Longitudinal Assessment of Financial Burden in Patients With Colon or Rectal Cancer Treated With Curative Intent
Conditions: Stage I Colon Cancer AJCC v8, Stage I Rectal Cancer AJCC v8, Stage II Colon Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Stage IIA Colon Cancer AJCC v8, Stage IIA Rectal Cancer AJCC v8, Stage IIB Colon Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8, Stage IIC Colon Cancer AJCC v8, Stage IIC Rectal Cancer AJCC v8, Stage III Colon Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IIIA Colon Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIB Colon Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8, Stage IIIC Colon Cancer AJCC v8, Stage IIIC Rectal Cancer AJCC v8
Sponsor: ECOG-ACRIN Cancer Research Group

 
EAQ162CD 
1 
Longitudinal Assessment of Financial Burden in Patients 
with Colon or Rectal Cancer Treated with Curative Intent 
STUDY CHAIR: 
Sheetal Kircher, MD 
STUDY CO-CHAIR: 
Ruth C. Carlos, MD 
STUDY STATISTICIAN: 
Fenghai Duan, PhD 
STUDY EPIDEMIOLOGIST: 
Ilana F. Gareen, PhD 
CANCER CARE DELIVERY RESEARCH (CCDR) 
COMMITTEE CHAIR: 
 
Ruth C. Carlos, MD 
CANCER CONTROL AND SURVIVORSHIP 
COMMITTEE CHAIR: 
 
Lynne Wagner, PhD 
Version Date:  June 19, 2019 
 
STUDY PARTICIPANTS 
 
ACTIVATION DATE 
ECOG-ACRIN / NCORP SITES ONLY 
 
May 17, 2018 
ALLIANCE / Alliance for Clinical Trials in 
Oncology – NCORP SITES ONLY 
 
Addendum #1 
Addendum #2 
NRG / NRG Oncology – NCORP SITES ONLY 
 
 
SWOG / SWOG – NCORP SITES ONLY 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
Schema ...................................................................................................................... 6 
1. Introduction ........................................................................................................ 7 
1.1 Study Foundation ...................................................................................... 7 
1.2 Background ............................................................................................... 7 
2. Objectives ......................................................................................................... 12 
2.1 Primary Endpoints ................................................................................... 12 
2.2 Secondary Endpoints............................................................................... 12 
3. Selection of Sites ............................................................................................... 12 
4. Selection of Patients ......................................................................................... 13 
4.1 Eligibility Criteria for Patient Participants ............................................... 13 
5. Registration Procedures.................................................................................... 15 
5.1 Protocol Number ..................................................................................... 18 
5.2 Investigator Identification ....................................................................... 18 
5.3 Patient Identification .............................................................................. 18 
5.4 Eligibility Verification .............................................................................. 18 
5.5 Stratification Factors ............................................................................... 18 
5.6 Additional Requirements ........................................................................ 19 
6. Methodology Plan ............................................................................................. 20 
6.1 This is a single arm, prospective, longitudinal cohort study. .................. 20 
6.2 Setting ..................................................................................................... 20 
6.3 Screening, Consent and Patient Registration ......................................... 20 
6.4 Data Collection ........................................................................................ 20 
7. Questionnaires .................................................................................................. 22 
7.1 Financial Measures.................................................................................. 22 
8. Patient Reported Outcomes (PRO) and Quality of Life (QOL) Administration . 26 
8.1 Data Collection Approach ....................................................................... 26 
8.2 Questionnaire Administration Process ................................................... 26 
8.3 ECOG-ACRIN Systems for Easy Entry of Patient Reported Outcomes 
(EASEE-PRO) System: .............................................................................. 27 
9. Site completed forms and administration ........................................................ 31 
9.1 Data Collection Approach ....................................................................... 31 
9.2 Questionnaire Administration Process ................................................... 31 
10. Study Calendar .................................................................................................. 34 
11. Statistical Considerations .................................................................................. 35 
11.1 Sex and Ethnicity ..................................................................................... 35 
11.2 Study Design and Objectives ................................................................... 35 
11.3 Sample Size Considerations and Monitoring Plan .................................. 35 
11.4 Statistical Analysis Plan ........................................................................... 38 

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12. Electronic Data Capture .................................................................................... 42 
13. Patient Consent and Peer Judgment ................................................................ 42 
14. References ........................................................................................................ 42 
Appendix I  Patient Thank You Letter ...................................................................... 47 
Appendix II  ECOG Performance Status ................................................................... 48 
Appendix III  Participant Retention-Focused Communication Calendar ................. 49 
 

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STUDY CHAIR 
Sheetal Kircher, MD 
Northwestern University 
676 N. Saint Clair, Suite 850 
Chicago, IL 60611 
Tel: 312-695-6180 
Fax: 312-695-6189 
Email: skirche1@nm.org 
 
 
 

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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 
must be submitted to the 
CTSU via the Regulatory 
Submission Portal. 
Regulatory Submission Portal: 
(Sign in at www.ctsu.org, and 
select the Regulatory 
Submission sub-tab under the 
Regulatory tab.) 
Institutions with patients 
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. 
Please refer to the patient 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 at 
ctsucontact@westat.com. 
Data collection for this 
study will be done through 
Medidata Rave and the 
ECOG-ACRIN Systems for 
Easy Entry of Patient 
Reported Outcomes 
(EASEE-PRO) system. 
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.  
For clinical questions (i.e., patient eligibility or treatment-related) Contact the Study PI of the 
Coordinating Group. 
For non-clinical questions (i.e., unrelated to patient 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 
Stratification Factors:
• Colon vs rectal cancer
• Chemotherapy vs no 
chemotherapy
Colon or rectal 
cancer diagnosis 
Stage I, II, or III
Assessment 0:
Baseline
Assessment 2:
6 months 
(+/- 4 weeks)
Assessment 3:
12 months 
(+/- 4 weeks)
Assessment 4:
24 months 
(+/- 4 weeks)
R
E
G
I
S
T
R
A
T
I
O
N
60 days
Assessment 1:
3 months 
(+/- 4 weeks)
 

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1. 
Introduction 
1.1 
Study Foundation 
The impact of a cancer diagnosis on employment and financial burden is poorly 
understood but is increasingly important to patients and families as the cost of 
cancer diagnostics and therapeutics increase. Understanding the longitudinal 
impacts of a cancer diagnosis and treatment on patient’s financial distress, 
employment, and quality of life will be essential in developing interventions to 
address the financial consequences of a cancer diagnosis.   
1.2 
Background 
1.2.1 
Rising Cost of Cancer Care and Impact on Patients 
The number of cancer treatment options has significantly increased 
over the past two decades leading to improvements in patient 
outcomes in many malignancy types (1). These advancements, 
however, have come with a high cost and cancer is now the second 
most expensive disease in the United States, after heart disease, with 
an annual estimated cost of $124 billion dollars in 2010 and a 
projected rise to $157 billion dollars in 2020, a 27% increase (2). As 
the cost of cancer diagnostics and therapeutics escalate, financial 
concerns of patients and families, physicians, health systems, and 
payers are increasingly common (3, 4). Little is known about the 
impact of cancer treatment costs on an individual patient, but it has 
been increasingly the focus of study.  
Previous reports demonstrate that cancer patients are at particular 
risk for financial burden when compared to persons without cancer 
(5). In a study using pooled data for 1997 through 2007 from the 
Medicare Current Beneficiary Survey linked to Medicare claims, 50% 
of elderly patients with a diagnosis of cancer paid at least 10% of their 
income towards out-of-pocket, cancer-related expenses (6). In a 
sample from the 2001 to 2008 Medical Expenditure Panel Survey 
(MEPS), non-elderly patients with cancer reported higher out of 
pocket cost burden (defined as spending more than 20% of their 
income on health) when compared to patients with and without other 
chronic illnesses (13.4%, 9.7%, and 4.4% respectively) (7). Cost 
sharing for cancer patients can lead to the inability to afford basic 
needs such as food and clothes (8-12), non-adherence (8, 9, 11, 13), 
spending savings (10), and even bankruptcy (8, 14, 15). Previous 
studies have explored predictors of increased financial burden, and 
those that appear to be vulnerable subgroups include racial and 
ethnic minorities (16, 17), younger age (17, 18), lower annual 
household income (17, 18), less than a college degree (17), 
unemployment (17), and Medicaid insurance (17). In a study from the 
National Health Interview Survey (NHIS), increased financial burden 
as a result of cancer care costs was the strongest independent 
predictor of poor quality of life among cancer survivors (19).  
Rising costs for patients are unlikely to reverse as researchers and 
physicians continue to develop innovative, and expensive cancer 

