perfectionism.

To identify post-traumatic stress disorder (PTSD) symptoms, the PTSD checklist for DSM-5 (PCL-5) will be used. Values range from 0 to 80, and higher values indicate more symptoms of post-traumatic stress. This will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter. A cut-off score of 33 indicates PTSD.

To measure subjective cognitive functioning as assessed by the EORTC QLQ-C30, cognitive functioning subscale. Transformed scores range from 0 to 100, with higher scores meaning better cognitive functioning. This will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter. The scores will be compared to the Threshold of Clinical Importance, developed by Giesinger et al. (2020). To evaluate change over time, the changes of at least 10 points are regarded, which are supported to be clinically meaningful changes (Snyder et al., 2014).

Brugmann University Hospital

Universitair Ziekenhuis Brussel

Prof. Dr.

Diseases and Abnormalities at or Before Birth

Nervous System Diseases

Neoplasms

Heart and Blood Diseases

Congenital Abnormalities

Hydrocephalus

Brain Neoplasms

Arteriovenous Malformations

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Vascular Malformations

Cardiovascular Abnormalities

Vascular Diseases

Patients with a brain tumour/AVM scheduled for maximum safe resection via craniotomy.

Participants fulfilling all of the following inclusion criteria are eligible for the study:

* Consent of the patient
* Age: ≥18
* Fluent language skills in German
* Patient is capable to use a smartphone (based on the Google Android system) and uses a smartphone since at least 3 months
* Preoperative smartphone-assessed day-to-day behaviour can be recorded for at least 1 week (7 days)

Patients with hydrocephalus scheduled for VP-shunting

Participants fulfilling all of the following inclusion criteria are eligible for the study:

* Consent of the patient
* Age: ≥18
* Fluent language skills in German
* Patient is capable to use a smartphone (based on the Google Android system) and uses a smartphone since at least 3 months
* Preoperative smartphone-assessed day-to-day behaviour can be recorded for at least 1 week (7 days)

There is no study-specific intervention

Martin N Stienen, MD, FEBNS

Luca Regli, MD

Kevin Akeret, MD

Flavio Vasella, MD

Olivia Geisseler, PhD

Noemi Dannecker, MSc

Peter Brugger, PhD

Oliver Bozinov, MD

Niklaus Krayenbühl, MD

Lennart Stieglitz, MD

Arko Ghosh, PhD

This study will thus examine daily behaviour based on smartphone use and link it to the neurological and neuropsychological status as well as to neuroradiological studies that are part of the clinical routine. The study will examine behaviour changes before and after surgery, and how this change in measured behaviour with the smartphone relates to today's "gold standard", namely professional neuropsychological examination and quantification of brain damage on imaging studies (MRI).

This study is a proof-of-principle study that intends to build the basis for larger future observational studies on patients with focal or diffuse brain pathologies.

Pathologies of the central nervous system (CNS), as well as their surgical treatment, may interfere with the physiological and behavioural functions of the human brain. Commonly, before and after surgical treatment, the neurosurgeon examines the patient carefully for neurological deficits and additionally asks neuropsychologists to evaluate higher cognitive functions. These examinations, however, only represent the situation at a given point in time, and currently longitudinal or continuous evaluation of physiological and behavioural functions of the human brain is highly limited. Furthermore, in the conventional examinations the complex human behaviour is reduced to very simplified scores (e.g. the NIHSS for neurological or MoCA for neuropsychological functioning). Fluctuations in physiological and behavioural functions are very likely, but are unlikely to be captured with current evaluations at single (discrete) pre- and postoperative points in time. To date, "on-line" continuous evaluation of brain function in patients undergoing (potentially risky) neurosurgical procedures has not been established.

The touchscreen interface of smartphones offers a fresh avenue to capture day-to-day behaviour (engagement of finger tips) by exploiting the technology intrinsic to a smartphone. For instance, the speed of touchscreen use, the distinct behavioural contexts (compartmentalised into Apps) and the corresponding habits can be seamlessly and non-obtrusively captured. More importantly, compared with current discrete approaches of evaluation, this continuous approach can account for - and even exploit - the natural fluctuations in brain functions.

Nevertheless, behavioural data from touchscreens is new to scientific exploration and various fundamental questions remain to be answered, such as what are the basic statistical features of smartphone behaviour, how does this behaviour vary from one day to another, and how does this behaviour reflect basic demographic information? This gap in our understanding of smartphone behavioural data also implies that the exact statistical methods to be employed may need to undergo adjustments. For instance, the common central tendency measure of the sample mean may be highly unstable if the parameter/s occupy a power-law distribution rather than a Poisson or Gaussian distribution. In summary, ever-new exploration of the neuroscience of touchscreen behaviour must trigger the right choice of analytical and statistical methods.

The focus of this study is laid on patients with pathologies of the CNS. The investigators aim to examine both patients with diffuse and focal pathologies. In order to study diffuse pathologies, the investigators will include patients with hydrocephalus. In order to study focal pathologies, the investigators will include patients with brain tumours or arteriovenous malformations (AVMs) - which are localised and described using clinical neuroimaging. Patients will be examined before and after a neurosurgical procedure.

At the "UniversitätsSpital Zürich", both patients with hydrocephalus that are scheduled for ventriculo-peritoneal (VP)-shunting and patients with brain tumours/AVMs that are scheduled for microsurgical resection routinely undergo a neurosurgical, neuropsychological and neuroradiological examination (by MRI) preoperatively and at 3 months postoperative (for clinical purpose). Patients that agree to participate in this study will install a free App (programmed by the University of Zurich (UZH) spin-off QuantActions and freely available on the Google Play store) on their smartphone that records their day-to-day physiological and behavioural status associated with use of the hand (smartphone touchscreen). The study will examine behaviour changes before and after surgery, and how this change in measured behaviour with the smartphone relates to the neuropsychological examination and quantification of brain damage on imaging studies (MRI).

Linking Digital Smartphone Behaviour With Brain Function

Linking Day-to-day Digital Behaviour Captured on the Smartphone With Brain Function in Patients Undergoing Brain Surgery - the "Smart Surgery" Study

For each individual patient, the secondary endpoints before and after surgery will be compared (in-subject differences) and related to the patterns of smartphone-assessed day-to-day behaviour.

In general, patients with brain tumours and patients with hydrocephalus are analysed separately.

As this study is a proof-of-concept study, no formal sample size calculation is performed.

For the primary endpoint, the patterns of smartphone-assessed day-to-day behaviour in the time period before the operation (day -7 until day 0) will be graphically illustrated and compared for obvious differences to the behaviour in the first postoperative week (+7 days) and in the week before the postoperative consultation at three months after the operation. Towards this we shall employ exhaustive statistical and numerical methods that are typical of complex systems research. This includes comparing the patterns in defined parameter space, clustering of patterns dependent on the diseased state and defining new parameter spaces where the data conforms to the working hypothesis.

For the secondary endpoints, several scores have to be correlated to the complex data generated. Towards this we shall deploy large-scale multivariate approaches that span various time scales - from ms to hours, and that are conducted using sweeping windows across the entire period recording. By using statistical clustering methods, we shall correct for multiple comparison when inferring our data.

University of Zurich

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Substance Related Disorders

Rare Diseases

Leukemia

Sarcoma

Lymphoma

Hodgkin Disease

Testicular Neoplasms

Chemotherapy-Related Cognitive Impairment

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Soft Tissue Sarcoma

Lymphosarcoma

Hodgkin Lymphoma

Patients diagnosed with solid tumor cancers

Patients diagnosed with haematological cancers

Lisa L Hjalgrim, PhD, MD

Barbara Nordhjem, PhD

Barbara JT Nordhjem, PhD

Helle Pappot, Professor, MD

The MyBrain study investigates the brain function of children, adolescents and young adults during and after chemo treatment for cancer. The tests include 1) cognitive skills such as memory and attention; 2) the brain's electrical activity; 3) and biological markers related to brain function.

The aim of the study is to better understand the trajectories of cognitive functioning and measures that have been associated with cognitive impairment in patients treated with chemotherapy.

Background:

Numerous studies indicate that many patients with cancer, regardless of cancer type, develop cancer-related cognitive impairment (CRCI), which may persist for many years after ended treatment. CRCI can occur regardless of cancer type and most often affects cognitive domains, such as memory, attention processing speed, and executive functions. In daily life, this may manifest as difficulties in attention and concentration, learning, multitasking, mentally organize tasks, and cognitive fatigue. The cognitive impact of cancer and cancer treatments for non-CNS patients has been shown with several research disciplines, such as neuropsychological tests, neuroimaging, biomarkers, and animal studies.

Cognitive impairment affects children, adolescents, and young adults with cancer and their families. Young cancer patients may be particularly vulnerable to cognitive impairment as the brain undergoes development in childhood and continues into the twenties. However, there is a lack of knowledge about when a decrease in cognitive capacity may occur, how long it will persist, and which cognitive domains are affected for children adolescents and young adults with cancer.

Aim:

MyBrain is an explorative study which will explore and describe trajectories of CRCI as measured by neuropsychological assessment, self-reported quality of life and fatigue, brain functioning measured with electroencephalogram (EEG), and biomarkers of neural impairment and inflammation.

Design:

Single-centre, prospective longitudinal study including patients diagnosed with cancers outside the brain at age 7-29 years. Each patient is paired with a healthy control matched on age and social circle.

Time points:

The MyBrain study includes patients with different cancer types and assigned to different treatment protocols. Therefore, some patients will undergo treatment for several months (for instance testicular cancer, lymphomas), while others will be treated over several years (acute lymphoblastic leukaemia). The measurement time points will vary between different protocols.

T0: Patients are assessed as close to the day of diagnosis as possible, within 30 days from the day they receive their diagnosis.

T1abc: Up to three time points (2-3) during chemo treatment. Blood samples will be taken immediately before and 10-14 days after the chemo dosing for the specific chemo cycles. For patients who receive more than three cycles of chemotherapy, the timepoints T1abc, will be placed at the chemo treatments with the highest doses (denoted the major chemo treatments) according to the treatment protocol the patient follows. If the treatment protocol allocates the same dose to all chemo treatments, the T1abc will be placed with the aim to obtain approximate equidistance between T0, T1abc and T2.

HDM1-3: Three additional time points during treatment for the patients who are treated with high dose methotrexate (HDM). Blood samples will be taken immediately before and 10-14 days after HDM treatment.

T2: End of treatment. End of treatment is defined as two weeks after the final antineoplastic treatment. For ALL patients, end of treatment is defined as the end of consolidation treatment.

T3: Follow-up, 6 months after T2.

All outcome measures are collected at the time points T0, T2 and T3 for patients and at similar time intervals for controls. T1abc and HDM1-3 only includes biological samples from the patients.

Data includes:

* Clinical information obtained from medical charts including cancer diagnosis, treatment protocol, duration of treatment and adverse events.
* Sociodemographic information collected with a brief questionnaire which includes level of education, occupation, economic status, and the parents' level of education and occupation.
* Cognitive functioning assessed with a clinical battery. The battery includes: Nepsy-II Verbal Fluency, Wechsler Coding (WISC-V or WAIS-IV), Wechsler Symbol Search (WISC-V or WAIS-IV), RBANS Word List Memory, RBANS Word List memory recall, RBANS Word List memory recognition, Wechsler Vocabulary (WISC-V or WAIS-IV), Wechsler Matrix (WISC-V or WAIS-IV), Digit Span (WISC-V or WAIS-IV), Conner´s CPT-III, Grooved Pegboard. For the Wechler tests, participants \<16 years of age are tested with WISC-V and participants 16 or older are tested with WAIS-IV.
* Cognitive functioning assessed with the Cambridge Neuropsychological Test Automated Battery (CANTAB). The following tests are included: Spatial Working Memory, Pattern Recognition Memory, Spatial Span, Paired Associates Learning, Pattern Recognition Memory (delayed), Delayed Matching to Sample.
* Qualitive of life measured with the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales 4.0
* Fatigue measured with the PedsQL Multidimensional Fatigue Scales 3.0
* Resting state EEG is recorded with eyes-open (EO) and eyes-closed (EC) in four blocks of three minutes each (EO-EC-EO-EC).
* Event-related potentials (ERP) during a two-tone auditory oddball task. The participants are instructed to mentally count the rare stimulus.
* Biomarkers of associated with cognitive functioning, measured in serum: neurofilament light chain, glial fibrillary acidic protein, brain derived neurotrophic factor, and pro- and anti-inflammatory markers (IFNy, IL10, IL12p70, IL17A, IL6, TNFa and IL1β).
* Biomarkers of associated with cognitive functioning, measured in cerebrospinal fluid (CSF) for the haematological patients if CSF is drawn as part of their treatment: neurofilament light chain, glial fibrillary acidic protein, brain derived neurotrophic factor, pro- and anti-inflammatory markers.

Data analyses Large inhomogeneity in the data is expected due to the inclusion of patients over a wide age-span with different cancer types, varying treatment protocols, and varying timelines from diagnosis to end of treatment and there are no predefined, specific hypotheses due to the many sources of inhomogeneity. All analyses are exploratory, and confidence limits (rather than nominal p-values) will be used as the indication of the strength of an association when quantified in statistical analyses.

The initial analyses will be data visualizations of quantitative variables will include trajectories for single variables, bivariate plots with smoothed mean curves added, and plots of patient observations against the corresponding observations for the matched control connecting the points in temporal order for each matched pair. The trajectories will be presented for different timescales, e.g., time since diagnosis, or time from T2. Potential risk factors, like cancer type, sex, or age will be indicated in the data visualizations by using different colours and symbols.

Neurocognitive test scores will be investigated at each time point (T0, T2, and T3) for each subtest. Raw as well as scaled scores, age-adjusted from Danish population norms, will be used in the analysis. For the visualizations of the raw test scores, the scores will be plotted as a function of age including reference curves based on back-converted means, ±SD, and -2 SD.

Investigating Cognitive Impairment in Young Patients With Cancer Prospectively

A Multidisciplinary Neuroscience Approach to Investigate Cognitive Impairment in Young Patients With Cancer Prospectively

Scores on the clinical neurocognitive tests (Wechler Intelligence Scale for Children Fifth edition for participants 7-15.9 years of age, Wechler Adult Intelligence Scale Fourth edition for participants 16 years of age or older). Scaled scores range from 0-19, higher = better performance.

The Grooved Pegboard (Lafayette Instrument) is a neurocognitive test consisting of consisting of key shapes (pegs) and matching holes used to test visual-motor coordination. Scores are in milliseconds, lower scores = better performance.

The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtests List Learning, List Recall and List Recognition evaluates learning and memory. Scaled scores (t-scores) range from 0-100, higher = better performance.

The Conner's Continuous Performance Test Third edition evaluates attention-related performance in areas of inattentiveness, impulsivity, sustained attention, and vigilance. Scaled scores (t-scores) range from 0-100, higher = better performance.

The NEPSY Second edition Verbal Fluency subtest is used to evaluate executive and verbal cognitive skills. The scores are the number of correct words generated for the two semantic and two lexical fluency tasks, rang 0-no upper limit, more words = higher score.

Neuropsychological functions measured with the Cambridge Neuropsychological Test Automated Batteries(CANTAB), using the subtests Spatial Working Memory, Pattern Recognition Memory, Spatial Span, Paired Associates Learning, Pattern Recognition Memory (delayed), Delayed Matching to Sample. The tests can generate several outcomes, % of correct responses will primarily be used (0-100, higher = better performance).

Pediatric Quality of Life Inventory Generic Core Scales 4.0 (5-point Likert scale from 0 (Never) to 4 (Almost always), lower meaning better outcome).

Pediatric Quality of Life Inventory Multidimensional Fatigue Scales 3.0 (5-point Likert scale from 0 (Never) to 4 (Almost always), lower meaning better outcome).

Absolute power (microvolts squared) in the delta band.

Absolute power (microvolts squared) in the theta band.

Absolute power (microvolts squared) in the alpha band.

Absolute power (microvolts squared) in the beta band.

Amplitude (in microvolts) of the P300 peak.

Latency (in microseconds) of the P300 peak.

Concentration (pg/ml) of neurofilament light chain, glial fibrillary acidic protein, brain derived neurotrophic factor, pro- and anti-inflammatory markers (IFNy, IL10, IL12p70, IL17A, IL6, TNFa and IL1β).

Rigshospitalet, Denmark

Principal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Patients are admitted to the day hospital 2 days a week for 6 weeks and participate in a group-based (4 patients per group) rehabilitation program conducted by a multidisciplinary team including a PMR doctor, a neuropsychologist, an occupational therapist, and a physical activity monitor).

Patients are admitted to the day hospital 5 days a week for 6 weeks and participate in a one-on-one intensive rehabilitation program conducted by a multidisciplinary team including a speech therapist, neuropsychologist, occupational therapist, physiotherapist, physical activity monitor and a psychologist.

Evaluation of REmediation programs for patients suffering from mild cognitive deficits after Cancer

Cognitive remediation program

Sophie JACQUIN-COURTOIS, PhD

Mélanie COGNÉ, MD

Mélanie Cogné, MD

Isabelle Bonan, PhD

Cancer survival rates have improved significantly over the past decades and patients now experience a number of side effects including cancer-related cognitive impairment (CRCI): problems with memory, executive function, attention, and difficulties performing two tasks at the same time. The frequency of CRCI in cancer patients is estimated to be between 10 to 40%, and more than 50% of patients describe difficulties in their daily life. These cognitive difficulties negatively impact the patient's quality of life as well as that of their family, and can also have negative consequences for their social and professional reintegration once cancer treatment is finished. Despite an increasing number of studies on CRCI, a standard of care for patients with CRCI after breast cancer is yet to be established. In the absence of clear directives, and in an attempt to respond to the increasing demand to provide care for breast cancer patients with CRCI, physical medicine and rehabilitation units in France have started providing day-hospital multidisciplinary interventions. The objective of this project is to use the single case experimental design method to investigate the efficacy of two such rehabilitation programs: a group-based program and a one-on-one program.

Remediation for Mild Cognitive Deficits After Cancer

EvalUation of REmediation Programs for Patients Suffering From Mild Cognitive Deficits After CAncer

The Fact-COG questionnaire assesses subjective cognitive impairment. The score directly reflects the patient's feelings about/perceptions of their cognitive function over the previous week. A total score out of 132 is obtained as well as 4 subscales: Perceived Cognitive Impairments (0-72), Impact on Quality of Life (0-16), Comments from Others (0-16), and Perceived Cognitive Abilities (0-28).

Neuropsychological function will be measured using three sub-tests of the Test of Attentional Performance (alertness, covert shift of attention, divided attention), the Paced Auditory Serial Addition Test, the Montreal Cognitive neuropsychological Assessment, and the Symbol Digit Modalities Test.

Psychological distress will be measured using 4 questionnaires: The Hospital Anxiety and Depression Scale; the Brief Symptom Inventory-18; the Rosenberg self-esteem scale; the MCQ-30 Meta-cognition self-report questionnaire.

The FACT-B questionnaire assesses cancer-related quality of life. A total score out of 148 is obtained as well as 5 subscales: Physical Well-Being (0-28), Social/Family Well-Being (0-28), Functional-Well-Being (0-28), Emotional Well-Being (0-24), and Breast Cancer Subscale (0-40).

The FACTIT-Fatigue questionnaire assesses fatigue/ tiredness and its impact on daily activities and functioning in chronic disease. A total score out of 52 is obtained.

Hospices Civils de Lyon

Symptoms and General Pathology

Stroke

Sclerosis

Multiple Sclerosis

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Experimental group. Receives T-ScEmo Treatment during the study between T0 and T1

Waiting list group: Will be on waiting list for instead of the treatment for the duration of the treatment between T0 and T1.

