Fast-Track proposals will be accepted. Number of anticipated awards: 3-4 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.
The goal of this topic is to develop mobile applications for reporting toxicities after radiation therapy, either alone or in combination with other modalities in accordance with Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). Cancer survivorship is expected to improve over the next decade. Radiotherapy plays a major role in improving survival. However, cancer registries do not collect information on treatment-related toxicities; treatment-related adverse effects after radiation therapy are not being reported accurately. Therefore, mobile apps in accordance with PRO-CTCAE provided to patients for reporting of treatment-related toxicities with an interface to hospital-managed patient databases are needed. Such mobile apps would allow early reporting of toxicities by patients to their physicians, by which clinicians could intervene to provide appropriate treatment and better designs in future patient-centric clinical trials. These mobile apps will be made available for patients’ use at radiation oncology academic research centers and radiation oncology clinics around the world. This need, when filled, will ultimately help improve treatment outcomes.
Improvements and access to treatments around the world will result in improved survival of cancer patients. Radiotherapy, alone or in combination, plays a major role in the treatment of cancer. Currently, treatment decisions in radiotherapy/radiochemotherapy are primarily defined by disease stage, tumor location, volume, and patient co-morbidities, together with normal tissue tolerance for surrounding organs. As there are variations in sensitivities of individual patients and tumors to radiation, a substantial number of patients suffer from severe to life-threatening adverse effects, as well as debilitating late reactions. Acute side effects (e.g., skin reactions, mucositis, etc.) are often dose-limiting, but may be reversible in contrast to the late effects such as fibrosis in the lungs and cognitive decline, which are irreversible and progressive.
Consider: 1) Treatment-related toxicities are not being reported accurately and/or adequately by patients; 2) existing cancer registries often do not capture such information; 3) clinicians often underestimate the toxicity burden among patients; and 4) there is a post-treatment health-related quality-of-life (HRQOL) discordance among patients and clinicians. In this context, PRO-CTCAE, which is a patient-centric approach necessary for reporting adverse effects, is gaining importance.
Smartphone apps have become valuable tools in health care management for many diseases, but none addresses improving
patients’ HRQOL after radiotherapy/radiochemotherapy. A mobile app that interfaces with hospital managed patient
databases, and collects and archives toxicity data will allow clinicians to interact with their patients early to provide personalized care. Further, increasingly granular data driven by patient reports will also help clinicians to design better future clinical trials with active patient participation (patient-centric) in radiation oncology. The goal is to develop a mobile app for reporting toxicities for use with iOS and Android platforms.
In Phase I the contractor will define project needs and develop requirements by “mind-mapping” (i.e., collecting information to develop ideas and concepts via creative, logical, and hierarchical means towards the specific goal of developing mobile apps for surveillance of post-treatment toxicities) expert opinions on radiation therapy-induced normal tissue toxicities in accordance with PRO-CTCAE. Treatment-related toxicities will depend on patient profile, organ/site, disease stage, tumor type, treatment, volume, location, and patient co-morbidities. Contractors may address toxicities related to the treatment of a specific organ/site or inclusive of all organ/sites. Project documentation, proposed functionalities, specifications, and technical documents are essential. Activities will also include designing the application, coding, framing, developing screens, and delivering a prototype app on iOS and/or Android platforms, and then conducting a small-scale usability test with at least 25 cancer patients.
Phase II activities will include further development, refinement, and validation of the app. Specifically, these activities are refinement of coding, based on Phase I usability testing, interfacing with databases, and integration of analytics (e.g., tracking
download numbers; identifying, reporting, and eliminating bugs; requesting features; etc), as well as introducing additional features. Such additional features may include developing a module for social networking among patients and their families to develop a support structure and assist clinicians in designing patient-centric clinical trials. Contractors must validate the product with an expanded “large-scale test” with the appropriate radiation therapy patient groups of interests and identify potential customers for marketing. The number of patients required for validation should be determined in consultation with a biostatistician and proposed to NCI by the offeror.
Activities not supported by this topic:
Any proposal that does not address specific goals of addressing normal tissue toxicity induced by radiation therapy alone or in combination with other treatment modalities will not be considered for funding.
Phase I Activities and Deliverables:
Develop application requirements and proto-type in iOS and/or Android platforms.
Establish a project team, including expertise in: mobile app development, radiation oncology specific to the treatment of at least one anatomical tumor location/site, and relevant adverse effects related to a specific tumor site or all sites. Demonstrate verifiable knowledge and design of systems architecture, health IT interoperability, data security and HIPAA and other laws and regulations to protect privacy and confidentiality of patient information will be essential.
Conduct a focused workshop with appropriate key opinion leaders (consisting of no more than 12 experts) to deliver a definitive list of reportable normal tissue toxicities in accordance with PRO-CTCAE. The list should attribute toxicities based on pre-defined patient profiles, a specific disease site or multiple sites, disease stage, tumor and treatment type, treatment volume, patient co-morbidities, etc.
In consultation with NCI, develop requirements for mobile application(s).
o The app must be able to assist clinicians to better design patient centric future clinical trials.
Deliver project documentation – functionalities, specifications, and technical documents.
Create application design, framing, screens, and coding.
Deliver product requirement documentation to NCI.
Develop a prototype mobile application on the iOS and/or Android platforms.
Design app to address potential users including radiation oncology/cancer clinics, academic/research/clinical centers,
individuals within healthcare systems, health insurance companies and health IT departments.
Perform small scale usability testing with at least 25 cancer patients.
[Note: The offeror may be required to be meet compliance with HIPPAA privacy act policies.]
Phase II Activities and Deliverables
Develop and refine applications for use in iOS and/or Android platforms. Refine coding, interface with databases, and introduce features and functionalities. Refine the prototype based on Phase I usability and internal testing results. Integrate analytics (to track downloads, identify bugs, opportunities to improvise, etc.). Introduce and refine features, and eliminate bugs. Validate the product with an expanded testing with a larger cohort for adverse effects related to the treatment of a
specific tumor site or all tumor sites.
Product features could also allow social networking to develop support structure among patients and their families
based on patient-reported symptoms.
Provide letters of interest from potential customers.
Provide letters of commitment to purchase the product from customers.
Provide letter of acceptance of the product by the iOS and/or Android platforms.
The offeror will be required to be meet compliance with HIPPAA privacy act, IT security, and compliance policies.