Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Substance Related Disorders

Breast Neoplasms

Cognitive Dysfunction

Chemotherapy-Related Cognitive Impairment

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

2 elderly healthy volunteers and 2 participants with lasting cognitive impairments following chemotherapy for breast cancer. All will perform evaluation of a computer-based experimental system. Participants will be

* Female Either healthy or breast cancer survivor;
* Age 20 to 65 years;
* Have st least 12 years of formal education;
* Be English speakers;

Participants will first be screened for propensity to simulation sickness and for cognitive state using the MoCA evaluation test. Those who passed the screening will perform 4 usability sessions rating the ease of use and perceived benefit of the experimental system and of a caregiver interface laptop. The 2 healthy volunteers will evaluate first, such that issues may be resolved before testing is done on the impaired participants. Each session will be compensated with a $35 payment. During each session participants will play a series of increasing difficulty simulated tasks, aimed to train primarily the executive functions domain. At the end of each session participants will rate their experience using custom subjective evaluation forms with multiple items. Each item will be scored using a 5-point Likert scale. At the end of the 4th session, participants will also fill the USE standardized usability form.

This usability evaluation will be conducted at the NJ Bioscience Center.

Usability study

Grigore C Burdea, PhD

Develop a game-based upper-extremity motor and cognitive rehabilitation system using custom and adaptable virtual reality simulations.

Perform usability study on 2 elderly healthy volunteers and 2 breast cancer survivors with lasting cognitive impairments following chemotherapy, so to improve the product design. The usability evaluation will be done at NJ Bioscience Center (North Brunswick, NJ).

The study will generate data on ease of use of a system for subjects with stage II or stage III breast cancer survivors with lasting cognitive impairments subsequent to their first chemotherapy regimen. The usability component will uncover technical issues in its usability, as well as its rating on perceived usefulness. Data will also be collected on the ease of remote monitoring of the subjects by clinicians.

This portion of the study is intended to provide information pertaining to the usability of the experimental system for remote integrative (cognitive and motor) therapy of breast cancer survivors (Stage II or III) with lasting chemotherapy related cognitive impairment (CRCI) subsequent to first chemotherapy regimen, living in the community.

Specific aims are:

1. testing of a added biosensors, new technology acceptance and ease of use at home by these individuals;
2. a caregiver console and enhanced automatic session report that will allow remote monitoring of patient exercising and offline data processing and review.

Participants will each perform 4 usability evaluation sessions. At the end of each session participants will fill a custom evaluation form, using 5-point Likert scale scoring. At the end of the last session participants will also fill a USE standardized usability evaluation form.

Since the study targets breast cancer survivors, participants will all be female. Breast cancer prevalence is overwhelmingly in women.

Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study

Home-based Virtual Reality System for the Treatment of Chemotherapy-related Cognitive Impairments

We will not disclose data on individual participants.

Form used at screening post-consent to determine a participant's propensity for simulation sickness \[Kennedy et al.,1993\]. The questionnaire asks participants to score 16 symptoms on a four point scale (0-3). Score range is 0 (best outcome - no likelihood of experiencing simulation sickness with the device) to 48 (worst outcome - certainty that the participant will experience severe simulation sickness).

Form used at screening post-consent to determine a participant's propensity for simulation sickness \[Freiwald et al., 2020\]. The questionnaire asks participants 26 questions The first 13 questions ascertain the general heath and fitness of the subject, and have Yes/No answers The remaining 13 questions are score on a on a 5 point Likert scale, with five point Likert scales, referring to the frequency of each complaint's occurrence. These scales range from 0 to 4 with the labels "very rarely", "rarely", "occasionally", "frequently" and "very often".

Used at screening post-consent to determine level of cognitive impairment \[Nasreddine et al 2005\] for participants. The form has a score range from 0 (worst) to 30 (best) - no cognitive impairments. For the participants with early Alzheimer's Disease the form will confirm the participant is in the score range of 19-25.

Custom biosensors will provide additional data which will be used to gauge levels of cognitive engagement with the tasks performed during the evaluation.

Game difficulty level when performing a simulated game task using the experimental system. Levels are 1 (easiest) to 16 (hardest)

Heart rate (Pulse) measured with a medical meter at start and end of each usability evaluation session

Blood pressure (Systolic and diastolic) measured with a medical meter before and after each Usability evaluation session.

A standardized questionnaire to assess the usefulness, satisfaction and ease of use of the experimental system \[Lund, 2001\] when evaluated by study participants. The form consists of 30 questions, each rated on a 7-point Likert scale (1 worst 7 best). The score range for this form is 30 (min) to 210 (max).

Participants will also be able to comment in free form on aspects they liked most and least about the device.

Participants rate the usefulness, satisfaction issues, and ease of use of the experimental system and its therapeutic games, as well as ease of use of the Caregiver laptop. The Subjective Evaluation Form consists of questions, each rated on a 5-point Likert scale (1 worst to 5 best outcome).

National Cancer Institute (NCI)

Rutgers, The State University of New Jersey

Bright Cloud International Corp

Anxiety Disorders

Depression

Depressive Disorder

Breast Diseases

Skin Diseases

Quality of Life

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Combination of different neuropsychological rehabilitation programs

This intervention focuses on a deficit in emotional regulation common in all emotional disorders (ED).

The control group will receive the Adapted Mnesic Cognitive Training (ACTIVE) (Jobe, et al., 2001), as well as the Insight (Posit Science) program (Mahncke et al., 2006) once the interventions in groups 1 and 2 have been completed.

combination of the programs tested by (Von Ah et al. 2012). These programs are, on the one hand, a cognitive training adapted from the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) (Jobe et al., 2001) and, on the other, a processing speed training using the Insight program (from Posit Science) (Mahncke et al., 2006). The first consists of teaching patients memorization techniques, and the second consists of a series of exercises on information processing of varying difficulty. These exercises automatically adjust your difficulty to maintain an 85% rate of return. Treatment is carried out in groups of 10 cancer survivors. It consists of 10 weekly sessions of 2 hours each (the first hour for memory training and the second for processing speed exercises). In order to improve the adherence to treatment of the participants, emails and telephone text messages will be sent with reminders of appointments and tasks to be performed.

Neuropsychological treatment

This intervention focuses on a deficit in emotional regulation common in all emotional disorders (ED). Therefore, it focuses on the adaptive value of emotions and promotes tolerance to intense emotions as well as the identification and modification of dysfunctional emotional regulation strategies. Patients receive 10 group therapy sessions (3-5 cancer survivors per group) with all PU modules (Barlow et al., 2011). The Spanish version of the therapist's guide and the patient's workbook are used (Barlow et al., 2015). All patients receive the workbook to help them read the contents of each session, do the recommended exercises between sessions, and to help them once the treatment is finished. The treatment lasts 10 weeks (one session a week). As in the previous intervention group, emails and telephone text messages will be used with reminders of appointments and tasks to be carried out.

Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU).

Waitlist group

Enrique Aranda, PhD

Francisco Garcia Torres, PhD

Francisco García-Torres, PhD

Background: Cognitive impairment appears frequently in cancer survivors, negatively affecting the quality of life and emotional well-being of patients. This study compares the effectiveness of a well-established treatment (cognitive rehabilitation) with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) to alleviate these cognitive deficits and evaluate its effect on anxiety-depressive symptoms and the quality of life of survivors.

Methods: A three-arm randomized superiority clinical trial, with a pre-post and follow-up repeated measures and intergroup design with a 1:1:1 allocation ratio will be carried out. A hundred and twenty-three breast cancer survivors with mild to moderate cognitive impairment will be randomly assigned to one of the interventions of the study: cognitive rehabilitation intervention group, an intervention group with UP intervention, or a control group on the waiting list. The primary outcome is to observe a significant improvement in cognitive function and quality of life in both intervention groups and a significant decrease in emotional impairments in comparison with the waitlist group. These results will be maintained at six months of follow-up.

Discussion: The aim of this work is to test the efficacy of the Unified Barlow Protocol in reducing cognitive deficits in breast cancer survivors. The results of this trial may be useful in reducing the presence of cognitive problems in survivors and improving their emotional state and quality of life.

This study is a three-arm randomized clinical trial, with a pre-post-follow-up repeated measures intergroup design.

Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments

Effectiveness of Cognitive Rehabilitation and the Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments: a Randomized Controlled Trial

This is an instrument developed to assess chemotherapy-induced cognitive problems in cancer patients. It includes four different subscales: Perceived Cognitive Impairments (score range from 0-72), Impact of Perceived Cognitive Impairments on QoL (score range from 0-16), Comments from Others (score range from 0-16), and Perceived Cognitive Abilities (scores range from 0-28) that are scored using a Likert scale of five points from 0 (never) to 4 (several times a day). The higher the score, the better the cognitive function

It is a unifactorial questionnaire that measures a single construct: "cognitive complaints". It is made up of 30 items that are answered on a 5-point Likert scale from 1 (never) to 4 (always or almost always) with higher scores indicate poorer memory function. Scores are from 1 to with higher scores indicating higher memory impairments

This test measures primary and secondary memory, the rate of verbal learning throughout three trials, as well as three forms of mnesic organization: serial ordering, semantic grouping, and subjective organization. The test consists of a list of 12 words that are presented orally at a speed of one word for every two seconds. a higher number of words is interpreted as better recall and recognition

The TMT consists of two parts: Part A measures attention, processing speed, visual search, and working memory; on the other hand, part B is used to measure attention, executive function (cognitive flexibility, ability to change tasks, coordination of categories), working memory, visual-motor skills and processing speed. A greater time to complete the tasks is interpreted as a greater deterioration

The COWAT is a test that measures verbal fluency and is a recognized and sensitive indicator of cognitive functioning. the participant has to say as many words as possible in one minute, and a greater number of words is associated with greater verbal fluency.

This scale is used to assess anxiety and depression in a hospital settings. It is made up of 14 items (7 for anxiety and 7 for depression), which are answered on a scale from 0 to 3, with maximum values of 21 in each of the subscales. Higher scores indicates the presence of anxiety and depression.

EORTC QLQ C-30 (version 3), this is an instrument developed to assess the quality of life in cancer patients using 30 questions that refer to the quality of life experienced by the patient during the last week. The first twenty-eight items include questions about different symptoms and are answered on a scale that ranges from 1 (not at all) to 4 (a lot), while the last two ask patients about the perception of their global health and quality of life in a scale from 1 (terrible) to 7 (excellent). The different items are grouped into functional scales (physical / role / emotional / cognitive / social and global) and symptom scale (fatigue / nausea and vomiting / dyspnea / sleep problems / loss of appetite / constipation / diarrhea and financial impact ). Higher scores indicates a better function.

Universidad de Córdoba

Principal Investigator

Symptoms and General Pathology

Fatigue

30 minutes of intervention systematic light exposure daily for 4 weeks.

30 minutes of comparison systematic light exposure daily for 4 weeks.

Intervention systematic light exposure

Dim light using modified Litebook device.

Comparison systematic light exposure

Lisa M Wu, PhD

Cognitive impairment (such as memory problems) due to cancer and its treatment can interfere with quality of life and can linger long after treatment has ended, yet research examining cognitive rehabilitation approaches has produced limited clinical benefit. The proposed study will provide information about systematic light exposure for the treatment of cognitive impairment in hematopoietic stem cell transplant (HSCT) survivors and will investigate how it works. This study would facilitate the development of this potential treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related cognitive impairment.

The "Light for the Brain" Study

Treating Cognitive Impairments in Cancer Patients Via Systematic Light Exposure

Range between 0 and 5, with 5 meaning higher treatment satisfaction

Treatment credibility and outcome expectancy were assessed at baseline with the mean of the first 3 items of the Credibility/Expectancy Questionnaire. Items are scored on a Likert scale from 1 to 9, and the term "symptoms" was replaced with "thinking, memory and concentration problems." Higher scores represent greater credibility and outcome expectancy.