T-ScEmo is a multifaceted treatment protocol that has the overall aim to improve social cognition, regulation of social behaviour and social participation in everyday life (Westerhof et al., 2017; 2019). The treatment includes, in addition to practicing social cognitive skills throughout the treatment, close involvement of a significant other, and homework assignments. The treatment consists of three modules that address 1) perception of social information including facial expressions of emotions, 2) perspective taking and understanding of social information and 3) regulation of social behaviour. The treatment contains 15-one hour live treatment sessions with a neuropsychologist and 5 online practice sessions, once or twice a week. In the online sessions, the patient can practice the information at home as a neuropsychologist is available for questions. When patients find it too difficult to practice individually at home, there is a opportunity to offer these sessions as live sessions

Treatment social cognition and emotion regulation (T-ScEmo)

A Heegers, MSc.

M.J.J. Gerritssen, dr.

Amber Heegers, MSc.

J.M. Spikman, Prof. Dr.

Impairments in aspects of social cognition are disorder-transcending: these have been demonstrated in various neurological disorders, such as traumatic brain injury (TBI), stroke, brain tumours (both low grade glioma's and meningioma's) and multiple sclerosis (MS). Social cognition involves processing of social information, in particular the abilities to perceive social signals, understand others and respond appropriately (Adolphs 2001). Crucial aspects of social cognition are the recognition of facial expressions of emotions, perspective taking (also referred to as mentalizing or Theory of Mind), and empathy. Impairments in social cognition can have a large negative impact on self-care, communication, social and professional functioning, and thus on quality of life of patients.

Recently, a first multi-faceted treatment for social cognitive impairments in TBI was developed and evaluated; T-ScEmo (Training Social Cognition and Emotion). T-ScEmo turned out to be effective in reducing social cognitive symptoms and improving daily life social functioning in this particular group, with effects lasting over time (Westerhof-Evers et al, 2017, 2019).

Unfortunately, up till now there are no evidence based, transdiagnostic treatment possibilities available for these impeding social cognition impairments in neurological patient groups, other than TBI. Therefore the aim of the present study is to investigate whether T-ScEmo is effective for social cognition disorders in patients with different neurological impairments, such as stroke (including subarachnoidal haemorrhage (SAH)), brain tumours, MS, infection (meningitis, encephalitis) and other. The secondary objective is to determine which patient related factors are of influence on treatment effectiveness. In short, hopefully this study can contribute to a treatment possibility for social cognition disorders for all patients with various neurological disorders.

It is expected that T-ScEmo will be effective for various neurological disorders, based on previous research of Westerhof-Evers et al. (2017, 2019). Since social cognition disorders within patients with traumatic brain injury do all have the same ethiology it is expected that the treatment will show the same effects for patients with various neurological disorders. Therefore it is expected that patients will improve on social cognition, social participation and quality of life and social behaviour, that these results will last over time.

Experimental condition T0, baseline measurement at point of inclusion (at least \> 6 months post-acute injuries) T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatment

Waiting list condition T0, baseline measurement at point of inclusion (at least \> 6 months post-acute injuries) T1, post measurement within 3 months after T0 T2, follow-up measurement within 3 - 5 months after T1

TBI group T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatment

The participating patients are randomly allocated into two groups: an experimental condition and a waiting list condition.

In addition, a group of patients with Traumatic Brain Injury will receive T-ScEmo following regular care.

The neuropsychologist who leads T1 and T2 measurements will be masked for the fact of which patient will be draw in which clinical condition (experimental group or control group), however this cannot be guaranteed since patients may talk about their experience.