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therapies and also observe changing trends in health insurance 
coverage.  According to an analysis by the National Center for Health 
Statistics, between 1984 and 2013, there was an overall decrease in 
private insurance obtained through the workplace (20). For those with 
employee-based insurance, health insurance premiums for family 
coverage increased 69% between 2004 and 2014 (from $9,950 to 
$16,834) and there was an 81% increase in the worker’s contribution 
of the premium cost (from $2,661 to $4,823) (21). Further adding to 
out of pocket cost for patients, annual deductible amounts have 
increased from $584 in 2006 to $1,217 in 2014 (21) and there are 
many additional costs in the forms of co-payments and co-insurances. 
The 2010 Affordable Care Act (ACA) was intended to ensure access 
to affordable health care, and specific provisions would have either 
helpful or harmful effects on cost sharing for patients.  Provisions that 
have the potential to lower out of pocket costs include annual out of 
pocket limits, Medicaid expansion, expansion of parents’ insurance 
coverage to 26 years of age, and mandatory primary care and 
preventative service coverage requirements. Despite these 
provisions, the degree to which an individual’s out of pocket spending 
varies by plan and how much health care they utilize. For example, 
those with lower income and high-utilization of services will likely 
experience the greatest reduction in cost sharing (22). With the new 
administration, however, it is expected there may be some changes to 
this policy. 
1.2.2 
Financial Burden and Employment  
In addition to direct cost of care, a cancer diagnosis can impact a 
patient’s employment status or increase work limitations due to 
symptoms, treatment, or any medical complications (23-27). Previous 
literature has reported that in early stage breast and prostate cancer, 
the greatest work limitations (defined as weekly hours worked) 
occurred at 6 months, and by 12-18 months, most patients had 
returned to work (28). An estimate of lost work time was studied in 
pooled data from the 2000-2005 MEPS, where working-aged 
participants (age range, 25-64 years) (n = 89,520) with a diagnosis of 
cancer were included and estimates were made for the probability of 
being employed and the annual number of workdays missed because 
of illness or injury (29). Four respondent groups for comparison were 
constructed during the analysis period: (1) respondents with no 
cancer, and (among those who reported having cancer) (2) 
respondents with active cancer care, (3) respondents with follow-up 
cancer care, and (4) respondents with no cancer care. This analysis 
showed that, compared with those without cancer, patients 
undergoing active cancer care have a 3.3% absolute (4.5% relative) 
decrease in the probability of employment.  Among respondents who 
were employed, those undergoing active cancer care missed 22.3 
more workdays per year than those without cancer. Follow-up cancer 
care is associated with about 1 more workday missed per year 
compared with those without cancer.   
At this point, we do not know the interaction between perceived 
financial burden and changes in employment status or limitations. 

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Understanding the timing of employment changes and limitations is 
important in designing optimal interventions and this study will 
prospectively follow employment changes and its interactions with 
perceived financial burden.  
1.2.3 
Challenges to Addressing Cost of Cancer Care 
In response to this unsustainable cost burden, The Institute of 
Medicine (IOM) has emphasized the urgent need to address multiple 
strategies to deliver more efficient, coordinated, and high quality care 
that is still affordable. As part of this challenge, the IOM recommends 
that providers improve communication about value and cost of 
treatment options and incorporate this information in decision making 
(30). There are many recognized challenges, however, to discussing 
costs with patients that stem from barriers at the systems level, 
interpersonal level between the provider and patient, and individual 
patient level (31). From a health system’s level, patients are not 
systematically screened for financial burden, there is a lack of price 
transparency to both the patients and providers, and oftentimes 
institutions do not have adequate financial resources (i.e. social 
worker, financial counselors) to address a need if identified. From an 
interpersonal standpoint, there is evidence that patients desire to talk 
about the cost of their therapy (32), however there is discomfort and 
lack of training in conducting these sensitive conversations both 
among physicians and patients (33). From an individual patient 
perspective, patients are often unprepared and unaware of costs and 
resources. They are overwhelmed with a new diagnosis and cost 
discussions become neglected by both patients and providers as 
other issues quickly dominate clinic time. Because of these 
challenges, better characterization of the optimal population, timing, 
and content of an intervention for financial burden is still unknown. 
1.2.4 
Preliminary Data for Assessing Financial Burden in Cancer Patients  
Our study team has experience studying financial burden in cancer 
patients (5, 11, 12, 17, 34-42), and has specifically developed and 
utilized the COST measure (17, 42). In order to further test the 
validity, feasibility, and acceptability of longitudinally measuring 
financial burden using a validated measure of financial burden in 
cancer patients, our group completed a pilot study at Robert H. Lurie 
Comprehensive Cancer Center at Northwestern University (36). In this 
study, 96 patients with either a gastrointestinal, sarcoma, or lung 
cancer were longitudinally assessed over three months for both level 
financial burden (using COST, Incharge (43), and EORTC financial 
question) and health related quality of life. The COST score 
(described in more detail below) ranges from 0 to 44 with a score of 0 
representing the highest financial toxicity and a score of 44 
representing the lowest financial toxicity. In a population of both early 
and advanced stage disease, the mean COST score was 25.5 (SD 
11.8) at baseline and there was no change in any of the financial 
burden measures at Assessment 2 (3 months after baseline). It is 
possible that no change was seen because this study did not follow 
patients long enough to see an increase in burden. Feasibility was 

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demonstrated with a 35% attrition rate. When accounting only for 
those that were alive to complete Assessment 2, attrition was 24%.   
Acceptability of asking patient’s questions regarding their financial 
situation were assessed in this pilot study with results summarized in 
Table 2. The majority of participants answered that they were either 
“somewhat” or “a lot” comfortable with answering questions about 
their financial situation and cost of treatment.  
Table 2: Acceptability of answering financially related questions.  
Acceptability question 
Not at all 
(%) 
A little bit 
(%) 
Somewhat 
(%) 
A lot 
(%) 
How comfortable did you feel 
answering questions about your 
general financial situation? 
6 
12 
29 
53 
How comfortable did you feel 
answering questions about how 
the cost of your treatment has 
affected your finances? 
6 
12 
24 
59 
How comfortable do you feel 
discussing your finances and 
insurance with your physician? 
12 
24 
35 
29 
How comfortable do you feel 
discussing your finances and 
insurance with a counselor?  
0 
24 
24 
53 
Factors affecting employment have been evaluated by Tevaarwerk et 
al (26, 27, 44) (co-investigator on this proposal) using data from the 
ECOG-ACRIN Symptom Outcomes and Practice Patterns study in 
both the early and advanced stage.  The analysis of those with non-
metastatic disease found that 24% reported a change in employment. 
Participants with at least moderate symptom interference were more 
likely to report no longer working than their less effected counterparts 
(odds ratio (OR) = 8.0, 95 % CI, 4.2–15.4), as were minority 
participants compared with their non-Hispanic white counterparts 
(OR = 3.2, 95 % CI, 1.8–5.6) (26). We will build on this observational 
data to determine the association of perceived financial burden and 
employment factors in a longitudinal period over both active therapy 
and surveillance.  
1.2.5 
Feasibility and Motivation for Proposed Study through the NCI 
Community Oncology Research Program (NCORP) 
The overarching goal of this study is to reliably measure the changes 
in financial burden and its interaction with access and utilization of 
financial services over a period of a cancer patient’s treatment 
schedule. Once we gain a better understanding of the “life cycle” of 
financial burden and access/utilization of financial services, we can 
more effectively study the educational content, timing, and quality of 
cost discussions with patients that can lead to effective 
implementation studies. The NCORP is an ideal mechanism to accrue 
a diverse population of patients being treated at a community setting. 
Specifically, the minority/underserved sites within NCORP provide a 

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unique opportunity to include patients that may be at most risk of 
financial distress. 
1.2.6 
Description of the Patient Population and Assessment Time Points in 
Proposed Study 
This study will focus on patients receiving curative-intent treatment for 
colon or rectal cancer specifically for several reasons.  Colon and 
rectal cancer were chosen because these are common malignancies 
that are most frequently diagnosed in the curative-intent setting (45). 
Because these patients typically have longer survival than those with 
metastatic disease, they potentially have a longer period of time to be 
impacted by the costs of their cancer and changes in employment. 
Previous studies have largely focused only on patients receiving 
chemotherapy and/or with metastatic disease (18, 42, 46). The 
recently opened SWOG trial investigating financial burden (PI: Veena 
Shankaran) focuses on metastatic disease, and our proposed study of 
early stage disease will synergize with her work and will contain some 
common variables to allow for cross-study analysis.   
There remain many unanswered questions about the financial burden 
that our study will address. We hypothesize that those who receive 
chemotherapy may have higher burden than those who do not, 
however this is currently unknown and will be prospectively studied in 
this study. We will stratify by both disease type and receipt of 
chemotherapy to allow for robust comparisons between these groups, 
which has not been previously reported in a prospective study. These 
comparisons may be important as we develop implementation studies 
and education to focus on malignancy types and treatment settings 
that demonstrate the highest level of burden. 
We chose the time points, baseline at diagnosis, 3, 6, 12, and 24 
months because they correlate with important landmarks in the 
treatment of colorectal cancer. At three months after diagnosis, most 
patients are in the initial phase of their therapy (either surgery for 
colon cancer or chemo-radiation for rectal). By 6 months, most 
patients are approaching the end of their planned therapy, and by 12 
months most patients are typically done with therapy.  The 24 month 
time point is an opportunity to collect data related to adherence to 
follow-up guidelines, more specifically either a colonoscopy, 
sigmoidoscopy, or barium enema.  By analyzing data at each of these 
time points, there is hope to gain better understanding of the timing of 
changes in employment and financial burden to inform when in the 
cancer continuum would a future intervention be optimal.  
 

