EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options - RCT of Usual Chemotherapy Educational Tools Versus Investigational Chemotherapy Educational Tools
Phase: NA
Conditions: Metastatic Pancreatic Cancer, Unresectable Pancreatic Cancer, Metastatic Colorectal Cancer
Sponsor: Dana-Farber Cancer Institute

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 1 of 50 
 
 
PROTOCOL TITLE: 
EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options - RCT of 
Usual Chemotherapy Educational Tools versus Investigational Chemotherapy 
Educational Tools 
 
 
Overall Study PI:  
Andrea Enzinger, MD  
andrea_enzinger@dfci.harvard.edu 
617-582-7335 
 
Participating Sites under DF/HCC 
IRB: 
 
Lead Site & Coordinating Center: 
Dana-Farber Cancer Institute 
Co-I: Deborah Schrag, MD, MPH  
Deb_schrag@dfci.harvard.edu 
 
Co-I: Richard Leiter, MD 
Richard_Leiter@DFCI.HARVARD.ED
U 
 
Collaborating Site not under DF/HCC 
IRB: 
University of Massachusetts Boston 
Site PI: Ana Lindsay, PhD 
Ana.Lindsay@umb.edu  
 
 
 
Participating Sites not under DF/HCC 
IRB: 
University of New Mexico Cancer 
Center 
Site PI: Heloisa Soares, MD  
HSoares@salud.unm.edu 
 
University of Texas Southwestern 
Medical Center  
Site PI: Muhammed Beg, MD  
Muhammad.Beg@UTSouthwestern.edu  
 
Moffitt Cancer Center  
Site PI: Sarah Hoffe, MD  
Sarah.Hoffe@moffitt.org 
 
Boston Medical Center 
Site PI: Kevan Hartshorn, MD  
Kevan.Hartshorn@bmc.org  
 
Baystate Medical Center  
Site PI: Chandravathi Loke, MD  
Chandravathi.loke@baystatehealth.org 
 
 
VERSION NUMBER: 
Protocol Version #2 
DATE: 
Initial Protocol Submission: July 19, 2018 
 
 
 
 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 2 of 50 
 
1.0 
Objectives* ....................................................................................................................................... 3 
2.0 
Background* ................................................................................................................................... 3 
3.0 
Inclusion and Exclusion Criteria* .......................................................................................... 5 
4.0 
Study‐Wide Number of Subjects* .......................................................................................... 7 
5.0 
Study‐Wide Recruitment Methods* ...................................................................................... 7 
6.0 
Multi‐Site Research* .................................................................................................................... 9 
7.0 
Study Timelines* ........................................................................................................................... 9 
8.0 
Study Endpoints* ....................................................................................................................... 10 
9.0 
Procedures Involved* .............................................................................................................. 13 
10.0  Data and Specimen Banking* ............................................................................................... 26 
11.0  Data Management* and Confidentiality ........................................................................... 27 
12.0  Provisions to Monitor the Data to Ensure the Safety of Subjects* ....................... 30 
13.0  Withdrawal of Subjects* ......................................................................................................... 30 
14.0  Risks to Subjects* ....................................................................................................................... 30 
15.0  Potential Benefits to Subjects* ............................................................................................. 31 
16.0  Vulnerable Populations* ......................................................................................................... 32 
17.0  Community‐Based Participatory Research* .................................................................. 32 
18.0  Sharing of Results with Subjects* ....................................................................................... 32 
19.0  Setting ............................................................................................................................................. 32 
20.0  Resources Available .................................................................................................................. 32 
21.0  Prior Approvals .......................................................................................................................... 34 
22.0  Recruitment Methods .............................................................................................................. 34 
23.0  Local Number of Subjects ....................................................................................................... 35 
24.0  Provisions to Protect the Privacy Interests of Subjects ............................................ 35 
25.0  Compensation for Research‐Related Injury ................................................................... 36 
26.0  Economic Burden to Subjects ............................................................................................... 36 
27.0  Consent Process ......................................................................................................................... 36 
28.0  Process to Document Consent in Writing ....................................................................... 36 
29.0  Drugs or Devices ........................................................................................................................ 37 
30.0  References..................................................................................................................................... 37 
31.0  Appendices ................................................................................................................................... 49 
 
 
 
 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 3 of 50 
 
1.0 
Objectives 
 
Objective 1: Determine the impact of a multimedia chemotherapy educational 
intervention on understanding of chemotherapy risks and benefits among Latinos 
with advanced gastrointestinal cancers and their caregivers.  
 
Objective 2: Determine the impact of the multimedia chemotherapy educational 
intervention on communication satisfaction and quality of informed decision-
making about palliative chemotherapy among Latinos with advanced GI cancers.  
 
Objective 3: Characterize Latino patients’ & caregivers’ financial well-being, 
financial strain, and occupational outcomes over the first 6 months of palliative 
chemotherapy. Explore relationships between financial strain and patients’ 
quality of life and symptoms, and caregiver well-being. 
 
Hypothesis 1a: The intervention will improve patients’ understanding of the 
purpose and benefits of palliative chemotherapy. (Primary outcome) 
Hypothesis 1b: The intervention will improve patients’ understanding of the risks 
associated with their chemotherapy regimen. (Secondary outcome) 
Hypothesis 1c: The intervention will improve caregivers’ understanding of the 
purpose and benefits of the patients’ chemotherapy. 
 
Hypothesis 2a: The educational intervention will improve patients’ satisfaction 
with communication with clinicians around treatment decision-making. 
Hypothesis 2b: Patients who receive the intervention will be more likely to 
achieve their preferred role in treatment decision-making. 
Hypothesis 2c: Patients who receive the intervention will experience less 
decisional conflict. 
 
Objective 3 is exploratory.  
 
2.0 
Background* 
 
Patient-centered communication is an essential element of quality care for patients 
with advanced incurable cancer.1-3 Skilled and compassionate communication is a 
cornerstone of shared decision-making, it is necessary to equip patients with an 
understanding of their prognosis and treatment options, and it plays a critical role in 
supporting terminally-ill patients and their caregivers.1,4 Unfortunately the quality of 
patient-provider communication is suboptimal for ethnic minorities with advanced 
cancer,4-6 particularly Latinos.7,8-10  
 
Latinos are the largest minority group in the US, yet they suffer some of the greatest 
barriers to quality cancer communication.11 Nearly 40% of Latinos have limited 
English proficiency (LEP),11 60% have low health-literacy,12 and Latinos have the lowest 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 4 of 50 
 
educational attainment of any US ethnic group.13 Use of professional interpreters 
partially mitigates these barriers,14 but interpretation can also introduce errors that result 
in misinformation15 and missed opportunities for rapport building.16 It is not surprising 
that Latinos have high rates of dissatisfaction with their healthcare providers’ 
communication skills.9,10 Oncologists are similarly frustrated by their inability to 
communicate with Latinos effectively, and report that discussions about prognosis & 
treatment options are not patient-centered.8 These co-occurring barriers uniquely 
compromise Latinos’ ability to understand their cancer care providers and to participate 
optimally in their care.10  
 
Communication disparities are evidenced by gaps in Latinos’ understanding about 
the prognosis of advanced cancer and the benefits of palliative chemotherapy.7,17-20 
We recently reported from the Cancer Care Outcomes Research & Surveillance 
Consortium (CanCORS) study that an alarming 91% of Latinos with metastatic 
colorectal cancer and 79% of those with metastatic lung cancer failed to understand 
chemotherapy was unlikely to cure their cancer.20 Other research demonstrates that 
Latino advanced cancer patients are less likely than Whites to acknowledge that they are 
terminally ill,21 and have poor understanding of advance directives,19,22 and hospice.18 
These findings belie the fact that most patients23,24 including Latinos25-27 want detailed 
information about prognosis, chemotherapy benefits, and end-of-life (EOL) care options.  
 
Misconceptions about prognosis and chemotherapy benefits are detrimental to the 
quality of advanced cancer care, and may contribute to known disparities in quality 
of EOL care for Latinos. A realistic grasp of curability and prognosis is essential to 
patients’ ability to come to terms with their illness, make value-consistent care decisions, 
prioritize their limited time, and plan for EOL. Patients with unrealistic expectations have 
been shown to prefer care focused on life-extension rather than comfort,23,28-29 to be less 
likely to complete advance directives,23 less likely to access hospice,30 and more likely to 
receive intensive care near EOL.28 These examples of poor quality EOL care31 contribute 
to suffering of patients and their families,32 and pose significant financial burdens33 
without appreciable benefit.28,32  Because prognostic misconceptions are more common 
among Latinos than Whites, these knowledge gaps may partly drive Latino EOL care 
disparities including high rates of hospital and ICU death, underutilization of hospice, 
and EOL care counter to patients’ preferences.34-36 Interventions to enhance Latino 
advanced cancer patients’ understanding of their illness and chemotherapy options are 
desperately needed, and are a promising approach to reduce ethnic disparities in EOL 
care.5 
 
We have developed a dual Spanish/English language suite of chemotherapy 
educational tools with the goal of better informing patients about the risks, 
benefits, and goals of common chemotherapy regimens used to treat advanced GI 
cancers. Each chemotherapy educational tool consists of a video, website, and 
written booklet, and improves upon existing resources in several ways: 1) 
balanced discussion of benefits as well as risks, 2) focus on regimens rather than 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 5 of 50 
 
drugs, 3) use of both written and video format, and 4) inclusion of Latino patient 
and provider perspectives (e.g. video clips of Latino patients describing their 
experiences on treatment). 
The overarching objective of this project is to evaluate whether the developed 
chemotherapy educational toolkit improves the quality of advanced cancer care 
and treatment decision making by Latinos. If effective, the tools will be amenable 
to broad dissemination via patient accessible cancer education websites and 
oncology clinics. 
 
3.0 
Inclusion and Exclusion Criteria* 
 
The research assistant will identify potentially eligible participants by systematically 
reviewing new patient and existing patient scheduling reports, as well as by accepting 
physician referrals. We are requesting a HIPAA waiver of authorization so that the 
research assistant may look in the Electronic Health Record to determine eligibility before 
approaching potential participants. 
 
1) For patients presenting to oncology clinic for an initial consultation/new 
treatment decision regarding first-line chemotherapy for their metastatic 
colorectal cancer, locally advanced pancreatic cancer, or metastatic 
pancreatic cancer: the research assistant will identify potentially eligible 
patients by screening new patient scheduling reports. The research assistant 
will notify the oncology attending physician of the patients’ potential 
eligibility prior to this initial consultation, will confirm the patients’ 
potential eligibility, and will ask permission to approach the patient for 
participation. The study team will reach out to the clinician via email the 
day before a consult to ask permission to approach a potential participant. 
The email will contain an “opt-out” message meaning that clinicians only 
have to respond if they do not want a patient to be approached. Therefore, 
no response from a clinician will be considered as approval for a potential 
approach. Study research assistants will keep track of the number of 
potentially eligible patients, the number of physician refusals, and the reason 
for those refusals. Most potentially eligible patients will be approached 
before their initial consultation with the oncologist.  
2) Oncology clinicians (physicians, nurse practitioners, physician assistants, 
and pharmacists from medical oncology, surgical oncology, and radiation 
oncology) will be able to refer eligible participants for enrollment in the 
study. Each site will determine the logistics of the referral process 
depending on its clinic model and staffing. At all sites, if the referral is 
made by a provider other than the attending physician, the research assistant 
will ask the attending physician’s permission prior to approaching a patient. 
The research assistants will keep track of the number of potentially eligible 
patients referred, the number of physician refusals, and the reason for those 
refusals. 
 
 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 6 of 50 
 
Patient Inclusion Criteria: 
 
Group 1 – Patients: 
 Self-identifies as Hispanic/Latino OR self-identifies with nationality from a Spanish-
speaking country or territory  
 Has been diagnosed with metastatic colorectal cancer (mCRC) OR locally advanced 
pancreatic cancer (LAPC) OR metastatic pancreatic cancer (mPC) AND is making a 
decision regarding treatment with 1st line palliative chemotherapy.  
 Treating oncologist has recommended consideration of one or more of the regimens for 
which we have developed chemotherapy educational (CEI) toolkits  
o For mCRC: FOLFOX, FOLFOX + bevacizumab, FOLFIRI, FOLFIRI + 
bevacizumab 
o For LAPC or mPC: FOLFIRINOX, Gemcitabine, or Gemcitabine + nab-
paclitaxel  
o Patients who are also considering treatment on a clinical trial of one of these 
regimens +/- an investigational agent would still be eligible, so long as the 
treating MD believes to the content of the CEI to be relevant to the trial regimen. 
 Planning to receive treatment at the enrolling site 
 Age ≥ 21 
 English proficient  
 
Group 2 – Patients: 
 Self-identify as Hispanic/Latino OR self-identifies with nationality from a Spanish-
speaking country or territory 
 Has been diagnosed with metastatic colorectal cancer (mCRC) OR locally advanced 
pancreatic cancer (LAPC) OR metastatic pancreatic cancer (mPC) AND is making a 
decision regarding treatment with 1st line palliative chemotherapy.  
 Treating oncologist has recommended consideration of one or more of the regimens for 
which we have developed chemotherapy educational (CEI) toolkits  
o For mCRC: FOLFOX, FOLFOX + bevacizumab, FOLFIRI, FOLFIRI + 
bevacizumab 
o For LAPC or mPC: FOLFIRINOX, Gemcitabine, or Gemcitabine + nab-
paclitaxel  
o Patients who are also considering treatment on a clinical trial of one of these 
regimens +/- an investigational agent would still be eligible, so long as the 
treating MD believes to the content of the CEI to be relevant to the trial regimen. 
 Planning to receive treatment at the enrolling site 
 Age ≥ 21 
 Spanish proficient 
 
Patient Exclusion Criteria: 
 For mCRC patients: Patients with oligometastatic disease who have a definitive 
plan for curative surgical resection are not eligible. 
 Significant delirium/dementia as judged by the treating oncologist 
 
 
 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 7 of 50 
 
 
 
Caregiver Inclusion Criteria: 
 
Group 1 – Caregivers: 
 Caregivers of eligible patient participants  
 Age ≥ 21 
 English proficient  
 
Group 2 – Caregivers: 
 Caregivers of eligible patient participants  
 Age ≥ 21 
 Spanish proficient  
 
Caregiver Exclusion Criteria:  
 Unable to comply with the study requirements per study team 
 
This study will exclude patients who are unable to consent, individuals who are 
not yet adults, pregnant women, and prisoners. The study will exclude caregivers 
who are unable to consent, individuals who are not yet adults, and prisoners.  
Also, please note: patients will still be able to enroll in the study if they do not have a 
participating caregiver. Caregivers, however, can ONLY enroll with a participating 
patient. 
4.0 
Study-Wide Number of Subjects* 
A total of 154 subjects and up to 154 caregivers will be recruited (both English 
and Spanish-speaking). The study team expects to recruit 77 English-speaking 
patients and caregivers and 77 Spanish-speaking patients and caregivers. 
Assuming a subject attrition rate of 25%, which would decrease the n to 116, this 
sample size would give the study 80% power to detect a two-fold improvement in 
our primary outcome (accurate chemotherapy expectations), with a one-sided 
p<0.05. The effect size for our primary outcome is based upon conservative 
projections of accurate understanding regarding cure from palliative 
chemotherapy reported in the literature,20,37 and based upon what would constitute 
a clinically meaningful improvement in understanding. 
 
5.0 
Study-Wide Recruitment Methods* 
Subject Recruitment: The majority of potential subjects will be recruited at their 
initial consultation with the oncologist at participating study sites. Potential 
subjects will be approached by study research assistants prior to their consultation 
and offered participation in a study seeking to study a new tool to enhance 
education around cancer treatment options. The RA will discuss the overall aims 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 8 of 50 
 
of the study (to improve understanding around cancer treatments), the study 
intervention (educational tools) and assessments (surveys). If the patient agrees to 
participate the RA will obtain written informed consent at that time.  
If it is not possible for logistic reasons to approach the patient prior to the initial 
consultation, or if the patient asks the RA to come back later, potential subjects 
may also be recruited after their initial consultation with the oncologist, but not 
after they have received their first chemotherapy infusion. If the subject meets 
eligibility criteria but was not approached prior to their consultation, the study RA 
will approach the potential subject, either at the conclusion of the initial 
consultation, or at a subsequent visit prior to the initiation of chemotherapy. The 
RA will again describe the study and offer the potential subject the opportunity to 
participate. If the subject agrees to participate, the RA or an authorized member of 
the study staff will obtain written informed consent at that time. 
Identifying Potential Participants: The research assistant will identify potentially 
eligible participants by reviewing patient scheduling reports, as well as by accepting 
physician referrals. We are requesting a HIPAA waiver of authorization so that the 
research assistant may look in the Electronic Health Record to determine eligibility before 
approaching potentially eligible participants. 
 
1) For patients presenting to oncology clinic for an initial consultation/new 
treatment decision regarding first-line chemotherapy for their metastatic 
colorectal cancer, locally advanced pancreatic cancer, or metastatic 
pancreatic cancer: the research assistant will identify potentially eligible 
patients by screening new patient scheduling reports. The research assistant 
will notify the oncology attending physician of the patients’ potential 
eligibility prior to this initial consultation, will confirm the patients’ 
potential eligibility, and will ask permission to approach the patient for 
participation. The study team will reach out to the clinician via email the 
day before a consult to ask permission to approach a potential participant. 
The email will contain an “opt-out” message meaning that clinicians only 
have to respond if they do not want a patient to be approached. Therefore, 
no response from a clinician will be considered as approval for a potential 
approach.  Study research assistants will keep track of the number of 
potentially eligible patients, the number of physician refusals, and the reason 
for those refusals. Most potentially eligible patients will be approached 
before their initial consultation with the oncologist.  
2) Oncology clinicians (physicians, nurse practitioners, physician assistants, 
and pharmacists from medical oncology, surgical oncology, and radiation 
oncology) will be able to refer eligible participants for enrollment in the 
study. Each site will determine the logistics of the referral process 
depending on its clinic model and staffing. At all sites, if the referral is 
made by a provider other than the attending physician, the research assistant 
will ask the attending physician’s permission prior to approaching a patient. 
The research assistants will keep track of the number of potentially eligible 
patients referred, the number of physician refusals, and the reason for those 
refusals. 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 9 of 50 
 
All potential subjects will be approached by a study research assistant or 
referred by an oncology provider. Advertisements (printed, audio, or 
video), will not be used to recruit subjects in this study. 
6.0 
Multi-Site Research* 
All sites will have the most current version of the protocol, consent 
document, and HIPAA authorization. All required approvals (the initial 
and continuing reviews, and any modifications) will be obtained at each 
site. This includes approval by each site’s IRB of record. All 
modifications will be communicated to participating sites and approved by 
the IRBs of record before the modifications are implemented. All engaged 
participating sites will safeguard data, including secure transmission of 
data, as required by local information security policies. All local site 
investigators will conduct the study in accordance with applicable federal 
regulations and local laws. All non-compliance with the study protocol or 
applicable requirements will be reported in accordance with local policy. 
Prior to patient enrollment, there will be a site initiation visit webinar to 
orient all investigators, research assistants, and study staff to study 
procedures, including eligibility criteria, and procedures for subject 
recruitment and study assessments. Following study commencement, there 
will be regular check-ins with study staff led by the study project manager 
(PM) and/or PI by conference call. These will initially take place weekly. 
Once deemed appropriate by the study PI, the co-investigators, and PM, 
the frequency of these check-ins will decrease to monthly and will 
continue for the duration of the study. 
Participating sites will receive regular updates during the weekly, then 
monthly conference calls with the project manager. For urgent updates, 
such as those relating to problems (inclusive of reportable events), the PI 
and project manager will contact site investigators and study staff by 
phone and email. Ad hoc conference calls will be convened as necessary. 
To the extent they are available, interim results will be communicated to 
participating sites during the regular conference calls and will be 
summarized via email. The closure of the study will be communicated to 
participating sites via an email from the study PI to the site investigators 
and study staff.  
 
7.0 
Study Timelines* 
Individual subjects (patients and caregivers) will participate in the study for 6-8 
months. Their participation run from the time of informed consent to the 
completion of the final study assessment, which takes place between 6 and 8 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 10 of 50 
 
months after either the initiation of chemotherapy or the decision not to initiate 
chemotherapy. 
We anticipate it will take 20 months to enroll all study subjects. Given the target 
sample size of 154 and that there are 6 participating sites, this timeline accounts 
for the enrollment of just over 1 subject and caregiver per month at each site, 
which we believe is reasonable and attainable given our knowledge of each site 
and its Latino GI cancer patient population. 
We estimate that we will complete primary analyses for the study after 24 months. 
Assuming enrollment is complete over 20 months, all data for the primary and 
secondary outcomes will be obtained by 23 months (at the 3-month assessment). 
We estimate it will take 1 additional month to complete primary analyses. 
Exploratory outcomes will take an additional 5 months to collect (at the 6-8-
month assessment) and analyze and will therefore be completed by 29 months 
after study initiation.  
8.0 
Study Endpoints* 
 
Objective 1: Determine the impact of a multimedia chemotherapy educational 
intervention on understanding of chemotherapy risks and benefits among Latinos with 
advanced gastrointestinal cancers and their primary informal caregivers.  
 
 Understanding of chemotherapy benefits: The primary study outcome is the 
proportion of patients who have accurate understanding of chemotherapy 
benefits, assessed at the 8-12-week follow-up. Patients and caregivers will be asked a 
single item from the CanCORS study20: “After talking with your doctors...how likely do 
you think chemotherapy is to cure your cancer?” Options: very likely, somewhat likely, a 
little likely, not at all likely, or don’t know. Responses will be dichotomized into accurate 
(not at all likely) and inaccurate (all others). Our primary outcome assessment has been 
successfully used among thousands of patients in the CanCORS study,20 and in a prior 
trial of our parent intervention, with little missing data. This outcome is relevant because 
it reflects core understanding required for informed consent; and it is predictive of 
hospice utilization.30 The 8-12 week timepoint was chosen to allow participants 
adequate time to review the intervention and discuss the information with their 
family and care providers. The post-decision assessment will have several other 
secondary assessments of patients understanding of chemotherapy benefits. This 
will include an item assessing their understanding of the purpose of the treatment 
(e.g. to cure, prolong life or palliate symptoms), and how likely they believe the 
treatment is to shrink their cancer. At 8-12 weeks’ patients and caregivers will be 
asked to estimate life expectancy, and will be asked about the typical prognosis of 
their cancer, using methods described by Weinfurt et al.38 Prognostic 
understanding will be analyzed as an ordinal variable, and dichotomized into 
realistic or unrealistic39 based upon published survival statistics.40-42 
 Understanding of chemotherapy risks. At the post-decision assessment, patients 
will answer a series of 6 items asking how likely they believe they are to 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 11 of 50 
 
experience specific chemotherapy side effects (fatigue, nausea/vomiting, 
neuropathy, myalgias/arthralgias, hair loss, diarrhea) using a 4-point likert scale 
(not at all likely to very likely). Patients’ responses to each question will be 
compared to the known side effect profile of their chemotherapy regimen, and 
characterized as accurate or inaccurate. The responses to all 6 questions will then 
be summed for a composite knowledge score. 
 
Objective 2: Determine the impact of the multimedia chemotherapy educational 
intervention on communication satisfaction and quality of informed decision-making 
about palliative chemotherapy among Latinos with advanced GI cancers.  
 
Communication satisfaction: will be assessed by five communication satisfaction 
items from the validated and widely used Consumer Assessment for Health 
Providers and Systems (CAHPS) Cancer Survey43: “How often did your 
doctor...listen carefully to you, explain things in a way that was easy to 
understand, seem to know important information about your medical history, 
spend enough time with you, and show respect for what you had to say?” Options: 
always, usually, sometimes, or never.44 Patient responses will be summed, with 
possible score of 0-100 (with higher scores indicating better communication) and 
then categorized into tertiles.  Patients will complete this assessment at the post-
decision and 3-month survey, but our primary analysis for this outcome will 
consider the post-decision assessment because it is most proximate to 
chemotherapy decision-making and exposure to the intervention. 
 Satisfaction with the CEI tools and process: At the post-decision assessment, 
patients will rate their satisfaction with the CEI or standard chemotherapy 
education tools using a Likert scale ranging from Very Poor to Excellent. Patients 
in the CEI arm will provide several other assessments of the intervention, which 
will not be used for comparative testing.   
 Decisional conflict: At the post-decision assessment, patients will assess 
decisional conflict using the 4 question SURE decisional conflict screening 
assessment developed by Legare et al.45 A score of < 3 is indicative of decisional 
conflict. 
 Decisional involvement: Whether patients achieved their desired degree of 
involvement in decision-making (patient-controlled, shared, or physician 
controlled) will be assessed post-decision using the modified Control Preferences 
Scale and compared with desired involvement (measured at baseline) using 
methods described elsewhere and widely used in decision aid trials.46  
 Decisional regret: Patient decisional regret will be assessed at 8-12 weeks using 5-
item Decisional Regret Scale developed by Brehaut et al.47 
 Advance care planning: At 8-12 weeks and 6 months, patients will indicate 
whether they have designated a healthcare proxy, or discussed end-of-life wishes 
with their physicians or proxy. 
 
Objective 3 (Exploratory): Characterize Latino patients’ & caregivers’ financial well-
being, financial strain, and occupational outcomes over the first 6 months of palliative 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 12 of 50 
 
chemotherapy. Explore relationships between financial strain and patients’ quality of life 
and symptoms, and caregiver wellbeing. 
 
 
Patients’ quality of life, occupational and financial well-being will be assessed at 
baseline, 3 months, and 6 months to allow for evaluation of the outcomes over the first 6 
months of treatment. 
 Quality of life: Patient and caregiver quality of life will be assessed using the 10-
item PROMIS Global Health Short Form48, which will be administered at all 
survey time points. 
 Symptoms: Patient symptoms will be measured using items from the PRO-
CTCAE49 that have been developed to reflect the expected and most common side 
effects and symptoms associated with mCRC and pancreatic cancer. 
 Occupation: Patient and caregiver occupation will be assessed using questions 
adapted from the National Health and Nutrition Examination Survey 
(NHANES)50 that assess occupational status and reasons for not working. Hours 
worked will also be assessed.  
 Income: Total household income and the number of individuals living in the 
household will be assessed and benchmarked with the Federal Poverty Limit (for 
1-8 household members). 
 Household material hardship: Patient and caregiver household material hardship 
will be assessed using 3 questions from Children’s Healthwatch that assess 
whether patients have been unable to pay their rent or mortgage, have had their 
electricity/gas/oil shut off for not paying bills or have experience significant food 
insecurity.51-53 
 Financial toxicity: Financial toxicity will be assessed using items adapted from 
the literature that assess cost-shifting (e.g. taking out a new mortgage or loans) 
and care-altering behaviors (e.g. not filling a prescription or skipping a 
recommended test) due to the costs of cancer care, in addition to catastrophic 
financial consequences (e.g. declaring bankruptcy, having home or car 
repossessed).54-56 
 Financial strain: Patient and caregiver financial strain will be assessed at baseline, 
3 months, and 6 months using measures derived from CanCORS and from the 
literature. Patients and caregivers will be asked “to what degree have the costs of 
cancer treatment been a financial burden for you or your family?” Response 
options range from not a financial burden at all to a catastrophic financial 
burden.57  
 Caregiver wellbeing: Caregiver quality of life, anxiety, depression, and emotional 
support will be assessed using PROMIS measures.48 Caregiver support will be 
assessed using questions from the California Universal Caregiver Assessment.58 
Caregiver burden will be assessed using the Zarit Burden Interview.59 Caregiver 
health behaviors will be assessed using items adapted from the literature that 
ascertain whether caregivers have delayed or otherwise altered their care due to 
their caregiving responsibilities.60  
 
Additional exploratory outcomes: End-of-study chart abstraction will assess the 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 13 of 50 
 
duration and type of chemotherapy, hospitalizations, ER visits, and survival. These chart 
abstractions will be performed at 6 months.  
 
Study Covariates assessed at baseline will include age, sex, race/ethnicity, marital 
status, education, and insurance. Given our  focus on Latinos we will collect information 
on nativity/country of origin, and acculturation (using the Marin scale61 for language 
preference). Health literacy and numeracy will be assessed using measures found in the 
literature.62-63 Patients will report religious affiliation & religiousness/spirituality,64 which 
influence prognostic beliefs,23 EOL care preferences,65 and care.66 Sources of health 
information will be assessed using items found in the HINTS survey.67-68 
There are no primary or secondary safety endpoints for this project.  
 
9.0 
Procedures Involved* 
This is a non-blinded randomized controlled trial of 154 patients with advanced 
colorectal or pancreatic cancer who are candidates to receive chemotherapy and 
their caregivers. Eligible patients will be randomized to receive either standard 
chemotherapy education or an enhanced chemotherapy education intervention 
(CEI) developed by our study team and consisting of a booklet and a video hosted 
on a secure website. Patients’ and their caregivers’ will be assessed at multiple 
time points throughout the study period on a variety of domains, including their 
understanding of chemotherapy’s risks and benefits, the patient’s prognosis, 
communication with their providers around treatment decisions, quality of life, 
financial well-being, and a variety of sociodemographic factors.  
The study schema can be found in Figure 1 below: 
Figure 1. Study Schema 
Study Procedures & Assessments 
 
Enrollment 
▪Screening 
 ▪Eligibility  
▪Sign consent for 
study 
Baseline Survey 
▪Demographics 
▪Psychosocial 
characteristics 
▪Clinical characteristics 
▪Communication 
preferences 
▪Quality of 
life/symptoms 
▪Financial well‐being 
 
 
 
 
 
Post‐Decision 
Survey  
▪Knowledge 
▪Decision quality 
▪Communication 
& care 
satisfaction 
▪Quality of 
life/symptoms 
▪MD relationship 
Follow‐up 
Survey 1 (8‐
12weeks)  
▪Knowledge 
▪Care satisfaction 
▪Quality of 
life/symptoms 
▪Advance care 
planning 
▪Financial well‐
being 
▪Caregiver 
burden and 
distress 
 
 
Follow‐up 
Survey 2 (6‐8 
months) 
▪Quality of life 
▪Financial well‐
being 
▪Advance care 
planning 
▪Caregiver 
burden and 
distress 
 
 
Data 
Sourc
 
▪Patient 
▪Caregiver 
▪Oncologist 
▪Patient 
▪Caregiver 
▪Chart abstraction 
 
 
 
 
▪Patient 
 
▪Patient 
▪Caregiver 
 
▪Patient 
▪Caregiver 
 
C
li
 
 
 
Usual CE Arm 
 
 
 
 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 14 of 50 
 
 
 
Procedure for registration: After the participant signs written informed consent to 
participate in research, the research assistant will fill out the registration form and 
register the participant and his/her caregiver using REDCap managed by the study 
team. 
 
Procedure for randomization (see schema above): 
After study consent and the baseline assessment, the study team will then 
randomize the participant to either the Usual IC Arm or the Investigational IC Arm 
of the study using REDCap’s 1:1 randomization algorithm, stratified by whether 
the participant has colorectal or pancreatic cancer (diagnosis) and stratified by 
language preference (English or Spanish).  
 
The name and telephone number of the research study person who will be 
responsible for registration and randomization is: Christine Cronin, 
Christine_cronin@dfci.harvard.edu, 617-632-3784. 
 
When registering subjects, the study team will ask for the following information (see 
Appendices 8-9): 
 Full name, telephone number, and email address of research assistant 
enrolling the participant 
 Date subject signed informed consent 
 Subject and caregiver’s phone numbers, emails, and postal mail 
addresses (reason for collecting these: so central research assistant at 
Dana-Farber can administer follow-up assessments) 
 Subject and caregiver’s ranks of preference regarding contact method 
 Subject and caregiver’s gender 
 Subject and caregiver’s race 
 Subject and caregiver’s ethnicity 
 Subject and caregiver’s initials 
 Subject and caregiver’s dates of birth 
 Subject ID number 
 Primary oncologist 
 Confirmation of eligibility 
 Stratification or classification factors (colorectal or pancreatic cancer 
diagnosis AND English or Spanish language preference) 
 
Procedure for patient assessment contact and reminders: It is acceptable to 
administer each assessment aloud (via phone or in-person), via email (REDCap 
 
Initial Clinic Visit 
▪ Options 
discussed 
▪ Treatment 
recommendation 
 
Standard chemo 
teaching  
 
Return to 
Clinic 
▪ Chemo 
decision 
▪ Chemo start 
 
 
 
 
CEI Arm  
Review CEI tools 
(in clinic & home) 
 
® 
Ongoing care/ 
 
Chemotherapy  

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 15 of 50 
 
weblink), via iPad (REDCap), or via hard copy (in-person or postal mail). 
Participants and caregivers will be offered the opportunity to complete all 
assessments in either English or Spanish. Spanish language interpreters may assist 
the RA with survey administration as necessary. 
 
The baseline assessment will be administered immediately after the participant signs 
informed consent, and prior to randomization. If immediate administration is not 
possible, the RA will follow-up with the participant up to 4 times post-informed 
consent.  One follow-up is defined as: an in-person approach OR a phone call with 
an accompanying email. If the participant is non-responsive after 4 attempts, the 
participant will be considered to have withdrawn from the study prior to 
randomization.  
 
The post-decision assessment will be administered by a research assistant at any 
point between the day the participant has started chemotherapy, and 3-weeks after 
they have received their first chemotherapy cycle. For patients who delay or decide 
against chemotherapy, they may complete the post-decision assessment up to 3 
weeks after the decision not to pursue chemotherapy. The first follow-up assessment 
will be administered between 8 and 12 weeks after their first chemotherapy 
treatment. 
 
The second follow-up assessment will be administered either by a central study RA 
at Dana-Farber or by the site research assistant, a determination that will be made 
by each site. The assessment will be given at any point between 6-months and 8-
months post-chemo start. Prior to contacting the participant, the study staff will 
confirm the participant’s vital status.  
 
For all assessments, the RA can contact or approach the participant up to 4 times. 
One follow-up is defined as: an in-person approach OR a phone call with an 
accompanying email. If the participant is non-responsive after 4 attempts, then the 
study research assistant will mark the post-decision assessment as missing and will 
not contact the participant about the missing assessment. 
 
Procedure for caregiver recruitment: To identify the appropriate caregiver, the 
RA will ask the consented patient who s/he would identify as his/her primary 
informal caregiver, if any.  If the caregiver is physically present with the patient, the 
RA will provide the caregiver the study letter, explain the study, answer any 
questions, and ask if the caregiver would like to participate.  If the caregiver verbally 
agrees, the RA will administer the caregiver baseline survey (available on paper, 
electronically, or orally per caregiver preference).  If the caregiver is not physically 
present, the RA will send the patient home with the caregiver study letter and follow 
up with a phone call.  When speaking to the caregiver on the phone, the RA will be 
sure that the caregiver has had time to read and consider the study letter.  If the 
caregiver does not have the study letter, the RA will offer to email or postal mail a 
duplicate. Because the caregiver is not always physically present at clinic visits, 
we are requesting waiver of documentation of consent for caregivers.  This will 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 16 of 50 
 
allow the RA the flexibility needed to verbally consent caregivers in person and 
over the phone since caregivers will not always be present in clinic. 
 
Procedure for caregiver assessments and contact reminders: It is acceptable to 
administer each assessment aloud (via phone or in-person), via email (REDCap 
weblink), via iPad (REDCap), or via hard copy (in-person or postal mail). 
Participants and caregivers will be offered the opportunity to complete all 
assessments in either English or Spanish. Spanish language interpreters may assist 
the RA with survey administration as necessary. 
 
The baseline assessment will be administered immediately after the participant 
agrees to consent to the study, and prior to randomization. If immediate 
administration is not possible, the RA will follow-up with the participant up to 4 
times post-informed consent.  One follow-up is defined as: an in-person approach 
OR a phone call with an accompanying email. If the participant is non-responsive 
after 4 attempts, the participant will be considered to have withdrawn from the 
study prior to randomization.  
 
The first follow-up assessment will be administered between 8 and 12 weeks after 
the patient’s first chemotherapy treatment. 
 
The second follow-up assessment will be administered either by a central study RA 
at Dana-Farber or by the site research assistant, a determination that will be made 
by each site. The assessment will be given at any point between 6-months and 8-
months post-chemo start. Prior to contacting the participant, the study staff will 
confirm the participant’s vital status.  
 
For all assessments, the RA can contact or approach the participant up to 4 times. 
One follow-up is defined as: an in-person approach OR a phone call with an 
accompanying email. If the participant is non-responsive after 4 attempts, then the 
study research assistant will mark the post-decision assessment as missing and will 
not contact the participant about the missing assessment. 
 
Description of Intervention 
 
Intervention Overview: The intervention consists of 10 sets of 
chemotherapy educational intervention (CEI) tools. Each tool consists of a 
video and a complementary booklet which explain a common 
chemotherapy option for metastatic colorectal cancer, locally advanced 
pancreatic cancer, or metastatic pancreatic cancer. This suite of tools 
reviews the following treatment options: 
 CEI Tool 1: FOLFOX & FOLFOX + bevacizumab are 
reviewed together in one CEI tool, comprised of a booklet and 
complementary video hosted on a password protected website 
(English Version – See Appendix 40)  

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 17 of 50 
 
 CEI Tool 2: FOLIRI & FOLFIRI + bevacizumab are reviewed 
together in one CEI tool: comprised of a booklet and complementary 
video hosted on a password protected website (English Version - See 
Appendix 41) 
 CEI Tool 3: FOLFIRINOX is reviewed in one CEI tool: 
comprised of a booklet and complementary video hosted on a 
password protected website (English Version - See Appendix 42) 
 CEI Tool 4: Gemcitabine + nab-paclitaxel is reviewed in one CEI tool: 
comprised of a booklet and complementary video hosted on a 
password protected website (English Version - See Appendix 43) 
 CEI Tool 5: Gemcitabine is reviewed in one CEI tool: 
comprised of a booklet and complementary video hosted on a 
password protected website (English Version - See Appendix 44) 
 CEI Tool 6: FOLFOX & FOLFOX + bevacizumab are 
reviewed together in one CEI tool, comprised of a booklet and 
complementary video hosted on a password protected website 
(Spanish Version – See Appendix 45) 
 CEI Tool 7: FOLIRI & FOLFIRI + bevacizumab are reviewed 
together in one CEI tool: comprised of a booklet and complementary 
video hosted on a password protected website (Spanish Version – 
See Appendix 46) 
 CEI Tool 8: FOLFIRINOX is reviewed in one CEI tool: 
comprised of a booklet and complementary video hosted on a 
password protected website (Spanish Version – See Appendix 47) 
 CEI Tool 9: Gemcitabine + nab-paclitaxel is reviewed in one CEI tool: 
comprised of a booklet and complementary video hosted on a 
password protected website (Spanish Version – See Appendix 48) 
 CEI Tool 10: Gemcitabine is reviewed in one CEI tool: 
comprised of a booklet and complementary video hosted on a 
password protected website (Spanish Version – See Appendix 49) 
 
Description of chemotherapy educational (CEI) websites: 
CEI videos and content described in the booklets will be available for 
patients to review at www.chemovideo.org. The website will use an 
individual site-specific password, with unique passwords for each of the 5 
chemotherapy regimens. This will ensure that participants will only see 
educational information for the chemotherapy regimen(s) recommended 
by their doctor. Website tracking will only produce aggregate data (i.e. # 
of views). There will not be any website tracking that is linked to 
individual patient IDs.. Website content includes the main chemotherapy 
educational videos, two brief supplementary videos about coping, all 
written content from the booklets, and some supplementary content taken 
from well vetted online educational materials (e.g. from NCI patient 
educational materials).   
 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 18 of 50 
 
Description of chemotherapy educational (CEI) videos 
Each video is approximately 20 minutes and was filmed and edited by a 
professional health communications firm. There are both English and 
Spanish versions of each video. Videos and booklets are complementary 
but do not entirely overlap. Latino and non-Latino oncologists and 
nurses narrate factual information about the chemotherapy regimen of 
interest. “B-roll” visually illustrates potentially confusing aspects of the 
chemotherapy regimen (for example: a chemotherapy home infusion 
pump). Candid patient interviews are interspersed throughout the video 
to present patients’ experience, with particular attention to quality of life 
and coping. Information about life expectancy is included as an optional 
link, allowing patients/caregivers a choice about whether or not to hear 
this information. Patients and providers in the video are diverse with 
respect to age, gender, and ethnicity – with a preponderance of Latinos. 
Videos will be accessible via a password-protected website suitable for 
viewing on tablet, mobile device, or computer. Website activity will be 
monitored. Website tracking will only produce aggregate data (i.e. # of 
views). There will not be any website tracking that is linked to 
individual patient IDs.  
 
The structure & content of the videos are outlined below. 
 
Basics: The drugs used as part of each regimen, their route of 
administration, schedule, logistics of administration. A nurse 
demonstrates a 5FU infusion pump. 
 
Risks: Toxicities reviewed, with greatest attention to the most common 
toxicities, followed by rare but serious complications. Side effects 
specific to bevacizumab highlighted. 
 
Benefits: State that chemo alone cannot cure mCRC, locally advanced 
pancreatic cancer, or metastatic pancreatic cancer, and review the 
palliative intent of chemotherapy. 
 
Alternatives: Mention other chemotherapy regimens, clinical trials, & 
palliative/supportive care. 
Description of chemotherapy educational (CEI) booklets 
Booklets are regimen-specific CEI documents, which serve as a regimen-
specific educational tool. There are both English and Spanish versions of 
each booklet with attention paid to patients’ information preferences. The 
tools are written at an 8th grade reading level, use generic drug names, and 
communicate risk clearly. 
 
Basics: The drugs used as part of each regimen are outlined, along with 
their route of administration. 
 
Benefits: Includes the purpose of treatment (palliative, prevent 
symptoms, not cure). 
 
Impact on prognosis: Patients have the option of reviewing a section that 
describes typical life-expectancy of mCRC and pancreatic cancer with 
and without chemotherapy. This section is closed by a seal, and preceded 
by a warning to allow them to make a conscious choice of whether or not 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 19 of 50 
 
to be exposed to this information. 
 
Risks: Most common toxicities listed in order of frequency (and 
approximate rates). Rare complications are listed, but de-emphasized to 
avoid the feel of a “laundry list.” 
 
Alternatives: Clinical trials, palliative /supportive care, & other 
chemotherapy regimens. 
 
FAQ’s: Identified by patient stakeholders 
 
Question prompt list: A list of questions developed by investigators and 
patient stakeholders that patients and caregivers may commonly ask their 
oncologists about the cancer and chemotherapy regimens.  
 
Randomization and Administration of Intervention 
 
Overview: Patients will be randomized by the study team using REDCap’s 1:1 
randomization algorithm. Patients randomized to the Usual CE Arm will 
undergo the standard institutional practice of chemotherapy education. The 
oncologist may also choose to give the patient the institutionally approved 
chemotherapy information sheets according to site-specific policies and 
clinical practice. 
 
Patients randomized to the CEI Arm will be given regimen specific written 
and video chemotherapy educational tools developed by the study team. The 
treating oncologist will identify which chemotherapy regimen(s) are being 
considered, in order to select the appropriate chemotherapy educational tool(s) 
to give the patient. The patient may be given more than one CEI tool if they 
are considering more than one regimen. Patients randomized to the 
intervention arm may receive the intervention in addition to OR in place of the 
standard institutionally approved chemotherapy information sheets (both are 
acceptable); this is at the discretion of the treating site or the treating 
physician. If sites have other standard chemotherapy educational processes 
aside from printed teaching materials (e.g. a nurse teaching session, or a 
group chemotherapy class), the patient will participate in these standard 
teaching processes.  
 
At the beginning of the study period, the video and booklet chemotherapy 
educational tools will be shared with medical oncologists, mid-level providers, 
or clinical staff who play a role in patient education. The purpose of this orientation 
is to help facilitate any subsequent conversations about the study 
chemotherapy educational tools that might occur between providers and 
patients randomized to the intervention. 
 
Timing of randomization and intervention delivery: Patients will be 
randomized to the intervention or control arm after completing the baseline 
assessment and receiving a treatment recommendation from their oncologist. 
Randomization and delivery of the intervention will occur as soon as possible after 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 20 of 50 
 
the initial treatment recommendation, and no later than the end of the day on their 
first chemotherapy treatment (see protocol schema in Figure 1).  
 
Administration of intervention: After completion of the baseline assessment and 
randomization, a RA or the treating physician/nurse practitioner (depending 
site preference) will give the patient the relevant CEI booklet(s) along with 
printed information containing the URL address and password to the relevant 
CEI video(s). Patients will be encouraged to review the CEI on their own; 
however, the RA will also schedule a time to meet the patient to orient them 
to the materials and allow them to watch the video on a study iPad. This 
meeting will ideally be anchored to a normal chemotherapy teaching session, 
depending upon the participating site’s usual clinical practice. If the patient 
does not receive the study materials at the initial consult, they will be mailed 
to the patient’s home and the research assistant will follow-up by phone 
and/or email to answer any questions and schedule a time to meet in-person. 
Patients will be encouraged to review the CEI with their caregiver or other 
supporters, and to discuss any questions with their care team. The RA will be 
instructed not answer any clinical questions raised as a result of the CEI. 
 
Study participants will complete 4 study assessments. Caregivers will 
complete 3 study assessments. Questionnaire-based instruments will be 
administered 1) in person by a trained research assistant at the time of a 
routinely scheduled visit, 2) by e-survey, 3) by phone, or 4) by postal mail. 
Mode of collection will be recorded. REDCap (Research Electronic Data 
Capture) will be used to collect and store all participant information and 
survey answers. REDCap is a secure, web-based, HIPAA-compliant 
application hosted by the Partners HealthCare Research Computing, 
Enterprise Research Infrastructure & iServices (ERIS) group, designed to 
support data capture for research studies, providing: 1) an intuitive interface 
for validated data entry; 2) audit trails for tracking data manipulation and 
export procedures; 3) automated export procedures for seamless data 
downloads to common statistical packages; and 4) procedures for importing 
data from external sources. 
 
Each patient will be asked to complete four assessments: 
 
Patient Instrument 1: Baseline Assessment (See Appendices 20,30) 
A baseline survey will occur immediately after enrollment and no later than 
the initiation of chemotherapy to assess socio-demographics, communication 
and information preferences, and quality of life. The baseline assessment will 
take approximately 15-20 minutes to complete. Patients will be compensated 
$10 for completing this assessment. 
 
Patient Instrument 2: Post-Decision Assessment (See Appendices 
21,22,31, 32) 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 21 of 50 
 
A post-decision survey within 0-2 weeks of the initiation of chemotherapy 
will assess understanding of prognosis and chemotherapy risks/benefits; 
quality of informed decision-making; distress; satisfaction with the 
chemotherapy education process and communication. The post-decision 
assessment will take approximately 15-20 minutes to complete.  
 
Patient Instrument 3: 3-Month Follow-up Assessments (See Appendices 
23,24,33,34) 
A follow-up survey at 8-12 weeks post-chemo start will assess 
stability/change in understanding of prognosis and chemotherapy benefits, 
patient-physician relationship, communication & care satisfaction, and 
financial strain. The post-decision assessment will take approximately 15-20 
minutes to complete. Patients will be compensated $10 for completing this 
assessment. 
 
Patient Instrument 4: 6-Month Follow-up Assessment (See Appendices 
25,35) 
A follow-up survey at 6-8 months post-chemo start will assess 
stability/change in quality of life and occupation/income, in addition to the 
financial strain (significant material hardship, care tradeoffs due to cost) of 
cancer care. Patients will be compensated $25 for completing this 
assessment. 
 
Each caregiver will be asked to complete three assessments: 
 
Caregiver Instrument 1: Baseline Assessment (See Appendices 26,36) 
A baseline survey will occur immediately after enrollment (but prior to 
intervention exposure) to assess socio-demographics, illness understanding, 
communication and information preferences, and quality of life. The baseline 
assessment will take approximately 15-20 minutes to complete. Caregivers 
will be compensated $10 for completing this assessment. 
 
Caregiver Instrument 2: 3-Month Follow-up Assessment (See 
Appendices 27,37) 
A follow-up survey within 8-12 weeks of the patient’s chemo start will assess 
understanding of prognosis and chemotherapy risks/benefits; quality of 
informed decision-making; distress; satisfaction with communication, quality 
of life, caregiver burden, and financial strain. The first follow-up assessment 
will take approximately 15-20 minutes to complete. Caregivers will be 
compensated $10 for completing this assessment. 
 
Caregiver Instrument 3: 6-Month Follow-up Assessment (See 
Appendices 28,29,38,39) 
A follow-up survey at 6-8 months post-decision will assess stability/change 
in quality of life and occupation/income, the financial strain (significant 
material hardship, care tradeoffs due to cost) of cancer care, quality of life, 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 22 of 50 
 
and caregiver burden. The second follow-up assessment will take 
approximately 15-20 minutes to complete. Caregivers will be compensated 
$25 for completing this assessment.  
 
Medical Record Abstraction (see Appendices 10-11): Research assistants 
will perform medical record abstraction for all enrolled patients. These 
medical record abstractions will be designed to assess relevant information 
about their clinical condition (e.g. stage at diagnosis, date of recurrence, 
performance status, comorbid conditions), treatment decision, and treatment 
experience. Information will be entered into a study specific structured 
medical record abstraction tool. See below for specific information to be 
abstracted: 
 date of diagnosis; stage at diagnosis; prior adjuvant or palliative 
chemotherapy; date of metastatic recurrence (if relevant); comorbid 
medical conditions; performance status; treatment decision made 
(e.g., what chemotherapy regimen, clinical trial, no chemotherapy); 
changes in treatment (e.g. dose reductions, change in chemotherapy); 
results of restaging scans (disease progression, stable disease, or 
response); changes in treatment; medical record documentation of 
advance care planning; and vital status at study completion. 
 
NOTE: Each site has the option to conduct the medical record review for 
their site’s participants using the unique study ID # and enter the 
information into REDCap using the participants’ unique study ID #. 
Medical records from participating sites will not be released to Dana-
Farber unless the participant signs the medical record release form 
(Appendices 6-7). 
 
In some cases, a participant will consent to participate in this study and begin 
this study while at a participating site, but then continue/transfer care at a 
non-participating site. In these instances, the participant will be asked to sign 
an optional, voluntary Global Medical Record Release Form (see Appendices 
6-7) so that the central research assistant at Dana-Farber can access the 
participant’s medical records in order to complete the study Medical Record 
Abstraction (Appendices 10-11). 
 
There are 3 types of risk to this study: 
 Physical risks: Physical risk to subjects in the proposed study is negligible. 
 Psychological risks: Participants may experience emotional/psychological distress 
as a result of participating, as a result of their diagnosis of advanced GI cancer, 
and/or as a result of learning that palliative chemotherapy is not at all likely to 
cure their cancer. Participants may decide at any time and for any reason not to 
participate in the proposed study. The alternative to participating in the proposed 
study is to not participate in the proposed study in which case the patient will 
receive the usual care chemotherapy informed consent materials. 
 Privacy risks: There is a risk of privacy violation or loss of confidentiality; 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 23 of 50 
 
however, this is anticipated to be minimal, and the study team is committed to 
guaranteeing adequate protection against risk as described in the following 
section. 
 
Adequacy of Protection Against Risks 
Recruitment and Informed Consent 
Participants will be approached by the RA in a private and confidential manner. If the 
patient is eligible and interested in participation, the IRB-approved IC document for 
research will be reviewed with and signed by the participant. The RA will keep all signed 
IC documents in a locked drawer, accessible only to the PI-designated study team member 
who holds the key. 
 
The informed consent to participate in research documents will be approved by each 
site’s IRB and will adhere to strict standards regarding its content. Required sections 
include: Introduction; Why is this research study being done? What other options are 
there? What is involved in the research study? How long will I be in this research 
study? What are the risks or discomforts of the research study? What are the benefits of 
the research study? Can I stop being in the research study and what are my rights? 
What are the costs? What happens if I am injured or sick because I took part in this 
research study? What about confidentiality? Whom do I contact if I have questions 
about the research study? 
  
Protection against the 3 types of risk to this study: 
 Protection against physical risks: physical risk to subjects in the proposed study is 
negligible. 
 Protection against psychological risks: First, we are minimizing risk by our 
extensive process of stakeholder involvement, piloting of the CEI tools on 
patients/caregivers of patients with advanced GI cancer, with iterative rounds of 
revisions to ensure that the CEI tools developed meet the information needs and 
preferences of Latino cancer patients/caregivers. Any patients who exhibit 
psychological distress stress as result of the study tools will be referred to the 
patients’ oncologist and social worker, or a mental health professional as 
appropriate. 
 Protection against privacy risks: To protect PHI, the following measures will be 
taken. Patients will be approached and interviewed in private settings. All study 
form hard copies will use only de-identified unique study ID numbers and be kept 
in the patients’ study files in locked drawers to which only the designated study 
team member has a key. All electronic data will be kept on Dana-Farber’s secure, 
password protected servers as managed by the Dana-Farber Department of 
Research Computing and IS. 
 
Departmental and institute-wide policies enforce the protection of our electronic 
information, especially with regards to HIPAA regulations and the integrity of patient 
care. These policies also safeguard again theft, abuse, misuse, and any form of damage. 
The scope of protection includes information which is printed from or stored on a 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 24 of 50 
 
database, mainframe, server desktop, laptop, PDA, CD-ROM, hard disk, flash drive, 
optical platter, tape, smart phone, network, telephone, and other computer-enabled 
medical devices. These policies regulate usage of system IDs, passwords, e-mail 
accounts, anti-virus mechanisms, encryption, mobile devices, remote access, remote 
control software, and wireless devices. IS responsibilities and governance include 
firewall protection of all Dana-Farber internal networks and the internet, system 
evaluation, risk analysis, information access, regular review of user accounts, systems 
audit, regular review of remote access, and physical location access. Specific to this 
project, no data will be stored on laptops at any point and secure transfer protocols will be 
used for any electronic exchange of information. All staff/users receive mandatory 
institutional trainings on Information Security and must adhere to policies at all times. 
Data will be collected using survey materials developed by the study team. 
These are attached in the appendices. Information from the medical record 
will be obtained through chart abstraction. The chart abstraction form is 
attached (Appendices 10-11). 
No specimens will be collected from study participants. Data will be collected (using 
unique study ID numbers) from each participant on the 4 study assessments, completed in 
either English or Spanish. Data will also be collected from each participant’s medical 
record via chart abstraction performed by the research staff at each site. Data will be 
collected (using unique study ID numbers) from each caregiver on the 3 study 
assessments, completed in either English or Spanish. 
 
Summary of measures used at each patient assessment  
Table 1: Key study outcomes, measures, and time points of assessment 
 
Domain 
Measures 
Baseline 
Assessmen
t 
Post-
decision 
Assessmen
t
Follow-up 
Assessmen
t 1 (3 
months)
Follow-up 
Assessmen
t 2 (6 
months)
Covariates 
Socio-demographics 
Standard assessments 
 
 
 
 
Health Literacy/numeracy 
Self-reported health 
literacy/numeracy 
 
 
 
 
Sources of health 
information 
Adapted from HINTS 
 
 
 
 
 
 
Communication & 
decision-making 
preferences 
Control Preferences Scale46 
 
 
 
 
 
Prognostic information preferences25
 
 
 
 
 
Religion/spirituality 
Balboni RSCC 
 
 
 
 
 
Acculturation 
SASH Language subscale 
 
 
 
 
Language concordance 
Adapted from literature 
 
 
 
 
 
Use of interpreters 
From CAHPS 
 
 
 
 
 
Key Outcomes 
Aim 1: Core Understanding  
 
     Chemotherapy benefits 
Adapted from CANCORS (primary 
outcome)20  
 
 
 
 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 25 of 50 
 
 
Summary of measures used at each caregiver assessment. All caregiver outcomes are 
exploratory. 
Information important to 
treatment decision-
making 
Adapted from parent study 
 
 
 
 
 
 
Risks, Benefits, 
Alternatives 
Adapted from parent study69 
 
 
 
 
     Prognosis 
Adapted from Coping with Cancer  
 
 
 
 
AIM 2: Satisfaction with communication and care  
     With MD 
communication  
5 items from CAHPS43,70 
 
 
 
 
     With CE process/CE 
tools 
Developed from parent study 
 
 
 
 
With communication 
around chemotherapy 
PACE scale  
 
 
 
 
 
Aim 2: Decision Making about cancer treatment  
     Decisional conflict 
SURE 
 
 
 
 
     Decisional involvement 
Modified Control Preferences 
Scale46 
 
 
 
 
 
Decisional regret 
Decisional Regret Scale 
 
 
 
 
 
     Advance care planning 
Standard metrics3 
 
 
 
 
 
Aim 3: Impact of cancer on quality of life, occupation, and financial strain 
Quality of life  
PROMIS Global Health Short Form 
 
 
 
 
 
Symptoms related to 
chemotherapy and GI 
cancer 
PRO-CTCAE 
 
 
 
 
 
 
 
Occupation/income 
Standard assessments 
 
 
 
 
 
 
 
Health Insurance 
Standard assessments 
 
 
 
 
 
 
Financial stress/strain 
From CanCORS, Zafar 
 
 
 
 
 
 
 
Significant material 
hardship 
From Children’s Healthwatch 
 
 
 
 
 
 
Adverse financial effects 
Adapted from literature 
 
 
 
 
 
 
Cost-shifting behaviors 
Adapted from literature 
 
 
 
 
 
 
Table 2: Key study outcomes, measures, and time points of assessment 
Domain 
Measures 
Baseline 
Assessment 
Follow-up 
Assessment 
1 (3 months) 
Follow-up 
Assessment 
2 (6-8 
months)
Covariates 
Socio-demographics 
Standard assessments 
 
 
 
 
Health Literacy/numeracy 
Self-reported health literacy/numeracy 
 
 
 
 
Religion/spirituality 
Balboni RSCC 
 
 
 
 
Acculturation 
SASH Language subscale 
 
 
 
 
Key Outcomes 
Core Understanding  
     Chemotherapy benefits 
Adapted from CANCORS 1 
 
 
 
 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 26 of 50 
 
 
 
 
These data will be collected at each site by a member of the study team as designated by 
the site’s lead study investigator as overseen by the site’s IRB. All original study form 
hard copies/source documentation will be kept in the patients’ study files in locked 
drawers to which only the designated study team member has a key. All electronic 
data will be securely transmitted to the lead site (Dana-Farber Cancer Institute) via 
encrypted file transfer where it will be kept on Dana-Farber’s secure, password-
protected servers as managed by the Dana-Farber Department of Research Computing 
and IS. Only the DF/HCC PI and her designees as overseen by the DF/HCC IRB will 
have access to the data collected during this study. All data collected during this study 
will be collected and stored using unique study ID numbers. All data analysis will be 
done in-house at Dana-Farber/UMB; no data will be released to an outside institution. 
Stakeholders will have access to aggregate interim results, but not to individual 
participant or raw study data. 
 
 
10.0 Data and Specimen Banking* 
Information important to 
treatment decision-making 
Adapted from parent study 
 
 
 
 
     Prognosis 
Adapted from Coping with Cancer  
 
 
 
 
Satisfaction with communication and care 
     With MD communication  
5 items from Cancer CAHPS1  
 
 
 
 
Decision Making about cancer treatment  
 
 
 
Information sharing 
preferences 
Adapted from literature 
 
 
 
 
     Advance care planning 
Standard metrics23 
 
 
 
 
Quality of life & distress 
 
 
 
Quality of life  
PROMIS Global Health Short Form 
 
 
 
 
 
 
Anxiety 
PROMIS Anxiety Short Form 
 
 
 
 
 
 
Depression 
PROMIS Depression Short Form 
 
 
 
 
 
 
Emotional support 
PROMIS Emotional Support Short Form 
 
 
 
 
 
 
Caregiver support 
California Universal Caregiver 
Assessment 
 
 
 
 
 
Caregiver health behaviors 
Adapted from literature 
 
 
 
 
 
Caregiver burden 
Zarit Burden Interview 
 
 
 
 
 
 
Occupation/income/financial strain 
Occupation/income 
Standard assessments 
 
 
 
 
 
 
Health Insurance 
Standard assessments 
 
 
 
 
Financial stress/strain 
From CanCORS, Zafar 
 
 
 
 
 
Significant material hardship 
From Children’s Healthwatch 
 
 
 
 
 
Adverse financial effects 
Adapted from literature 
 
 
 
 
 
Cost-shifting behaviors 
Adapted from literature 
 
 
 
 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 27 of 50 
 
For this study, no specimens will be collected from participants. All participants 
will however, complete up to 4 study surveys. All original study forms (including 
study surveys, consent forms, registrations forms, etc.) including hard 
copies/source documentation will be kept in the patients’ study files in locked 
drawers in Dana 1011 to which only the designated study team member has a key. 
All electronic data will be securely transmitted to the lead site (Dana-Farber Cancer 
Institute) via encrypted file transfer where it will be kept on Dana-Farber’s secure, 
password-protected servers as managed by the Dana-Farber Department of 
Research Computing and IS. Only the DF/HCC PI and her designees as overseen 
by the DF/HCC IRB will have access to the data collected during this study. All 
data collected during this study will be collected and stored using unique study ID 
numbers. Data will be stored on DFCI servers for 2 years after the completion of 
the study. 
 
Only the DFCI/HCC PI and her designees will have access to the data. Interim data will 
be released to stakeholders only in aggregate. 
 
Study results will be available on clinicaltrials.gov and study participants will also be 
asked if they would like to receive overall study results during the informed consent 
process.  
 
Collected study data may be stored and used for future research. If so, any personal 
identifiers will be removed so that the information or samples cannot be linked back to 
individual participants.  
 
Investigators, including investigators from collaborating institutions, can request this data 
for new research.  Data may also be shared with outside non-profit academic 
investigators as well as with for-profit pharmaceutical investigators or commercial 
entities, with whom we collaborate. All requests for data usage will be up to the 
discretion of the study PI.   
 
11.0 Data Management* and Confidentiality 
 
Primary analyses of the intervention effect will reflect the “intention to treat” 
principle, however, results will also be described according to participants’ actual 
use of the intervention. Differences between study arms in our primary outcome 
(patients’ understanding of chemotherapy benefits at 8‐12 weeks) will be examined 
using the Fisher’s exact test. Differences in all other patient and caregiver outcomes 
will be tested using Fisher’s exact test (for nominal categorical outcomes), and 
Wilcoxon tests for ordinal measures. Subgroup analyses will explore the effect of the 
intervention by cancer diagnosis (colorectal or pancreatic), primary language, 
health literacy, and by components of the intervention utilized. Because the 
intervention effect may be moderated by patient characteristics (e.g., English 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 28 of 50 
 
proficiency, degree of acculturation), interaction tests will examine treatment 
heterogeneity.  
 
Descriptive statistics will explore patient/caregiver financial and occupational outcomes 
and financial toxicity over time. Of note, we do not expect these “outcomes” to be 
impacted by the intervention, but we plan to analyze them across the overall study cohort. 
Trajectories in these outcomes over time will be examined using paired Wilcoxon tests, 
or difference scores. We will also explore relationships between financial toxicity, strain 
and household material hardship (independent variables) and patients’ and caregivers’ 
quality of life and emotional well-being (dependent variables) using multivariable linear 
regressions controlling for potentially confounding sociodemographic factors. 
Generalized estimating equations will also examine the influence of these independent 
variables on relevant outcome trajectories over time. 
 
Primary analysis for our primary and key secondary outcomes will employ multiple 
imputation to mitigate potential bias associated with missing data.  Multiple imputation 
will be performed according to a “missing at random” assumption, which postulates that 
the missingness of data is not completely random, but may be partly accounted for by 
observed data.71 
 
Accurate chemotherapy understanding (primary outcome): Assuming an attrition rate of 
25% and a resultant n=116, this study has 88% power to detect a two-fold improvement 
in our primary outcome, with a one-sided p<0.05 (see table 3). The effect size for our 
primary outcome is based upon conservative projections of accurate expectations 
regarding cure from palliative chemotherapy reported in the literature,20,37 and based 
upon what would constitute a clinically meaningful improvement in understanding.  
 
Excellent communication rating: The study also has 88% power to detect a 50% 
increase in the proportion of patients providing excellent communication ratings, a 
clinically meaningful effect size derived from CanCORS20, with a one‐sided p<0.05. 
 
Decisional conflict: In the parent study, 25% of patients in the usual care arm 
experienced any degree of decisional conflict. With 80% power, we will be able to 
detect a 17% decrease in decisional conflict with a one‐sided p<0.05.  
 
Achievement of desired decisional control: In the parent study, 38% of patients in 
the usual care arm achieved their desired level of decisional control, which is 
consistent with the literature.72 With 80% power, we will be able to detect a 23% 
increase in achievement of desired decisional control with a one‐sided p<0.05.  
 
Given that multiple imputation will be used for missing data, Table 3 also presents 
power calculations for the recruitment goal, n=154. 
 
 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 29 of 50 
 
Table 3: Power for primary and secondary outcome with n=116 and n=154, one-sided 
p<0.05 
 
Outcomes & source of estimate 
Estimated Effect 
Power for n=116, 
p<0.05, one-sided 
Power for n=154, 
p<0.05, one-sided
Usual care 
arm
CEI arm 
 
Accurate chemotherapy 
expectations1,73,74 
25% 
50% 
88% 
95% 
Excellent communication rating1 
50% 
75% 
88% 
95% 
Decisional conflict 
25% 
8% 
80% 
100% 
Achievement of desired 
decisional control 
38% 
61% 
80% 
89% 
 
 
In order to secure all data collected during this study, the research team will work 
on conjunction with all departmental and institute‐wide policies. These policies 
enforce the protection of our electronic information, especially with regards to 
HIPAA regulations and the integrity of patient care. These policies also safeguard 
against theft, abuse, misuse, and any form of damage. The scope of protection 
includes information which is printed from or stored on a database, mainframe, 
server desktop, laptop, PDA, CD‐ROM, hard disk, flash drive, optical platter, tape, 
smart phone, network, telephone, and other computer‐enabled medical devices. 
These policies regulate usage of system IDs, passwords, e‐mail accounts, anti‐virus 
mechanisms, encryption, mobile devices, remote access, remote control software, 
and wireless devices. IS responsibilities and governance including firewall 
protection of all Dana‐Farber internal networks and the internet, system evaluation, 
risk analysis, information access, regular review of user accounts, systems audit, 
regular review of remote access, and physical location access. Specific to this 
project, no data will be stored on laptops at any point and secure transfer protocols 
will be used for any electronic exchange of information. All staff/users receive 
mandatory institutional trainings on Information Security and must adhere to 
policies at all times. All study files will be stored in a shared folder in a HIPAA‐
compliant Dropbox Business folder shared ONLY with the study team (all of whom 
have Partners Dropbox Business).  
 
All consented patients and interested caregivers will be inputted into the Clinical 
Trials Management System (CTMS) OnCore as required by DF/HCC SOP REGIST-101. 
All Dana-Farber Participants will be registered with OnCore as soon as possible after the 
consenting/registration period, and always within the same day of enrollment. All 
external site participants will have registered with OnCore as soon as the external team 
notifies DFCI about the new enrollment and sends a copy of the consent form and 
registration form.  
 
Appendix 5 provides the Data and Safety Monitoring Plan (DSMP) for this study. 
The DSMP will ensure that our DF/HCC multi-site project will comply with Federal 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 30 of 50 
 
Regulations, Health Insurance Portability and Accountability Act (HIPAA) 
requirements, and applicable DF/HCC, DFCCC, and Standard Operating 
Procedures, and NCI Guidelines. 
 
 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
 
This is a social behavioral research project, not a treatment protocol.  The study involves 
questionnaire-based assessments.  As such, the only adverse event that will be monitored 
and reported is psychological distress as determined by the treating oncologist. For any 
patient who exhibits severe distress as result of the study procedures, the study research 
assistant will notify the patients’ oncologist and social worker for appropriate response, 
including possible mental health referral if necessary. Furthermore, participants will be 
reminded that participation is voluntary and can be stopped at any time for any reason. 
 
13.0 Withdrawal of Subjects* 
Subjects who do not complete the baseline assessment prior to the initiation of 
chemotherapy, or within 2 weeks of the decision not to undergo chemotherapy 
will be withdrawn from the research study without their consent. These patients 
will be informed of their withdrawal from the study by study staff.  
The overall DF/HCC study PI, Dr. Andrea Enzinger, will make all decisions 
regarding early termination of the study. The study team will then notify all 
participants accordingly.   
 
When subjects withdraw from the research, they will no longer be contacted by 
study staff to complete remaining assessments. Their assessments up to their 
withdrawal will be included in intention-to-treat analyses of the primary and 
secondary outcomes. If a participant withdraws consent at any time, all of their 
assessments will be discarded and will not be included in study analyses, unless 
otherwise noted by the withdrawing participant.  
14.0 Risks to Subjects* 
 Physical risks: Physical risk to subjects in the proposed study is negligible. 
 Psychological risks: Participants may experience emotional/psychological distress 
as a result of participating, as a result of their diagnosis of advanced GI cancer, 
and/or as a result of learning that palliative chemotherapy is not at all likely to 
cure their cancer. Participants may decide at any time and for any reason not to 
participate in the proposed study. The alternative to participating in the proposed 
study is to not participate in the proposed study in which case the patient will 
receive the usual care chemotherapy informed consent materials. 
 Privacy risks: There is a risk of privacy violation or loss of confidentiality; 
however, this is anticipated to be minimal, and the study team is committed to 
guaranteeing adequate protection against risk as described in the following 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 31 of 50 
 
section. 
 
Protection Against Risks 
Recruitment and Informed Consent 
Participants will be approached in by the RA in a private and confidential manner. If the 
patient is eligible and interested in participation, the IRB-approved IC document for 
research will be reviewed with and signed by the participant. The RA will keep all signed 
IC documents in a locked drawer, accessible only to the PI-designated study team member 
who holds the key. 
 
The informed consent to participate in research documents will be approved by each 
site’s IRB and will adhere to strict standards regarding its content. Required sections 
include: Introduction; Why is this research study being done? What other options are 
there? What is involved in the research study? How long will I be in this research 
study? What are the risks or discomforts of the research study? What are the benefits of 
the research study? Can I stop being in the research study and what are my rights? 
What are the costs? What happens if I am injured or sick because I took part in this 
research study? What about confidentiality? Whom do I contact if I have questions 
about the research study? 
  
Protection against the 3 types of risk to this study: 
 Protection against physical risks: physical risk to subjects in the proposed study is 
negligible. 
 Protection against psychological risks: First, we are minimizing risk by our 
extensive process of stakeholder involvement, piloting of the CEI tools on 
patients/caregivers of patients with advanced GI cancer, with iterative rounds of 
revisions to ensure that the CEI tools developed meet the information needs and 
preferences of Latino cancer patients/caregivers. Any patients who exhibit 
psychological distress as a result of the study tools will be referred to the patients’ 
oncologist and social worker, or a mental health professional as appropriate. 
 Protection against privacy risks: To protect PHI, the following measures will be 
taken. Patients will be approached and interviewed in private settings. All study 
form hard copies will use only de-identified unique study ID numbers and be kept 
in the patients’ study files in locked drawers to which only the designated study 
team member has a key. All electronic data will be kept on Dana-Farber’s secure, 
password protected servers as managed by the Dana-Farber Department of 
Research Computing and IS. 
 
15.0 Potential Benefits to Subjects* 
By taking part in the research, individual subjects, particularly those randomized 
to the intervention, may gain an improved knowledge of the risks and benefits of 
the chemotherapy regimen for their cancer. This knowledge may prepare them for 
what lies ahead in their treatment course and may therefore improve quality of life 
and decrease distress. Subjects may also gain a more accurate understanding of 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 32 of 50 
 
their prognosis, which may help facilitate end-of-life planning and the pursuit of 
goal-concordant care. It is our hope that the knowledge gained through this study 
will be durable and subjects will retain it beyond the completion of the study. 
 
16.0 Vulnerable Populations* 
Not applicable to this study. 
17.0 Community-Based Participatory Research*. 
Not applicable to this study. 
18.0 Sharing of Results with Subjects* 
Study results will be shared with participants in aggregate at the conclusion of 
primary and secondary analyses. 
19.0 Setting 
Study Setting: The study will be conducted at the Dana-Farber Cancer Institute 
Longwood Campus. Participants will be identified through 2 different methods: 1) direct 
referral from clinicians in the Gastrointestinal Oncology group and 2) review of new and 
existing patient scheduling reports in EPIC. For consenting purposes, both patients and 
caregivers will be approached in clinic in-person by a member of the research team. All 
study assessments can be completed in-person, over the phone, or via email in order to 
minimize burden on participants. This study will also be open at 6 additional academic 
and community oncology practices across the US, serving large and diverse Latino 
populations. Diversity of sites will ensure generalizability of our findings. 
 
20.0 Resources Available 
This study team will be taking place under the Population Sciences Division at Dana‐
Farber. The Population Sciences Division maintains its own server infrastructure 
and systems administration staff that provide data storage, data backup, and data 
security in support of large data analysis projects. The servers are configured as a 
virtual server pool with virtual server hosts connected to a centralized Storage Area 
Network (SAN) device. Server virtualization increases the efficiency and flexibility of 
the server pool while minimizing downtime and cost. The server pool currently has 
20 processor cores and a data storage capacity of 9 terabytes. This server 
infrastructure has a dedicated Systems Administrator to optimize performance, 
maintain security patches, perform backups, and execute other related tasks. 
Researchers in the Division have access to additional resources through the 
Research Computing group. Research Computing provides a variety of services 
including file server space, backup services, website hosting, and support of some 
workstation computers. 
Additionally, the research staff is well‐qualified to perform their duties. Drs. 
Enzinger and Schrag have extensive experience in conducting multi‐center research 
studies in cancer disparities, health services, and education. They have deep 
knowledge of the clinical and research environments and the patient population and 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 33 of 50 
 
culture at DFCI. Dr. Lindsay has extensive experience in health disparities and socio‐
behavioral intervention, particularly with regard to Latino health. The project 
manager, Christine Cronin has significant experience in running large, multi‐center 
trials in this area, and she has overseen the management of DF/HCC Protocol #15‐
143 (the parent study for this project that was funded by PCORI).  
 
We believe that it is feasible to recruit the required number of suitable subjects 
within the agreed recruitment period. The GI oncology clinic at DFCI sees an 
average of 25-30 patients with advanced colorectal and pancreatic cancers about 
to start chemotherapy per month. Of these, roughly 10% are Latino. This study 
will also be open at 6 additional academic and community oncology practices 
across the US, serving large and diverse Latino populations.  
 
Dr. Enzinger will devote 5% of her time to conducting and completing the 
research project. Her main responsibilities will include overseeing subject 
recruitment and ensuring interim project analyses. Christine Cronin, the PM will 
also devote 75% of her time to the oversight and management of this project.  
The Population Sciences Division maintains its own server infrastructure and systems 
administration staff that provide data storage, data backup, and data security in support of 
large data analysis projects. The servers are configured as a virtual server pool with 
virtual server hosts connected to a centralized Storage Area Network (SAN) device. 
Server virtualization increases the efficiency and flexibility of the server pool while 
minimizing downtime and cost. The server pool currently has 20 processor cores and a 
data storage capacity of 9 terabytes. This server infrastructure has a dedicated Systems 
Administrator to optimize performance, maintain security patches, perform backups, and 
execute other related tasks. Researchers in the Division have access to additional 
resources through the Research Computing group. Research Computing provides a 
variety of services including file server space, backup services, website hosting, and 
support of some workstation computers. 
 
Any patients who exhibit psychological distress as a result of the study tools will be 
referred to the patients’ oncologist and social worker, or a mental health professional as 
appropriate. Given the nature of the intervention, there are no anticipated medical 
consequences of this study. 
 
All investigators, research assistants, and study staff will be oriented to the protocol 
during a study-initiation webinar. During this webinar, the PI and PM will provide a 
detailed orientation to all study procedures and all study staff members’ duties and 
functions. Each site will also have electronic and hard copies of the protocol which will 
be made available to study staff. Regular check-in conference calls with study staff will 
be used to provide updates on the protocol if changes have been made, discuss issues at 
the individual sites with regard to recruitment, administration of the intervention, 
assessment, or any other issue that may arise.  
  

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 34 of 50 
 
21.0 Prior Approvals 
Not applicable for this study.  
 
22.0 Recruitment Methods 
The majority of potential subjects will be recruited at their initial consultation with the 
oncologist at participating study sites. These patients will be aware that they have been 
diagnosed with either colorectal or pancreatic cancer but will have not yet started 
treatment with chemotherapy. Potential subjects will be approached by study research 
assistants prior to their consultation and offered participation in a study seeking to study a 
new tool to enhance education around treatments for colorectal and pancreatic cancers. 
The RA will discuss the overall aims of the study (to improve education around cancer 
treatments), the study intervention (educational tools) and assessments (surveys). The RA 
will refer to cancer treatments and not mention chemotherapy specifically as these 
patients have not yet discussed treatment options and the potential for chemotherapy with 
their oncologists. If the patient agrees to participate the RA will obtain written informed 
consent at that time.  
 
Potential subjects may also be recruited after their initial consultation with the oncologist. 
If the subject meets eligibility criteria but was not approached prior to their consultation, 
the study RA will approach the potential subject, either at the conclusion of the initial 
consultation, or at a subsequent visit prior to the initiation of chemotherapy. The RA will 
again describe the study and offer the potential subject the opportunity to participate. If 
the subject agrees to participate, the RA will obtain written informed consent at that time. 
 
The source of subjects at DFCI will be the GI Oncology clinic where patients with 
colorectal and pancreatic cancers. 
 
The research assistant will identify potentially eligible participants by systematically 
reviewing new patient and existing patient scheduling reports, as well as by accepting 
physician referrals. We are requesting a HIPAA waiver of authorization so that the 
research assistant may look in the Electronic Health Record to determine eligibility before 
approaching potential participants. 
 
1) For patients presenting to oncology clinic for an initial consultation/new 
treatment decision regarding first-line chemotherapy for their metastatic 
colorectal cancer, locally advanced pancreatic cancer, or metastatic 
pancreatic cancer: the research assistant will identify potentially eligible 
patients by screening new patient scheduling reports. The research assistant 
will notify the oncology attending physician of the patients’ potential 
eligibility prior to this initial consultation, will confirm the patients’ 
potential eligibility, and will ask permission to approach the patient for 
participation. Study research assistants will keep track of the number of 
potentially eligible patients, the number of physician refusals, and the reason 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 35 of 50 
 
for those refusals. Most potentially eligible patients will be approached 
before their initial consultation with the oncologist.  
2) Oncology clinicians (physicians, nurse practitioners, physician assistants, 
and pharmacists from medical oncology, surgical oncology, and radiation 
oncology) will be able to refer eligible participants for enrollment in the 
study. Each site will determine the logistics of the referral process 
depending on its clinic model and staffing. At all sites, if the referral is 
made by a provider other than the attending physician, the research assistant 
will ask the attending physician’s permission prior to approaching a patient. 
The research assistants will keep track of the number of potentially eligible 
patients referred, the number of physician refusals, and the reason for those 
refusals. 
 
All potential subjects will be approached by a study research assistant or referred by an 
oncology provider. Advertisements (printed, audio, or video), will not be used to recruit 
subjects in this study. 
 
Subjects will be paid $10 for completion of the baseline assessment. They will be 
paid $10 for the 8-12-week follow-up questionnaire. Participants will receive $25 
for the final follow-up questionnaire given at 6-8 months.   
 
23.0 Local Number of Subjects:  
The study team is looking to enroll 100 total subjects and caregivers locally. 
 
24.0 Provisions to Protect the Privacy Interests of Subjects 
To protect PHI, the following measures will be taken. Patients will be approached and 
interviewed in private settings. All study form hard copies will use only de-identified 
unique study ID numbers and be kept in the patients’ study files in locked drawers to 
which only the designated study team member has a key. All electronic data will be kept 
on Dana-Farber’s secure, password protected servers as managed by the Dana-Farber 
Department of Research Computing and IS. 
 
Departmental and institute-wide policies enforce the protection of our electronic 
information, especially with regards to HIPAA regulations and the integrity of patient 
care. These policies also safeguard again theft, abuse, misuse, and any form of damage. 
The scope of protection includes information which is printed from or stored on a 
database, mainframe, server desktop, laptop, PDA, CD-ROM, hard disk, flash drive, 
optical platter, tape, smart phone, network, telephone, and other computer-enabled 
medical devices. These policies regulate usage of system IDs, passwords, e-mail 
accounts, anti-virus mechanisms, encryption, mobile devices, remote access, remote 
control software, and wireless devices. IS responsibilities and governance including 
firewall protection of all Dana-Farber internal networks and the internet, system 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 36 of 50 
 
evaluation, risk analysis, information access, regular review of user accounts, systems 
audit, regular review of remote access, and physical location access. Specific to this 
project, no data will be stored on laptops at any point and secure transfer protocols will be 
used for any electronic exchange of information. All staff/users receive mandatory 
institutional trainings on Information Security and must adhere to policies at all times. 
Subjects will be approached for potential participation in private They will also 
complete all study assessments in private. At each assessment, subjects will be 
reminded that they can skip any questions they do not wish to answer and are free 
to withdraw from the study at any time. 
Study research assistants will have access to subject’s medical records to abstract 
information as discussed in other sections of this protocol. RAs will only access 
information that is necessary to collect for the study protocol and will not be 
permitted to access the medical record for other purposes. 
25.0 Compensation for Research-Related Injury 
Not applicable for this study.  
 
26.0 Economic Burden to Subjects 
Subjects will complete study assessments at previously scheduled oncology visits. 
We do not anticipate that the study will lead to any new costs for subjects. 
27.0 Consent Process 
We will be obtaining informed consent for this study. The study RAs will obtain 
written informed consent from subjects after they agree to participate in the study. 
For most subjects, this will occur immediately before their initial oncology 
consultation. We will follow SOP: Informed Consent Process for subjects 
enrolled at DFCI. Each site will follow its own institutionally-mandated informed 
consent procedures. 
Because the caregiver is not always physically present at clinic visits, we are 
requesting waiver of documentation of consent for caregivers.  This will allow the 
RA the flexibility needed to verbally consent caregivers in person and over the 
phone since caregivers will not always be present in clinic. 
Non-English Speaking Subjects: Many study participants will speak Spanish. All 
study materials, including informed consent forms, will be translated into Spanish 
by native Spanish speakers with expertise in medical oncology or health 
communication. Spanish speaking subjects will be approached either by Spanish-
speaking research assistants, or by research assistants with professional Spanish 
interpreters.  
 
28.0 Process to Document Consent in Writing 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 37 of 50 
 
For patient subjects, we will follow SOP: Informed Consent Process (CON-100). 
For caregivers, we will be requesting a waiver of documentation of consent as 
they may not always be present with the patients for whom they care. All 
caregivers, however, will be given a study letter that contains the elements of 
informed consent and informs them about their involvement with this project.  
See Appendices 1-2 for the model informed consent forms in Spanish and English for 
patient subjects. See Appendices 3-4 for consent scripts in English and Spanish for 
caregiver subjects.  
 
29.0 Drugs or Devices 
Not applicable for this study.  
 
30.0 References 
 
1.  
Baile WF, Aaron J. Patient-physician communication in oncology: past, present, 
and future. Curr Opin Oncol. 2005;17(4):331-5. 
2.  
Institute of Medicine (IOM) Report: Delivering high quality cancer care: Charting 
a new course for a system in crisis. Washington, D.C.2014. 
3. 
Epstein RM, Street RL. Patient-centered communication in cancer care. National 
Cancer Institute; 2007. 
4.  
Trice ED, Prigerson HG. Communication in end-stage cancer: review of the 
literature and future research. J Health Commun. 2009;14 Suppl 1:95-108. 
5.  
Ashton CM, Haidet P, Paterniti DA, Collins TC, Gordon HS, O'Malley K, Petersen 
LA, Sharf BF, Suarez-Almazor ME, Wray NP, Street RL, Jr. Racial and ethnic 
disparities in the use of health services: bias, preferences, or poor 
communication? J Gen Intern Med. 2003;18(2):146-52. 
6. 
Ackerson LK, Viswanath K. The social context of interpersonal communication 
and health. J Health Commun. 2009;14 Suppl 1:5-17. 
7. 
Smith AK, McCarthy EP, Paulk E, Balboni TA, Maciejewski PK, Block SD, 
Prigerson HG. Racial and ethnic differences in advance care planning among 
patients with cancer: impact of terminal illness acknowledgment, religiousness, 
and treatment preferences. J Clin Oncol. 2008;26(25):4131-7. 
8. 
Karliner LS, Hwang ES, Nickleach D, Kaplan CP. Language barriers and patient-
centered breast cancer care. Patient Educ Couns. 2011;84(2):223-8. 
9. 
Morales LS, Cunningham WE, Brown JA, Liu H, Hays RD. Are Latinos less 
satisfied with communication by health care providers? J Gen Intern Med. 
1999;14(7):409-17. 
10. 
Sudore RL, Landefeld CS, Perez-Stable EJ, Bibbins-Domingo K, Williams BA, 
Schillinger D. Unraveling the relationship between literacy, language proficiency, 
and patient-physician communication. Patient Educ Couns. 2009;75(3):398-402. 
11.  
Statistical portrait of hispanics in the United States, 2012. [Cited December 1, 
2015]. Available from www.pewhispanic.org/2014/04/29/statistical-portrait-of-
hispanics-in-the-united-states-2012/. 
12. 
Sentell T, Braun KL. Low health literacy, limited English proficiency, and health 
status in Asians, Latinos, and other racial/ethnic groups in California. J Health 
Commun. 2012;17 Suppl 3:82-99.  

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 38 of 50 
 
13. 
Kutner M, Greenbery E, Baer JA. A first look at the literacy of America's adults in 
the 21st century. National Center for Education Statistics. 2005. 
14. 
Kale E, Syed HR. Language barriers and the use of interpreters in the public 
health services. A questionnaire-based survey. Patient Educ Couns. 
2010;81(2):187-91. 
15. 
Pham K, Thornton JD, Engelberg RA, Jackson JC, Curtis JR. Alterations during 
medical interpretation of ICU family conferences that interfere with or enhance 
communication. Chest. 2008;134(1):109-16. 
16. 
Thornton JD, Pham K, Engelberg RA, Jackson JC, Curtis JR. Families with 
limited English proficiency receive less information and support in interpreted 
intensive care unit family conferences. Crit Care Med. 2009;37(1):89-95. 
17.  
Allen RS, Allen JY, Hilgeman MM, DeCoster J. End-of-life decision-making, 
decisional conflict, and enhanced information: race effects. J Am Geriatr Soc. 
2008;56(10):1904-9. 
18. 
Born W, Greiner KA, Sylvia E, Butler J, Ahluwalia JS. Knowledge, attitudes, and 
beliefs about end-of-life care among inner-city African Americans and Latinos. J 
Palliat Med. 2004;7(2):247-56. 
19. 
Fischer SM, Sauaia A, Min SJ, Kutner J. Advance directive discussions: lost in 
translation or lost opportunities? J Palliat Med. 2012;15(1):86-92.  
20. 
Weeks JC, Catalano PJ, Cronin A, Finkelman MD, Mack JW, Keating NL, Schrag 
D. Patients' expectations about effects of chemotherapy for advanced cancer. N 
Engl J Med. 2012;367(17):1616-25. 
21. 
Smith AK, Sudore RL, Perez-Stable EJ. Palliative care for Latino patients and 
their families: whenever we prayed, she wept. JAMA. 2009;301(10):1047-57, E1. 
22. 
Romero LJ, Lindeman RD, Koehler KM, Allen A. Influence of ethnicity on 
advance directives and end-of-life decisions. JAMA. 1997;277(4):298-9. 
23. 
Enzinger AC, Zhang B, Schrag D, Prigerson HG. Outcomes of prognostic 
disclosure: Associations with prognostic understanding, distress, and relationship 
with physician among patients with advanced cancer. J Clin Oncol. 
2015;33(32):3809-16. 
24. 
Hagerty RG, Butow PN, Ellis PA, Lobb EA, Pendlebury S, Leighl N, Goldstein D, 
Lo SK, Tattersall MH. Cancer patient preferences for communication of 
prognosis in the metastatic setting. J Clin Oncol. 2004;22(9):1721-30. 
25. 
Noguera A, Yennurajalingam S, Torres-Vigil I, Parsons HA, Duarte ER, Palma A, 
Bunge S, Palmer JL, Bruera E. Decisional control preferences, disclosure of 
information preferences, and satisfaction among Hispanic patients with advanced 
cancer. J Pain Symptom Manage. 2014;47(5):896-905. 
26. 
Yennurajalingam S, Parsons HA, Duarte ER, Palma A, Bunge S, Palmer JL, 
Delgado-Guay MO, Allo J, Bruera E. Decisional control preferences of Hispanic 
patients with advanced cancer from the United States and Latin America. J Pain 
Symptom Manage. 2013;46(3):376-85. 
27. 
Yennurajalingam S, Noguera A, Parsons HA, Torres-Vigil I, Duarte ER, Palma A, 
Bunge S, Palmer JL, Delgado-Guay MO, Bruera E. A multicenter survey of 
Hispanic caregiver preferences for patient decision control in the United States 
and Latin America. Palliat Med. 2013;27(7):692-8. 
28.  
Weeks JC, Cook EF, O'Day SJ, Peterson LM, Wenger N, Reding D, Harrell FE, 
Kussin P, Dawson NV, Connors AF, Jr., Lynn J, Phillips RS. Relationship 
between cancer patients' predictions of prognosis and their treatment 
preferences. JAMA. 1998;279(21):1709-14. 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 39 of 50 
 
29. 
Meropol NJ, Weinfurt KP, Burnett CB, Balshem A, Benson AB, 3rd, Castel L, 
Corbett S, Diefenbach M, Gaskin D, Li Y, Manne S, Marshall J, Rowland JH, 
Slater E, Sulmasy DP, Van Echo D, Washington S, Schulman KA. Perceptions of 
patients and physicians regarding phase I cancer clinical trials: implications for 
physician-patient communication. J Clin Oncol. 2003;21(13):2589-96. 
30. 
Mack JW, Walling A, Dy S, Antonio AL, Adams J, Keating NL, Tisnado D. Patient 
beliefs that chemotherapy may be curative and care received at the end of life 
among patients with metastatic lung and colorectal cancer. Cancer. 
2015;121(11):1891-7. 
31. 
Earle CC, Park ER, Lai B, Weeks JC, Ayanian JZ, Block S. Identifying potential 
indicators of the quality of end-of-life cancer care from administrative data. J Clin 
Oncol. 2003;21(6):1133-8. 
32. 
Wright AA, Zhang B, Ray A, Mack JW, Trice E, Balboni T, Mitchell SL, Jackson 
VA, Block SD, Maciejewski PK, Prigerson HG. Associations between end-of-life 
discussions, patient mental health, medical care near death, and caregiver 
bereavement adjustment. JAMA. 2008;300(14):1665-73.  
33. 
Zhang B, Wright AA, Huskamp HA, Nilsson ME, Maciejewski ML, Earle CC, 
Block SD, Maciejewski PK, Prigerson HG. Health care costs in the last week of 
life: associations with end-of-life conversations. Arch Intern Med. 
2009;169(5):480-8. 
34. 
Iwashyna TJ, Chang VW. Racial and ethnic differences in place of death: United 
States, 1993. J Am Geriatr Soc. 2002;50(6):1113-7. 
35. 
Lackan NA, Eschbach K, Stimpson JP, Freeman JL, Goodwin JS. Ethnic 
differences in in-hospital place of death among older adults in California: effects 
of individual and contextual characteristics and medical resource supply. Med 
Care. 2009;47(2):138-45. 
36. 
Smith AK, Earle CC, McCarthy EP. Racial and ethnic differences in end-of-life 
care in fee-for-service Medicare beneficiaries with advanced cancer. J Am 
Geriatr Soc. 2009;57(1):153-8. 
37.  
El-Jawahri A, Podgurski LM, Eichler AF, Plotkin SR, Temel JS, Mitchell SL, 
Chang Y, Barry MJ, Volandes AE. Use of video to facilitate end-of-life 
discussions with patients with cancer: a randomized controlled trial. J Clin Oncol. 
2010;28(2):305-10. 
38. 
Weinfurt KP, Seils DM, Lin L, Sulmasy DP, Astrow AB, Hurwitz HI, Cohen RB, 
Meropol NJ. Research participants' high expectations of benefit in early-phase 
oncology trials: are we asking the right question? J Clin Oncol. 
2012;30(35):4396-400. 
39. 
Liu PH, Landrum MB, Weeks JC, Huskamp HA, Kahn KL, He Y, Mack JW, 
Keating NL. Physicians' propensity to discuss prognosis is associated with 
patients' awareness of prognosis for metastatic cancers. J Palliat Med. 
2014;17(6):673-82. 
40. 
Burris HA, 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano 
MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, 
Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with 
gemcitabine as first-line therapy for patients with advanced pancreas cancer: a 
randomized trial. J Clin Oncol. 1997;15(6):2403-13. 
41. 
Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, 
Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, 
Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 40 of 50 
 
E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with 
nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369(18):1691-703. 
42. 
Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis 
A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet 
JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, 
Michel P, Montoto-Grillot C, Ducreux M, Groupe Tumeurs Digestives of U, 
Intergroup P. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. 
N Engl J Med. 2011;364(19):1817-25. 
43.  
CAHPS Cancer Care Survey. Content last reviewed September 2017. Agency for 
Healthcare Research and Quality, Rockville, MD. 
http://www.ahrq.gov/cahps/surveys-guidance/cancer/index.html 
44.  
Weeks JC, Catalano PJ, Cronin A, Finkelman MD, Mack JW, Keating NL, Schrag 
D. Patients' expectations about effects of chemotherapy for advanced cancer. N 
Engl J Med. 2012;367(17):1616-25. 
45.  
Legare F, Kearing S, Clay K, Gagnon S, D’Amours D, Rousseau M, O’Connor A. 
Are you SURE?: Assessing patient decision conflict with a 4-item screening test. 
Can Fam Physician. 2019; 56(8); e308-14.  
46.  
Degner LF, Kristjanson LJ, Bowman D, Sloan JA, Carriere KC, O'Neil J, Bilodeau 
B, Watson P, Mueller B. Information needs and decisional preferences in women 
with breast cancer. JAMA. 1997;277(18):1485-92. 
47.  
Brehaut JC, O’Connor AM, Wood TJ, Hack TF, Simioff L, Gordon E, Feldman-
Stewart D. Validation of a decision regret scale. Med Decis Making. 2003; 23(4): 
281-92. 
48.  
Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical 
and mental health summary scores from the patient-reported outcomes 
measurement information system (PROMIS) global items. Qual Life Res. 2009; 
18(7): 873-880). 
49.  
Dueck AC, Mendoza TR, Mitchell SA, Reeve BB, Castro KM, Rogak LJ, Atkinson 
TM, Bennett AV, Denicoff AM, O'Mara AM, Li Y, Clauser SB, Bryant DM, 
Bearden JD 3rd, Gillis TA, Harness JK, Siegel RD, Paul DB, Cleeland 
CS, Schrag D, Sloan JA, Abernethy AP, Bruner DW, Minasian LM, Basch E; 
National Cancer Institute PRO-CTCAE Study Group. Validity and Reliability of 
the US National Cancer Institute's Patient-Reported Outcomes Version of the 
Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol. 
2015 Nov;1(8):1051-9. 
50.  
Centers for Disease Control and Prevention (CDC). National Center for Health 
Statistics (NCHS). National Health and Nutrition Examination Survey 
Questionnaire (or Examination Protocol, or Laboratory Protocol). Hyattsville, MD: 
U.S. Department of Health and Human Services, Centers for Disease Control 
and Prevention, [2015-2016] [https://wwwn.cdc.gov/nchs/data/nhanes/2015-
2016/questionnaires/OCQ_Family_I.pdf]. 
51. 
Hager ER, Quigg AM, Black MM, Coleman SM, Heeren T, Rose-Jacobs R, Cook 
JT, Ettinger de Cuba SA, Casey PH, Chilton M, Cutts DB, Meyers AF, Frank DA. 
Development and validity of a 2 
item screen to identify families at risk for food insecurity. Pediatrics. 2010 
Jul;126(1):e26-32;  
52.  
Garg A, Toy S, Tripodis Y, Silverstein M, Freeman E. Addressing social 
determinants of health at well child care visits: A cluster 
RCT. Pediatrics2015; 135:e296–e304. 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 41 of 50 
 
53.  
Children's Healthwatch Survey. 2010. Available 
at: http://www.childrenshealthwatch.org/upload/resource/englishinterview_revisio
n4a.pdf 
54.  
Cagle JG, Carr DC, Hong S, Zimmerman S. Financial burden among US 
households affected by cancer at the end of life. 
Psychooncology. 2016 Aug;25(8):919-26 
55.  
Irwin B, Kimmick G, Altomare I, Marcom PK, Houck K, Zafar SY, Peppercorn J. 
Patient experience and attitudes toward addressing the cost of breast cancer 
care. Oncologist. 2014 Nov;19(11):1135-40. 
56.  
Abel GA, Albelda R, Khera N, Hahn T, Salas Coronado DY, Odejide OO, et al. 
Financial hardship and patient-reported outcomes after hematopoietic cell 
transplantation. Biol Blood Marrow Transplant 2016;22: 1504–10. 
57.  
Zafar SY, Peppercorn JM, Schrag D, Taylor DH, Goetzinger AM, Zhong X, 
Abernethy AP. The financial toxicity of cancer treatment: a pilot study assessing 
out-of-pocket expenses and the insured cancer patient’s experience. Oncologist. 
2013; 18(4): 381-90. 
58.  
California Caregiver Resource Centers Uniform Assessment Tool. 2003. 
Available at: 
https://www.caregiver.org/sites/caregiver.org/files/pdfs/tk_california_assessment
_tool.pdf  
59.  
Higginson IJ, Gao W, Jackson D, Murray J, Harding R. Short-
form Zarit Caregiver Burden Interviews were valid in advanced conditions. J Clin 
Epidemiol. 2010 May;63(5):535-42 
60.  
Burton LC, Newsom JT, Schulz R, Hirsch CH, German PS. Preventive health 
behaviors among spousal caregivers. Prev Med. 1997 Mar-Apr;26(2):162-9. 
61.  
Marin G, Marin BV, Perez-Stable EJ, Sabogal F, Otero-Sabogal R. Changes in 
information as a function of a culturally appropriate smoking cessation 
community intervention for Hispanics. Am J Community Psychol. 1990;18(6):847-
64. 
62.  
Sarkar U, Schillinger D, López A, Sudore R. Validation of self-reported health 
literacy questions among diverse English and Spanish-speaking populations. J 
Gen Intern Med. 2011 Mar;26(3):265-71. 
63.  
Stagliano V, Wallace LS. Brief health literacy screening items predict newest vital 
sign scores. J Am Board Fam Med. 2013 Sep-Oct;26(5):558-65. 
64.  
Balboni TA, Paulk ME, Balboni MJ, Phelps AC, Loggers ET, Wright AA, Block 
SD, Lewis EF, Peteet JR, Prigerson HG. Provision of spiritual care to patients 
with advanced cancer: associations with medical care and quality of life near 
death. J Clin Oncol. 2010;28(3):445-52.  
65. 
Balboni TA, Maciejewski PK, Balboni MJ, Enzinger AC, Paulk E, Munoz F, 
Rivera L, Mutchler J, Finlay E, Marr L, McCorkle R, Temel JS, Weeks JC, 
Vanderweele TJ, Prigerson HG, editors. Racial/ethnic differences in end-of-life 
(EoL) treatment preferences: The role of religious beliefs about care. American 
Society of Clinical Oncology; 2013; Chicago, IL. 
66. 
Phelps AC, Maciejewski PK, Nilsson M, Balboni TA, Wright AA, Paulk ME, Trice 
E, Schrag D, Peteet JR, Block SD, Prigerson HG. Religious coping and use of 
intensive life-prolonging care near death in patients with advanced cancer. 
JAMA. 2009;301(11):1140-7. 
67. 
Price M, Cameron R, Butow P. Communicating risk information: the influence of 
graphical display format on quantitative information perception-Accuracy, 
comprehension and preferences. Pat Educ Couns. 2007;69(1-3):121-8. 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 42 of 50 
 
68. 
Rothman RL, Montori VM, Cherrington A, Pignone MP. Perspective: the role of 
numeracy in health care. J Health Commun. 2008;13(6):583-95.  
 
69.  
Leighl NB, Shepherd HL, Butow PN, Clarke SJ, McJannett M, Beale PJ, Wilcken 
NR, Moore MJ, Chen EX, Goldstein D, Horvath L, Knox JJ, Krzyzanowska M, 
Oza AM, Feld R, Hedley D, Xu W, Tattersall MH. Supporting treatment decision 
making in advanced cancer: a randomized trial of a decision aid for patients with 
advanced colorectal cancer considering chemotherapy. J Clin Oncol. 
2011;29(15):2077-84. 
70.  
Consumer Assessment of Healthcare Providers and Systems (CAHPS). 
Retrieved March 2, 2019, from https://www.cms.gov/Research-Statistics-Data-
and-Systems/Research/CAHPS/ 
71.  
Schafer JL. Multiple imputation: a primer. Stat Methods Med Res. 1999 
Mar;8(1):3-15. 
72.  
Leighl NB, Shepherd HL, Butow PN, Clarke SJ, McJannett M, Beale PJ, Wilcken 
NR, Moore MJ, Chen EX, Goldstein D, Horvath L, Knox JJ, Krzyzanowska 
M, Oza AM, Feld R, Hedley D, Xu W, Tattersall MH. 
Supporting treatment decision making in advanced cancer: a randomized trial of 
a decision aid for 
patients with advanced colorectal cancer considering chemotherapy. J Clin 
Oncol. 2011 May 20;29(15):2077-84 
73. 
Strauss AL, Corbin JM. Basics of qualitative research: techniques and 
procedures for developing grounded theory. 2nd ed. Thousand Oaks, CA: Sage 
Publications; 1998. 
74. 
Shoemaker SJ, Wolf MS, Brach C. The Patient Education Materials Assessment 
Tool (PEMAT) and User's Guide. Rockville, MD: Agency for Healthcare Research 
and Quality; 2013. 
75. 
QOPI Certification Site Assessment Standards. 2013 [updated 2013; cited 
December 15, 2015]; Available from: 
http://qopi.asco.org/Documents/QCPstandards_Round8_01_15_2013.pdf. 
76.  
Colon Cancer. Version 3.2013. NCCN Clinical Practice Guidelines in Oncology 
[serial on the Internet]. 2013 [cited December 15, 2015]: Available from: 
www.nccn.org. 
77. 
Abrams TA, Meyer G, Moloney J, Meyerhardt JA, Schrag D, Fuchs CS. Patterns 
of chemotherapy use in a U.S.-wide population-based cohort of patients with 
metastatic colorectal cancer. J Clin Oncol. 2012;30(suppl; abstr 3537). 
78. 
Shoemaker SJ, Wolf MS, Brach C. The Patient Education Materials Assessment 
Tool (PEMAT) and User's Guide. In: Quality AfHRa, editor. Rockville, MD: 
AHRQ; 2013. 
79. 
Hawley ST, Zikmund-Fisher B, Ubel P, Jancovic A, Lucas T, Fagerlin A. The 
impact of the format of graphical presentation on health-related knowledge and 
treatment choices. Pat Educ Couns. 2008;73(3):448-55. 
80. 
Zikmund-Fisher BJ, Fagerlin A, Ubel PA. A demonstration of ''less can be more'' 
in risk graphics. Med Decis Making. 2010;30(6):661-71. 
81. 
Fagerlin A, Zikmund-Fisher BJ, Ubel PA. Helping patients decide: ten steps to 
better risk communication. J Natl Cancer Instit. 2011;103(19):1436-43. 
82.  
El-Jawahri A, Traeger L, Park ER, Greer JA, Pirl WF, Lennes IT, Jackson VA, 
Gallagher ER, Temel JS. Associations among prognostic understanding, quality 
of life, and mood in patients with advanced cancer. Cancer. 2014;120(2):278-85. 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 43 of 50 
 
83. 
Temel JS, Greer JA, Admane S, Gallagher ER, Jackson VA, Lynch TJ, Lennes 
IT, Dahlin CM, Pirl WF. Longitudinal perceptions of prognosis and goals of 
therapy in patients with metastatic non-small-cell lung cancer: results of a 
randomized study of early palliative care. J Clin Oncol. 2011;29(17):2319-26. 
84. 
Arora NK, Hesse BW, Rimer BK, Viswanath K, Clayman ML, Croyle RT. 
Frustrated and confused: the American public rates its cancer-related 
information-seeking experiences. Journal of General Internal Medicine. 
2008;23(3):223-8. 
85. 
Gabrijel S, Grize L, Helfenstein E, Brutsche M, Grossman P, Tamm M, Kiss A. 
Receiving the diagnosis of lung cancer: patient recall of information and 
satisfaction with physician communication.  J Clin Oncol. 2008;26(2):297-302. 
86. 
Gaston CM, Mitchell G. Information giving and decision-making in patients with 
advanced cancer: a systematic review. Soc Sci Med. 2005;61(10):2252-64. 
87. 
Jenkins V, Solis-Trapala I, Langridge C, Catt S, Talbot DC, Fallowfield LJ. What 
oncologists believe they said and what patients believe they heard: an analysis of 
phase I trial discussions. J Clin Oncol. 2011;29(1):61-8. 
88. 
Di Maio M, Gallo C, Leighl NB, Piccirillo MC, Daniele G, Nuzzo F, Gridelli C, 
Gebbia V, Ciardiello F, De Placido S, Ceribelli A, Favaretto AG, de Matteis A, 
Feld R, Butts C, Bryce J, Signoriello S, Morabito A, Rocco G, Perrone F. 
Symptomatic toxicities experienced during anticancer treatment: agreement 
between patient and physician reporting in three randomized trials. J Clin Oncol. 
2015;33(8):910-5. 
89. 
Pollak KI, Arnold RM, Jeffreys AS, Alexander SC, Olsen MK, Abernethy AP, 
Sugg Skinner C, Rodriguez KL, Tulsky JA. Oncologist communication about 
emotion during visits with patients with advanced cancer. J Clin Oncol. 
2007;25(36):5748-52. 
90. 
Viswanath K, Emmons K. Message effects and social determinants of health: its 
application to cancer disparities. Journal of Communication. 2006;56(s1):S238-
64. 
91. 
Deep KS, Hunter A, Murphy K, Volandes A. "It helps me see with my heart": How 
video informs patients' rationale for decisions about future care in advanced 
dementia. Patient Educ Couns. 2010;81(2):229-34. 
92. 
Cooper-Patrick L, Gallo JJ, Gonzales JJ, Vu HT, Powe NR, Nelson C, Ford DE. 
Race, gender, and partnership in the patient-physician relationship. JAMA. 
1999;282(6):583-9. 
93. 
Volandes AE, Lehmann LS, Cook EF, Shaykevich S, Abbo ED, Gillick MR. Using 
video images of dementia in advance care planning. Arch Intern Med. 
2007;167(8):828-33. 
94. 
Mack JW, Cronin A, Taback N, Huskamp HA, Keating NL, Malin JL, Earle CC, 
Weeks JC. End-of-life care discussions among patients with advanced cancer: a 
cohort study. Ann Intern Med. 2012;156(3):204-10. 
95. 
Mack JW, Wolfe J, Cook EF, Grier HE, Cleary PD, Weeks JC. Hope and 
prognostic disclosure. J Clin Oncol 2007;25(35):5636-42. 
96. 
Annas GJ. Informed consent, cancer, and truth in prognosis. N Engl J Med. 
1994;330(3):223-5. 
97. 
Faden R, Beauchamp T. A history and theory of informed consent. New York: 
Oxford University Press; 1986. 
98. 
Audrey S, Abel J, Blazeby JM, Falk S, Campbell R. What oncologists tell patients 
about survival benefits of palliative chemotherapy and implications for informed 
consent: qualitative study. BMJ. 2008;337:a752.  

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 44 of 50 
 
99. 
Koedoot CG, Oort FJ, de Haan RJ, Bakker PJ, de Graeff A, de Haes JC. The 
content and amount of information given by medical oncologists when telling 
patients with advanced cancer what their treatment options are. palliative 
chemotherapy and watchful-waiting. Eur J Cancer. 2004;40(2):225-35. 
100. 
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 
2015;65(1):5-29. 
101. 
Siegel RL, Fedewa SA, Miller KD, Goding-Sauer A, Pinheiro PS, Martinez-Tyson 
D, Jemal A. Cancer statistics for Hispanics/Latinos, 2015. CA Cancer J Clin. 
2015;65(6):457-80. 
102. 
Lindsay AC, Sussner KM, Greaney M, Wang ML, Davis R, Peterson KE. Using 
qualitative methods to design a culturally appropriate child feeding questionnaire 
for low-income, Latina mothers. Matern Child Health J. 2012;16(4):860-6.  
103. 
Lindsay AC, Sussner KM, Pfeiffer EM, Greaney M, Wang M, Petersen KE. 
Social-cultural, organizational and community influences on physical activity and 
sedenteray behaviors of Latina mothers and their preschool-aged children 
enrolled in the WIC program: a qualitative study. International Journal of Child 
Health and Nutrition. 2014;3(1):27-40. 
104. 
Greaney ML, Hardwick C, Megzebu S, Lindsay AC, Roover ML, Peterson KE. 
Assessing the feasibility of a multi-program intervention to promote physical 
activity and healthful eating in middle schools prior to wide-scale implementation. 
Am J Health Educ. 2007;38(5):250-7. 
105. 
Tournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux 
E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A. 
FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal 
cancer: a randomized GERCOR study. J Clin Oncol. 2004;22(2):229-37. 
106. 
Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis 
A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet 
JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, 
Michel P, Montoto-Grillot C, Ducreux M. FOLFIRINOX versus gemcitabine for 
metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817-25. 
107. 
Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, 
Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Cassidy J. Bevacizumab 
in combination with oxaliplatin-based chemotherapy as first-line therapy in 
metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 
2008;26(12):2013-9. 
108. 
Van Cutsem E, Rivera F, Berry S, Kretzschmar A, Michael M, DiBartolomeo M, 
Mazier MA, Canon JL, Georgoulias V, Peeters M, Bridgewater J, Cunningham D. 
Safety and efficacy of first-line bevacizumab with FOLFOX, XELOX, FOLFIRI 
and fluoropyrimidines in metastatic colorectal cancer: the BEAT study. Ann Oncol 
ESMO. 2009;20(11):1842-7. 
109. 
del Carmen MG, Joffe S. Informed consent for medical treatment and research: a 
review. Oncologist. 2005;10(8):636-41. 
110. 
Ko LK, Reuland D, Jolles M, Clay R, Pignone M. Cultural and linguistic 
adaptation of a multimedia colorectal cancer screening decision aid for Spanish-
speaking Latinos. J Health Commun. 2014;19(2):192-209. 
111. 
Balboni TA, Paulk ME, Balboni MJ, Phelps AC, Loggers ET, Wright AA, Block 
SD, Lewis EF, Peteet JR, Prigerson HG. Provision of spiritual care to patients 
with advanced cancer: associations with medical care and quality of life near 
death. J Clin Oncol. 2010;28(3):445-52.  

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 45 of 50 
 
112. 
Phelps AC, Lauderdale KE, Alcorn S, Dillinger J, Balboni MT, Van Wert M, 
Vanderweele TJ, Balboni TA. Addressing spirituality within the care of patients at 
the end of life: perspectives of patients with advanced cancer, oncologists, and 
oncology nurses. J Clin Oncol. 2012;30(20):2538-44. 
113. 
Shane DM, Ayyagari P. Will health care reform reduce disparities in insurance 
coverage?: Evidence from the dependent coverage mandate. Med Care. 
2014;52(6):528-34. 
114. 
Talamantes M, Gomez C, Braun K. Advanced directives and end-of-life care: The 
Hispanic perspective.  Cultural issues in end-of-life decision making. Thousand 
Oaks, CA: Sage Publications; 2000. 
115. 
Bureau UC. Latino/Hispanic definition. 2015. 
116. 
Larkey LK, Gonzalez JA, Mar LE, Glantz N. Latina recruitment for cancer 
prevention education via Community Based Participatory Research strategies. 
Contemp Clin Trials. 2009;30(1):47-54. 
117. 
Temel JS, Greer JA, Admane S, Gallagher ER, Jackson VA, Lynch TJ, Lennes 
IT, Dahlin CM, Pirl WF. Longitudinal perceptions of prognosis and goals of 
therapy in patients with metastatic non-small-cell lung cancer: results of a 
randomized study of early palliative care. J Clin Oncol. 2011;29(17):2319-26. 
118. 
Tellez-Giron P. Providing culturally sensitive end-of-life care for the Latino/a 
community. WMJ. 2007;106(7):402-6. 
119. 
Ayanian JZ, Zaslavsky AM, Arora NK, Kahn KL, Malin JL, Ganz PA, van Ryn M, 
Hornbrook MC, Kiefe CI, He Y, Urmie JM, Weeks JC, Harrington DP. Patients' 
experiences with care for lung cancer and colorectal cancer: findings from the 
Cancer Care Outcomes Research and Surveillance Consortium.  J Clin Oncol. 
2010;28(27):4154-61.  
120. 
Mack JW, Block SD, Nilsson M, Wright A, Trice E, Friedlander R, Paulk E, 
Prigerson HG. Measuring therapeutic alliance between oncologists and patients 
with advanced cancer: the Human Connection Scale. Cancer. 
2009;115(14):3302-11.  
121. 
Trevino KM, Abbott CH, Fisch MJ, Friedlander RJ, Duberstein PR, Prigerson HG. 
Patient-oncologist alliance as protection against suicidal ideation in young adults 
with advanced cancer. Cancer. 2014;120(15):2272-81. 
122. 
Trevino KM, Fasciano K, Prigerson HG. Patient-oncologist alliance, psychosocial 
well-being, and treatment adherence among young adults with advanced cancer. 
J Clin Oncol. 2013;31(13):1683-9. 
123. 
Fiset V, O'Connor AM, Evans W, Graham I, Degrasse C, Logan J. Development 
and evaluation of a decision aid for patients with stage IV non-small cell lung 
cancer. Health expectations : an international journal of public participation in 
health care and health policy. 2000;3(2):125-36. 
124. 
O'Connor AM. User Manual - Decisional Conflict Scale (10 item question format).  
[cited December 5, 2015]; Available from: 
http://decisionaid.ohri.ca/docs/develo/User_Manuals/UM_Decisinal_Conflict.pdf. 
125. 
Bass PF, 3rd, Wilson JF, Griffith CH. A shortened instrument for literacy 
screening. J Gen Intern Med. 2003;18(12):1036-8.  
126. 
Lee SY, Bender DE, Ruiz RE, Cho YI. Development of an easy-to-use Spanish 
Health Literacy test. Health Serv Res. 2006;41(4 Pt 1):1392-412.  
127. 
O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 
1995;15(1):25-30. 
128. 
Weeks JC, Cook EF, O'Day SJ, Peterson LM, Wenger N, Reding D, Harrell FE, 
Kussin P, Dawson NV, Connors AF, Jr., Lynn J, Phillips RS. Relationship 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 46 of 50 
 
between cancer patients' predictions of prognosis and their treatment 
preferences. JAMA. 1998;279(21):1709-14. 
129. 
Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen 
SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy 
scale: development and validation of the general measure. J Clin Oncol. 
1993;11(3):570-9. 
130. 
Dapueto JJ, Francolino C, Servente L, Chang CH, Gotta I, Levin R, Abreu Mdel 
C. Evaluation of the Functional Assessment of Cancer Therapy-General (FACT-
G) Spanish Version 4 in South America: classic psychometric and item response 
theory analyses. Health Qual Life Outcomes. 2003;1:32.  
131. 
Mack JW, Weeks JC, Wright AA, Block SD, Prigerson HG. End-of-life 
discussions, goal attainment, and distress at the end of life: predictors and 
outcomes of receipt of care consistent with preferences. J Clin Oncol. 
2010;28(7):1203-8. 
132. 
Silveira MJ, Kim SY, Langa KM. Advance directives and outcomes of surrogate 
decision making before death. The N Engl J Med. 2010;362(13):1211-8.  
133. 
Karnofsky DA. Determining the extent of the cancer and clinical planning for 
cure. Cancer. 1968;22(4):730-4. 
134. 
Mack JW, Cronin A, Keating NL, Taback N, Huskamp HA, Malin JL, Earle CC, 
Weeks JC. Associations between end-of-life discussion characteristics and care 
received near death: A prospective cohort study. J Clin Oncol. 2012;30(35):4387-
95. 
135. 
Newgard CD, Lewis RJ. Missing Data: How to Best Account for What Is Not 
Known. JAMA. 2015;314(9):940-1. 
136. 
Tech V. What is RE-AIM.  [cited December 15, 2015]; Available from: www.re-
aim.hnfe.vt.edu/about_re-aim/what_is_re-aim/. 
137. 
Viswanath K, Ackerson LK. Race, ethnicity, language, social class, and health 
communication inequalities: a nationally-representative cross-sectional study. 
PLoS One. 2011;6(1):e14550.  
138. 
Gattellari M, Voigt KJ, Butow PN, Tattersall MH. When the treatment goal is not 
cure: are cancer patients equipped to make informed decisions? J Clin Oncol. 
2002;20(2):503-13. Epub 2002/01/12.  
139. 
Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Informed consent -- why are 
its goals imperfectly realized? N Engl J Med. 1980;302(16):896-900. 
140. 
Bureau UC. Facts for Features: Hispanic Heritage Month 2014 2015 [December 
17, 2015]. Available from: www.census.gov/newsroom/facts-for-
features/2014/cb14-ff22.html. 
141.   Blake K, Flynt-Wallington S, Viswanath K. Health communication channel 
preferences by class, race, and place.  In: Kreps G, editor. Health 
communication: building the evidence base in cancer control. Cresskill (NJ): 
Hampton Press; 2011. p. 149-174. 
 
 
 
 
 
 
 
 
 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 47 of 50 
 
 
31.0 Appendices 
  
1. Model Informed Consent Form for External Sites (ENGLISH VERSION)  
2. Model Informed Consent Form for External Sites (SPANISH VERSION)  
3. Caregiver Informed Consent Study Letter (ENGLISH VERSION)  
4. Caregiver Informed Consent Study Letter (SPANISH VERSION)  
5. Multi-Center Data Safety Monitoring Plan  
6. Global Medical Release Form (ENGLISH VERSION)   
7. Global Medical Release Form (SPANISH VERSION)  
8. Participant Registration Form  
9. Caregiver Registration Form  
10. Medical Record Abstraction Form – Pancreatic Cancer   
11. Medical Record Abstraction Form – Colorectal Cancer  
12. Phone script for approaching potential participants via phone (ENGLISH 
VERSION) 
13. Phone script for approaching potential participants via phone (SPANISH 
VERSION)  
14. Phone script for approaching potential caregivers via phone (ENGLISH 
VERSION)  
15. Phone script for approaching potential caregivers via phone (SPANISH 
VERSION)  
16. Phone script for assessment administration (ENGLISH VERSION)  
17. Phone script for assessment administration (SPANISH VERSION)  
18. Site Recruitment Checklist (ENGLISH VERSION)  
19. Site Recruitment Checklist (SPANISH VERSION)  
 
Study Assessments  
20. Patient Baseline Assessment (ENGLISH VERSION)  
20a. Patient Baseline Assessment - for administration online 
20b. Patient Baseline Assessment - for written administration   
21. Patient Post-Decision Assessment Version 1 - Usual CEI Arm (ENGLISH 
VERSION)  
      21a. Patient Post-Decision Version 1 – for administration online  
      21b. Patient Post-Decision Version 1 – for written administration 
22. Patient Post-Decision Assessment Version 2 - Investigational CEI Arm 
(ENGLISH VERSION)  
22a. Patient Post-Decision Version 2 – for administration online  
22b. Patient Post-Decision Version 2 – for written administration  
23. Patient 3-Month Follow-Up Assessment Version 1 - Usual CEI Arm (ENGLISH 
VERSION) 
23a. Patient 3-Month Follow-Up Version 1 – for administration online  
23b. Patient 3-Month Follow-Up Version 1 – for written administration  
24. Patient 3-Month Follow-Up Assessment Version 2 - Investigational CEI Arm 
(ENGLISH VERSION)  

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 48 of 50 
 
24a. Patient 3-Month Follow-Up Version 2 – for administration online  
24b. Patient 3-Month Follow-Up Version 2 – for written administration  
25. Patient 6-Month Follow-Up Assessment (ENGLISH VERSION)  
25a. Patient 6-Month Follow-Up – for administration online 
25b. Patient 6-Month Follow-Up – for written administration  
26. Caregiver Baseline Assessment (ENGLISH VERSION)  
26a. Caregiver Baseline Assessment – for administration online 
26b. Caregiver Baseline Assessment – for written administration 
27. Caregiver 3-Month Follow-Up Assessment (ENGLISH VERSION)  
27a. Caregiver 3-Month Follow-Up Assessment – for administration 
online 
27b. Caregiver 3-Month Follow-Up Assessment – for written 
administration 
28. Caregiver 6-Month Follow-Up Assessment Version 1 – For Active Caregivers 
(ENGLISH VERSION)  
28a. Caregiver 6-Month Follow-Up Version 1 – for administration online 
28b. Caregiver 6-Month Follow-Up Version 1 – for written administration 
29. Caregiver 6-Month Follow-up Assessment Version 2- For Bereaved Caregivers 
(ENGLISH VERSION)  
29a. Caregiver 6-Month Follow-Up Version 2 – for administration online 
29b. Caregiver 6-Month Follow-Up Version 2 – for written administration 
30. Patient Baseline Assessment (SPANISH VERSION)  
30a. Patient Baseline Assessment - for administration online 
30b. Patient Baseline Assessment - for written administration   
31. Patient Post-Decision Assessment Version 1 - Usual CEI Arm (SPANISH 
VERSION)  
31a. Patient Post-Decision Version 1 - for administration online 
31b. Patient Post-Decision Version 1 - for written administration   
32. Patient Post-Decision Assessment - Investigational CEI Arm (SPANISH 
VERSION)  
32a. Patient Post-Decision Version 2 - for administration online 
32b. Patient Post-Decision Version 2 - for written administration   
33. Patient 3-Month Follow-Up Assessment Version 1 - Usual CEI Arm (SPANISH 
VERSION)  
33a. Patient 3-Month Follow-Up Version 1 – for administration online 
33b. Patient 3-Month Follow-Up Version 1 – for written administration 
34. Patient Follow-Up Assessment 1 - Investigational CEI Arm (SPANISH 
VERSION)  
34a. Patient 3-Month Follow-Up Version 2 – for administration online 
34b. Patient 3-Month Follow-Up Version 2 – for written administration 
35. Patient Follow-Up Assessment 2 (SPANISH VERSION)  
35a. Patient 6-Month Follow-Up Assessment – for administration online 
35b. Patient 6-Month Follow-Up Assessment – for written administration 
36. Caregiver Baseline Assessment (SPANISH VERSION)  
36a. Caregiver Baseline Assessment – for administration online 
36b. Caregiver Baseline Assessment – for written administration 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 49 of 50 
 
37. Caregiver Follow-Up Assessment 1 (SPANISH VERSION)  
37a. Caregiver 3-Month Follow-Up Assessment – for administration online 
37b. Caregiver 3-Month Follow-Up Assessment – for written administration 
38. Caregiver 6-Month Follow-Up Assessment Version 1 – For Active Caregivers 
(SPANISH VERSION)  
38a. Caregiver 6-Month Follow-Up Version 1 – for administration online 
38b. Caregiver 6-Month Follow-Up Version 1 – for written administration 
39. Caregiver 6-Month Follow-Up Assessment Version 2 – For Bereaved Caregivers 
(SPANISH VERSION)  
39a. Caregiver 6-Month Follow-Up Version 2 – for administration online 
39b. Caregiver 6-Month Follow-Up Version 2 – for written administration 
 
Investigational Chemotherapy Educational Materials 
40. FOLFOX +/- bev CEI Materials (ENGLISH VERSION) 
a. Video & Website 
b. Booklet  
41. FOLFIRI +/- bev CEI Materials (ENGLISH VERSION)  
a. Video & Website 
b. Booklet  
42. FOLFIRINOX CEI Materials (ENGLISH VERSION)  
a. Video & Website 
b. Booklet  
43. Gemcitabine + nab-paclitaxel CEI Materials (ENGLISH VERSION)  
a. Video & Website 
b. Booklet  
44. Gemcitabine CEI Materials (ENGLISH VERSION)  
a. Video & Website 
b. Booklet  
45. FOLFOX +/- bev CEI Materials (SPANISH VERSION)   
a. Video & Website 
b. Booklet  
46. FOLFIRI +/- bev CEI Materials (SPANISH VERSION)   
a. Video & Website 
b. Booklet  
47. FOLFIRINOX CEI Materials (SPANISH VERSION)    
a. Video & Website 
b. Booklet  
48. Gemcitabine + nab-paclitaxel CEI Materials (SPANISH VERSION)  
a. Video & Website 
b. Booklet  
49. Gemcitabine CEI Materials (SPANISH VERSION)  
a. Video & Website 
b. Booklet  
50. Video Vignette – Coping with a new cancer diagnosis (ENGLISH & SPANISH 
VERSIONS) 
 

Protocol Title: Engaging Latinos in the Center of Cancer Treatment Options  
Protocol Version/Date: Version #2/July 19, 2018 
 
Page 50 of 50 
 
51. Video Vignette – How do I feel the best that I can on chemo? (ENGLISH & 
SPANISH VERSIONS)