COVID-19 Related Financial Hardship and Distress in Women Who Decline TMIST (EA1151) Participation
Conditions: Breast Cancer, NOS
Sponsor: Eastern Cooperative Oncology Group

 
EAQ201 
1 
COVID-19 Related Financial Hardship and Distress in 
Women Who Decline TMIST (EA1151) Participation 
STUDY CHAIR: 
Ruth C. Carlos, MD 
STUDY STATISTICIANS: 
Fenghai Duan, PhD 
Constantine Gatsonis, PhD 
STUDY CO-CHAIR: 
Gelareh Sadigh, MD 
STUDY EPIDEMIOLOGIST: 
Ilana F. Gareen, PhD 
IMAGING STATISTICIAN: 
Na An, MS 
CANCER CARE DELIVERY RESEARCH (CCDR) 
COMMITTEE CHAIR: 
 
Ruth C. Carlos, MD 
CANCER CONTROL AND SURVIVORSHIP 
COMMITTEE CHAIR: 
 
Lynne Wagner, PhD 
Version Date:  May 3, 2022 
 
STUDY PARTICIPANTS 
 
ACTIVATION DATE 
ECOG-ACRIN / NCORP SITES ONLY 
 
December 2, 2021 
ALLIANCE / Alliance for Clinical Trials in 
Oncology – NCORP SITES ONLY 
 
Amendment #1 - incorporated prior to activation 
Amendment #2 
NRG / NRG Oncology - NCORP SITES ONLY 
 
 
SWOG / SWOG - NCORP SITES ONLY 
 
 
Limited to following selected non-NCORP sites: 
 
 
Cleveland Clinic (OH027) 
University of Iowa/Holden CCC (IA018) 
University of Virginia Health System (VA009) 
 
 
 
 
 
 
Rev. Add2 

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Table of Contents 
Schema ...................................................................................................................... 5 
1. Introduction ........................................................................................................ 6 
1.1 Study Foundation ...................................................................................... 6 
1.2 Background ............................................................................................... 6 
2. Objectives ........................................................................................................... 9 
2.1 Primary Objectives .................................................................................... 9 
2.2 Secondary Objectives ................................................................................ 9 
2.3 Exploratory Objectives .............................................................................. 9 
3. Selection of Sites ............................................................................................... 10 
3.1 Eligibility Criteria for Participants ........................................................... 10 
4. Site Investigators and Personnel CTEP Registration Procedures ...................... 11 
4.1 Registration Demographics ..................................................................... 14 
4.2 Eligibility Verification .............................................................................. 15 
4.3 Additional Requirements ........................................................................ 15 
5. Methodology Plan ............................................................................................. 22 
6. Study Calendar .................................................................................................. 27 
7. Statistical Considerations .................................................................................. 28 
7.1 Study Design and Objectives ................................................................... 28 
7.2 Primary Objective .................................................................................... 29 
7.3 Secondary Objectives .............................................................................. 30 
7.4 Assess the effects of sociodemographic characteristics, and federal-, 
state- or local-level COVID-19 factors on TMIST participation, in WOC vs 
non-WOC. ................................................................................................ 30 
7.5 Handling Missing Data ............................................................................ 31 
7.6 Gender and Ethnicity .............................................................................. 31 
7.7 Study Monitoring .................................................................................... 32 
8. Electronic Data Capture .................................................................................... 33 
9. Participant Consent and Peer Judgment .......................................................... 33 
10. References ........................................................................................................ 33 
 
 

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STUDY CHAIR 
Ruth C. Carlos, MD 
University of Michigan 
Department of Radiology 
1500 E Medical Center Dr. 
Ann Arbor, MI 48109 
rcarlos@med.umich.edu 
 
 

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CANCER TRIALS SUPPORT UNIT (CTSU) ADDRESS AND CONTACT INFORMATION 
For regulatory requirements: 
For patient enrollments: 
For study data 
submission: 
Regulatory documentation can 
be submitted to the CTSU via 
the Regulatory Submission 
Portal. 
(Sign in at www.ctsu.org, and 
select the Regulatory > 
Regulatory Submission.) 
Institutions with subjects 
waiting that are unable to use 
the Portal should alert the 
CTSU Regulatory Office 
immediately at 1-866-651-
2878 to receive further 
instruction and support. 
Contact the CTSU Regulatory 
Help Desk at 1-866-651-2878 
for regulatory assistance. 
Refer to the participant enrollment 
section of the protocol for instructions 
on using the Oncology Patient 
Enrollment Network (OPEN) which can 
be accessed at 
https://www.ctsu.org/OPEN_SYSTEM/ 
or https://OPEN.ctsu.org. 
Contact the CTSU Help Desk with any 
OPEN-related questions by phone or 
email : 1-888-823-5923, or 
ctsucontact@westat.com. 
Data collection for this 
study will be done through 
Medidata Rave and the 
ECOG-ACRIN Systems for 
Easy entry of PRO data 
(EASEE-PRO). Please see 
the data submission section 
of the protocol for further 
instructions. 
The most current version of the study protocol and all supporting documents must be downloaded 
from the protocol-specific Web page of the CTSU Member Web site located at https://www.ctsu.org.  
Access to the CTSU members’ website is managed through the Cancer Therapy and Evaluation 
Program - Identity and Access Management (CTEP-IAM) registration system and requires user log on 
with CTEP-IAM username and password.  
Permission to view and download this protocol and its supporting documents is restricted and is based 
on person and site roster assignment housed in the CTSU RSS. 
For clinical questions (i.e., subject eligibility or treatment-related) Contact the Study PI of the 
Coordinating Group. 
For non-clinical questions (i.e., unrelated to subject eligibility, treatment, or clinical data 
submission) contact the CTSU Help Desk by phone or e-mail:  
CTSU General Information Line – 1-888-823-5923, or ctsucontact@westat.com. All calls and 
correspondence will be triaged to the appropriate CTSU representative.  
The CTSU Web site is located at https://www.ctsu.org. 
 

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Schema 
TMIST Eligible
Women Ages 45-74 Presenting for Breast 
Screening
Agree to TMIST
Decline TMIST
COVID and other 
issues related to 
TMIST non-
participation
Federal-, State- and Local-level COVID 
prevention policies
 
 

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Introduction
1.1
Study Foundation
Breast cancer claims 40-250% more African-American lives compared to White 
and Asian-Americans1 and is the most frequent cause of cancer deaths in 
Hispanics/Latinas. Breast cancer is diagnosed at later stages in African-
Americans and Latinas suggesting persistent disparities in care delivery by 
race/ethnicity3. Participation in clinical trials by women of color (WOC, which is 
defined as non-white women for the purposes of this study) is needed to improve 
outcomes, reduce health inequity and increase trial generalizability. 
Disappointingly, within ECOG-ACRIN, WOC participation remains less than 10% 
regardless of trial type (therapeutic, diagnostic/ surveillance or screening). 
Improving clinical trial participation among WOC is therefore a high priority to 
ensure that trial results are truly generalizable to women of all racial/ethnic 
groups.
1.2
Background
In EA1151 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, participation by Asians and 
Hispanics in particular have lagged. Cost concerns are a known barrier to trial 
participation2 disproportionately affecting WOC. The COVID-19 pandemic will 
likely worsen trial participation among WOC. Unfortunately for many women, 
participation in TMIST can result in out-of-pocket costs since commercial 
insurance coverage of TM is widely variable4. Concerns about study-related 
costs are a known barrier to trial participation2 and the COVID-19 pandemic has 
resulted in record unemployment5,6 and insurance loss that has 
disproportionately affected minorities7. 
The economic toll can be broadly considered as financial hardship which has two 
main components, 1) material condition referring to actual financial resources 
available, and 2) psychological response to their material condition (see model).  
This financial hardship will further constrain many participants’ financial 
resources (material condition) and ability to afford out-of-pocket expenses 
associated with trial participation and may lead to financial distress (representing 
the psychological response), preferentially affecting WOC who decline 
participation compared to non-WOC who decline. Additional federal-, state- and 
local-level factors (e.g., shelter-in-place policies, local unemployment during 
COVID-19) may also contribute to trial nonparticipation (Fig 1). COVID-19 is a 
natural experiment to compare the role of financial hardship on willingness to 
participate in clinical trials between WOC and non-WOC and any widening of 
disparities in WOC trial participation in TMIST. This observational ancillary study 
results will be used to inform future trials of interventions to improve trial 
participation among WOC, e.g., financial assistance and financial navigation 
services for trial-related expenses.
In a population of women who decline participation in TMIST (EAQ201 
participants), we plan to compare the proportion of WOC who experience 
COVID-related change in their material condition (income/employment/insurance 
loss) vs non-WOC. Secondary and exploratory analyses will compare the 
proportions of WOC vs non-WOC with other person-level COVID-related factors 

