Fast-Track proposals will NOT be accepted. Direct-to-Phase II proposals will NOT be accepted. Number of anticipated awards: 2-3 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 Next-generation sequencing (NGS)–based technology has lowered the cost of testing for genomic alterations in a patient's cancer and is now commercially available from many diagnostic laboratories. Due to increasing numbers of approved or investigational targeted therapies, cancer patients are more routinely undergoing tumor/somatic genetic testing at the time of diagnosis or progression. Although the decision to undergo tumor/somatic testing can have profound medical implications for patients, oncology providers traditionally have not been trained to interpret and communicate NGS results. Yet, they are increasingly advised by professional societies to consider NGS testing, and thus face the need to counsel patients about generated results. Published data indicate that the growing uptake of NGS in cancer care has left many oncology providers inadequately prepared to discuss the complex and potentially hereditary implications of such testing. Often, clinicians lack not only the expertise but also the time needed to counsel cancer patients about whether to undergo tumor/somatic testing, and the layered implications of test results. Tumor/somatic testing creates several added responsibilities for oncology providers such as guiding follow-up care - including clinical trial options - and facilitating communication within families. The need for assistance is particularly acute in low-resourced settings that lack access to geneticists, genetic counselors, tumor boards, or other such consultation. Indeed, clinicians in such lower resourced oncology settings face unique challenges discussing NGS testing with cancer patients. Tools, technologies and/or services are needed to help providers: (i) evaluate the benefits of somatic/tumor testing for their individual patients, (ii) understand and interpret test findings, including potential familial implications for suspected inherited cancer and (iii) communicate findings with their patients both before testing (to obtain truly informed consent) and after testing (to explain results). Such products must be integrated with current care models and be easily accessible to oncology providers given the time constraints of medical practice. These tools or technologies must distill complex genomic data so that oncology providers appropriately implement tumor/somatic genomic testing in the context of evolving National Comprehensive Cancer Network (NCCN) guidelines. They should also provide information in a legible format to facilitate patient comprehension and engagement in decision-making. Companies should incorporate provider and community input into the design of these products, to ensure utility and uptake. Project Goals The goal is to design and develop products such as tools, technologies, and/or services to: (i) inform oncology providers about tumor/somatic testing and current NCCN guidelines, (ii) help oncology providers evaluate the need for tumor/somatic testing for specific cancer patients, (iii) assist oncology providers with interpretation of tumor/somatic test results, including the impact of incidental germline findings, and (iv) help oncology providers communicate NGS results to their patients. Interpretation of NGS results must be personalized for individual patients. Products that cater to settings with limited or no access to genetic counselors, or on-site tumor boards, are encouraged. Products should: (i) identify strategies for enhancing provider understanding of cancer genomic test results; (ii) assist with provider communication of test results in a clear and lay-friendly manner, to aid both treatment and life planning decisions; (iii) inform providers about genetic counseling and clinical trial resources for their patients; (iv) offer remote technology applications such as video and telephone guidance; and (v) incorporate perspectives of populations experiencing disparities in cancer outcomes, such as minority and rural communities. In addition, contractors must evaluate, pilot and disseminate the product. The product(s) should aim to accomplish as many of the following as primary goals: • provide a resource for improving knowledge of somatic genetic testing for oncology health care providers; • assist health care providers to evaluate patients and determine need of genetic testing; • facilitate interpretation of somatic genetic test results (include noting germline findings vs. somatic findings and flagging germline variants for possible follow-up), using existing clinical guidelines, available resources and established standards to help health care providers understand medical and familial implications of test results; Page 81 • promote communication of genetic test results in a clear and lay-friendly manner, to assist with treatment or life planning decisions; • explain to health care providers how and why information on variants of unknown significance may evolve over time and provide guidance about how to communicate this information to patients; • provide a discussion guide to facilitate communications regarding genetic results with providers and related family; • inform health care providers about genetic counseling resources they may provide to their patients; • offer options for video and telephone guidance if a patient is located in a remote setting; and • include and incorporate perspectives of populations experiencing disparities in cancer outcomes, such as minority, underserved and rural communities as well as identify and meet needs that would improve use and access for understanding cancer genomic test results. Some recommended practices for product development include: • Including patients’ and families’ perspectives in deciding when, whether and how to communicate specific genetic findings, and when to offer genetic counseling and confirmatory testing based on counseling. This could be accomplished using the principles and elements of a design thinking approach focused on designing the communication strategies for oncology care providers from the perspective of the patients, in an agile, iterative