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

NCT05076266 | Terminated Results DMC

• 2 other identifiers: EAQ201NCI-2021-05681
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer, NOS

Outcome Measures

Primary Outcomes (1)

• 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

  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

  at baseline

• Compare the Proportions of WOC vs Non-WOC Participants With COVID-specific Perceived Financial Distress

  at baseline

• Compare the Proportion of WOC in TMIST Participants vs EAQ201 Participants

  baseline

Other Outcomes (5)

• Compare the Proportion of WOC vs Non-WOC EAQ201 Participants With COVID-related Employment Change

  baseline

• Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With COVID-specific Perceived Distress and Perceived Susceptibility to COVID and Breast Cancer

  baseline

• Compare the Proportions of WOC vs Non-WOC EAQ201 Participants With Relative Increase in Smoking and Alcohol Use, Risk Factors for Breast Cancer

  baseline

Study Arms (2)

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.

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.

Other: Questionnaire

Interventions

Questionnaire OTHER

Complete the survey questions

Non-[Women of Color (WOC)]; Women of Color (WOC) Who Decline TMIST

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Study Statistician
• Organization: ECOG-ACRIN Statistical Office

eatrials@jimmy.harvard.edu

617-632-3012

Study Officials

• Ruth Carlos

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 13, 2021
• Study Start: March 14, 2022
• Primary Completion: February 2, 2023
• Study Completion: February 3, 2023
• Last Updated: July 20, 2026
• Results First Posted: February 10, 2025

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)