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(including distress and fear of exposure during medical care) and assess federal-
, state- or local-level COVID-related factors (e.g., state infection rates and 
shelter-in-place policies and local-level unemployment during shelter-in-place) as 
moderators. 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. 
We will compare the effects of sociodemographics, and federal-, state- or local-
level COVID-19 factors on TMIST participation, in WOC vs non-WOC. We 
hypothesize that federal-, state- or local-level COVID-19 factors more severely 
affect participation among WOC after controlling for other sociodemographic 
factors at the person-level (e.g., insurance type, socioeconomic status (SES)). 
Our conceptual model integrates components of a traditional health services/care 
delivery model, an emerging model of financial hardship effect on health, and a 
model of psychological distress and coping to provide an innovative multi-level 
perspective on the effects of COVID-19 on a unique outcome, screening trial 
nonparticipation. While other studies have evaluated person-level factors9-11 or 
region-level12 factors, few can integrate factors at the individual, 
provider/organization, federal and state level to comprehensively evaluate 
barriers to trial participation. Incorporating COVID-specific distress and financial 
distress in trial nonparticipation is also novel, and to date the impact of these 
factors, particularly among WOC, is completely unknown.  
We previously demonstrated that imaging out-of-pocket (OOP) costs cause worry 
among 36% of outpatients undergoing CT/MRI at UMichigan out-patient imaging 
clinics13. Those with ACA marketplace insurance were twice as likely to report 
worry over OOP costs of the test (OR 2.0, 95%CI 1.1, 3.5) compared to those 
with employer-sponsored insurance. 10% reported nonadherence to 
recommended care over the last 3 months such as declining a test or skipping or 
taking less medication than prescribed because of cost. Participants who worry 
about OOP costs were more likely to report nonadherence by 5-fold (OR 5.7, 
95%CI 3.3, 9.8) than that those who did not. We hypothesize that when 
approached to participate for an imaging trial such as TMIST, women with 
existing OOP concerns or less generous insurance plans are more likely to 
decline participation than those who do not have existing OOP concerns or more 
generous insurance plans.  
We have successfully used a combination of paper and online survey 
administration and data collection in EAQ162CD, a longitudinal observational 
study of financial hardship in early stage colorectal cancer and two imaging trials 
that collected patient reported outcomes, E4112 Prospective Study of MRI and 
Multiparametric Expression Assay in Ductal Carcinoma in Situ and EA1141 
Comparison of Abbreviated Breast MRI and Digital Breast Tomosynthesis in 
Breast Cancer Screening in Women with Dense Breasts14. Depending on the 
study, 47-78% of women opted for online surveys. We have developed email and 
telephone reminders (see Section 4.3.5) for timely survey completion and 
processes for collecting any missing information. 

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Fig 1: Model of COVID effects on health
Federal, State and Local Health Environment: COVID 
disease burden, shelter-in-place policies, Medicaid coverage 
policies, state vs local-level unemployment
Organization/Practice Setting/Provider: COVID-related
service/medication unavailability, provider-initiated delay
Participant: Race/ethnicity (WOC vs non-WOC), other 
sociodemographics, COVID-related job/insurance loss
Cancer Care Delivery Outcome
WOC vs non-WOC TMIST trial nonparticipation
Participant- or provider-initiated care delay
Health Outcomes
Health-related quality of life
Material Condition
Composite financial burden 
measure (debt/loans/decreased 
income >20%, home sale/refi)
FINANCIAL HARDSHIP
Psychological response
Financial distress
Food / housing insecurity
DISTRESS 
Psychological response
COVID-specific distress
Preference for avoiding COVID 
vs obtaining care
Coping behavior that increases 
breast cancer risk (e.g. alcohol 
use)

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Objectives
2.1
Primary Objectives
2.1.1
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.
2.2
Secondary Objectives
2.2.1
Compare the proportions of WOC vs non-WOC EAQ201 participants 
with COVID-related change in their material condition, a composite 
measure.
2.2.2
Compare the proportions of WOC vs non-WOC EAQ201 participants 
with COVID-specific perceived financial distress.
2.2.3
Compare the proportion of WOC in TMIST participants vs EAQ201 
participants. A key hypothesis (now 2.2.3) is that financial hardship 
preferentially affects WOC and therefore their participation in TMIST.  
In order, to test this hypothesis, we need to compare the proportion of 
WOC who participated in TMIST compared to those who declined to 
participate in TMIST (estimated by EAQ201 participants).
2.3
Exploratory Objectives
2.3.1
Compare the proportion of WOC vs non-WOC EAQ201 participants
with COVID-related employment change, a composite measure.
2.3.2
Compare the proportions of WOC vs non-WOC EAQ201 participants
with COVID-specific perceived distress and perceived susceptibility to 
COVID and breast cancer.
2.3.3
Compare the proportions of WOC vs non-WOC EAQ201 participants
with relative increase in smoking and alcohol use, risk factors for 
breast cancer.
2.3.4
Compare participant-reported quality of life, anxiety and depression 
between WOC and non-WOC EAQ201 participants. 
2.3.5
Assess the effects of sociodemographic characteristics, and federal-, 
state- or local-level COVID-19 factors on TMIST participation, in WOC 
vs non-WOC.

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Selection of Sites
All interested NCORP and the three selected non-NCORP TMIST sites located in the 
United States will be invited to participate. There will be no specific exclusion criteria 
(i.e., minimum number of cases) because we would like to include a wide variety of 
different systems to better understand the variability in available financial resources and 
participant experiences.
Selection of Participant
Each of the criteria in the checklist that follows must be met in order for a person to be 
considered eligible for this study. Use the checklist to confirm a person’s eligibility. For 
each person, this checklist must be photocopied, completed and maintained in the 
person’s chart.
ECOG-ACRIN Participant No. ____________________________
Person’s Initials (L, F, M) _______________________
Treating Physician (Radiologist) or Designated Study Personnel Signature and Date 
___________________
NOTE:
CTEP Policy does not allow for the issuance of waivers to any protocol 
specified criteria 
(http://ctep.cancer.gov/protocolDevelopment/policies_deviations.htm). 
Therefore, all eligibility criteria listed in Section 3 must be met, without 
exception. The registration of individuals who do not meet all criteria listed in 
Section 3 can result in the participant being censored from the analysis of the 
study, and the citation of a major protocol violation during an audit, and
require reporting to the IRB of record as non-compliance.
All questions regarding clarification of eligibility criteria must be directed to the 
Group's Executive Officer (EA.ExecOfficer@jimmy.harvard.edu) or the 
Group's Regulatory Officer (EA.RegOfficer@jimmy.harvard.edu).
NOTE:
Institutions may use the eligibility checklist as source documentation if it has 
been reviewed, signed, and dated prior to registration/randomization by the 
treating physician.
3.1
Eligibility Criteria for Participants
3.1.1
Participant must have been eligible for and declined EA1151/TMIST in 
the preceding 6 months.
3.1.2
Participant must be able to complete questionnaires in English.
3.1.3
Participant must have a U.S. zip code.
Physician Signature
Date
OPTIONAL:
This signature line is provided for use by institutions wishing to 
use the eligibility checklist as source documentation.
Rev. Add2
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Site Investigators and Personnel CTEP Registration Procedures
Cancer Therapy Evaluation Program Investigator Registration Procedures
Food and Drug Administration (FDA) regulations and National Cancer Institute (NCI) 
policy require all individuals contributing to NCI-sponsored trials to register and to renew 
their registration annually. To register, all individuals must obtain a Cancer Therapy 
Evaluation Program (CTEP) Identity and Access Management (IAM) account 
(https://ctepcore.nci.nih.gov/iam). In addition, persons with a registration type of 
Investigator (IVR), Non-Physician Investigator (NPIVR), or Associate Plus (AP) must 
complete their annual registration using CTEP’s web-based Registration and Credential 
Repository (RCR) at https://ctepcore.nci.nih.gov/rcr.
RCR utilizes five person registration types.
•
IVR — MD, DO, or international equivalent;
•
NPIVR — advanced practice providers (e.g., NP or PA) or graduate level 
researchers (e.g., PhD);
•
AP — clinical site staff (e.g., RN or CRA) with data entry access to CTSU 
applications such as the Roster Update Management System [RUMS], OPEN, Rave, 
acting as a primary site contact, or with consenting privileges;
•
Associate (A) — other clinical site staff involved in the conduct of NCI-sponsored 
trials; and
•
Associate Basic (AB) — individuals (e.g., pharmaceutical company employees) with 
limited access to NCI-supported systems.
RCR requires the following registration documents:
Documentation Required
IVR
NPIVR
AP
A
AB
FDA Form 1572


