Opportunity Information: Apply for RFA CA 21 031

The Exercise and Nutrition Interventions to Improve Cancer Treatment-Related Outcomes (ENICTO) in Cancer Survivors Consortium funding opportunity (RFA-CA-21-031) is a National Cancer Institute (NCI) cooperative agreement (U01) designed to push forward clinical trial research testing exercise and/or medically focused nutrition interventions for people undergoing cancer therapy intended to cure disease or extend life. The core idea is to move beyond general wellness benefits and instead evaluate whether specific, well-defined behavioral interventions can measurably improve concrete outcomes that are directly tied to cancer treatment itself. The FOA is explicitly clinical trial required, meaning applicants are expected to run rigorous intervention studies rather than observational or purely mechanistic projects.

A central requirement is that each project must name a treatment-related outcome as the primary endpoint. In practice, this means the main outcome has to be something meaningfully connected to the delivery, tolerance, effectiveness, or consequences of cancer therapy, not just general health markers. Alongside that, applicants must include at least one relevant patient-reported outcome as a secondary endpoint, ensuring that the patient experience (symptoms, functioning, quality of life, or other self-reported impacts) is captured in a structured and measurable way. Studies may focus on either pediatric or adult populations, giving applicants flexibility to address treatment-related problems across the lifespan, as long as the trial is designed around the cancer treatment context.

The FOA emphasizes direct clinical relevance and translational potential, signaling that NCI is looking for interventions that could realistically be adopted in oncology care pathways if proven effective. Priority is given to studies that fill clear research gaps about the efficacy of particular exercise approaches and/or dietary strategies in improving treatment-related outcomes, rather than broad or vaguely specified lifestyle programs. The expected deliverables are not only evidence of benefit (or lack of benefit) for specific protocols, but also practical knowledge that can strengthen behavioral intervention design for patients actively receiving treatment. The announcement also notes the value of feasibility information that can support eventual implementation in real-world clinical settings, such as issues related to adherence, safety, delivery logistics, and integration with standard oncology care.

Awardees are required to participate in the ENICTO in Cancer Survivors Consortium, which means funded projects are not operating as isolated grants. As a cooperative agreement mechanism, U01s typically involve substantial scientific and programmatic involvement from NIH/NCI staff compared with standard research project grants, and the consortium structure generally implies coordinated activities such as shared measures or common data elements, collaborative problem-solving, cross-study learning, and alignment around consortium goals. The intent is to accelerate progress by connecting teams working on related intervention questions and creating a stronger, more harmonized evidence base.

Eligibility is broad and includes many types of U.S.-based organizations and agencies: state, county, city, township, and special district governments; public housing authorities/Indian housing authorities; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; and other entities. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions. At the same time, it restricts foreign involvement in a specific way: non-U.S. entities (foreign institutions) cannot apply, and non-U.S. components of U.S. organizations are not eligible. However, foreign components are allowed as defined by the NIH Grants Policy Statement, which typically means a U.S. applicant can include certain foreign collaborations or activities when justified and compliant, even though the applicant organization itself must be domestic.

Administratively, the opportunity sits under NIH with CFDA numbers 93.395 and 93.399 and was posted on May 3, 2021, with an original closing date of July 14, 2021. The listed award ceiling is $875,000. The announcement lists “ExpectedAwards:” without a number in the provided source, so the total number of awards is not specified here. Overall, the FOA’s focus is tightly centered on generating actionable clinical trial evidence that specific exercise and/or nutrition interventions can improve how patients fare during cancer treatment, while also building a coordinated consortium that can speed translation of effective protocols into routine cancer care.

  • The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Exercise and Nutrition Interventions to Improve Cancer Treatment-Related Outcomes (ENICTO) in Cancer Survivors Consortium (U01 Clinical Trial Required)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395, 93.399.
  • This funding opportunity was created on 2021-05-03.
  • Applicants must submit their applications by 2021-07-14. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $875,000.00 in funding.
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
Apply for RFA CA 21 031

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Frequently Asked Questions (FAQs)

What is the ENICTO in Cancer Survivors Consortium funding opportunity?

The Exercise and Nutrition Interventions to Improve Cancer Treatment-Related Outcomes (ENICTO) in Cancer Survivors Consortium funding opportunity (RFA-CA-21-031) is a National Cancer Institute (NCI) cooperative agreement (U01). It supports clinical trial research that tests exercise and/or medically focused nutrition interventions in people undergoing cancer therapy intended to cure disease or extend life.

What is the main goal of this FOA?

The goal is to move beyond general wellness benefits and determine whether specific, well-defined exercise and/or nutrition interventions can measurably improve outcomes that are directly related to cancer treatment. The emphasis is on concrete, treatment-related endpoints (not just general health markers).

