Abstract

The broad long-term objective is to reduce cancer health disparities in women of color (WOC) through increased participation in clinical trials. Cost concerns are a known barrier to trial participation that disproportionately affect WOC. The personal and state- and local-level economic consequences of COVID-19 may disproportionately affect WOC, intensifying financial hardship and widening the gap in trial participation between WOC and non-WOC.
The specific aims of this study are to compare 1) the proportion of WOC who experience COVID-related financial hardship (income/employment/insurance loss) vs non-WOC, in a population of women who decline participation in Tomosynthesis Mammographic Imaging Screening Trial (TMIST), a randomized controlled trial of digital mammography (DM) vs tomosynthesis (TM) to evaluate stage shift in screen-detected cancers; 2) the effects of other sociodemographics, and state- or local-level COVID-19 factors on TMIST participation, between WOC and non-WOC. The proposed study is an observational cohort of women who decline to participate in TMIST.
In Aim 1, decliners will be surveyed regarding COVID-19 related financial hardship and distress. Among decliners, the proportion of WOC vs non-WOC who experience COVID-related financial hardship will be compared, accounting for patient-, practice-, local- and state-level COVID- related factors.
In Aim 2, the observational cohort of decliners will be combined with an observational cohort of agree-ers during the same time period. The effects of sociodemographics, and state- and local-level COVID-19 on trial participation will be compared between WOC vs non-WOC. The COVID-19 specific survey in Aim 1 will not be administered to agree-ers and patient-level COVID-19 financial hardship and distress will not be incorporated into AIM 2 analyses.

Public Health Relevance

Breast cancer claims more African-American lives compared to White and Asian-Americans and is the most frequent cause of cancer deaths in Latinx. Participation in clinical trials by women of color (WOC) is needed to improve outcomes, reduce health inequity and increase trial generalizability. This study will assist development of interventions to reduce the participation cost for WOC and decrease disparities.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Clinical Research Cooperative Agreements - Single Project (UG1)
Project #
3UG1CA189828-07S3
Application #
10208475
Study Section
Special Emphasis Panel (ZCA1)
Program Officer
Lee, Cecilia H
Project Start
2014-08-01
Project End
2025-07-31
Budget Start
2020-08-01
Budget End
2021-07-31
Support Year
7
Fiscal Year
2020
Total Cost
Indirect Cost

  Institution

Name
Ecog-Acrin Medical Research Foundation
Department
Type
DUNS #
078579855
City
Philadelphia
State
PA
Country
United States
Zip Code
19103

  Publications

Wong, Yu-Ning; Manola, Judith; Hudes, Gary R et al. (2018) Phase 2 Study of Weekly Paclitaxel Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma: ECOG-ACRIN Cancer Research Group (E1898) Trial. Clin Genitourin Cancer 16:e315-e322
Wagner, Lynne I; Zhao, Fengmin; Goss, Paul E et al. (2018) Patient-reported predictors of early treatment discontinuation: treatment-related symptoms and health-related quality of life among postmenopausal women with primary breast cancer randomized to anastrozole or exemestane on NCIC Clinical Trials Group (CCTG Breast Cancer Res Treat 169:537-548
Ailawadhi, Sikander; Jacobus, Susanna; Sexton, Rachael et al. (2018) Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials. Blood Cancer J 8:67
Morgans, Alicia K; Chen, Yu-Hui; Sweeney, Christopher J et al. (2018) Quality of Life During Treatment With Chemohormonal Therapy: Analysis of E3805 Chemohormonal Androgen Ablation Randomized Trial in Prostate Cancer. J Clin Oncol 36:1088-1095
Cohee, Andrea A; Bigatti, Silvia M; Shields, Cleveland G et al. (2018) Quality of Life in Partners of Young and Old Breast Cancer Survivors. Cancer Nurs 41:491-497
Yeruva, Sri Lakshmi Hyndavi; Zhao, Fengmin; Miller, Kathy D et al. (2018) E2112: randomized phase iii trial of endocrine therapy plus entinostat/placebo in patients with hormone receptor-positive advanced breast cancer. NPJ Breast Cancer 4:1
Charkhchi, Paniz; Fazeli Dehkordy, Soudabeh; Carlos, Ruth C (2018) Housing and Food Insecurity, Care Access, and Health Status Among the Chronically Ill: An Analysis of the Behavioral Risk Factor Surveillance System. J Gen Intern Med 33:644-650
Gee, Michael S; Atri, Mostafa; Bandos, Andriy I et al. (2018) Identification of Distant Metastatic Disease in Uterine Cervical and Endometrial Cancers with FDG PET/CT: Analysis from the ACRIN 6671/GOG 0233 Multicenter Trial. Radiology 287:176-184
Gareen, Ilana F; Black, William C; Tosteson, Tor D et al. (2018) Medical Care Costs Were Similar Across the Low-dose Computed Tomography and Chest X-Ray Arms of the National Lung Screening Trial Despite Different Rates of Significant Incidental Findings. Med Care 56:403-409
Sparano, Joseph A; Gray, Robert J; Makower, Della F et al. (2018) Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. N Engl J Med 379:111-121

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