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临床试验/NCT05076266
NCT05076266终止不适用

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

Eastern Cooperative Oncology Group1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年3月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
14
试验地点
1
主要终点
Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

研究组 & 干预措施

Non-[Women of Color (WOC)]

Non-[Women of Color (WOC)] 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.

干预措施: Questionnaire (Other)

Women of Color (WOC) Who Decline TMIST

Women of Color (WOC) 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.

干预措施: Questionnaire (Other)

结局指标

主要结局

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

时间窗: at baseline

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

次要结局

  • Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure(at baseline)
  • Compare the Proportions of WOC vs Non-WOC Participants With COVID-specific Perceived Financial Distress(at baseline)
  • Compare the Proportion of WOC in TMIST Participants vs EAQ201 Participants(baseline)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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