Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-28 @ 7:41 PM
Study NCT ID:
NCT05076266
Status:
TERMINATED
Last Update Posted:
2025-11-24
First Post:
2021-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COVID-19 Related Financial Hardship and Distress in Women Who Decline TMIST (EA1151) Participation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eatrials@jimmy.harvard.edu', 'phone': '617-632-3012', 'title': 'Study Statistician', 'organization': 'ECOG-ACRIN Statistical Office'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'during registration visit.', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Women of Color (WOC) Who Decline TMIST', 'description': '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.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'non-[Women of Color (WOC)] Who Decline TMIST', 'description': '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.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women of Color Who Decline TMIST', 'description': '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.\n\nQuestionnaire: Complete the survey questions'}, {'id': 'OG001', 'title': 'non-Women of Color Who Decline TMIST', 'description': '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.\n\nQuestionnaire: Complete the survey questions'}], 'classes': [{'title': 'work hours reduction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'layoff or furlough', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'new job/increased hours to increase income', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'greater or equal to 20% income lose', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'savings use for living expenses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'home sale/refinance', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'increased debt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'declared bankruptcy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at baseline', 'description': '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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women of Color Who Decline TMIST', 'description': 'WOC who decline TMIST and fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.\n\nQuestionnaire: Complete the survey questions'}, {'id': 'OG001', 'title': 'non-Women of Color Who Decline TMIST', 'description': 'non-WOC who decline TMIST and fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.\n\nQuestionnaire: Complete the survey questions'}], 'classes': [{'title': 'More than 20% loss of income', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Used savings to pay for living expenses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sold or refinanced my/our car', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sold or refinanced my/our home', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Took out loans', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reached my/our credit limits', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Had debt collectors contact me/us', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Declared bankruptcy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at baseline', 'description': '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)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Compare the Proportions of WOC vs Non-WOC Participants With COVID-specific Perceived Financial Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women of Color Who Decline TMIST', 'description': 'WOC who decline TMIST and fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.\n\nQuestionnaire: Complete the survey questions'}, {'id': 'OG001', 'title': 'non-Women of Color Who Decline TMIST', 'description': 'non-WOC who decline TMIST and fill out a survey with questions about demographics, income and employment, attitudes and experiences about COVID-19, and emotional well-being.\n\nQuestionnaire: Complete the survey questions'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'comment': 'SD cannot be computed with only 1 observation', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compare the Proportion of WOC in TMIST Participants vs EAQ201 Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16427', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women who enrolled in EAQ201', 'description': 'Women who declined TMIST and enrolled in EAQ201'}, {'id': 'OG001', 'title': 'Women who enrolled in TMIST', 'description': 'Women who enrolled in TMIST in the same time period (March 14 20222 to Feb 2, 2023)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1138', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline', 'description': 'The proportions will be determined by calculating the number of women who self-report as non-White versus the total number of participants enrolled.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Compare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women of Color Who Decline TMIST', 'description': '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.\n\nQuestionnaire: Complete the survey questions'}, {'id': 'OG001', 'title': 'non-Women of Color Who Decline TMIST', 'description': '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.\n\nQuestionnaire: Complete the survey questions'}], 'classes': [{'title': 'Had work hours reduced', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Was laid off or furloughed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Used sick time or vacation time', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Took a new or additional job or worked additional hours to make ends meet', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Prefer not to say', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline', 'description': '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)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated early with insufficient data to generate planned logistic models to generate the composite material condition measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women of Color Who Decline TMIST', 'description': '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.\n\nQuestionnaire: Complete the survey questions'}, {'id': 'OG001', 'title': 'non-Women of Color Who Decline TMIST', 'description': '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.\n\nQuestionnaire: Complete the survey questions'}], 'classes': [{'title': 'anxious about getting or becoming ill with COVID-19', 'categories': [{'measurements': [{'value': '5', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '2.09', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'concerned about spreading COVID-19 to others', 'categories': [{'measurements': [{'value': '5', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '2.82', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'about the possibility of dying from COVID-19', 'categories': [{'measurements': [{'value': '5', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'I have no control over how COVID-19 will impact my life', 'categories': [{'measurements': [{'value': '5', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'I feel negatively about the future', 'categories': [{'measurements': [{'value': '3', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'anxious about losing or having lost my job, or losing my primary source of income', 'categories': [{'measurements': [{'value': '5', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'COVID-19 has been a financial hardship to my family', 'categories': [{'measurements': [{'value': '2', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'I feel in control of my financial situation', 'categories': [{'measurements': [{'value': '3', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '4.45', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'I worry about having enough money to pay my rent/mortgage', 'categories': [{'measurements': [{'value': '3', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '1', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'I worry about having enough money to buy enough food for my family', 'categories': [{'measurements': [{'value': '3', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Do you think you will get breast cancer in the next 5 years?', 'categories': [{'measurements': [{'value': '2', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '2.27', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Do you think you will get COVID-19 in the next 5 years?', 'categories': [{'measurements': [{'value': '4', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '3.09', 'spread': '0.