Latinos' Beliefs and Communication About Advance Care Planning
Phase: NA
Conditions: Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
Sponsor: Fred Hutchinson Cancer Center

 
 
Official Title 
Latinos’ Beliefs and Communication about Advance Care 
Planning 
NCT Number 
NCT04889144 
Document Type 
Study Protocol and Statistical Analysis Plan 
Document Date 
6/5/2024 
 
 

i
TITLE: Latinos’ Beliefs and Communication about Advance Care Planning 
Protocol #: RG1121949
Version Date: May 17, 2024
Funding Source(s): (if applicable): National Institutes of Health/National Cancer Institute
Principal Investigator (FHCC):
Megan Shen, PhD
1100 Fairview Avenue N, D5-290
phone: (206) 667-4172
fax: (206) 667-1034
mshen2@fredhutch.org
Stephanie Lee, MD, MPH
1100 Fairview Avenue N, D5-290
phone: (206) 667-5160
fax: (206) 667-1034
sjlee@fredhutch.org
Co-Investigators (Weill Cornell Medicine):
Holly Prigerson, PhD
420 East 70th St. 3rd Floor, Suite B
phone: (646) 962-9655
fax: (646) 962-0812
hgp2001@med.cornell.edu
Paul Maciejewski, PhD
420 East 70th St. 3rd Floor, Suite B
fax: (646) 962-0812
pam2056@med.cornell.edu 
M. Carrington Reid, MD, PhD
525 East 68th St., Baker 14
fax: (646) 962-0812
mcr2004@med.cornell.edu 
Co-Investigator (UT Southwestern
/ Parkland Hospital and Health Systems):
Elizabeth Paulk, MD
5323 Harry Hines Boulevard
phone: (214)648-2992
elizabeth.paulk@UTSouthwestern.edu
Co-Investigator (Confluence Health):
Lindsay Overton, MD
820 N. Chelan Ave.
phone: (509)663-8711
lindsay.overton@confluencehealth.org
Fred Hutch IRB
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6/5/2024

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Version Date: May 1, 2024
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Statistician (Weill Cornell Medicine):
Paul Maciejewski, PhD
420 East 70th St. 3rd Floor, Suite B
fax: (646) 962-0812
pam2056@med.cornell.edu 
Participating Sites:  
Fred Hutchinson Cancer  Center
Megan Shen, PhD (PI)
Weill Cornell Medicine
Holly Prigerson, PhD (Co-Investigator/Site Lead)
UT Southwestern and Parkland Hospital and Health Systems (PHHS)
Elizabeth Paulk, MD (Co-Investigator/Site Lead)
Confluence Health:
Wenatchee Valley Hospital and Clinics
Moses Lake Clinic
Omak Clinic
Lindsay Overton, MD (Co-Investigator/Site Lead)
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Table of Contents
LIST OF ABBREVIATIONS........................................................................................................V
1. PROTOCOL SUMMARY.........................................................................................................1
1.1.1 Objectives
3
1.1.2 Hypotheses / Research Questions
3
2. BACKGROUND AND SIGNIFICANCE.................................................................................3
3. STUDY DESIGN AND METHODS ........................................................................................4
3.1 Overall Design.......................................................................................................................4
3.2 Study Population...................................................................................................................5
3.3 Inclusion Criteria ...................................................................................................................5
3.4 Exclusion Criteria..................................................................................................................5
3.5 Strategies for Recruitment and Retention.........................................................................6
3.6 Interviews, Focus Groups, Surveys, and/or Observations.............................................8
3.7 Intervention (PLAN)............................................................................................................10
3.8 Interviewer Training and Instrument Administration......................................................10
3.9 Intervention Administration................................................................................................11
3.10 Special Concerns .............................................................................................................11
3.11 Compensation...................................................................................................................12
4. REGISTRATION PROCEDURES........................................................................................13
4.1 Subject Registration (FHCC and Sub-sites)...................................................................13
5. STUDY PROCEDURES........................................................................................................13
5.1 Schedule of Assessments.................................................................................................13
6. DATA REPORTING / REGULATORY CONSIDERATIONS ...........................................14
6.1 Data Collection....................................................................................................................14
6.1.1 REDCap
14
6.2 Regulatory Considerations................................................................................................14
6.2.1 Institutional Review Board/Ethics Committee Approval
14
6.2.2 Ethical Conduct of the Study
15
6.2.3 Informed Consent
15
6.2.4 Compliance with Trial Registration and Results Posting Requirements
16
6.2.5 Record Retention
16
7. STATISTICAL CONSIDERATIONS ....................................................................................16
8. ADVERSE EVENT REPORTING REQUIREMENTS.......................................................17
9. UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS..21
REFERENCES............................................................................................................................26
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Confidentiality Statement
This document is confidential and is to be distributed for review only to investigators, potential 
investigators, consultants, study staff, and applicable independent ethics committees or 
institutional review boards. The contents of this document shall not be disclosed to others without 
written authorization from FHCC.
Fred Hutchinson Cancer Center
_________________________________________________________________
Institution Name
Weill Cornell Medicine
_________________________________________________________________
Institution Name
UT Southwestern 
_________________________________________________________________
Institution Name
Confluence Health
_________________________________________________________________
Institution Name
______________________________     _______________________________    ____________
Principal Investigator’s Name                 Principal Investigator’s Signature            Date
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v
List of Abbreviations
AE
Adverse Event
CFR
Code of Federal Regulations
CRF
Case Report Form
CTSC
Clinical Translational Science Center 
DSMP
Data Safety Monitoring Plan
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act of 1996
HRBFA
Human Research Billing Analysis Form
HUD
Humanitarian Use Device 
ICF
Informed Consent Form
IDE
Investigational Device Exemption 
IND
Investigational New Drug
IRB
Institutional Review Board
PLAN
PHHS
Planning for Your Advance Care Needs
Parkland Hospital and Health Systems
PHI
Protected Health Information
PI
Principal Investigator
REDCap
Research Electronic Data Capture
SAE
Serious Adverse Event
SUSAR
Suspected Unexpected Serious Adverse Reaction 
UIRTSO
Unanticipated Problem Involving Risks to Subjects or Others
UT Southwestern
University of Texas Southwestern
WCM
FHCC
Weill Cornell Medicine
Fred Hutchinson Cancer Center
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1. Protocol Summary
Full Title:
Latinos’ Beliefs and Communication about Advance Care 
Planning
Short Title:
PLAN (Planning For Your Advance Care Needs) Intervention 
Principal Investigator:
Megan Shen, PhD
Study Description: 
The goal of this study is to develop and pilot test a culturally 
competent communication intervention designed to enhance 
Latino advanced cancer patients’ engagement in advance care 
planning (ACP).
Sample Size:
N=50 advanced cancer patients
Study Population:
Latino advanced cancer patients
Enrollment Period:
12 months
Study Design:
Pilot randomized controlled trial (RCT)
Description of Sites/ 
Facilities Enrolling
Participants:
Fred Hutchinson Cancer Center Alliance
UT Southwestern
Confluence Health
Study Duration:
November 1, 2021 to April 30, 2024 
Participant Duration:
4 to 6 weeks
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Primary Objective:
To determine the feasibility, acceptability, and potential efficacy of 
the culturally competent communication to improve engagement in 
ACP (i.e., end-of-life discussions with providers and families, 
completion of advance directives) for Latino patients with 
advanced cancer.
Secondary Objectives:
Not applicable
Exploratory Objectives:
Not applicable
Endpoints:
Feasibility will be measured by intervention completion 
(Benchmark: ≥ 70% complete the intervention sessions). 
Acceptability will be measured by a single-item question 
assessing helpfulness of the intervention (1 = not at all helpful, 5 = 
very helpful) as well an open-ended question about helpfulness of 
the intervention (“What was helpful about the intervention?”) 
(Benchmark: ≥ 70% rate it as “helpful” or “very helpful”).
Advance Care Planning Readiness will be measured using the 
Advance Care Planning Engagement Survey, which is a validated 
49-item scale (α=.94)1 designed to assess knowledge, 
readiness/motivation, and self-efficacy of ACP. Engagement in 
ACP will measure two key elements of ACP. First, EOL care 
discussions will be measured by asking patients to self-report 
whether they have discussed any of the following: (1) wishes they 
have about the care they would like to receive if they were dying 
and/or (2) advance care directives, with an oncology provider or 
family member: DNR orders, living wills, durable powers of 
attorney for health care, assignments of health care proxies 
(yes/no format). Second, completion of advance directives will be 
assessed by examining the medical chart for completed advance 
directive documents (DNR order, living will, durable power of 
attorney, health care proxy).
Analytic Plan:
SPSS version 23.0 will be used to conduct all quantitative 
statistical analyses. Participants (N=50) will be randomly assigned 
to the culturally competent communication intervention group or 
PLAN (n=25) or the control group (n=25). They will then complete 
measures of engagement in ACP post-intervention. Preliminary 
analyses will utilize t-tests to compare the two groups on baseline 
characteristics (e.g., education, age). Using a criterion of p < .10, 
any variables that are different among the groups will be included 
in the final logistic regression models as potential confounders. 
Five separate logistic regression models will be run in which ACP 
outcomes (end-of-life care discussions with family and providers; 
and the completion of advance directives DNR, health care proxy, 
and living will) will be predicted by the group variable (intervention 
vs. control). The statistical power of the proposed logistic 
regressions to detect a minimum odds ratio of 2.0 for dichotomous 
outcome measures of ACP, for a two-tailed test with power (1 – β) 
equal to 0.80, and α = 0.05, requires a sample size of 113. Our 
proposed sample size of n=50 will be underpowered if the effect 
size is small but adequately powered if it is large. 
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 1.1 Study Objectives
1.1.1 Objectives
To determine the feasibility, acceptability, and potential efficacy of the culturally 
competent communication to improve engagement in ACP (i.e., end-of-life discussions 
with providers and families, completion of advance directives) for Latino patients with 
advanced cancer.
1.1.2 Hypotheses / Research Questions
The culturally competent communication intervention will be feasible, acceptable, and 
result in greater engagement in ACP than those in the control condition.
2. Background and Significance
Latino/non-Latino, white disparities are prevalent in ACP and quality of EOL care. Cancer 
is the leading cause of death among US Latinos.2 This highlights the importance of addressing 
advance care planning (ACP) for Latino cancer patients. So do recent U.S. Census Bureau 
statistics indicating that Latinos are the fastest growing minority group in the U.S., with expected 
growth rates of 57% from 2015 to 2050 (totaling to 103 million).3. Latino/white disparities are 
prevalent in end-of-life care planning and outcomes. For instance, terminally ill Latinos are less 
likely than non-Latino, whites (hereafter referred to as “whites”) to engage in ACP.4-8 ACP 
enables patients to achieve their preferred EOL goals of care. Latinos are significantly less likely 
than whites to engage in two main forms of ACP: (1) end-of-life discussions (32% vs. 85%)4 and 
(2) completing advance directives such as having a living will (9% vs. 67%) or naming a health 
care proxy (4% vs. 59%).4 Engaging in ACP is critical to receiving preferred end-of-life care. 
Among all groups, patients who engage in ACP have been shown to be significantly more likely 
to receive care in line with their end-of-life care wishes (86% vs. 30%)9 and to die in their 
preferred place (85% preferred home).10 The absence of ACP, in turn, is linked to higher rates 
of death in the Intensive Care Unit (ICU). ICU death is linked to greater physical and emotional 
distress and poorer quality of life.11,12 Latino patients are more likely than their white 
counterparts to receive aggressive care (e.g., CPR, ICU stays) at the end of life.13-15 They are 
also less likely to use hospice services.14,16-18 The aggressive care that Latinos often receive is 
generally contrary to their preferences and values,19-24 associated with poorer quality of 
life,12,19,25,26 and very costly.13
Engaging in ACP is critical to 
having quality and value-
consistent EOL care. Prior 
research as well as our pilot data 
show that engaging in ACP is 
critical to improving end-of-life 
care among Latinos. For 
example, one of our prior studies 
found that among Latino 
advanced cancer patients who 
completed a do not resuscitate 
(DNR) order and/or had an end-
of-life discussion, none received 
aggressive care at the end of 
life.27 More recent findings from 
our recent publication28 
demonstrate that when Latino 
patients had an end-of-life discussion, it increased their odds of completing a DNR order tenfold, 
nearly eliminating the pre-existing Latino/white disparities in DNR order completion. Thus, it is 
critical to develop an intervention that will increase engagement in ACP to improve quality of 
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care at the EOL among Latino advanced cancer patients.
An effective intervention to increase Latinos’ engagement in ACP should incorporate 
communication competence and cultural values. In designing an effective intervention for 
increasing Latinos’ engagement in ACP, it is necessary to consider what contributes to Latinos’ 
low rates of ACP. First, as highlighted by a narrative review of the literature (33 empirical 
studies), lack of knowledge about advance directives29 contributes to less engagement in ACP. 
Second, Latinos prefer a family-centered approach to determining end-of-life goals of care.29 
Finally, distinct cultural and religious beliefs about end-of-life care also reduce engagement in 
ACP.15,17,18,20,21 Based on these findings, an effective intervention should target communication 
and knowledge of ACP while also incorporating cultural, religious, and familial beliefs about 
ACP.
A patient-targeted “coaching” intervention may be the most effective approach for 
Latinos. Prior research in other clinical contexts indicates that clinicians give more information 
and achieve a better understanding of patients’ goals of care when patients engage in a more 
participatory consultation style (asking more questions, stating preferences).30-33 Patients’ 
participation has been shown to benefit disadvantaged and minority groups most, indicating its 
importance among Latinos.32 One way to improve patient participation and communication in 
medical consultations is to utilize a patient-targeted coaching intervention (demonstrated to be 
effective across 137 intervention trials).34 Because Latinos’ beliefs surrounding ACP are also 
influenced by specific cultural, familial, and religious beliefs,15,17,18,20,21 an effective intervention 
should communicate about ACP in a culturally sensitive manner. Communication that focuses 
on incorporating social and cultural context in communication as a way to reduce racial and 
ethnic disparities in quality care35 is referred to as culturally competent communication.36 Social 
psychological theories, such as sociocultural theory37 which examines how social and culture 
influence behaviors, provides a useful framework for understanding the influence of social 
relationships and culture on engagement in ACP. In short, a patient-targeted coaching 
intervention that is culturally competent may be the most effective intervention for improving 
Latinos’ engagement in ACP. Despite the great promise of the effectiveness of a culturally 
competent communication coaching intervention, little research has focused on identifying 
effective strategies for improving Latino advanced cancer patients’ engagement in ACP. The 
proposed K07 aims to address this gap in the literature through developing and examining the 
feasibility, acceptability, and efficacy of a theoretically-guided, culturally competent 
communication intervention that will coach Latinos on how to engage in ACP and communicate 
their preferred end-of-life goals of care. This intervention will be developed based on current 
literature grounded in models of communication competence.38,39 The proposed work will make 
a significant contribution by developing an effective, low-resource intensive intervention 
designed to improve Latino advanced cancer patients’ engagement in ACP, ultimately leading to 
a reduction in disparities in end-of-life care. Results from this study will also guide the 
development of a future, multisite study (R01) examining the efficacy of the culturally competent 
communication intervention among various sub-groups of Latinos.
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3. Study Design and Methods
3.1 Overall Design
Following Phase IIb of the ORBIT model,40 
we will pilot test the developed intervention 
(PLAN) to demonstrate feasibility, 
acceptability, and preliminary effectiveness 
at improving patients’ engagement in ACP. 
To assess this, 50 Latino advanced cancer 
patients will be recruited and randomly 
assigned to the intervention group (n=25) or 
the control group (n=25). After completing 
the intervention/control, patients will fill out 
measures of completion of end-of-life 
discussions and advance directives 
(confirmed via medical charts). Phase III (of 
the ORBIT model)40 (Efficacy) will be tested 
in a future R01 RCT. 
Because this is a protocol being transferred 
from Weill Cornell to FHCC, the PI (Shen) 
requested that two additional sites (UT Southwestern and Confluence Health) be added to 
the protocol to ensure the proper number of Latino patients can be enrolled in this study. 
Confluence Health reports a base rate population of 58% Latino patients. UT Southwestern 
(UTSW) has been a prior collaborator of the PI and her collaborators at Weill Cornell on R01 
projects examining advanced cancer patients over time. In this prior work, they have 
consistently recruited several Latinx advanced cancer patients successfully and met all 
recruitment goals (often n=50 to 75 patients within 12 to 18 months), Additionally, Dr. Paulk 
has collaborated on this research and has several publications in the area of end-of-life 
care. Finally, the current number of eligible Latinx advanced cancer patients at this site is 
n=15 to 20 patients per week. Finally, of great importance, UT Southwestern has trained 
and devoted bi-lingual research staff to assist with study recruitment. These features of the 
site and the lead collaborator, Dr. Paulk, make it a highly feasible collaborative site for this 
multi-site project. Dr. Paulk is the founder of palliative medicine programs at UTSW and 
currently serves as the Medical Director of ambulatory and inpatient palliative medicine 
programs for the Parkland Health and Hospital System (PHHS). Additionally, this site is 
expected to serve as a site for future R01 submissions, thus inclusion at this point will 
enhance the ability to demonstrate feasibility. This request was approved by the NCI PO for 
this K07 award.
3.2 Study Population
Patient subjects with an advanced cancer diagnosis who meet the inclusion and exclusion 
criteria will be eligible for this study. 
3.3 Inclusion Criteria
Patient eligibility criteria: (1) identifying ethnically as Latino; (2) locally advanced or 
metastatic cancer and/or have experienced disease progression on at least first-line 
chemotherapy and (3) ability to provide informed consent. 
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3.4 Exclusion Criteria 
Patient exclusion criteria: (1) not fluent in English or Spanish; (2) severely cognitively 
impaired (as measured by Short Portable Mental Status Questionnaire scores of ≥ 6 to be 
delivered by trained study research staff during screening);41 (3) too ill or weak to complete 
the interviews (as judged by interviewer); (4) currently receiving hospice at the time of 
enrollment (to allow prediction of ACP); (5) children and young adults under age 18; and (6) 
patients deemed inappropriate for the study by their treating oncologist. Because the 
primary outcomes include both completion of advance care planning documentation as well 
as conversations around ACP, we have chosen not to add exclusion criteria around 
completion of advance directives. The goal of PLAN is two-fold – which is to increase 
completion of these documents but also to increase engagement in conversations around 
ACP with loved ones and providers (which can be present or not present despite completion 
of documents).
3.5 Strategies for Recruitment and Retention
To recruit patients at FHCC, trained bi-lingual, bi-cultural research staff will review the 
electronic health record to identify potentially eligible patients. And will contact the treating 
oncologist to confirm initial eligibility and obtain permission to approach these patients about 
the study. Using the eligibility criteria outlined, study staff will screen participating 
oncologists’ clinic schedules for patients that meet the inclusion criteria (e.g., cancer 
diagnosis and treatment status). Alternatively, oncologists will refer their patients directly to 
the study.
To recruit patients at Confluence Health, a clinical roster will be reviewed daily by 
oncologists or clinical team members. Potentially eligible patients will be identified and 
forwarded in a list to FHCC study staff. Trained bi-lingual, bi-cultural FHCC research staff 
will approach, determine eligibility, and consent eligible patients.
To recruit PHHS patients by UTSW study staff, the site PI (Dr. Paulk) or trained bi-lingual, 
bi-cultural staff at UTSW will obtain verbal consent either in-person or over the phone from 
Parkland patients eligible for the study. All consented patients will then be given 
assessments/surveys. For patients randomized to the intervention condition, they will 
receivethe telephone-based intervention by the FHCC study staff. These approaches are 
outlined and will be approved by the participating site’s local IRB.
 
