Description:
Fast-Track proposals will be accepted.
Direct-to-Phase II proposals will NOT be accepted.
Number of anticipated awards: 2-4 Budget (total costs, per award):
Phase I: up to $252,131 for up to 9 months Phase II: up to $1,680,879 for up to 2 years
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Summary
An estimated 11,060 new cases of cancer were expected to be diagnosed among children ages 0 to 14 years and approximately 70,000 among adolescent and young adults (AYAs) between ages 15 and 39 in 2019. Advances in diagnostic capabilities and treatment have resulted in increased survival rates, with more than 80% of children and AYAs surviving 5 years or more after their cancer diagnosis. This has led to exponential growth in the number of survivors of pediatric cancers. However, survival often comes at the cost of many life-altering late and long-term effects and other unique challenges including the following:
• Adverse long-term and late effects including higher risk of secondary cancers, premature/accelerated aging, cardiotoxicity, endocrine dysfunction, reproductive and developmental issues like infertility, neurocognitive defects (e.g. learning disabilities), and psychosocial issues (e.g. anxiety and depression), poor mental and physical health (e.g. impaired stress management), poor health habits (e.g. alcohol use, physical activity levels), developmental issues, impaired/delayed social development
• Challenges in coordinating care across multiple clinical teams, especially the transition from pediatric to adult care providers
• Need for better care models to improve monitoring for recurrence of primary cancer and screening for early detection of secondary tumors and
• Need for better care models to improve monitoring and management of symptoms arising from long-term adverse effects of cancer treatments
Childhood cancer survivorship care is complex and improved care models are urgently needed. The increased use of digital tools in medical care can be leveraged to improve health outcomes and survivorship in these cancer survivors. This contract topic encourages innovative approaches to improve the quality of health outcomes for long-term childhood and adolescent cancer survivors.
Project Goals
The goal of this solicitation is to stimulate the development and evaluation of innovative digital tools (software, database systems, digital platforms and/or mobile applications) that are integrated with existing EHRs or other clinical IT systems and that support delivery of patient-centered, coordinated, high-quality care to pediatric cancer survivors. To accomplish these goals, the offerors should build a system/tool/app with one of the following two capabilities:
• Creation and implementation of survivorship care plans including integration of National Academy of Medicine, Children’s Oncology Group and other relevant long- term follow-up and care guidelines for survivors of childhood and adolescent cancer, OR
• Integration of accountability tools, checklists, and reminders that improve follow-up care adherence and clinical workflow
Additionally, the following capabilities will also be required:
• Seamless coordination of care across healthcare systems either from oncology-based practice to primary care setting or from pediatric to adult care setting
• Remote collection of data from a patient to support and reinforce remote screening and monitoring, symptoms management and disease prevention, behavior modification and personalized intervention patient-reported outcomes
• Secure bi-directional communication between clinical teams and the patients and caregivers that meets HIPAA requirements
• Adopting current interoperability standards such as FHIR
• Integration of technology into clinical workflows
The tools can optionally be integrated with wearables and other devices for cancer recurrence screening and early detection of secondary tumors, monitoring symptoms and adverse effects, and support behavior or other lifestyle modifications needed to improve patient outcomes. The tool must support bi-directional communication; it may be focused on either patient/caregiver tasks or clinical team tasks. The design requirements must include protection of patient privacy and adherence to all relevant regulations.
Activities not responsive to announcement:
This solicitation is focused on development of integrated tools including software, database systems, digital platforms and/or mobile applications-based approaches. The following topic areas are not supported:
• Drug development
• New in vitro, in vivo, or ex vivo diagnostics for symptoms and cancer monitoring
• Digital tools focused on adult cancer survivors
Phase I Activities and Deliverables
• Establish a project team with expertise in the areas of software development and implementation, human-centered design, health communication, pediatric oncology, pediatric cancer survivorship, primary care, behavioral science, health services, care delivery and clinical workflows.
• Perform an environmental scan of relevant, existing software systems and apps designed to support the delivery of pediatric survivorship care, especially during the transitions of care, and identify major gaps that need to be addressed.
• Conduct a small number of key informant interviews with childhood and adolescent cancer survivors, adult caregivers, pediatric oncology providers, and primary care providers to further refine and prioritize areas of unmet needs.
