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

Trial Status: Active

This phase III study compares the proportion of women of color versus non-women of color to assess the COVID-19 related financial hardship and distress in those who decline tomosynthesis mammographic imaging screening trial (TMIST) participation. This study may find out which factors may lead women of color to decline participation in EA1151 (TMIST).

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

Idaho

Boise
Saint Luke's Cancer Institute - Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774

Illinois

Danville
Carle on Fairchild
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Hoopeston
Carle Hoopeston Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532

Indiana

Hobart
Saint Mary Medical Center
Status: ACTIVE
Contact: Site Public Contact
Munster
Women's Diagnostic Center - Munster
Status: ACTIVE
Contact: Site Public Contact
Phone: 219-934-8869

Michigan

Battle Creek
Bronson Battle Creek
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Grand Rapids
Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Kalamazoo
West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230

Minnesota

Aitkin
Riverwood Healthcare Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Brainerd
Essentia Health Saint Joseph's Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Burnsville
Fairview Ridges Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Minnesota Oncology - Burnsville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Cambridge
Cambridge Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Coon Rapids
Mercy Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Deer River
Essentia Health - Deer River Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Detroit Lakes
Essentia Health Saint Mary's - Detroit Lakes Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Duluth
Essentia Health Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Essentia Health Saint Mary's Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Miller-Dwan Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Edina
Fairview Southdale Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Fergus Falls
Lake Region Healthcare Corporation-Cancer Care
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Fosston
Essentia Health - Fosston
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Fridley
Unity Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Hibbing
Essentia Health Hibbing Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Saint John's Hospital - Healtheast
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Health Partners Inc
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Hennepin County Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Monticello
Monticello Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
New Ulm
New Ulm Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Park Rapids
Essentia Health - Park Rapids
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Princeton
Fairview Northland Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Robbinsdale
North Memorial Medical Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
United Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Sandstone
Essentia Health Sandstone
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Shakopee
Saint Francis Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Stillwater
Lakeview Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Virginia
Essentia Health Virginia Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Waconia
Ridgeview Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Wyoming
Fairview Lakes Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517

North Dakota

Fargo
Essentia Health Cancer Center-South University Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Jamestown
Essentia Health - Jamestown Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308

Pennsylvania

Philadelphia
Pennsylvania Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-789-7366

Washington

Seattle
Swedish Medical Center-First Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086

Wisconsin

Ashland
Duluth Clinic Ashland
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Northwest Wisconsin Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Hayward
Essentia Health-Hayward Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
New Richmond
Cancer Center of Western Wisconsin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Spooner
Essentia Health-Spooner Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 218-786-3308
Superior
Essentia Health Saint Mary's Hospital - Superior
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-364-6272

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