Financial Disclosure Form



NCI Biosketch (education, 
training, employment, license, 
and certification)



GCP training



Agent Shipment Form (if 
applicable)

CV (optional)



An active CTEP-IAM user account and appropriate RCR registration is required to 
access all CTEP and Cancer Trials Support Unit (CTSU) websites and applications. In 
addition, IVRs and NPIVRs must list all clinical practice sites and IRBs covering their 
practice sites on the FDA Form 1572 in RCR to allow the following:
•
Added to a site roster
•
Assigned the treating, credit, consenting, or drug shipment (IVR only) tasks in OPEN
•
Act as the site-protocol PI on the IRB approval
In addition, all investigators act as the Site-Protocol PI (investigator listed on the IRB 
approval), consenting/treating/drug shipment investigator in OPEN, or as the CI on the 
DTL must be rostered at the enrolling site with a participating organization. Additional 

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information can be found on the CTEP website at 
https://ctep.cancer.gov/investigatorResources/default.htm. 
For questions, please contact the RCR Help Desk by email at RCRHelpDesk@nih.gov. 
Cancer Trials Support Unit Registration Procedures 
Permission to view and download this protocol and its supporting documents is restricted 
and is based on person and site roster assignment housed in the CTSU Regulatory 
Support System (RSS). 
This study is supported by the NCI Cancer Trials Support Unit (CTSU). 
IRB Approval: 
For CTEP and Division of Cancer Prevention (DCP) studies open to the National Clinical 
Trials Network (NCTN) and NCI Community Oncology Research Program (NCORP) 
Research Bases after March 1, 2019, all U.S.-based sites must be members of the NCI 
Central Institutional Review Board (NCI CIRB). In addition, U.S.-based sites must accept 
the NCI CIRB review to activate new studies at the site after March 1, 2019. Local IRB 
review will continue to be accepted for studies that are not reviewed by the CIRB, or if 
the study was previously open at the site under the local IRB. International sites should 
continue to submit Research Ethics Board (REB) approval to the CTSU Regulatory 
Office following country-specific regulations. 
Sites participating with the NCI CIRB must submit the Study Specific Worksheet for 
Local Context (SSW) to the CIRB using IRBManager to indicate their intent to open the 
study locally. The NCI CIRB’s approval of the SSW is automatically communicated to the 
CTSU Regulatory Office, but sites are required to contact the CTSU Regulatory Office at 
CTSURegPref@ctsu.coccg.org to establish site preferences for applying NCI CIRB 
approvals across their Signatory Network. Site preferences can be set at the network or 
protocol level. Questions about establishing site preferences can be addressed to the 
CTSU Regulatory Office by email or calling 1-888-651-CTSU (2878). 
In addition, the Site-Protocol Principal Investigator (PI) (i.e., the investigator on the 
IRB/REB approval) must meet the following criteria in order for the processing of the 
IRB/REB approval record to be completed: 
• 
Holds an active CTEP status; 
• 
Rostered at the site on the IRB/REB approval (applies to US and Canadian sites 
only) and on at least one participating roster; 
• 
If using NCI CIRB, rostered on the NCI CIRB Signatory record; 
• 
Includes the IRB number of the IRB providing approval in the Form FDA 1572 in the 
RCR profile; and 
• 
Holds the appropriate CTEP registration type for the protocol. 
Additional Requirements 
Additional requirements to obtain an approved site registration status include: 
• 
An active Federal Wide Assurance (FWA) number; 
• 
An active roster affiliation with the Lead Protocol Organization (LPO) or a 
Participating Organization (PO); and 
• 
Compliance with all protocol-specific requirements (PSRs). 

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Downloading Site Registration Documents: 
• 
Download the site registration forms from the protocol-specific page located on the 
CTSU members’ website. Permission to view and download this protocol and its 
supporting documents is restricted based on person and site roster assignment. To 
participate, the institution and its associated investigators and staff must be 
associated with the LPO or a Protocol Organization (PO) on the protocol. One way to 
search for a protocol is listed below. 
• 
Log in to https://www.ctsu.org and log in to the members’ area using your CTEP-IAM 
username and password 
• 
Click on the Protocols tab in the upper left of the screen 
• 
Enter the protocol # in the search field at the top of the protocol tree, or 
• 
Click on the By Lead Organization folder to expand then select ECOG-ACRIN, 
and protocol number EAQ201. 
• 
Click on Documents, select Site Registration, and download and complete the forms 
provided.  
NOTE: 
For sites under the CIRB, IRB data will load automatically to the CTSU. 
Requirements For EAQ201 Site Registration:  
• 
Site Registration Status for EA1151 
Required Protocol Specific Regulatory Documents 
1. Copy of IRB Informed Consent Document. 
NOTE: 
Any deletion or substantive modification of information concerning risks or 
alternative procedures contained in the sample informed consent 
document must be justified in writing by the investigator and approved by 
the IRB. 
2. A. CTSU IRB Certification Form 
 
Or 
B. Signed HHS OMB No. 0990-0263 (replaces Form 310). 
 
Or 
C. IRB Approval Letter 
NOTE: 
The above submissions must include the following details: 
• 
Indicate all sites approved for the protocol under an assurance 
number. 
• 
OHRP assurance number of reviewing IRB 
• 
Full protocol title and number 
• 
Version Date 
• 
Type of review (full board vs. expedited) 
• 
Date of review. 
• 
Signature of IRB official 
Checking Your Site’s Registration Status: 
Site’s registration status may be verified on the CTSU members’ website. 
• 
Click on Regulatory at the top of your screen; 
• 
Click on Site Registration; and  
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• 
Enter the site’s 5-character CTEP Institution Code and click on Go 
• 
Additional filters are available to sort by Protocol, Registration Status, Protocol 
Status, and/or IRB Type. 
NOTE: 
The status shown only reflects compliance with site registration requirements 
as outlined within the protocol. It does not reflect compliance with protocol 
requirements for individuals participating on the protocol or the enrolling 
investigator’s status with the NCI or their affiliated networks. 
Participant Enrollment 
The Oncology Patient Enrollment Network (OPEN) is a web-based registration system 
available on a 24/7 basis. OPEN is integrated with CTSU regulatory and roster data and 
with the LPOs registration/randomization systems or the Theradex Interactive Web 
Response System (IWRS) for retrieval of participant registration/randomization 
assignment. OPEN will populate the participant enrollment data in NCI’s clinical data 
management system, Medidata Rave. 
Requirements for OPEN access: 
• 
A valid CTEP-IAM account; 
• 
To perform enrollments or request slot reservations: Must be on an LPO roster, 
ETCTN corresponding roster, or participating organization roster with the role of 
Registrar. Registrars must hold a minimum of an Associate Plus (AP) registration 
type; 
• 
Have an approved site registration for the protocol prior to participant enrollment. 
To assign an Investigator (IVR) or Non-Physician Investigator (NPIVR) as the treating, 
crediting, consenting, drug shipment (IVR only), or receiving investigator for a participant 
transfer in OPEN, the IVR or NPIVR must list the IRB number used on the site’s IRB 
approval on their Form FDA 1572 in RCR. 
Prior to accessing OPEN, site staff should verify the following: 
• 
Participant has met all eligibility criteria within the protocol stated timeframes; and  
• 
All participants have signed an appropriate consent form and HIPAA authorization 
form (if applicable). 
NOTE: 
The OPEN system will provide the site with a printable confirmation of 
registration and procedure/randomization information. You may print this 
confirmation for your records. 
Access OPEN at https://open.ctsu.org or from the OPEN link on the CTSU members’ 
website. Further instructional information is in the OPEN section of the CTSU website at 
https://www.ctsu.org or https://open.ctsu.org. For any additional questions, contact the 
CTSU Help Desk at 1-888-823-5923 or ctsucontact@westat.com. 
4.1 
Registration Demographics 
The following information is to be provided at the time of registration to the trial: 
4.1.1 
Protocol Number  
4.1.2 
Investigator Identification  
• 
Institution and affiliate name 
• 
Investigator’s name 
4.1.3 
Participant Identification  