Recruitment and retention. We will recruit advanced cancer patients from three sites: FHCC, 
UT Southwestern, and Confluence Health. To maximize recruitment rates and ensure timely 
completion of the proposed study, we will use multiple methods and processes used in our 
prior (R01-CA106370, PI: Prigerson) and current work (K07-CA207580, PI: Shen; R21-
CA224874, PI: Shen) outlined below. Our team of investigators, most notably Dr. Shen (PI), 
Dr. Prigerson (Co-Investigator), and Dr. Paulk (Co-Investigator) have a long track record of 
success recruiting advanced cancer patients to research studies. Sampling and recruitment 
procedures to be utilized in the present study, as noted, have been used for similar NCI-
funded studies (e.g., CwC I, II, and III; PI: Prigerson: Site PI: Paulk). Recruitment across 
these studies (e.g., R01-CA106370, PI: Prigerson) have indicated recruitment rates of 70-
80% for an advanced cancer patient population with the same eligibility criteria outlined in 
this application. As such, we project a conservative estimate of 70% of eligible patients. The 
average number of new advanced cancer patients seen annually at FHCC (based on solid 
tumors included in the proposed study) is n= 2,405, of whom n=372 identify as Latinx 
(based on 2019 numbers from formerly Seattle Cancer Care Alliance). Given this projected 
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patient flow, the allowed year for active recruitment is a highly feasible timeline for recruiting 
n=50 patients at FHCC. 
Although our prior studies have successfully recruited 70% of advanced cancer patients, we 
acknowledge that recruitment to the present study may pose different and unique 
challenges. As such, we outline here the specific measures we will take to maximize rates of 
recruitment and retention to ensure timely and full completion of the study at each site. 
At FHCC, study staff will review FHCC clinic schedules twice weekly to identify advanced 
cancer patients who meet the eligibility criteria. Study staff will confirm the potential eligibility 
of all identified patients through medical record review. Once a potentially eligible patient is 
identified, research study staff will email the patient’s treating oncologist or other clinical 
team member to confirm eligibility and request permission to approach the patient. When an 
eligible patient is identified and confirmed to be eligible by the patient’s treating oncologist or 
clinical team member, the research study member will approach the patient in the clinic and 
describe the study to the patient in person. If the research study member is unable to meet 
the patient during his/her clinic appointment, the study member will mail a letter out 
describing the study, which includes contact information for the study team. The letter will 
instruct the patient to call the study team either to learn more about the study or indicate he 
or she is not interested. If no contact is made by the patient, the study team member will 
follow up with a phone call to provide additional information about the study and assess 
interest in participating. Once the patient has expressed interest and is deemed eligible, 
they will each be given an introductory letter, a study information sheet, and consented to 
the study. Once consented, the assessments and telephone-based intervention will be 
conducted by FHCC study staff. 
At UTSW, Dr. Paulk and other providers within the PHHS palliative care clinic will refer 
potentially eligible patients to UTSW research study members. A Form HH HIPPA 
supplement and waiver of authorization has been sent and approved by Fred Hutch and 
UTSW IRB in order to review EMRs to determine eligibility for recruitment purposes. When 
an eligible patient is identified and confirmed, the UTSW study member will either approach 
the eligible patient in person, during a clinic visit, or mail out recruitment material, if they are 
unable to approach the patient in person. If approaching the eligible patient in person, the 
study member will coordinate with the clinic staff to find an appropriate time to approach the 
patient. When approaching the patient, the study member, will proceed to describe the study 
and give the patient a study flyer. If the research study member is unable to meet the patient 
during their clinic visit, they will mail the patient an envelope containing a study flyer and 
information sheet. An information sheet is a UTSW form used to provide study information to 
potential participants and used for guiding the verbal consenting process. Two weeks after 
mailing out the letters, UTSW study staff will contact the participant over the phone to gauge 
interest for study participation. A Form HH Waiver of Consent documentation has been sent 
and approved by Fred Hutch and UTSW IRB in order to waive documentation of consent 
(signed form) in order to obtain verbal consent. 
If the patient is interested after the in person or telephone call approach, the patient will give 
verbal consent for participation to the UTSW study member. Once verbal consent has been 
obtained the UTSW research assistants, will notify the Fred Hutch coordinator. The Fred 
hutch coordinator and social worker will then carry out the rest of the study procedures with 
the UTSW participants over the phone. Since the Fred Hutch Coordinator and social worker 
conduct the remaining study procedures, they will mail out the gift cards to participants who 
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have completed the surveys. Due to workflow, timing, scheduling and sessions/surveys 
conducted over the phone, Fred Hutch will take responsibility to compensate the 
participants, as UTSW staff will not be involved in the downstream of study procedures. To 
avoid any delays and to ensure timely compensation, once the participant has completed 
the survey with the participant over the phone, the Fred Hutch team will mail out the gift card 
to the participant. For each completed survey, the compensation will be a gift card in the 
amount of $25.00. Participants are eligible to receive up to $50.00 for completed both first 
and last survey.
At Confluence Health, oncologists within the cancer clinic will refer potentially eligible 
patients directly to the FHCC study team. Dr. Overton (Co-Investigator, Confluence Health) 
will directly assist in this process by communicating with and overseeing oncologist referrals 
at Confluence. When an eligible patient is identified and referred to FHCC study staff, staff 
members will be responsible for approaching the participant with an introductory letter and a 
study information sheet via mail. If interested, the patient will be consented to the study. All 
consented patients will then be given assessments as well as the telephone-based 
intervention by FHCC study staff.
Each of these methods for approaching and consenting methods have been used 
successfully previously at Weill Cornell (PI’s previous institution) to recruit advanced cancer 
patient. 
Additionally, the following measures will be taken to improve retention. Follow up calls or 
texts (depending on participant preference) to participants will be utilized to remind patients 
of upcoming study activity (interviews, assessments, etc.). A social worker interventionist 
and “coach” has been included as the study interventionist to improve patients’ access to 
needed resources throughout the study intervention, which has been shown in our prior 
work to improve retention to intervention studies. Throughout the study period, accrual and 
retention rates will be monitored at weekly study meetings through CONSORT flow 
diagrams reporting reasons for missed approaches, study refusal, and loss to follow up. This 
will allow the PI and study team members to notice quickly issues in accrual and/or retention 
and the potential reasons for it so that proper action can be taken to resolve the issue. This 
approach has previously helped similar studies which had fallen to 50% accrual to improve 
to 90% accrual through a targeted approach system that addressed the specific reasons for 
refusal (e.g., accommodating schedules, fatigue, etc.). Finally, all attempts have been made 
to keep interviews and questionnaires brief and flexible in order to reduce burden on the 
patients.
Patients at the FHCC and Confluence sites, who are approved for contact by the treating 
oncologist will be sent a letter in the mail that includes a brief description of the study and 
contact information of study staff. Research staff will then meet these patients in the clinic, 
introduce themselves, and provide the patient with a study information sheet and consent 
form. Patients who indicate they want to participate will be consented at that time or 
provided a pre-paid postmarked return envelope in which to return the consent form and 
contacted within one week via telephone for follow-up. Patients who study staff are unable 
to meet during clinic appointments will be contacted by study staff over the telephone and 
will be provided with information on the study and administered informed consent. Once 
consented, participants will be enrolled in the study.
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3.6 Interviews, Focus Groups, Surveys, and/or Observations 
A. Administration