Is a clinical trial required under this opportunity?

Yes. The FOA is explicitly clinical trial required. Applicants are expected to conduct rigorous intervention studies rather than observational studies or purely mechanistic projects.

What types of interventions are supported?

This opportunity supports exercise interventions and/or medically focused nutrition interventions that are designed specifically for patients actively receiving cancer therapy. The FOA prioritizes clearly defined, protocol-driven interventions rather than broad or vague lifestyle programs.

Who is the target participant population for supported studies?

Studies may focus on either pediatric or adult populations. The key requirement is that the trial is designed around the cancer treatment context (patients undergoing therapy intended to cure disease or extend life).

What does the FOA require for the primary endpoint?

Each project must name a treatment-related outcome as the primary endpoint. The main outcome must be meaningfully connected to cancer therapy, such as outcomes tied to the delivery, tolerance, effectiveness, or consequences of treatment, rather than general wellness outcomes.

Are patient-reported outcomes required?

Yes. Applicants must include at least one relevant patient-reported outcome as a secondary endpoint. This ensures the patient experience (such as symptoms, functioning, quality of life, or other self-reported impacts) is measured in a structured way.

What kinds of outcomes are considered “treatment-related” in this FOA?

The FOA describes treatment-related outcomes as those directly tied to cancer therapy, including outcomes connected to treatment delivery, tolerance, effectiveness, or consequences. The opportunity specifically discourages using only general health markers as the main endpoint.

How does this FOA define “clinical relevance” and “translational potential”?

The FOA emphasizes interventions that could realistically be adopted in oncology care pathways if proven effective. It prioritizes studies designed to fill clear research gaps about the efficacy of specific exercise approaches and/or dietary strategies in improving treatment-related outcomes.

Does the FOA value feasibility and implementation-related information?

Yes. In addition to testing efficacy, the FOA notes the value of feasibility information that can support eventual real-world implementation. Examples include adherence, safety, delivery logistics, and integration with standard oncology care.

What is a U01 cooperative agreement, and why does it matter here?

This FOA uses the U01 cooperative agreement mechanism. As described in the opportunity, U01s typically involve substantial scientific and programmatic involvement from NIH/NCI staff compared with standard research project grants, reflecting a more collaborative and coordinated award structure.

What does it mean to participate in the ENICTO in Cancer Survivors Consortium?

Awardees are required to participate in the consortium, meaning projects will not operate as isolated grants. The consortium structure generally implies coordinated activities such as shared measures or common data elements, collaborative problem-solving, cross-study learning, and alignment around consortium goals to accelerate progress and strengthen the evidence base.

Who is eligible to apply?

Eligibility is broad and includes many U.S.-based organizations and agencies, including state/county/city/township/special district governments; public housing authorities/Indian housing authorities; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; and other entities.

Are specific institution types explicitly highlighted as eligible?

Yes. The FOA highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions.

Can foreign institutions apply for this funding opportunity?

No. Non-U.S. entities (foreign institutions) cannot apply under this opportunity.

Are non-U.S. components of U.S. organizations eligible?

No. The FOA states that non-U.S. components of U.S. organizations are not eligible.

Are any foreign activities allowed at all?

Yes, in a limited way. The FOA indicates that foreign components are allowed as defined by the NIH Grants Policy Statement. This typically means a U.S. applicant may include certain foreign collaborations or activities when justified and compliant, even though the applicant organization must be domestic.

Which agency is sponsoring this opportunity?

This is a National Institutes of Health (NIH) funding opportunity under the National Cancer Institute (NCI).

What is the funding mechanism for this FOA?

The mechanism is a cooperative agreement (U01).

What are the CFDA numbers associated with this opportunity?

The opportunity lists CFDA numbers 93.395 and 93.399.

When was this opportunity posted, and what was the closing date listed?

The opportunity was posted May 3, 2021, with an original closing date of July 14, 2021.

What is the award ceiling for this funding opportunity?

The listed award ceiling is $875,000.

How many awards are expected to be made?

The provided source does not specify the number of expected awards. The announcement lists “ExpectedAwards:” without a number.

What kinds of deliverables does NCI appear to be seeking from funded projects?

The FOA indicates it is seeking actionable clinical trial evidence about whether specific exercise and/or nutrition protocols improve treatment-related outcomes during cancer therapy. It also aims to generate practical knowledge to strengthen behavioral intervention design and to support translation and implementation within oncology care settings.

Is this FOA focused on general lifestyle improvement programs?

No. The FOA explicitly prioritizes specific, well-defined behavioral intervention protocols with direct clinical relevance to cancer treatment-related outcomes, rather than broad or vaguely specified lifestyle programs.

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