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

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ClinicalTrials.gov Identifier: NCT05076266
Recruitment Status : Not yet recruiting
First Posted : October 13, 2021
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

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.

Condition or disease Intervention/treatment
Breast Cancer, NOS Other: Questionnaire

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 Related Financial Hardship and Distress in Women Who Decline TMIST (EA1151) Participation
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Women Who Decline TMIST
Women 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
Complete the survey questions




Primary Outcome Measures :
  1. Compare the proportion of WOC EAQ201 participants who experience COVID-related financial hardship vs non-WOC EAQ201 participants [ Time Frame: Through study completion, an average of 1 year ]
    Composite outcome, defined as answering in the affirmative to any of the following personal changes due to COVID: layoff or furlough, insurance loss, work hours reduction, new job/increased hours to increase income, food or housing insecurity OR answering in the affirmative to any of the following household changes due to COVID: greater or equal to 20% income lose, savings use for living expenses, home sale/refinance, increased debt, declared bankruptcy


Secondary Outcome Measures :
  1. Compare the proportions of WOC vs non-WOC EAQ201 participants with COVID-related change in their material condition, a composite measure [ Time Frame: Through study completion, an average of 1 year ]
    Self-reported material condition of any of the following: >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)

  2. Compare the proportions of WOC vs non-WOC EAQ201 participants with COVID-specific perceived financial distress [ Time Frame: Through study completion, an average of 1 year ]
    Adapted from the summary item from COST measure (continuous) "COVID-19 has been a financial hardship to my family

  3. Compare the proportion of WOC in TMIST participants vs EAQ201 participants [ Time Frame: Through study completion, an average of 1 year ]
    Race/ethnicity, age, insurance, and ZIP


Other Outcome Measures:
  1. Compare the proportion of WOC vs non-WOC EAQ201 participants with COVID-related employment change, a composite measure [ Time Frame: Through study completion, an average of 1 year ]
    Employment change of any of the following: Self-reported work hours reduction, layoff or furlough, sick time, vacation time use or new job/increased hours to increase income (binary)

  2. Compare the proportions of WOC vs non-WOC EAQ201 participants with COVID-specific perceived distress and perceived susceptibility to COVID and breast cancer [ Time Frame: Through study completion, an average of 1 year ]
    Adapted from Penedo (personal communication) to capture the emotional response to COVID related to fear of infection, financial anxiety, housing and food insecurity (single items) (categorical)(11 items) Single items for breast cancer and COVID-19, modified from previous studies of intention to undergo breast cancer screening. (categorical) (2 items)

  3. Compare the proportions of WOC vs non-WOC EAQ201 participants with relative increase in smoking and alcohol use, risk factors for breast cancer [ Time Frame: Through study completion, an average of 1 year ]
    Assess change in frequency or amount of tobacco or alcohol use during COVID compared to before COVID. Will not assess absolute amount of use. (categorical) (2 items)

  4. Compare participant-reported quality of life, anxiety and depression between WOC and non-WOC EAQ201 participants [ Time Frame: Through study completion, an average of 1 year ]
    Participant-Reported Outcomes Measurement Information System (PROMIS)-1018 10-item physical and mental health assessment. Sum of item responses (continuous) (10 items) PROMIS Anxiety 4-item Short Form. Sum of item responses (continuous) (4 items) PROMIS Depression 4-item Short Form. Sum of item responses (continuous) (4 items)

  5. Assess the effects of sociodemographic characteristics, and federal-, state- or local-level COVID-19 factors on TMIST participation, in WOC vs non-WOC [ Time Frame: Through study completion, an average of 1 year ]
    Compare maximum number of COVID-19 cases, state unemployment during shelter-in-place, local unemployment during shelter-in-place) on TMIST participation, stratified by WOC vs non-WOC



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women age 45 or older and under age 75 who decline participation in EA1151/TMIST
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076266


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Contact: Ruth C Carlos, MD       rcarlos@med.umich.edu   
Principal Investigator: Ruth C Carlos, MD         
Sponsors and Collaborators
Eastern Cooperative Oncology Group
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Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT05076266    
Other Study ID Numbers: EAQ201
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Financial Stress
Neoplasms
Stress, Psychological
Behavioral Symptoms
Neoplasms by Site
Breast Diseases
Skin Diseases