Timing and Frequency
Pre-interview/baseline assessment, intervention, and post assessment follow up 
post-intervention (within a week).

Location
Telephone-based delivery of the intervention and in person or over the phone 
assessments. Cancer patients may opt to have their interview(s) during infusion 
at participating sites (FHCC, UT Southwestern/PHHS, Confluence Health).
*Additional measures to protect participants in the in-person interviews or 
usability testing from COVID-19 related exposure and infection. In-person 
interviews will only be conducted in line with all the safety regulations and 
recommended procedures for vulnerable and at-risk patient populations. As such, 
no in person approaches will happen prior to the appropriate approval and 
authorization at each participating site. In the even in person approaches are 
approved, study personnel will ensure proper PPE is worn by approaching study 
staff, proper social distancing is observed, and that all patients consent to and are 
comfortable with in person interviews. Due to potential risks, telephone-based 
interviews will be promoted among participating patients, when available.

Person Identifiers
Clinical variables will be collected from medical records and will include the 
following: cancer diagnosis and stage, treatment received, co-morbid conditions 
(i.e., Charlson Comorbidity Index, CCI), and Karnofsky performance status.
B. Study Instruments
Feasibility will be measured by intervention completion (Benchmark: ≥ 70% complete 
the intervention sessions). Acceptability will be measured by a single-item question 
assessing helpfulness of the intervention (1 = not at all helpful, 5 = very helpful) as 
well an open-ended question about helpfulness of the intervention (“What was 
helpful about the intervention?”) (Benchmark: ≥ 70% rate it as “helpful” or “very 
helpful”). Demographics will be measured via self-report assessing: age, gender, 
race, ethnicity, marital status, employment status, education, income, religion, 
insurance coverage, national origins (e.g., Mexican), cultural heritage, and 
acculturation.42 Clinical variables will be assessed using records from medical charts 
and will include the following: cancer diagnosis, treatment, site, and stage; co-morbid 
conditions, and Karnofsky43 performance status. 
Quality of life will be measured using the validated, 27-item Functional Assessment 
of Cancer Therapy-General (FACT-G) scale.44 Cultural beliefs will be measured 
using three brief scales developed for the present studies (included in the R01). 
Fatalismo45 will be measured using a 4-item scale assessing the acceptance of belief 
that all events are predetermined and inevitable. Personalismo46,47 will be measured 
using a 4-item scale assessing the existence of a warm, personal relationship with 
the medical professional and trust based on mutual respect. Respeto48 will be 
measured using a 4-item scale assessing the degree to which patients endorse the 
role of authority in following doctor’s orders. Familial beliefs will be measured using 
two brief scales developed for the present studies (included in R01). Familismo61,62 
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will be measured using a 5-item scale assessing the degree of family loyalty and 
cohesion. Related to familismo, filial duty49 will be measured with a 6-item scale 
assessing the degree to which children should be involved in caring for their elderly 
parents. Religious/spiritual beliefs will be measured with two scales: (1) Religious 
coping will be measured using Pargament’s brief RCOPE,50 which is a validated 14-
item scale (α > .8050) assessing the extent to which patients engage in 7 types of 
positive and 7 types of negative religious coping. (2) Religious beliefs about EOL 
medical care will be measured using a 9-item scale. We have recently begun to 
validate this scale among advanced cancer patients in our prior studies.51 Potential 
confounders to be measured include terminal illness acceptance, which will be 
assessed using our validated, single-item question,19,52 which asks patients how they 
would define their current health status and illness understanding, a single item 
measure that assesses understanding of incurability of illness. We will use the 
Advance Care Planning Engagement Survey, which is a validated 49-item scale 
(α=.94)1 designed to assess knowledge, readiness/motivation, and self-efficacy of 
ACP. Engagement in ACP will measure two key elements of ACP. First, EOL care 
discussions will be measured by asking patients to self-report whether they have 
discussed any of the following: (1) wishes they have about the care they would like to 
receive if they were dying and/or (2) advance care directives, with an oncology 
provider or family member: DNR orders, living wills, durable powers of attorney for 
health care, assignments of health care proxies (yes/no format). Second, completion 
of advance directives will be assessed by examining the medical chart for completed 
advance directive documents (DNR order, living will, durable power of attorney, 
health care proxy). Patient’s Medical Status. Patients’ current and past cancer 
diagnoses, the dates of each, patients’ Karnofsky performance score43 and the 
number and type of oncology providers seen at that clinic will be obtained from the 
patient’s medical chart. Advance Directives and Referrals for Palliative Care. 
Patient’s medical charts will be reviewed for documentation of advance directives 
and referrals for palliative care during the study observation period (consent to 
interview).
3.7 Intervention (PLAN)
The intervention for this study, Planning For Your Advance Care Needs (PLAN), is a 
coaching-based communication information designed to be culturally competent, In PLAN, 
all coaching sessions will occur over the phone and be a maximum of 45 minutes to reduce 
patient burden. These sessions will focus on creating individualized messages and skill-
building exercises based on patients’ learning needs, goals, and values (as indicated on the 
intake form). The intervention will be delivered across three sessions, with the following 
modules, as based on prior communication competence coaching interventions:53 (1) 
Assessment of current knowledge, motivation, and self-efficacy (action) as well as cultural 
and religious preferences/values surrounding EOL care (tablet-based intake questionnaire); 
(2) clarification and correction of misconceptions about EOL care and ACP; (3) teaching of 
relevant concepts (education about ACP and EOL care options); (4) planning (identifying 
goals of care, creating achievable goals of care, and creating strategies to communicate 
goals of care to providers and family members); (5) rehearsal of communication skills using 
role play exercises (practice question-asking, etc.); (6) portrayal of learned skills (patient 
applies learned skills in their oncology visit and/or with family members).
3.8 Interviewer Training and Instrument Administration
Interviewer Training. Staff working on this protocol have extensive experience interviewing 
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patients with advanced cancer in an end-of-life care settings from our previous NCI-funded 
studies. These fully trained, experienced interviewers will train new interviewers. Training will 
consist of learning the interview question prompts/guides, practice sessions, and instruction 
in administration of surveys, including IRB approved procedures for approaching potential 
study participants. Newly trained interviewers will be required to have a high degree of inter-
rater-reliability (e.g., κ=0.85) with fully-trained, experienced interviewers on core 
assessments (e.g., religious beliefs about end-of-life medical care) before they will be 
allowed to collect data for the study.
Scheduling of Assessments. Study staff will contact enrolled patient study participants to 
schedule their interviews. Patients will be given the option to communicate about their 
assessments and the scheduling of the assessments via phone calls, emails, and/or text 
messages. Patient assessments will be scheduled to occur at the earliest convenient time for 
the participant following study enrollment. All baseline assessments will be given first. Then, 
patients will engage in their first intervention session within one week of completing a 
baseline assessment. The three intervention sessions will then be given approximately a 
week a part, taking approximately four weeks to complete. After completion of the 
intervention, patients will complete a post-intervention assessment within one week. Finally, 
a brief three month follow up will occur that extracts data from their EHR on healthcare 
utilization. For those in the control condition, they will receive a baseline assessment and 
then a “post-intervention” session four weeks later, which is the expected span of time 
between baseline and post-intervention assessments for those in the experimental condition. 
Three month follow up data extraction will occur for subjects in experimental and control 
conditions. 
Conduct of Patient Assessments. Patients’ assessments will be conducted either in 
person in clinic or at home, or over the telephone depending on the wishes of the patient. 
Interviews will be conducted in English or Spanish depending on the preference of the 
patient. We have previously validated all measures to be used in samples of English- and 
Spanish-speaking advanced cancer patients, and all assessments will be translated into 
Spanish through Datagain, a professional translation service which utilizes HIPAA compliant 
procedures and has been used in prior studies by the PI. We will document the language in 
which the interview was conducted. Each interview will be conducted alone with the patient 
to permit greater freedom of expression and will be approximately 45 minutes in length. If 
patients appear depleted or otherwise unable to be interviewed at that time, the interviewer 
will reschedule the interview at a time and place of their choosing within a few days. 
Considerable care has been taken to ensure that the interviews are as brief as possible. All 
Spanish translated materials will be submitted for IRB approval after receiving approval for 
the English documents.
Medical Chart Extraction. Study staff will review participating patients’ medical charts 
during the course of the study to extract information about patients’ health and disease 
status, healthcare, documentation of advance care directives, and referrals for palliative care 
during the study observation period.
Reducing Missing Data. To reduce missing data, following all assessments study staff will 
review the contents and scan for missing information. If missing information is found, the 
staff member will contact the subject or review the medical chart to fill-in missing data.
3.9 Intervention Administration
A total of 50 Latino advanced cancer patients will be enrolled in this study and randomly 
assigned to the intervention (n=25) or control (n=25) condition. Pre-intervention, patients’ 
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communication goals will be assessed. Then, patient will participate in the intervention or a 
usual care control condition. After participating in the intervention or control condition, 
patients’ engagement in ACP will be assessed to determine if the intervention improved 
ACP engagement and planning.
The intervention itself will be administered by a fully trained, licensed social worker via 
telephone. This interventionist will use a culturally competent communication intervention to 
“coach” patients in how to be motivated for and to actually engage in ACP, and will be bi-
lingual in Spanish and English.
Patients randomized into the control group will receive usual care. For usual care, patients 
will engage in standard care with no modifications. Thus, ACP discussions will only occur as 
they do in usual clinical care (i.e. brought up in clinical encounters). 
3.10 Special Concerns
Patients who agree to participate in the study and provide informed consent will be asked to 
complete an intervention and post-intervention assessment. Assessments will occur within a 
few weeks of study enrollment. Each patient assessment will be scheduled to take place at 
a time and a location that is convenient for the participant, and will take approximately 30 
minutes to complete. Patient assessments are designed to be focused and brief. The 
assessment batteries are less lengthy than those for a prior, similarly designed study 
(Coping with Cancer), for which rates of incomplete assessments were extremely low, with 
no interviews of patients requiring rescheduling, and with minimal missing data.
3.11 Compensation
Patient participants will each receive $25 (gift card) compensation for each completed 
survey assessments (2) for a total of up to $50. The issue of compensation is addressed in 
the respective consent forms. This amount was selected to compensate patients for their 
time without coercion to enrollment in the study. UTSW participants will receive their gift 
cards via mail, by the Fred Hutch team following survey and assessments completed over 
the phone.
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4. Registration Procedures
4.1 Subject Registration (FHCC and Sub-sites)
Subjects will be registered within OnCore CTMS as per the standard operating 
procedure for Subject Registration.
5. Study Procedures
5.1 Schedule of Assessments 
Table 1. Schedule of trial events
Baseline
Post-
intervention 
(with 1 week 
of completing 
intervention)
3 mos. after 
completion of 
intervention 
Off Study
Informed consent
X
Demographics
X
Clinical variables
X
Acceptability
X
Usability 
X
Feasibility
X
Quality of life
X
X
Cultural beliefs 
(Fatalismo, personalismo, 
respeto)
X
X
Familial beliefs 
(Familismo, filial duty)
X
X
Religious/spiritual beliefs 
(Religious coping, 
religious beliefs about 
end-of-life medical care)
X
X
Terminal illness 
acceptance
X
X
Illness understanding
X
X
Readiness for ACP
X
X
Engagement in ACP
X
X
Healthcare utilization
X
X
X
Goal-concordant care
X
X
X
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6. Data Reporting / Regulatory Considerations
6.1 Data Collection
The source of the data to be collected will be verbally administered surveys and (with patient 
consent) extraction of data from medical records. All materials outlined here will be used 
specifically for the purposes described in this proposal and not for any other purpose. All 
data collected during the study will be de-identified. Participants will be informed that all 
responses will be kept confidential. Data will be linked to participants’ names only by means 
of an assigned study identification number. Authorized study staff are the only individuals 
who will have access to participants' identification numbers and personal information. This 
information will be stored in a password protected database on the secure FHCC server as 
well as in hard copy format in a locked file cabinet in a locked office that is only accessible to 
the study PI and relevant study staff. The files linking participant study identification 
