Design of a cluster randomized multi-level intervention to decrease barriers to minority cancer patient referral and enrollment to cancer clinical trials: The ACT WONDER 2 S study

Dana E Rollison; Melany A Garcia; Rossybelle P Amorrortu; Yayi Zhao; Brian Mittman; Kea Turner; Kedar Kirtane; Hatem Soliman; Margaret M Byrne; Cathy Meade; Clement K Gwede; Steven Eschrich; Jun Yin; Nathanael B Stanley; Lindsay Fuzzell; Delilah Hernandez; Elliott Tapia-Kwan; Susan T Vadaparampil

doi:10.1016/j.cct.2025.108096

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Design of a cluster randomized multi-level intervention to decrease barriers to minority cancer patient referral and enrollment to cancer clinical trials: The ACT WONDER 2 S study

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Design of a cluster randomized multi-level intervention to decrease barriers to minority cancer patient referral and enrollment to cancer clinical trials: The ACT WONDER 2 S study

Dana E Rollison, Melany A Garcia, Rossybelle P Amorrortu, Yayi Zhao, Brian Mittman, Kea Turner, Kedar Kirtane, Hatem Soliman, Margaret M Byrne, Cathy Meade, …

Contemporary clinical trials, Vol.158, 108096

11/2025

DOI: 10.1016/j.cct.2025.108096

PMCID: PMC12707367

PMID: 40992541

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Abstract

Non-Hispanic (NH) Black/African American (AA) and Hispanic cancer patients are underrepresented in cancer clinical trials (CCTs) due to patient, physician, and system-level barriers. Therefore, multi-level approaches are critical to address barriers to CCT participation. Presented here are the study design and baseline characteristics of ACT WONDER S, a multi-level intervention (MLI) aimed to decrease barriers to NH Black/AA and Hispanic patient referral and enrollment in CCTs. ACT WONDER S is an MLI including community outreach and digital interventions for community and Moffitt Cancer Center (MCC) populations. Geospatial analytics were used to identify clusters of census tracts ("priority zones") with high NH Black/AA and Hispanic populations for intervention deployment. Priority zones were then matched on population characteristics and randomized to receive the intervention (n = 7) or to serve as controls (n = 7). Baseline characteristics of the priority zones were described using US Census data and other public sources. Approximately 16.5 % and 35.8 % of the intervention priority zones are NH Black/AA or Hispanic, respectively. There are no statistically significant differences between groups in total population size (paired t-test p-value = 0.63), proportions of NH Black/AA (p = 0.13) and Hispanic populations (p = 0.17), or distance in miles from MCC (p = 0.64). The estimated number of cancer cases and CCT enrollment rates at baseline are also similar between groups. If shown to be effective in increasing referral and enrollment of NH Black/AA and Hispanic cancer patients to CCTs, ACT WONDER S can be deployed across other geographic settings, thereby reducing disparities to CCT referral and enrollment on a national scale.

Study designs

Multi-level interventions

Cancer clinical trials

Geospatial analysis

Health disparities

Details

Title: Subtitle: Design of a cluster randomized multi-level intervention to decrease barriers to minority cancer patient referral and enrollment to cancer clinical trials: The ACT WONDER 2 S study
Creators: Dana E Rollison - Moffitt Cancer Center
Melany A Garcia - Moffitt Cancer Center
Rossybelle P Amorrortu - Moffitt Cancer Center
Yayi Zhao - Moffitt Cancer Center
Brian Mittman - Kaiser Permanente
Kea Turner - University of North Carolina at Chapel Hill
Kedar Kirtane - Moffitt Cancer Center
Hatem Soliman - Moffitt Cancer Center
Margaret M Byrne - Moffitt Cancer Center
Cathy Meade - University of North Carolina at Chapel Hill
Clement K Gwede - University of North Carolina at Chapel Hill
Steven Eschrich - Moffitt Cancer Center
Jun Yin - Moffitt Cancer Center
Nathanael B Stanley - Moffitt Cancer Center
Lindsay Fuzzell - University of North Carolina at Chapel Hill
Delilah Hernandez - Moffitt Cancer Center
Elliott Tapia-Kwan - Moffitt Cancer Center
Susan T Vadaparampil - Moffitt Cancer Center
Resource Type: Journal article
Publication Details: Contemporary clinical trials, Vol.158, 108096
DOI: 10.1016/j.cct.2025.108096
PMID: 40992541
PMCID: PMC12707367
NLM abbreviation: Contemp Clin Trials
ISSN: 1551-7144
eISSN: 1559-2030
Publisher: ELSEVIER SCIENCE INC; NEW YORK
Grant note: National Cancer InstituteNational Institutes of Health: U01-CA274971 Biostatistics and Bioinformatics Shared ResourceMoffitt Merit Society Fund at the H. Lee Moffitt Cancer Center & Research Institute, an NCI designated Comprehensive Cancer Center: P30-CA076292
This work was supported by the National Cancer Institute and the National Institutes of Health (U01-CA274971) and awarded to Dr. Susan T. Vadaparampil. This work has also been supported in part by the Biostatistics and Bioinformatics Shared Resource and the Moffitt Merit Society Fund at the H. Lee Moffitt Cancer Center & Research Institute, an NCI designated Comprehensive Cancer Center (P30-CA076292) .
Language: English
Electronic publication date: 09/22/2025
Date published: 11/2025
Academic Unit: Biostatistics
Record Identifier: 9984966330502771

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