Videos for Advance Care Planning in Young Adults
Phase: NA
Conditions: Advanced Cancer
Sponsor: Dana-Farber Cancer Institute

PROTOCOL TITLE: Videos for Advance Care Planning in Young Adults 
 
 
 
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PROTOCOL TITLE: 
Videos for Advance Care Planning in Young Adults 
 
PRINCIPAL INVESTIGATORS: 
 
Jennifer Snaman, MD, MS 
Dana-Farber Cancer Institute 
Boston Children’s Hospital 
 
Joanne Wolfe, MD, MPH 
Dana-Farber Cancer Institute 
Boston Children’s Hospital 
 
 
VERSION NUMBER: 
Version 1.75 
DATE: 
March 189thXNovember 9th, 20210 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Role of the Protocol Contributor: 
Angelo Volandes at Massachusetts General Hospital (MGH) will serve as a protocol 
contributor to this study. He will assist the investigators with protocol development and 
analyses but will only receive de-identified data. Dr. Volandes is a co-founder of and 
receives income from ACP Decisions Nous, a nonprofit organization developing the 
advanced care planning video decision support tools being evaluated in this study. Dr. 
Volandes’ financial interests have been reviewed and are managed by Massachusetts 
General Hospital and Partners HealthCare in accordance with their conflict of interest 
policies. 

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Table of Contents 
1.0 
Objectives ...................................................................................................................... 43 
2.0 
Background ................................................................................................................... 53 
3.0 
Inclusion and Exclusion Criteria ................................................................................. 73 
4.0 
Study-Wide Number of Subjects ................................................................................ 83 
5.0 
Study-Wide Recruitment Methods ............................................................................. 93 
6.0 
Study Timelines .......................................................................................................... 104 
7.0 
Procedures Involved ................................................ Error! Bookmark not defined.5 
8.0 
Data Management and Confidentiality .................. Error! Bookmark not defined.5 
9.0 
Risks to Subjects ...................................................... Error! Bookmark not defined.7 
10.0 
Potential Benefits to Subjects .................................................................................... 167 
11.0 
Vulnerable Populations .............................................................................................. 167 
12.0 
Setting .......................................................................................................................... 168 
13.0 
Recruitment Methods ................................................................................................. 179 
14.0 
Consent Process ........................................................................................................ 1710 
15.0 
References .............................................................. Error! Bookmark not defined.13 
 

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1.0 
Objectives 
 
The Institute of Medicine report "Dying in America" called for the development of 
interventions to increase effective advance care planning (ACP) and shared decision 
making among adolescent and young adult (AYA) patients.(1-3) Such interventions aim 
to help AYAs and their caregivers discuss goals of care together to make sure patients 
receive medical care "consistent with their values, goals, and informed preferences."(1, 2)  
Communication surrounding preferences and goals of care and subsequent decision 
making is formalized in ACP, a process involving the provision of verbal or written 
information informing individuals about possible medical options such as 
cardiopulmonary resuscitation (CPR) or mechanical ventilation.(4-6)  However, this ACP 
process is often inadequate as it is presently conducted, particularly for AYAs.(7-10) 
Our research group has developed and studied video decision aids to assist 
patients with advanced cancer and their caregivers in making important decisions about 
their medical care.(11-25)  Video can improve decision-making by providing visual 
information to present complex medical and emotional scenarios; a growing body of 
evidence supports the feasibility and effectiveness of using video aids in medical decision 
making.(2) Video enhances patients’ and caregivers’ understanding of complex health 
information by providing realistic visual images that can facilitate their education about 
hospitalizations, intensive care unit (ICU) admissions, and medical procedures, leading to 
greater concordance of preferences between patients and caregivers and improved 
caregiver outcomes in bereavement. Our work has shown that among adult patients, these 
videos can educate patients and family caregivers about their care options more 
effectively than verbal-only explanations, enhance their knowledge about medical 
interventions, and improve patient-caregiver concordance.(11-25) 
 
We have developed a video decision aid for AYAs and their caregivers that 
reviews treatment options and begins to discuss goals and preferences for their care. The 
overall objective of this study is to conduct a randomized controlled trial of the video (vs. 
usual care) in 50 dyads of AYA with advanced cancer and their caregivers. Our 
hypothesis is that the video better informs patients and caregivers of their options, leads 
to more ACP conversations, engagement and documentation, and leads to more 
congruent decision making between AYA and caregivers (primary outcome). 
Demonstrating the effectiveness of using a video aid in this pilot provides evidence for 
conducting a larger trial integrating such a video into clinical practice. The  
 
Specific Aims are: 
 
Aim 1: To compare knowledge, preferences and decisional conflict among 50 dyads of 
AYA with advanced cancer and their caregivers randomly assigned to one of two ACP 
modalities: 1. The newly created video depicting various goals of care (intervention, 25 
dyads), or 2. usual care (control, 25 dyads).   
 
Hypothesis H1a: Patients and caregivers randomized to the video will have higher 
congruence of preferences between patient and caregiver dyads compared to dyads in the 
control group (primary outcome). H1b: Those randomized to the video group will have 

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higher knowledge, fewer preferences for life-prolonging interventions and lower 
decisional conflict than those randomized to the control group.  
 
Aim 2: To compare ACP conversations between patients with their health care team and 
caregivers, and ACP documentation between intervention and control dyads. H2: Patients 
randomized to the video will have more ACP conversations and higher levels of 
engagement, and more ACP documentation after 3 months. 
 
 
2.0 
Background 
 
AYA oncology patients often receive intensive medical services at the end of life 
(EOL).(26-28) Compared to younger children, AYA oncology patients have higher rates 
of hospitalization, more frequent ICU admissions, and receive more chemotherapy 
treatments during the last 30 days of life.(27, 28) To date, the majority of AYA cancer 
deaths occur in the hospital and minority race, Hispanic ethnicity, and hematological 
malignancy increased the odds of dying in the inpatient setting.(29) Palliative care has 
been associated with receipt of less intensive interventions at the EOL in hospitalized 
AYA patients with cancer, possibly due to the facilitation of greater AYA involvement in 
communication and decision-making.(26) A growing body of research suggests that 
AYA patients identified a spectrum of possible roles in medical decision-making, with 
the majority preferring an active role while still expressing a desire for parental presence 
in decision-making.(30) Fulfilling the roles of  “good child” and “good patient” may 
impact AYA decision-making, adherence to medical treatment plans, and social 
interactions.(31) As a part of fulfilling these roles and in the absence of communication 
between patients and their caregivers around preferences and goals of care, AYAs may 
continue intensive therapies.(32, 33) ACP tools have been developed to facilitate ACP 
discussions between patients and their caregivers around preferences for care at the 
EOL,(32, 33) but these tools remain underutilized in the clinical setting. In the only 
randomized controlled trial of an ACP tool in AYA patients with cancer, patients 
randomized to receive the intervention (consisting of three, 1-hour family-centered ACP 
sessions and the Five Wishes tool), had statistically greater congruence to limit 
treatments in various clinical scenarios. 
 
The lack of ACP is associated with greater use of intensive or burdensome interventions, 
more hospitalizations at the EOL, lower palliative care use, and worse family 
bereavement outcomes.(34-38) Unfortunately, ACP communication between AYA and 
their caregivers remains inadequate.(2) For the ACP process to lead to optimal decisions, 
AYA and caregivers require engaging, accurate, impartial and comprehensible 
information about treatment options, and a care setting where communication needs are 
addressed early in their illness.(39-42) However, studies show that traditional written and 
verbal ACP do not effectively engage or inform patients and their caregivers.(2) Patient 
understanding may also be clouded due to developmental needs and stage, psychological 
distress, and the inability to realistically envision accurate future health states.  
 