numbers to participant names will be destroyed after study completion. All necessary 
precautions will be taken to ensure that there is no breach of confidentiality.
Participants’ completed interviews and self-report measures will be saved in a password 
protected file on the secure FHCC network server (electronic format) or stored in a locked 
file cabinet in a locked office (hard copy format) accessible only to the PI and relevant study 
staff. Participants’ responses will be entered into a password-protected electronic database 
for analytic purposes. This database will be stored on the secure FHCC network server that 
is password protected. 
Data will be obtained by experienced research staff trained in interviewing study 
participants. All study staff involved in the research will be educated on the protection of 
human research participants, including attending formal training in the Responsible Conduct 
of Research provided at FHCC (for FHCC study staff) and UT Southwestern (for UT 
Southwestern study staff). All personnel involved in the proposed protocol will be educated 
regarding HIPAA regulations and will fully understand their responsibility to safeguard the 
personal health information of every participant involved in the research. The data will be 
used specifically for the purposes outlined in this proposal or a subsequently IRB approved 
protocol and not for any other purpose.
*Additional measures to protect participants in the in-person interviews or usability 
testing from COVID-19 related exposure and infection. In-person interviews will only be 
conducted in line with all the safety regulations and recommended procedures for vulnerable 
and at risk patient populations. As such, no in person approaches will happen prior to the 
appropriate approval and authorization at each participating site. In the even in person 
approaches are approved, study personnel will ensure proper PPE is worn by approaching 
study staff, proper social distancing is observed, and that all patients consent to and are 
comfortable with in person interviews. Due to potential risks, telephone based interviews will 
be promoted among participating patients.
6.1.1 REDCap
All data will be entered and stored securely on FHCC REDCap servers.
6.2 Regulatory Considerations
6.2.1 Institutional Review Board/Ethics Committee Approval 
As required by local regulations, the Investigator will ensure all legal aspects are 
covered, and approval of the appropriate regulatory bodies obtained, before study 
initiation. 
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Before initiation of the study at each study center, the protocol, the ICF, other written 
material given to the patients, and any other relevant study documentation will be 
submitted to the appropriate Ethics Committee. Written approval of the study and all 
relevant study information must be obtained before the study center can be initiated or 
the IP is released to the Investigator. Any necessary extensions or renewals of IRB 
approval must be obtained for changes to the study, such as amendments to the 
protocol, the ICF, or other study documentation. The written approval of the IRB together 
with the approved ICF must be filed in the study files. 
The Investigator will report promptly to the IRB any new information that may adversely 
affect the safety of the subjects or the conduct of the study. The Investigator will submit 
written summaries of the study status to the IEC/IRB as required. On completion of the 
study, the IRB will be notified that the study has ended. 
The Investigator will not modify or alter this protocol without the agreement of the IRB. 
All agreed protocol amendments will be clearly recorded on a protocol amendment form 
and will be signed and dated by the original protocol approving signatories. All protocol 
amendments will be submitted to the relevant institutional IRB for approval before 
implementation, as required by local regulations. The only exception will be when the 
amendment is necessary to eliminate an immediate hazard to the trial participants. In 
this case, the necessary action will be taken first, with the relevant protocol amendment 
following shortly thereafter. 
Once protocol amendments or consent form modifications are implemented at the lead 
site, FHCC, updated documents will be provided to participating sites. FHCC must 
approve all consent form changes prior to local IRB submission. 
Relevant study documentation will be submitted to the regulatory authorities of the 
participating countries, according to local/national requirements, for review and approval 
before the beginning of the study. On completion of the study, the regulatory authorities 
will be notified that the study has ended. 
6.2.2 Ethical Conduct of the Study 
The Investigators and all parties involved should conduct this study in adherence to the 
ethical principles based on the Declaration of Helsinki, GCP, ICH guidelines and the 
applicable national and local laws and regulatory requirements. 
This study will be conducted under a protocol reviewed and approved by the applicable 
ethics committees and investigations will be undertaken by scientifically and medically 
qualified persons, where the benefits of the study are in proportion to the risks.
6.2.3 Informed Consent
The investigator or qualified designee must obtain documented consent according to 
ICH-GCP and local regulations, as applicable, from each potential subject or each 
subject’s legally authorized representative prior to participating in the research study. 
Subjects who agree to participate will sign the approved informed consent form and will 
be provided a copy of the signed document.  
The initial ICF, any subsequent revised written ICF and any written information provided 
to the subject must approved by IRB prior to use. The ICF will adhere to IRB 
requirements, applicable laws and regulations.
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Informed Consent will occur under the IRB of FHCC and UT Southwestern.
At UTSW, verbal consent will be obtained from recruited participants who give consent. 
A waiver for documentation has been approved by Fred Hutch and UTSW IRB.
6.2.4 Compliance with Trial Registration and Results Posting Requirements 
The following refers to the proposed project, which will be considered a clinical trial 
according to NIH standards. This dissemination plan is consistent with NIH Guide Notice 
NOT-OD-16-149. Dr. Shen (PI) will register the proposed trial on ClinicalTrials.gov prior 
to recruiting and consenting the first participant. All study results from the trial will be 
submitted to ClinicalTrials.gov no later than 12 calendar months after the trial’s primary 
completion date. Dr. Shen (PI) will review all ClincalTrials.gov entries for accuracy and 
comprehensiveness prior to submission for review. 
Compliant with NIH policy, all informed consent documents for the pilot trial will include a 
statement that these results will be made available at the ClinicalTrials.gov website after 
the initial analysis is complete. Additionally, all participants will be informed that study 
findings will be presented in aggregate form and that participant-level and identifying 
information will not be included to ensure confidentiality.
FHCC has an internal policy to ensure that clinical trials registration and results occur in 
compliance with policy requirements. Specifically, the FHCC Clinicaltrials.gov 
administrator will facilitate the Principal Investigator’s dissemination of study results 
through ClinicalTrials.gov registration and reporting. Dr. Shen will be responsible for 
handling ClinicalTrials.gov requirements for this project according to FHCC 
Clinicaltrials.gov policy. Once a record is established, Dr. Shen will confirm accuracy of 
record content; resolve problems; and maintain records including content update and 
modifications. Dr. Shen will also be responsible for results reporting and Adverse Events 
reporting at the conclusion of the project.  
6.2.5 Record Retention
Essential documents are those documents that individually and collectively permit 
evaluation of the study and quality of the data produced.  After completion of the study, 
all documents and data relating to the study will be kept in an orderly manner by the 
Investigator in a secure study file.  Essential documents should be retained for 2 years 
after the final marketing approval in an ICH region or for at least 2 years since the 
discontinuation of clinical development of the IP. In addition, all subject medical records 
and other source documentation will be kept for the maximum time permitted by the 
hospital, institution, or medical practice.  
7. Statistical Considerations
Participants (N=50) will be randomly assigned to the intervention group (n=25) or the 
control group (n=25). They will then complete measures of engagement in ACP post-
intervention. Feasibility and acceptability will be examined with frequency and 
descriptive statistics (i.e., mean, median, standard deviation, range) for enrollment rates, 
number of sessions completed, number of weeks required to complete the intervention, 
and Likert-scale items assessing satisfaction with the intervention and perceived 
helpfulness. Because this is a pilot study, in accordance with published standards for 
pilot feasibility clinical trials,54 inferential statistics on measures of feasibility (≥70% 
intervention completion rates) and acceptability (≥70% rate it as “helpful” or “very 
helpful”) are not recommended. Rather, we will examine the average rates of completion 
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as well as satisfaction and helpfulness ratings to determine feasibility and acceptability 
based on those values being equal to or greater than 70%. We will also conduct 
qualitative analyses on the open-ended questions related to helpfulness. Thematic 
analysis using an iterative process will be conducted for all qualitative analyses.55-59 A 
coding scheme and codebook will be created to analyze transcripts of the responses to 
the open-ended question. Transcripts will be coded separately by two individual coders 
for manifest (e.g., frequencies) and latent (e.g., underlying themes) variables. If 
discrepancies occur, a third coder will resolve these conflicts. Interviews will continue 
until thematic saturation is achieved.60,61 Based on our prior field testing of interventions 
with patients with advanced illness, we anticipate reaching saturation with n=10 
participants. Thus, n=25 in the experimental condition should be well powered to reach 
thematic saturation.
To examine potential efficacy, preliminary analyses will utilize t-tests to compare the two 
groups on baseline characteristics (e.g., education, age). Using a criterion of p < .10, any 
variables that are different among the groups will be included in the final logistic 
regression models as potential confounders. To test the study aim, five separate logistic 
regression models will be run in which ACP outcomes (yes/no to EOL discussions with 
family and providers; and the completion of advance directives DNR, health care proxy, 
and living will) will be predicted by the group variable (CCC intervention vs. control). The 
statistical power of the proposed logistic regressions to detect a minimum odds ratio of 
2.0 for dichotomous outcome measures of ACP, for a two-tailed test with power (1 – β) 
equal to 0.80, and α = 0.05, requires a sample size of 113. Our proposed sample size of 
n=50 will be underpowered if the effect size is small but adequately powered if it is large. 
However, this study is a preliminary pilot and the main focus and goal of this is to 
determine feasibility, acceptability, and to provide preliminary data to inform a fully-
powered RCT in future research (R01 submission). 
7.1 Randomization. We will utilize stratified randomization at the level of each site to 
ensure balance across the interventional and control groups at the level of each site. To 
randomize, we will employ a random number generator to randomize participants to 
study arms at the level of each site. To ensure randomization was effective, separately 
for each binary outcome, we will perform a two-sample proportions test to test if the rate 
of outcomes is significantly different between intervention and control groups. Separately 
for each continuous outcome, we will perform a two-sample unpaired t-test or unpaired 
Wilcoxon test (as appropriate) to test if the rate of outcomes is significantly different 
between intervention and control groups.
7.2 Missing data. To reduce missing data, study staff will conduct interviews rather than 
relying on written self-reports. This approach has been used previously in our prior work 
to help reduce data that is missing due to patients accidentally overlooking or missing 
items or requiring clarification of certain terms (e.g., what is an advance directive). Due 
notice is taken to ensure that patients know that they are free to skip items they prefer 
not to answer.
8. Adverse Event Reporting Requirements
8.1 Potential Adverse Events
Potential adverse events (AEs) for this project are all non-medical in nature. Participants 
may experience mild distress when discussing the status of the patients’ cancer, 
decision-making, or care. Study staff may become aware of adverse events through 
participant self-report, routine study assessments, or study staff interactions with 
participants. 
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We will use standard NIH definitions of AEs/SAEs and UPs as follows:
Adverse Event (AE): Any untoward or unfavorable medical occurrence in a human 
study participant, including any abnormal sign (e.g. abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the participants’ 
involvement in the research, whether or not considered related to participation in the 
research. The most likely event for the present study is elevated psychological distress.
Serious Adverse Event (SAE): Any adverse event that: Results in death; Is life 
threatening, or places the participant at immediate risk of death from the event as it 
occurred; Requires or prolongs hospitalization; causes persistent or significant disability 
or incapacity; Results in congenital anomalies or birth defects; Is another condition which 
investigators judge to represent significant hazards. An example in the present study is a 
hospitalization or institutionalization or suicidal ideation.
Unanticipated Problem (UP): Any incident, experience, or outcome that is: 
Unexpected, in terms of nature, severity, or frequency; related or possibly related to 
participation in the research; and suggests that the research places participants or 
others at a greater risk of harm (including physical, psychological, economic, or social 
harm) than was previously known or recognized.
We will use the following grading and relatedness scales in use at FHCC, UT 
Southwestern, and Confluence Health for severity rating and relatedness raring: 
Grading scale:
0.
No adverse event
1.
Mild AE – No treatment needed
2.
Moderate AE – Resolved with treatment
3.
Severe AE – Inability to carry on normal activities, required professional medical 
attention
4.
Life-threatening or disabling AE
5.
Fatal AE
Relatedness scale:

Definitely related

Probably related

Possibly related

Unlikely to be related

Definitely not related
To summarize, potential adverse events (AEs) for this project are all non-medical in 
nature and are expected to be graded as mild to moderate. Participants may 
experience mild distress when discussing the status of the patients’ prognosis or 
advance care planning. Serious adverse events (SAE) will include the following: 
suicidal ideation and/or discussing plans to harm another individual. Study staff may 
become aware of adverse events through participant self-report, routine study 
assessments, or study staff interactions with participants.
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An unanticipated problem (UP) in the present study would include physical harm of 
any form to patients, as the proposed study only poses to potentially increase 
distress. As outlined in NIH policy, the AEs are expected to be mild to moderate in 
severity; the SAEs are expected to be serious in severity; and the UPs are expected 
to be mild to moderate in severity. 
Based on our prior work, we anticipate that AEs will occur rarely (in less than 2% of 
cases based on prior studies); SAEs to be 0% (based on prior work); and UPs to be less 
than 1% based on prior work. In most cases, only an AE of distress is expected to be 
directly related to study procedures whereas SAEs and UPs are rarely linked to study 
procedures directly in similar work
8.2 AE/SAE Reporting
To identify possible AEs and SAEs, all study staff will be trained in identifying possible 
AEs or SAEs and will be required to keep a written log after each participant completes 
study procedures. In the event an AE or SAE is noticed, study staff will notify the PI 
either within 24 hours (for SAEs) or within five days (for AEs). Additionally, the PI will 
review all study materials, including recording interviews and answers to study questions 
to ensure that no AEs or SAEs go undetected. 
All SAEs noted by study staff will be discussed with the PI or designee and reported 
within 24 hours of discovery by study staff to the IRB and the NCI Program Officer. The 
PI is required to report adverse events to the Institutional Review Board (IRB) on an 
ongoing basis. In addition, yearly IRB renewal submissions require detailed adverse 
event reporting, which will also be sent to the NCI Program Officer and the grant PI (Dr. 
Shen). Adverse events are also reported as part of the progress reports in the non-
competitive and competitive renewals for the NIH. All study staff will complete the NIH 
required training in participation and conduct of studies that involve human subjects. If 
study staff discover any untreated physical conditions, they will refer participants to 
appropriate treatment immediately. 
Some participants will be receiving active treatment at the time of study participation; 
therefore, fluctuations in cancer-related symptoms will not be considered adverse events 
related to the study. The PI will discuss safety concerns, adverse events, participant 
complaints and, if any, protocol violations with co-investigators as well.
Meetings with co-investigators will be used to determine if any additional procedures are 
needed to augment data and safety monitoring. When SAEs occur that are 
unanticipated, they will be reported to and verified by Dr. Shen, and reported to the IRB 
and the NCI Program Officer.
After reporting to the IRB, the PI will determine necessity for further reporting and next 
steps, which will include the following:

No further reporting of a “definitely not related” AE (but not SAE) will occur. 

All deaths will be reported to the IRB and NCI Program Officer within 24 hours of 
learning about this event. 
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
All adverse events that are both serious (SAE) and unexpected (i.e., have not been 
previously reported for the study's intervention) will be reported to the IRB and NCI 
Program Officer as well as the PI within 48 hours of the study’s knowledge of the 
SAE. (All deaths within 24 hours, as per above.)

The summary of all other SAEs will be reported to NIA Program Officer and SO, 
quarterly.
Few AEs or SAEs are expected for this slightly greater than minimal risk study of a 
behavioral intervention. As such, it is possible based on the high morbidity and 
multimorbidity of this population (i.e., advanced cancer patients) that there will occur 
one or more hospitalizations and/or other moderate to severe illness-related events 
during the study period that are unrelated to study participation. Nonetheless, if these 
occur, they will be reported as AEs or SAEs and the appropriate steps as outlined 
above will be taken.
Below are the specific events that will trigger reporting to the parties described above:
Acute alerts/Serious Adverse Events (SAEs)

