COVID-19 RELated Barriers to Trial Participation Equity (CO-RELaTE)

The broad long-term objective is to reduce cancer health disparities in women of color (WOC) through increased participation in clinical trials. Cost concerns are a known barrier to trial participation that disproportionately affect WOC. The personal and state- and local-level economic consequences of COVID-19 may disproportionately affect WOC, intensifying financial hardship and widening the gap in trial participation between WOC and non-WOC. The specific aims of this study are to compare 1) the proportion of WOC who experience COVID-related financial hardship (income/employment/insurance loss) vs non-WOC, in a population of women who decline participation in Tomosynthesis Mammographic Imaging Screening Trial (TMIST), a randomized controlled trial of digital mammography (DM) vs tomosynthesis (TM) to evaluate stage shift in screen-detected cancers; 2) the effects of other sociodemographics, and state- or local-level COVID-19 factors on TMIST participation, between WOC and non-WOC. The proposed study is an observational cohort of women who decline to participate in TMIST. In Aim 1, decliners will be surveyed regarding COVID-19 related financial hardship and distress. Among decliners, the proportion of WOC vs non-WOC who experience COVID-related financial hardship will be compared, accounting for patient-, practice-, local- and state-level COVIDrelated factors. In Aim 2, the observational cohort of decliners will be combined with an observational cohort of agree-ers during the same time period. The effects of sociodemographics, and state- and local-level COVID-19 on trial participation will be compared between WOC vs non-WOC. The COVID-19 specific survey in Aim 1 will not be administered to agree-ers and patient-level COVID-19 financial hardship and distress will not be incorporated into AIM 2 analyses.