This Notice of Special Interest (NOSI) announces an opportunity for supplemental funding to active, eligible NCI-funded grants and cooperative agreements to support global cancer survivorship research. These administrative supplements are intended to support NCI-funded investigators to leverage existing relationships/partnerships with stakeholders in low- and middle-income countries (LMICs) to conduct research that will enhance understanding of the gaps in post-treatment follow-up care, with the goal of addressing physical and psychosocial needs of cancer survivors and their caregivers at the individual, facility, and systems levels.
Background
Overall improvement in early detection and treatment of cancer has led to an increase in survival. The NCI considers an individual to be a cancer survivor from the time of diagnosis through the balance of their life. Survivors include those living with cancer and those who are free of cancer. In the United States (US), there were 16.9 million cancer survivors in 2019, a number projected to increase to over 25 million in the next two decades. Evidence-based interventions delivered in community and hospital settings for cancer survivors in the US and other high-income countries (HICs) have demonstrated improved ability to detect post-treatment sequelae and cancer recurrence, enhance psychosocial support, and support better/improved quality of life.
By 2040, it is estimated that 64% of the globally projected 28 million new cancer cases and 16 million annual cancer deaths will occur in LMICs. Data from cancer centers in many LMICs suggests that the number of cancer survivors are increasing. These statistics reflect key trends in LMICs, including population growth and aging, environmental and lifestyle changes, and enhanced ability to detect and treat cancer. Well-resourced cancer centers in some LMICs report 5-year cancer survival rates for breast cancer patients that are comparable what is found for breast cancer patients living in HICs.
Despite growing numbers of cancer survivors in LMICs, cancer survivorship research is limited. The limited number of available descriptive studies from LMICs document several challenges faced by cancer survivors, including poor quality of life, high psychological morbidity, unaddressed needs of their caregivers, and poor translation of evidence-based strategies for cancer prevention and support. There are also substantial barriers to treatment uptake and completion among those affected, including cost, access, and psychosocial factors. In addition, few interventions are focused on cancer survivors and their caregivers.
Key definitions in the context of this notice
- Cancer Survivor: any individual diagnosed with cancer from the time of diagnosis through the balance of life.
- Pediatric Survivor: any individual diagnosed with cancer between 0-14 years of age.
- Adolescent and Young Adult (AYA) Survivor: any individual diagnosed with cancer between 15-39 years of age.
- Caregiver: Informal cancer caregivers are individuals who manage care for cancer survivors, usually a friend or family member. The care that they manage is typically uncompensated, delivered at home, and may involve performing clinical care tasks, communicating with healthcare professionals, assisting with activities of daily living, and providing psychosocial support.
- Survivorship Outcomes: late, long-term, or persistent behavioral, physical, and psychosocial adverse outcomes that result from cancer or cancer treatments.
- Low- and Middle-Income Countries (LMICs): LMICs are defined by the World Bank classification system, according to Gross National Income per capita. For this supplement opportunity, LMICs include upper middle-income countries.
Research Objectives
This supplement opportunity encourages research that focuses on cancer survivors (including adult, adolescent and young adult (AYA), and pediatric cancer survivors), their caregivers, and their healthcare providers. The parent award need not have included a cancer survivorship research aspect or question as part of their original scientific aims. However, the supplemental funding request must propose to enhance the already funded research project/program by incorporating a cancer survivorship aspect, and by including a global population, biospecimens, and/or data. Where appropriately justified, supplemental funding may be applied towards attaining adequate global populations for cancer survivorship research. Applicants are encouraged to leverage existing resources and partnerships, and to design projects that can reasonably be completed within the given time and budget.
Specific areas of interest include, but are not limited to the following:
- Studies to identify psychosocial, health literacy, and other supportive care needs of cancer survivors and their caregivers.
- Research to understand health behaviors of cancer survivors and identify strategies/opportunities for developing health promotion interventions.
- Qualitative and mixed-methods studies to understand treatment expectations and goals from clinical, survivor, caregiver, and health systems perspectives.
- Research that examines models and current practice of post-treatment surveillance and follow-up and identifies barriers and facilitators to intervention development.
- Research to identify individual level, health systems level, and structural factors that contribute to survivorship issues and impact survivorship outcomes including financial toxicity, social isolation, availability and access to pain relief, palliative care, and psychosocial services.
- Studies that seek to develop, adapt and/or evaluate data collection instruments and methodologies for survivorship research in diverse LMIC settings.
- Studies that examine context-relevant models of care and identify strategies to optimally utilize available personnel to provide services to cancer survivors and caregivers, which includes, but is not limited to, nurse-led, community health worker-led, social worker-led, and peer-led approaches, telehealth approaches, as well as involvement of patient navigators, traditional healers, community leaders, and providers in care coordination and support of cancer survivors and caregivers.
- Research to understand feasibility of non-health care settings to deliver interventions to cancer survivors including home and community-based care delivery models.
- Feasibility studies to understand adoption and adaption of evidence-based survivorship interventions including those that study multiple levels of care delivery.
- Analysis of policies, guidelines and national cancer control plans or non-communicable diseases plans for cancer survivorship to inform research needs, implementation processes, and development of metrics to realistically measure impact on patient outcomes (including physical, psycho-social, quality-of-life related, patient-reported, etc.).
- Investigations that focus on survivors of specific cancers to identify unique issues and needs for post-treatment surveillance, supportive care, psychosocial well-being, and improved quality of life.
- Secondary analysis of data, as well as evaluation of data collection processes, including use of data from cancer registries and studies to improve availability of information on cancer outcomes and survivorship.
- Research training that allows for curriculum development and mentored research relevant to cancer survivorship research in LMICs.
Applications responsive to this NOSI must:
- Focus on studying global cancer survivorship in LMICs; and
- Include LMIC-based investigators in the research team who are involved in the development of the research aims and in the performance of the research.
Applications not responsive to this NOSI include:
- Projects that engage collaborators only in high-income countries (HICs); and/or
- Projects that do not consider cancer survivorship as relevant to the LMIC(s).
Applicants are encouraged to discuss their application with the scientific/research contact person listed in this NOSI prior to submission.
Application and Submission Information
Applications for this initiative must be within the scope of the parent award consistent with its originally approved objectives and submitted using the following opportunity or its subsequent reissued equivalent.
- PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:
- Eligibility
- Administrative supplement applications from PDs/PIs are limited to currently funded and active R01, R21, R25, R33, R37, P01, P20, P30, P50, U19, U01, UH2, UG3, UH3, U54, or UM1 awards from NCI -- no other grant or cooperative agreement activity codes or mechanisms are eligible for this program.
- For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.
- NCI grants in an extension (or needing an extension in order to be eligible) at the time the award is made in FY21 are not eligible for this supplement. In other words, requests for no-cost extensions on the parent grant or cooperative agreement to accommodate a supplement will not be permitted.
- Only one supplement application per grant or cooperative agreement award will be accepted for consideration through this Notice.
- Only electronic submissions will be accepted for this funding opportunity. Use one of the methods described in PA-20-272. Paper submissions and applications submitted as email attachments will be rejected without review.
- Application Due Date: Submissions must be received by June 11, 2021, at 5:00 PM local time of applicant organization.
- Applicants should begin the supplement application abstract by stating This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA-21-058.
- For funding consideration, applicants must include NOT-CA-21-058 (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.
- Budget and Period of Support:
- The budget should not exceed $125,000 in direct costs for the entire allowable 1-year project period of the application/award.
- At least one full year on the parent grant must remain at the time of funding. The application budget is limited to 1 year only.
- Research Strategy (must not exceed three (3) pages): The attachment should summarize the activities of the parent award and describe how those activities would be augmented and/or enhanced through supplemental funding by:
- Describing the supplement's purpose, its relationship to the parent award (proposed research must be within scope of the parent award), and the additional value to the research in the parent award;
- Describing the proposed global population and/or data and how the applicant will access the same; and
- Justifying the cancer survivorship research question being investigated and how inclusion of the LMIC population and/or data will advance the understanding of cancer survivorship and/or interventions that address it.
- Administrative Review Process: NCI will conduct administrative reviews of submitted applications and will support the most meritorious applications based upon the programmatic priorities and availability of funds, using the following criteria:
- Are the proposed activities relevant to the parent grant and original work scope?
- Does the proposed project address a knowledge and/or research gap in global cancer survivorship research?
- Does the proposed project appropriately justify the proposed LMIC research focus?
- Does the proposed project for supplemental funding include, and appropriately justify the inclusion of the global population and/or data?
- Does the applicant demonstrate reasonable access to the appropriate populations or datasets?
- Is the project design scientifically rigorous and serve the needs of the target population?
- Does the proposal demonstrate the feasibility of accomplishing project goals within the time and budget?
Applicants are strongly encouraged to notify the program contact at the NCI that a request has been submitted in response to this NOSI to facilitate efficient processing of the application.