Hospitalization of study participant

Institutionalization of participant

Emergency room visit of participant

Death of participant
Safety Alerts/Adverse Events

Severe medical problem of participant

Participant threatens to harm him or herself or others

Evidence of abuse to participants
8.3 Plans for Assuring Compliance Regarding Adverse Events Reporting
All serious adverse events noted by study staff will be discussed with the PI or designee 
and reported within 24 hours of discovery by study staff to IRB. The PI is required to 
report adverse events to the IRB on an ongoing basis. In addition, yearly IRB renewal 
submissions require detailed adverse event reporting, which will include logs of adverse 
events. Adverse events are also reported as part of the progress reports in the non-
competitive and competitive renewals for the NIH. All study staff will complete the NIH 
required training in participation and conduct of studies that involve human subjects. If 
study staff discover any untreated physical conditions, they will refer participants to 
appropriate treatment immediately. Some participants will be receiving active cancer 
treatment at the time of study participation; therefore, fluctuations in cancer-related 
symptoms will not be considered adverse events. The PI will discuss safety concerns, 
adverse events, participant complaints and, if any, protocol violations with co-
investigators. These meetings will be used to determine if any additional procedures are 
needed to augment data and safety monitoring.
8.4 Plans for Assuring that Action Resulting in Suspension of Trial is Reported
The PI is responsible for contacting the NIH grant program director in the event that any 
action resulting in temporary or permanent suspension of the trial/study occurs. Because 
this trial/study does not involve any investigational medication, the action would be 
limited to an IRB-or investigator-initiated suspension.
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8.5 Plans for Assuring Unanticipated Problems are Managed and Reported
The PI will meet with study staff on a weekly basis to review study progress and discuss 
unanticipated problems in subject recruitment, data collection, randomization, and 
intervention administration. Further, the PI will be available to study staff on a continuous 
basis (i.e., between scheduled meetings) to discuss and address unanticipated 
problems. Unanticipated problems that result in protocol deviations will be reported to 
the IRB, consistent with IRB policy. Further, the PI will report unanticipated problems to 
all study investigators and will obtain their input on and approval of solutions to these 
problems.
8.6 Plans for Assuring Data Accuracy and Protocol Compliance
Study data will be entered by a research assistant trained to enter data into a password-
protected, secure database. A percentage (5%) of overall data entry will be entered a 
second time, by a different study team member to assure data accuracy. The PI will 
oversee first and second pass data entry and will generate reports based on data 
entered. The reports enable the PI to oversee data entry and level of accuracy as well as 
percentage of error in data entry. These reports will be generated on a regular basis and 
discussed with Co-Investigators.
Protocol compliance will be monitored at the weekly project staff meetings. The PI will 
meet with the study staff, convened via conference call, on a weekly basis to train and 
ensure adherence to the intended protocol. The PI will be responsible for updating all 
investigators regarding any study related issues that arise of that need to be addressed.
9. Unanticipated Problems Involving Risks to Subjects or Others 
9.1 Potential Risks: The risks involved in this study are minimal. There are no risks of 
physical injury. We anticipate that there may be questions in the interview that some 
study participants find upsetting. However, based on interviewing patients with advanced 
cancers in prior NCI-funded studies, we do not anticipate that this will be problematic. 
Should participants become exceedingly upset, overwhelmed or fatigued, or need to 
attend to matters of personal care during the interview, interviewers will be instructed to 
ask the participant if he or she would like to take a break or reschedule the interview for 
another time. However, across all prior studies (PI: Shen), distress caused by engaging 
in these conversations has been minimal. 
In addition, participants may find engagement in the intervention to be upsetting, 
particularly due to the potential for family conflict to arise. In addition, discussing 
advance care planning and end-of-life goals of care can be difficult. Patients will be in 
weekly contact with study interventionists who will be licensed social workers with 
experience working with medically ill patients and their families. These social workers 
will have the skills to assess exacerbations in distress in study participants and provide 
appropriate support. Additionally, the social workers will provide patients with continued 
support throughout the intervention. In the event a study participant requires a higher 
level of care than provided in this study,  a FHCC licensed on call psychiatrist or mental 
health professional, UT Southwestern Licensed Clinical Psychologist, or a Confluence 
Health licensed on call psychiatrist or mental health professional will be consulted and 
the participant will be referred to the appropriate level of care. Dr. Shen (PI) will also be 
contacted if a patient endorses suicidal ideation. If additional intervention is necessary, 
Dr. Shen will coordinate with FHCC’s clinical team for referral and care, Dr. Paulk will 
coordinate with UT Southwestern’s Psychiatry Department, and Dr. Overton will 
coordinate with a mental health professional at Confluence Health. Study participants 
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who express a desire following the post-intervention interview to talk at greater length 
about issues raised during the study will be encouraged to call study staff at the 
telephone number provided, and should they want a referral for psychological 
counseling, study staff will provide them with a referral to a mental health professional at 
a location that is convenient for them. 
9.2. Adequacy of Protection against Risks 
9.2.1 Recruitment 
Study staff will review medical records and consult with the treating oncologists 
to identify patients who may be eligible for the proposed study. When a 
potentially eligible patient is identified and study staff have received permission 
from the treating oncologist to contact the patient, a research staff member will 
send the patient a brief letter describing the study. The letter will encourage 
patients to contact the study team if they are interested in receiving more 
information about the study or if they would prefer not to be contacted further. 
Study staff will then attempt to meet the patient during their next clinic visit in 
order to introduce him/herself to the patient, and provide the patient with a study 
information sheet and consent form. Research staff will review study aims and 
procedures and answer any questions that prospective participants might have 
regarding the study at that time. If research staff are not able to meet the patient 
during their clinic appointment, research staff will call the patient to provide 
additional information about the study and review the consent form. All consent 
forms will receive proper IRB approval. Treating oncologists may also refer 
patients to the study.
9.2.2 Informed Consent 
Informed consent is a process, not a one-time event. During the informed 
consent process, the study staff obtaining consent will review the study in detail 
allowing the participant to interject with questions at any time during the 
discussion. It is extremely important that the participant has an opportunity to 
have his/her questions addressed as well as ample time to read the consent 
document and determine whether or not they would like to participate in the 
study. Study staff conducting informed consent will be trained by the PI on 
techniques for effective administration of informed consent. Study staff will also 
be trained on HIPAA regulations and will fully understand their responsibility to 
safeguard the personal health information of study participants.
The main points that will be addressed by study staff obtaining informed consent 
include explaining why the current research study is being conducted, the source 
of funding for the project, and what purpose the proposed research serves. 
Additionally, the subject will be made aware of who is responsible for conducting 
the research, what other sites are involved as well as how participants, including 
themselves, are selected for participation in the research.
The study staff will explain in explicit detail what will be asked of the participants 
if they agree to participate in the study and estimate the potential time 
commitment involved. Participants will know what their responsibilities will entail, 
what risk or benefit may be involved and what potential costs could be incurred 
should they agree to participate. The study staff will underscore the importance 
placed upon maintaining participant confidentiality as well as their rights while 
involved in the study, which includes the right to withdraw participation at any 
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time during the research due to the fact that their participation is entirely 
voluntary in nature. The informed consent will also contain a section dedicated to 
explaining what constitutes protected health information and how this information 
remains confidential per HIPAA (Health Insurance Portability and Accountability 
Act) guidelines. Additionally, it will contain the necessary language to indicate 
that the aggregate data resulting from the study will be made available on 
ClinicalTrials.gov. 
Finally, the informed consent will provide contact information for the Principal 
Investigator as well as the Office for the Protection of Research Subjects. All 
informed consent processes will adhere to the policies set forth by the 
Institutional Review Board. All informed consent forms will be stored in a locked 
file cabinet or locked computer file in a locked office to maintain the privacy of all 
study participants. In summary, the consent form will include a description of all 
study procedures, information regarding the risks and benefits of participation, 
contact information for study staff who can answer participants’ questions, and 
alternatives to participation in the study. The consent form will also state that: (1) 
participation is voluntary, (2) participants can refuse to answer any questions, (3) 
participants can withdraw from the study at any time, (4) all responses will remain 
confidential, and (5) participation in the study is not related to care received at 
the cancer center. The consent form will also describe circumstances justifying a 
breach of confidentiality in the event of a psychological emergency. All patients 
will be given a hard copy of the consent document. This hard copy will be mailed 
to participants who provide oral consent.
9.2.3 Protection against Risks
The potential risk of this study is emotional distress and family conflict. In the 
event that a participant is actively suicidal and/or at risk of harming self or others, 
a FHCC licensed mental health professional, UT Southwestern clinical 
psychologist or psychiatrist, or Confluence Health mental health professional will 
be contacted immediately to determine the appropriate level of acute care. In the 
event of a psychiatric emergency, confidentiality may be suspended. Participants 
will be informed of the limits of confidentiality during the consent process and will 
be provided with the PI’s contact information should they have additional 
questions. In the event family conflict arises from using the intervention (PLAN), 
the social worker interventionist will determine and provide the appropriate level 
of care and guidance to resolve the conflict and handle any undue distress. 
Should the resulting distress be severe, the above procedures outlined will be 
conducted.
Measures taken to protect study participants include the exclusion of patients 
who would be too weak to participate in the interviews, the curtailed length of the 
interviews, and the option for administration of the interviews over the telephone. 
All interviews will be designed to be brief, focused, and of minimal burden to 
participants. Only essential information will be asked of participants. Similarly, the 
intervention is designed to be brief and focused only on information relevant to 
the patients’ current situation. Additionally, specific measures have been taken to 
reduce and oversee potential family conflict, including close monitoring of 
participants in the intervention. The inclusion of a licensed social worker as the 
interventionist was made to ensure proper study design, monitoring of 
participants, and handling of any potentially resulting distress or family conflict. 
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Thorough training of project interviewers is also designed to ensure adequate 
protection of human subjects. All project interviewers will receive all required 
training and certification in FHCC’s or UT Southwestern’s human subjects in 
research. Project interviewers will be required to participate in a training program 
designed to ensure that they administer the interviews and evaluate participant 
responses in a sensitive manner. Interviewers will begin each interview with a 
series of statements that remind participants of their right to refuse to answer a 
question, to stop the interview at any time, or to continue at a later date. 
Interviewers will be trained to speak clearly and audibly and let participants 
determine the pace of the interview. In addition, study interventionists will be 
licensed social workers. Study interventionists will be provided with thorough 
training on administration of the intervention in a manner that recognizes the 
difficult nature of the ACP decision-making process in the context of advanced 
cancer. 
Should participants become upset, disoriented or fatigued or need to attend to 
matters of personal care during study procedures, interviewers and 
interventionists will ask the participants if they would like to take a break or 
reschedule the interview/session for another time. Participants who express a 
desire following the final interview to talk at greater length about issues raised 
during the study will be encouraged to call study staff at the telephone number 
provided, and should they want a referral for additional psychological counseling, 
staff will provide them with a referral to a mental health professional at a location 
that is convenient for them.
To ensure protection against study risks, the IRB will review and approve the 
study procedures, materials, and consent form prior to study initiation. Consistent 
with previously approved IRB protocols, the following procedures will be 
implemented to minimize the potential risk of loss of confidentiality: (1) all study 
data will be coded with unique participant identification numbers; (2) participant 
names and other identifying information will not be recorded on study measures; 
(3) study data will be stored either in secure databases (digital copies) or in 
locked file cabinets in a locked office; (4) all information saved on the FHCC  
secure network will be password protected; and (5) only authorized study staff 
will have access to the study data. These procedures have been utilized in other 
studies managed by the PI and Co-Investigators with no breaches of 
confidentiality or other risks to participants, indicating their effectiveness.
Study participants will be assured that all responses will be kept confidential. All 
data collected during the interview process will be de-identified. To ensure 
confidentiality, data collected will be linked to participants’ personal information 
only by means of an assigned study identification number. Authorized study staff 
will be the only individuals who have access to participants’ personal information. 
This information will be stored in a password protected computer file on the 
secure FHCC server and/or in a locked file cabinet in a locked office. De-
identified study data will be stored in REDCap, a secure HIPAA-compliant data 
management system supported by FHCC IT services. All necessary precautions 
will be taken to ensure that there is no breach of confidentiality.
All study staff involved in the research proposed are required to be educated on 
the protection of human research participants and the proposed research will 
comply with the regulations set forth in 45 CFR Part 46, Protection of Human 
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Subjects. All personnel involved in the proposed protocol have been educated 
regarding HIPAA regulations and fully understand their responsibility to 
safeguard the personal health information of every participant involved in the 
study.
The following steps will be taken to minimize participant burden. First, significant 
effort will be made to coordinate in-person study contacts (e.g., to provide 
information on the study and administer informed consent) with existing 
appointments to minimize the number of trips to FHCC, UT 
Southwestern/Parkland Hospital, or Confluence Health required of participants. 
Second, with the participant’s permission, study visits can be conducted during 
scheduled chemotherapy infusions (if applicable, as some advanced cancer 
patients will no longer be receiving chemotherapy). Chemotherapy infusion 
appointments are often long (multiple hours) and patients are unable to leave the 
clinic during the appointment. In our previous NCI-funded studies (PI: Dr. Shen) 
of patients with advanced cancer, patients often elected to conduct research 
meetings during infusion appointments to provide activity during the appointment 
and reduce the overall time spent at the hospital. Prior to conducting visits during 
infusion appointments, participants will be reminded that infusion clinics are often 
not private and their permission to conduct the visit during infusion will be 
obtained. Participants will also be informed that they can discontinue at any time 
if they become uncomfortable due to the setting. If participants are not 
comfortable conducting visits during infusion appointments, separate 
appointments will be scheduled over the telephone. Third, participants will be 
given the option to complete administration of all study measures over the 
telephone, if preferred. This method will eliminate the need for participants to 
travel to the clinic to complete study measures. Any subject participating in the 
study may decline to continue participation and may withdraw from the study at 
any time. If they do not wish to participate but are interested in exploring other 
options such as counseling or support groups, we will provide appropriate 
referrals. 
9.2.4 Vulnerable Subjects
Vulnerable subjects will not be involved in the proposed project.
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