Fast-Track proposals will be accepted. Number of Anticipated Awards: 2-3 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.
One of the consequences of living longer is the symptom burden of cancer survivorship, which is having a substantial impact on quality of life for many survivors. Persistent and late effects of cancer treatment include physical limitations, cognitive sequelae, depression, anxiety, sleep problems, fatigue, sexual dysfunction, and, in some patients, a great deal of pain.
Similarly, when cancer survivors transition from oncology-based to primary care, they still need coordinated monitoring for cancer recurrence, screening, and early detection of second primary cancers, assessment and management of potential physical and psychosocial effects of cancer and its treatment, counseling on health promotion strategies for nutrition, physical activity, tobacco cessation, and alcohol consumption.
Individuals increasingly are using wearable devices and smartphone apps to collect health-related data and help them reach personal health goals. These person-generated health data provide valuable insights into people’s everyday lives and have potential to help individuals more accurately track symptoms and healthcare providers deliver more patient-centered care. Among other things, personal devices can be used to gather patient-reported outcomes (e.g., symptom self-reporting), which can enhance quality of care.
Through this contract topic, NCI is seeking to capitalize on its rich portfolio of research to develop and link data from connected devices and patient reports in meaningful ways to enhance symptom management, timely patient-centered clinical care, and improve health outcomes for cancer survivors --- particularly those who are managing the late and long-term effects of cancer treatment and transitioning to primary and community-based care.
By integrating person-generated health data -- readily collected by connected devices --- with robust symptom lifestyle reporting and management systems, this contract topic encourages novel and essential approaches to improve the quality of life for long-term cancer survivors. This concept helps address the compelling need not just to improve symptom care and ensure adherence to long-term treatment and health promotion strategies, but expand evidence-based self-management strategies, identify recurrence and secondary cancers, and extend survival.
The overall goal is for small businesses to develop "connected health" (software, database systems and/or mobile application) tools which will readily allow for the efficient and comprehensive monitoring, managing, and reporting of patient-reported symptoms by long-term cancer survivors. The result will enhance care quality and effectiveness, provide real-time feedback to cancer survivors, and allow care delivered beyond clinic walls into the home setting, ultimately aiming to improve patient outcomes.
This goal will be accomplished by:
• Building a system/tool/app/device capable of remotely collecting individual health behavior data to support and reinforce efficacious self-management and disease prevention, remote monitoring, behavior modification and personalized intervention patient-reported outcomes.
• A system that follows best behavioral and disease prevention guidelines for adherence to care recommendations while keeping track of psychological needs.
• A system that allows for bi-directionality of symptom data: to bring poorly controlled symptoms to the attention of the cancer care team and use the patient-reported outcome (PRO) data to guide symptom control efforts.
• Prompts to monitor for psychosocial quality of life effects (e.g., sexual dysfunction, marital discord, depression) should be included.
• Integrating accountability tools, checklists, and reminders into the system to ensure safe and timely delivery of services as well as reinforcing positive health behaviors.
Expected Activities and Deliverables
Scope of activities to be supported:
• A review of currently available technological platforms for cancer survivors to identify gaps, existing capabilities, and resources.
• Interviews/focus groups with cancer survivors and healthcare providers, and survivorship researchers to further identify areas of unmet needs.
• The development of a software system with mobile application to connect cancer survivors with healthcare provider teams to extend clinical interactions and provide further information resources and service referral.
• Key task domains should include organization-level (hospital or clinic), provider-level, and individual (survivor)-level dashboards that allow for assessment of adherence to treatment and post-treatment clinical practice guidelines, capability to identify high-risk patients, ability to identify care gaps and enable clinical data query functions.
• The development of secure bi-directional communication system to allow healthcare providers and individual cancer survivors to push messages directly through the system.
• The development and testing of a prototype of a platform and applications to be tested with cancer survivors and their healthcare providers, and survivorship researchers.
• Further enhancement and refinement of the software system and mobile application.
Phase I Activities and Deliverables:
• Establish a project team with expertise in the areas of software development, patient-centered design, health communication, oncology, oncology nursing, behavioral science, health services, and computer programming
• Perform an environmental scan of available and relevant software systems designed to support symptom management, health maintenance behaviors and to identify major gaps
• Conduct a small number of key informant interviews with longer-term cancer survivors and primary care providers to further refine and prioritize areas of unmet needs
• Provide a report including detailed description and/or technical documentation of the proposed system capabilities and specifications, including: o Database structure for the proposed modules and user-interfaces (survivors, healthcare provider) and metadata requirements
o Architecture that includes the following components: a personal health dashboard to track key symptom indicators, and prompt survivor to share critical information with their primary care provider.
A psycho-social health dashboard to track key factors associated with Quality of Life (QOL) outcomes in cancer survivors
o The dashboard would be needed to be able to communicate with the survivor as well as primary care provider and download and upload information
•Data and security standards for collection, transport, and storage of data inputs that ensure patient and caregiver privacy following standard NIH policies.
•Data visualization, feedback and reporting systems for clinical monitoring and research applications
•Data adaptation for mobile application(s)
Develop a functional prototype of the software system that includes:
•Front-end mobile application(s) to facilitate tracking and monitoring of care, communications, and survivor support.
•Healthcare provider systems to facilitate remote patient care monitoring, communications, and resource provisions (e.g. content management for tailored caregiver support).
•Required server systems architecture to facilitate interaction with necessary provider Health IT systems or patient facing portals and personal health records.
•Present Phase I findings and demonstrate functional prototype to an NCI Evaluation Panel.
•Develop a prototype into a pilot system for usability testing.
•Conduct usability testing mobile applications and user interface features including system management, analyses, and reporting applications.
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.
•Conduct beta-testing of the software system and corresponding portals and mobile applications.
•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 trouble-shooting.
•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.
•Present finding and demonstrate functional product to NCI evaluation panel via webinar.
•Provide the program and contract officers with a letter(s) of commercial commitment.