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COVID-19 Related Financial Hardship and Distress in Women Who Decline TMIST (EA1151) Participation

NCT ID: NCT05076266

Last Updated: 2025-11-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-14

Study Completion Date

2023-02-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer, NOS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Questionnaire

Intervention Type OTHER

Complete the survey questions

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.

Questionnaire

Intervention Type OTHER

Complete the survey questions

Interventions

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Questionnaire

Complete the survey questions

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eastern Cooperative Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ruth Carlos

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2021-05681

Identifier Type: REGISTRY

Identifier Source: secondary_id

EAQ201

Identifier Type: OTHER

Identifier Source: secondary_id

EAQ201

Identifier Type: OTHER

Identifier Source: secondary_id

EAQ201

Identifier Type: -

Identifier Source: org_study_id