Behaviors and Mental Disorders

All Conditions

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Patient-Reported Outcomes (PRO) will be evaluated in a group of 30 childhood cancer survivors with global neurocognitive impairment classified by IQ of \<90 and ≥40 and 30 of their parents.

Patient-Reported Outcomes (PRO) will be evaluated in a group of 10 childhood cancer survivors with global neurocognitive unimpairment classified by IQ of ≥90 and 10 of their parents.

I-Chan Huang, PhD

This study will examine self-reported neurocognitive functioning in pediatric cancer survivors whose cancer therapy may have included cranial radiation, intrathecal chemotherapy, and high-dose intravenous antimetabolite chemotherapy. There is evidence that these therapies which are directed at the central nervous system (CNS) can lead to reduced volumes of normal-appearing white matter and neurocognitive dysfunction.

Neurocognitive deficits can significantly impact pediatric cancer survivors' academic success, daily functional status, and quality of life. Previous studies demonstrate the need for screening and treating neurocognitive dysfunction in childhood cancer patients and survivors.

This pilot study will conduct cognitive debriefing tests with childhood cancer survivors, 30 with and 10 without neurocognitive deficits, and their parents. The collected data will aid in developing a comprehensive patient-reported outcomes (PRO) toolkit consisting of generic and specific cognitive and behavioral domains that are content-appropriate and interface-friendly for pediatric cancer populations.

PRIMARY OBJECTIVE:

* To conduct cognitive debriefing tests with 30 pediatric cancer survivors who have global neurocognitive impairment (i.e., the impaired group) to understand the cognitive process of answering the extant pediatric PRO measures by different levels of general intelligence quotient (IQ). Additionally, 10 pediatric cancer survivors who have at least average general IQ (i.e., the unimpaired group) will be recruited for a comparison purpose.

SECONDARY OBJECTIVE:

* To conduct semi-structured interviews with 30 parents/legal guardians of individuals who have global cognitive impairment as described in the primary objective in order to explore the general concept of their child's neurocognitive functioning, to rank the relative importance of different neurocognitive functioning domains, to inform a strategy for communicating with children and adolescents with impaired neurocognitive functioning for PRO research, and to suggest a user-friendly interface to collect PRO data from cognitively impaired children and adolescents. Additionally, 10 parents/legal guardians of individuals at least average general IQ will be recruited for comparison.

Pediatric participants will undergo a 30-45 minute cognitive interview including three sections:

1. Introduction to the study and warm-up debriefing exercise.
2. Determination of participant's level of understanding by arranging circles of different sizes.
3. Completion of individual surveys including the Child Health \& Illness Profile-Child Edition/Child Report Form (CHIP-CE/CRF), the Applied Cognition scale of the Neuro-QOL, and the Pediatric Perceived Cognitive Function (PedPCF - Child).

For patient participants who have not had IQ testing within the prior 3 years, IQ testing may be repeated.

Semi-structured interviews will be conducted with parents/legal guardians of pediatric participants including:

1. Open-ended questions to help researchers understand whether their child is able to complete the CHIP-CE/CRF, Applied Cognition scale of the Neuro-QOL, and the PedPCF - Child.
2. Concerns they may have about cognitive functioning issues and its importance for their child. They will also be asked their thoughts on how to communicate and interact effectively with children and adolescents who have cognitive delays and their feedback about a user-friendly way to collect patient-reported health data.
3. The pediatric participant responses will be compared with their parent/legal guardian responses to confirm the answers were accurate and to evaluate whether the child can recall appropriate information for a given time frame.

Interviews will be conducted primarily on the St. Jude campus, or via Skype video meeting as a secondary option.

Development of the Pediatric Neurocognitive Functioning Questionnaire

Assessing Patient-Reported Neurocognitive Functioning in Pediatric Oncology: A Pilot Study Toward Developing the Pediatric Neurocognitive Questionnaire (PNCQ)

Capability will be defined as the number of participants who complete the survey based on comprehension for the content of survey items.

St. Jude Children's Research Hospital

It takes the patient on average 15 minutes to complete the Brainlab Cognition app.

Observational study

Rupesh R Kotecha

Jessica Injiac

Rupesh Kotecha

Rupesh R Kotecha, MD

This is prospective observational registry study that will assess 1) if the neurocognitive function app (Brainlab Cognition) can be used in a widespread neuro-oncology clinic setting and 2) if patient reported quality of life parameters can be obtained electronically and integrated into clinic.

Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic

Learning and memory will be assessed by the number of correct responses (the total number of words correctly recalled). The "Verbal Recall" test will be used to measure the number of correct responses over 3 trials, the "Verbal Revision" will be used to measure the number of total correct responses, and the "Verbal Recognition" test will be used to measure number of correct responses minus the incorrect responses. Change is calculated as baseline score subtracted from post-baseline score over time.

This will be measured by the "Symbols Matching" test. Subjects will be asked to match symbols and corresponding numbers during 90 seconds. The score will be calculated by totaling the number of correct answers during the allotted time. A higher score indicates better functioning.

This will be measured by the "Words That Start With" test. The total number of words correctly generated (no numbers, no proper names) by the subject will be recorded to generate their score. A higher score indicates better functioning.

This will be measured by the "Numbers Ordering" test. This test assesses visual scanning and motor tracking requiring focused attention. Subjects are required to sequentially connect numbered dots in ascending order that are randomly scattered on the screen in consecutive order. The total time in seconds to complete the array will be recorded as the score result. A lower score indicates better functioning.

This will be measured by "Numbers and Letters Ordering" test. This test includes a divided attention component requiring mental flexibility (i.e., executive function). On this subtest, dots with numbers and letters are randomly scattered. Subjects are required to alternate between connecting numbers and letters in an ascending sequential order. Subjects will order numbers and letters from 1 to 13 and from A to M by tapping them as fast as possible in consecutive and alternating order. The total time in whole seconds to complete the array will be recorded. A lower score indicates better functioning.

Brainlab AG

Baptist Health South Florida

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Cognitive Dysfunction

Breast Diseases

Skin Diseases

Cognition Disorders

This arm will receive a 5-month (20 weeks) supervised exercise program based on aerobic and resistance/strength training together with a weekly calorie or step challenge.

This arm will receive a 5-month (20 weeks) supervised and simultaneous dual-task program based on aerobic, resistance, and cognitive stimulation training together with a weekly calorie or step challenge

This arm will receive a 5-month health and wellness program.

Participants will complete a 5-month exercise program structured in 4 blocks of 5 weeks. Three supervised and combined aerobic/strength exercise sessions each week will be performed together with an aerobic weekly challenge. Aerobic exercise will be performed for 20-30 minutes using a treadmill, bicycle, or circuit training at light to moderate intensities (40-75% of heart rate reserve) during the first two blocks; gradually achieving high intensity (\>75% of HHR) in the last two blocks. Heart rate and the subjective perception of the exertion scale (6-20 Borg scale) will be monitored. Strength exercises will be started at light to moderate intensities (2 sets of 15-20 repetitions at 40-50% of repetition maximum), performed muscle actions at high intensities in the last two blocks (2 sets of 8-15 repetitions at 50-75% RM); using elastic bands, free weights, and weights gym exercises.

Exercise

Participants will complete the same four-block exercise program in terms of type, frequency, intensity, and volume of physical/motor training. Simultaneous with the progression of physical/motor training, the complexity of cognitive stimulation will be increased according to the performance of the participants. General dual-task training will be performed, which describes the use of a physical/motor intervention with different cognitive stimulations (memory, language, intelligence, attention, processing speed, calculation, inhibitory control) that are not specific to the methods to be used for their assessment.

Motor-cognitive Training

Participants randomly assigned to the health and wellness group will be advised and re-educated to support and improve health aspects. Participants in this group will aim to achieve the physical activity recommendations, and in addition, they will receive bi-weekly emails and phone call coaching with tools to empower patients with knowledge about physical exercise, nutrition, and brain health guidelines. Following completion of the 5-month exercise program, this group will receive an exercise program for 12 weeks.

Health and Wellness

Jesus Orellana

Luis Carrasco Páez, PhD

Jorge Tihriet

Alfonso J García González

Lourdes Valero

Matilde Mora Fernández, PhD

Jesús Orellana Jaén

The goal of this interventional study is to assess the effects of either physical exercise program or combined with cognitive training (dual motor and cognitive training program) on breast cancer survivors. The main questions it aims to answer are:

* Analyze the effectiveness of a supervised dual-task training program or a physical exercise program on the executive functions of the participants.
* Evaluate the impact of both interventions on physical function, emotional aspects, and important biomarkers related to muscle-brain crosstalk.

Participants will perform a 20-week supervised and controlled program, three times a week, along with weekly calorie and step challenges.

Researchers will compare the dual-task training group, with the physical exercise group, and with a control group, which will perform the guideline recommendations of physical activity (non-supervised) to see how these intervention approaches can impact cognitive functions, physical functions, emotional aspects, and biomarkers related to muscle-brain crosstalk.

Assessments will take place at three-time points: at baseline, after the intervention (20 weeks post-baseline) and after a 12-week follow-up period (32 weeks post-baseline).

This study has been designed as a randomised, controlled, longitudinal (20 weeks), three-arm, parallel study with a follow-up phase (12 weeks).

Regarding the control of experimental bias, simple blinding will be used. Thus, participants will be blinded to the research problem. They will be informed that three interventions will be applied (without comment on specific details of each one) randomly allocated, to compare the impact on cognitive functions, circulating levels of certain biomarkers, and different symptoms associated with breast cancer. Therefore, study participants will not be able to know to which experimental or control group they belong.

Motor-cognitive Training Effects on Cognition in Breast Cancer Survivors: the BRAINonFIT Study (BRAINonFIT).

Motor-cognitive Training Effects on Cancer-related Cognitive Impairment and Muscle-brain Crosstalk Biomarkers in Breast Cancer Survivors: the BRAINonFIT Study

Trail Making Test A and B (minimum and maximum values, defined by the time in seconds, depend on the age- and education-normalised groups; higher scores mean worse results)

Stroop Color and Word test (minimum and maximum values, defined by the time in seconds, depend on the age- and education-normalised groups; higher scores mean worse results)

Reynolds Intellectual Assessment Scale (Global index values range from ≤ 69 to ≥ 130, mean value of 100; higher scores mean better results)

Wechsler Memory Scale subtest "word pairs" (The subtest score range from 40 to 60, mean value of 100; higher scores mean better results)

Functional Assessment of Cancer Therapy: Cognition (FACT-Cog) (Total score ranges from 0 to 148; higher scores mean better results)

Spirometry (FEV/FVC ratio, represented in percentages)

Accelerometer (Volume in minutes per week)

Accelerometer (Intensity in metabolic equivalents)

Body Mass Index (weight and height will be combined to report BMI in kg/m\^2)

Concentration of these proteins in plasma by ELISA kit (Concentration of these proteins will be expressed in pg/mL or ng/mL)

Functional Assessment of Chronic Illness Therapy: Fatigue (FACIT-F) (Total score range from 0 to 52; higher scores mean better results)

Visual Analogue Scale (Total score ranges from 0 to 10; higher scores mean worse results)

Back Depression Inventory (Total score ranges from 0 to 63; higher scores mean worse results)

State-Trait Anxiety Inventory (The score ranges from 20 to 80; higher scores mean worse results)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Development of the Pediatric Neurocognitive Functioning Questionnaire	NCT03213431	Neurocognitive ...		8 Years - 17 Years	St. Jude Children's Research Hospital
Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic	NCT05504681	Neurocognitive ...	Observational s...	18 Years -	Baptist Health South Florida
Motor-cognitive Training Effects on Cognition in Breast Cancer Survivors: the BRAINonFIT Study (BRAINonFIT).	NCT06073717	Breast Cancer S... Cognitive Impai... Executive Dysfu...	Exercise Motor-cognitive... Health and Well...	25 Years - 65 Years	University of Seville

Spots Global Cancer Trial Database for neurocognitive disorders