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The traditional approach to ACP, which primarily relies on ad hoc verbal descriptions of 
hypothetical clinical situations and treatment choices, is limited because complex 
scenarios are difficult for AYAs and caregivers to envision, clinician information is 
inconsistent, and verbal explanations are hampered by literacy, emotional and language 
barriers.(41, 43, 44) Over the past few years, investigators have recognized the 
shortcomings of prior efforts and have developed new interventions to better facilitate 
ACP in adult patients.(11-15, 17-23, 25, 45-47) The video intervention proposed for this 
study focuses on treatments for AYAs with advanced cancer. Video decisions aids to 
better educate and inform decision-making are commonly used. To the best of our 
knowledge, this is the first use of an ACP video decision aid in AYAs. 
 
For AYAs and their caregivers to have informed ACP conversations about patient 
preferences, both patients and caregivers need accurate information presented in a 
standardized and easy to understand manner. Presently, clinicians do not provide any 
routine or standardized information about goals of care to AYAs or caregivers. AYAs 
and their caregivers often receive intensive interventions as a default option, without a 
shared decision-making conversation or awareness of different treatment options or 
blended goals of care. Poor ACP and communication about AYA preferences for end-of-
life care contribute substantially to the receipt of intensive medical care and possibly 
increased suffering at the EOL. Therefore, improving ACP with a standardized video 
decision aid that accurately informs AYAs and their caregivers about ACP decisions may 
prove to be an effective strategy to enhance the delivery and quality of medical care for 
AYAs with advanced cancer and their caregivers. ACP video tools have shown 
promising efficacy in educating patients and caregivers about their options and informing 
their preferences for care. This study has the potential to improve the concordance of 
AYAs and caregiver preferences leading to better shared decision making and ultimately 
the delivery of AYA-centered care that is consistent with the patient’s values. 
 
Preliminary Studies in cancer: Over the last decade, the research team has focused on 
improving decision making for persons with serious illness by creating and studying 
innovative decision aids. The work cited below demonstrates the research team's 
experience, commitment, and ability to use effectively a wide array of clinical research 
methods to design, administer, and complete projects focused on serious illness.  
 
The first video our team produced was a 5-minute decision aid depicting the goals 
of care for adults with cancer.(20) In a randomized controlled trial, patients with 
advanced cancer were randomized to either listen to a verbal description of the goals of 
care (N=27) or view the video decision aid (N=27), and then asked the level of care they 
would want. The three levels of care included: life-prolonging care (hospitalization, 
intensive care unit); limited care (hospitalization but no ICU); or, comfort care (symptom 
relief only). We also assessed uncertainty regarding decision making using the Decisional 
Conflict Scale with scores ranging from 3 (high uncertainty) to 15 (no uncertainty). End 
points were the selected goal of care in each arm of the study, uncertainty in decision 
making, and comfort viewing the video. Patients in the video arm (vs. control) were more 
likely to opt for comfort care, were more informed, and more certain of their decision. 
Among patients receiving the verbal narrative, 26% desired life-prolonging care, 52% 

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chose limited care, and 22% preferred comfort care. In the video group, none desired life-
prolonging care, 4% chose limited care, 92% preferred comfort care, and, 4% were 
uncertain (P < 0.001). Participants in the video group had less uncertainty (mean 
uncertainty score, 13.7; [95% CI, 12.8 to 14.6]; P = 0.002) compared to participants 
randomized to the verbal group (mean uncertainty score, 11.5; [95% CI, 10.5 to 12.6]). 
Of the patients randomized to the video group, 82% felt “very comfortable” watching the 
video, and 82% would “definitely recommend” the video to other patients. Based on this 
work, the research team completed a larger NCI trial that was published in the Journal of 
Clinical Oncology and presented as an oral abstract at ASCO.(15) Dr. Volandes is 
leading a larger trial of this video decision aid in 4,500 patients with advanced cancer 
along with the adult palliative care team at Dana Farber Cancer Institute. 
 
Overview of the Trial: This study is a randomized trial of the video in 50 AYAs with 
advanced cancer and their caregivers that will assess preferences for care in advanced 
cancer and concordance rate of preferences between dyad. We will randomly assign 
dyads to one of two ACP modalities: 1. the ACP video decision aid (intervention), or 2. 
Usual care. Patients' and caregivers' knowledge, preferences (goals of care, CPR, 
ventilation), and decisional conflict be assessed before and after exposure to the video or 
control ACP modality. Telephone-based interviews will be conducted at 3 months to 
assess patients' and caregivers' preferences, ACP conversations with caregivers and 
clinicians, and the medical record will be queried to examine ACP documentation. The 
primary outcome is AYA and caregiver concordance regarding treatment preferences for 
advanced cancer (Aim 1). Secondary outcomes include knowledge, preferences, 
decisional conflict, and ACP engagement (Aims 1 and 2). We will also explore the 
stability of preferences, presence of ACP conversations and documentation after 3 
months (Aim 2). We hypothesize that the video decision aid better informs patients 
and their caregivers and leads to more informed decision making. 
 
 
3.0 
Inclusion and Exclusion Criteria 
 
Subject Enrollment: All patients will be recruited from the outpatient clinics of Dana-
Farber Cancer Institute (both pediatric and adult clinics),the inpatient settings of Boston 
Children’s Hospital and Brigham and Women’s Hospital, the inpatient or outpatient 
clinics of Massachusetts General Hospital, or virtually. Eligible study participants will 
give written consent to the primary investigator or study staff member before initiation of 
study procedures if recruited in-person. If participants are enrolled and complete study 
procedures virtually, they will provide verbal consent before initiating study procedures.  
 
If in-person visits cannot be conducted, eligible participants will be still be mailed a pre-
notice letter (Appendix B) that offers the chance for participants to opt-out or opt-in via 
email or phone call. After one week, we will call participants we have not heard from and 
ask if they would consider participating. 
 
 

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Patient Eligibility criteria will include patients who are:  
i) 
Diagnosed with advanced cancer (i.e., initial first-line therapy is unsuccessful, 
marked by progression or relapsed disease) 
ii) 
Aged between 18-39, which is the legal age for completing an ACP document 
(e.g., POLST/MOLST);  
iii) 
Speak English; and 
iv) 
Have a caregiver or identified surrogate decision maker who is able to 
participate.  
iv)v) 
Treated at Dana-Farber Cancer Institute or Massachusetts General Hospital 
 
Exclusion criteria will include:  
i) 
A diagnosis of low-grade glioma given the fact that progressive or relapsed 
low grade may not be clinically characterized as advanced disease and 
associated poor prognosis. 
ii) 
Visually impaired (note, hearing impaired is not an exclusion as the video is 
closed captioned);  
iii) 
Psychological state not appropriate for ACP discussions as determined by the 
primary oncologist; and,  
iv) 
Unable to participate in ACP discussions due to mental incapacity as 
determined by the Short Portable Mental Status Questionnaire(48).  
 
. 
Eligible patient participants will be asked to self-identify one caregiver or surrogate 
decision-maker that will also be approached for enrollment.  
 
Caregiver eligibility criteria include:  
(i) 
Speak English; 
(ii) 
Aged 18 or older,  
(iii) 
Not visually impaired, and  
(iv) 
Have an associated patient with advancer cancer who is able to participate. 
 
Only dyads will be enrolled, both patient and caregiver must consent to participation in 
the study. 
 
4.0 
Number and Selection of Subjects 
 
We will conduct a pilot trial in 50 AYA with advanced cancer and their caregivers who 
will be randomized as dyads to either the video (intervention) or usual care (control). No 
exclusions by sex will be made. 
 
Given the linguistic limitations of study personnel and materials (English-speaking only) 
who will be conducting structured interviews, the current study is limited to English-
speaking patients only. 
 

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5.0 
Study-Wide Recruitment Methods 
 
5.1 
Training of RAs 
 
Each research assistant (RA) who works on the study will thoroughly review the 
protocol. Prior to approaching potential participants, the RA will be required to complete 
a practice consent with the study PI to ensure study procedures are being followed. The 
RA as well as associated personnel will complete the respective CITI training. In 
addition, all study staff will be familiar with the DF/HCC Operations and Policies library. 
In addition to the training mentioned above, new staff will observe a minimum of one 
consent led by the current RA. 
 
5.2 
Subject Recruitment  
 
Participant recruitment: Potential participants will be identified by reviewing the 
monthly census for AYA with advanced cancer who meet our eligibility criteria from the 
inpatient and outpatient clinics. Additionally, information about this research study along 
with the study team’s contact information may be included in patient-facing materials 
(i.e.,  the young adult program (YAP) newsletter, YAP phone app, fliers in waiting 
rooms, etc.) to help spread awareness and better identify eligible participants. If an 
interested patient and or family reaches out to the study team after hearing or reading 
about our study, we will inform the AYA that we will check to make sure they are 
eligible and their medical team believes it is appropriate for them to participate. The RA 
will then confirm the patient’s eligibility and still afford the oncologist 72 hours (3 
business AYAs) to opt their patient out of the study. Once a potential participant is 
identified from observing clinic lists, an email will be sent to the oncologist to seek 
permission to present the study to the patient. The email will detail information about the 
study, including eligibility and outlined protocol (Appendix A). The oncologist will have 
72 hours (3 business days) to opt-out of their patient being approached. Three days will 
be a sufficient amount of time for providers to reply while not obstructing the progress of 
our study and is a similar timeframe used in other clinical studies by our research team 
using an opt-out approach. We may also ask providers if they have any patients that are 
eligible and would be good candidates for this study as a way to increase our eligible 
pool. The patient and caregiver will then be mailed a letter outlining the study. The letter 
will explain the goals of the study and inform the patients that a RA from DFCI will try 
to approach them at their next clinic visit (Appendix B) or over the phone. This letter 
includes the email address of the RA for this study and an option for patients to opt-out of 
being approached or called. All mailings, phone-based approaches, and consent meetings 
will be conducted by the research team at Dana-Farber. 
 
If in-person enrollment cannot be conducted, eligible participants will still be mailed a 
pre-notice letter (Appendix B) that offers the chance for participants to opt-out or opt-in 
via email. After one week, we will call participants we have not heard from using and ask 
if they would consider participating. If there is no answer, the study team may leave a 
voicemail without identifying information but that includes a call-back number to contact 

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a study team member. For interested participants, we will email them a consent form and 
given the opportunity for them to read the form, ask questions, and consider participating. 
The research assistant will inform participants of an overview of the study, risks, and 
benefits, and the RA will also ask if participants wish to go through each section of the 
consent form together. If there are no further questions and the individual wishes to 
participate, the RA will ask for verbal consent. Following, the RA will document in the 
study team’s tracking log the date of consent, where it occurred (zoom, phone call), and 
any important notes. If a dyad enrolls, we will set up a time for the study procedures to be 
completed via DFCI Zoom, which is HIPPA compliant. The Zoom meetings will be 
password protected and set up at a time that is convenient for the participant.  
 
The RA will verify the ability of the patient and caregiver to provide consent by 
explaining the study and having the patient repeat (teach-back) the aims and risks. 
The clinical staff will not play any role in asking the patient to participate to 
minimize any coercion. However, the patient and caregiver may ask their 
clinician for additional details about the study. 
Each study participant will receive a $20.00 gift card after the initial items are completed 
and a second $10.00 gift card for completing the follow-up interview 3 months later. 
Study visits will be coordinated to coincide with regularly scheduled clinical visits or lab 
draws to reduce out-of-pocket expenses. 
 