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• 
Participant’s initials (first and last) 
• 
Participant’s Hospital ID and/or Social Security number 
• 
Sex 
• 
Birth date (mm/dd/yyyy) 
• 
Race 
• 
Ethnicity 
• 
Nine-digit ZIP code 
• 
Method of payment 
• 
Country 
4.2 
Eligibility Verification  
Participants must meet all of the eligibility requirements listed in Section 3.1. 
4.3 
Additional Requirements  
4.3.1 
Participants must provide a signed and dated, written study informed 
consent form. 
NOTE: 
Copies of the consent are not collected by the ECOG-
ACRIN Operations Office – Boston. 
4.3.2 
Sites must maintain a record of participant identification information. 
4.3.3 
ECOG-ACRIN Outcomes and Economics Assessment Unit (OEAU) 
data collection 
4.3.3.1 
ECOG-ACRIN Systems for Easy Entry of Participant 
Reported Outcomes (EASEE PRO): 
EASEE-PRO is comprised of a group of systems, 
interfaces, and databases designed to aid in the 
management, providing information, and collection of PRO 
data from participants. While EASEE-PRO is a single 
entity, the security framework and data flow for the main 
system components are described later in this section. The 
PRIDE portal provides a single common interface for 
participants and CRAs whose access to system 
components restricted by role, location, and study 
specification (Similar to using Imedidata.com to access 
RAVE and its subcomponents). 
Access to the study in EASEE-PRO is granted to all 
participants registered to the study through the OPEN 
registration system with a valid participant email address. 
Upon registration, an account verification email will be sent 
to the user with a link to activate their account. The user 
will be required to enter some verification information (e.g., 
DOB) in order to activate their EASEE-PRO account. Site 
personnel (e.g., CRAs) are granted limited access to the 
systems, which only allows them to view reports on survey 
completion and expectedness. Additionally, if required by 
the study, they may be granted special access (provided a 
special role in the system) that allows them to assist 

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participants completing questionnaires and viewing other 
study materials, as described in the PROVIDE system 
component below.  
Neither participant nor CRA access allows them to 
view/retrieve participant identifying information or survey 
responses stored in EASEE-PRO databases. 
EASEE-PRO Participant Access: 
To enter data, the participant must have an active EASEE-
PRO user account. This account is automatically created 
when the participant is registered to the study in OPEN. 
For all web participants, an account activation email will be 
sent to the address entered in the OPEN eligibility 
checklist. This email address must be a valid email 
address for the web participant. (If the email address was 
entered incorrectly in OPEN, the CRA must contact the 
OEAU (pro-help@stat.brown.edu to manually correct the 
error.) To activate their account, participant must access 
the Participant Reporting Interface for Data Entry (PRIDE) 
web portal (https://pride.stat.brown.edu/Participant-Login) 
(i.e., click the link in the activation email) and verify their 
account before they can login and complete surveys or 
view web education materials. Once the account is 
activated, participants may return to the PRIDE portal at 
any time and login. Upon login, users will be presented 
with any available surveys and materials they can view. 
EASEE-PRO CRA Access: 
To access EASEE-PRO, the site user must have an active 
CTEP IAM account (https://eapps-ctep.nci.nih.gov/iam). In 
addition, site users that are a member of ECOG-ACRIN 
must have the mapped ECOG-ACRIN roles or explicit 
Rave role (Rave CRA) in RSS at the enrolling site. Site 
users that are not members of ECOG-ACRIN must have 
the Rave role on the CTSU roster at the enrolling sites. 
The Site Administrator or Data Administrator at the 
enrolling site may assign the appropriate roles from the 
Site Roles tab on the CTSU website. To login, CRAs will 
use their CTSU (IAM) credentials on the OEAU-PRIDE 
web portal (https://pride.stat.brown.edu/CRA-Login) using 
the familiar IAM interface. No e learnings are required for 
use of this site. 
The OEAU can be contacted for via email at pro-
help@stat.brown.edu. An EASEE-PRO instructional guide 
for both sites and participants can be found on both the 
ECOG-ACRIN and CTSU websites. 
EASEE-PRO Systems: 
1) Participant Reporting Interface for Data Entry (PRIDE) 
web portal: 

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a) PRIDE (https://pride.stat.brown.edu) provides a 
front facing web portal for participants, CRA, 
monitors and investigators. 
b) The interface between internet users and the 
EASEE-PRO data entry subsystems (outlined 
below). 
c) A secure site using HTTPS encryption (2048-bit 
SSL/TLS; 256-bit encryption) and requiring a 
username and password login in order enter data 
or view materials. 
d) A web portal to provide general study information, 
links, help and support. 
2) Secure environment for control of user records, 
information, and transactions (SECURIT): Provides a 
secure – limited access point for entering data into the 
restricted secure PII Database, for management of 
user data, creating user accounts, and reporting. The 
SECURIT interface requires the secure hypertext 
transfer protocol (HTTPS) to ensure encryption of 
transmitted data and is not accessible outside the 
OEAU. 
a) PII database: is a dedicated secure limited access 
database, used to store protected PII. 
i. Secure: All communications to the PII database 
through SECURIT are encrypted. The database 
resides behind a firewall and cannot be reach 
from outside the OEAU. 
ii. Limited access: this database is restricted not 
only by username and password but is also 
restricted to specified internal OEAU computers 
by IP address, so that only authorized users 
logging in at the OEAU from pre-specified 
computers may access/enter PII. At no time is 
outside access allowed to this database. 
iii. Protected restricted PII (e.g., SSN) are 
encrypted at the time of data entry and double 
data entered for verification. All users 
regardless of their security level are blinded to 
this protected data, and it cannot be decrypted 
without the encryption key, housed in a safe, in 
a location separate from the OEAU. This type of 
data is generally collected for long term follow-
up where it may be needed to be decrypted for 
select participants in order to search registries 
like the national death index to determine 
survival status of lost participants. In these 
instances, with appropriate approvals, the 
Database Administrator will decrypt this data in 

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accordance with the approved retrieval 
specification. 
b) User records: This functionality allows OEAU 
personnel, using specific computers within the 
OEAU, to create user records, enter user 
information into the PII database, and manually 
establish user web accounts in the separate user 
database. Allows the management of users and 
their data, including the ability to update a 
participant’s preferred contact method, address, 
and participation status (e.g., no longer wishes to 
be contacted with respect to the PRO component of 
the study). 
c) Information: This functionality allows the OEAU to 
record all participant contact, document any 
changes to the participant, and make any important 
notes related to the participant. 
d) Transactions: SECURIT provides a reporting and 
monitoring interface to the PRO database (separate 
from the PII database above), which is used to 
store non-PII data (e.g., participants reported 
survey responses.) 
i. Allows OEAU to monitor per participants form 
completion status using the tracking 
management facility. This facility reports on what 
data is currently expected from participants, 
CRAs, and the OEAU interviewers. 
ii. Aggregate reporting: this series of reports allows 
the OEAU to monitor the distribution of 
participants over data completion methods and 
form completion methods (both overall and by 
site). 
3) Database utility and control environment (PRO-DUCE): 
This utility interfaces with the main clinical database 
containing CRF/trigger data (Medidata RAVE), 
monitors the clinical database for events (e.g., 
participant registrations, scheduled procedures, and 
other triggers) and establishes event scheduling. The 
system sets up e-mail reminders [and SMS text 
message and/or push notifications, when applicable to 
the study] to relevant parties (CRAs, participants, C-
BAC, OEAU personnel, etc.) to ensure timely 
completion of surveys, follow-up, or other interventions. 
4) Web entry subsystems (PROWESS): 
a) On participant login to the PRIDE portal and 
selecting the survey to complete, PROWESS 
generates the survey and layout including 
instructions, approx. time for completion, the 
number of questions to be completed in this 

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session, any important information regarding this 
survey (including help and contact information), and 
the survey itself 
b) Secure HTTPS communications requiring a 
username and password login. 
c) PROWESS presents each survey question, collects 
entered responses, and pushes the resulting data 
to the PRO-DB. 
d) PROWESS is a one-way interface; data cannot be 
returned from the PRO-DB to the user. PROWESS 
cannot retrieve data from the PII-DB. 
5) PRO Valet Interface and Data Entry System 
(PROVIDES). 
a) The PROVIDES subsystem allows CRAs to act as 
a valet/scribe and enter a participant’s responses to 
a survey into the PRO-DB. 
• 
Allows CRAs to enter forms completed by the 
participant on paper (either on-site or 
completed remotely). 
• 
Allows CRAs to act as scribes (if allowed), to 
read questions and enter data for participants. 
b) Similar to PROWESs, PROVIDES is the linkage 
between EASEE-PRO and the PRIDE portal. 
c) Secure HTTPS communications requiring a 
username and password login. 
d) Which forms can be entered is restricted by 
username, site affiliation, and role, thus CRAs can 
only enter surveys predesignated as on-site data 
collection surveys and only for their own 
participants.  
e) On login, user is presented with brief instructions; is 
requested to select the protocol, case number, 
time-point and verify the case Id by providing the 
participant birthdate.  
f) PROVIDES presents each survey question, collects 
entered responses, and pushes the resulting data 
to the PRO-DB. 
g) PROVIDES is a one-way interface; data cannot be 
returned from the PRO-DB to the user. PROVIDES 
cannot retrieve data from the PII-DB. 
4.3.4 
Data Integration Approach 
Database Utilities and Control Environment (PRODUCE) sub-system 
allows for the collection and management of study critical events. This 
allows EASEE to interface with a variety of systems and use external 
APIs to retrieve data necessary for study operations. 
4.3.5 
Questionnaire Administration Process 

