Design of a cluster randomized multi-level intervention to decrease barriers to minority cancer patient referral and enrollment to cancer clinical trials: The ACT WONDER2S study

Introduction

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 WONDER²S, a multi-level intervention (MLI) aimed to decrease barriers to NH Black/AA and Hispanic patient referral and enrollment in CCTs.

Methods

ACT WONDER²S 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.

Results

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.

Conclusion

If shown to be effective in increasing referral and enrollment of NH Black/AA and Hispanic cancer patients to CCTs, ACT WONDER²⁾S can be deployed across other geographic settings, thereby reducing disparities to CCT referral and enrollment on a national scale.