• Develop a functional prototype of the tool with at least one of the following system capabilities and specifications:
o Creation and implementation of survivorship care plans including integration of National Academy of Medicine, Children’s Oncology Group and other relevant long- term follow-up and care guidelines for survivors of childhood and adolescent cancer. Potential features for this type of tool may include:
A personal healthcare information management tool (dashboard or other innovative tool) on treatment summary, individualized survivorship care plan including associated risk factors and screening recommendations, key symptom indicators, and prompt survivor to share critical information with their care provider
Support module to educate patients and their adult caregivers about the disease, treatments and the potential impact of disease and treatments on a patient’s life. This module will also list the relevant clinicians, their contact information, and their roles in managing the patient’s care.
Seamless coordination of care across healthcare systems such as from oncology-based practice to primary care setting or from pediatric to adult care setting
o Integration of accountability tools, checklists, and reminders that improve follow-up care adherence and clinical workflow. Potential features of this type of tool include:
A personal healthcare information management tool (dashboard or other innovative tool) with all these features
A psycho-social health information management tool (dashboard or other innovative tool) to track key factors associated with Quality of Life (QOL) outcomes in cancer survivors
Front-end mobile application(s) to facilitate scheduling, tracking and monitoring of care delivery processes, including referrals and the outcome of a referral; communications between patients and clinicians or between clinicians; and survivor support
Interfaces with healthcare delivery systems to facilitate remote patient monitoring, communications, and resource provisions (e.g. content management for tailored caregiver support).
• In addition, all tools should include all the following capabilities and specifications:
o Seamless coordination of care across healthcare systems from oncology-based practice to primary care setting or from pediatric to adult care setting
o Remote collection of individual health data to support and reinforce efficacious remote screening and monitoring, symptoms management and disease prevention, behavior modification and personalized intervention patient-reported outcomes.
o Secure bi-directional communication between clinical teams and the patients and caregivers
o Adopt current interoperability standards such as FIHR
o Integration into clinical workflows
• The information management tool (dashboard or other innovative tool) needs to have a either patient/caregiver- facing and/or clinician-facing interface and the ability to download and upload relevant information as it becomes available.
• The tool must adhere to relevant data and security standards for collection, transmission, and storage of data that ensure patient and caregiver privacy as required by relevant federal and state laws and regulations.
• Data adaptation for mobile application(s) as needed.
• Conduct a pilot usability testing of the protype tool with at least 25 potential users.
• Present Phase I findings and demonstrate functional prototype to an NCI Evaluation Panel.
Phase II Activities and Deliverables
• Establish a project team for Phase II activities and outcomes. This team should include personnel with training and research experience in chronic disease patient clinical trial or intervention design, implementation, and statistical methods for validation/evaluation as appropriate for the proposed project. Provide a report outlining team member credentials, specific project roles, and timelines for performance.
• Evaluate specific IT customization requirements to support hardware, software, or communications system integration of the technology into the target clinical, health system or service, or other relevant software environment in preparation for validation. Provide a report documenting the specific IT customization requirements and timelines for implementation.
• Evaluate, enhance as necessary and provide documentation that the technology and communications systems maintain compliance with HIPAA, data security, privacy, and consent management protocols as required for the proposed project.
• Enhance systems interoperability for deployment in diverse software environments and provider networks. Provide a report detailing communication systems architecture and capability for data reporting as appropriate for the proposed project.
• Test the integration of the technology into the target clinical, health system or service, or other relevant software environment in preparation for validation. Provide a report documenting the results of system testing and timelines for troubleshooting.
• Develop user support documentation to support all applicable potential users of the technology. Provide a report documenting user support resources, including but not limited to, links to online resources and copies of electronic or paper user support resources as appropriate.
• Design and conduct a validation and evaluation study, including:
o specify study aims, participant characteristics, recruiting plans, inclusion and exclusion criteria, measures, primary and secondary endpoints, design and comparison conditions (if appropriate), power analyses and sample size, and data analysis plan;
o develop appropriate human subjects protection / IRB submission packages and documentation of approval for the research plan; and
o provide study progress reports quarterly, documenting recruitment and enrollment, retention, data quality assurance and control measures, and relevant study specific milestones.
• Present finding and demonstrate functional product to NCI evaluation panel in a webinar.
• In the first year of the contract, provide the program and contract officers with a letter(s) of commercial commitment.
