NIH – A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials (CUSP2CT; U01 Clinical Trial Optional)

October 29, 2021 by


Through this funding opportunity announcement (FOA), the National Cancer Institute (NCI) solicits applications for Connecting Underrepresented Populations to Clinical Trials (CUSP2CT), a program that will implement and evaluate multilevel and culturally tailored outreach and education interventions with the primary goal of increasing referral and ultimately, accrual of underrepresented racial/ethnic (R/E) minority populations, to NCI-supported clinical trials (CTs) (National Clinical Trial Network (NCTN), NCI’s Community Oncology Research Program (NCORP), and Experimental Therapeutics Clinical Trials Network (ETCTN)). The target population(s) should include individuals from underrepresented racial/ethnic (R/E) minority populations. Applicants should address cancer health disparities (CHD) through a network of local multidisciplinary and integrated partners that include community health educators (CHEs), lay health advisors (LHAs), community members, healthcare providers, and researchers working in coordination to educate and refer R/E minority populations to NCI-supported CTs, and increase awareness in providers about R/E minority participation in NCI clinical trials. This will require multilevel outreach and education interventions at the CT site, provider, and/or patient levels. The proposed interventions should be informed by relevant theories, frameworks, or models. Further, the interventions should be guided by baseline information on participant, health care provider and facilitator -related strategies for increasing CT referral of R/E minority populations. It is expected that U01 grantees will establish partnerships with the community, primary care providers, and other stakeholders to enhance identification of R/E minority referral barriers and interventions to NCI-supported CTs.

A companion funding opportunity (see U24 funding opportunity RFA-CA-21-058) will support a Data, Evaluation & Coordinating Center (DECC) that will provide experienced project management for CUSP2CT Program activities, which include data receipt, management, and analysis from U01 sites, metrics development for program evaluation, and identification and dissemination of successful interventions and best practices.

The research activities will address key issues that affect diversity in clinical trials and will improve the dissemination of information and care into underserved communities, where they are needed most.


NCI, through the Center to Reduce Cancer Health Disparities (CRCHD) in collaboration with several Offices and Divisions at the NCI, assessed the state-of-the-science in CT participation and accrual. The effort was focused on R/E minority populations and the identification of major research opportunities that could uniquely benefit the support of NCI-supported CTs and could lead to significant advances in our understanding of cancer CTs. Specifically, the initiative was envisioned to focus on multilevel interventions to increase R/E minority individual referral, a first step in CT accrual from underrepresented communities where participation rates are equivalent when people are invited to participate.

Challenges Associated with CT Accrual of R/E Minority Patients. R/E minority populations experience disproportionately higher rates of incidence, morbidity, and mortality for numerous cancer types in comparison to Non-Hispanic Whites (NHW). However, despite higher rates of cancer incidence and mortality, the representation of R/E minority populations in cancer CTs, including therapeutic and non-therapeutic trials, remains low in some disease areas. Without adequate representation, especially in therapeutic trials, cancer disparities are likely to increase as R/E minority populations may not be able to fully benefit from cutting-edge treatments and the promises of precision medicine.

Multilevel Interventions to Increase CT Referral and Accrual. Numerous barriers and challenges to R/E minority participation in CTs have been identified that span multiple levels: site, provider, and patient levels. Studies have demonstrated that targeted outreach and education to R/E minority patients and strategic engagement of providers increases participation in CTs. Research further shows that patient navigation supported by LHAs can increase CT participation among R/E populations, and that input from a trusted provider can facilitate CT participation. While these studies have demonstrated limited success in addressing known barriers and diversifying CTs, systematic, coordinated, and integrated approaches have not been widely implemented and reported on.

NCI-supported CTs. NCI has been supporting clinical trials. For more than 50 years, the NCI National Clinical Trials Network (NCTN), and previously the National Clinical Trials Cooperative Group Program, have been supporting large-scale, clinical treatment trials across the nation. While these trials have successfully led to new cancer treatments, participation from R/E minority patients varies across disease areas. The NCI Community Oncology Research Program (NCORP), which includes Minority Underserved Community Sites, significantly contributes to the R/E minority participation in the NCTN. NCORP works across NCI programs and CT types to bring cancer CTs and care delivery studies to people in their own communities. With NCORP’s support, the NCTN Groups convene committees with site and researcher participants and patient advocates who are focused on addressing disparities in trial participation. NCI’s Experimental Therapeutics Clinical Trials Network (ETCTN) recently launched the Create Access to Targeted Cancer Therapy for Underserved Populations (CATCH-UP) program to provide administrative supplements to cancer centers to enroll at least 24 patients annually to the Experimental Therapeutics Clinical Trials Network (ETCTN) trials, with at least 50% of these patients belonging to a minority/underserved population. The NCTN, NCORP and ETCTN are the three largest NCI supported CT networks that enroll the majority of participants in NCI-supported CTs annually. Therefore, CTs from these NCI-supported networks will be a major focus for CT referrals for the CUSP2CT Program to enhance the diversity of participants. NCI’s Cancer Center Support Grants for NCI-designated Cancer Centers also provide support to NCI CTs and successful discoveries from their investigator-initiated CTs may move into larger trials in NCI’s CT networks. A Community Outreach and Engagement (COE) component was recently made a requirement for Cancer Center Support Grants for NCI-designated Cancer Centers (P30). The COE components are tasked with developing knowledge, best practices, and tools for effective outreach and engagement of the Cancer Center’s catchment area. While impactful, these efforts are being addressed uniquely and individually by each Cancer Center. Lastly, NCI’s Center to Reduce Cancer Health Disparities (CRCHD) has supported several programs over the past 15 years that have informed evidence-based interventions and strategies. Specifically, they are focused on R/E minority outreach and provided feasibility for the community-focused strategies that this FOA seeks to focus on. These include: (1) The Patient Navigation Research Program (PNRP; 2005-2011); (2) The Community Networks Program Centers (CNPC; 2010-2016); and (3) The National Outreach Network (NON; 2010-Present).

Key Dates:

Earliest Submission/Letter of Intent Due Date(s): November 10, 2021
Applications Due Date: December 10, 2021

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Filed Under: Funding Opportunities