Fast-Track proposals will be accepted.
Direct-to-Phase II will not be accepted.
Number of anticipated awards: 2-3
Budget (total costs, per award):
Phase I: $225,000 for 9 months;
Phase II: $1,500,000 for 2 years
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Informal cancer caregivers are individuals (usually family members or friends) who manage patient care which is typically uncompensated and delivered at home, involves significant amounts of time and energy, and requires the performance of tasks that may be physically, emotionally, socially, or financially demanding. These tasks include monitoring for treatment side effects, helping manage symptom burden, treatment decision-making, administering medication, and performing technical medical tasks (e.g., managing infusion ports, changing dressings). Despite these demands, caregivers are often underprepared to perform the many tasks required of them. Simultaneously, cancer treatment is more frequently provided in outpatient and community-based centers, which increases the day-to-day demands on informal caregivers.
Technology offers the potential of mitigating these demands and alleviating distress and burden for caregivers by offering decision-making tools, strategies for managing and communicating symptoms with providers, assistance with technical medical tasks, and care coordination. Furthermore, a majority of caregivers endorse the idea that technology may aid in preventing burnout and may reduce financial burden on both families and the healthcare system. Despite this, there is a lack of evidence-driven technologies to ease cancer caregiving burden available on the market.
The purpose of the proposed concept is to develop evidence-based technologies to alleviate cancer caregiving burden, assist family/informal caregivers to manage the needs of their care recipients, juggle their own healthcare needs, and enhance caregivers’ connections with their care recipients’ healthcare team. The SBIR mechanism is ideally suited to support this activity because it pairs investigators with software developers to create evidence-based technologies that can be scaled and disseminated with wide reach.
Purpose & Goals
The overall goal of this project is to develop software, database systems and mobile application tools to support cancer caregivers and connect them with their patients’ care teams. These systems will enhance care quality and effectiveness and will allow care delivered beyond clinic walls into the home setting, ultimately aiming to improve patient outcomes. Systems should be designed to be flexible and customizable, to be modified based on feedback from patients, caregivers, or providers, and to evolve as patient and caregiver needs evolve. Development should utilize an iterative, user-centered design approach informed by actual cancer patients, caregivers, and healthcare providers.
A recent environmental scan of technological resources available to informal cancer caregivers was performed to determine current available software systems and capabilities. The following caregiving support categories were identified based on previous reviews in the topic area: consultation and clinical care delivery, medical skills training, therapy/counseling, financial resources, and peer-to-peer support. Of the ten software systems identified, none provided support in all areas (most provided support in only 1-2 areas). Many of the cancer-focused apps identified targeted patients only; only three targeted caregivers. None of the systems identified directly connected cancer caregivers back to the patients’ healthcare provider team or associated electronic health record (EHR) and patient portals.
The following are specific modules that the caregiving platform should consider:
(1) Direct communication with the patients’ healthcare provider teams;
(2) Care plan dissemination/updates pushed directly from healthcare provider teams to caregivers;
(3) Tracking/monitoring of patients’ care delivery, patient reported outcomes, side effects, etc. using structured data entry forms, standard measures (e.g., PROMIS®) or ecological momentary assessment;
(4) Guidance for assisting with daily medical tasks;
(5) Assistance with patient’s activities of daily living;
(6) Opportunities for peer-to-peer connection; including informal caregivers (e.g., family members) as well as informal caregiving communities for social support;
(7) Guidance for caregiver self-care (including physical and emotional well-being);
(8) Local information/service referrals when available and appropriate
The platform should allow end-users (i.e., patients and caregivers) the ability to opt in or opt out of studies.
Scope of activities to be supported:
- A review of currently available technological platforms for cancer caregivers to identify gaps, existing capabilities and resources.
- Interviews/focus groups with cancer caregivers, patients, healthcare providers, and caregiving researchers to further identify areas of unmet caregiving needs.
- The development of a software system with mobile application to connect cancer patients and their caregivers 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, caregiver-level, and patient-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 authorized caregivers to push messages, including adjustments to the care plan, directly through the system.
- The development and testing of a prototype of a platform and caregiver-facing applications to be tested with cancer caregivers, patients and caregiving researchers.
- Further enhancement and refinement of the software system and mobile application.
Activities not responsive to announcement:
Tools that don’t target cancer caregivers; tools that don’t incorporate safeguards to protect privacy and confidentiality of information; design approaches that don’t account for scalability, interoperability or user-centered design.
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, palliative care, family medicine behavioral science, health services, and computer programming. Note that team members may have dual expertise (eg. e.g., oncology nurse with palliative care expertise; behavioral scientist with communications background).
- Perform an environmental scan of available and relevant software systems designed to support cancer patients and caregivers to identify major gaps
- Conduct a small number of key informant interviews with cancer patients and caregivers 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:
- structure for the proposed caregiving support modules and user-interfaces (caregiver, patient, Database healthcare provider) and metadata requirements
- Architecture that includes the following components:
- A provider/ clinic health system dashboard to be able to communicate with the caregiver and download and upload information and integrate that information with electronic health records where possible and appropriate
- A caregiver application and dashboard to be able to communicate with provider and download and upload information
- A function within the application that allows the caregiver to communicate with other caregivers within the network of caregivers on the application "community"
- A dashboard/database that would communicate to caregivers, patients, and providers about community resources
- 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 care plan dissemination, tracking and monitoring or care, communications and caregiver support.
- Healthcare provider systems to facilitate care plan prescription, 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
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.
- Develop a prototype into a pilot system for usability testing.
- Enhance systems interoperability for deployment in diverse software environments and provider networks. Provide a report detailing communication systems architecture and capability for data reporting to patients, caregivers, healthcare providers, researchers, electronic health records, and health surveillance systems as appropriate for the proposed project.
- Conduct beta-testing of the software system and corresponding portals and mobile applications
- Conduct usability testing of caregiver/patient/care team/researcher facing mobile applications and care team/researcher facing user interface features including system management, analyses, and reporting 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, including but not limited to patients/consumers, family/caregivers, and providers. 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.
- Develop appropriate human subjects protection / IRB submission packages and documentation of approval for your research plan.
- Develop final study design including 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.
- Create a publication plan outlining potential research and other publications resulting from the research
- Provide study progress reports quarterly, documenting recruitment and enrollment, retention, data quality assurance and control measures, and relevant study specific milestones.
- Prepare a tutorial session for presentation at NCI and/or via webinars describing and illustrating the technology and intended use.
- Include funds in budget to present Phase II findings and demonstrate the technology to an NCI evaluation panel.
- 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.