COVID-19 Related Financial Hardship and Distress in Women Who Decline TMIST (EA1151) Participation
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Women Who Decline TMIST 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
Complete the survey questions
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Outcome Measures
Primary Outcome Measures
- Compare the proportion of WOC EAQ201 participants who experience COVID-related financial hardship vs non-WOC EAQ201 participants [Through study completion, an average of 1 year]
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
Secondary Outcome Measures
- Compare the proportions of WOC vs non-WOC EAQ201 participants with COVID-related change in their material condition, a composite measure [Through study completion, an average of 1 year]
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)
- Compare the proportions of WOC vs non-WOC EAQ201 participants with COVID-specific perceived financial distress [Through study completion, an average of 1 year]
Adapted from the summary item from COST measure (continuous) "COVID-19 has been a financial hardship to my family
- Compare the proportion of WOC in TMIST participants vs EAQ201 participants [Through study completion, an average of 1 year]
Race/ethnicity, age, insurance, and ZIP
Other Outcome Measures
- Compare the proportion of WOC vs non-WOC EAQ201 participants with COVID-related employment change, a composite measure [Through study completion, an average of 1 year]
Employment change of any of the following: Self-reported work hours reduction, layoff or furlough, sick time, vacation time use or new job/increased hours to increase income (binary)
- Compare the proportions of WOC vs non-WOC EAQ201 participants with COVID-specific perceived distress and perceived susceptibility to COVID and breast cancer [Through study completion, an average of 1 year]
Adapted from Penedo (personal communication) to capture the emotional response to COVID related to fear of infection, financial anxiety, housing and food insecurity (single items) (categorical)(11 items) Single items for breast cancer and COVID-19, modified from previous studies of intention to undergo breast cancer screening. (categorical) (2 items)
- Compare the proportions of WOC vs non-WOC EAQ201 participants with relative increase in smoking and alcohol use, risk factors for breast cancer [Through study completion, an average of 1 year]
Assess change in frequency or amount of tobacco or alcohol use during COVID compared to before COVID. Will not assess absolute amount of use. (categorical) (2 items)
- Compare participant-reported quality of life, anxiety and depression between WOC and non-WOC EAQ201 participants [Through study completion, an average of 1 year]
Participant-Reported Outcomes Measurement Information System (PROMIS)-1018 10-item physical and mental health assessment. Sum of item responses (continuous) (10 items) PROMIS Anxiety 4-item Short Form. Sum of item responses (continuous) (4 items) PROMIS Depression 4-item Short Form. Sum of item responses (continuous) (4 items)
- Assess the effects of sociodemographic characteristics, and federal-, state- or local-level COVID-19 factors on TMIST participation, in WOC vs non-WOC [Through study completion, an average of 1 year]
Compare maximum number of COVID-19 cases, state unemployment during shelter-in-place, local unemployment during shelter-in-place) on TMIST participation, stratified by WOC vs non-WOC
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- Eastern Cooperative Oncology Group
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EAQ201
- NCI-2021-05681
- EAQ201
- EAQ201