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At the time EASEE-PRO account activation, (or at the time of 
recruitment for subjects preferring paper surveys) participants will be 
asked to complete the Participant Contact Information Form. This 
form collects information used to maintain contact with the participant 
over the course of the study, including name, home address, phone 
number, and may include the name of a primary (or other) physician 
to whom requests for participant location may be made. 
This form is retained in the study participant’s chart at the site and is 
not entered in the RAVE clinical database; however, the completed 
form is faxed to the OEAU at Brown University. This information is 
necessary so that participants can be contacted by the OEAU for the 
Participant Reported Outcomes (PRO) portion of the study as 
required. The contact information is entered and stored in a dedicated 
SQL database (PII-DB) and IS NOT accessible by ECOG-ACRIN 
clinical database. The OEAU RA will not have access to the main 
ECOG-ACRIN database that contains clinical data. 
At registration, participants will be asked to express a preference for 
on-line or paper administration of PRO forms. Participants may 
choose to complete questionnaires using a web-based application or 
paper at the site. 
Participants will be prompted to complete web-based forms via an 
email prompt [push notifications or SMS as applicable to the study]. 
This notification will include a link to the PRIDE web portal for 
questionnaire completion. Questionnaires will be completed on line 
using a unique participant account. The web site will reference a toll-
free phone number and email address that participants can use to 
reach the OEAU staff should they have questions or need assistance. 
All data will be stored on a secure server. Participants who do not 
complete the web questionnaires within 3 working days of the initial 
request e-mail will receive up to 3 additional reminders, each about 3 
days apart. These reminders, like the initial notification, will provide a 
link to the current surveys, ask the participant to confirm that they 
have been able to access the web site, and provide both the e-mail 
address and the toll free help number for support. 
If participants still have not responded within 12 days of the original e-
mail, the OEAU Research Associate may attempt to telephone the 
participant and administer the questionnaire over the telephone. If 
participant requests that a paper questionnaire by mailed, the OEAU 
Research Associate may send out a paper questionnaire. If 
questionnaires are telephone-administered, they will be marked as 
such in the database. All surveys, while desired within 3 days of the 
event, will remain available for participants until either the surveys are 
completed or they are off-study. Since the completion date is recorded 
for all surveys, the study team will be able to make relevant 
determinations for inclusion of these data in specific analyses. 
However, after telephone follow-up, no additional or extraordinary 
means will be employed to collect overdue/missing questionnaires. 

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4.3.6 
RAVE data collection 
RAVE is the NCI-DCP approved Electronic Data Management System 
(EDM) 
Medidata Rave is a clinical data management system being used for 
data collection for this trial/study. Access to the trial in Rave is 
controlled through the CTEP-IAM system and role assignments. 
Requirements to access Rave via iMedidata: 
• 
A valid CTEP-IAM account; and  
• 
Assigned a Rave role on the LPO or PO roster at the enrolling site 
of: Rave CRA, Rave Read Only, Rave CRA (LabAdmin), Rave 
SLA, or Rave Investigator. 
Rave role requirements: 
• 
Rave CRA or Rave CRA (Lab Admin) role must have a minimum 
of an Associate Plus (AP) registration type; 
• 
Rave Investigator role must be registered as an Non-Physician 
Investigator (NPIVR) or Investigator (IVR); and 
• 
Rave Read Only role must have at a minimum an Associates (A) 
registration type. 
Refer to https://ctep.cancer.gov/investigatorResources/default.htm for 
registration types and documentation required. 
Upon initial site registration approval for the study in RSS, all persons 
with Rave roles assigned on the appropriate roster will be sent a study 
invitation e-mail from iMedidata. To accept the invitation, site users 
must log into the Select Login (https://login.imedidata.com/selectlogin) 
using their CTEP-IAM user name and password, and click on the 
“accept” link in the upper right-corner of the iMedidata page. Please 
note, site users will not be able to access the study in Rave until all 
required Medidata and study specific trainings are completed. 
Trainings will be in the form of electronic learnings (eLearnings), and 
can be accessed by clicking on the link in the upper right pane of the 
iMedidata screen. If an eLearning is required and has not yet been 
taken, the link to the eLearning will appear under the study name in 
iMedidata instead of the Rave EDC link; once the successful 
completion of the eLearning has been recorded, access to the study 
in Rave will be granted, and a Rave EDC link will display under the 
study name. 
Users that have not previously activated their iMedidata/Rave account 
at the time of initial site registration approval for the study in RSS will 
also receive a separate invitation from iMedidata to activate their 
account. Account activation instructions are located on the CTSU 
website, Rave tab under the Rave resource materials (Medidata 
Account Activation and Study Invitation Acceptance). Additional 
information on iMedidata/Rave is available on the CTSU members’ 
website under the Rave tab at www.ctsu.org/RAVE/ or by contacting 
the CTSU Help Desk at 1-888-823-5923 or by e-mail at 
ctsucontact@westat.com. 

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Methodology Plan
We will conduct an observational study to compare 1) the proportion of COVID-related 
participant factors (including financial hardship and distress among WOC who decline 
participation in TMIST (EAQ201 participants) compared to non-WOC EAQ201 
participants; and 2) effects of federal-, state- and local-level COVID-19 factors on TMIST 
participation, in WOC vs non-WOC. The primary objective compares COVID-related 
financial hardship between WOC vs non-WOC EAQ201 participants (see Table 1 
definition). Federal-, state-, local-, practice- and participant-level moderators (see Fig. 1 
conceptual model) will be evaluated with hierarchical regression models. For the 
exploratory objectives, we will compare the effects of federal-, state- and local-level 
COVID-related factors on TMIST participation (secondary outcome), stratified by WOC 
vs non-WOC. Any woman 45-74 years old who is scheduled for breast cancer screening 
and is eligible for TMIST but declines will be approached by the TMIST site research 
associates (RAs). Enrollment for TMIST typically occurs immediately prior to the 
scheduled breast screening visit. Solicitation for participation in EAQ201 will occur at the 
same time for those who decline TMIST. TMIST site RAs will ask women who decline 
TMIST if they are interested in participating in EAQ201.
Sites participating in the parent study may approach potential participants using written 
materials, by phone or at the time of screening mammography.  We will use the same 
enrollment processes. For those who are approached by phone and who decline to 
participate in TMIST will recruited for EAQ201 during the same call.  
For those sites that use the written materials, it is up to the participant to actively 
respond to the site at which point they are additionally screened for eligibility for TMIST, 
usually by phone. Among those who respond to written materials and are additionally 
screened by phone, we will be able to approach the women who decline to participate in 
TMIST for EAQ201 recruitment.
Paper documentation of consent is required. It may be signed when the participant 
attends the schedule screening mammogram.
We will also compare the sociodemographic characteristics of women who complete the 
EAQ201 participant survey with women who agree to participate in TMIST over the 
same time period using only data collected as part of the TMIST study that have also 
been collected as part of the current study. No additional data will be collected from 
women who participate in the TMIST study.
No additional participant-level data will be collected from TMIST participants related to 
COVID-19 given the supplement scope. We elected to more completely understand the 
effects of COVID-19 on those who declined participation in TMIST.
Site characteristics and recruitment process: All sites will receive $30 per-case 
reimbursement for each eligible participant who registered to EAQ201. As with 
EAQ162CD, the study will provide some resources to assist the site, in particular: 1) site 
RA guides for engaging women who decline TMIST to enhance EAQ201 participation; 2) 
biweekly webinars/ phone calls for sites to check-in and discuss issues regarding 
recruitment and/or other study related issues, as needed. Sites that have implemented 
successful recruitment processes will be encouraged to attend and share their 
experiences.
Site Recruitment Plan: EAQ201 Study Chair or her designee will present the EAQ201 
study to TMIST participating sites via standing TMIST Open Sites calls and through 