6.0 
Study Timelines 
Participants enrollment in the study will last the course of 3 months with one in-
person study visit and one phone-based interview. The study entails a one-time 
30-40 minute in-person visit or over Zoom where participants will be randomized 
to the video aid intervention or information sheet control. Around three months 
following this initial visit, participants will complete a 5-10 minute follow-up 
phone-based interview. This follow-up interview will be audio recorded with the 
participants’ knowledge and transcribed for analysis. Participants will have 
consented to be audio recorded during the informed consent process. All 
recordings will be de-identified. Given the number of AYA patients typically 
treated at this institution, we anticipate the study to span 2 years, including 3-
month data collection tools preparation and survey training, 16 months rolling 
recruitment, surveying, and 3-month follow-up, 2 months data cleaning, analysis, 
and manuscript preparation. This timeline will continue to be updated given 
changes to recruitment/enrollment strategies in the setting of COVID-19. 
 
 
7.0 
Procedures Involved 
 
Study design, randomization, intervention, and control arm: We will conduct a 
randomized controlled trial in 50 AYA with advanced cancer and their caregivers who 

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will be randomized as dyads to either the video (intervention) or usual care (control) 
(Figure 1). After enrollment, we will collect the following information from the 
caregiver: full name, date of birth, zip code, and gender for the purposes of reporting to 
the NCI and subject level registration.  
 
 
 
The interview script for the encounter with participants is provided in Appendix C. 
Following completion of the pre-intervention questionnaire (Appendix D), the RA will 
provide a brief explanation of the three types of care (life-prolonging, selective, comfort) 
and the subjects will be randomized to intervention or usual care. 
Patients and caregivers in the control group will only receive the verbal description of the 
three types of care (Appendix C, page 1). 
 
Randomization: We will use a central, computer-generated simple randomization design 
stratified by race and ethnicity for even recruitment in both arms of the study. 
 
Intervention: The intervention group will use the video decision aid describing the 
goals-of-care options. Patients and caregivers will review the video using an iPad and 
will have access to the video via a weblink to review the video on their own (Appendix E 
for video script, Appendix F for link to video). The development of the video followed a 
systematic approach, using an iterative process of reviews by oncologists, palliative care 
clinicians, AYA with advanced cancer and caregivers regarding the design, content, and 
structure of the video. The video decision aid was developed using the International 
Patient Decision Aid Standards with content that is intended to be objective and 
balanced.(49) It is scripted at a fourth-grade level of health literacy in English and has 
closed captioning (Appendix E). The video is available in English. The video is designed 
for AYAs with advanced cancer and their caregivers making future decisions. The goal of 
the decision aid is to use decision science to structure the decision in a way that support's 
the person's ability to make reasoned decisions by considering: 1). accurate information 
about each option; 2). the risks and benefits of each alternative; 3). to evaluate each 
choice within the context of their spiritual and emotional values, and their lifestyles; 4). 
to make a decision based on trade-offs among options; and, 5). to support ACP 
discussions with caregivers and clinicians about values, lifestyle, and medical history.  
 
The video is narrated by an AYA who opens with an empathic statement regarding the 
situation any AYA finds themselves in. Then, there is a transition to contemplating what 
Baseline 
Data 
Randomization 
Outpatient Setting 
1° and 2° 
Outcomes  
3 Months 
Control 
Intervention 
Figure 1. Data collection time periods for the proposed study. 
2° Outcomes 
(Stability of Prefs) 
 

