Fast-Track proposals will 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 9 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 and covered by an increasing number of insurers. Due to increasing numbers of approved or investigational targeted therapies for cancer, patients are more routinely undergoing tumor or somatic tissue NGS testing at the time of diagnosis or progression. Oncology providers, particularly in low resource settings, need tools to interpret, appropriately utilize, and communicate with patients about NGS somatic test results. Unfortunately, the uptake of NGS testing in cancer care has grown faster than the oncology field’s understanding of somatic and tumor testing, and the dire shortage of genetic counselors has only served to exacerbate the problem. Many oncologists and other cancer providers lack time or expertise to interpret the results of NGS testing, and to counsel patients meaningfully about test implications. Published data indicate that providers are often at a loss for how to interpret somatic testing and have few resources for assistance, especially in low resource community settings. Yet, patients’ decisions about whether to undergo NGS tumor testing, and understanding of their test results can have profound medical, psychological and familial implications. Furthermore, NGS testing creates added responsibilities for the patient’s health care provider team beyond interpretation and communication of results to patients, such as guiding follow-up management, and facilitating communication to family members. Oncology health care providers have traditionally not been trained in the use of tumor or somatic testing technologies; yet, they are increasingly advised by professional societies to consider NGS testing and determine how to inform patients about these tests and the generated results. Resources are needed to help providers: (i) evaluate the need for somatic/tumor testing for their individual patients, (ii) understand, interpret and explain test findings, and (iii) communicate with their patients both before testing (to obtain truly informed consent) and after testing (to explain results). The need is particularly acute in low-resource settings where patients are more often treated by primary care physicians or other providers without access to tumor boards or experts in Precision Oncology. In settings without access to genetic consultants, clinicians face unique challenges communicating with patients about tumor test results that are suggestive of incidental germline findings. Tools are needed to provide high quality information and interpretation of patient NGS test results to health care providers in communities with limited access to genetic counselors, to enhance utilization of NGS testing in such areas, and to assist with point of care decision-making by clinicians. Such tools must be integrated with current care models and be easily accessible to providers given time constraints and other realities of medical practice. These tools must also provide complex information in a clear format so that providers can facilitate patient understanding and improve patient engagement in informed decision-making about their health. Companies should incorporate field testing, including patient and provider input into the design of these tools, to ensure utility and uptake. Project Goals The goal is to design and develop tools, technologies, or products to: (i) inform oncologists and other health care providers treating cancer patients in settings with low access to genetic counselors about NGS testing and current NCCN guidelines, (ii) help such providers evaluate the need for NGS somatic testing for their cancer patients, (iii) assist providers with interpretation of NGS results (including distinguishing between somatic and incidental germline findings), and (iv) help providers communicate NGS results to their patients. Interpretation of NGS results must be personalized for individual patients. Tools that cater to settings with limited or no access to genetic counselors are encouraged. Tools should: (i) assist providers with communicating test results in a clear and lay-friendly manner, to aid patients’ treatment or life planning decisions; (ii) inform providers about genetic counseling resources for their patients; (iii) offer options for video and telephone guidance, especially for patients located in remote settings; (iv) incorporate perspectives of populations experiencing disparities in cancer outcomes, such as minority, underserved and rural communities; and (v) identify strategies for enhancing access to tools for understanding cancer genomic test results. In addition, contractors must evaluate, pilot and disseminate the tool. Some recommended practices for tool development include: 1. 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. 2. 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. 3. 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. 4. 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: 1. Methodologies of genetic counseling that do not focus on development of provider-facing tools 2. Methods, reports, and tools that include only germline genetics/genomics 3. Genetic testing services 4. Reports and tools requiring genetic testing services be conducted by offeror Phase I Activities and Deliverables • Establish a project team with expertise in the area of genetic counseling, 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 oncology providers 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 counseling. • Develop a prototype tool or technology based on formative research, to explain to oncology providers the basis for somatic testing and the meaning of test results. This could be a tool/technology for enhancing provider understanding, a communication tool for providers to use with patients, and/or a tool/technology to support remote genetic counseling or use of other educational resources. It should have an oncology provider and counselor interface to meet the goals of genetic testing and counseling while maintaining confidentiality. Prototype must include 1. The database structure for the proposed platform, user-interfaces, and metadata requirements; 2. Data visualization, data query functions, feedback and reporting systems; 3. Data adaptation for mobile or tablet application(s) if applicable; 4. Ability to generate lay-friendly reports of genetic testing results that health care providers may use and are understandable to patients; 5. Ability to continuously incorporate new information on genetic variants for oncology providers to update their patients as necessary (i.e. when it impacts clinical care or has familial implications). 6. Incorporate and adhere to current data privacy and security standards • 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 oncology care providers 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: • Prototype design • Demonstration of the tool and practicality of use by end users • Provide technical specifications as well as an operations/user guide for the tool to NCI • 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 (providers and patients), recruiting plans, primary and secondary end points and data analysis plans. The validation study should evaluate oncology provider communication of results and patient understanding of information communicated by the oncology provider. • 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 oncology care providers. • Metrics demonstrating that oncology care providers understand information provided, and patients understand materials communicated by providers. • 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, oncology care providers 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.