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PA-20-183 - NIH Research Project Grant (Parent R01 Clinical Trial Required)

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PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)

PAR-20-077 - National Cancer Institute Program Project Applications (P01 Clinical Trial Optional)

Issued by

National Cancer Institute (NCI)

Purpose

The purpose of this Notice is to highlight the interest of the National Cancer Institute (NCI) Division of Cancer Control and Population Sciences (DCCPS) in receiving applications to understand and address the full spectrum of factors that contribute to disparities in survivorship care, healthcare utilization, and health outcomes among childhood cancer survivors. Studies that focus on factors that extend beyond the individual (e.g., survivor, caregiver, clinician) to include an examination or intervention that involves healthcare teams, healthcare system, community, payer, and/or policy-level factors that contribute to disparities in health outcomes and result in inequitable survivorship care are strongly encouraged.

Key definitions:

• Childhood cancer survivor: Any individual who was diagnosed with cancer before the age of 19.
• Health outcomes: Any physical, social, or psychological state that occurs as a result of a health condition or associated treatment. For cancer survivors, health outcomes may result from their cancer, anti-cancer treatments, or other healthcare received.
• Healthcare utilization: The use of services by individuals to prevent, treat, or improve health problems, promote maintenance of health or well-being, or obtain information about health status and prognosis.
• Survivorship care: Care delivered to any individual who has been diagnosed with cancer, including one or more of the following components: prevention/surveillance for recurrence and subsequent malignancies, surveillance/management of physical and psychosocial impacts of cancer and its treatment; and health promotion, including the encouragement of positive health behaviors and the cessation or reduction of harmful behaviors (e.g., smoking, alcohol use).
• Multilevel intervention: An intervention at more than one level of individuals, healthcare teams, healthcare systems, community, payer, or policy settings, and that measures outcomes at two or more of these levels.

Levels include:

• Individuals: Patients, survivors, caregivers and family members, and clinicians.
• Healthcare team:Two or more health professionals, social care professionals, and/or staff who identify as a team and work together interdependently to deliver services, coordinate their activities or services, and solve care problems.
• Healthcare system: Collection of primary and specialty-care clinicians and support staff, medical facilities, and organizational structures. Together, these people, institutions, and resources provide the environment for the comprehensive delivery of healthcare services for childhood cancer survivors.
• Community setting: nvironments in which the process of delivering survivorship healthcare reflects approaches typically followed by clinicians whose primary responsibilities are patient care (e.g., Federally Qualified Health Centers). Patient populations in these environments tend to be more representative of the local population -- and may be populations with fewer resources -- than those referred to academic medical centers for specialty care, or who are enrolled in clinical trials.
• Payer: Insurance company or other organization that delivers payment for services.
• Policy setting: Law, procedure, or rules that govern healthcare delivery or reimbursement.

Background

Over the past several decades, advances in cancer treatment and supportive care have resulted in an increasing population of children and adults who were diagnosed with cancer before the age of 19 (childhood cancer survivors). There is a growing body of research that aims to understand and address the needs of childhood cancer survivors, due in part to the support of the 2018 Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act. Yet, some children have not benefitted from these advances to the same extent as others; differences in the access to and delivery of survivorship care, healthcare utilization, and health outcomes have been observed based on factors such as race/ethnicity, insurance status, rural place of residency, and biological sex.

The recent Agency for Healthcare Research and Quality Technical Brief Number 39, “Disparities and Barriers to Pediatric Cancer Care,” examined observational and interventional research focused on disparities in survivorship care, healthcare utilization, and health outcomes. The report noted a small number of studies that identified individual-level factors that may contribute to observed disparities in care and outcomes, including financial or employment status, language, literacy, and trust in providers. At the provider level, knowledge, or comfort in the ability to provide care, and the availability of non-medical resources (e.g., transportation) were the most studied factors. There was a paucity of studies focused on the health system and payer levels. Furthermore, very few studies were identified that examined the impact of strategies or interventions designed to address disparities in survivorship care.

To appropriately assess the full spectrum of factors that may contribute to disparities in survivorship care, it is necessary to examine multiple levels of influence that extend beyond the individual (patient/survivor, caregiver, clinician), to include healthcare teams, healthcare system, community, payer, and policy levels.

Research Objectives

NCI is interested in studies that will advance the scientific understanding of factors that may contribute to disparities in survivorship care, healthcare utilization, and health outcomes among childhood cancer survivors, as well as studies to develop, test, refine, and implement strategies to mitigate these disparities. Of specific interest are studies of factors operating at two or more of the following levels: individual, healthcare teams, healthcare system, community, payer, and policy.

Applications in response to this Notice may propose observational or interventional research related to childhood cancer survivors. Observational studies can be proposed to identify or characterize factors that perpetuate disparities; interventional studies can be proposed to design and evaluate interventions to mitigate factors that contribute to disparities. All applications should consider outcomes in one or more of these domains: care delivery, healthcare utilization, or health outcomes.

As part of the proposed research, investigators should specify a framework that guided the selection of study variables and intervention strategies (in the case of interventional research). Investigators may consider the use of hybrid implementation/effectiveness study designs if justified. Potential study settings of interest include primary care, community cancer centers, academic medical centers, and community health centers.

The long-term goal of this NOSI is to generate research that promotes equitable, high-quality care and health outcomes for all childhood cancer survivors.

Responsiveness

Applicants submitting in response to this NOSI must:

1. Focus on survivors of childhood cancers (diagnosed prior to the age of 19).
2. Address factors contributing to disparities in survivorship care and outcomes that extend beyond the individual (i.e., survivor, caregiver, clinician) level to include healthcare teams, healthcare systems, community, and policy-level factors.
3. Include populations commonly experiencing disparities based on race or ethnicity, sex, sexual or gender minority status, insurance status, rural residence, socioeconomic disadvantage, or other demonstrated differences.

Research encouraged through this Notice includes (but is not limited to) studies that propose to:

• Assess healthcare team, healthcare system, community, payer, and policy level factors or practices that result in inequities such as disparities in long-term follow-up care.
• Develop and test novel methods for identifying barriers to survivorship care delivery using data elements available in the medical record, administrative datasets, surveys, or interviews.
• Evaluate multilevel interventions that promote guideline-concordant survivorship care for childhood cancer survivors.
• Develop and test multilevel interventions to mitigate barriers that contribute to disparities in health outcomes for childhood cancer survivors.
• Characterize barriers to behavioral health, tobacco cessation, or alcohol reduction interventions for childhood cancer survivor populations that experience health disparities.

Investigators are encouraged to discuss their application with the scientific/research contacts listed in this Notice prior to submission.

Application and Submission Information

This notice applies to due dates on or after March 7, 2022, and subsequent receipt dates through October 9, 2024. 

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-CA-22-029” (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.

Eligibility and Eligible Individuals (Program Director/Principal Investigator): Eligibility criteria are per the guidelines in the corresponding FOA.

Budget: Budget guidelines are per instructions in the corresponding FOA.

Applicants are strongly encouraged to notify the NCI program contact via email (cholletv@mail.nih.gov) that a request has been submitted in response to this NOSI to facilitate efficient processing of the request.

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Inquiries

Veronica Chollette, RN, MS
National Cancer Institute (NCI)
Telephone: (240) 276-6969
Email: cholletv@mail.nih.gov

Emily Tonorezos, MD, MPH
National Cancer Institute (NCI)
Telephone: (240) 276-6942
Email: emily.tonorezos@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov