Fast-Track proposals will be accepted.
Direct to Phase II will not be accepted.
Number of anticipated awards: 1 – 3
Budget (total costs, per award): Phase I: up to $225,000 for up to 9 months
Phase II: up to $1,500,000 for up to 2 years
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Persistent cognitive deficits are a frequent complaint of the increasing population of cancer survivors, particularly those who have undergone chemotherapy. Cancer patients experience both acute and chronic cognitive effects during both the treatment and survivorship phases of the cancer control continuum. One significant barrier to assessing cognitive symptoms in cancer populations is the inability to administer a brief, scientifically valid cognitive battery, either remotely or within a clinical visit.
The current gold standard in the field is standardized neuropsychological tests. These tests were devised for the purpose of diagnosing severe and focal cognitive impairments, such as stroke, and present consistent research challenges. First, they lack sensitivity to less severe, but still debilitating cognitive impairments such as those observed in chemotherapy patients. Second, they lack specificity; it is difficult to tell which cognitive function is responsible for poor performance. Third, they lack repeatability; tests were designed for a single diagnostic administration, and thus it is difficult or impossible to administer the same test multiple times over the course of a treatment protocol. Fourth, most such tests were originally devised decades ago and thus make no contact with the considerable advances in cognitive and neuro-scientific theory over the last thirty years. Fifth, a trained neuropsychologist must be on site to administer the test, pushing up the costs of research and limiting use in the clinical oncology setting. Therefore, there is a substantial unmet need for a suite of computerized cognitive tests, based on contemporary cognitive psychology and neuroscience research, designed for repeated testing, that could be easily administered remotely.
The goal of this project is to develop a scalable, secure, and privacy-compliant software system, and tools to support computerized administration of brief cognitive assessments specifically focused on measuring the subtle cognitive changes associated with cancer and cancer treatment.
The software system must support assessments of basic cognitive processes that are repeatable and can be remotely administered across diverse settings (i.e., clinic or home) using multiple technology platforms (i.e., PC, tablet, smartphone). In addition, the system must support provider/researcher portal functionality for patient management functions including (but not limited to) adding patients, ordering and scheduling assessments, automated scoring, visualization and triage of results, and standards based data reporting to third party systems. Where appropriate and relevant for project goals, the software system should integrate measures available via third party systems such as PROMIS, NIH Toolbox, and NeuroQOL rather than validate duplicative resources.
In Phase I, offerors will establish a multidisciplinary team for validation/evaluation of the proposed platform, provide documentation that appropriate software-based assessments have been developed, as well scoring protocols in the minimum specified cognitive domains. A report providing a detailed description, visual design, and technical documentation will be required, as well as a functional prototype. Phase I will also include client side user testing. Lastly, documentation detailing output reporting systems feasibility will be included in the demonstration of the final prototype to an NCI evaluation panel via webinar. In Phase II, offerors will evaluate specific IT customization requirements, test and finalize client, server, and data systems, including technical documentation for the software systems application programming interface. Usability testing and support documentation will be provided, and submission of a research plan and presentation to NCI will be delivered via webinars.
The short term goal of this topic is to:
- Develop innovative software systems which support brief, remotely administered patient assessments and scoring of cognitive processes affected by cancer and cancer treatment
- Develop paired provider portal tools for remote administration and management of patient assessments and results
- Conduct user testing of the client side assessment tools and modes of administration
- Conduct clinical validation of the cancer cognitive assessment instruments delivered via the software system
Longer term goals include the integration of these software tools in clinical assessment and monitoring in both oncology research and care settings, with the eventual goal of embedding assessment results into electronic medical records used in health systems and accountable care organizations (ACO).
This topic aims to support customized development and/or integration of information technology into the cognitive assessment process. The primary focus will be brief administration and scoring of assessments of cognitive processes affected by cancer and cancer treatments. Minimum cognitive domains to be assessed include: Attention, executive function, working memory, verbal abilities, visuospatial ability, motor function, and processing speed.
In addition to technical development, this topic is intended to support validation (e.g., efficacy and/or effectiveness) of the assessment battery, specifically with respect to reliably detecting cognitive changes in cancer populations.