way. • Considering a range of cancer treatment scenarios to elicit a broad range of provider needs that can inform tool development. This range includes pediatric, adolescent and young adult as well as adult cancer types. • Assembling trans-disciplinary teams that include but are not limited to geneticists, genetic counselors, behavioral researchers, psychologists, oncologists as well as patient navigators, patient advocates, and user experience designers to inform development and validation of tools. • Planning for pilot implementation testing of the tool in clinical or other applicable settings as the tool is developed. The following would be considered out of scope: • Methodologies of genetic counseling that do not focus on development of provider-facing tools • Methods, reports, and tools that include only germline genetics/genomics • Genetic testing services • Reports and tools requiring genetic testing services be conducted by offeror Phase I Activities and Deliverables: The goal of Phase I is to design and develop tools, technologies, or products to 1) inform the user about the role of tumor (somatic) genetic testing and counseling in cancer research and treatment 2) aid understanding and interpretation of somatic genetic findings; 3) aid in effective communication of tumor (somatic) genetic test results. • Establish a project team with expertise in the area of genetic counselling, software development, user-centric design, oncology, patient navigation as appropriate for this proposed project. • Conduct or utilize formative/exploratory research during the trial period to identify barriers and facilitators faced by physicians in staying up to date regarding genetic testing best practices and regulations, understanding test results (and evolution of results as more is known about impact of specific genetic variants/somatic mutations), and accessing counseling resources based on currently available platforms for genetic counselling. • Develop a prototype tool or technology based on formative research, to explain genetic tests and test result to physicians for them to provide to their patients. This could be a tool/technology for physicians, a communication tool for physicians to use, and/or a tool/technology to support remote genetic counseling or use of other educational resources. It should have a physician and counselor interface to meet the goals of genetic testing and counseling while maintaining confidentiality. Prototype must include - o The database structure for the proposed platform, user-interfaces, and metadata requirements; o Data visualization, data query functions, feedback and reporting systems; o Data adaptation for mobile application(s) if applicable; o Ability to generate lay-friendly reports of genetic testing results that health care providers may use and are understandable to patients; o Ability to continuously incorporate new information on genetic variants for physicians to update their patients as necessary (i.e. when it impacts clinical care or has familial implications). • Identify at least one clinical setting where the tool may be used and integrated within a research or practice setting and develop process maps and algorithms to set up appropriate data flows and ensure privacy protections. • Test the feasibility /usability of tool in a sample population of physicians and patients and providing written report and recommendations on the best practices for use of the tool in research and practice settings. Deliverables for this Phase include: Page 82 • Prototype design • Demonstration of the tool and practicality of use by patients, counselors and providers • Provision of technical specifications as well as an operations/user guide for the tool • Outline of metrics that can be used to assess the successful application of the tool Phase II Activities and Deliverables The goal of Phase II is to evaluate application of the tool as well as pilot and disseminate in an ongoing research project or community practice setting after procurement of needed human subjects and operational approvals. Finally, a plan for commercialization based on the pilot should be developed. In order to meet these goals, the offeror will • Outline a plan to use the tool, technology, or product in practice settings. • 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 healthcare providers, electronic health records, and health surveillance systems as appropriate for the proposed project. • Refine prototype and scale up. • Perform an evaluation of the interpretation of genetic results by comparing to gold standard guidelines for interpretation. • Design and conduct a validation study including specifying study aims, participant characteristics (physicians and patients), recruiting plans, primary and secondary end points and data analysis plans. The validation study should evaluate physician communication of results and patient understanding of information communicated by the physician. • Prepare a tutorial session for presentation at NCI and/or via webinars describing and illustrating the technology, its intended use and results from the validation study. • In the first year of the contract, provide the project and contract officers with a letter(s) of commercial interest. • Provide the project and contract officers with a letter(s) of commercial commitment. Deliverables and activities include: • Validated tool, technology or product that has been successfully used in active research or community settings by physicians or health care providers. • Metrics demonstrating that physicians/health care providers understand information provided, and patients understand materials communicated by physicians. • Finalized user guide and operations manual for use of tool within an active research study. This will include technical specifications, process guides/flow charts for how and by whom the tool will be used. • Finalized trouble shooting guide as well as frequently asked questions. • Analysis and discussions from exit interviews of study participants, physicians and counselors to understand and improve utility and usability of tool in a practical setting. • A plan to develop the tool commercially and disseminate it to the wider research and practice communities.