Trial Outcomes & Findings for COVID-19 Related Financial Hardship and Distress in Women Who Decline TMIST (EA1151) Participation (NCT NCT05076266)
NCT ID: NCT05076266
Last Updated: 2025-11-12
Results Overview
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
TERMINATED
14 participants
at baseline
2025-11-12
Participant Flow
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.
Participant milestones
| Measure |
Non-[Women of Color] who decline TMIST
Non-WOC who decline TMIST participation 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 who decline TMIST
This group contains Women of Color who declined participation in TMIST
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
1
|
|
Overall Study
COMPLETED
|
11
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Non-[Women of Color] who decline TMIST
Non-WOC who decline TMIST participation 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 who decline TMIST
This group contains Women of Color who declined participation in TMIST
|
|---|---|---|
|
Overall Study
Survey not complete - Participant refusal
|
2
|
0
|
Baseline Characteristics
COVID-19 Related Financial Hardship and Distress in Women Who Decline TMIST (EA1151) Participation
Baseline characteristics by cohort
| Measure |
Women Who Decline TMIST
n=14 Participants
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
|
|---|---|
|
Age, Continuous
|
61 years
n=10 Participants
|
|
Sex/Gender, Customized
Female
|
14 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Survey Completed
|
12 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: at baselinePopulation: 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
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
Outcome measures
| Measure |
Women of Color Who Decline TMIST
n=1 Participants
WOC who decline TMIST asked to fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
non-Women of Color Who Decline TMIST
n=11 Participants
non-WOC who decline TMIST will fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
|---|---|---|
|
Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants
new job/increased hours to increase income
|
0 Participants
|
0 Participants
|
|
Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants
increased debt
|
0 Participants
|
0 Participants
|
|
Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants
work hours reduction
|
0 Participants
|
1 Participants
|
|
Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants
layoff or furlough
|
0 Participants
|
1 Participants
|
|
Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants
greater or equal to 20% income lose
|
0 Participants
|
1 Participants
|
|
Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants
savings use for living expenses
|
0 Participants
|
0 Participants
|
|
Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants
home sale/refinance
|
0 Participants
|
1 Participants
|
|
Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants
declared bankruptcy
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at baselinePopulation: 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
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)
Outcome measures
| Measure |
Women of Color Who Decline TMIST
n=1 Participants
WOC who decline TMIST asked to fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
non-Women of Color Who Decline TMIST
n=11 Participants
non-WOC who decline TMIST will fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
|---|---|---|
|
Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure
Sold or refinanced my/our home
|
0 Participants
|
1 Participants
|
|
Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure
Took out loans
|
0 Participants
|
0 Participants
|
|
Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure
Reached my/our credit limits
|
0 Participants
|
0 Participants
|
|
Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure
Had debt collectors contact me/us
|
0 Participants
|
0 Participants
|
|
Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure
Declared bankruptcy
|
0 Participants
|
0 Participants
|
|
Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure
More than 20% loss of income
|
0 Participants
|
1 Participants
|
|
Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure
Sold or refinanced my/our car
|
0 Participants
|
0 Participants
|
|
Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure
Used savings to pay for living expenses
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at 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
Outcome measures
| Measure |
Women of Color Who Decline TMIST
n=1 Participants
WOC who decline TMIST asked to fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
non-Women of Color Who Decline TMIST
n=11 Participants
non-WOC who decline TMIST will fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
|---|---|---|
|
Compare the Proportions of WOC vs Non-WOC Participants With COVID-specific Perceived Financial Distress
|
2 score on a scale
SD cannot be computed with only 1 observation
|
1.45 score on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: baselineThe proportions will be determined by calculating the number of women who self-report as non-White versus the total number of participants enrolled.
Outcome measures
| Measure |
Women of Color Who Decline TMIST
n=14 Participants
WOC who decline TMIST asked to fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
non-Women of Color Who Decline TMIST
n=16427 Participants
non-WOC who decline TMIST will fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
|---|---|---|
|
Compare the Proportion of WOC in TMIST Participants vs EAQ201 Participants
|
1 Participants
|
1138 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baselinePopulation: Study terminated early with insufficient data to generate planned logistic models to generate the composite material condition measure.
