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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-05681 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| EAQ201 | Other Identifier | ECOG-ACRIN Cancer Research Group | |
| EAQ201 | Other Identifier | DCP |
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slower than expected accrual.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Complete the survey questions |
|
| 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 |
| 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 |
| 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 |
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:
Women
Women age 45 or older and under age 75 who decline participation in EA1151/TMIST
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Carlos | ECOG-ACRIN Cancer Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Women of Color Who Decline TMIST | This group contains Women of Color who declined participation in TMIST |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | Posted | Count of Participants | Participants | at baseline |
|
during registration visit.
As minimal risk study, comprised of a single survey completed after registration, participants went off study after completing the initial survey - adverse events were not monitored survey completion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG-ACRIN Statistical Office | 617-632-3012 | eatrials@jimmy.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2022 | Jan 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 3, 2022 | Jan 22, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 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 |
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 |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Survey Completed | Count of Participants | Participants |
|
| OG001 | Non-Women of Color Who Decline TMIST | 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 |
|
|
| 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) | 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 | Posted | Count of Participants | Participants | at baseline |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | at baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | baseline |
|
|
|
| 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) | Study terminated early with insufficient data to generate planned logistic models to generate the composite material condition measure. | Posted | Count of Participants | Participants | baseline |
|
|
|
| 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 | 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 | Posted | Mean | Standard Deviation | score on a scale | baseline |
|
|
|
| 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) | Study terminated early with insufficient data to generate planned logistic models to generate the composite material condition measure. | Posted | Count of Participants | Participants | baseline |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | baseline |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | participants | Through study completion, an average of 1 year |
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Non-[Women of Color (WOC)] Who Decline TMIST | non-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. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Sold or refinanced my/our car |
|
| Sold or refinanced my/our home |
|
| Took out loans |
|
| Reached my/our credit limits |
|
| Had debt collectors contact me/us |
|
| Declared bankruptcy |
|
| Used sick time or vacation time |
|
| Took a new or additional job or worked additional hours to make ends meet |
|
| Prefer not to say |
|
| about the possibility of dying from COVID-19 |
|
| I have no control over how COVID-19 will impact my life |
|
| I feel negatively about the future |
|
| anxious about losing or having lost my job, or losing my primary source of income |
|
| COVID-19 has been a financial hardship to my family |
|
| I feel in control of my financial situation |
|
| I worry about having enough money to pay my rent/mortgage |
|
| I worry about having enough money to buy enough food for my family |
|
| Do you think you will get breast cancer in the next 5 years? |
|
| Do you think you will get COVID-19 in the next 5 years? |
|
| Same |
|
| Not applicable (do not partake) |
|
| Smoking or tobacco use during the past 30 days compared to BEFORE the COVID-19 pandemic |
|
| PROMIS Depression |
|