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women of Color Who Decline TMIST', 'description': '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.\n\nQuestionnaire: Complete the survey questions'}, {'id': 'OG001', 'title': 'non-Women of Color Who Decline TMIST', 'description': '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.\n\nQuestionnaire: Complete the survey questions'}], 'classes': [{'title': 'Alcohol Consumption(freq/number of drinks on the same occasion) compared to BEFORE the COVID-19?', 'categories': [{'title': 'More', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Less', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Same', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Not applicable (do not partake)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Smoking or tobacco use during the past 30 days compared to BEFORE the COVID-19 pandemic', 'categories': [{'title': 'More', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Less', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Same', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not applicable (do not partake)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline', 'description': '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)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated early with insufficient data to generate planned logistic models to generate the composite material condition measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Compare Participant-reported Quality of Life, Anxiety and Depression Between WOC and Non-WOC EAQ201 Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women of Color Who Decline TMIST', 'description': '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.\n\nQuestionnaire: Complete the survey questions'}, {'id': 'OG001', 'title': 'non-Women of Color Who Decline TMIST', 'description': '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.\n\nQuestionnaire: Complete the survey questions'}], 'classes': [{'title': 'PROMIS Global Health', 'categories': [{'measurements': [{'value': '34', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '33.09', 'spread': '4.44', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Anxiety', 'categories': [{'measurements': [{'value': '0', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '5.73', 'spread': '1.85', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Depression', 'categories': [{'measurements': [{'value': '0', 'comment': 'Insufficient data to compute SD', 'groupId': 'OG000'}, {'value': '4.73', 'spread': '1.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Assess the Effects of Sociodemographic Characteristics, and Federal-, State- or Local-level COVID-19 Factors on TMIST Participation, in WOC vs Non-WOC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women of Color Who Decline TMIST', 'description': '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.\n\nQuestionnaire: Complete the survey questions'}, {'id': 'OG001', 'title': 'non-Women of Color Who Decline TMIST', 'description': '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.\n\nQuestionnaire: Complete the survey questions'}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, an average of 1 year', 'description': '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', 'unitOfMeasure': 'participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-[Women of Color] who decline TMIST', 'description': '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.'}, {'id': 'FG001', 'title': 'Women of Color who decline TMIST', 'description': 'This group contains Women of Color who declined participation in TMIST'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Survey not complete - Participant refusal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Women Who Decline TMIST', 'description': '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.\n\nWomen of Color(WOC and Non-WOC Groups combined to protect confidentiality for single participant in "Women of Color Who Decline TMIST" Group'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Survey Completed', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-03', 'size': 644891, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-22T12:49', 'hasProtocol': True}, {'date': '2022-05-03', 'size': 240935, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-22T12:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'slower than expected accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2021-10-06', 'resultsFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2021-10-11', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-02-06', 'studyFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Compare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment Change', 'timeFrame': 'baseline', 'description': '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)'}, {'measure': 'Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer', 'timeFrame': 'baseline', 'description': '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'}, {'measure': 'Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast Cancer', 'timeFrame': 'baseline', 'description': '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)'}, {'measure': 'Compare Participant-reported Quality of Life, Anxiety and Depression Between WOC and Non-WOC EAQ201 Participants', 'timeFrame': 'baseline', 'description': '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'}, {'measure': 'Assess the Effects of Sociodemographic Characteristics, and Federal-, State- or Local-level COVID-19 Factors on TMIST Participation, in WOC vs Non-WOC', 'timeFrame': 'Through study completion, an average of 1 year', 'description': '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'}], 'primaryOutcomes': [{'measure': 'Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants', 'timeFrame': 'at baseline', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure', 'timeFrame': 'at baseline', 'description': '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)'}, {'measure': 'Compare the Proportions of WOC vs Non-WOC Participants With COVID-specific Perceived Financial Distress', 'timeFrame': 'at baseline', 'description': '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'}, {'measure': 'Compare the Proportion of WOC in TMIST Participants vs EAQ201 Participants', 'timeFrame': 'baseline', 'description': 'The proportions will be determined by calculating the number of women who self-report as non-White versus the total number of participants enrolled.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer, NOS']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women age 45 or older and under age 75 who decline participation in EA1151/TMIST', 'genderDescription': 'Women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants must be women age 45 or older and under age 75 at the time of study entry.\n\nParticipant must be scheduled for, or have intent to schedule, a screening mammogram.\n\nParticipant 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.\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT05076266', 'briefTitle': 'COVID-19 Related Financial Hardship and Distress in Women Who Decline TMIST (EA1151) Participation', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'COVID-19 Related Financial Hardship and Distress in Women Who Decline TMIST (EA1151) Participation', 'orgStudyIdInfo': {'id': 'EAQ201'}, 'secondaryIdInfos': [{'id': 'NCI-2021-05681', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'EAQ201', 'type': 'OTHER', 'domain': 'ECOG-ACRIN Cancer Research Group'}, {'id': 'EAQ201', 'type': 'OTHER', 'domain': 'DCP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women of Color (WOC) Who Decline TMIST', 'description': '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.', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Non-[Women of Color (WOC)]', 'description': '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.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Complete the survey questions', 'armGroupLabels': ['Non-[Women of Color (WOC)]', 'Women of Color (WOC) Who Decline TMIST']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Ruth Carlos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ECOG-ACRIN Cancer Research Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}