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

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 United States (U.S.) zip code

PRIMARY OBJECTIVE:

I. In a population of women who decline participation in TMIST (EAQ201 participants), compare the proportion of women of color (WOC) versus (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.

SECONDARY OBJECTIVES:

I. Compare the proportions of WOC vs non-WOC EAQ201 participants with COVID-related change in their material condition, a composite measure.

II. Compare the proportions of WOC vs non-WOC EAQ201 participants with COVID-specific perceived financial distress.

III. Compare the proportion of WOC in TMIST participants vs EAQ201 participants.

EXPLORATORY OBJECTIVES:

I. Compare the proportion of WOC vs non-WOC EAQ201 participants with COVID-related employment change, a composite measure.

II. Compare the proportions of WOC vs non-WOC EAQ201 participants with COVID-specific perceived distress and perceived susceptibility to COVID and breast cancer.

III. Compare the proportions of WOC vs non-WOC EAQ201 participants with relative increase in smoking and alcohol use, risk factors for breast cancer.

IV. Compare participant-reported quality of life, anxiety and depression between WOC and non-WOC EAQ201 participants.

V. Assess the effects of sociodemographic characteristics, and federal-, state- or local-level COVID-19 factors on TMIST participation, in WOC vs non-WOC.

OUTLINE:

Participants complete survey over 18 minutes.

Trial Phase Phase III

Trial Type Observational

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Ruth Carlos

• Primary ID EAQ201
• Secondary IDs NCI-2021-05681, ECOG-ACRIN-EAQ201
• Clinicaltrials.gov ID NCT05076266