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

Terminated

Conditions: Breast Cancer, NOS

Interventions: Other: Questionnaire

Registration Number: NCT05076266

Lead Sponsor: Eastern Cooperative Oncology Group

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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 14

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

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women Who Decline TMIST	Questionnaire	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure	at baseline	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)
Compare the Proportions of WOC vs Non-WOC Participants With COVID-specific Perceived Financial Distress	at baseline	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
Compare the Proportion of WOC in TMIST Participants vs EAQ201 Participants	baseline	The proportions will be determined by calculating the number of women who self-report as non-White versus the total number of participants enrolled.