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)
Outcome measures
| Measure |
Women of Color Who Decline TMIST
n=1 Participants
WOC who decline TMIST asked to fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
non-Women of Color Who Decline TMIST
n=11 Participants
non-WOC who decline TMIST will fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
|---|---|---|
|
Compare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment Change
Had work hours reduced
|
0 Participants
|
1 Participants
|
|
Compare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment Change
Was laid off or furloughed
|
0 Participants
|
1 Participants
|
|
Compare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment Change
Used sick time or vacation time
|
0 Participants
|
1 Participants
|
|
Compare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment Change
Took a new or additional job or worked additional hours to make ends meet
|
0 Participants
|
0 Participants
|
|
Compare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment Change
Prefer not to say
|
0 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baselinePopulation: 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
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
Outcome measures
| Measure |
Women of Color Who Decline TMIST
n=1 Participants
WOC who decline TMIST asked to fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
non-Women of Color Who Decline TMIST
n=11 Participants
non-WOC who decline TMIST will fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
|---|---|---|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer
anxious about losing or having lost my job, or losing my primary source of income
|
5 score on a scale
Insufficient data to compute SD
|
1.09 score on a scale
Standard Deviation 0.30
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer
anxious about getting or becoming ill with COVID-19
|
5 score on a scale
Insufficient data to compute SD
|
2.09 score on a scale
Standard Deviation 0.94
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer
concerned about spreading COVID-19 to others
|
5 score on a scale
Insufficient data to compute SD
|
2.82 score on a scale
Standard Deviation 1.25
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer
about the possibility of dying from COVID-19
|
5 score on a scale
Insufficient data to compute SD
|
1.64 score on a scale
Standard Deviation 0.92
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer
I have no control over how COVID-19 will impact my life
|
5 score on a scale
Insufficient data to compute SD
|
2.36 score on a scale
Standard Deviation 1.21
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer
I feel negatively about the future
|
3 score on a scale
Insufficient data to compute SD
|
1.45 score on a scale
Standard Deviation 0.93
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer
COVID-19 has been a financial hardship to my family
|
2 score on a scale
Insufficient data to compute SD
|
1.45 score on a scale
Standard Deviation 0.93
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer
I feel in control of my financial situation
|
3 score on a scale
Insufficient data to compute SD
|
4.45 score on a scale
Standard Deviation 1.21
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer
I worry about having enough money to pay my rent/mortgage
|
3 score on a scale
Insufficient data to compute SD
|
1 score on a scale
Standard Deviation 0
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer
I worry about having enough money to buy enough food for my family
|
3 score on a scale
Insufficient data to compute SD
|
1.09 score on a scale
Standard Deviation 0.30
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer
Do you think you will get breast cancer in the next 5 years?
|
2 score on a scale
Insufficient data to compute SD
|
2.27 score on a scale
Standard Deviation 0.65
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer
Do you think you will get COVID-19 in the next 5 years?
|
4 score on a scale
Insufficient data to compute SD
|
3.09 score on a scale
Standard Deviation 0.83
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baselinePopulation: Study terminated early with insufficient data to generate planned logistic models to generate the composite material condition measure.
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)
Outcome measures
| Measure |
Women of Color Who Decline TMIST
n=1 Participants
WOC who decline TMIST asked to fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
non-Women of Color Who Decline TMIST
n=11 Participants
non-WOC who decline TMIST will fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
|---|---|---|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast Cancer
Smoking or tobacco use during the past 30 days compared to BEFORE the COVID-19 pandemic · More
|
0 Participants
|
0 Participants
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast Cancer
Smoking or tobacco use during the past 30 days compared to BEFORE the COVID-19 pandemic · Same
|
0 Participants
|
0 Participants
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast Cancer
Alcohol Consumption(freq/number of drinks on the same occasion) compared to BEFORE the COVID-19? · More
|
0 Participants
|
2 Participants
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast Cancer
Alcohol Consumption(freq/number of drinks on the same occasion) compared to BEFORE the COVID-19? · Same
|
0 Participants
|
8 Participants
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast Cancer
Alcohol Consumption(freq/number of drinks on the same occasion) compared to BEFORE the COVID-19? · Not applicable (do not partake)
|
1 Participants
|
1 Participants
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast Cancer
Alcohol Consumption(freq/number of drinks on the same occasion) compared to BEFORE the COVID-19? · Less
|
0 Participants
|
0 Participants
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast Cancer
Smoking or tobacco use during the past 30 days compared to BEFORE the COVID-19 pandemic · Not applicable (do not partake)
|
1 Participants
|
11 Participants
|
|
Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast Cancer
Smoking or tobacco use during the past 30 days compared to BEFORE the COVID-19 pandemic · Less
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baselineParticipant-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
Outcome measures
| Measure |
Women of Color Who Decline TMIST
n=1 Participants
WOC who decline TMIST asked to fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
non-Women of Color Who Decline TMIST
n=11 Participants
non-WOC who decline TMIST will fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.
Questionnaire: Complete the survey questions
|
|---|---|---|
|
Compare Participant-reported Quality of Life, Anxiety and Depression Between WOC and Non-WOC EAQ201 Participants
PROMIS Global Health
|
34 score on a scale
Insufficient data to compute SD
|
33.09 score on a scale
Standard Deviation 4.44
|
|
Compare Participant-reported Quality of Life, Anxiety and Depression Between WOC and Non-WOC EAQ201 Participants
PROMIS Anxiety
|
0 score on a scale
Insufficient data to compute SD
|
5.73 score on a scale
Standard Deviation 1.85
|
|
Compare Participant-reported Quality of Life, Anxiety and Depression Between WOC and Non-WOC EAQ201 Participants
PROMIS Depression
|
0 score on a scale
Insufficient data to compute SD
|
4.73 score on a scale
Standard Deviation 1.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 1 yearPopulation: 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.
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
Outcome measures
Outcome data not reported
Adverse Events
Women of Color (WOC) Who Decline TMIST
non-[Women of Color (WOC)] Who Decline TMIST
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60