Improving Social Cognition and Social Behaviour in Various Brain Disorders

Improving Social Cognition and Social Behaviour in Various Brain Disorders.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Executive functioning will be measured with the Controlled Oral Word Association Test (COWAT).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Executive functioning will be measured with the Key Search Test of the Behavioural Assessment of the Dysexecutive Syndrome.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Verbal memory will be measured with Dutch version of the Rey Auditory Verbal Learning Test (15 Words Test).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Working memory will be measured with the Digit Span Test of the Wechsler Adult Intelligence Scale IV.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Language will be measured with the semantic fluency test.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Mental speed and attention will be measured with the Trail Making Test (TMT).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Mental speed will be measured with the Symbol Digit Modalities Test (SDMT).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Premorbid intelligence will be measured with Dutch version of the Adult Reading Test (NLV).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

The level of physical and mental fatigue will be measured with the Dutch Multifactor Fatigue Scale (DMFS).

This scale has a range between 38 and 190. A higher outcome means more complaints.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Health related physical and practical limitations will be measured with the RAND-36 Health Survey.

A higher outcome means better functioning.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Coping will be measured with the Utrecht Coping List (UCL)

A higher outcome means a better fitting coping style.

The main study parameter will be the difference between baseline (T0) and follow-up (T2) on Dysexecutive Questionnaire Social scales proxy version (DEX-Socproxy; Spikman et al., 2013; Westerhof-Evers, 2017). This scale is scored by the involved proxy of the patient (life partner, family member, friend) and measures the social aspects in daily life: 1) social convention, 2) behavioural-emotional selfregulation 3) metacognition. A higher outcome means more behavioural complaints.

Performance on neuropsychological test measuring emotion recognition; Eckman-60 faces test (EFT). This test has a range between 0 and 60. A higher outcome means a better performance.

Performance on neuropsychological test measuring Theory of Mind; Happé cartoons test. This test has a range between 0 and 36. A higher outcome means a better performance.

Performance on neuropsychological test measuring Theory of Mind: Faux Pas test. This test has a range between 0 and 10. A higher outcome means a better performance.

Performance on neuropsychological test measuring inhibition; Hailing Sentence Completion Test. This test has a range between 1 and 10. A higher outcome means a better performance.

Demographic information such as age, sex, educational level, will be obtained from medical records and anamnesis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Longitudinal Neurocognitive, Psychosocial and Health-related Quality of Life Assessment in Advanced Cancer Survivors Treated With Immunotherapy and the Efficacy of Integrative Neurocognitive Remediation Therapy	NCT05667857	Cognitive Remed... Neuropsychology Quality of Life Psycho-Oncology Cognitive Behav... Cancer Survivor... Immunotherapy Cognitive Dysfu... Psychological D...	Integrative neu...	18 Years -	Universitair Ziekenhuis Brussel
Linking Digital Smartphone Behaviour With Brain Function	NCT03516162	Brain Tumor Hydrocephalus Arteriovenous M...	There is no stu...	18 Years -	University of Zurich
Investigating Cognitive Impairment in Young Patients With Cancer Prospectively	NCT05840575	Chemotherapy-Re... Chemotherapeuti... Chemo-brain Cancer Childhood Cance... Hodgkin Lymphom... Non Hodgkin Lym... Testicular Canc... Sarcoma Leukemia		7 Years - 29 Years	Rigshospitalet, Denmark
Remediation for Mild Cognitive Deficits After Cancer	NCT04808674	Cognitive Remed... Breast Cancer	Cognitive remed...	18 Years - 65 Years	Hospices Civils de Lyon
Linking Digital Smartphone Behaviour With Brain Function	NCT03516162	Brain Tumor Hydrocephalus Arteriovenous M...	There is no stu...	18 Years -	University of Zurich
Investigating Cognitive Impairment in Young Patients With Cancer Prospectively	NCT05840575	Chemotherapy-Re... Chemotherapeuti... Chemo-brain Cancer Childhood Cance... Hodgkin Lymphom... Non Hodgkin Lym... Testicular Canc... Sarcoma Leukemia		7 Years - 29 Years	Rigshospitalet, Denmark
Improving Social Cognition and Social Behaviour in Various Brain Disorders	NCT06330298	Stroke Multiple Sclero... Brain Tumor	Treatment socia...	18 Years - 75 Years	University Medical Center Groningen

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