Breast Cancer, NOSNCT05076266

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

An observational study of Breast Cancer, NOS, run by Eastern Cooperative Oncology Group at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 45 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Cancer, NOS
What is being tested?: Questionnaire
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 14 Mar 2022to 3 Feb 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 75 years
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: Women age 45 or older and under age 75 who decline participation in EA1151/TMIST

Who may be able to join

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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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.

Read the 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.

Conditions: Breast Cancer, NOS
Being tested: Questionnaire
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QuestionnaireOther
Complete the survey questions

Study groups in NCT05076266
Study group	Role	What they receive
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. Receives: Other: Questionnaire
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. Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: at baseline

Secondary outcomes (3)

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)
Measured: at baseline
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
Measured: 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.
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 20223 Feb 2023

First posted13 Oct 2021
Study start14 Mar 2022
Primary completion2 Feb 2023
Study completion3 Feb 2023

Why it stopped: slower than expected accrual.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast Cancer, NOSStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05076266
Sponsor's protocol ID: EAQ201
Other IDs: NCI-2021-05681, EAQ201, EAQ201
Status last verified: Sep 2026
First submitted: 6 Oct 2021
Last updated: 15 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer, NOS trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: COVID-19 Related Financial Hardship and Distress in Women Who Decline TMIST (EA1151) Participation
ClinicalTrials.gov ID: NCT05076266
Acronym / sponsor ID: EAQ201
Conditions: Breast Cancer, NOS
Study type: Observational
Recruitment status: TerminatedReason stopped: slower than expected accrual.
Enrolment: 14 participants (actual)
Lead sponsor: Eastern Cooperative Oncology GroupResearch network
Study start: 14 Mar 2022 (actual)
Primary completion: 2 Feb 2023 (actual)
Study completion: 3 Feb 2023 (actual)
First posted: 13 Oct 2021 (actual)
Results: Posted 10 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Women of Color (WOC) Who Decline TMIST	–	Other: QuestionnaireWomen 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)]	–	Other: QuestionnaireNon-[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.

Who may qualify

Ages: 45 to 75 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Women age 45 or older and under age 75 who decline participation in EA1151/TMIST

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QuestionnaireComplete the survey questions	Other	Non-[Women of Color (WOC)], Women of Color (WOC) Who Decline TMIST

Primary outcome

Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants
Time frame: at baseline
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

3 secondary outcomes

Compare the Proportions of WOC vs Non-WOC Participants With COVID-related Change in Their Material Condition, a Composite Measure
Time frame: at baseline
Compare the Proportions of WOC vs Non-WOC Participants With COVID-specific Perceived Financial Distress
Time frame: at baseline
Compare the Proportion of WOC in TMIST Participants vs EAQ201 Participants
Time frame: baseline

Results and safety

Results posted to the registry on 10 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-[Women of Color] Who Decline TMIST	13	11
Women of Color Who Decline TMIST	1	1

Primary outcome: Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants

Time frame: at baseline. Count of participants. Unit: Participants

Measure	Women of Color Who Decline TMIST n = 1	Non-Women of Color Who Decline TMIST n = 11
work hours reduction	0	1
layoff or furlough	0	1
new job/increased hours to increase income	0	0
greater or equal to 20% income lose	0	1
savings use for living expenses	0	0
home sale/refinance	0	1
increased debt	0	0
declared bankruptcy	0	0

Population analysed: 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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: during registration visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Women of Color (WOC) Who Decline TMIST	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Non-[Women of Color (WOC)] Who Decline TMIST	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ruth Carlos principal investigator

ECOG-ACRIN Cancer Research Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, NOS, run by Eastern Cooperative Oncology Group at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the Proportion of Women of Color (WOC) Participants Who Experience the Composite Outcome of COVID-related Financial Hardship vs Non-WOC Participants (time frame: at baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05076266.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.