Clinical trial NCT05076266: COVID-19 Related Financial Hardship and Distress in Women Who Decline TMIST (EA1151) Participation
Official title: COVID-19 Related Financial Hardship and Distress in Women Who Decline TMIST (EA1151) Participation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer, NOS
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
First posted: 2021-10-13
Enrollment: 14
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women age 45 or older and under age 75 who decline participation in EA1151/TMIST

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.

Eligibility criteria: 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:

Primary outcomes:
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
Secondary outcomes:
measure: Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure
timeFrame: at baseline
measure: Compare the Proportions of WOC vs Non-WOC Participants With COVID-specific Perceived Financial Distress
timeFrame: at baseline
measure: Compare the Proportion of WOC in TMIST Participants vs EAQ201 Participants
timeFrame: baseline
Other outcomes:
measure: Compare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment Change
timeFrame: baseline
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
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
measure: Compare Participant-reported Quality of Life, Anxiety and Depression Between WOC and Non-WOC EAQ201 Participants
timeFrame: baseline
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
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: ECOG-ACRIN Cancer Research Group
name: Ruth Carlos
role: PRINCIPAL_INVESTIGATOR
References: