Implementation of a Prospective Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer
Conditions: Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer
Sponsor: SWOG Cancer Research Network

 
S1417CD 
 
Page 1 
 
Version Date 11/21/17 
 
 
 
PRIVILEGED COMMUNICATION 
Activation Date April 15, 2016 
FOR INVESTIGATIONAL USE ONLY 
 
 
 
 
SWOG 
TITLE 
IMPLEMENTATION OF A PROSPECTIVE FINANCIAL IMPACT ASSESSMENT TOOL  
IN PATIENTS WITH METASTATIC COLORECTAL CANCER 
 
 
STUDY CHAIRS: 
BIOSTATISTICIANS: 
 
Veena Shankaran, M.D., M.S. (Medical Oncology) 
Joseph M. Unger, Ph.D. (Biostatistics) 
Fred Hutchinson Cancer Research Center 
Amy K. Darke, M.S. (Biostatistics) 
825 Eastlake Ave. E, MS G4-830 
SWOG Statistics and Data Management Center 
Seattle, WA 98109 
Fred Hutchinson Cancer Research Center 
Phone: 206/667-7844  
1100 Fairview Avenue N, M3-C102 
FAX: 206/288-2042 
Seattle, WA 98109 - 1024 
E-mail: vshank@uw.edu  
Phone:  206/667-4623 
  
 
FAX:  206/667-4408 
Scott D. Ramsey, M.D., Ph.D. (Medical Oncology) 
E-mail:  junger@fredhutch.org 
Fred Hutchinson Cancer Research Center 
E-mail:  adarke@fredhutch.org 
1100 Fairview Avenue N, MS-B232 
Seattle, WA 98109 
 
Phone: 206/667-7846 
 
FAX: 206/667-5977 
 
E-mail: sramsey@fredhutch.org 
 
 
  
Dawn L. Hershman, M.D., M.S. (Medical Oncology) 
Columbia University Medical Center 
161 Fort Washington 
10th Floor, Room 1068 
New York, NY 10032 
Phone: 212/305-1945 
FAX: 212/305-0178 
E-mail: dlh23@columbia.edu 
 
 
 
PARTICIPANTS 
 
 
 
 
 
 
 
 
THIS STUDY IS OPEN TO ALL 
NCORP COMPONENTS AND SUBCOMPONENTS 
(ALLIANCE, ECOG-ACRIN, NRG, SWOG) 
 

 
S1417CD 
 
Page 2 
 
Version Date 11/21/17 
 
 
 
TABLE OF CONTENTS 
 
TITLE  ......................................................................................................................................................... 1 
PARTICIPANTS ............................................................................................................................................ 1 
TABLE OF CONTENTS ............................................................................................................................... 2 
CANCER TRIALS SUPPORT UNIT (CTSU) ADDRESS AND CONTACT INFORMATION ....................... 3 
SCHEMA FOR FLOW OF STUDY ............................................................................................................... 4 
1.0 
OBJECTIVES .................................................................................................................................. 5 
1.1 
Primary Objective(s) ......................................................................................................................... 5 
1.2 
Secondary Objective(s) .................................................................................................................... 5 
1.3 
Tertiary Objective ............................................................................................................................. 5 
2.0 
BACKGROUND ............................................................................................................................... 5 
3.0 
ELIGIBILITY CRITERIA .................................................................................................................. 7 
3.1 
Disease Related Criteria .................................................................................................................. 7 
3.2 
Clinical Criteria ................................................................................................................................. 8 
3.3 
Regulatory Criteria ........................................................................................................................... 8 
4.0 
INTERVENTION .............................................................................................................................. 8 
4.1 
Setting .............................................................................................................................................. 8 
4.2 
Screening, Consent and Patient Registration .................................................................................. 8 
4.3 
Administration of Questionnaires to Patients ................................................................................... 8 
4.4 
Additional Quality Control Procedures: .......................................................................................... 10 
4.5 
Caregiver Questionnaires .............................................................................................................. 11 
4.6 
Credit Reports ................................................................................................................................ 11 
4.7 
Criteria for Removal of Patient from Protocol Participation ........................................................... 11 
4.8 
Discontinuation of Study Participation ........................................................................................... 11 
4.9 
Follow-up Period ............................................................................................................................ 12 
5.0 
STUDY CALENDAR ...................................................................................................................... 13 
6.0 
CRITERIA FOR EVALUATION AND ENDPOINT ANALYSIS ..................................................... 13 
6.1 
Primary Endpoint ............................................................................................................................ 13 
6.2 
Secondary Endpoints ..................................................................................................................... 13 
6.3 
Definition of Primary Caregiver ...................................................................................................... 14 
6.4 
Questionnaires ............................................................................................................................... 14 
6.5 
Performance Status: ...................................................................................................................... 15 
7.0 
STATISTICAL CONSIDERATIONS .............................................................................................. 15 
7.1 
Primary Objective ........................................................................................................................... 15 
7.2 
Secondary Objectives .................................................................................................................... 16 
7.3 
Other Secondary Endpoints: .......................................................................................................... 17 
7.4 
Data and Safety Monitoring Committee ......................................................................................... 18 
8.0 
REGISTRATION GUIDELINES ..................................................................................................... 18 
8.1 
Registration Timing ........................................................................................................................ 18 
8.2 
Investigator/Site Registration ......................................................................................................... 18 
8.3 
OPEN Registration Requirements ................................................................................................. 20 
8.4 
Registration Procedures................................................................................................................. 22 
8.5 
Exceptions to SWOG registration policies will not be permitted. ................................................... 22 
9.0 
DATA SUBMISSION SCHEDULE ................................................................................................ 23 
9.1 
Data Submission Requirements .................................................................................................... 23 
9.2 
Master Forms ................................................................................................................................. 23 
9.3 
Data Submission Procedures ........................................................................................................ 23 
9.4 
Data Submission Timeline ............................................................................................................. 23 
10.0 
SPECIAL INSTRUCTIONS............................................................................................................ 25 
10.1 
Caregiver Eligibility and Consent ................................................................................................... 25 
10.2 
Administration of Questionnaires to Caregivers ............................................................................ 25 
10.3 
Criteria for Removal for Consented Caregiver from Study Participation ....................................... 26 
11.0 
ETHICAL AND REGULATORY CONSIDERATIONS ................................................................... 26 
12.0 
BIBLIOGRAPHY ............................................................................................................................ 27 
 

 
S1417CD 
 
Page 3 
 
Version Date 11/21/17 
 
 
 
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 866-651-2878 
to receive further information 
and support.   
 
Contact the CTSU Regulatory 
Help Desk at 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/OPE
N_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 
exclusively through Medidata Rave.  Please 
see that data submission section of the 
protocol for further instructions. 
 
Other Tools and Reports: Institutions 
participating through the CTSU continue to 
have access to other tools and reports 
available on the SWOG Workbench via the 
SWOG website (www.swog.org). 
 
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 patient eligibility questions and study procedure-related questions contact the SWOG Statistics 
and Data Management Center by phone or email: 
 
206-652-2267 
cancercontrolquestion@crab.org 
 
For study procedure related questions contact the SWOG Statistics and Data Management Center by 
phone or e-mail. 
For questions unrelated to patient eligibility, site requirements or data submission contact the 
CTSU Help Desk by phone or e-mail: 
 
CTSU General Information Line: 
888-823-5923 
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 
 

 
S1417CD 
 
Page 4 
 
Version Date 11/21/17 
 
 
 
SCHEMA FOR FLOW OF STUDY 
 
Cancer diagnosis* 
 
 
 
Patient consent 
Caregiver consent (optional) 
 
 
 
120 days maximum 
 
Patient completes baseline questionnaires** 
Consented caregiver completes baseline 
questionnaire** 
 
 
 
Registration *** 
 
 
 
 
 
Patient completes Month 3 questionnaires 
 
 
 
Patient completes Month 6 questionnaires 
Consented caregiver completes Month 6 questionnaire 
 
 
 
Patient completes Month 9 questionnaires 
 
 
 
Patient completes Month 12 questionnaires 
Consented caregiver completes Month 12 questionnaire 
 
 
 
Off protocol 
 
 
*  Patients must have newly diagnosed metastatic colon or rectal cancer (de novo metastatic 
diagnosis or metastatic recurrence after prior treatment for Stage I-III disease) at registration and 
be within 120 days after diagnosis. 
 
**  Patient and caregiver may complete baseline questionnaires at any time following consent. 
Questionnaires are to be submitted within 7 days after registration. Caregiver participation is 
optional. 
 
*** Systemic chemotherapy and/or systemic biologic therapy must be planned to be administered ≤ 
30 days after registration or must have been initiated ≤ 60 days prior to registration. 

 
S1417CD 
 
Page 5 
 
Version Date 11/21/17 
 
 
 
1.0 
OBJECTIVES 
 
1.1 
Primary Objective(s) 
 
To estimate the incidence of treatment-related major financial hardship over 12 months, 
among patients with newly diagnosed metastatic colorectal cancer (mCRC) treated at 
components and subcomponents of the NCI Community Oncology Research Program 
(NCORP). 
 
1.2 
Secondary Objective(s) 
 
a. 
To describe the association of major financial hardships with mCRC treatment by 
demographic factors, including age, race, marital status, employment status, and 
income. 
 
b. 
To explore whether occurrence of major financial hardship is associated with 
poorer health-related quality of life over time. 
 
c. 
To profile the magnitude and timing of treatment-related changes in patients’ 
income, assets, debt, and employment, and to quantify major out-of-pocket 
expenses during the 12 months following registration. 
 
d. 
To explore the extent to which health insurance factors (e.g. high copayments, 
deductibles, premiums, loss/change of insurance plan) are associated with major 
financial hardship and treatment non-adherence. 
 
e. 
To determine feasibility of recruiting primary caregivers and measuring caregiver 
burden and caregivers’ perceptions about cancer treatment costs. 
 
f. 
To determine the feasibility of conducting a prospective-multi-site longitudinal 
cohort study assessing financial outcomes in patients with mCRC undergoing 
treatment within the NCORP network. 
 
1.3 
Tertiary Objective 
 
To obtain objective measures of expenses, debt and credit through linkage with individual 
patient credit reports (TransUnion) at enrollment (baseline), at 6 months, and end of 
follow up (12 months). 
 
 
2.0 
BACKGROUND 
 
Rising Cancer Treatment Costs – Implications for Patients 
 
By 2015, it is expected that 20% of the United States Gross Domestic Product (GDP) will be 
spent on health care, compared with 5% of GDP in 1965. (1) Cancer treatment costs are 
expected to comprise an increasing percentage of total health care spending due, in large part, to 
the rapid adoption of expensive new drugs and diagnostics. From a societal standpoint, the 
economic sustainability of current trends in cancer spending is of increasing concern. However, 
the impact of rising cancer treatment costs on individual patients remains a largely understudied 
area in oncology. 
 
Recent reports have demonstrated that cancer patients may be at particular risk for treatment-
related financial difficulty. In a recent study using data from the 2001 to 2008 Medical Expenditure 
Panel Survey, the proportion of non-elderly insured patients reporting high out-of-pocket cost 
burdens (defined as spending more than 20% of income on health care) was greatest among 
patients with cancer (13.4%) compared to patients with and without other chronic illness (9.7% 
and 4.4%, respectively). (2) In a 2008 national survey of 930 individuals with various cancer 

 
S1417CD 
 
Page 6 
 
Version Date 11/21/17 
 
 
 
diagnoses, 25% reported depletion of savings accounts to pay for treatment and 11% reported an 
inability to pay for basic necessities such as food, heat, or housing as a result of cancer treatment 
costs. (3) 
 
Previous studies that have attempted to describe patient out-of-pocket costs have been small, 
retrospective, and have not captured the financial impact of routine use of newer, high-cost 
therapeutics. (4,5,6,7,8,9,10,11) Importantly, the degree to which various factors (e.g. age, 
employment, income, assets, health insurance cost-sharing scheme) predispose certain patients 
to treatment-related financial hardships are poorly understood. Further, lack of standardized 
financial assessments in clinical practice limits early detection of treatment-related financial 
issues. Finally, financial hardships may theoretically contribute to depression, anxiety, and poor 
treatment tolerance. Yet very little is known about the impact of financial hardships on health-
related quality of life. 
 
The development of more reliable ways to capture economically-motivated treatment non-
adherence, financial hardship, and quality of life decrements due to financial stress will be critical 
in developing interventions to address the financial consequences of cancer treatment and, in 
turn, improve the lives of cancer patients.  
 
Preliminary Data:  Fred Hutchinson Cancer Research Center/ Cancer Surveillance System Study 
 
Investigators at the Fred Hutchinson Cancer Research Center recently conducted a population-
based study of treatment-related financial changes in patients with Stage III colorectal cancer 
(CRC).  A multi-dimensional survey was administered to 550 CRC patients diagnosed between 
2008 and 2010 identified from the Western Washington Surveillance, Epidemiology, and End 
Results (SEER) registry. (12) The study questionnaire was developed through a series of 
cognitive interviews conducted at the Seattle Cancer Care Alliance.  A total of 284 patients 
responded to the mailed questionnaire, for an overall response rate of 51.2%.  A significant 
percentage of patients (38%) reported at least one treatment-related financial hardship (defined 
as:  debt accumulation, borrowing money from family/friends, ≥ 20% income decline, 
selling/refinancing primary home). In a multivariate logistic regression analysis, factors most 
closely associated with financial hardship were younger age (age < 65) and annual income < 
$50,000. Treatment non-adherence was similarly associated with younger age and lower income, 
but was also associated with unemployment, disability, or leave-of-absence from work. A minority 
of respondents (42%) reported discussing treatment-related expenses with their physicians.  
Thirty-four patients (12%) reported a total of 45 insurance coverage denials for recommended 
medications, tests, or procedures. Denials for chemotherapy (capecitabine, in most cases) and 
supportive medications (e.g. anti-emetics or pain medications) comprised 42% of all coverage 
denials. While this retrospective study is the first large population-based assessment of 
treatment-related financial consequences in CRC patients, there were many limitations to this 
approach.  In particular, there was no assessment of baseline pre-diagnosis financial information, 
timing of financial hardship in relation to diagnosis, and impact of financial hardships on quality of 
life.  In addition, non-response bias may have skewed the observed rate of financial hardship. 
 
Feasibility and Motivation for Proposed Study through the NCI Community Oncology Research 
Program (NCORP) 
 
The ultimate goal of this research is to measure the association between cancer treatment and 
financial hardship, using a comprehensive financial impact assessment tool that can be adopted 
in routine clinical care and alongside cooperative group clinical trials. By developing a system to 
track treatment-related financial changes over time and by improving our understanding of the 
major risk factors for financial hardship, we hope to set the stage for the development of 
interventions to help patients avoid major financial strain. Interventions such as comprehensive 
financial counseling, advanced planning for patient drug assistance programs, and tools to inform 
physicians about potential high copayments could help lessen patients’ treatment-related financial 
burden. The NCI Community Oncology Research Program (NCORP) represents a unique 
mechanism to accrue patients being treated in community clinical settings to cancer care delivery 
research studies.  

 
S1417CD 
 
Page 7 
 
Version Date 11/21/17 
 
 
 
 
Description of Patient Population 
 
This study will focus on patients with mCRC for several reasons. First, patient recruitment is likely 
to be more feasible in a common malignancy such as CRC compared with a rarer disease. 
Second, the FDA approval of several new, expensive CRC drugs over the last decade has 
increased the cumulative lifetime cost of CRC treatment; the degree to which these costs have 
been shifted to individual patients is poorly understood. (13) Finally, as the median survival for 
metastatic CRC continues to improve, the financial impact of chronic palliative therapy over a 
longer period of time may be significant. 
 
Inclusion of Women and Minorities 
 
This study was designed to include women and minorities, but was not designed to measure 
differences of intervention effects.  The anticipated accrual in the ethnicity/race and sex 
categories is shown in the table below.  Because several components of the questionnaire have 
only been validated in English, we will limit enrollment only to patients who can complete the 
forms in English.  Translation of the questionnaire into other languages will require testing and 
validation in a population of patients who speak the language and is outside the scope of the 
current study. 
 
Racial Categories 
Ethnic Categories 
Not Hispanic or Latino 
Hispanic or Latino 
 
Total 
Female 
Male 
Female 
Male 
American Indian/Alaska Native 
1 
1 
0 
0 
2 
Asian 
13 
15 
0 
0 
28 
Native Hawaiian or Other 
Pacific Islander 
1 
1 
0 
0 
2 
Black or African American 
20 
22 
0 
0 
42 
White  
123 
141 
17 
19 
300 
More Than One Race 
0 
0 
0 
0 
0 
Total 
158 
180 
17 
19 
374 
 
 
3.0 
ELIGIBILITY CRITERIA 
 
Each of the criteria in the following section must be met in order for a patient to be considered eligible for 
registration.  Any potential eligibility issues should be addressed to the SWOG Statistics and Data 
Management Center in Seattle at 206/652-2267 or cancercontrolquestion@crab.org prior to registration. 
NCI policy does not allow for waiver of any eligibility criterion  
(https://ctep.cancer/gov/protocolDevelopment/policies_deviations.htm). 
 
When calculating time frame for date of diagnosis, the date that the pathological diagnosis was made is 
considered Day 0.  If Day 30 or 120 falls on a weekend or holiday, the limit may be extended to the 
next working day. 
 
 
3.1 
Disease Related Criteria 
 
a. 
Patients must have newly diagnosed metastatic colon or rectal cancer (mCRC) 
(de novo metastatic diagnosis) or metastatic recurrence after prior treatment for 
Stage I-III disease and be ≤ 120 days after diagnosis at time of registration. 
 

 
S1417CD 
 
Page 8 
 
Version Date 11/21/17 
 
 
 
b. 
Systemic chemotherapy and/or systemic biologic therapy must be planned to be 
administered ≤ 30 days after registration OR must have been initiated ≤ 60 days 
prior to registration. Patients who are planning palliative or hospice care only (no 
chemotherapy or biologic therapy) are not eligible. 
 
3.2 
Clinical Criteria 
 
a. 
Patients must be at least 18 years of age. 
 
3.3 
Regulatory Criteria 
 
a. 
Registering site must be an NCORP site.  
 
NOTE:  It is recommended that patients receive medical care for the mCRC at 
the registering site to ensure accessibility of patient records.   
 
b. 
Patients must be able to complete questionnaires in English. 
 
c. 
Patients must provide their full name, primary address in the U.S., birth date and 
social security number at registration for the purposes of accessing credit report 
data. 
 
d. 
Patients must sign and give written informed consent in accordance with 
institutional and federal guidelines.  
 
e. 
As a part of the OPEN registration process (see Section 8.0 for OPEN access 
instructions) the treating institution’s identity is provided in order to ensure that 
the current (within 365 days) date of institutional review board approval for this 
study has been entered in the system. 
 
 
4.0 
INTERVENTION 
 
4.1 
Setting 
 
This study will be conducted through all NCORP components and subcomponents. 
Enrollment will be limited to these sites in order to capture the financial impact of 
treatment in community clinical practices. The infrastructure for charity care and financial 
counseling may be different in NCORP sites compared with larger comprehensive cancer 
centers and the financial experiences of patients treated at NCORP sites may be more 
representative of the financial experiences of all mCRC patients in the United States.  
 
4.2 
Screening, Consent and Patient Registration 
 
Eligible patients will be identified by the treating providers who will, together with the 
clinical research associate (CRA), describe the study and obtain written informed consent 
from eligible patients and their consenting caregivers (optional).  Refer to Section 10.0 for 
information on caregiver eligibility and administering consent and questionnaires to 
caregivers. Register the eligible, consented patient to S1417CD within 120 days after 
cancer diagnosis per Section 8.0. 
 
4.3 
Administration of Questionnaires to Patients 
 
a. 
Patients will be assessed at baseline following consent, and at subsequent 
routine clinical visits (3, 6, 9 and 12 months) following registration. (See Section 
5.0 for the list of questionnaires and time points they are to be administered.) 
Questionnaires will be self-administered and are anticipated to require 30 
minutes to one hour to complete at each study time point. 

 
S1417CD 
 
Page 9 
 
Version Date 11/21/17 
 
 
 
 
b. 
Target follow-up assessment dates should be based on the date of registration. A 
window of ± 21 days is allowed for each assessment to provide more flexibility in 
scheduling. 
 
c. 
Patients undergoing treatment for mCRC will generally be seen at the clinic or 
practice approximately every two weeks.  In order to minimize patient burden and 
streamline patient visits, it is preferable for questionnaires to be given to the 
patient at the clinical visit immediately prior to the study time point, completed at 
home and returned at the routine clinical visit coinciding with the study time point; 
however, the study staff should accommodate the patient’s preferences for filling 
out the questionnaires as described below. Some questionnaires will require 
detailed financial information so it is recommended that the CRA contact the 
patient a week before their scheduled visit to remind him/her to bring the 
appropriate information to the visit to complete the questions on the forms. At 
time of consent, the patient should be provided with a copy of the forms for 
reference. 
 
d. 
The research site should provide the patient with options for completing the 
questionnaires after the patient has reviewed them. The patient’s review may 
help them decide if they need information they do not have with them at their visit 
or they may need assistance from a family member or caregiver. The patient may 
also be more comfortable completing the questionnaire(s) at home. The options 
for the patient are as follows: 
 
 
• 
Complete 
questionnaires 
at 
home. 
Provide 
the 
patient 
with 
questionnaires in advance and instructions to return them to the site at 
the clinical visit corresponding to the study time point (e.g., give patient 
questionnaires 2 weeks in advance at a routine clinical visit). Review the 
returned questionnaires for completeness at the clinical visit and clarify 
answers while the patient is at the clinic.  If the patient does not return 
the completed questionnaires as scheduled, the patient should complete 
the questionnaires at the clinical visit or schedule a phone contact. 
 
• 
Complete the questionnaires in the clinic or practice. Due to the sensitive 
information being asked, when possible, offer the patient a private 
location to sit and complete the questionnaires. Supply additional paper, 
pencil and a calculator. One question requests the total amount of owed 
debts. The patient may need to perform some calculations to answer the 
question. After completion of the questionnaires, the CRA should 
immediately review the questionnaires for completeness and confirm the 
patient answered the questions per the directions on the form and clarify 
questions with the patient while they are still at the clinic or practice. 
 
• 
Partially complete the questionnaires in the clinic or practice. If due to 
illness, time or any reason the patient begins completing the 
questionnaires in the clinic or practice but then decides he/she cannot 
finish one or more questionnaire, make a photocopy of the incomplete 
questionnaire(s), give the patient the copy and keep the original in the 
patient’s research chart. Give the patient a pre-addressed stamped 
envelope to return the questionnaire(s) by mail to the clinic or practice, 
but also schedule a phone call with the patient 1 week later. If 
questionnaire(s) are returned (by mail or in person) within 1 week, use 
the scheduled phone call to clarify any missing or unclear responses (if 
applicable).  If questionnaire(s) are not returned, use the scheduled 
phone call to complete the questionnaire(s) by phone interview. 
 

 
S1417CD 
 
Page 10 
 
Version Date 11/21/17 
 
 
 
• 
Complete questionnaires by phone interview. If the patient is unable to 
come in for their clinical visits or questionnaires were not completed 
before or at the clinical visit, questionnaires may be completed by phone 
interview.  Phone interviews should be scheduled within 1 week of the 
clinical visit corresponding to the study time point.  The patient should be 
given a copy of blank forms (or partially-completed, if applicable) so that 
the patient may look at a copy of the questionnaires while the staff 
conducts the interview.  The date of the telephone interview is to be 
noted on the S1417CD Cover Sheet for Patient- and Caregiver-
Completed Questionnaires.  If the phone interview is to complete data on 
a partially-completed, form, review all the questions with the patient, 
even those previously completed, in case the patient needs to change a 
previously answered question.  If the phone interview is not completed 
as scheduled, reschedule to remain within the ± 21-day window for the 
study time point. 
 
 
e. 
As a general reminder, review all completed questionnaires to be sure all of the 
questions have been answered and, when the patient is directed to mark only 
one response, that only one answer is marked. If the patient has marked more 
than one answer per question, ask which answer reflects how the patient is 
feeling. If the patient has skipped a question, tell the patient that a question was 
not answered and ask if the patient would like to answer the question.  If the 
patient is unable to answer the question at the time of the visit, site staff are 
encouraged to retain the questionnaire and contact the patient by phone to 
obtain outstanding information.  If patient does not want to answer a particular 
question, the CRA will enter “Not answered by the patient” in Medidata RAVE®. 
 
f. 
Caregivers may assist patients with their questionnaires by administering the 
questionnaire orally to the patient, helping the patient find information and/or 
recording the patient’s answers.  Caregivers cannot answer for the patient. For 
patients who are too sick to complete the questionnaire (even with assistance 
from the caregiver) or who are not able to come to a clinical visit (e.g. enrolled in 
hospice care), the CRA will record on the S1417CD Cover Sheet that the patient 
was too sick to complete the questionnaire. 
 
g. 
Patients will not receive incentives (e.g. gift cards, monetary compensation) for 
participation in this study.   
 
h. 
S1417CD Cover Sheet for Patient and Caregiver-Completed Questionnaires 
 
For each time point, the nurse or CRA completes the S1417CD Cover Sheet for 
Patient and Caregiver-Completed Questionnaires. The Cover Sheet is submitted 
with the set of patient-completed forms at each scheduled assessment. The 
Cover Sheet is very important for tracking how and when the patient forms were 
completed. When a patient-completed form is not administered at a scheduled 
time point, it is important to know why the assessment did not occur; the form 
includes potential reasons for a patient not completing a form. All issues of 
noncompliance are noted on the S1417CD Cover Sheet. 
 
4.4 
Additional Quality Control Procedures: 
 
a. 
When a patient is registered on S1417CD, a calendar should be made with dates 
of upcoming patient-completed questionnaires noted. A copy of this calendar can 
be given to the patient with the notation that the questionnaires should be 
completed. You may wish to photocopy the Study Calendar (Section 5.0), and 
include the patient's name and specific dates.  Alternatively, an editable version 
of the Study Calendar is available on the S1417CD abstract page on the SWOG 

 
S1417CD 
 
Page 11 
 
Version Date 11/21/17 
 
 
 
website (http://www.swog.org) or CTSU member website (https://www.ctsu.org).  
A copy of this should be kept in the patient file.  If the patient is off the study time 
point schedule, all attempts should be made to complete the next assessment 
within the target follow-up assessment schedule per Section 4.3b and 5.0. 
 
b. 
Anyone involved in the collection of quality of life data in SWOG trials should 
review the training program available on the SWOG website accessible from 
three locations. On the SWOG Home Page (prior to member login), in the 
QUICKLINKS section on the bottom right corner of the page, there is a link to the 
Patient Reported Outcomes Training. The other two locations that the training is 
available are after SWOG member login on the CRA Workbench. The Training 
section and the New CRAs! Section both contain access to the Patient Reported 
Outcomes (PROs) training module. The training program is a narrated set of 
slides designed to standardize the way quality of life data is collected from 
patients. Questions regarding the quality of life assessments can be addressed 
to the SWOG Statistics and Data Management Center (206-652-2267). 
 
4.5 
Caregiver Questionnaires 
 
For instructions related to administration of the caregiver questionnaires, please see 
Section 10.0. 
 
4.6 
Credit Reports 
 
The patient’s full name, address, birth date, and Social Security number (SSN) will be 
used by the SWOG Statistics and Data Management Center (SDMC) to request a copy of 
the patient’s credit report at baseline, at 6 months, and at the time the patient goes off 
protocol (at 12 months or sooner if the patient discontinues participation prior to the 12 
month time point) directly from the credit report agency for research purposes. This is 
considered a “soft pull” and will not have an effect on the patient’s credit score. This 
process will occur automatically at SDMC, and beyond obtaining the patient’s name, 
address, birthdate, and SSN, no further efforts on the part of the site staff or patients is 
required for this portion of the study.  The credit report will remain confidential and will not 
be shared with the patient, treating institution/study site, insurance companies, or any 
other entities.  Funding for the acquisition of credit reports from TransUnion and the 
handling of credit reports by SDMC will come from an American Society of Clinical 
Oncology (ASCO) 2013 Career Development Award (PI Shankaran).  Patients are not 
responsible for any costs related to the credit report. 
 
4.7 
Criteria for Removal of Patient from Protocol Participation 
 
a. 
Patient completes 12 months of study participation. 
 
b. 
Patient does not receive at least one cycle of chemotherapy within the first 90 
days after registration. 
 
c. 
The patient may withdraw from the study at any time for any reason.  (Research 
staff should only submit the S1417CD Off Protocol Notice if the patient refuses 
both direct and indirect follow-up on the study. If the patient allows for indirect 
follow-up or is refusing to complete any further patient forms but will allow the site 
to follow them directly, do not submit the S1417CD Off Protocol Notice and 
continue to submit the site-completed forms at the time points required in Section 
9.4b.) 
 
d. 
Patient death. 
 
4.8 
Discontinuation of Study Participation 
 

 
S1417CD 
 
Page 12 
 
Version Date 11/21/17 
 
 
 
All reasons for discontinuation of study participation as defined in Section 4.7, including 
patient death, must be documented on the S1417CD Off Protocol Notice and submitted 
per Section 9.4c. 
 
NOTE:  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. Do not submit 
the S1417CD Off Protocol Notice. Submit the site-completed forms for the time point per 
Section 9.4b, the S1417CD Cover Sheet for Patient- and Caregiver-Completed 
Questionnaires documenting the reason the questionnaires were not completed at the 
time point and the S1417CD Follow-up Patient Status and Disease Characteristics form 
at the time point. Administer questionnaires to the patient at the next study time point. 
See also Section 4.7c for additional follow-up and forms management information. 
 
4.9 
Follow-up Period 
 
No further follow-up will be required once the patient completes 12 months of study 
participation or if the patient discontinues study participation as defined in  Sections 4.7b, 
4.7c and 4.7d prior to 12 months of participation and the S1417CD Off Protocol Notice is 
submitted. 
 

 
S1417CD 
 
Page 13 
 
Version Date 11/21/17 
 
 
 
 
5.0 
STUDY CALENDAR 
 
REQUIRED 
Prestudy/ 
Baseline 
Month 
3 
Month 
6 
Month 
9 
Month 
12 
PATIENT QUESTIONNAIRES 
 
 
 
 
 
S1417CD Baseline Questionnaire 
X 
 
 
 
 
S1417CD  Financial/Employment Impact 
Questionnaire 
 
X 
X 
X 
X 
S1417CD Insurance Impact 
Questionnaire 
 
X 
X 
X 
X 
S1417CD Quality Of Life Questionnaire 
X 
X 
X 
X 
X 
S1417CD Treatment Perceptions 
Questionnaire 
X 
X 
X 
X 
X 
 
 
 
 
 
 
CAREGIVER QUESTIONNAIRE 
 
 
 
 
 
S1417CD Caregiver Questionnaire √ 
X 
 
X 
 
X 
 
 
 
 
 
 
SITE COMPLETED FORMS 
 
 
 
 
 
S1417CD Registration Worksheet (Not 
submitted) 
X 
 
 
 
 
S1417CD Onstudy Form 
X 
 
 
 
 
S1417CD Follow-Up Patient Status and 
Disease Characteristics 
 
X 
X 
X 
X 
S1417CD Cover Sheet for Patient- and 
Caregiver- Completed Questionnaires 
X 
X 
X 
X 
X 
S1417CD Off Protocol Notice 
 
 
 
 
XΩ 
 
NOTE:  Forms are found on the protocol abstract page on the SWOG website (www.swog.org) or 
CTSU member website (https://www.ctsu.org). 
Forms submission guidelines are found in Section 9.0. 
 
√  For consenting caregivers (optional).  See Section 10.0 for administration guidelines. 
Ω If patient discontinues study participation earlier than 12 months, submit the S1417CD Off 
Protocol Notice per Section 4.8. 
 
 
6.0 
CRITERIA FOR EVALUATION AND ENDPOINT ANALYSIS 
 
6.1 
Primary Endpoint 
 
a. 
Major Financial Hardship:  Defined as one or more of the following during the 12 
month study period:  debt accumulation of any amount, selling or refinancing 
home, ≥ 20% income decline, borrowing money of any amount from 
family/friends. 
 
6.2 
Secondary Endpoints 
 
a. 
Treatment Non-Adherence:  Defined as refusing treatment or skipping doses due 
to cost concerns (e.g., lack of coverage, high co-payment requirement) 
 

 
S1417CD 
 
Page 14 
 
Version Date 11/21/17 
 
 
 
b. 
Health-related Quality of Life (HRQOL):  As measured by the EORTC Quality of 
Life Questionnaire C30 (QLQ-C30) v. 3.0. (14) This is a well-validated 
questionnaire which includes 30 items assessing global quality-of-life, functioning 
in five domains (physical, role, cognitive, emotional social) and several items 
assessing specific symptoms (e.g. fatigue, trouble sleeping, pain).  Importantly, 
the QLQ-C30 does include one item assessing the impact of medical treatment 
on finances.  Questionnaire responses will be transformed into a linear score (0 
to 100) using the EORTC scoring manual.   
 
c. 
Out-of-Pocket Expenses:  Defined as total out-of-pocket direct medical (e.g., 
prescriptions, physician visits, deductibles) and non-medical (transportation, 
meals) expenses in the 3 months prior to each study visit. 
 
d. 
Credit History (TransUnion):  Credit reports are obtained at baseline, 6 months, 
and when the patient goes off protocol and measure the following: non-mortgage 
amounts past due on credit cards and bankcards; non-mortgage credit card and 
bankcard balances; bankruptcies, liens, collections or repossessions. 
 
6.3 
Definition of Primary Caregiver 
 
a. 
Primary caregiver is defined as a family member or friend who provides the 
greatest degree of emotional, physical, logistical, and/or financial support in 
navigating cancer treatment 
 
6.4 
Questionnaires 
 
The majority of items in the final financial impact assessment tool were adapted from the 
a questionnaire used in our previous work that was successfully administered to a 
population-based sample of patients with stage III colon cancer in the Seattle/Puget 
Sound region. (15) Several questions were also adapted from the Medical Expenditures 
Panel Survey (MEPS), a large-scale survey of households, employers, and medical 
providers on the cost and use of health care in the United States and the University of 
Michigan’s Health and Retirement Study (HRS), a longitudinal panel survey of older 
adults. (16) The EORTC Quality of Life Questionnaire (QLQ C-30), an existing, validated 
quality of life instrument, will also be used to assess HRQOL. (17) Questions measuring 
caregivers’ stress and anxiety related to cancer treatment expenses were adapted from a 
questionnaire used in the Family and Cancer Therapy Selection (FACTS) Study 
conducted at the Fred Hutchinson Cancer Research Center as well as the Caregiver 
Strain Index, an existing validated survey of cancer caregiver burden. Additional 
questions were obtained from a survey-based study of caregivers performed by 
Evercare, in collaboration with the National Alliance for Caregiving, entitled “Family 
Caregivers:  What they Spend, What they Sacrifice.” (18) The final questionnaires focus 
on different aspects of patients’ or caregivers’ financial experience: 
 
BASELINE QUESTIONNAIRE: Baseline patient financial, employment, and 
insurance characteristics – education level, annual income, preexisting debt, total 
assets (including retirement and savings), baseline employment status. 
 
FINANCIAL/EMPLOYMENT IMPACT QUESTIONNAIRE:  Treatment-related financial 
or employment changes – accumulation of debt, depletion of assets, inability to pay 
other bills, changes in income, job loss, borrowing money, selling home. 
 
INSURANCE IMPACT QUESTIONNAIRE:  Treatment-related insurance issues and 
out-of-pocket expenses – insurance coverage denials, high copayments, changes in 
premiums, treatment non-adherence, all treatment-related out-of-pocket expenses. 
 
QUALITY OF LIFE QUESTIONNAIRE:  Health-related quality of life – EORTC Quality of 
Life Questionnaire (QLQ C-30)  

 
S1417CD 
 
Page 15 
 
Version Date 11/21/17 
 
 
 
 
TREATMENT PERCEPTIONS QUESTIONNAIRE:  Subjective financial burden 
assessment – which includes questions assessing stress, anxiety, and guilt related to 
cancer treatment costs as well as prioritization of treatment costs in the list of disease-
related concerns. 
 
CAREGIVER QUESTIONNAIRE:  (Consented caregiver only.) Assessment of financial 
changes made to accommodate patient’s cancer treatment expenses and subjective 
caregiver burden assessment (adapted Caregiver Strain Index), which will include 
questions assessing stress and anxiety related to patient’s cancer treatment costs as well 
as prioritization of treatment costs in the list of disease-related concerns. 
 
6.5 
Performance Status: 
 
Patients will be graded according to the Zubrod Performance Status Scale. 
 
POINT DESCRIPTION 
 
0 
Fully active, able to carry on all pre-disease performance without restriction. 
 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out 
work of a light or sedentary nature, e.g., light housework, office work. 
 
2 
Ambulatory and capable of self-care but unable to carry out any work activities; 
up and about more than 50% of waking hours. 
 
3 
Capable of limited self-care, confined to bed or chair more than 50% of waking 
hours. 
 
4 
Completely disabled; cannot carry on any self-care; totally confined to bed or 
chair, 
 
 
7.0 
STATISTICAL CONSIDERATIONS 
 
7.1 
Primary Objective 
 
The primary objective is to estimate the incidence of treatment-related major financial 
hardship (debt, selling/refinancing home, borrowing money from friends/family, ≥ 20% 
income decline) among evaluable patients with newly diagnosed metastatic colorectal 
cancer (mCRC) treated at NCORP sites. 
 
Given serial measurements, the primary endpoint is time to first evidence of major 
financial hardship.  Dropout due to death from mCRC will be a significant factor in this 
study.  Recent randomized clinical trial data have reported 1-year survival of around 60% 
for this population. (19) Therefore death represents a substantial competing risk in the 
detection of financial hardship, which is accounted for in the study design.  Both time to 
first evidence of major financial hardship and death are assumed to exhibit exponential 
decline.  Dropout for reasons other than death (e.g. transferring care to another 
institution, withdrawal of consent) following enrollment in the study is estimated to be 
around 10% based on other studies in the literature. (20,21)  Non-death related dropouts 
will be censored.   
 
Based on preliminary data, we anticipate that 40% of patients will experience major 
financial hardship at some point in the first year after diagnosis.  Estimates of major 
financial hardship at 1 year will be derived using cumulative incidence to account for 
competing risks.   
 

 
S1417CD 
 
Page 16 
 
Version Date 11/21/17 
 
 
 
Under this scenario, a sample size of n=320 eligible, evaluable patients will allow us to 
estimate the confidence interval to within ± 8% (based on the upper bound of the 95% 
confidence interval using an exact binomial in patients with complete follow-up), if the 
assumed incidence is at least 40%.  Thus this sample size will allow us to estimate the 
confidence interval to within ± 20% of the assumed incidence (the “relative accuracy”).  
The relative accuracy will improve with higher incidence as shown in the table below.  
This estimate is conservative as it is based on the assumption of no information from the 
50% of patients estimated to drop out. 
 
Assumed incidence (p) 
95% confidence interval 
about p 
Confidence 
range 
Relative accuracy 
[(95% CI upper 
bound – p)/p] 
20% 
14.1% - 27.0% 
± 7.0% 
± 35.2% 
30% 
23.0% - 37.7% 
± 7.7% 
± 25.8% 
40% 
32.3% - 48.0% 
± 8.0% 
± 20.1% 
50% 
42.0% - 58.0% 
± 8.0% 
± 16.0% 
 
Given non-restrictive eligibility criteria, we anticipate a low rate of ineligibility (5%).  In 
addition, 10% of patients are anticipated not to complete their baseline forms and will be 
inevaluable.  Therefore 374 total patients will be enrolled to obtain 320 eligible, evaluable 
patients. 
 
The total number of patients experiencing at least one financial hardship at each study 
interval will be determined.  The proportion of patients experiencing multiple financial 
hardships will also be reported. 
 
7.2 
Secondary Objectives 
 
Risk Factors for Financial Hardship 
 
Sample size calculation will be driven by the key secondary objective of this study, which 
is to assess whether major financial hardship at one year differs by age (< 65 vs. ≥ 65), 
race (white vs. non-white), marital status (married vs. unmarried), employment status 
(any employment vs. unemployed), and income (household income < $50,000 / year vs. 
≥ $50,000 / year).  In particular, we hypothesize that financial hardships are more likely in 
patients who, at diagnosis, are younger, non-white, unmarried, unemployed, or have 
lower incomes.   
 
With a series of 5 hypotheses to be tested, we account for multiple comparisons using a 
conservative Bonferroni alpha = 0.01 two-sided test for each comparison.  Three years of 
accrual with one year of follow-up is anticipated.  Based on a two-sample survival design 
accounting for the competing risk of death (40% deaths at 1 year [hazard rate of 0.51]), 
n=320 eligible, evaluable patients will give 90% power to detect an absolute difference of 
20% (that is, 30% rate at year 1 in good performing group [hazard rate 0.356] vs. 50% in 
poor performing group [hazard rate of 0.693]) in the proportion of patients with major 
financial hardship, if a ratio of patients between two groups is 1:1.  This corresponds to a 
hazard ratio of 1.95.  Power drops to 83% if the ratio of patients in subgroups is 2:1.   
 
The effect of age, race, marital status, employment status, and income on major financial 
hardship will be estimated using multivariable Cox regression.  The regression will 
include the 5 covariates of interest plus insurance status, education, and gender.  A 
sample size of 320 eligible patients ensures that the ratio of events to independent 
predictors will be at least 10:1. (22,23) 
 
 
 

 
S1417CD 
 
Page 17 
 
Version Date 11/21/17 
 
 
 
Major Financial Hardship and HRQOL: 
 
A secondary objective of this study is to assess the relationship between major financial 
hardship and HRQOL.  These factors are likely positively correlated and associated with 
the same general status of poor prognosis (endogenous factors).  Therefore, any 
analysis that evaluates, from baseline, the association of major financial hardship and 
HRQOL will find a positive correlation as an artifact of the endogeneity, and adjustment 
for performance status is unlikely to fully account for this.  Therefore we will use landmark 
analysis to establish major financial hardship as a baseline predictor of HRQOL.  In 
particular, patients will be categorized as having major financial hardship at their 3 month 
assessment (yes vs. no).  We will then use linear regression to assess whether the 3-
month assessment of financial hardship predicts the 6-month HRQOL score.  HRQOL at 
3 months will be included as an adjustment covariate.  The 6-month HRQOL score will be 
based on the EORTC QLQ-C30 questionnaire transformed into a linear score (0 to 100) 
using the EORTC scoring manual.  A difference in mean score of ≥ 10 between time 
points is considered clinically relevant.  In addition, to assess the robustness of potential 
associations between major financial hardship and HRQOL to large changes in a subset 
of patients, HRQOL at 6 months will also be categorized as decline vs. no decline and 
logistic regression performed.  This analysis is limited by the fact that patients without 6 
months follow-up scores are more likely to be worse prognosis patients that may also be 
related to predictive factors of interest (that is, age, race, marital status, employment 
status, and income).   
 
Feasibility 
 
The feasibility of successfully accruing to a prospective-multi-site longitudinal cohort 
study assessing financial outcomes in patients with metastatic colorectal cancer (mCRC) 
undergoing treatment within the NCORP network will be examined. The total anticipated 
accrual time is 3 years. To be conducted in that timeframe, each of the NCORP 
components (we anticipate 25 NCORP components) will each need to enroll, on average, 
about 5 patients per year.  Accrual will be monitored regularly.  Given the open eligibility 
criteria, we hypothesize that enrollment will be feasible. However accrual will be 
assessed at 1.5 years after study activation. If monthly average accrual in quarters 5-6 
after study registration is < 50% of projected accrual, efforts will be made to increase 
accrual over the succeeding 6 month period. If after 2 years, monthly accrual remains < 
50% of projected accrual, study revision will be considered. In order to address the 
potential for selection bias, we will compare demographics (age, race, gender, etc.) of the 
final cohort to the typical patient population seen at the various practice sites.   
 
The feasibility of incorporating a caregiver component to the study will also be examined. 
Caregiver participation is optional. The caregiver component will be considered feasible if 
the designated caregivers for > 50% of eligible patients complete and submit their 
baseline and at least one follow-up assessment.  We will use means, medians, 
proportions to describe the participating caregiver population. Our analyses will be largely 
descriptive.  We will look at the proportion of caregivers who experienced changes in 
employment and expenses (caregiver questionnaire items 11 and 13).  We expect that 
caregivers of patients who experience financial hardship will be more likely to report 
financial burden.  We will therefore investigate the association between patient-reported 
financial hardship and level of caregiver-reported financial burden.  We will compare 
proportion of caregivers experiencing ‘high financial burden’ (≥ 3 on Likert scale) for 
patients who do vs. do not report major financial hardship using two-sample t tests. If our 
caregiver accrual is very poor (<20%), we will focus on describing the patient population 
rather than attempting to correlate caregiver and patient responses. 
 
7.3 
Other Secondary Endpoints: 
 
The linkage of clinical and financial data with credit histories obtained from TransUnion 
will allow us to explore additional indicators of financial stress, including high balances 

 
S1417CD 
 
Page 18 
 
Version Date 11/21/17 
 
 
 
and past due amounts of credit card and bankcards as well as evidence of bankruptcies, 
liens, and collections or repossessions.  These data will also allow us to corroborate self-
reports of debt and bankruptcy in order to investigate the reliability of self-reports in 
estimating financial hardship. Credit reports will be obtained at baseline and at 6 and 12 
months after registration.  Given the poor 1-year survival for this patient cohort (60%), 
multiple post-baseline credit reports are requested to limit bias due to missing data 
related to death. 
 
Other secondary objectives including measurement of out-of-pocket expenses, health 
insurance changes, changes in assets/income/wealth, measurement of debt and 
spending by credit report histories, and assessment of patient, caregiver, and bereaved 
caregiver financial stress will be handled using descriptive statistics (e.g. mean, median, 
proportions).  We will use descriptive statistics to summarize baseline patient 
characteristics and will compare populations using two-sample means and proportions 
tests (α level 0.05).  Caregiver strain index will be scored based on responses (score 
range 0 to 26).  Mean scores will be compared for caregivers of patients reporting vs. not 
reporting at least one financial hardship. 
 
7.4 
Data and Safety Monitoring Committee 
 
There is no formal data and safety monitoring committee for this study.  Monitoring of 
study conduct and accrual for feasibility will be performed routinely by the Study 
Coordinator, Study Statistician, and the Disease Committee Chair.  Accrual reports are 
generated weekly. 
 
 
8.0 
REGISTRATION GUIDELINES 
 
8.1 
Registration Timing 
 
Registration must be within 120 days after diagnosis of metastatic colorectal cancer.  
Treatment must start ≤ 30 days after registration or must have been initiated ≤ 60 days 
prior to registration. 
 
8.2 
Investigator/Site Registration  
 
Prior to the recruitment of a patient for this study, investigators must be registered 
members of a NCTN Group.  Each investigator must have an NCI investigator number 
and must maintain an “active” investigator registration status through the annual 
submission of a complete investigator registration packet to CTEP. 
 
a. 
CTEP Investigator Registration Procedures 
 
Food and Drug Administration (FDA) regulations and National Cancer Institute 
(NCI) policy require all investigators participating in any NCI-sponsored clinical 
trial to register and to renew their registration annually. 
 
Registration requires the submission of: 
 
• 
a completed Statement of Investigator Form (FDA Form 1572) with an 
original signature 
• 
a current Curriculum Vitae (CV) 
• 
a completed and signed Supplemental Investigator Data Form (IDF) 
• 
a completed Financial Disclosure Form (FDF) with an original 
signature 
 
Fillable PDF forms and additional information can be found on the CTEP website 
at <http://ctep.cancer.gov/investigatorResources/investigator_registration.htm>.   

 
S1417CD 
 
Page 19 
 
Version Date 11/21/17 
 
 
 
 
For questions, please contact the CTEP Investigator Registration Help Desk 
by email at <pmbregpend@ctep.nci.nih.gov>. 
 
b. 
CTEP Associate Registration Procedures 
 
The Cancer Therapy Evaluation Program (CTEP) Identity and Access 
Management (IAM) application is a web-based application intended for use by 
both Investigators (i.e., all physicians involved in the conduct of NCI-sponsored 
clinical trials) and Associates (i.e., all staff involved in the conduct of NCI-
sponsored clinical trials). 
 
Associates will use the CTEP-IAM application to register (both initial registration 
and annual re-registration) with CTEP and to obtain a user account. 
 
Investigators will use the CTEP-IAM application to obtain a user account only. 
(See CTEP Investigator Registration Procedures above for information on 
registering with CTEP as an Investigator, which must be completed before a 
CTEP-IAM account can be requested.) 
 
An active CTEP-IAM user account will be needed to access all CTEP and CTSU 
(Cancer Trials Support Unit) websites and applications, including the CTSU 
members’ website. 
 
Additional 
information 
can 
be 
found 
on 
the 
CTEP 
website 
at 
<http://ctep.cancer.gov/branches/pmb/associate_registration.htm>.  
For 
questions, please contact the CTEP Associate Registration Help Desk by 
email at <ctepreghelp@ctep.nci.nih.gov>. 
 
c. 
CTSU Registration Procedures 
 
This study is supported by the NCI Cancer Trials Support Unit (CTSU), but it is 
not under the purview of the DCP CIRB. 
 
1. 
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: an active Federal Wide Assurance (FWA) 
number, an active roster affiliation with the Lead Network or a 
participating organization, a valid IRB approval, and compliance with all 
protocol specific requirements. 
 
2. 
Downloading Site Registration Documents:   
 
Site registration forms may be downloaded from the S1417CD 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 SWOG link to expand, then select trial protocol 

 
S1417CD 
 
Page 20 
 
Version Date 11/21/17 
 
 
 
S1417CD 
• 
Click on LPO Documents, select the Site Registration documents 
link, and download and complete the forms provided. 
 
3. 
Requirements For S1417CD Site Registration: 
 
• 
CTSU IRB Certification 
• 
CTSU IRB/Regulatory Approval Transmittal Sheet 
 
4. 
Submitting Regulatory Documents: 
 
Submit 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 1100 
Philadelphia, PA 19103 
 
Institutions with patients waiting that are unable to use the Portal should 
alert the CTSU Regulatory Office immediately at 866-651-2878 in order 
to receive further instruction and support. 
 
5. 
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 at the top of your screen 
• 
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 as 
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. 
 
8.3 
OPEN Registration Requirements 
 
The individual registering the patient must have completed the appropriate SWOG 
Registration Worksheet.  The completed form must be referred to during the registration 
but should not be submitted as part of the patient data. 
 
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 at < https://eapps-
ctep.nci.nih.gov/iam/index.jsp >) and a 'Registrar' role on either the LPO or participating 
organization roster. 
 

 
S1417CD 
 
Page 21 
 
Version Date 11/21/17 
 
 
 
OPEN will also ask additional questions that are not present on the SWOG Registration 
Worksheet.  The individual registering the patient must be prepared to provide answers to 
the following questions: 
 
a. 
Institution CTEP ID 
 
b. 
Protocol Number 
 
c. 
Registration Step 
 
d. 
Treating Investigator 
 
e. 
Cooperative Group Credit 
 
f. 
Credit Investigator 
 
g. 
Patient Name (full name is required for this study) 
 
h. 
Patient’s Date of Birth (required for this study) 
 
i. 
Patient SSN (SSN is required for this study.  Do not enter invalid numbers.) 
 
j. 
Country of Residence 
 
k. 
Patient address (required for this study) 
 
l. 
ZIP Code 
 
m. 
Gender (select one): 
• 
Female Gender 
• 
Male Gender 
 
n. 
Ethnicity (select one): 
• 
Hispanic or Latino 
• 
Not Hispanic or Latino 
• 
Unknown 
 
o. 
Method of Payment (select one): 
• 
Private Insurance 
• 
Medicare 
• 
Medicare and Private Insurance 
• 
Medicaid 
• 
Medicaid and Medicare 
• 
Military or Veterans Sponsored NOS 
• 
Military Sponsored (Including Champus & Tricare) 
• 
Veterans Sponsored 
• 
Self Pay (No Insurance) 
• 
No Means of Payment (No Insurance) 
• 
Other 
• 
Unknown 
 
p. 
Race (select all that apply): 
• 
American Indian or Alaska Native 
• 
Asian 
• 
Black or African American 
• 
Native Hawaiian or other Pacific Islander 
• 
White 
• 
Unknown 

 
S1417CD 
 
Page 22 
 
Version Date 11/21/17 
 
 
 
 
8.4 
Registration Procedures 
 
a. 
All site staff will use OPEN to enroll patients to this study.  OPEN is integrated 
with the CTSU Enterprise System for regulatory and roster data and, at the time 
of patient registration, 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, or from the OPEN Patient 
Registration link on the SWOG CRA Workbench. 
 
b. 
Prior to accessing OPEN site staff should verify the following: 
 
• 
All eligibility criteria have been met within the protocol stated timeframes 
and the affirmation of eligibility on the Registration Worksheet has been 
signed 
by 
the 
registering 
investigator 
or 
another 
investigator 
designate. Site staff should refer to Section 3.0 to verify eligibility. 
 
• 
All patients have signed an appropriate consent form and HIPAA 
authorization form (if applicable). 
 
• 
The study site is listed as “approved” in the CTSU RSS. 
 
c. 
Access requirements for OPEN: 
 
• 
Site staff will need to be registered with CTEP and have a valid and 
active CTEP-IAM account. This is the same account (user ID and 
password) used for the CTSU members' web site.  Additional information 
about 
obtaining 
a 
CTEP-IAM 
account 
can 
be 
found 
at 
http://ctep.cancer.gov/branches/pmb/associate_registration.htm.  
Questions should be directed to the CTEP Associate Registration Help 
Desk by e-mail at ctepreghelp@ctep.nci.nih.gov. 
 
• 
To perform registrations, the site user must have been assigned the 
'Registrar' role on the SWOG roster: 
 
1 
If you are a SWOG member, to perform registrations on SWOG 
protocols you must have an equivalent 'Registrar' role on the 
SWOG roster.  Role assignments are handled through SWOG. 
 
Note:  The OPEN system will provide the site with a printable confirmation of 
registration and treatment information.   Please print this confirmation for your 
records. 
 
d. 
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. 
 
8.5 
Exceptions to SWOG registration policies will not be permitted. 
 
a. 
Patients must meet all eligibility requirements. 
 
b. 
Institutions must be identified as approved for registration. 
 
c. 
Registrations may not be cancelled. 

 
S1417CD 
 
Page 23 
 
Version Date 11/21/17 
 
 
 
 
 
9.0 
DATA SUBMISSION SCHEDULE 
 
9.1 
Data Submission Requirements 
 
Data must be submitted according to the protocol requirements for ALL patients 
registered, including patients deemed to be ineligible.  Patients for whom documentation 
is inadequate to determine eligibility will generally be deemed ineligible. If the caregiver 
consented, submit the Caregiver Questionnaire under the patient’s SWOG ID number in 
Rave®. 
 
9.2 
Master Forms 
 
Master forms can be found on the protocol abstract page on the SWOG website 
(www.swog.org) as well as the S1417CD page of the CTSU members’ website 
(www.ctsu.org) and (with the exception of the sample consent form and the Registration 
Worksheet) must be submitted on-line via the Web; see Section 9.3 for details. 
 
9.3 
Data Submission Procedures 
 
a. 
Data collection for this study will be done exclusively through the Medidata 
Rave® clinical data management 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, 
you must have an active CTEP-IAM account (check at https://eapps-
ctep.nci.nih.gov/iam/index.jsp) and the appropriate Rave role (Rave CRA, Read-
Only, Site Investigator) on either the LPO or participating organization roster at 
the enrolling site. 
 
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 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 888/823-5923 or by e-mail at ctsucontact@westat.com. 
 
b. 
You may also access Rave® via the SWOG CRA Workbench via the SWOG 
website (www.swog.org). 
 
For 
difficulties 
with 
the 
CRA 
Workbench, 
please 
email 
technicalquestion@crab.org. 
 
9.4 
Data Submission Timeline 
 
a. 
WITHIN 7 DAYS AFTER REGISTRATION: 

 
S1417CD 
 
Page 24 
 
Version Date 11/21/17 
 
 
 
 
Submit the following site completed form: 
 
S1417CD Onstudy Form 
 
S1417CD Cover Sheet for Patient and Caregiver-Completed Questionnaires 
 
Submit the following patient-completed questionnaires: 
 
S1417CD Baseline Questionnaire 
 
S1417CD Quality Of Life Questionnaire 
 
S1417CD Treatment Perceptions Questionnaire 
 
Submit the following caregiver-completed questionnaire: 
 
S1417CD Caregiver Questionnaire (if caregiver consented) 
 
 
b. 
WITHIN 7 DAYS AFTER PATIENT COMPLETES QUESTIONNAIRE* AT 
MONTHS 3, 6, 9 AND 12 STUDY TIMEPOINTS: 
 
*  
A +/- 21-day window is permitted for administration of patient and 
caregiver follow-up questionnaires.  See Sections 4.3b and 10.2b. 
 
Submit the following site-completed forms: 
 
S1417CD Follow-Up Patient Status and Disease Characteristics 
 
S1417CD Cover Sheet for Patient and Caregiver-Completed Questionnaires 
 
NOTE:  If a patient cannot or refuses to complete forms at a specific time point, 
the site-completed forms must still be submitted. Refer to Sections 4.7c and 4.8. 
 
Submit the following patient-completed forms: 
 
S1417CD Financial/Employment Impact Questionnaire  
S1417CD Insurance Impact Questionnaire 
 
S1417CD Quality Of Life Questionnaire 
 
S1417CD Treatment Perceptions Questionnaire 
 
Submit the following caregiver-completed form: 
 
S1417CD Caregiver Questionnaire (at months 6 and 12 only, if caregiver 
consented)  
 
c. 
WITHIN 
7 
DAYS 
AFTER 
PATIENT 
DISCONTINUES 
PROTOCOL 
PARTICIPATION: 
 
Submit the following patient-completed form: 
 
S1417CD Off Protocol Notice 
 
NOTE: The S1417CD Off Protocol Notice is submitted to reflect the patient’s 
participation status only.  If the consented caregiver discontinues study 

 
S1417CD 
 
Page 25 
 
Version Date 11/21/17 
 
 
 
participation prior to the patient’s completion of 12 months of study participation, 
refer to Section 10.3 for instructions for reporting caregiver discontinuation on the 
S1417CD Cover Sheet for Patient and Caregiver-Completed Questionnaires. 
 
 
10.0 
SPECIAL INSTRUCTIONS 
 
Instructions for Sites Related to Caregivers 
 
10.1 
Caregiver Eligibility and Consent 
 
a. 
The caregiver must be a family member or friend who provides the greatest 
degree of emotional, physical, logistical, and/or financial support in navigating 
cancer treatment. 
 
b. 
Caregiver participation is optional; however, the caregiver must provide separate 
written informed consent if they choose to participate. 
 
c. 
The caregiver must be present during the patient consent process at the time the 
study is explained to the patient and the caregiver must provide consent at the 
same time the patient consents for the study. 
 
d. 
Caregiver participation status is required at the time of patient registration. 
 
e. 
The same caregiver must be retained throughout the study.  If the caregiver 
discontinues participation, a new caregiver may not be recruited to complete the 
Caregiver Questionnaire(s). 
 
10.2 
Administration of Questionnaires to Caregivers 
 
a. 
Caregivers will be asked to fill out the S1417CD Caregiver Questionnaire at 
baseline (following consent), and subsequently at 6 and 12 months following 
patient registration. The questionnaire will be self-administered and is anticipated 
to require a total of 30 minutes to complete at each study time point, by phone or 
by mail. The caregiver should be asked to complete the Caregiver Questionnaire 
even if the patient does not complete the patient questionnaires at the time point. 
Upon patient death, the caregiver’s participation will discontinue and no further 
Caregiver Questionnaires are required. 
 
b. 
It is preferable for the caregiver to complete the Caregiver Questionnaire during 
the patient’s routine clinical visits coinciding with the appropriate study time point; 
however, the study staff should defer to the caregiver’s preferences for 
completing the questionnaires. Questionnaires may be done at home and mailed 
back to the research staff. Target follow-up assessments should be based on the 
date of patient registration. A window of + 21 days is allowed for each 
assessment to provide more flexibility in scheduling. 
 
c. 
If the caregiver prefers to mail it back, the research site will provide a pre-
addressed stamped envelope.  If the caregiver prefers to answer the 
questionnaire over the phone, research staff will make arrangements for a phone 
interview. When responses are obtained via phone interview, it is important that 
the caregiver is looking at a copy of the questionnaire while the staff conducts the 
interview. The date of the telephone interview is to be recorded on the Caregiver 
Questionnaire. 
 
d. 
It is very important to review the completed questionnaire with the caregiver 
during the clinic visit or over the phone to be sure all of the questions have been 
answered and, when the caregiver is directed to mark only one response, that 

 
S1417CD 
 
Page 26 
 
Version Date 11/21/17 
 
 
 
only one answer is marked. If the caregiver has marked more than one answer 
per question, ask them which answer reflects how he/she is feeling. If the 
caregiver has skipped a question, bring it to their attention and ask if they would 
like to answer the question.  If the caregiver does not want to answer a particular 
question, the CRA will enter “Not answered by the caregiver” in Medidata 
RAVE®. 
 
10.3 
Criteria for Removal for Consented Caregiver from Study Participation 
 
a. 
Caregiver completes 12 months of study participation. 
 
b. 
Patient death. 
 
c. 
Patient removed from protocol participation (see Section 4.7). 
 
d. 
The caregiver may withdraw from the study at any time for any reason.  The 
patient will continue participation even if the consented caregiver discontinues 
study participation. 
 
NOTE:  If the patient is alive cannot or refuses to complete questionnaires at a 
study time point, but remains on protocol, the caregiver will continue to complete 
the Caregiver Questionnaire at the study time points. 
 
e. 
If the Caregiver Questionnaire is not completed at a time point, document the 
reason on the S1417CD Cover Sheet for Patient and Caregiver-Completed 
Questionnaires for that time point.  If the caregiver discontinues study 
participation prior to 12 months, document the reason on all cover sheet 
submissions for the remaining time points the patient continues study 
participation. 
 
 
11.0 
ETHICAL AND REGULATORY CONSIDERATIONS 
 
The following must be observed to comply with Food and Drug Administration regulations for the 
conduct and monitoring of clinical investigations; they also represent sound research practice: 
 
Informed Consent 
 
The principles of informed consent are described by Federal Regulatory Guidelines (Federal 
Register Vol. 46, No. 17, January 27, 1981, part 50) and the Office for Protection from Research 
Risks Reports:  Protection of Human Subjects (Code of Federal Regulations 45 CFR 46).  They 
must be followed to comply with FDA regulations for the conduct and monitoring of clinical 
investigations. 
 
Institutional Review 
 
This study must be approved by an appropriate institutional review committee as defined by 
Federal Regulatory Guidelines (Ref. Federal Register Vol. 46, No. 17, January 27, 1981, part 56) 
and the Office for Protection from Research Risks Reports:  Protection of Human Subjects (Code 
of Federal Regulations 45 CFR 46). 
 
Monitoring 
 
This study will be monitored by the Clinical Data Update System (CDUS) Version 3.0.  
Cumulative CDUS data will be submitted quarterly to CTEP by electronic means.  Reports are 
due January 31, April 30, July 31 and October 31. 

 
S1417CD 
 
Page 27 
 
Version Date 11/21/17 
 
 
 
 
Adverse Experiences 
 
There is no SAE Reporting for this study. 
 
 
12.0 
BIBLIOGRAPHY 
 
1  
Meropol NJ, Schulman KA. Cost of cancer care: issues and implications. J ClinOncol. 25(2): p. 
180-6, 2007. 
 
2  
Bernard DS, Farr SL. Fang Z. National Estimates of Out-of-Pocket Health Care Expenditure 
Burdens Among Nonelderly Adults With Cancer: 2001 to 2008. J Clin Oncol, 2011. 
 
3  
Kaiser Family Foundation., Employer Health Benefits 2008 Annual Survey. Accessed February 
2012 at following URL: http://ehbs.kff.org/pdf/7790.pdf. 
 
4  
Arozullah AM, et al.. The financial burden of cancer: estimates from a study of insured women 
with breast cancer. J Support Oncol, 2(3): p. 271-8, 2004. 
 
5  
Finkelstein EA, et al. The personal financial burden of cancer for the working-aged population. 
Am J Manag Care, 15(11): p. 801-6, 2009. 
 
6  
Jayadevapp, R, et al. The burden of out-of-pocket and indirect costs of prostate cancer. Prostate, 
70(11): p. 1255-64, 2010. 
 
7  
Kilgore ML, Goldman SL. Drug costs and out-of-pocket spending in cancer clinical trials. 
ContempClin Trials, 29(1): p. 1-8, 2008. 
 
8  
Langa KM, et al. Out-of-pocket health-care expenditures among older Americans with cancer. 
Value Health, 7(2): p. 186-94, 2004. 
 
9  
Longo CJ, et al. An examination of cancer patients' monthly 'out-of-pocket' costs in Ontario, 
Canada. Eur J Cancer Care (Engl), 16(6): p. 500-7, 2007. 
 
10  
Markman M, Luce R Impact of the cost of cancer treatment: an internet-based survey. J 
OncolPract, 6(2): p. 69-73, 2010. 
 
11  
Thorpe KE, Howard D. Health insurance and spending among cancer patients. Health Aff 
(Millwood), Suppl Web Exclusives: p. W3-189-98, 2003. 
 
12  
Shankaran V, et al. Risk Factors for Financial Hardship in Patients Receiving Adjuvant 
Chemotherapy for Colon Cancer: A Population-Based Exploratory Analysis. J Clin Oncol, 2012. 
epub March 12, 2012. 
 
13  
Schrag D. The price tag on progress--chemotherapy for colorectal cancer. N Engl J Med, 351(4): 
p. 317-9, 2004. 
 
14  
Aaronson NK, et al. The European Organization for Research and Treatment of Cancer QLQ-
C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer 
Inst, 85(5): p. 365-76, 1993. 
 
15  
Shankaran V, et al. Risk Factors for Financial Hardship in Patients Receiving Adjuvant 
Chemotherapy for Colon Cancer: A Population-Based Exploratory Analysis. J Clin Oncol, 2012. 
epub March 12, 2012. 
 
16  
Agency for Healthcare Research and Quality.  Medical Expenditure Panel Survey (MEPS).  
Accessed January 2013 at:  http://meps.ahrq.gov/mepsweb/. 

 
S1417CD 
 
Page 28 
 
Version Date 11/21/17 
 
 
 
 
 
17  
Aaronson NK, et al. The European Organization for Research and Treatment of Cancer QLQ-
C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer 
Inst, 85(5): p. 365-76, 1993. 
 
18  
Evercare® Study “Family Caregivers:  What they Spend, What they Sacrifice.” Finding from a 
National Survey in collaboration with the National Alliance for Caregiving, November 2007. 
 
19  
Giantonio BJ, et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin 
(FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern 
Cooperative Oncology Group Study E3200. J Clin Oncol, 25(12): p. 1539-44, 2007. 
 
20  
Biazevic MG, et al, Survival and quality of life of patients with oral and oropharyngeal cancer at 1-
year follow-up of tumor resection. J Appl Oral Sci, 18(3): p. 279-84, 2010. 
 
21  
Huybrechts I, et al. Inventory of experiences from national/regional dietary monitoring surveys 
using EPIC-Soft. Eur J Clin Nutr, 65 Suppl 1: p. S16-28, 2011. 
 
22  
Bartlett II JE, Kotrlik J, Chadwick CH. Organizational Research:  Determining Appropriate Sample 
Size in Survey Research. Information Technology, Learning, and Performance Journal, 19(1): p. 
43-50, 2001. 
 
23  
Collett D. Modelling binary data. 2nd ed. Chapman & Hall/CRC texts in statistical science series. 
Boca Raton: Chapman & Hall/CRC. p. 387, 2003. 
 
 

 
 
 
S1417CD 
 
Page 1 
 
Version Date 11/21/17 
 
 
 
 
Informed Consent Model for S1417 
   
*NOTES FOR LOCAL INSTITUTION INFORMED CONSENT AUTHORS:  
 
This model informed consent form has been reviewed by the DCTD/NCI and is the official 
consent document for this study. Local IRB changes to this document are allowed.  (Institutions 
should attempt to use sections of this document that are in bold type in their entirety.)  Editorial 
changes to these sections may be made as long as they do not change information or intent.  If 
the institutional IRB insists on making deletions or more substantive modifications to the risks or 
alternatives sections, they may be justified in writing by the investigator and approved by the 
IRB.  Under these circumstances, the revised language, justification and a copy of the IRB 
minutes must be forwarded to the SWOG Operations Office for approval before a patient may be 
registered to this study.   
 
Please particularly note that the questions related to banking of specimens for future study 
are in bolded type and may not be changed in any way without prior approval from the 
SWOG Operations Office. 
Readability Statistics:   
 
Flesch Reading Ease  
_56.1___   (targeted above 55) 
Flesch-Kincaid Grade Level  _9.5   (targeted below 8.5) 
 
• 
Instructions and examples for informed consent authors are in [italics].  
• 
A blank line,  __________, indicates that the local investigator should provide the 
appropriate information before the document is reviewed with the prospective 
research participant.  
• 
The term "study doctor" has been used throughout the model because the local 
investigator for a cancer treatment trial is a physician.   If this model is used for a 
trial in which the local investigator is not a physician, another appropriate term 
should be used instead of "study doctor".  
• 
The dates of protocol updates in the header and in the text of the consent is for 
reference to this model only and should not be included in the informed consent 
form given to the prospective research participant.  
• 
The local informed consent must state which parties may inspect the research 
records. This includes the NCI, the drug manufacturer for investigational studies, 
any companies or grantors that are providing study support (these will be listed in 
the protocol's model informed consent form) and SWOG.  
 
"SWOG" must be listed as one of the parties that may inspect the research records 
in all protocol consent forms for which patient registration is being credited to 
SWOG.  This includes consent forms for studies where all patients are registered 
directly through the SWOG Data Operations Office, all intergroup studies for 

 
S1417CD 
 
Page 2 
 
Version Date 11/21/17 
 
 
 
which the registration is being credited to SWOG (whether the registration is 
through the SWOG Data Operations Office or directly through the other group), as 
well as consent forms for studies where patients are registered via CTSU and the 
registration is credited to SWOG. 
 
• 
When changes to the protocol require revision of the informed consent document, 
the IRB should have a system that identifies the revised consent document, in order 
to preclude continued use of the older version and to identify file copies.  An 
appropriate method to identify the current version of the consent is for the IRB to 
stamp the final copy of the consent document with the approval date.  The stamped 
consent document is then photocopied for use.  Other systems of identifying the 
current version of the consent such as adding a version or approval date are allowed 
as long as it is possible to determine during an audit that the patient signed the most 
current version of the consent form.  
 
*NOTES FOR LOCAL INVESTIGATORS:  
• 
The goal of the informed consent process is to provide people with sufficient information 
for making informed choices about participating in research. The consent form provides 
a summary of the study, of the individual's rights as a study participant, and documents 
their willingness to participate. The consent form is, however, only one piece of an 
ongoing exchange of information between the investigator and study participant. For 
more information about informed consent, review the "Recommendations for the 
Development of Informed Consent Documents for Cancer Clinical Trials" prepared by 
the Comprehensive Working Group on Informed Consent in Cancer Clinical Trials for 
the National Cancer Institute. The Web site address for this document is 
http://cancer.gov/clinicaltrials/understanding/simplification-of-informed-consent-docs/ 
 
• A blank line, “__________”, indicates that the local investigator should provide the 
appropriate information before submitting to the IRB. 
 
*These notes for investigators are instructional and should not be included in the consent form 
sent to IRBs. 
 
 
 
 
 
 
 

 
S1417CD 
 
Page 3 
 
Version Date 11/21/17 
 
 
 
Consent Form 
 
Study Title for Study Participants: 
Impact of Cancer on Finances 
 
Official Study Title for Internet Search on http://www.ClinicalTrials.gov: 
S1417, “Implementation of a Prospective Financial Impact  
Assessment Tool in Patients with Metastatic Colorectal Cancer”. 
 
Why is this study being done? 
 
Studies have shown that cancer patients may be at high risk for financial problems because of the 
cost of treatment.  These financial problems can be stressful and sometimes might cause patients 
to avoid or refuse treatment. We want to measure how often financial problems happen in 
patients with colorectal cancer, using questionnaires that collect information about finances and 
quality of life.  In order to get a full picture of the financial impact of colorectal cancer, we also 
want to collect credit reports for all patients in this study.  
 
You have been asked to participate in this study because you have colorectal cancer. This 
research does not involve medical treatment.  Our findings will hopefully help us to better 
understand the financial impact of cancer and come up with ways to help patients avoid financial 
problems during treatment. Your participation is very important to this study. 
 
There will be about 374 people taking part in this study. 
 
What is the usual approach to use of medical information for research? 
 
Hospitals or doctor’s offices usually use a “Release of Medical Information” form to get medical 
information from patients.  For this study, we are using a consent form that describes what type 
of information we want from your medical records.  Your signing the consent form gives us 
permission to use this information from your medical records along with your answers to the 
questionnaires for research. 
 
What are my other choices if I do not take part in this study? 
 
Your decision to participate (or not to participate) in this research study will NOT affect your 
cancer treatment. If you decide not to take part in this research study, you have other choices. For 
example: 
 
• You can get treatment for your cancer without being on a study 
• You may choose to take part in a different study, if one is available 
  
 

 
S1417CD 
 
Page 4 
 
Version Date 11/21/17 
 
 
 
How long will I be in this study? 
 
You will be in the study for 12 months. 
 
What is involved? 
 
If you agree to take part in the study, you agree to answer questionnaires at the following times: 
 
• on the day you agree to be in the study (baseline) 
• 3 months after entering the study 
• 6 months after entering the study 
• 9 months after entering the study 
• 12 months after entering the study 
  
It may take between 30 and 60 minutes to answer each questionnaire.  You will have the option 
to fill out the questionnaires during the clinic visit, at home, or over the phone.  If you fill out the 
questionnaire at home, you can either mail it back to the research staff using a pre-addressed 
stamped envelope that we will provide, or you can bring it with you the next time you come into 
clinic for an appointment. The research staff will work with you to find the easiest option for 
you. 
 
We will obtain the following information, directly from you (through questionnaires) or from 
your medical record.  
 
• Basic information about you (e.g., gender and race) and your cancer (e.g., names of 
chemotherapy drugs you will receive) from the medical record. 
• Information about your health insurance and finances (e.g., household income, home 
value, assets) from the questionnaire. 
• Information about your physical and emotional health from the questionnaire. 
• Information about changes in health insurance or finances after cancer (for instance 
changes in work, income, expenses).  
• Your full name, social security number, address and date of birth in order to obtain your 
credit report. (This will be obtained from both the questionnaire and medical record.) 
 
A company has been contracted to give us your credit reports for research purposes at the time 
you agree to participate in this study, at 6 months, and again at the time your study participation 
has ended at 12 months (or sooner, if you come off study earlier for any reason). (11/21/17) You 
will need to provide your full name, date of birth, address and social security number in order for 
us to get your credit report.  Your social security number will only be seen by research staff who 
will enter your number into the database, however, it will not be used for any other purpose 
besides obtaining credit reports. (Revised 6/20/16) The credit reports will remain private and will 
not be shared with you, the treating institution/research office, insurance companies or any other 
parties. 
 

 
S1417CD 
 
Page 5 
 
Version Date 11/21/17 
 
 
 
You will also be asked to identify a primary caregiver (the family member or friend who 
provides the most support to you during your cancer treatment).  
 
Your caregiver will also be asked to fill out a questionnaire at the time you agree to participate in 
the study, and again 6 months and 12 months.  The caregiver questionnaires will ask for their 
point of view about treatment, finances and caregiver duties. The primary caregivers’ 
participation is optional; you can still take part in the study even if your primary caregiver says 
“no” to filling out the questionnaires. 
 
What extra tests and procedures will I have if I take part in this study? 
 
No extra testing or procedures are needed for participation in this study. 
 
What are the possible risks of taking part in this study? 
 
You may feel uncomfortable being asked about your finances or physical and emotional health.  
 
We have procedures in place to protect your personal information and we will do our best to 
make sure that the personal information used for this study will be kept private.  However, we 
cannot guarantee total privacy. Your financial information (answers to the questionnaires and 
credit reports) will not be disclosed and cannot be required to be given out by law. If information 
from this study is published or presented at scientific meetings, your name and other personal 
information will not be used.  
 
To help make sure your information remains private, study staff will use a secure electronic 
submission program (Meditata Rave) approved by the National Cancer Institute (NCI) to send us 
your information.  All data collected during this study will be kept in a password protected, 
secure, firewalled (blocks unauthorized access) database at the SWOG Statistical and Data 
Management Center (SDMC).  Personal information including your name, address, and social 
security number will be used for the purpose of obtaining your credit report.  Your personal 
information and credit report will be sent to the SWOG SDMC via a secure, coded (encrypted) 
transmission.  A minimum number of authorized staff will be given access to this data.  Specific 
information will be pulled from the credit reports and included in the study database.  Your 
personal information including your name, address, and social security number will not be 
shared with investigators who are analyzing the data or reporting results. The pulling of your 
credit report for this study will not affect your credit score. 
 
What are the possible benefits of taking part in this study? 
 
The information you provide will help us to better understand the financial impact of cancer and 
come up with ways to help other patients like yourself avoid financial problems during 
treatment. 
 
 

 
S1417CD 
 
Page 6 
 
Version Date 11/21/17 
 
 
 
 
Can I stop taking part in this study? 
 
Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let 
the study doctor know as soon as possible. If you stop, you can decide whether or not to let the 
study doctor continue to provide your medical information to the organization running the study. 
 
What are my rights in this study? 
 
Taking part in this study is your choice. No matter what decision you make, and even if your 
decision changes, there will be no penalty to you. You will not lose medical care or any legal 
rights. 
 
For questions about your rights while in this study, call the ________________________ (insert 
name of center) Institutional Review Board at __________________ (insert telephone number). 
(Note to Local Investigator: Contact information for patient representatives or other individuals 
at a local institution who are not on the IRB or research team but take calls regarding clinical 
trial questions can also be listed here.) 
 
What are the costs of taking part in this study? 
 
There are no costs for participating in the study.  You do not have to pay for credit reports. We 
will coordinate our research with your other medical appointments so that you do not need to 
make separate trips to the clinic for this study.  The research staff will provide a stamped 
envelope if you choose to return questionnaires by mail. If you choose to do the questionnaire 
over the phone, the study staff will call you so that you do not incur long distance phone charges 
(if this applies to you). 
 
What happens if I am injured or hurt because I took part in this study? 
 
There will be little risk of being injured on this study since it does not involve medical treatment. 
 
Who will see my study information? 
 
Your privacy is very important to us and the researchers will make every effort to protect it. 
Researchers will do their best to make sure that any information that is released will not identify 
you. Some of your health information from this study will be kept in a central database for 
research. Your name or contact information will not be put in the database. 
 
There are organizations that may inspect your medical records. These organizations are required 
to make sure your information is kept private, unless required by law to provide information. 
Some of these organizations are: 
• The study sponsor, SWOG. 

 
S1417CD 
 
Page 7 
 
Version Date 11/21/17 
 
 
 
• The Institutional Review Board, IRB, is a group of people who review the research with 
the goal of protecting the people who take part in the study. 
• The National Cancer Institute in the U.S. 
• Qualified representative(s) of the NCI Community Oncology Research Program 
(NCORP) Research Base with whom your institution is affiliated (Alliance, ECOG-
ACRIN, NRG). (1/24/17)  
 
The organizations that will look at the financial records are:   
• The study sponsor, SWOG 
• TransUnion (the company doing the credit reports). 
 
[Note to Local Investigators: The NCI has recommended that HIPAA regulations be addressed 
by the local institution.  The regulations may or may not be included in the informed consent 
form depending on local institutional policy.] 
 
Where can I get more information? 
 
You may visit the NCI Web site at http://cancer.gov/ for more information about studies or 
general information about cancer. You may also call the NCI Cancer Information Service to get 
the same information at: 1-800-4-CANCER (1-800-422-6237). 
 
A description of this study will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the 
Web site will include a summary of the results. You can search this Web site at any time. 
 
Who can answer my questions about this study? 
 
You can talk to the study doctor about any questions or concerns you have about this study or to 
report side effects or injuries. Contact the study doctor __________________ (insert name of 
study doctor[s]) at __________________ (insert telephone number). 
 
Future Contact 
 
Sometimes researchers working with SWOG may have another research idea that relates to 
people who were on a SWOG study.  In some cases, to carry out the new research, we would 
need to contact participants in a particular study.  You can agree or not agree to future contact by 
circling “yes or no” 
 
I agree that my study doctor, or their representative, may contact me or my physician to 
see if I wish to participate in other research in the future. 
 
 
YES 
 
NO 
 
 

 
S1417CD 
 
Page 8 
 
Version Date 11/21/17 
 
 
 
 
My Signature Agreeing to Take Part in the Study 
 
I have read this consent form or had it read to me. I have discussed it with the study doctor and 
my questions have been answered. I will be given a signed copy of this form. I agree to take part 
in this study. 
 
Participant’s (or legally authorized representative’s) signature____________________________ 
 
Date of signature_____________________________________ 
 
Signature of researcher obtaining consent  
 
 
Date of signature  
  
 

 
 
 
S1417CD 
 
(Primary Caregiver) Page 1 
 
Version Date 11/21/17 
 
 
 
 
Informed Consent Model for S1417 
CONSENT FOR PRIMARY CAREGIVER 
   
*NOTES FOR LOCAL INSTITUTION INFORMED CONSENT AUTHORS:  
 
This model informed consent form has been reviewed by the DCTD/NCI and is the official 
consent document for this study. Local IRB changes to this document are allowed.  (Institutions 
should attempt to use sections of this document that are in bold type in their entirety.)  Editorial 
changes to these sections may be made as long as they do not change information or intent.  If 
the institutional IRB insists on making deletions or more substantive modifications to the risks or 
alternatives sections, they may be justified in writing by the investigator and approved by the 
IRB.  Under these circumstances, the revised language, justification and a copy of the IRB 
minutes must be forwarded to the SWOG Operations Office for approval before a patient may be 
registered to this study.   
 
Please particularly note that the questions related to banking of specimens for future study 
are in bolded type and may not be changed in any way without prior approval from the 
SWOG Operations Office. 
Readability Statistics:   
 
Flesch Reading Ease  
_57.1___   (targeted above 55) 
Flesch-Kincaid Grade Level  _9.3___   (targeted below 8.5) 
 
• 
Instructions and examples for informed consent authors are in [italics].  
• 
A blank line,  __________, indicates that the local investigator should provide the 
appropriate information before the document is reviewed with the prospective 
research participant.  
• 
The term "study doctor" has been used throughout the model because the local 
investigator for a cancer treatment trial is a physician.   If this model is used for a 
trial in which the local investigator is not a physician, another appropriate term 
should be used instead of "study doctor".  
• 
The dates of protocol updates in the header and in the text of the consent is for 
reference to this model only and should not be included in the informed consent 
form given to the prospective research participant.  
• 
The local informed consent must state which parties may inspect the research 
records. This includes the NCI, the drug manufacturer for investigational studies, 
any companies or grantors that are providing study support (these will be listed in 
the protocol's model informed consent form) and SWOG.  

 
S1417CD 
 
(Primary Caregiver) Page 2 
 
Version Date 11/21/17 
 
 
 
 
"SWOG" must be listed as one of the parties that may inspect the research records 
in all protocol consent forms for which patient registration is being credited to 
SWOG.  This includes consent forms for studies where all patients are registered 
directly through the SWOG Data Operations Office, all intergroup studies for 
which the registration is being credited to SWOG (whether the registration is 
through the SWOG Data Operations Office or directly through the other group), as 
well as consent forms for studies where patients are registered via CTSU and the 
registration is credited to SWOG. 
 
• 
When changes to the protocol require revision of the informed consent document, 
the IRB should have a system that identifies the revised consent document, in order 
to preclude continued use of the older version and to identify file copies.  An 
appropriate method to identify the current version of the consent is for the IRB to 
stamp the final copy of the consent document with the approval date.  The stamped 
consent document is then photocopied for use.  Other systems of identifying the 
current version of the consent such as adding a version or approval date are allowed 
as long as it is possible to determine during an audit that the patient signed the most 
current version of the consent form.  
 
*NOTES FOR LOCAL INVESTIGATORS:  
• 
The goal of the informed consent process is to provide people with sufficient information 
for making informed choices about participating in research. The consent form provides 
a summary of the study, of the individual's rights as a study participant, and documents 
their willingness to participate. The consent form is, however, only one piece of an 
ongoing exchange of information between the investigator and study participant. For 
more information about informed consent, review the "Recommendations for the 
Development of Informed Consent Documents for Cancer Clinical Trials" prepared by 
the Comprehensive Working Group on Informed Consent in Cancer Clinical Trials for 
the National Cancer Institute. The Web site address for this document is 
http://cancer.gov/clinicaltrials/understanding/simplification-of-informed-consent-docs/ 
 
• A blank line, “__________”, indicates that the local investigator should provide the 
appropriate information before submitting to the IRB. 
 
*These notes for investigators are instructional and should not be included in the consent form 
sent to IRBs. 
 
 
 
 

 
S1417CD 
 
(Primary Caregiver) Page 3 
 
Version Date 11/21/17 
 
 
 
Consent Form for Primary Caregiver 
 
Study Title for Study Participants: 
Impact of Cancer on Finances 
 
Official Study Title for Internet Search on http://www.ClinicalTrials.gov: 
S1417, “Implementation of a Prospective Financial Impact Assessment  
Tool in Patients with Metastatic Colorectal Cancer”. 
 
Why is this study being done?  
 
Studies have shown that cancer patients may be at high risk for financial problems because of the 
cost of treatment.  These financial problems can be stressful and sometimes might cause patients 
to avoid or refuse treatment. We want to measure how often financial problems happen in 
patients with colorectal cancer, using questionnaires that collect information about finances and 
quality of life.  In order to get a full picture of the financial impact of colorectal cancer, we also 
want to collect credit reports for all patients in this study.  
 
You have been asked to participate because ____patient name__________ has identified you as 
their primary caregiver.  ____patient name__________________ is participating in a non-
treatment research study. As the primary caregiver, you will be asked to fill out a questionnaire 
that will capture your point of view about treatment, finances and caregiver duties.  We also want 
to find out about caregivers in general therefore some of the questions may be about how you are 
related to the patient, your gender, age, race, etc. Our findings will hopefully give us a better 
understanding of the financial burden of cancer and help us develop ways to lessen the burden. 
Your participation is very important to this study. 
 
There will be about 374 patients with metastatic colorectal cancer taking part in the study.  We 
hope to capture an equal number of caregivers, though patients may still participate in the study 
even if their designated caregiver chooses not to. 
 
What is the usual approach to use of medical information for research? 
 
Hospitals and doctor’s offices usually use a “Release of Medical Information” form to gather 
medical information from patients.  Since the information we are requesting from you as a 
caregiver will not be in the patient’s medical chart, we are using this consent form to inform you 
of the study and to get your permission to use the information you provide as part of the research 
data. 

 
S1417CD 
 
(Primary Caregiver) Page 4 
 
Version Date 11/21/17 
 
 
 
 
What are my other choices if I do not take part in this study? 
 
Participation in this study is optional. 
 
How long will I be in this study? 
 
You will be in the study for 12 months.  Participation ends if you discontinue being the caregiver 
for the patient or choose to no longer participate. 
 
What is involved? 
 
If you agree to take part in the study, you agree to answer a questionnaire at each of the 
following times: 
 
• at the time you and the patient agrees to be in the study (baseline) 
• 6 months after the patient enters the study 
• 12 months after the patient enters the study 
  
It may take between 30 and 60 minutes to answer each questionnaire.  You may fill out the 
questionnaires during the patient’s clinic visit, at home, or over the phone. If you fill out the 
questionnaire at home, you can either mail it back to the research staff using a pre-addressed 
stamped envelope that we will provide, or you can bring it with you the next time you come to 
the clinic for the patient’s appointment.  The study staff will work with you to find the easiest 
option for you.   
 
We will obtain the following information, directly from you (through questionnaires) and it will 
be included as part of the research data: 
 
• Basic information about you, changes to your financial status, quality of life, your point 
of view on aspects of your dependent’s cancer treatment.  
 
What risks can I expect from taking part in this study? 
 
You may feel uncomfortable being asked about your finances or physical and emotional health.  
 
We have procedures in place to protect your personal information and we will do our best to 
make sure that the personal information used for this study will be kept private.  However, we 
cannot guarantee total privacy. Your personal information may be given out if required by law. If 
information from this study is published or presented at scientific meetings, your name and other 
personal information will not be used.  

 
S1417CD 
 
(Primary Caregiver) Page 5 
 
Version Date 11/21/17 
 
 
 
To help make sure your information is private, your doctor or nurse will go to a secure data 
submission program sponsored by the National Cancer Institute (NCI) to send us your 
information. We can then go to the same secure program and get your information to include it 
with the information from all of the other patients taking part in the study. 
 
What are the possible benefits of taking part in this study? 
 
We hope to be able to use these questionnaires in the future to reliably capture financial hardship 
information in cancer patients and their caregivers. 
 
Can I stop taking part in this study? 
 
Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let 
the study staff know as soon as possible. If you stop, you can decide whether or not to let the 
study staff continue to provide your information to the organization running the study. 
 
What are my rights in this study? 
 
Taking part in this study is your choice. No matter what decision you make, and even if your 
decision changes, there will be no penalty to you or to the patient. You will not lose any legal 
rights. 
 
For questions about your rights while in this study, call the ________________________ (insert 
name of center) Institutional Review Board at __________________ (insert telephone number). 
(Note to Local Investigator: Contact information for patient representatives or other individuals 
at a local institution who are not on the IRB or research team but take calls regarding clinical 
trial questions can also be listed here.) 
 
What are the costs of taking part in this study? 
 
There are no costs to you associated with this study.  The research staff will provide a stamped 
envelope if you choose to return questionnaires by mail.  If you choose to do the questionnaire 
over the phone, the study staff will call you so that you do not incur long distance phone charges 
(if this applies to you). 
 
What happens if I am injured or hurt because I took part in this study? 
 
There will be little risk of being injured on this study as it does not involve medical treatment. 
 
Who will see my personal information? 
 
Your privacy is very important to us and the researchers will make every effort to protect it. 
Your name or contact information will not be put in the database because this information will 
not be obtained from you.  Your questionnaire responses will be entered under the participating 
patient’s ID.   

 
S1417CD 
 
(Primary Caregiver) Page 6 
 
Version Date 11/21/17 
 
 
 
There are organizations that may inspect your records. These organizations are required to make 
sure your information is kept private, unless required by law to provide information. Some of 
these organizations are: 
 
• The study sponsor, SWOG. 
• The Institutional Review Board, IRB, is a group of people who review the research with 
the goal of protecting the people who take part in the study. 
• The National Cancer Institute in the U.S., and similar ones if other countries are involved 
in the study. 
• Qualified representative(s) of the NCI Community Oncology Research Program 
(NCORP) Research Base with whom your institution is affiliated (Alliance, ECOG-
ACRIN, NRG). (1/24/17)  
 
[Note to Local Investigators: The NCI has recommended that HIPAA regulations be addressed 
by the local institution.  The regulations may or may not be included in the informed consent 
form depending on local institutional policy.] 
 
Where can I get more information? 
 
You may visit the NCI Web site at http://cancer.gov/ for more information about studies or 
general information about cancer. You may also call the NCI Cancer Information Service to get 
the same information at: 1-800-4-CANCER (1-800-422-6237). 
 
A description of this study will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the 
Web site will include a summary of the results. You can search this Web site at any time. 
 
Who can answer my questions about this study? 
 
You can talk to the study doctor or study site staff about any questions or concerns you have 
about this study.  Contact the study doctor or research staff __________________ (insert name 
of study doctor[s]) at __________________ (insert telephone number). 
 
My Signature Agreeing to Take Part in the Study 
 
I have read this consent form or had it read to me. I have discussed it with the study doctor and 
my questions have been answered. I will be given a signed copy of this form. I agree to take part 
in this study. 
 
Primary Caregiver (Participant’s) signature____________________________ 
 
Date of signature_____________________________________ 
 
Signature of researcher obtaining consent  
 
 
Date of signature