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2. 
Objectives 
2.1 
Primary Endpoints 
2.1.1 
Evaluate the change in level of self-reported financial burden from 
baseline (within 60 days of diagnosis) to 12 months after diagnosis of 
colon or rectal cancer treated with curative-intent.   
2.2 
Secondary Endpoints 
2.2.1 
Evaluate reported access and utilization of financial services (i.e. 
financial counselor, navigator, social workers) and its association to 
financial burden in the first 12 months after diagnosis of colon or rectal 
cancer treated with curative-intent. 
2.2.2 
Evaluate the change in level of self-reported financial burden and 
employment limitations from baseline (within 60 days of diagnosis) to 
3, 6, and 12 months after diagnosis of colon or rectal cancer treated 
with curative-intent. 
2.2.3 
Evaluate long term outcomes at 24 months after diagnosis including 
financial burden, employment limitations and adherence to clinical 
follow-up guidelines. 
2.2.4 
Evaluate the change of quality-of-life outcome (QoL) from baseline to 
12 months and its association with predictors. 
2.2.5 
Evaluate the change in level of self-reported financial burden from 
baseline to 12 months using alternate measures of financial burden 
(i.e. impact of cost questions and single item from EORTC Q30) 
3. 
Selection of Sites 
All interested NCORP sites 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 patient experiences. To ensure patient diversity in this study, all 
Minority/Underserved National Cancer Institute Community Oncology Research 
Programs (MU NCORP) sites will be specifically invited to participate. 

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4. 
Selection of Patients 
Each of the criteria in the checklist that follows must be met in order for a patient to be 
considered eligible for this study. Use the checklist to confirm a patient’s eligibility. For 
each patient, this checklist must be photocopied, completed and maintained in the 
patient’s chart.  
In calculating days of tests and measurements, the day a test or measurement is 
done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 
four weeks later would be considered Day 28.  
ECOG-ACRIN Patient No. ____________________________ 
Patient’s Initials (L, F, M) _______________________ 
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 4.1 must be met, without 
exception. The registration of individuals who do not meet all criteria listed in 
Section 4.1 can result in the participant being censored from the analysis of 
the study, and the citation of a major protocol violation during an audit.  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. 
4.1 
Eligibility Criteria for Patient Participants 
4.1.1 
Age ≥ 18 years. 
4.1.2 
Patients must have a life expectancy of ≥ 24 months 
4.1.3 
ECOG PS 0-3  
4.1.4 
Patients must have a newly diagnosed colon or rectal cancer or 
rectosigmoid junction (initial diagnosis, either a biopsy or curative 
surgery, whichever is most recent) within 60 days of registration and 
have either not yet received radiation or chemotherapy or are starting 
radiation or chemotherapy on the same day as registration. 
4.1.5 
Patients must have Stage I, II, or III disease at the time of enrollment 
and will be treated with curative-intent. This can be defined either 
clinically or pathologically if they have already undergone surgery. For 
staging of both colon and rectal cancer, the definition of stage I-III is 
based on the seventh edition (2010) or an updated version of the 
TNM staging system. 
4.1.6 
Patients are not eligible if they are already enrolled on a treatment 
clinical trial at the time of registration. They can remain on the study if 
they subsequently enroll on a treatment clinical trial during the study 
time period. 
4.1.7 
Patients are not eligible if they are to receive treatment at an outside 
facility throughout the duration of the trial. 
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4.1.8 
Patients who choose to not receive radiation and/or chemotherapy 
after a curative-intent surgery are eligible to participate. 
4.1.9 
Patients with a history of previous malignancy (except non-melanoma 
skin or cervical in-situ cancer) treated (with either surgery, 
chemotherapy, and/or radiation) within the last 3 years are not eligible 
because it is possible that their employment and burden due to cancer 
care may be impacted by their previous malignancy and therefore add 
heterogeneity to the study. 
4.1.10 
Patients with two primary cancers that consist of colon, rectal or 
colorectal are not eligible. 
4.1.11 
Patients must be able to complete questionnaires in English. 
4.1.12 
Patients must sign and give written informed consent in accordance 
with institutional and federal guidelines 
 
 
 
 
 
Physician Signature 
 
Date 
OPTIONAL: 
This signature line is provided for use by institutions wishing to 
use the eligibility checklist as source documentation. 
 

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5. 
Registration Procedures 
CTEP 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) (i.e., 
clinical site staff requiring write access to OPEN, RAVE, or TRIAD or acting as a primary 
site contact) must complete their annual registration using CTEP’s web-based 
Registration and Credential Repository (RCR) (https://ctepcore.nci.nih.gov/rcr). 
Documentation requirements per registration type are outlined in the table below. 
Documentation Required 
IVR 
NPIVR 
AP 
A 
FDA Form 1572 
 
 
 
 
Financial Disclosure Form 
 
 
 
 
NCI Biosketch (education, training, 
employment, license, and certification) 
 
 
 
 
HSP/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 CTSU (Cancer Trials Support Unit) 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 
Additional 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>. 
CTSU Registration Procedures 
This study is supported by the NCI Cancer Trials Support Unit (CTSU). 
IRB Approval: 
Each investigator or group of investigators at a clinical site must obtain IRB approval for 
this protocol and submit IRB approval and supporting documentation to the CTSU 
Regulatory Office before they can be approved to enroll patients.  Assignment of site 
registration status in the CTSU Regulatory Support System (RSS) uses extensive data 
to make a determination of whether a site has fulfilled all regulatory criteria including but 
not limited to the following: 
• 
An active Federal Wide Assurance (FWA) number 
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• 
An active roster affiliation with the Lead Network or a participating organization 
• 
A valid IRB approval 
• 
Compliance with all protocol specific requirements. 
In addition, the site-protocol Principal Investigator (PI) must meet the following criteria: 
• 
Active registration status 
• 
The IRB number of the site IRB of record listed on their Form FDA 1572 
• 
An active status on a participating roster at the registering site. 
Sites participating on the NCI CIRB initiative that are approved by the CIRB for this study 
are not required to submit IRB approval documentation to the CTSU Regulatory Office. 
For sites using the CIRB, IRB approval information is received from the CIRB and 
applied to the RSS in an automated process. Signatory Institutions must submit a Study 
Specific Worksheet for Local Context (SSW) to the CIRB via IRB Manager to indicate 
their intent to open the study locally. The CIRB’s approval of the SSW is then 
communicated to the CTSU Regulatory Office. In order for the SSW approval to be 
processed, the Signatory Institution must inform the CTSU which CIRB-approved 
institutions aligned with the Signatory Institution are participating in the study. 
Downloading Site Registration Documents:  
Site registration forms may be downloaded from the EAQ162CD protocol page located 
on the CTSU members’ website.   
• 
Go 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 your screen 
• 
Either enter the protocol # in the search field at the top of the protocol tree, or 
• 
Click on the By Lead Organization folder to expand 
• 
Click on the ECOG-ACRIN link to expand, then select trial protocol EAQ162CD 
• 
Click on LPO Documents, select the Site Registration documents link, and download 
and complete the forms provided. 
Requirements For EAQ162CD Site Registration:  
• 
IRB approval (For sites not participating via the NCI CIRB; local IRB documentation, 
an IRB-signed CTSU IRB Certification Form, Protocol of Human Subjects Assurance 
Identification/IRB Certification/Declaration of Exemption Form, or combination is 
accepted.) 
Submitting Regulatory Documents 
Submit required forms and documents to the CTSU Regulatory Office via the Regulatory 
Submission Portal, where they will be entered and tracked in the CTSU RSS. 
Regulatory Submission Portal: www.ctsu.org  (members’ area)  Regulatory Tab  
 Regulatory Submission 
When applicable, original documents should be mailed to: 
CTSU Regulatory Office 
1818 Market Street, Suite 3000 
Philadelphia, PA 19103 
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Institutions with patients waiting that are unable to use the Portal should alert the CTSU 
Regulatory Office immediately at 1-866-651-2878 in order to receive further instruction 
and support. 
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: 
You can verify your site registration status on the members’ section of the CTSU 
website. 
• 
Go to https://www.ctsu.org and log in to the members’ area using your CTEP-IAM 
username and password 
• 
Click on the Regulatory tab 
• 
Click on the Site Registration tab 
• 
Enter your 5-character CTEP Institution Code and click on Go 
NOTE: 
The status given only reflects compliance with IRB documentation and 
institutional compliance with protocol-specific requirements outlined by the 
Lead Network. 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. 
Patient Enrollment 
Patients must not start protocol treatment prior to registration. 
Patient enrollment will be facilitated using the Oncology Patient Enrollment Network 
(OPEN). OPEN is a web-based registration system available on a 24/7 basis. To access 
OPEN, the site user must have an active CTEP-IAM account (check 
<https://ctepcore.nci.nih.gov/iam/>) and a 'Registrar' role on either the LPO or 
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participating organization roster. Registrars must hold a minimum of an AP registration 
type. 
All site staff will use OPEN to enroll patients to this study.  It is integrated with the CTSU 
Enterprise System for regulatory and roster data and, upon enrollment, initializes the 
patient in the Rave database. OPEN can be accessed at https://open.ctsu.org or from 
the OPEN tab on the CTSU members’ side of the website at https://www.ctsu.org. To 
assign an IVR or NPIVR as the treating, crediting, consenting, drug shipment (IVR only), 
or investigator receiving a transfer in OPEN, the IVR or NPIVR must list on their Form 
FDA 1572 in RCR the IRB number used on the site’s IRB approval. 
Prior to accessing OPEN, site staff should verify the following: 
• 
All eligibility criteria have been met within the protocol stated timeframes.  
• 
All patients 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 treatment information. Please print this confirmation for your 
records.  
Further instructional information is provided on the OPEN tab of the CTSU members’ 
side of the CTSU website at https://www.ctsu.org or at https://open.ctsu.org.  For any 
additional questions contact the CTSU Help Desk at 1-888-823-5923 or 
ctsucontact@westat.com. 
5.1 
Protocol Number  
5.2 
Investigator Identification  
• 
Institution and affiliate name 
• 
Investigator’s name 
5.3 
Patient Identification  
• 
Patient’s initials (first and last) 
• 
Patient’s Hospital ID 
• 
Patient demographics 
• 
Sex 
• 
Birth date (mm/yyyy) 
• 
Race 
• 
Ethnicity 
• 
Nine-digit ZIP code 
• 
Method of payment 
• 
Country of residence 
5.4 
Eligibility Verification 
Patients must meet all of the eligibility requirements listed in Section 4.1. 
5.5 
Stratification Factors 
• 
Rectal or colon cancer 
• 
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5.6 
Additional Requirements  
5.6.1 
Patients must provide a signed and dated, written informed consent 
form. 
NOTE: 
Copies of the consent are not collected by the ECOG-
ACRIN Operations Office – Boston. 
5.6.2 
Data collection for this study will be done exclusively through the 
Medidata Rave clinical data management system and the EASEE-
PRO system. Access to the trial in Rave is granted through the 
iMedidata application to all persons with the appropriate roles 
assigned in Regulatory Support System (RSS). To access Rave via 
iMedidata, the site user must have an active CTEP-IAM account  
(check at <https://ctepcore.nci.nih.gov/iam/>) and the appropriate 
Rave role (Rave CRA, Read-Only, CRA, Lab Admin, SLA or Site 
Investigator) on either the LPO or participating organization roster at 
the enrolling site. To the hold Rave CRA role or CRA Lab Admin role, 
the user must hold a minimum of an AP registration type. To hold the 
Rave Site Investigator role, the individual must be registered as an 
NPIVR or IVR. Associates can hold read-only roles in Rave. 
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. 
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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6. 
Methodology Plan 
6.1 
This is a single arm, prospective, longitudinal cohort study.  
6.2 
Setting 
This study will be conducted through NCORP community sites and 
minority/underserved sites across the NCI network. Enrollment will be limited to 
these sites in order to explore the financial experiences of those treated for 
cancer in the community setting. The infrastructure of resources (i.e. social 
workers, navigators, financial counselors) may be different at NCORP community 
sites when compared to large comprehensive cancer centers. Because most 
patients with these types of common malignancies are treated in the community 
setting, utilizing NCORP sites will provide a more representative picture of the 
financial experience of cancer patients in the United States. 
6.3 
Screening, Consent and Patient Registration 
Patients from a gastroenterology, surgical oncology, radiation oncology, or 
medical oncology clinic with newly diagnosed colon or rectal cancer are potential 
candidates for the study. Participants must enroll within 60 days of their 
diagnostic biopsy or curative-intent surgery and prior to any chemotherapy and/or 
radiation (participants may enroll on the first day of chemotherapy and/or 
radiation). 
Institutions will identify a clinical research nurse (CRN) or clinical research 
associate that will be responsible for all aspects of this study. The designated 
CRN/CRA from each institution will be available to work with physicians during 
the clinical session to identify and recruit patients. The CRN/CRA or other 
members of the research team will discuss the details of this study with 
appropriate care and thoughtfulness as patients have recently received the 
diagnosis of a cancer. Because of the sensitive nature of a new diagnosis of 
cancer as well as financial questions, a script with talking points will be provided 
that address common concerns. Talking points will include: ensured privacy of 
financial information and sensitivity to new diagnosis. If the patient agrees, they 
will be screened for study eligibility at that time or at a subsequent visit as 
deemed appropriate by study personnel. This person will also be available to 
answer any questions regarding the study and obtain written informed consent. 
6.4 
Data Collection 
Patients will be followed for the duration of the study and all questionnaires will 
be administered as described in Section 8. 
6.4.1 
Patients will be assessed at baseline (following consent and 
registration), and at subsequent time points (3, 6, 12 and 24 months) 
following registration. See Section 7 for a description of the 
questionnaires administered at each time point). Questionnaires are 
self-administered and require approximately 45-60 minutes to 
complete at each time point. 
6.4.2 
Patients will receive survey instrument at 5 time points over a 24-
month period of time. A0 (baseline) assessment will occur after 
registration and within 60 days after initial diagnosis. A1 will be 
completed at 3 months after baseline (+/- 4 weeks), A2 at 6 months 
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after baseline (+/- 4 weeks), A3 12 months after baseline (+/- 4 
weeks), and A4 24 months after baseline (+/- 4 weeks).  
6.4.3 
Participants will be asked at the time of registration if they would like 
to complete the surveys online or on paper. The time points were 
chosen with 4-week flexibility as they typically correlate with 
scheduled clinic visits. 
6.4.4 
It is acceptable to have a caregiver assist the participant with 
completing the questionnaires. 
6.4.5 
Criteria for Removal of Patient from Protocol Participation 
6.4.5.1 
Patient completes 24 months of study participation. 
6.4.5.2 
The patient may withdraw from the study at any time for 
any reason. Research staff should only submit the End of 
Study Clinical Form if the patient refuses all future direct 
and indirect follow-up on the study.  
6.4.5.3 
If a patient cannot or refuses to complete the patient 
questionnaires for a study time point, this is not a criterion 
for discontinuation of protocol participation. Submit the 
Baseline Clinical Form and Follow-up Clinical Form and 
document the reason the questionnaires were not 
completed at the time point and administer questionnaires 
to the patient at the next study time point. 
6.4.6 
Follow-up Period 
There is no further follow up required once the patient completes 24 
months of study participation.  
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7. 
Questionnaires  
7.1 
Financial Measures 
7.1.1 
Financial burden 
7.1.1.1 
COST- This instrument assesses the degree of financial 
distress experienced by cancer patients and will be used at 
each time point. The Comprehensive Score for Financial 
Toxicity (COST) measure is the primary outcome and has 
undergone validation, and was created via a robust 
development process (42). The COST is an 11-item PRO 
measure of financial toxicity that uses a 7-day time window 
and a 5-point Likert response scale ranging from 0 (“not at 
all”) to 4 (“a lot”). Higher COST scores (range: 0-44) 
represent better Financial Well-Being. Negatively valenced 
items are reverse coded so that higher scores indicate 
greater financial wellbeing, which is assessed as a uni-
dimensional construct. Development of the COST included 
literature review, iterative qualitative interviews with 
patients and providers (informing item generation and 
selection), selection of candidate items based on factor 
analyses and other psychometric properties (e.g., inter-
item correlation, IIC). The COST has demonstrated 
excellent internal consistency (Cronbach alpha coefficient 
= 0.9), item non-redundancy (mean IIC = 0.47, range, 
0.22-0.69), and good construct validity (mean item-total 
correlation = 0.71, range, 0.62-0.79) (Appendix B). Further, 
a financial toxicity grading scale has been developed for 
the COST based on clinically meaningful changes in 
health-related quality of life as measured by the FACT-G 
measure (17). Based on previous cross-sectional studies 
(36, 42, 47), we assume that the baseline COST score 
follows a normal distribution with the mean 25 and 
standard deviation 12.  
7.1.1.2 
Impact of Cost- Patients will be asked questions about 
their insurance status at each assessment. They will be 
asked about insurance denials in addition to specific out of 
pocket costs related premiums, deductibles/co-pays for 
doctor visits, prescription and over the counter drug costs, 
and other services related to their cancer treatment at each 
time point. We will assess various lifestyle coping 
strategies to help pay for cancer care such as asking about 
cutting back on leisure activities, reducing spending on 
basic needs (food or utilities), spending savings, selling 
possessions, or borrowing money (18). We will ask 
questions related to communication preferences with their 
health care team about the cost of cancer care. 
7.1.2 
Access and Utilization of Financial Resources- The Consumer 
Based Cancer Care Value Index (CCVI) was developed in 
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the aspects of care patients value most and the degree to which these 
aspects of care were experienced during their treatment. The CCCVI 
is a patient-centric, value-based tool that reflects the patients’ vision 
and experience in defining the value of the care they seek. We 
modified items from this measure that reflect access and utilization of 
financial resources and experience of paying for their cancer care. 
This is an 8-item measure. 
7.1.3 
Employment- We will use items from both the Work Productivity and 
Activity Impairment Questionnaire (WPAI:SHP) (49), Work Ability 
Index (WAI) (50), and Work after cancer survey (WACS) (44). The 
WPAI:SHP evaluates effects of disease on employment status, hours 
missed due to health problems, hours worked, and the degree to 
which health problems affect productivity and regular activity. This 
scale has been utilized previously in breast cancer patients (51). The 
Work Ability Index (WAI) is an instrument used in occupational health 
care and it reveals how well a worker is able to perform his or her 
work. The WAI and all its items reliably predicted work disability, 
retirement and mortality in a Finnish population (50). The measure 
has been used in patients with a variety of cancers (52-54), including 
early stage colon and rectal cancer (55). We will use items from the 
WAI that represent data not captured by other surveys (items can 
stand alone). The item regarding employment benefits (i.e. disability, 
sick leave) is from the WACS, a survey utilized in patients (including 
colon cancer) receiving curative intent therapy (44). The Baseline 
Employment Questionnaire will include 18 items and Follow up will 
include 14 items.  
7.1.4 
Quality of Life (FACT-G7) - The Functional Assessment of Cancer 
Therapy- General (FACT-G) is a validated measure that incorporates 
many prevalent symptoms and functional domains (56). This measure 
has been further developed into a rapid version (FACT-G7) that 
includes 7 items which we will utilize to reduce survey burden (57). 
Quality of life is an important domain to include in relation to financial 
burden. Fenn et al. reported data from the National Health Interview 
Survey where increased financial burden was the strongest 
independent predictor of poor quality of life among cancer survivors 
(68). 
7.1.5 
Self-Efficacy- The 6-item Stanford Self-Efficacy for Managing 
Chronic Disease measures self-efficacy of patients with chronic 
illnesses. The instrument consists of several domains including 
symptom control, role function, emotional functioning, and 
communication with physicians (66). Self-efficacy measure may be an 
important predictor or moderator of financial well-being. In previous 
studies, self-efficacy was found to play a moderating role for the 
relationship between depression and distress in cancer patient. We 
hypothesize that patients with high self-efficacy may be a predictor of 
improved financial well-being (67). 
7.1.6 
Baseline Questionnaire and Sociodemographic Follow up- 
Patients will be asked information about their sociodemographics (i.e. 
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both the baseline and follow up, we will ask participants details about 
their insurance plan and coverage. Because we hypothesize that the 
site will collect more accurate insurance information when compared 
to patient knowledge of insurance information, when there is a 
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7.1.7 
Study Measures and Objectives Table 
Patient Questionnaires 
Objectives 
Baseline Questionnaire  
Sociodemographics, comorbities, insurance information. Used as predictor variables for all objectives 
Sociodemographic Follow-up  
Sociodemographics and insurance information. Used as predictor variables for all objectives 
Baseline Employment   
Secondary Endpoint (2.2.2) 
Follow-up Employment  
Secondary Endpoint (2.2.2). Employment asked at baseline, 6, 12, and 24 months as these are time points in 
cancer continuum that we hypothesize change and we want to understand longitudinal change. We omitted 3 
month due to patient burden. We include a 24 month time point to understand long term survivorship 
employment limitations. 
FACT-G7  
Secondary Endpoint (2.2.4). QOL asked at baseline, 6, 12, and 24 months as these are time points in cancer 
continuum that we hypothesize change. We omitted 3 month due to patient burden. We include a 24 month time 
point to understand long term survivorship QOL 
Self-Efficacy  
This will be used as predictor variable for all objectives. To limit burden we omitted 3 and 12 month 
COST  
Primary Endpoint (2.1.1)- needed at all time points to understand changes at diagnosis (baseline), beginning of 
tx (3), end of therapy (6), short term survivorship(12), and long term survivorship(24).  
Impact of Cost  
Secondary Endpoint (2.2.5)- needed at all time points to understand changes at diagnosis (baseline), beginning 
of tx (3), end of therapy (6), short term survivorship(12), and long term survivorship(24). 
Access and Utilization of 
Financial Resources  
Secondary Endpoint (2.2.1)- needed at all time points to understand changes at diagnosis (baseline), beginning 
of tx (3), end of therapy (6), short term survivorship(12), and long term survivorship(24). 
Acceptability  
Because of sensitive nature of questions will include these questions to assess acceptability at the 12 month 
time point.  
Site Completed Forms 
 
Site Survey 
Assesses available resources for financial assistance. Will be used as predictor variable 
Baseline Clinical Form 
Clinical information collected at all time points to correlate with primary endpoint of financial burden 
Follow-up Clinical Form 
Clinical information collected at all time points to correlate with primary endpoint of financial burden 
24-month Follow-up Clinical 
Form 
Clinical information and adherence variables collected for Secondary Endpoint (2.2.3) 
End of Study Clinical Form 
Completed if the patient has completed 24 months of study participation and refuses all future direct and indirect 
follow-up on the study. 
 

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8. 
Patient Reported Outcomes (PRO) and Quality of Life (QOL) Administration 
8.1 
Data Collection Approach 
We will use a combination of EASEE-PRO and mailed questionnaires for this 
study. A proxy or family member can complete the questionnaires on behalf of 
the patient as long as they can speak English. The questionnaires are only 
available in English. See Appendix III for a Participant Retention-Focused 
Communication Calendar. 
8.2 
Questionnaire Administration Process  
8.2.1 
Participant Contact Information Form 
At the time of recruitment into this study, patients 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 their name, home address, phone 
number, and e-mail (if available). Additionally, information for one 
contact person (the participant’s spouse, next of kin or close family 
member), and a primary (or other) physician is collected to assist with 
requests for patient location (if necessary). 
This form is retained in the study participant’s chart at the site and is 
not submitted to the ECOG-ACRIN master database. The completed 
form is faxed to the central ECOG-ACRIN Outcomes and Economic 
Assessment Unit (OEAU) located at Brown University so that the 
participants can be contacted for the Patient Reported Outcomes 
(PRO) portion of the study. The contact information is stored in a 
dedicated SQL database and IS NOT linked to the master ECOG-
ACRIN database. The OEAU RA will not have access to the main 
ECOG-ACRIN database that contains screening results. 
On the Participant Contact Information Form, patients will be asked to 
express a preference for on-line or paper administration of patient 
reported outcome (PRO) forms. Patients may choose to complete 
questionnaires using a web-based application (see Section 8.3 for a 
description) or by mail.  Administration of questionnaires, both web-
based and paper will be coordinated by the OEAU. Administration of 
the questionnaires will be triggered based on completion of study 
milestones marked by submission of forms in RAVE. 
8.2.2 
Web-based questionnaire completion 
Patients will be prompted to complete web-based forms via an email 
prompt. These emails will include a link to the web site for 
questionnaire completion. Questionnaires will be completed on line 
using a unique patient account. The web site will reference a study-
specific toll-free phone number that patients can use to reach the 
OEAU staff should they have questions or need assistance. All data 
will be stored on a secure server. Patients who do not complete the 
web questionnaires within 3 working days of the initial request e-mail 
will receive up to 3 additional e-mail reminders, each 3 days apart. 
These reminder e-mails, like the initial e-mail, will provide a link to the 
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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 patients still have not responded within 12 days of the original e-
mail, the OEAU Research Associate may attempt to telephone the 
patient and administer the questionnaire over the telephone. If 
questionnaires are telephone-administered, they will be marked as 
such in the database. Up to five attempts will be made to contact the 
participant over the telephone. 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 this data in specific analyses. 
However, after telephone follow-up, no additional or extraordinary 
means will be employed to collect overdue/missing questionnaires 
8.2.3 
Mailed questionnaire completion  
Mailed questionnaire packets will include a letter introducing the study 
and include a study-specific toll-free phone number that patients can 
use to reach the OEAU staff should they have questions or need 
assistance, questionnaires, and pre-addressed, stamped envelopes 
for return mailing to the OEAU. If patients do not complete the paper 
questionnaire within 10 working days of the date of the mailing, the 
OEAU RA will attempt to telephone the patient. If the patient has not 
received the paper questionnaires, additional questionnaires will be 
sent after confirming the correct mailing address. If the questionnaire 
is available to the patient, the OEAU RA will urge the study patient to 
complete and return the questionnaire. If the patient has still not 
responded within 20 working days of the original mailing, the OEAU 
will attempt to telephone the patient and telephone administer the 
questionnaire. Up to five attempts will be made to contact the 
participant over the telephone. If questionnaires are telephone-
administered, they will be marked as such in the data base. 
8.2.4 
Evaluation of patient survey burden 
We will provide the NCI an interim report providing the range and 
median time to completion of the totality of the baseline 
questionnaires. This will be reported to the NCI within 90 days of the 
first 50 patients completing this questionnaire. 
8.3 
ECOG-ACRIN Systems for Easy Entry of Patient Reported Outcomes (EASEE-
PRO) System: 
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. 
Additionally, site persons with the appropriate roles in RSS will be granted 
access after IRB approval is obtained.  In some studies, this access may allow 
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CRAs to assist the participant accessing baseline surveys, educational materials, 
or other EASEE-PRO materials. 
EASEE-PRO Participant Access: 
To access EASEE-PRO, the participant must have an active EASEE-PRO user 
account. Upon registration to the study in OPEN, an account activation email will 
be sent to the address entered for the participant in OPEN eligibility checklist.  
This email address must be a valid email address for the participant. (If the 
patient email address were entered incorrectly in OPEN, the CRA must contact 
the OEAU (pro-help@stat.brown.edu to manually correct the error.) To activate 
their account, users must click the link in the email and verify their account before 
they can login and complete surveys or view web education materials. Once the 
account is activated, participants may login to the EASEE-PRO system through 
the OEAU-PRIDE web portal (https://pride.stat.brown.edu/Participant-Login).  
Upon login, users will be presented with a list of 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 roles 
(Rave CRA) in RSS at the enrolling site. Site users that are not members of 
ECOG-ACRIN must have the Rave roles 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 ECOG-ACRIN Outcomes and Economics Assessment Unit can be 
contacted for Patient Reported Outcome Questions via email at pro-
help@stat.brown.edu. An EASEE-PRO instructional guide for both sites and 
patients can be found on both the E-A and CTSU websites. 
Please see below for additional details on the EASEE-PRO system. 
1) A 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 web management 
interface requires the secure hypertext transfer protocol (HTTPS) to ensure 
encryption of transmitted data. 
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 
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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 
patients 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 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 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, which is used to store non-PII patient reported survey 
responses. 
i) Allows OEAU to monitor per patient 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 patients over data completion methods and form 
completion methods (both overall and by site). 
2) 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 (eg., participant 
registrations, scheduled procedures, and other triggers) and establishes 
event scheduling. The system sets up e-mail reminders to CRAs, participants 
and OEAU personnel to ensure timely completion of surveys. 
3) Web entry systems (PROWESs): a Web site where participants complete 
online surveys 
a) PROWESs provides a front facing web portal for participants to complete 
questionnaires and have those results stored in the PRO database. 
b) Secure site using HTTPS and requiring a username and password login. 
c) On login, user is presented with brief instructions; including approx. time 
for completion, number of questions to be completed in this session, any 
important information regarding this survey (including help and contact 
information) 
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d) PROWESs is a one-way interface, data cannot be returned from the 
PRO-DB to the user. 
4) Valet Interface and data entry system (PROVIDES). 
a) The PROVIDES system is a web interface that allows site CRAs to act as 
a valet and enter a participant’s responses to a survey into the PRO 
database should the survey be completed on paper. This allows Site 
CRAs to enter forms completed by the patient on site. 
b) Secure site using HTTPS and requiring a username and password login. 
c) Which forms can be entered is restricted by username, site affiliation, and 
role, thus Sites RAs can only enter surveys predesignated as on-site data 
collection surveys and only for their own patients.  
d) On login, user is presented with brief instructions; is requested to select 
the protocol, case number, timepoint and verify the case Id by providing 
the participant birthdate. 
PROVIDES is a one-way interface, data cannot be returned from the PRO-
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9. 
Site completed forms and administration 
9.1 
Data Collection Approach 
The principal investigators of the participating NCORP sites with CCDR 
components or subcomponents will be instructed to identify points-of-contact 
(CCDR leaders) who will be responsible for completing the site completed forms. 
Each participating NCORP site will complete forms including one Site Survey, 
Baseline Clinical form, Follow-up form at 3, 6, 12, and 24 months, and End of 
Study form. One Site Survey is filled out per site and should be completed within 
30 days of the first participant enrollment. The Baseline, Follow-up, and End of 
Study form are participant-specific and contain data collection from the medical 
records. The designated site research coordinator will be responsible for data 
abstraction.  Specifics about where in the medical record to locate each variable 
will be generally described within the form. Further questions and trouble-
shooting for finding these variables will occur in personal communication with the 
study team. 
9.2 
Questionnaire Administration Process 
9.2.1 
Site Survey 
At the time the NCORP site opens the study, the CCDR leader will 
complete the “Site Survey” which asks analytic numbers for colorectal 
cancer at their site, resources available at their institution (i.e. social 
worker, financial counselor, navigator), and institutional practice 
regarding referrals for financial concerns. Details of where the data for 
of these variables can be found are included in the form. Each site 
with an individual CTEP ID is required to fill out one “Site Survey” 
within 30 days of the first participant enrollment. 
9.2.2 
Baseline Clinical Form 
This form should be completed within 14 days of registration. For 
participants who choose paper surveys, the date the survey was 
completed (date signed) must be within 14 days of starting radiation 
or chemotherapy. It contains questions related to type of malignancy 
(colon versus rectum) and if chemotherapy is planned. These two 
variables (malignancy type and chemotherapy use) will be used for 
stratification. In the case that it is uncertain if chemotherapy is 
planned, the site research coordinator will choose the option 
“uncertain”, and this question will again be asked in the 3 month 
follow-up form. This form will also ask about the insurance status of 
participant.  Because we hypothesize that the site will collect more 
accurate insurance information when compared to patient knowledge 
of insurance information, when there is a discrepancy, we will use the 
response from the site in analysis. 
9.2.3 
Follow-up Clinical Form 
This form will be completed by the research coordinator at 3, 6, 12, 
and 24 month time points. It contains questions regarding vital status 
(dead/alive), chemotherapy use, performance status, stage, status of 
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treatment, if there was any insurance changes, and if the participant 
required help from a caregiver from their knowledge. 
9.2.4 
24 Month Clinical Form 
This form is completed once the participant has completed 24 months 
of study. This form contains questions on vital status, reasons for 
being off study, and questions regarding adherence to guidelines. 
9.2.4.1 
Adherence to guidelines questions 
There are questions contained within the “24 Month 
Assessment” that ask if the patient has received a 
colonoscopy, sigmoidosocpy, and barium enema since 
completing therapy (and how many months this test was 
performed after surgery). These adherence questions also 
include how often the patient has been examined by their 
oncologist and had a serum CEA performed. We will define 
adherent versus non-adherent according to below 
questions and responses. 
Considered ADHERENT if they answer the following (must 
have ALL) in bold. 
Has the patient received a colonoscopy, sigmoidoscopy, or 
barium enema at some point since their initial surgery (if 
applicable)? 
• 
Yes 
• 
If yes, how many months since surgery was it 
completed 
• 
No 
• 
Unsure 
How many times has the patient been seen by their 
oncologist for a history/physical since ending treatment? 
• 
The patient has not been seen by their oncologist since 
ending treatment 
• 
Once 
• 
Twice 
• 
More than twice 
• 
I don’t know the reason 
How many times has the patient had a carcinoembryonic 
(CEA) serum checked since ending treatment? 
• 
The patient has not had a CEA checked since ending 
treatment 
• 
Once 
• 
Twice 
• 
More than twice 
• 
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9.2.5 
End of Study Clinical Form 
The patient may withdraw from the study at any time for any reason. 
Research staff should only submit the End of Study form if the patient 
refuses all future direct and indirect follow-up on the study. 
 

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10. 
Study Calendar 
See below for a schedule of study assessments  
 
Baseline1 
3 month 
6 month 
12 month 
24 month 
Patient questionnaires (min/max # questions based on skip 
pattern) 
 
 
 
 
 
Baseline Questionnaire (32/44) 
X 
 
 
 
 
Sociodemographic Follow-up (3) 
 
X 
X 
X 
X 
Baseline Employment  (18) 
X 
 
 
 
 
Follow-up Employment (14) 
 
 
X 
X 
X 
FACT-G7 (7) 
X 
 
X 
X 
X 
Self-Efficacy (6) 
X 
 
X 
X 
 
COST (11) 
X 
X 
X 
X 
X 
Impact of Cost (31/41) 
X 
X 
X 
X 
X 
Access and Utilization of Financial Resources (8) 
X 
X 
X 
X 
X 
Acceptability (2) 
 
 
 
X 
 
Minimum/Maximum number of items at each time point 
113/144 
56/66 
83/93 
85/95 
77/87 
Site Completed Forms 
 
 
 
 
 
Site Survey2 
X 
 
 
 
 
Baseline Clinical Form 
X 
 
 
 
 
Follow-up Clinical Form 
 
X 
X 
X 
X 
24-month Follow-up Clinical Form 
 
 
 
 
X 
End of Study Clinical Form 
 
 
 
 
X 
1 Baseline study assessments must be completed within 14 days of registration. For participants who choose paper surveys, the date the survey 
was completed (date signed) must be within 14 days of starting radiation or chemotherapy. 
2 Each site with an individual CTEP ID is required to fill out one Site Survey within 30 days of the first participant enrollment. 
 
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11. 
Statistical Considerations 
11.1 
Sex and Ethnicity  
Based on previous CDC data of 2009-2013 Colon and Rectum by Cancer Type 
and Race (age-adjusted) (66) the anticipated accrual in subgroups defined by 
sex and race is: 
Ethnic Category 
Sex 
Females 
Males 
Total 
Hispanic or Latino 
20 
23 
43 
Not Hispanic or Latino 
252 
268 
520 
Ethnic Category: Total of all subjects 
272 
291 
563 
 
