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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer, NOS

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women Who Decline TMIST<br>Women who decline TMIST will be asked to fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being. | Other: Questionnaire<br>* Complete the survey questions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the proportion of WOC EAQ201 participants who experience COVID-related financial hardship vs non-WOC EAQ201 participants | Composite outcome, defined as answering in the affirmative to any of the following personal changes due to COVID: layoff or furlough, insurance loss, work hours reduction, new job/increased hours to increase income, food or housing insecurity OR answering in the affirmative to any of the following household changes due to COVID: greater or equal to 20% income lose, savings use for living expenses, home sale/refinance, increased debt, declared bankruptcy | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the proportions of WOC vs non-WOC EAQ201 participants with COVID-related change in their material condition, a composite measure | Self-reported material condition of any of the following: >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) | Through study completion, an average of 1 year | 
| Compare the proportions of WOC vs non-WOC EAQ201 participants with COVID-specific perceived financial distress | Adapted from the summary item from COST measure (continuous) COVID-19 has been a financial hardship to my family | Through study completion, an average of 1 year | 
| Compare the proportion of WOC in TMIST participants vs EAQ201 participants | Race/ethnicity, age, insurance, and ZIP | Through study completion, an average of 1 year |