COVID-19 Related Financial Hardship and Distress in Women Who Decline TMIST (EA1151) Participation

Eastern Cooperative Oncology Group14 enrolled

Overview

The purpose of this study is to find out whether factors that lead Women of Color to decline participation in the breast cancer screening trial EA1151 (TMIST) differ from non-women of color.

In a population of women who decline participation in TMIST (EAQ201 participants), we will compare the proportion of WOC vs non-WOC with respect to who experience COVID-related financial hardship, a composite endpoint defined as any psychological response (financial distress, food/housing insecurity) or change in their material condition. We hypothesize that COVID-19 related financial hardship and distress are more prevalent in WOC who decline TMIST participation compared to non-WOC who decline participation.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer, NOS

Interventions

QuestionnaireOTHER

Complete the survey questions

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Participants must be women age 45 or older and under age 75 at the time of study entry. Participant must be scheduled for, or have intent to schedule, a screening mammogram. Participant must be eligible for EA1151/TMIST. Participant must have declined participation in EA1151/TMIST. Participant must be able to complete questionnaires in English. Participant must have a U.S. zip code. Exclusion Criteria:

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants

Composite outcome, defined as the logistic modeling of personal changes due to COVID: including layoff or furlough, insurance loss, work hours reduction, new job/increased hours to increase income, food or housing insecurity OR household changes due to COVID: greater or equal to 20% income lose, savings use for living expenses, home sale/refinance, increased debt, declared bankruptcy

Time frame: at baseline

Secondary Outcomes

Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure

Outcome is the result of a logistic regression with covariates: \>20% income loss, savings use, home sale or refinance, loans, reaching credit limits, becoming subject to a collection agency, or bankruptcy in the last 3 months (binary)

Time frame: at baseline

Compare the Proportions of WOC vs Non-WOC Participants With COVID-specific Perceived Financial Distress

Adapted from the summary item from COST measure "COVID-19 has been a financial hardship to my family" rated from 0="Not at all" to 4="Very much" Larger Values indicate greater hardship

Time frame: at baseline

Compare the Proportion of WOC in TMIST Participants vs EAQ201 Participants

The proportions will be determined by calculating the number of women who self-report as non-White versus the total number of participants enrolled.

Time frame: baseline

Data from ClinicalTrials.gov

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