Exercise and Nutrition Interventions to Improve Cancer Treatment-Related Outcomes (ENICTO) in Cancer Survivors Consortium (U01 Clinical Trial Required) | RFA CA 21 031

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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