Objectives: To develop a computer-based cognitive training system for breast cancer survivors who are suffering from cognitive impairments subsequent to chemotherapy. A home-based system will be developed, targeting executive functions, attention and memory cognitive domains. The system will incorporate a novel low-cost biosensor device. Specific Aims: 1) Development, validation and usability evaluation of the integrative therapy system; 2) Feasibility study on breast cancer survivors with lasting cognitive impairments post chemotherapy. Methods: 1) Develop a biosensor system to detect cognitive load variation during game play; 2) Validation study of the biosensor prototype; 3) Develop therapeutic games with focus on cognitive intervention; 4) System integration; 5) Develop cloud-based database and remote monitoring software; 6) Conduct a usability study of the system with 4 individuals; 7) Sample standardized outcome measures at pre-treatment, post- treatment and at follow up on 12 breast cancer survivors post-chemotherapy. The primary outcome measures will be cognitive metrics of executive function (Wechsler Test of Adult Reading (WTAR), NAB Attention Module, Controlled Oral Word Association Test (CFL), Trail Making Test, Hopkins Verbal Learning Test, Revised (HVLT-R), Brief Visuospatial Memory Test, Revised (BVMT-R). One standard deviation difference in score will be considered a clinically important change. For attention primary outcomes will be NAB Digit Span and Dots for attention, and for memory HVLT-R and BVMT-R scores. Secondary outcomes will be biosensor data, game performance (scores, error rates, intensity of play), changes in activities of daily living, and depression severity (Beck Depression Inventory, 2nd Ed); 8) Conduct a feasibility clinical trial with 12 breast cancer survivors post chemotherapy and their 12 caregivers. The cancer survivors will be randomized into two groups: experimental treatment (n=6) and sham treatment (n=6). The treatment group will use the biosensor device with custom games, while the sham group will use a laptop with mock up headband with only occupancy/contact sensors. By detecting the wearing of the headband, sham group's total session time will be matched to the experimental group, detected and logged by computer software. 9) Analyze adherence to protocol and outcome data using descriptive and multivariate regression analysis to determine motor functional improvements, cognitive benefits and group changes in cognitive load. NIH Relevance: Current chemotherapy-based cancer treatments are associated with Chemobrain, namely mild cognitive impairments affecting long-term about a third of cancer survivors [Vannorsdall, 2017]. The proposed home-based cognitive intervention is an innovative medication- free approach, provided in the convenience of home. This increases access to care especially for those with illness or treatment-related fatigue.
Public Health Relevance Statement: 8. PROJECT NARRATIVE
Public Health Relevance: Current chemotherapy-based cancer treatments are associated with mild cognitive impairments, affecting long-term about a third of cancer survivors [Vannorsdall, 2017]. The proposed home-based cognitive intervention is an innovative medication-free approach, provided in the convenience of home.
Project Terms: 3-Dimensional; Activities of Daily Living; Adherence; Adult; Affect; Aftercare; Age; American; arm movement; Artificial Intelligence; Attention; base; Beck depression inventory; Biosensor; Blood flow; Brain; Breast Cancer Patient; Breast Cancer survivor; Breast Cancer therapy; Cancer Institute of New Jersey; Cancer Survivor; Caregivers; Caring; chemobrain; chemotherapy; chronic pain; Clinic; Clinical; Clinical Trials; cloud based; Cognition; Cognitive; cognitive benefits; cognitive load; cognitive rehabilitation; cognitive training; Computer software; Computers; cost; Custom; Data; Data Analyses; Databases; Decision Making; Dementia; Development; Devices; Digit structure; Dose; Evaluation; executive function; Exercise; experience; experimental group; Fatigue; Feasibility Studies; Feedback; finger movement; follow-up; functional improvement; Health Services Accessibility; Home environment; Impaired cognition; Impairment; improved; indexing; Individual; information processing; innovation; Integrative Therapy; interest; Intervention; laptop; Libraries; Maintenance; Malignant Neoplasms; Measures; Memory; Mental Depression; Methods; mild cognitive impairment; Monitor; Morale; Motor; Movement; Near-Infrared Spectroscopy; Neuropsychological Tests; novel; novel therapeutics; Office Visits; Online Systems; Oral; Outcome; Outcome Measure; Participant; Performance; Pharmaceutical Preparations; Pharmacology; Phase; Physical Exercise; placebo group; Placebos; Play; Population; primary outcome; processing speed; Protocols documentation; prototype; public health relevance; Quality of life; Questionnaires; Randomized; Reading; recruit; Regression Analysis; Reporting; Research Personnel; Sampling; secondary outcome; sensor; Severities; Small Business Innovation Research Grant; Standardization; standardize measure; Stroke; Structure; success; System; Systems Integration; Technology; Testing; Therapeutic; therapeutic development; Time; tool; Trail Making Test; Training; Travel; treatment group; Treatment-Related Cancer; United States National Institutes of Health; Upper Extremity; usability; Validation; validation studies; Variant; Verbal Learning; virtual reality; Visuospatial; Word Association Tests