Measure determines chronotype with a lower score indicating an evening type and a higher score indicating a morning type.

Global composite z-score from baseline to 8 weeks after the intervention based on the HVLT-R; BVMT-R; Psychomotor vigilance task; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Block Design; D-KEFS Color-Word Inhibition, Verbal Fluency; Conners Continuous Performance Test III.

Raw scores at baseline of tests within single domains were averaged and then standardized to z-scores. The mean of the z-scores was calculated, and then this composite z-score was standardized to z-scores. Follow up intervention z-scores were calculated based on differences between raw scores at baseline and raw scores at follow-up time points and divided by the standard deviation of the baseline domain z-score) within each domain, and then averaged to create follow up global composite scores.

A z-score below 0 indicated poorer performance than at baseline and a z-score above 0 indicated better performance than at baseline.

F statistic from actigraphy was assessed as a measure of circadian activity rhythm robustness.

The Pittsburgh Sleep Quality Index consists of 19 self-rated items used to calculate sleep quality

The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report instrument that measures symptoms of depressed mood over the past week.

Total raw score for entire scale (minimum = 46, maximum = 230) with a higher score indicating greater neurobehavioral symptomatology.

This 50-item scale is a commonly used and well-validated measure of the functional status of cancer patients who have undergone BMT (SCT).

The 33-item Patient Assessment of Own Functioning Inventory (PAOFI) is a reliable and valid measure of perceptions of cognitive functioning (Bell et al., 2013; Chelune et al., 1986). Using a Likert scale from 1 (Almost Always) to 6 (Almost Never), ratings of 1-3 were scored "1" indicating impairment, and ratings from 4 to 6 were scored "0" indicating no impairment. Total impairment was calculated by summing the number of impaired items.

Northwestern University

Assistant Professor

30 minutes of intervention systematic light exposure daily for 4 weeks.

Intervention systematic light exposure: Bright light using Litebook device.

Intervention Light

30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks.

Comparison systematic light exposure: Dim light using modified Litebook device.

Comparison Light

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Baseline estimate of premorbid intellectual functioning; The WTAR (Wechsler, 2001) comprises 50 words with irregular pronunciations that participants read aloud. The raw score ranges from 0 to 50, with a higher score indicating better performance, and the raw score can be transformed to an age-adjusted standard score, which is used to predict IQ (M = 100; SD = 15).

Wechsler Test of Adult Reading

Lisa M. Wu, Ph.D.

End of intervention

8 weeks after intervention

Cognitive Functioning (Neuropsychological Tests)

Baseline

Circadian Activity Rhythms (Actigraphy)

Mid-treatment

End of treatment

8 weeks later

30 minutes of comparison systematic light exposure daily for 4 weeks.

Comparison systematic light exposure: Dim light using modified Litebook device.

Sleep Quality (Pittsburgh Sleep Quality Index)

Mid-intervention

8 weeks post-intervention

Fatigue (FACIT-fatigue)

8 weeks post intervention

Depressed Mood (CESD)

End-of-intervention

Participants did not always complete this measure, which accounts for why there are sometimes fewer participants than the overall number of participants analyzed at different time points. Linear mixed models allows for missing time points.

Neurobehavioral Functioning (Frontal Systems Behavioral Scale)

Quality of Life (FACT-BMT)

Interleukin-6

Two participants did not provide blood samples at the end-of-intervention

Pro-inflammatory Cytokine - TNF Alpha

C-Reactive Protein

Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)

Treatment Satisfaction (FACT-TS)

Credibility/Expectancy (Credibility/Expectancy Questionnaire)

Usage of Light Box (Integrated Meter Measurement and Litebook Log)

Chronotype (Morningness-eveningness Questionnaire)

Overall Study

Experimental training will occur in the home. The experimental training will last 8 weeks, each week having up to 4 sessions of therapeutic game play (based on tolerance). Each session will start with vitals being measured and logged. Data will be uploaded on a secure cloud server to which clinicians will have access.