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direct email outreach to site TMIST PIs and lead TMIST research coordinators.  This 
introduction to the study is expected to occur as close as possible to EA activation of the 
trial.  The purpose of the study, site responsibilities, survey team responsibilities, and 
timeline will be presented on these calls.  Along with materials to help support 
recruitment effort including phone script, study talking points, FAQs to help sites 
understand the study and to be able to communicate it to potential participants. 
All EA1151 participating sites in the United States that are approved to enroll to EA1151 
according to CTSU and actively recruiting and enrolling new participants to EA1151 
based on at least one new enrollment attributed to the site in the most recent CTSU 
monthly enrollment report will be cleared to activate EAQ201 by ECOG-ACRIN upon 
obtaining EAQ201 NCI CIRB approval. 
EAQ201 project manager will create a list of eligible sites based on EA1151 recruitment 
and enrollment status and will notify CTSU of ECOG-ACRIN clearance of this site 
qualification criteria.  Site submission of required IRB documentation to NCI CIRB will be 
monitored in RSS weekly by the EAQ201 project manager who will report site activation 
clearances in CTSU weekly to the EAQ201 study chair by [define weekly communication 
mechanism you prefer here].  All sites that plan to open EAQ201 are strongly 
encouraged to activate EAQ201 within 30 days of ECOG-ACRIN activation of the trial as 
there will be no maximum number of subjects that can be enrolled in the trial at any one 
site and enrollment is expected to be completed within a few months. 
EAQ201 project manager will reach out weekly to all eligible EA1151 sites to remind 
them about the EAQ201 study and obtain IRB approval through NCI CIRB.  This 
outreach will occur by email to TMIST PI and TMIST lead coordinator until the site opens 
EAQ201, declines to participate, or EAQ201 enrollment reaches 50% of planned 
enrollment, 500.  
Participant Recruitment Plan: All participating EAQ201 TMIST sites will be expected to 
approach at least 20 women per month in person or over the phone as part of their 
TMIST recruitment effort while EAQ201 is open to participant enrollment with at least 5 
women approached that are classified as Women of Color [definition] according to 
information documented in the site’s electronic medical record system.   
All women presenting for screening mammography who meet the eligibility criteria for 
EA1151 but ultimately decline to participate in EA1151 should be immediately invited to 
participate in EAQ201 by EA1151 site designated recruiters.   
All EAQ201 TMIST sites are expected to keep local TMIST recruitment logs for duration 
of EAQ201 enrollment period.  The first two weeks of local TMIST recruitment logs for 
each site are to be submitted to the EAQ201 project manager to confirm that recruitment 
effort is happening for TMIST and to monitor number of WOC TMIST declines at the site.  
This information will be summarized across all sites for reporting to the EAQ201 central 
trial team to compare to EAQ201 enrollment rates at each site to determine if site is on 
track to complete within timeline planned and that overall WOC versus non-WOC 
participation ratio is within 10%-25% range planned. 
Survey administration and data collection: We will use the ECOG-ACRIN Systems for 
Easy Entry of Participant Reported Outcomes (EASEE-PRO), our online survey platform 
supplemented by paper and/or telephone surveys using methods successfully employed 
in EAQ162CD financial burden assessment in colorectal cancer (Carlos co-PI) and 
E4112 prospective study of MRI and multiparameter gene expression assay in DCIS 
(Carlos co-I). Proxies are not allowed to complete questionnaires on behalf of 
participants. However, participants may use assistance and other accommodations to 

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complete questionnaires, including: CRAs, participant navigators/advocates, family 
members, and/or other individuals or aids that allow the participant to understand and 
record their answers to the survey questions (for example, visually impaired individuals 
may have questions read to them and their responses recorded). The surveys are 
available only in English. 
TMIST site RAs will collect contact information at EAQ201 enrollment using Participant 
Contact Information Forms (name, home address, phone number and e-mail) and fax it 
to the central ECOG-ACRIN OEAU at Brown University. The COVID factors survey may 
be completed at the screening visit by paper or online. We assume that 40% will opt to 
complete the survey after the screening visit based E4112 patient preferences. Those 
who elect to complete the survey after the screening visit will only be able to do so online 
to conform to the scope of a supplement. These women will receive an invitation and 
account activation email from the central ECOG-ACRIN Outcomes and Economic 
Assessment Unit (OEAU) within 7 days to complete the online survey. Each online 
participant will use a unique account to complete the survey.  
Women who choose to complete their survey online either during or after the screening 
visit will use our EASEE-PRO web-based participant-facing system. Through EASEE-
PRO, study staff communicate with participants about study participation (e.g., email 
solicitations to logon and complete the survey using unique links and reminders). All 
study participants can access EASEE-PRO with a valid email address. Upon enrollment 
into the study, women will be able to activate their account using their email address, 
either in person or remotely. Activation requires entry of verification information (e.g., 
DOB) in order to complete activation. TMIST site RAs with the appropriate study roles 
will be granted access allowing them to assist participants who experience any difficulty. 
The web site includes a study-specific toll-free phone number to contact OEAU staff for 
assistance. All data will be stored on a secure server. Participants who do not complete 
the web surveys within 3 working days of initial e-mail request will receive up to 3 
additional e-mail reminders, each 3 days apart. These reminder e-mails provide a link to 
the current surveys, ask the participant to confirm that they have been able to access the 
web site and provide both the e-mail address and the toll-free help number for support. 
All surveys will remain available for participants until either completed or participants are 
off-study. Since the completion date is recorded for all surveys, the study team will 
determine appropriate inclusion of these data in specific analyses. If a participant is non-
compliant, the OEAU may contact the site CRA and/or the participant in an effort re-
establish contact, remove barriers, and obtain the survey responses. These efforts may 
include email, mail, and phone contact with no more than 3 attempts by any method (i.e., 
three failed recovery attempts, at least 3 days apart, will be considered participant 
refusal.)  
Women who choose to complete their surveys on paper at the site, should be provided 
with a paper copy of the survey to complete. The site personnel may then enter the 
answers into EASEE-PRO. Alternatively, the questionnaire may be faxed to the OEAU. 
Also, the CRA may have the participant complete the questionnaire on a site-provided 
tablet or computer. 
Outcome and moderator measures are summarized in Table 1 and 2. Participant survey 
burden in EAQ162CD was 3.25–5.18 questions per minute. The approximately 60 item 
survey is estimated to take 12-18 minutes. 

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TABLE 1 : Participant-completed items 
Primary Endpoints 
Measure (collected from EAQ201 participants) 
COVID-related financial 
hardship among EAQ201 
participants 
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 (items used in EAQ162CD) 
OR answering in the affirmative to any of the following household 
changes due to COVID: 20% income lose, savings use for living 
expenses, home sale/refinance, increased debt, declared bankruptcy 
(items used in EAQ162CD) 
Secondary Endpoints 
Collected from EAQ201 participants 
Material condition composite 
measure  
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) (1 item, used in EAQ162CD) 
COVID-specific perceived 
financial distress 
Adapted from the summary item from COST measure.16,17 (continuous) 
“COVID-19 has been a financial hardship to my family.” (1 item) 
Exploratory Endpoints 
Collected from EAQ201 participants 
Employment change  
Self-reported work hours reduction, layoff or furlough, sick time or 
vacation time use or new job/increased hours to increase income 
(binary) (1 item, used in EAQ162CD) 
COVID-specific perceived 
distress 
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) 
Perceived susceptibility to 
disease 
Single items for breast cancer and COVID-19, modified from previous 
studies of intention to undergo breast cancer screening and used in 
EA2185 and EAQ162CD. (categorical) (2 items) 
Distress coping behavior that 
increase breast cancer risk 
We previously demonstrated that risky behaviors (e.g., cancer 
screening adherence, not smoking and seatbelt use22, 23). Alcohol24 use 
has been described a risk factor for breast cancer. Smoking25,26 has 
been raised as a risk factor. We will assess change in frequency or 
amount of tobacco or alcohol use during COVID compared to before 
COVID. We will not assess absolute amount of use. (categorical) (2 
items) 
HRQL 
Participant-Reported Outcomes Measurement Information System 
(PROMIS)-1018 10-item physical and mental health assessment. Sum 
of item responses (continuous) (10 items) 
General anxiety 
PROMIS Anxiety 4-item Short Form. Sum of item responses 
(continuous) (4 items) 
Depression 
PROMIS Depression 4-item Short Form. Sum of item responses 
(continuous) (4 items) 
Covariates 
 
