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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer, NOS
• Intervention / Treatment: Other: Questionnaire

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 Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women age 45 or older and under age 75 who decline participation in EA1151/TMIST

Description

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:

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Questionnaire; Complete the survey questions
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.	Other: Questionnaire; Complete the survey questions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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.	baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment Change	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)	baseline
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer	Survey to capture the emotional response to COVID related to fear of infection, financial anxiety, housing and food insecurity. ratings from 0=Not at All to 4=Very Much Single items for breast cancer and COVID-19, modified from previous studies of intention to undergo breast cancer screening. ratings from 5=Definitely will not to 1=Definitely will	baseline
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast Cancer	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)	baseline
Compare Participant-reported Quality of Life, Anxiety and Depression Between WOC and Non-WOC EAQ201 Participants	Participant-Reported Outcomes Measurement Information System (PROMIS) PROMIS-10 Global Health: Overall Quality of Life physical and mental health assessment. Sum of the 10 item responses (continuous) each item scored: 5="Excellent to 1="Poor"; higher values indicate Better Health Continuous score range 10 to 50 with higher values indicating better health PROMIS Anxiety: 4-item Short Form. Sum of item responses (continuous) each item scored: 1="Never" to 5="Always"; higher values indicate greater Anxiety Continuous score range 4 to 20 with higher values indicating greater Anxiety PROMIS Depression: 4-item Short Form. Sum of item responses (continuous) each item scored: 1="Never" to 5="Always"; higher values indicate greater Depression Continuous score range 4 to 20 with higher values indicating greater Depression	baseline
Assess the Effects of Sociodemographic Characteristics, and Federal-, State- or Local-level COVID-19 Factors on TMIST Participation, in WOC vs Non-WOC	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	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Eastern Cooperative Oncology Group
• Investigators: Principal Investigator: Ruth Carlos, ECOG-ACRIN Cancer Research Group

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): February 2, 2023
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: EAQ201 (Other Identifier: DCP); NCI-2021-05681 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No