Participants will perform web-based game play while wearing sham equipment. Duration of sessions will be fixed and frequency of sessions will equal that of the experimental group training. Over the total training the control group will have an equal duration of training with the experimental group.

Experimental training will occur in the home. The experimental training will last 8 weeks, each week having up to 4 sessions of therapeutic game play (based on tolerance). Each session will start with vitals and subjective pain level being measured and logged.

They will wear a computer system modified with biosensors, then do motor and cognitive baselines. Subsequently, participants will play an increasing number of games, targeted at cognitive domains of executive function (primary), memory and attention. At the end of every session vitals and subjective pain will be measured and logged.

Clinical Coordinator will call homes weekly to ascertain general health and issues with participation.

At the end of week 4 and 8 participants and their caregivers in the experimental group will fill a subjective evaluation questionnaire to gauge perceived benefits and technical difficulties when using the experimental system. Questions will be scored on a 5-point Likert scale.

Telerehabilitation Experimental Group

Sham control group will train playing web games while wearing a biosensor connected to a laptop provided, showing the web games. However biosensor data will not be used to control game difficulty.

Sham group controls will start every session with vitals and subjective pain levels being measured and logged. Then participants will play the same frequency and duration of sessions, however those will consist of web games training the same domains (memory, focusing, executive function). Interaction will be through a mouse, and data will be downloaded to a server maintained by the company doing the web games. Data will then be transferred to the research team.

At the end of every session vitals and subjective pain levels will again be measured and logged.

Once a week the Clinical Coordinator will call the home to ascertain general health and determine is there were issues with that week participation.

Telerehabilitation Sham Control Group

Edward A Burde, MS

Jasdeep Hundal, PsyD

Daniel Valdivia, M.S.

Edward A Berde, MS

Develop a game-based upper-extremity motor and cognitive rehabilitation system using custom and adaptable virtual reality simulations on a wearable device enhanced with biosensors.

Participants are stage II and stage III breast cancer survivors with lasting cognitive impairments following their first round of chemotherapy. They will be randomized 1:1 into an experimental group and a sham control group. Each group will train in the home for 8 weeks, during which they will perform up to 4 rehabilitation sessions/week (based on tolerance). Each session will start with vitals being measured and logged. Each group will have three clinical evaluations: 1) at baseline; 2) at 8 weeks post-baseline; and 3) at 16 weeks from baseline for follow up.

Experimental group sessions will consist of increasingly more difficult cognitive training tasks in the form of simulated tasks. Biosensors will be sampled while participants interact with these games while wearing the computer system.

Sham control group will have the same number, suration and frequency of sessions, however they will play web games while wearing some the same biosensors.

Caregivers of all subjects will receive a laptop to be used in filling subjective evaluation forms and sending messages to research team. Training will be in the home, so caregivers will need to support the trials by ensuring compliance with the protocol.

All subjects will undergo standardized clinical evaluations at baseline, at 8 weeks and at 16 weeks from baseline. The subjects in the experimental group will have computerized measures taken during each session, and will fill subjective evaluation forms every 4 weeks of active training.

This portion of the study is intended to provide information pertaining to the feasibility of the experimental system for remote integrative (cognitive and motor) therapy of breast cancer survivors (Stage II or III) with lasting cognitive impairments subsequent to their first chemotherapy regimen, and living in the community with a caregiver.

We aim primarily at determining any clinical benefits in improved cognition (primarily in the executive functions domain), but also increased independence in ADLs, and improved mood (reduced depression). Another outcome is the degree of technology acceptance by the targeted population. Training will be done in the home, thus co-dwelling caregivers will also be recruited.

Specific aims are:

1. testing of a wearable device modified with added biosensors, by breast cancer survivors with CRCI.
2. new technology acceptance and ease of use at home by these individuals;
3. clinical benefit to improved cognition (primarily executive functions and cognitive endurance) when experimental therapy is added to daily routine vs. daily routine plus web-based cognitive games;
4. a therapist console module and enhanced automatic session report that will allow remote monitoring of patient exercising and offline data processing and review.