Sociodemographics collected 
from EAQ201 participants 
Race/ethnicity, age, education, marital status, annual household 
income, insurance, ZIP+4* to estimate neighborhood SES the using 
the Area Deprivation Index15   
Sociodemographics collected 
from women who participate 
in TMIST 
Race/ethnicity, age, insurance, and ZIP  

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TABLE 1 : Participant-completed items 
Provider-initiated delay 
Participant-reported provider-initiated service delay or reduced access 
for any health service and for screening mammography in the last 3 
months due to COVID  
TABLE 2: Study team collected items 
Federal-, State- and local-
level 
Medicaid coverage policies, COVID burden and shelter-in-place 
policies (initiation, duration and extent of implementation) including any 
changes during the study period. Local unemployment rates19 during 
shelter-in-place estimated from ZIP+4 using Local Area Unemployment 
Statistics from the Bureau of Labor. 
State-level variables: COVID burden is assessed as: 
1) Maximum new cases and deaths reported in one day as of registration of the first 
participant in that state;  
2) Total case numbers in the 3-month period following the World Health Organization 
classification as a pandemic on 3/11/20 (raw and population-adjusted values);  
3) Number of days from 3/11/20 to peak single-day report of new cases;  
4) Occurrence of a “second peak” defined as a subsequent wave of new cases from the 
previous maximum number of new cases;  
5) Cumulative death/infection rates at the time of study activation.  
This data will be derived from the states’ departments of health and the Centers for 
Disease Control and Prevention. We will also examine state statutes and regulations 
including: 
1) Timing of initiation of shelter-in-place policies (defined as the number of days from 
3/11/20);  
2) Duration of policies (number of days from initiation to any relaxation of shelter-in-
place policies); and  
3) Medicaid coverage of COVID-related care.  
4) Shelter-in-place policy extent will be categorized as high (closure of all businesses 
except essential services e.g., grocery stores and pharmacies) or low (any business 
closure less complete than the above definition).  
5) State legislation/regulation searches through Lexis-Nexis will be conducted using 
methods we previously employed to describe Medicaid coverage of trial participation 
costs20. 
 

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Study Calendar
Survey is collected at baseline. See below for number of questions in the study 
assessment.
Table 3
Baseline
Participant questionnaires 
(min/max # 
questions based 
on skip pattern)
Sociodemographics
Max 3q*
Insurance and COVID-related change 
Min 4q/ Max 8q
Distance traveled for mammogram
Max 1q
Reason for refusing to participate in TMIST
Max 1q
Employment and COVID-related change 
Max 2q
Financial situation and COVID-related change
Max 7q
COVID testing or infection 
Max 2q
Participant reported COVID-related delays in care 
Min 3q/Max 4q
COVID-specific distress 
Max 10q
Change in smoking and alcohol use 
Max 2q
Preference for delaying screening due to COVID 
Max 1q
Perceived susceptibility to disease 
Max 2q
PROMIS-10 Overall quality of life 
Max 10q
PROMIS ASF
Max 4q
PROMIS DSF
Max 4q
Assistance needed questions
Min 1q/Max 3q
Minimum/Maximum number of items 
Min 57q/64q
*Some of the sociodemographic questions are collected at registration and entered into the 
OPEN database and not listed here.

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Statistical Considerations
7.1
Study Design and Objectives
7.1.1
Primary Objectives
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.
Hypothesis: Compared to non-WOC, WOC will experience more 
COVID-related financial hardship.
7.1.2
Secondary Objectives
7.1.2.1
Compare the proportions of WOC vs non-WOC EAQ201 
participants with COVID-related change in their material 
condition, a composite measure.
Hypothesis: Compared to non-WOC, WOC will experience 
more COVID-related change in their material condition.
7.1.2.2
Compare the proportions of WOC vs non-WOC EAQ201 
participants with COVID-specific perceived financial 
distress.
Hypothesis: Compared to non-WOC, WOC will experience 
more COVID-specific perceived financial distress.
7.1.2.3
Compare the proportion of WOC in TMIST participants vs 
EAQ201 participants.
Hypothesis: The proportion of WOC should be higher in 
the TMIST decliners than that in TMIST agree-ers.
7.1.3
Exploratory Objectives
7.1.3.1
Compare the proportion of WOC vs non-WOC EAQ201 
participants with COVID-related employment change, a 
composite measure.
7.1.3.2
Compare the proportions of WOC vs non-WOC EAQ201 
participants with COVID-specific perceived distress and 
perceived susceptibility to COVID and breast cancer.
7.1.3.3
Compare the proportions of WOC vs non-WOC EAQ201 
participants with relative increase in smoking and alcohol
use, risk factors for breast cancer.
7.1.3.4
Compare participant-reported quality of life, anxiety and 
depression between WOC and non-WOC EAQ201 
participants. 
7.1.3.5
Assess the effects of sociodemographic characteristics, 
and federal-, state- or local-level COVID-19 factors on 
TMIST participation, in WOC vs non-WOC.

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7.2 
Primary Objective 
The primary objective is to compare the proportion of WOC EAQ201 participants 
who experience COVID-related financial hardship vs non-WOC EAQ201 
participants. The results, with and without adjustment for missing values (see 
7.5), will be compared as a sensitivity analysis. Logistic regression models, with 
and without stratification by WOC status, will be fit with financial hardship as the 
response variable to investigate other sociodemographics (e.g., age, marital 
status, insurance status) and state- and local-level factors (e.g., state COVID 
severity, shelter-in-place policies, state and local unemployment during shelter-
in-place) as moderators. 
Sample Size Considerations for the Primary Objective (7.1.1): 
The primary objective is to compare the proportion of WOC EAQ201 participants 
who experience COVID-related financial hardship (see Table 1 for definition) with 
the proportion of non-WOC EAQ201 participants who experience COVID-related 
financial hardship. The National Bureau of Economic Research estimated 
unemployment rates by race and ethnicity in April 2020, around shelter-in-place 
regulations7. Unemployment in African-American and Latinx populations 
averaged 18% compared to Whites (13%). At a sample size of 1000 women who 
decline TMIST participation, we expect to recruit at least 10-25% WOC into this 
study. Assuming alpha of 0.05, we estimated power over a range of differences 
across various proportions (see Table 4). For instance, at a sample size of 1000 
with 10% of WOC, we have 77% power to detect a minimum difference of 0.10 
between two proportions (0.2 vs. 0.1); at a sample size of 1000 with 25% of 
WOC, we have 88% power to detect a minimum difference of 0.08 between two 
proportions (0.18 vs. 0.1). Please note that based on DCP-001, 16% of the 
women who declined TMIST were WOC. Accrual onto TMIST is expected to 
continue for another 4.4 years. Also based on DCP-001 and extrapolating to the 
Non-NCORP US sites, accruing 1,000 women to this study is achievable. We do 
not envision any danger that this study will close due to lack of accrual. 
Table 4: Estimated power for a two-sample proportions using  
Fisher’s Exact test (two-sided). N1: # of WOC; N2: # of non-WOC 
Sample 
size (N) 
N1/N2 
P1 
(WOC) 
P2 (non-
WOC) 
Delta 
Alpha 
Power 
(Sample size: 1000; N1/N2=1/9, i.e.,10% of WOC) 
1000 
1/9 
0.200 
0.100 
0.100 
0.05 
0.77 
1000 
1/9 
0.225 
0.100 
0.125 
0.05 
0.90 
1000 
1/9 
0.250 
0.100 
0.150 
0.05 
0.96 
1000 
1/9 
0.250 
0.150 
0.100 
0.05 
0.66 
1000 
1/9 
0.275 
0.150 
0.125 
0.05 
0.83 
1000 
1/9 
0.300 
0.150 
0.150 
0.05 
0.92 
(Sample size: 1000; N1/N2=1/3, i.e.,25% of WOC) 
1000 
1/3 
0.180 
0.100 
0.080 
0.05 
0.88 
1000 
1/3 
0.200 
0.100 
0.100 
0.05 
0.97 
1000 
1/3 
0.220 
0.100 
0.120 
0.05 
0.99 
1000 
1/3 
0.230 
0.150 
0.080 
0.05 
0.79 

