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:
Eastern Cooperative Oncology Group
Organization:
Study Overview
Official Title:
COVID-19 Related Financial Hardship and Distress in Women Who Decline TMIST (EA1151) Participation
Status:
TERMINATED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slower than expected accrual.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: