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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05076266
Enrollment
14
Registered
2021-10-13
Start date
2022-03-14
Completion date
2023-02-03
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, NOS

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.

Interventions

OTHERQuestionnaire

Complete the survey questions

Sponsors

Eastern Cooperative Oncology Group
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

MeasureTime frameDescription
Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measureat baselineOutcome 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 Distressat baselineAdapted 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 ParticipantsbaselineThe proportions will be determined by calculating the number of women who self-report as non-White versus the total number of participants enrolled.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRuth Carlos

ECOG-ACRIN Cancer Research Group

Participant flow

Recruitment details

This is a single arm observational study of socioeconomic, financial hardship, distress, and COVID related factors among women decline participation in TMIST (EAQ1151). All women presenting for screening mammography who meet the eligibility criteria for EA1151 but ultimately decline to participate in EA1151 should be immediately invited to participate in EAQ201 by EA1151 site designated recruiters. Stratified sub-group analysis will be conducted between Women of Color (WOC) and non-WOC.

Participants by arm

ArmCount
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. Women of Color(WOC and Non-WOC Groups combined to protect confidentiality for single participant in Women of Color Who Decline TMIST Group
14
Total14

Baseline characteristics

CharacteristicWomen Who Decline TMIST
Age, Continuous61 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
13 Participants
Sex/Gender, Customized
Female
14 Participants
Survey Completed12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 1
other
Total, other adverse events
0 / 130 / 1
serious
Total, serious adverse events
0 / 130 / 1

Outcome results

Primary

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

Time frame: at baseline

Population: Study terminated early with insufficient data for planned logistic models based on financial hardship and thus, the composite (modeled) measure data values cannot be calculated

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantswork hours reduction0 Participants
Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantslayoff or furlough0 Participants
Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantsnew job/increased hours to increase income0 Participants
Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantsgreater or equal to 20% income lose0 Participants
Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantssavings use for living expenses0 Participants
Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantshome sale/refinance0 Participants
Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantsincreased debt0 Participants
Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantsdeclared bankruptcy0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantsdeclared bankruptcy0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantswork hours reduction1 Participants
Non-Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantssavings use for living expenses0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantslayoff or furlough1 Participants
Non-Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantsincreased debt0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantsnew job/increased hours to increase income0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantshome sale/refinance1 Participants
Non-Women of Color Who Decline TMISTCompare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participantsgreater or equal to 20% income lose1 Participants
Secondary

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.

Time frame: baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Women of Color Who Decline TMISTCompare the Proportion of WOC in TMIST Participants vs EAQ201 Participants1 Participants
Non-Women of Color Who Decline TMISTCompare the Proportion of WOC in TMIST Participants vs EAQ201 Participants1138 Participants
Secondary

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)

Time frame: at baseline

Population: Study terminated early with insufficient data for planned logistic models based on change in material condition and thus, the composite (modeled) measure data values cannot be calculated

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureMore than 20% loss of income0 Participants
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureUsed savings to pay for living expenses0 Participants
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureSold or refinanced my/our car0 Participants
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureSold or refinanced my/our home0 Participants
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureTook out loans0 Participants
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureReached my/our credit limits0 Participants
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureHad debt collectors contact me/us0 Participants
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureDeclared bankruptcy0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureDeclared bankruptcy0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureMore than 20% loss of income1 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureTook out loans0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureUsed savings to pay for living expenses0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureHad debt collectors contact me/us0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureSold or refinanced my/our car0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureReached my/our credit limits0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite MeasureSold or refinanced my/our home1 Participants
Secondary

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

Time frame: at baseline

ArmMeasureValue (MEAN)Dispersion
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-specific Perceived Financial Distress2 score on a scale
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC Participants With COVID-specific Perceived Financial Distress1.45 score on a scaleStandard Deviation 0.93
Other Pre-specified

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

Time frame: Through study completion, an average of 1 year

Population: Maximum number of COVID-19 cases, state unemployment during shelter-in-place, local unemployment during shelter-in-place not available for the accrued participants at the time of study termination.

Other Pre-specified

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

Time frame: baseline

ArmMeasureGroupValue (MEAN)Dispersion
Women of Color Who Decline TMISTCompare Participant-reported Quality of Life, Anxiety and Depression Between WOC and Non-WOC EAQ201 ParticipantsPROMIS Global Health34 score on a scale
Women of Color Who Decline TMISTCompare Participant-reported Quality of Life, Anxiety and Depression Between WOC and Non-WOC EAQ201 ParticipantsPROMIS Anxiety0 score on a scale
Women of Color Who Decline TMISTCompare Participant-reported Quality of Life, Anxiety and Depression Between WOC and Non-WOC EAQ201 ParticipantsPROMIS Depression0 score on a scale
Non-Women of Color Who Decline TMISTCompare Participant-reported Quality of Life, Anxiety and Depression Between WOC and Non-WOC EAQ201 ParticipantsPROMIS Global Health33.09 score on a scaleStandard Deviation 4.44
Non-Women of Color Who Decline TMISTCompare Participant-reported Quality of Life, Anxiety and Depression Between WOC and Non-WOC EAQ201 ParticipantsPROMIS Anxiety5.73 score on a scaleStandard Deviation 1.85
Non-Women of Color Who Decline TMISTCompare Participant-reported Quality of Life, Anxiety and Depression Between WOC and Non-WOC EAQ201 ParticipantsPROMIS Depression4.73 score on a scaleStandard Deviation 1.19
Other Pre-specified

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)

Time frame: baseline

Population: Study terminated early with insufficient data to generate planned logistic models to generate the composite material condition measure.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Women of Color Who Decline TMISTCompare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment ChangeWas laid off or furloughed0 Participants
Women of Color Who Decline TMISTCompare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment ChangeTook a new or additional job or worked additional hours to make ends meet0 Participants
Women of Color Who Decline TMISTCompare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment ChangeUsed sick time or vacation time0 Participants
Women of Color Who Decline TMISTCompare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment ChangePrefer not to say0 Participants
Women of Color Who Decline TMISTCompare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment ChangeHad work hours reduced0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment ChangePrefer not to say3 Participants
Non-Women of Color Who Decline TMISTCompare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment ChangeHad work hours reduced1 Participants
Non-Women of Color Who Decline TMISTCompare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment ChangeWas laid off or furloughed1 Participants
Non-Women of Color Who Decline TMISTCompare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment ChangeUsed sick time or vacation time1 Participants
Non-Women of Color Who Decline TMISTCompare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment ChangeTook a new or additional job or worked additional hours to make ends meet0 Participants
Other Pre-specified

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

Time frame: baseline

Population: Study terminated early with insufficient data for specific components of this composite Outcome Measure, and thus, the composite (modeled) measure data values cannot be calculated

ArmMeasureGroupValue (MEAN)Dispersion
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Canceranxious about getting or becoming ill with COVID-195 score on a scale
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancerconcerned about spreading COVID-19 to others5 score on a scale
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancerabout the possibility of dying from COVID-195 score on a scale
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerI have no control over how COVID-19 will impact my life5 score on a scale
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerI feel negatively about the future3 score on a scale
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Canceranxious about losing or having lost my job, or losing my primary source of income5 score on a scale
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerCOVID-19 has been a financial hardship to my family2 score on a scale
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerI feel in control of my financial situation3 score on a scale
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerI worry about having enough money to pay my rent/mortgage3 score on a scale
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerI worry about having enough money to buy enough food for my family3 score on a scale
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerDo you think you will get breast cancer in the next 5 years?2 score on a scale
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerDo you think you will get COVID-19 in the next 5 years?4 score on a scale
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerDo you think you will get breast cancer in the next 5 years?2.27 score on a scaleStandard Deviation 0.65
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Canceranxious about getting or becoming ill with COVID-192.09 score on a scaleStandard Deviation 0.94
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerCOVID-19 has been a financial hardship to my family1.45 score on a scaleStandard Deviation 0.93
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancerconcerned about spreading COVID-19 to others2.82 score on a scaleStandard Deviation 1.25
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerI worry about having enough money to buy enough food for my family1.09 score on a scaleStandard Deviation 0.3
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancerabout the possibility of dying from COVID-191.64 score on a scaleStandard Deviation 0.92
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerI feel in control of my financial situation4.45 score on a scaleStandard Deviation 1.21
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerI have no control over how COVID-19 will impact my life2.36 score on a scaleStandard Deviation 1.21
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerDo you think you will get COVID-19 in the next 5 years?3.09 score on a scaleStandard Deviation 0.83
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerI feel negatively about the future1.45 score on a scaleStandard Deviation 0.93
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast CancerI worry about having enough money to pay my rent/mortgage1 score on a scaleStandard Deviation 0
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Canceranxious about losing or having lost my job, or losing my primary source of income1.09 score on a scaleStandard Deviation 0.3
Other Pre-specified

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)

Time frame: baseline

Population: Study terminated early with insufficient data to generate planned logistic models to generate the composite material condition measure.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerAlcohol Consumption(freq/number of drinks on the same occasion) compared to BEFORE the COVID-19?More0 Participants
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerSmoking or tobacco use during the past 30 days compared to BEFORE the COVID-19 pandemicMore0 Participants
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerAlcohol Consumption(freq/number of drinks on the same occasion) compared to BEFORE the COVID-19?Same0 Participants
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerSmoking or tobacco use during the past 30 days compared to BEFORE the COVID-19 pandemicLess0 Participants
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerAlcohol Consumption(freq/number of drinks on the same occasion) compared to BEFORE the COVID-19?Less0 Participants
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerAlcohol Consumption(freq/number of drinks on the same occasion) compared to BEFORE the COVID-19?Not applicable (do not partake)1 Participants
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerSmoking or tobacco use during the past 30 days compared to BEFORE the COVID-19 pandemicNot applicable (do not partake)1 Participants
Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerSmoking or tobacco use during the past 30 days compared to BEFORE the COVID-19 pandemicSame0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerSmoking or tobacco use during the past 30 days compared to BEFORE the COVID-19 pandemicNot applicable (do not partake)11 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerAlcohol Consumption(freq/number of drinks on the same occasion) compared to BEFORE the COVID-19?More2 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerAlcohol Consumption(freq/number of drinks on the same occasion) compared to BEFORE the COVID-19?Less0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerAlcohol Consumption(freq/number of drinks on the same occasion) compared to BEFORE the COVID-19?Same8 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerAlcohol Consumption(freq/number of drinks on the same occasion) compared to BEFORE the COVID-19?Not applicable (do not partake)1 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerSmoking or tobacco use during the past 30 days compared to BEFORE the COVID-19 pandemicMore0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerSmoking or tobacco use during the past 30 days compared to BEFORE the COVID-19 pandemicLess0 Participants
Non-Women of Color Who Decline TMISTCompare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast CancerSmoking or tobacco use during the past 30 days compared to BEFORE the COVID-19 pandemicSame0 Participants

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026