Funding Agency: National Cancer Institute
This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research. The purpose of this FOA is to increase case ascertainment and optimize delivery of evidence-based healthcare for individuals at high risk of cancer due to an inherited genetic susceptibility. Specifically, this FOA targets the following area designated as a scientific priority by the Blue Ribbon Panel (BRP) Recommendation E: "To realize the potential of cancer prevention and early detection in our nation, NCI should sponsor an initiative to improve the current state of early detection, genetic testing, genetic counseling, and knowledge landscape of the mechanisms and biomarkers associated with cancer development. This initiative should include demonstration projects that will show how cancer screening programs can simultaneously save lives, improve quality of life, and reduce healthcare costs."
This Funding Opportunity Announcement (FOA) invites U01 application for projects aimed at identifying best practices to improve case ascertainment of hereditary cancers, with the goal of improving prevention and detection.
Beau Biden Cancer Moonshot Initiative: NCI convened the Blue Ribbon Panel (BRP) in 2016 to provide recommendations for achieving the Cancer Moonshot's ambitious goal of making a decade's worth of progress in cancer prevention, diagnosis, and treatment in just 5 years, now called the Beau Biden Cancer MoonshotSM Initiative. The BRP was charged with assessing the state of the science in specific areas and identifying major research opportunities that could uniquely benefit from the support of the Cancer Moonshot and could lead to significant advances in our understanding of cancer and in how to intervene in its initiation and progression. The recommendations focused on areas in which a coordinated effort could profoundly accelerate the pace of progress in the fight against cancer and were not intended to replace existing cancer programs, initiatives, and policies already underway. The BRP final report was approved by the National Cancer Advisory Board and included a recommendation for Cancer Prevention and Early Detection in Individuals at High Risk for Cancer. The 21st Century Cures Act was signed into law in December 2016 dedicating new funds to support efforts associated with the Beau Biden Cancer MoonshotSM Initiative, including support for this FOA.
Applications submitted to this FOA should focus on methods to increase case ascertainment and delivery of evidence-based healthcare for individuals at high risk of cancer due to an inherited genetic susceptibility.
Specifically, the FOA aims to foster and advance scientific efforts focused on:
1) developing and testing strategies to increase case ascertainment of hereditary cancers through different approaches;
2) developing, testing, and adopting evidence-based healthcare delivery models for hereditary cancer prevention and detection;
3) testing sustainable implementation strategies across at least 2 healthcare settings or populations;
4) studying the behavioral and psychosocial outcomes of counseling and testing on at-risk individuals and the impact on their follow-up care, and
5) identifying how the healthcare delivery approaches can be sustained.
To accomplish the overall goals, the FOA supports studies that develop and test care delivery models to:
1) identify those at risk of developing hereditary cancer syndromes;
2) identify approaches to the delivery of genetic counseling, testing and preventive care to high-risk individuals;
3) focus on a variety of populations and care settings; and
4) develop strategies to provide counseling and interpretation of results for high risk families.
To meet the research goals of this program, the research applications will be expected to:
- Develop, test and adopt strategies to increase case ascertainment and improve evidence-based healthcare delivery for individuals with an inherited susceptibility to cancer;
- Focus on multiple hereditary cancer syndromes;
- Include at least two different healthcare settings or population groups;
- Compare more than one strategy which may include usual care; and
- Consider how the interventions can be implemented and sustained.
Research questions of interest may include, but are not limited to, the following:
- What strategies (e.g., targeting one or more of patient, provider, family, and healthcare setting) and complementary approaches (e.g., tumor-based testing and family history-based ascertainment) will improve case ascertainment for individuals with an inherited susceptibility to cancer in a variety of healthcare settings (e.g., solo or small group practices, large group and integrated healthcare practices to tertiary care settings) or across diverse populations (e.g., urban, rural, socioeconomic groups, minority groups)?
- What are the best strategies for identification, counseling, testing, and management of at-risk relatives in a variety of healthcare settings? How can these be widely adopted and sustained?
- What are the best practices for provision and coordination of follow-up care for the proband and at-risk relatives, including care transitions (e.g., pediatric to adult), with the greatest impact on adherence?
- How can technology be utilized to improve case ascertainment, consenting, testing, follow-up adherence, and registry development?
- What are the optimum strategies for reaching diverse communities such as rural, racial/ethnic minorities and low-socioeconomic groups?
- What are the best practices for genetic counseling and informed consent for testing?
- How can the behavioral and psychosocial impact of genetic testing on the individual and/or family be assessed and addressed effectively in the healthcare delivery setting?
- What strategies are needed to train and support a workforce capable of improving case ascertainment, cascade screening, and follow-up care in healthcare systems?
This FOA solicits multiple principal investigator (multi-PI) applications, with academic expertise to interpret and validate the success of the ascertainment strategies. This approach will provide complementary multidisciplinary expertise to cover the multifaceted challenges of care coordination in this patient population. Although each U01 will be an independent entity, funded investigators will meet annually to share knowledge and data to inform care delivery to high-risk populations.
Letter of Intent Due : December 9, 2017
Application Due: January 9, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date. No late applications will be accepted for this Funding Opportunity Announcement. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).