December 11, 2020
PAR-21-035 - Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)
PAR-18-869 - Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional)
PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
PAR-19-274 - Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)
National Cancer Institute (NCI)
The purpose of this Notice is to highlight the NCI Division of Cancer Control and Population Sciences’ interest in receiving applications focused on identifying important factors for defining risk-stratified survivorship care or developing and testing approaches to improve the clinical management and outcomes for adult cancer survivors using risk-stratified survivorship care pathways.
Risk-stratified survivorship care describes a personalized approach to care in which cancer survivors are triaged or stratified to distinct care pathways based on the complexity of their needs and the types of providers their care requires.
The exponential growth of cancer survivors is projected to overwhelm the already overburdened oncology workforce and cancer care delivery system. Survivors are typically seen by their oncology team from diagnosis onward, and the transition of oncology-related follow-up care to other care providers after active treatment is often unclear and inadequately coordinated. This situation can lead to care delivery inefficiencies, under- or over- utilization of surveillance tests, and poorly managed cancer-related symptoms and co-morbid medical conditions. There is consensus that higher risk survivors (i.e., those who have a higher risk of recurrence, have received more toxic therapies, and/or have higher potential for symptom burden) will benefit from more intense follow-up from the oncology team. Conversely, cancer survivors who have been diagnosed with early stage disease and are at lower risk for adverse effects and recurrence may benefit from self-management tools and follow-up care where the oncology team partners with other providers, including the Primary Care Provider (PCP). Many professional organizations have recommended implementation of risk-stratified survivorship care, where the nature of follow-up care (type of provider(s), frequency of follow-up visits and surveillance, components of survivorship care delivered) is tailored based on the needs of the survivor. Overall, there is a lack of evidence-based algorithms to risk-stratify survivors for most types of cancer, and even among those cancer types where risk-stratified algorithms exist, there has been limited research evaluating the efficacy of risk-stratified care pathways.
Thus, the questions that survivors, clinicians, and health system leaders need answered are: (1) What factors/variables should be considered in a risk-stratified survivorship care pathway algorithm?; and (2) What is the effectiveness of implementing an existing risk-stratified survivorship care model on quality of care, survivor outcomes, and healthcare utilization?
NCI is interested in R01 studies that will advance the scientific understanding of the important factors for risk-stratified survivorship care pathways or will test the effectiveness of implementing an existing risk-stratified care pathway on quality of care, survivor outcomes, and healthcare utilization. Applications in response to this Notice may propose observational or interventional research. Observational research should focus on the development of a framework/algorithm and care pathway for stratifying cancer survivors based on factors such as treatment exposure, risk for recurrence, symptom burden, functional status, or other factors relevant to the study population and/or setting. Interventional research should focus on the development and evaluation of a risk-stratified care pathway for cancer survivors based on an existing framework/algorithm and on improvement of meaningful outcomes (e.g., patient-centered outcomes, healthcare utilization, care quality, and/or cost-effectiveness of care). Investigators may consider the use of hybrid implementation/effectiveness study designs if supported by prior research.
Applications that are submitted in response to this NOSI must:
Research encouraged through this Notice includes studies that propose to:
Applicants are encouraged to discuss their application with the scientific/research contacts listed in this notice prior to submission.
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent:
All instructions in theSF424 (R&R) Application Guide and the listed funding opportunity announcement must be followed.
For funding consideration, applicants must include "NOT-CA-21-019" (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.
Applicants are strongly encouraged to notify the NCI program contacts (Michelle Mollica, PhD, MPH, RN, OCN, and Lisa Gallicchio, PhD) via email (firstname.lastname@example.org and email@example.com) that a request has been submitted in response to this NOSI in order to facilitate efficient processing of the request.
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.