Phase I Activities and Deliverables
- Establish a project team including personnel with training and research experience in cognitive psychology, neuroscience and/or neuropsychology, clinical oncology, implementation, and statistical methods for validation/evaluation as appropriate for the proposed technology platform.
- In addition, technical personnel should have experience in Health IT software standards (i.e., privacy, security, health data exchange protocols, etc.), electronic health records, cross platform client side software development, scalable sever side software development, data visualization, and systems architecture that will effectively address all objectives of the current topic.
- Provide documentation that software-based assessments have been developed based on current cognitive and neuroscience findings and evidence.
- Provide a report including detailed description of proposed assessments (including relevant modification for electronic administration) and scoring protocols planned for Phase I and Phase II development. Specifically address the minimum cognitive domains required including: attention, executive function, working memory, verbal abilities, visuospatial ability, motor function, and processing speed . In addition, patient reported cognitive complaints will need to be included.
- Provide documentation that planned software-based assessments have been developed based on current cognitive and neuroscience findings and evidence.
- Provide a report including detailed description, visual design, and/or technical documentation of the proposed:
- Database structure and data models for the proposed cognitive assessments, as well as system metadata requirements
- Client side graphical user interface and user experience
- Provider side graphical user interface and user experience
- Data standards for capture, transport, importation, and storage of data between client, server, and third party application as applicable
- Data visualization, feedback, or reporting systems, as required for target clinical monitoring and/or research applications
- Systems architecture for implementation of scalable software, as required based on development and commercialization targets.
- Develop a functional prototype system that includes
- Client software and wireframe user interface to facilitate and control the administration and transport of cognitive assessment and any associated metadata used within the system
- Server software and wireframe provider portal that supports automated schedule, administration, data scoring, and management of patient assessments and associated metadata
- Development release of end-to-end software system that connects client and server software & patient or provider portals for administration of planned Phase I assessments.
- Conduct user testing of client side software visual designs (or functional software) and proposed user experience for planned Phase I assessments.
- Provide a report detailing output reporting systems feasibility, proposed timelines, data standards, and communication architecture for reporting summary outputs to patients/subjects, clinicians/researchers, electronic medical records, and health surveillance systems.
- Finalize database formats and structure, data collection, transport, and importation methods for targeted cognitive assessments.
- Present Phase I findings and demonstrate the final prototype to an NCI evaluation panel via webinar
Phase II Activities and Expected Deliverables
- Evaluate specific IT customization requirements to support hardware, software, or communications system integration of the technology (e.g., HL7 compatibility); provide a report documenting the specific IT customization requirements and timeline for implementation.
- Enhance, user test and finalize client side software, patient portals and functionality listed in Phase I
- Enhance, user test and finalize server side software, provider portals and functionality listed in Phase I
- Enhance, beta test and finalize data visualization, feedback and reported systems listed in Phase I.
- Provide a report including technical documentation for the software systems application programing interface (API) for interaction with third party data systems.
- Conduct usability testing of
- Consumer/patient facing portals or mobile applications
- Care team/researcher facing portals or mobile applications
- Develop user support documentation for all applicable potential users of the technology, including but not limited to patients/consumers and providers. Provide a report documenting user support resources, including links to online resources and/or copies of electronic or paper user support resources as appropriate.
- Prior to evaluation/validation of software-based cognitive assessments, provide a final report of the research plan including at a minimum
- Appropriate human subjects protection/IRB submission packages, and documentation of approval for your research plan.
- Final study design including aims, participant characteristics, recruiting plans, inclusion and exclusion criteria, measures, design and comparison conditions (if appropriate), power analyses and sample size, and data analysis plan.
- Publication plan outlining potential research manuscripts and whitepaper publications resulting from the research.
- Prepare a tutorial session for presentation to NCI via webinars describing and illustrating the technology and intended use.
- In the first year of the contract, provide the program and contract officers with a letter(s) of commercial interest.
- In the second year of the contract, provide the program and contract officers with a letter(s) of commercial commitment.