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1000 
1/3 
0.250 
0.150 
0.100 
0.05 
0.92 
1000 
1/3 
0.270 
0.150 
0.120 
0.05 
0.98 
7.3 
Secondary Objectives 
Two-sample proportion tests (e.g., Z-test based on normal approximations or 
Fisher’s exact test) will be used to compare the proportions of WOC vs non-WOC 
EAQ201 participants with 1) COVID-related change in their material condition; 2) 
COVID-specific perceived financial distress. Logistic regressions may be 
performed to adjust for potential confounders during the comparisons. Missing 
data will be managed as below (See 7.5). 
The proportion of WOC in EAQ201 participants will be compared to the 
proportion of WOC in TMIST participants using the one-sample proportion test. 
Based on the TMIST data, the proportion of WOC in TMIST participants is 
around 25-%. Then we will have 80% power to detect a difference of 3.9% using 
a two-sided exact test with a significant level of 0.05.  
7.4 
Assess the effects of sociodemographic characteristics, and federal-, state- or 
local-level COVID-19 factors on TMIST participation, in WOC vs non-WOC. 
For the exploratory objective (7.1.3.5), we will compare the effects of 
sociodemographic characteristics, federal-, state- or local-level factors (e.g. 
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. We will fit a logistic regression model with 
TMIST participation status (EAQ201 participant or TMIST participant) as the 
response variable to investigate other sociodemographic (e.g., marital status, 
neighborhood SES, insurance type), federal-, state- or local-level factors (see 
Table 2). Regression modeling will be conducted with and without stratification 
by WOC vs non-WOC. 
The analysis set will include the 1000 EAQ201 participants from this study and a 
corresponding number of TMIST participants, who will be randomly selected from 
the enrolled participants in the main TMIST study. The selection will be stratified 
by site and enrollment time. Assuming that the proportion of overall EAQ201 
participants is from 0.20 to 0.50, Table 5 below shows the power analysis of 
testing for the odds ratio in the logistic regression. The variables of interest can 
be continuous or categorical (binary). For instance, 2000 women (1000 EAQ201 
participants versus 1000 randomly selected TMIST participants) achieves 90% 
power at a 0.050 significance level to detect a change in the proportion of 
EAQ201 participants from 0.50 at the mean of the testing variable to 0.538 when 
the value of the variable is increased to one standard deviation above the mean. 
This change corresponds to an odds ratio of 1.165. An adjustment was made 
since a multiple regression of the independent variable of interest on other 
independent variables in the logistic regression obtained an R-Squared of 0.10. 
Table 5: Tests for the Odds Ratio in Logistic Regression (Wald Test) 
A.    X is continuous 
Power 
N(EAQ201 
participants) 
N(TMIST 
participants) 
 
P0 
P1 
Odds 
Ratio 
R-
SQRD 
Alpha 
Beta 
 
(50% EAQ201 participants) 

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7.5 
Handling Missing Data 
As stated above, we will closely monitor the participant attrition and determine 
whether the dropout is informative or not. If the missing is random, we may 
implement a method like multiple imputation to impute the missing values. In 
case the missing is not random (e.g., participants who are lost to follow up may 
experience more financial burden), we will implement various methods for the 
adjustment in our analysis, e.g., Bayesian modeling with informative priors. 
Analysis under different scenarios will be conducted to explore sensitivity to 
different missing data assumptions21. 
7.6 
Gender and Ethnicity  
Based on TMIST data from participants enrolled in September 2020, at sites in 
the United States, the anticipated accrual in subgroups defined by gender and 
race is: 
Racial Categories 
Not 
Hispanic 
or Latino 
Female 
Not 
Hispanic 
or Latino 
Male 
Hispanic 
or Latino 
Female 
Hispanic 
or Latino 
Male 
Total 
American Indian/ Alaska 
Native 
2 
0 
0 
0 
2 
Asian 
19 
0 
0 
0 
19 
Native Hawaiian or Other 
Pacific Islander 
1 
0 
0 
0 
1 
0.9 
1000 
1000 
 
0.5 
0.538 
1.165 
0.1 
0.05 
0.1 
0.9 
1500 
1500 
 
0.5 
0.531 
1.133 
0.1 
0.05 
0.1 
 
(40% EAQ201 participants) 
0.9 
1400 
2100 
 
0.4 
0.429 
1.125 
0.1 
0.05 
0.1 
0.9 
2100 
3150 
 
0.4 
0.423 
1.101 
0.1 
0.05 
0.1 
 
(20% EAQ201 participants) 
0.9 
1200 
4800 
 
0.2 
0.218 
1.117 
0.1 
0.05 
0.1 
0.9 
1800 
7200 
 
0.2 
0.215 
1.094 
0.1 
0.05 
0.1 
B.    X is categorical (binary) 
Power 
N 
 
% N 
X=1 
P0 
P1 
Odds 
Ratio 
R-
SQRD 
Alpha 
Beta 
 
(50% EAQ201 participants) 
0.9 
1000 
1000 
50 
0.5 
0.576 
1.359 
0.1 
0.05 
0.1 
0.9 
1500 
1500 
50 
0.5 
0.562 
1.284 
0.1 
0.05 
0.1 
 
(40% EAQ201 participants) 
0.9 
1400 
2100 
50 
0.4 
0.457 
1.263 
0.1 
0.05 
0.1 
0.9 
2100 
3150 
50 
0.4 
0.447 
1.21 
0.1 
0.05 
0.1 
 
(20% EAQ201 participants) 
0.9 
1200 
4800 
50 
0.2 
0.236 
1.239 
0.1 
0.05 
0.1 
0.9 
1800 
7200 
50 
0.2 
0.23 
1.192 
0.1 
0.05 
0.1 

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Racial Categories 
Not 
Hispanic 
or Latino 
Female 
Not 
Hispanic 
or Latino 
Male 
Hispanic 
or Latino 
Female 
Hispanic 
or Latino 
Male 
Total 
Black or African American 
196 
0 
2 
0 
198 
White 
742 
0 
30 
0 
772 
More Than One Race 
6 
0 
2 
0 
8 
Total 
966 
0 
34 
0 
1,000 
7.7 
Study Monitoring 
This study will be monitored by the Data Safety Monitoring Committee (DSMC). 
The DSMC will meet twice each year. For each meeting, the study is reviewed 
for safety and progress toward completion. These group meeting reports are 
made available to the local investigators, who may provide them to their IRBs. 
Prior to completion of this study, any use of outcome data will require approval of 
the DSMC. Any DSMC recommendations for changes to this study will be 
circulated to the local investigators in the form of addenda to this protocol 
document. 
This protocol will be monitored under the jurisdiction of the EA1151 (TMIST) 
DSMC. 
The Brown office of the Statistics Center has extensive and long-term experience 
in monitoring large screening trials, including ACRIN 6652 (Digital Mammography 
Imaging Screening Trial), ACRIN 6654 (National Lung Screening Trial), ACRIN 
6664 (National CT Colonography Trial), and ACRIN 6666 (Screening Breast 
Ultrasound in High-Risk Women). Established approaches and practices for 
study monitoring in our organization will be followed and adapted to meet the 
monitoring needs of this protocol. 
We will learn from the experiences of the ongoing SWOG 1417CD trial 
investigating financial burden in metastatic disease. 
In addition to site visits and available phone and email support, as outlined 
above, the EASEE-PRO system will send email notifications and up to 3 follow-
up reminders to notify web-based participants to complete surveys. If a 
participant is non-compliant, the OEAU may contact the site CRA and/or the 
participant in an effort re-establish contact, remove barriers, and obtain the 
survey responses. The efforts may include email, mail, and phone contact with 
no more than 3 attempts by any method (i.e., three failed recovery attempts, at 
least 3 days apart, will be considered participant refusal.) 

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Electronic Data Capture
This study will be monitored by the Clinical Data Update System (CDUS) version 3.0. 
Cumulative CDUS data will be submitted quarterly from the ECOG-ACRIN Operations 
Office – Boston to CTEP by electronic means.
Please refer to the study parameters (Section 7) for the forms submission schedule. 
Clinical data collection will be performed in Medidata Rave. Survey data will be collected 
in EASEE-PRO.
This study will be monitored by the Clinical Data Update System (CDUS) version 3.0. 
Cumulative CDUS data will be submitted quarterly from the ECOG-ACRIN Operations 
Office – Boston to CTEP by electronic means.
Participant Consent and Peer Judgment
Current FDA, NCI, state, federal and institutional regulations concerning informed 
consent will be followed.
If a participant wishes to withdraw from all aspects of the trial including medical record 
review and registry searches, the withdrawal must be in writing (on paper or via email) 
and state their desire to withdraw from passive data collection: medical record review 
and registry search. If documentation is created in a language other than English, a copy 
of the original source document as well as a translated English version must be 
submitted. Women are not allowed to rejoin the trial after they withdraw from all aspects 
of the trial.
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