Participants will be randomized equally in an experimental group, or a sham control group. Experimental subjects will receive computer-based therapy, of increasing duration and intensity for up to 4 sessions/week for 8 weeks. The length of sessions will increase from 15 minutes in week 1 to 40 minutes of actual play in week 8. The longer sessions will also train cognitive endurance, or the ability for sustained cognitive effort. All experimental subjects will have their exercise duration and intensity data logged into the database and investigators will monitor them remotely. An Artificial Intelligence (AI) software layer in the system will progress game difficulty based on success in the games as well as on degree of cognitive engagement, as estimated by the biosensors. Higher cognitive difficulty will be indicative of improved cognition, thus progress in mitigating cognitive impairments subsequent to chemotherapy. Additionally, the duration of training will also be logged, as will be the frequency of training. Longer sessions will be indicative of ability to sustain cognitive engagement longer. Additional input will be obtained from caregivers in the form of periodic questionnaires.

Fatigue will be self-reported during weekly follow up calls by a Clinical Coordinator. Participants will train while seated, and (if needed) their arms can be supported on a table. Rest periods may be introduced as needed, to further mitigate fatigue.

At the end of every other week participants and their caregivers in the experimental group will fill a subjective evaluation questionnaire aimed at gauging perceived benefits and possible technical difficulties when using the BrightGo system. Questions will be scored on a 5-point Likert scale.

Control group will perform an equal amount of web-based game play of assigned cognitive-oriented games.

All participants will undergo screening for cognitive impairments (to confirm Mild Cognitive Impairment at baseline). Then they will continue with their daily routine during their 8-week training, and will undergo a second clinical evaluation at the end of these 8 weeks. All participants will then undergo a third (follow up) evaluation at 8 weeks post-end of training.

Caregivers will support the training by helping ensure compliance to protocol, and will complete subjective evaluation forms to rate the perceive benefit of training for the person they care for.

All participants will receive a weekly call from the Clinical Coordinator so to report on any health concerns and system issues.

Feasibility Sham comparison study:

Participants are randomized equally into the experimental group and a sham control group. Randomization will be based on a randomization table prepared by a contracted bio-statistician.

Outcomes Assessor will not be told which group the participant is part of, so not be biased in evaluations.

Only female will be recruited, as this study targets breast cancer survivors.

Telerehabilitation Cognitive Impairments Following Chemotherapy Feasibility Study

Home-based Virtual Reality System for the Treatment of Chemotherapy-related Cognitive Impairments - Feasibility Study

Data will be anonymized and made available through scientific publications.

Heart rate (Pulse) measured with a medical meter at start and end of each training session

Blood pressure (systolic and diastolic) measured with a medical meter at start and end of each training session

Measure of change in cognitive impairment for cancer survivors and their caregivers

Measure cognitive ability \[Pearson Education 2017\]

Measure of sustained attention \[Hartman 2006\]

Measure of word generation \[White and Stern 2003\]

A measure of executive functioning \[Raitan 1958\]

Verbal/auditory memory test \[Brandt 1991\];

Visual memory test \[Benedict et al., 1996\];

Quality of Life for Cancer Patients \[Ferrell, et al 2012\]. Form includes 41 items representing the four domains of quality of life incorporating physical, psychological, social, and spiritual well being.

Each question is scored on a 0 to 10 scale.

Questionnaire for caregiver oncology quality of life \[Weitzner et al 1999\]

Measure of depression severity \[Beck 1996\]

measure of upper extremity range of motion

Objective measure of participant performance in the therapeutic games.

subjective evaluation on a Likert scale of system and perceived benefits by participant and by caregiver

measure of skin conductance (indicative of sweat) as an indirect indication of cognitive engagement, blinking rate and gaze.

The global stimulation games active attention control intervention is composed of computerized games. These games are fully developed and are rated E (for everyone) by the Entertainment Software Rating Board. The program will present 8 non-speeded exercises that include spin-offs of such games as breaking hex, lineup four, battleship, gems swap, double klondike, solitaire, reversi, word search, and sudoku.