Racial Category 
American Indian or Alaskan Native 
2 
2 
4 
Asian 
9 
10 
19 
Black or African American 
35 
34 
69 
Native Hawaiian or other Pacific Islander 
0 
0 
0 
White 
223 
242 
465 
More than one race 
3 
3 
6 
Racial Category: Total of all subjects 
272 
291 
563 
11.2 
Study Design and Objectives 
This is a single-armed longitudinal study and the measurements of financial 
burden (COST score) will be collected at 5 time points over a 24-month follow-up 
time. The primary endpoint of this study is the change of COST score from 
baseline to the 12-month follow-up (FU) measurements.  
11.3 
Sample Size Considerations and Monitoring Plan 
11.3.1 
Stratification to be considered 
The type of disease (colon versus rectal cancer) and the 
chemotherapy status (getting chemotherapy versus not getting 
chemotherapy) will serve as the stratification factors. Chemotherapy 
for these strata includes all intravenous and oral cytotoxic 
chemotherapy. For those with rectal cancer, those receiving 
chemotherapy combined with radiation will be considered in the 
“chemotherapy” strata. For the chemotherapy stratification, some 
patients may not know their chemotherapy plan at the time of 
registration. For this group of patients, the stratification will be 
implemented at the time of the 3-month follow-up. In addition, based 
on the stage distribution (Table 3 below), stratifying by receiving 
chemotherapy or not shouldn’t be a bottleneck on patient’s 
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As illustrated in Table 3, it’s expected the patients with colon and 
rectal cancers will be enrolled into the study at a ratio of 2:1 and the 
group of patients receiving chemotherapy versus patients not 
receiving chemotherapy will roughly equal to each other in the 
enrollment. Therefore, the accrual thresholds would be set up 
according to these ratios (Table 3), after the overall sample size is 
determined in the next section. 
NOTE: 
Based on the actual enrollment as of 4/1/2019, the ratio of 
rectal cancer patients receiving chemotherapy versus not 
receiving chemotherapy is around 1:4. Thus, we 
accordingly changed the thresholds of these two strata. 
Table 3: Stage distribution of colon and rectal cancer from SEER data 
(82).  
Disease Type 
Stage 
Proportion* 
Receiving 
Chemotherapy 
Accrual 
Thresholds 
Colon cancer 
(70%) 
1 and 2 
38% 
Likely not 
180-190 
3 
37% 
Getting Chemo 
180-190 
4 
21% 
Excluding from 
study 
None 
Rectal cancer 
(30%) 
1 and 2 
44% 
Likely not 
36-38 
3 
33% 
Getting Chemo 
144-152 
4 
18% 
Excluding from 
study 
None 
* The relative proportion of new cancer cases in US, 2016 (www.cancer.org).  
11.3.2 
Sample Size 
Based on the data from previous cross-sectional studies (42, 50), we 
assume that the baseline COST score follows a normal distribution 
with the mean 25 and the standard deviation 12 and the 12-month FU 
score follows a normal distribution with the mean 22.5 and the 
standard deviation 12. Thus, the effect size of change is assumed to 
be 10%. The correlation between the baseline and the 12-month FU 
scores is assumed to be 0.2. Based on these assumptions, a sample 
size of 394 cancer patients will be needed to achieve a 90% power to 
detect the 2.5 difference (i.e., 10% change) at the 0.05 significance 
level using a two-sided Wilcoxon Signed-rank Test. These results are 
based on 20,000 Monte Carlo samples for the sample distributions 
under the null and the alternative hypothesis. The sample size will be 
296 if the power remains at 0.90 and the correlation is assumed to be 
0.4.  A pilot study assessing financial burden among patients with 
advanced cancers had a 24% attrition rate between baseline and 12 
month assessments, excluding those who died before the 12 month 
time point (36).  An ongoing study on employment among cancer 
patients across the stage spectrum had a 30% attrition rate at the 12-
month follow-up (Tevaarwerk, personal communication).  Therefore, 
we assume a 30% attrition rate at the 12-month follow-up and expect 
to enroll 563 patients into the study. Note: The imputation was based 

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on Monte Carlo samples in simulations, which caused slight 
fluctuations in the sample size. However, with 20,000 simulations, the 
fluctuation rate is only about 1%. 
With these sample sizes, we will have the power of 1.0 to detect a 
difference of 5 (i.e., 20% change) from the baseline to the 24-month 
FU score, while the latter is assumed to follow a normal distribution 
with mean 20 and standard deviation 12. The above computations 
were done using PASS 14 (83). 
Table 4:  Power Analysis.  Power: 0.80 and 0.90.  Correlation: 0.20 and 0.40. 
Power 
N 
H0 
Diff0 
H1 
Diff1 
Corr 
R 
Target 
Alpha 
Actual 
Alpha 
Beta 
 0.797 
292 
0.0 
2.5 
0.200 
0.050 
 0.050 
0.203 
(0.006) [0.791 0.802] 
 
 
 
 
(0.003) [0.047 0.053] 
 
 
 
 
 
 
 
 
 0.803 
218 
0.0 
2.5 
0.400 
0.050 
 0.049 
0.197 
(0.006) [0.798 0.809] 
 
 
 
 
(0.003) [0.046 0.052] 
 
 
 
 
 
 
 
 
 0.900 
394 
0.0 
2.5 
0.200 
0.050 
 0.051 
0.100 
(0.004) [0.896 0.904] 
 
 
 
 
(0.003) [0.048 0.054] 
 
 
 
 
 
 
 
 
 0.904 
296 
0.0 
2.5 
0.400 
0.050 
 0.051 
0.096 
(0.004) [0.900 0.908] 
 
 
 
 
(0.003) [0.048 0.054] 
11.3.3 
Accrual and Attrition Monitoring 
It is expected that the monthly accrual for this trial will be 
approximately 15 to 16 cases, excluding the first 6 months as 
institutions obtain IRB approval. Therefore, we anticipate that 563 
participants will be enrolled in about 3 to 3.5 years. 
After assessing the preliminary data in Tevaarwerk’s employment 
study (still ongoing), we didn’t observe an obvious pattern of the 
dropout that associates with cancer type, stage, or employment 
status. Thus, we will not implement the adaptive design in our study.  
However, we will closely monitor the patient’s attrition and then 
determine if the attrition rate will be significantly different among 
various groups.  Accordingly, the protocol may be amended and the 
sample size may need to be adjusted to oversample patients for the 
groups with high attrition rates.   
11.3.4 
Recruitment and Retention Plan 
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. Mail-based participants will receive surveys in the 
US mail as well as follow-ups for delinquent surveys. With both types 
of delivery, excessively delinquent participants may receive a phone 
call from the OEUA to determine if there is a problem completing the 
surveys. In the event that participants are unreachable by the OEAU, 
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the OEAU will coordinate with the site CRA in an effort to contact and 
retain participants. 
11.3.5 
Interim Analysis 
To assess the survey burden, we will provide the NCI an interim 
report to analyze the range and median time to completion for the 
totality of the baseline questionnaires. Survey completion time will be 
determined from the meta-data collected form patients who opt to 
complete the survey online. This will be reported to the NCI within 90 
days of the first 50 patients completing the questionnaire. 
11.4 
Statistical Analysis Plan 
11.4.1 
Primary Objective 
The primary aim is to evaluate the change in the level of self-reported 
financial burden from baseline (within 60 days of diagnosis) to 12 
months after diagnosis of colon or rectal cancer treated with curative-
intent. 
We will calculate the difference of COST measurements from baseline 
to 12-month FU for the completers who provide data at both time 
points, and use the paired t-test to assess if the mean difference is 
significantly different from zero. In case the data are not normally 
distributed, nonparametric methods (e.g., Wilcoxon signed-rank test) 
will be used instead to assess the difference. For the participants with 
missing measurements at one time point, we will implement the 
methods as described in Section 11.4.3 to handle the missing values. 
The two results will be compared as a sensitivity analysis. 
In addition, linear regression models with the change of COST from 
baseline to 12-month FU as the response variable will be fit to 
investigate the impact of other factors, including demographics 
variables (e.g., age, sex, marital status), clinical variables (e.g., stage 
of disease, malignancy type, chemotherapy status), baseline 
questionnaire variables (e.g., self-efficacy,). The three-level treatment 
status (IV chemotherapy, chemotherapy without IV, and no 
chemotherapy) will also be evaluated as a predictor. The impact of 
system level variables (including being designated a 
minority/underserved site or not, availability of financial resources for 
patients) will be examined in the regressions as well. Since pregnant 
women may have higher health-care related costs, the response will 
be compared between pregnant women and the others; if significant, 
the subset analysis may be performed in this population. 
11.4.2 
Secondary Objectives 
11.4.2.1 
Evaluate reported access and utilization of financial 
services (i.e. financial counselor, navigator, social workers) 
and its association to financial burden in the first 12 
months after diagnosis of colon or rectal cancer treated 
with curative-intent. 
The 8-question CCVI measure as described in Section 
7.1.2 will be analyzed to evaluate the change from 
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baseline to 12-month FU. For the continuous item variable, 
we will conduct the paired t test to examine the difference if 
the distribution is normal. If not normally distributed, 
Wilcoxon signed rank test will be used. For the categorical 
item variable, the paired proportion test (e.g., McNemar 
test) will be used instead. The association between CCVI 
and COST measures will be evaluated using the Pearson 
or Spearman correlation coefficient. 
Because we are aware that there is not a “gold standard” 
financial burden measure, we will include two other 
measures that have been used previously; (1) a series of 
items (Impact of cost questions) that are being used in the 
ongoing S1417CD; and (2) a single item in EORTC Q30 as 
our secondary endpoints. We acknowledge potential 
discrepancy between measures. Therefore we will conduct 
sensitivity analyses around the primary endpoint using the 
other measures and explore potential sources of 
discrepant outcomes. 
11.4.2.2 
Evaluate the change in level of self-reported financial 
burden and employment limitations from baseline (within 
60 days of diagnosis) to 3, 6, and 12 months after 
diagnosis of colon or rectal cancer treated with curative-
intent. 
The measurements of employment limitation by WPAI: 
SHP, WAI and WACS as described in Section 7.1.3 will be 
analyzed as continuous variables to evaluate the change 
from baseline to 3, 6, and 12-month FU.  If the distributions 
are normal, we will conduct the paired t tests to examine 
the differences of these variables.  If not normally 
distributed, Wilcoxon signed rank tests will be used. The 
association with COST measures will be evaluated using 
the Pearson or Spearman correlation coefficients. 
11.4.2.3 
Evaluate long-term outcomes at 24 months after diagnosis 
including financial burden, employment limitations and 
adherence to clinical follow-up guidelines. 
To evaluate the change of financial burden from baseline 
to the other time points (i.e., 3-month, 6-month, and 24-
month), the similar approaches described for the primary 
objective’s assessment will be implemented. In addition, 
longitudinal data analysis will be conducted to estimate the 
measurements’ trajectory across all five times points. 
Specially, linear (or generalized linear) mixed model will be 
fit to study the change in the mean response over time and 
also the effects of cancer type, stage, treatment plan and 
demographics, etc. on financial burden. In case the 
changes in the mean response over time are not linear, the 
quadratic trends or non-linear trends via spline may be 
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evaluated as well. The above analyses may be repeated to 
explore the categorized COST measures (63, 64). 
Logistic regressions will be fit to study whether or not the 
level of financial burden will impact the patient’s adherence 
to clinical follow-up guidelines, which is defined as follows: 
“adherent” is defined as completing all of the follow up 
guidelines within the 24 month study period and includes 
an endoscopic evaluation of their colon or barium enema, 
routine history and physical at least twice, and serum 
carcinoembryonic (CEA) level checked at least twice. The 
details of adherence questions can be found in Section 
9.2.4.1. 
11.4.2.4 
Evaluate the change of quality-of-life outcome (QoL) from 
baseline to 12 months and its association with predictors 
FACT-G7, as described in Section 7.1.4, will be analyzed 
to evaluate the change of QoL from baseline to 12 months. 
The sum of the 7-item scores will be modeled as a 
continuous variable in the linear regressions (57). The 
predictors will include demographics (age, sex, marital 
status), clinical variables (stage of disease, malignancy 
type, chemotherapy status), and financial variables (COST 
score). Similar to the primary aim assessment, the impact 
of the baseline questionnaire variables (e.g., self-efficacy) 
and the system level variables (including being designated 
a minority/underserved site or not, availability of financial 
resources for patients) will be examined in the models as 
well. FACT-G7 at 6 months will be included as an 
adjustment covariate. Similar analysis will be conducted to 
evaluate the change of FACT-G7 from baseline to 24 
months as well. 
11.4.2.5 
Evaluate the change in level of self-reported financial 
burden from baseline to 12 months utilizing alternate 
measures of financial burden (i.e. impact of cost questions 
and single item from EORTC Q30) 
Because there is not a “gold standard” financial burden 
measure, we will include two other measures that have 
been used previously; (1) a series of items (Impact of cost 
questions) that are being used in the ongoing S1417CD; 
and (2) a single item in EORTC Q30 assessing the impact 
of medical treatment on finances. We acknowledge 
potential discrepancy between measures. Therefore we 
will conduct sensitivity analyses around the primary 
endpoint using the other measures and explore potential 
sources of discrepant outcomes. 
Similar approaches as used in the primary aim will be 
conducted to evaluate the changes of these two measures 
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11.4.3 
Handling Missing Data 
As stated in the Section 11.3.3, we will closely monitor the patient 
attrition and determine whether the dropout is informative or not. If the 
missing is random, we may implement the method like multiple 
imputation to impute the missing values. In case the missing is not 
random (e.g., patients 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 assumptions (65). 
Since the COST is an 11-item PRO measure of financial toxicity, it is 
likely that partial data might be collected from some patients. 
According to the FACIT guidelines (www.facit.org), the patients who 
answer less than 6 out of 11 items will be excluded from the analysis. 
For patients who answer more than 6 but less than 11 items, the 
normalized score will be recorded according to the following formulae: 
(sum of individual item scores)* 11 / the number of items answered. 

