Risk-stratified cancer survivorship care tailors follow-up care based on the level of need of the survivor (e.g., risk for recurrence, subsequent malignancies, physical and/or psychosocial sequelae). This Notice of Special Interest informs current National Cancer Institute (NCI) grant awardees that the NCI is seeking supplement applications that develop and/or validate algorithms that categorize survivors into meaningful risk-stratified groups in order to inform appropriate follow-up care.

Background

In 2019, there were an estimated 16.9 million cancer survivors in the United States (U.S.), and this number is projected to grow to over 26 million survivors by 2040. Unfortunately, it is anticipated that the exponential growth in the number of cancer survivors will not be matched by a proportional increase in the number and availability of oncology healthcare providers. Many survivors lack a clear pathway for care after cancer treatment, and often remain in oncology providers’ care for longer than is clinically necessary. To relieve the impending burden of survivorship care that is likely to increase in the near future, and to ensure that survivor needs are appropriately managed, new models of survivorship care are needed. Risk-stratified models of survivorship care, where follow-up care for survivors is tailored based on factors such as risk for adverse outcomes, risk for recurrence, and functional ability, offer a possible solution. For example, cancer survivors diagnosed with early stage disease who are at lower risk for such issues may benefit from care delivered in part by providers other than oncology specialists (e.g., Primary Care Providers, Advanced Practice Practitioners, nurse-led follow-up clinics). Conversely, survivors with higher levels of needs would benefit from more intense follow-up care delivered by specialist providers. Although risk-stratified survivorship care models have been partially implemented in other countries, there is currently no evidence-based algorithm that identifies low-, medium-, and high-risk survivors for risk stratified survivorship care in the U.S.

Through this Notice, NCI is indicating interest in supplement applications that propose methodological approaches to identify individuals within low-, medium-, and high-need groups in a risk-stratified survivorship care algorithm. This work will inform future development of risk-stratified care pathways based on developed algorithms. Applications will be asked to utilize existing parent study data alone or in conjunction with data from other sources (e.g., electronic medical records, cancer registry data, claims data).

Please note the following:

1. This supplement call is focused on adult cancer survivors, including adult survivors of childhood cancers.
2. Applicants may propose the use of a single cancer or multiple cancer types. Applications that propose algorithms for one cancer type should address how this approach may serve as a prototype for other types of cancer.

Eligibility

Administrative supplement applications are limited to currently funded projects supported by NCI. Individual(s) must hold an active eligible grant (R01, U01, R37, P01, U19, or UM1). For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.

Description of circumstances for which administrative supplements are available.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in theSF424 (R&R) Application GuideandPA-18-591must be followed, with the following additions:

• Application Due Date:Submissions must be received by May 15, 2020,at 5:00 PM local time of applicant organization for FY 2020 funding.
• For funding consideration, applicants must include “NOT-CA-20-038” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Applicantsshouldbegin the supplement application abstract by stating“This application is being submitted in response to theNotice of Special Interest (NOSI) identified as NOT-CA-20-038.”

• Budget and Period of Support:

• Administrative supplements must support work within the scope of the original project of the eligible parent award.
• NCI will consider application budget requests of no more than $150,000 in total costs and budgets must reflect the actual needs of the proposed project.
• The project and budget periods must be within the currently approved project period for the existing parent award. The application budget is limited to 1 year only. Requests for no-cost extensions on the parent grant to accommodate a supplement will not be permitted.
• Salary support for the PI(s) and collaborators may be considered with strong justification. Salary for general study oversight is not permitted.

• The Research Strategy should not exceed five (5) pages. The Research Strategy should summarize the activities of the parent grant that encompass those proposed in the supplemental request and describe how those activities are proposed for augmentation and/or enhancement in the supplemental request by describing:

• The supplement's purpose;
• The relationship of the supplement request to the parent grant;
• How the application provides additional value to the underlying research (parent grant) of the PD(s)/PI(s) and the collaborating investigators; and
• Activities to be covered by the supplemental funding, including methodological development and/or validation of algorithm(s) for risk stratification.

• NCI requires applicants to submit electronically through Grants.gov. All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package with the Competition ID of “FORMS-E-ADMINSUPP-RESEARCH”
• The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.

Applicants should also inform Dr. Michelle Mollica ([email protected]) and Dr. Lisa Gallicchio ([email protected]) of the submission to ensure correct routing.

Administrative Review Process:

NCI will conduct administrative reviews of applications submitted to this Notice and will support the most meritorious applications submitted for consideration, based upon availability of funds.

NCI staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of the award. Primary considerations include, but are not limited to, the following:

• Scientific merit of the proposed study;
• Potential of the project to develop and/or validate a risk-stratified algorithm for cancer survivorship care;
• Potential of the developed algorithm to be utilized to inform care pathways for survivorship care; and
• Innovation of the research.

Additional selection factors include:

• Relevance of the proposed study to the parent grant;
• Adequate progress of the parent grant appropriate to the current stage of the project;
• Appropriate and well-described plan to accomplish goals within the time frame proposed;
• Expertise of the research team to conduct and achieve the goals of the supplement aims;
• Appropriateness of the budgets in consideration of the study proposed and the research environment for the scientific projects; and
• Feasibility of the project as proposed.