NIH/NCI 449 – Wearable Technologies to Facilitate Remote Monitoring of Cancer Patients Following Treatment

Fast-Track proposals will be accepted.

Direct-to-Phase II proposals will be accepted.

Number of anticipated awards: 3-5

Budget (total costs, per award):

Phase I: up to $400,000 for up to 12 months

Phase II: up to $2,000,000 for up to 2 years

Proposals that exceed the budget or project duration listed above may not be funded.

Summary

The growing sophistication of wearable device technologies coupled with recent advancements in machine learning, and other complex informatics approaches for biometric data analysis, have created new opportunities to develop tools capable of supporting clinical management of cancer patients during treatment. The goal of this contract topic is to accelerate the combination of wearable sensors, and other remote monitoring technologies, with sophisticated analytical approaches and user interfaces that allow patients to be remotely monitored for cancer- or treatment-related adverse events (e.g., acute chemotherapy-induced toxicities). Such technologies would offer complete solutions (e.g., hardware and software) to allow healthcare providers the ability to monitor a patient in real-time and preemptively mitigate adverse events when needed. A clear opportunity exists to substantially improve patient care and expand the footprint of clinical trials (decentralized) to more patients (e.g., medically underserved, rural, and more).

Project Goals

The goal is to improve the availability of remote monitoring tools for patients and their clinical care teams during sensitive periods of cancer treatment. Commercially available activity monitors that rely on accelerometer- and photoplethysmography (PPG)-based sensor technology (e.g. Fitbit or Apple Watch) have become increasingly more reliable to track measures like sleep cycles, exercise, fatigue, etc. These devices have expanded even further to include measurement of common vital signs such as heart rate, blood oxygen saturation, electrocardiograms, and more. However, they generally lack the ability to track vital clinical information with sufficient accuracy to serve clinical management teams who monitor a patient’s tolerance and overall reaction to therapy. Moreover, validation of data produced by these devices as actionable signal or linking to specific intended uses for cancer patients undergoing treatment is still needed to solidify their clinical use. New remote monitoring approaches are needed to assess a patient’s vitality and any deteriorating levels sufficiently early to allow earlier release of patients from costly hospital confinement while ensuring they can return to the clinic in time to manage adverse events. Beyond measurement capabilities, a robust user platform that connects and informs the clinical team while offering patients an intuitive user interface is also required. Commercial wearable devices and the smartphone and tablet apps developed to interface with them have pioneered effective, user-centered designs for the consumer market, thereby paving the way for new platforms that can enable remote clinical monitoring. Another emerging trend that has reduced the technical hurdles for this field is the advancement of novel machine learning and “deep learning” analytical approaches that can help overcome signal-to-noise challenges associated with biological signals measured by non-invasive wearable or ambient monitoring devices.

The expected activities under this topic should combine and validate emerging wearable and/or ambient, passive remote monitoring technologies with suitable analytic approaches focused on a well-defined cancer treatment scenario with documented adverse event risks, where effective remote monitoring is enabled through an appropriate user interface that serves the needs of both patients and clinical care teams, to actively monitor cancer patients during sensitive periods of their care. Fundamentally, this proposed contract topic would require tools, or suites of tools, that report objective clinical information to be delivered to the clinical care team (e.g., clinical decision support), for patients supported in the ambulatory setting. Projects may include activities leading to the development of a new device or hardware, or they may leverage existing devices capable of capturing relevant physiological measurements. The primary goal of this topic is the development of a complete remote monitoring capability that includes software and/or analytics capable of supporting clinical decision-making and patient care.

Activities not responsive to announcement:

Tools that don’t focus on an identified clinical cohort and associated treatments with at least some assessment of adverse event risks relevant to those patients that could be monitored with the identified wearable technology(s) proposed; approaches that seek to address cancer prevention or early detection of cancer; and applications from teams that don’t include clinical collaborators or lack relevant technology development expertise.

Phase I Activities and Deliverables:

Provide a clear description for the patient treatment monitoring scenario being targeted, including a description of the patient population being targeted, the kinds of treatments, and their known and/or suspected adverse effects that are being tracked in current clinical work practices. Examples could include (but are not limited to) conditions like neuropathy, depression, pain, etc. Offerors should provide a description for the anticipated improvement in patient outcomes that are anticipated, should the proposed monitoring technology be successful (as proposed).
Establish a project team including proven expertise in both the technology and methodology to be developed as well as clinical research.
- Technology team members should include expertise in sensor technology for physiological monitoring, wireless sensor integration with mobile devices, secure wireless transport of health data using standards-based protocols, secure cloud computing models, bioanalytical technologies, epidemiology, biostatistics/bioinformatics, machine learning, and deep learning, and systems architecture.
- Clinical team members should include expertise in oncology, nursing, and clinical trials management.
Select and validate a suitable wearable monitoring device(s) needed to assess required patient measures needed to monitor patient’s fitness and detect signs of patient deterioration. Alternatively, describe a plan to build and test a wearable device appropriate for the features/biomarkers to be measured. The offeror must propose detailed quantitative performance benchmarks that will be achieved to demonstrate robust capabilities for each of the attributes being measured and tracked. The demonstration deliverable for Phase I should include testing with at least 5 individuals/patients.
Design and conduct a needs assessment to ascertain a breadth of relevant use cases and appreciate the potential and challenges for adoption of the proposed technology.
Develop and validate the analytical methods necessary to assess patients’ fitness and detect signs of deterioration while monitoring the selected wearable device(s) in “real world conditions” over extended time periods (at least 72 hours continuous).
Develop the appropriate data visualization, feedback, and reporting systems for clinical monitoring.
Develop a functional prototype system. Establish user design and user experience wireframes as the basis for the user interface platforms that will ultimately be utilized by the patient being monitored and clinical care team members. The offeror must design a system that provides ease of use, including features that demonstrate user design features that accommodate the often busy and complex work environment for the clinical care team monitoring the patient and also the intuitive and enjoyable ease-of-use features needed to empower the patient being monitored.

Phase II Activities and Deliverables:

Design and perform properly powered clinical studies in relevant cancer populations to establish the clinical utility and performance of the prototype system.
Conduct usability testing of consumer/patient-facing mobile applications and any associated web portals and care team/researcher-facing user interface features developed in Phase I, including system management, analyses, and reporting applications.
Engage user testing with at least 30 patients utilizing the wearable monitoring device(s) and at least 3 distinct clinical care teams working with those patients (no members of any one clinical care team can be part of any of the other clinical care teams, to ensure a diversity of “real world” testing demonstrations).
Establish an appropriate mechanism (e.g., surveys) to receive ongoing feedback from health care providers to refine processes and protocols that will enable successful integration into clinical workflows.
Develop a scaled manufacturing and production plan for the wearable monitoring device(s) package (inclusive of the user apps and data analysis elements)
Present an appropriate regulatory plan consistent with intended use.

Receipt date: November 4, 2022, 5:00 p.m. Eastern Daylight Time

Apply for this topic on the Contract Proposal Submission (eCPS) website.

For full PHS2023-1 Contract Solicitation, c lick here.