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12. 
Electronic Data Capture 
Please refer to the EAQ162CDForms Completion Guidelines for the forms submission 
schedule. Data collection will be performed in Medidata Rave and 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. 
13. 
Patient Consent and Peer Judgment 
Current FDA, NCI, state, federal and institutional regulations concerning informed 
consent will be followed. 
14. 
References 
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States, 1990 to 2010. JAMA Oncol. 2015; 1: 88-96. 
2. Mariotto AB, Yabroff KR, Shao Y, et al. Projections of the cost of cancer care in the 
United States: 2010-2020. Journal of the National Cancer Institute. 2011; 103: 117-
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3. De Souza JA. The cost of cancer care: there is more than one elephant in the room. 
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4. Stump TK, Eghan N, Egleston BL, et al. Cost concerns of patients with cancer. 
Journal of oncology practice / American Society of Clinical Oncology. 2013; 9: 251-7. 
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affordability and accessibility. J Clin Oncol 34, 2016 (suppl; abstr 6535). 
6. Davidoff AJ, Erten M, Shaffer T, et al. Out-of-pocket health care expenditure burden 
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7. Bernard DS, Farr SL, Fang Z. National estimates of out-of-pocket health care 
expenditure burdens among nonelderly adults with cancer: 2001 to 2008. Journal of 
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8. USA Today/Kaiser Family Foundation/Harvard School of Public Health National 
Survey of Households Affected by Cancer. 
http://www.kff.org/kaiserpolls/pomr112006pkg.cfm. 
9. Zafar Y, Goetzinger M, Fowler R, et al. Impact of out-of-pocket expenses on cancer 
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Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer 
Treated with Curative Intent 
Appendix I 
 
Patient Thank You Letter 
We ask that the physician use the template contained in this appendix to prepare a letter 
thanking the patient for enrolling in this trial. The template is intended as a guide and can 
be downloaded from the web site at http://www.ecog.org. As this is a personal letter, 
physicians may elect to further tailor the text to their situation. 
This small gesture is a part of a broader program being undertaken by ECOG-ACRIN 
and the NCI to increase awareness of the importance of clinical trials and improve 
accrual and follow-through. We appreciate your help in this effort. 
 ________________________________________________________________________  
 
[PATIENT NAME] 
[DATE] 
[PATIENT ADDRESS] 
 
 
Dear [PATIENT SALUTATION], 
 
Thank you for agreeing to take part in this important research study. Many questions 
remain unanswered in cancer. With the participation of people like you in clinical trials, 
we hope to improve treatment and quality of life for those with your type of cancer. 
We believe you will receive high quality, complete care. I and my research staff will 
maintain very close contact with you. This will allow me to provide you with the best care 
while learning as much as possible to help you and other patients. 
On behalf of [INSTITUTION] and ECOG-ACRIN, we thank you again and look forward to 
helping you. 
 
 
Sincerely, 
 
 
 
 
[PHYSICIAN NAME] 
 
 

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Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer 
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Appendix II 
 
ECOG Performance Status 
PS 0 
Fully active, able to carry on all pre-disease performance without restriction 
PS 1 
Restricted in physically strenuous activity but ambulatory and able to carry out 
work of a light or sedentary nature e.g., light house work, office work. 
PS 2 
Ambulatory and capable of all self-care but unable to carry out any work 
activities. Up and about more than 50% of waking hours. 
PS 3 
Capable of only limited self-care, confined to bed or chair more than 50% of 
waking hours. 
PS 4 
Completely disabled. Cannot carry on any self-care. Totally confined to bed or 
chair. 
 

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Longitudinal Assessment of Financial Burden in Patients with Colon or Rectal Cancer 
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Appendix III 
 
Participant Retention-Focused Communication Calendar 
Based on the participants’ preferred method of communication, they will receive either an email 
or phone call. 
For those whose preferred method of communication is e-mail. 
Assessment 0, 
1, 2, 3, 4 
Prompted when 
assessment due 
If the participant wants to do the assessments online, a link to the 
survey will be sent. After completion of each assessment, 
participants taking survey online are immediately thanked on their 
screen for participating and provided with name and phone number 
of contact at their site. 
Assessment 0-
4 (if needed) 
No survey 
response – 3 
days after target 
date or 
appointment 
Participants will receive up to 3 additional e-mail reminders, each 3 
days apart. These reminder e-mails, like the initial e-mail, 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. 
Assessment 0-
4 (if needed) 
No survey 
response – 12 
days after target 
date or 
appointment 
If participants still have not responded within 12 days of the original 
e-mail, the central ECOG-ACRIN Outcomes and Economic 
Assessment Unit Research Associate may attempt to call the 
patient and administer the questionnaire over the telephone. Up to 
five attempts will be made to contact the participant over the 
telephone. 
Assessment 4 
After completion 
of all surveys – 
using preferred 
communication 
After completion of all assessments, participants taking survey 
online are immediately thanked on their screen for completing the 
study and provided with name and phone number of contact at 
their site. 
 
For those whose preferred method of communication is mail. 
Assessment 0, 
1, 2, 3, 4 
Prompted when 
assessment due 
If the participant wants to do paper surveys, these will be sent via 
mail. After completion of each assessment, a customized thank you 
letter will be sent. 
Assessment 0-
4 (if needed) 
No survey 
response – 10 
days after target 
date or 
appointment 
If paper was requested, participant will receive a telephone call 
from the site research coordinator.  If the patient has not received 
the paper questionnaires, additional questionnaires will be sent 
after confirming the correct mailing address. If the questionnaire is 
available to the patient, the OEAU RA will urge the study patient to 
complete and return the questionnaire. 
Assessment 0-
4 (if needed) 
No survey 
response – 20 
days after target 
date or 
appointment 
If the patient has still not responded within 20 working days of the 
original mailing, the OEAU will attempt to call the participant and 
telephone administer the questionnaire. Up to five attempts will be 
made to contact the participant over the telephone. If 
questionnaires are telephone-administered, they will be marked as 
such in the data base. 
Rev. Add1 

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Assessment 4 
After completion 
of all surveys – 
using preferred 
communication 
For mail participants, a customized thank you letter will be sent.