The neuroplasticity games provide core elements necessary for inducing neuroplasticity. The five core elements include the principles of speed of processing, accuracy of processing, adaptivity, generalizability, and engagement. Importantly, all of the exercises adapt to user skill and ability. Behavioral tracking built within the program is used to monitor individual performance and ensure that the person is training at their uppermost threshold level. Specifically, we will use eight of these exercises which are designed to address cognitive concerns most noted in BCS including exercises to improve attention and working memory, processing speed, and executive function.

The program will includes 8 non-speeded exercises that include spin-offs of such games as breaking hex, lineup four, battleship, gems swap, double klondike, solitaire, reversi, word search, and sudoku. These games are well matched for time on task, novelty, and progression across levels. These are strategy-based games without adaptive, speeded, or accuracy-based algorithms underlying their personalization.

Arm 1: Computerized Cognitive Training-Global Stimulation Games

Cognitive training exercises include Double Decision (targets visual speed of processing and useful field of view), Target Tracker (targets visuospatial working memory capacity), Visual Sweeps (targets speed of processing), Syllable Stacks (targets auditory memory), Eye for Detail (targets eye movement speed and visuo-spatial working memory), Mind Bender (targets mental flexibility), Divided Attention (a shape-color-pattern inhibitory control exercise that focuses on rapidly determining whether flashing colors, shapes, or patterns meet a pre-specified rule), Right Turn (targets spatial reasoning).

Arm 2: Computerized Cognitive Training-Neuroplasticity Games

Director Regulatory Affairs

Norman Wolmark, MD

Site Public Contact

Nicholas DiBella

Anushka H. Patel

Cynthia A. Lynch

Shahzad Siddique

Jay W. Carlson

Ricardo Salas

Edward J. Kim

Shannon B. Keating

Rose A. Juhasz

Kendrith M. Rowland

Bryan A. Faller

Regina M. Stein

Thomas E. Lad

Isoken Koko

This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.

The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.

Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors

Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial

FACT-Cog PCI scale score (Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive impairment)

Processing speed score as measured by Telephone-Based Assessment of Neuropsychological Status (TBANS) Symbol Digit Modalities Test

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study	NCT04839588	Chemotherapy-Re... Healthy	Usability study	20 Years - 65 Years	Bright Cloud International Corp
Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments	NCT05289258	Cancer, Breast	Neuropsychologi... Unified Protoco... Waitlist group	18 Years - 70 Years	Universidad de Córdoba
The "Light for the Brain" Study	NCT02677987	Hematopoietic S... Cognitive Impai... Sleep Depression Fatigue Quality of Life	Intervention sy... Comparison syst...	21 Years -	Northwestern University
The "Light for the Brain" Study	NCT02677987	Hematopoietic S... Cognitive Impai... Sleep Depression Fatigue Quality of Life	Intervention sy... Comparison syst...	21 Years -	Northwestern University
Telerehabilitation Cognitive Impairments Following Chemotherapy Feasibility Study	NCT04972019	Cognitive Impai...	Telerehabilitat... Telerehabilitat...	20 Years - 65 Years	Bright Cloud International Corp
Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors	NCT05896189	Breast Cancer Cognitive Impai...	Arm 1: Computer... Arm 2: Computer...	18 Years - 100 Years	NRG Oncology
Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments	NCT05289258	Cancer, Breast	Neuropsychologi... Unified Protoco... Waitlist group	18 Years - 70 Years	Universidad de Córdoba
Novel Cognitive Treatment Targets for Epidiolex in Sturge- Weber Syndrome	NCT04447846	Sturge-Weber Sy...	Cannabidiol	3 Years - 50 Years	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors	NCT05896189	Breast Cancer Cognitive Impai...	Arm 1: Computer... Arm 2: Computer...	18 Years - 100 Years	NRG Oncology

Spots Global Cancer Trial Database for cognitive impairments