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the future might hold and decisions about medical care and introducing the concept of 
ACP. There is acknowledgment that these can often be difficult decisions and that the 
presence of caregivers often helps. There is an explicit statement regarding values and 
spiritual beliefs and how that might impact decision making. The video then attempts to 
translate the preceding conversation into actionable medical orders using the most 
common three-goal framework that is based on the MOLST paradigm: life-prolonging 
care (live as long as possible); selective care (live as long and as well as possible); and, 
and comfort care (live as comfortably as possible). The narrator then begins to describe 
the salient features of each of the three goals of care, reviewing the risks and benefits of 
each option, and then discussing the trade-offs among the three options. For each option, 
visual images illustrate the interventions (CPR, intubation, and hospice care) while 
discussing risks and benefits. The video was created using filming criteria formulated by 
this research team and used widely around the country.(50) The video was filmed without 
the use of prompts or stage directions (i.e., no actors; all real clinicians, patients, and 
caregivers) to convey a candid realism in the style known as cinema verite.(50, 51) At the 
conclusion of the video, each patient and caregiver in the intervention arm will receive a 
code to access the video at home and a printout version of the checklist (Appendix G) 
 
Control arm: Patients and caregivers in the control group will only receive the verbal 
description of the three types of care (Appendix C, page 1). 
 
 
Study staff will pull data from the patient’s emergency medical record as a part of the 
baseline data collection and again after 3-month follow-up to determine ACP 
documentation. 
 
8.0 
Data Management and Confidentiality 
 
8.0 
The patient information sent by Massachusetts General Hospital (MGH) to Dana-
Farber will be sent through a send secure email. No PHI will be sent to MGH. 
 
Data elements of survey questionnaire: We are interested in studying the influence of 
the video compared to enhanced usual care on medical care options and concordance rate 
with 50 AYA with advanced cancer and their caregivers. To assess study outcomes, data 
will be collected, to the extent possible, using validated tools. Table 1 outlines the data 
elements that will be obtained from both patients and caregivers. The audio recording and 
de-identified transcripts will be stored in a stored location on a secured network only 
accessible to the study team. The audio recording and de-identified transcripts will be 
stored in a stored location on a secured network only accessible to the study team. 
 
Sociodemographics: Data on sociodemographics will include age, gender, race, ethnicity, 
health insurance, education, marital status, religion, and religious attendance. (Appendix 
D, page 1-2, questions 1-8). 
  

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Preferences: Patients and caregivers will be asked for their goals-of-care preference (life-
prolonging, selective, comfort, or Unsure), CPR preference (Yes, No, or Unsure), and 
ventilatory support (Yes, No, or Unsure) at baseline, and then again immediately after 
watching the video or reviewing the informational sheet (Appendix D, page 4, question 
1-3; Appendix H, page 1, question 1-3) and then we will contact all patients after 3 
months by telephone to ask for their preferences.(11, 13, 20) (Appendix I, page 2-3, 
question 1-3).  We will also have an open-ended question for those patients who change 
their preferences from the initial post-video or control survey ("Can you explain why you 
have changed your preference from the one stated three months ago?"). AYAs and 
caregiver concordance of preferences (i.e., the same preference) is our primary outcome. 
 
Knowledge: We will ask five true/false questions and one multiple choice question 
regarding knowledge of goals-of-care options which were used and validated in our 
previous studies.(11, 13, 20) (Appendix D, page 6; Appendix H, page 3). 
 
Decisional conflict: We will measure decisional conflict, which attempts to measure 
uncertainty regarding decision making.(52) The Decision Conflict Scale is a well-
validated and commonly used tool, we will use the 4-item SURE scale for ease of use and 
to reduce burden on the participant.(52) (Appendix D, bottom of page 4, questions 1-4; 
Appendix H, bottom of page 1, questions 1-4). 
 
ACP engagement: We will ask four validated questions to patients only regarding ACP 
engagement (How ready are you to talk to your caregiver? To your doctor? To appoint a 
surrogate? To sign an ACP document?).(54) (Appendix D, page 4; Appendix H, page 2). 
 
Comfort with the video: For those patients and caregivers randomized to the video, we 
will measure acceptability of the decision aid using four questions regarding comfort 
viewing the video, which we have validated in our prior work.(11, 13, 15, 17, 20-22, 25, 
46) (Appendix H, page 4). 
 
Additional outcomes: AYA-reported ACP conversations with caregivers and clinicians 
will be assessed after three months from baseline survey. Both patients and caregivers 
will be asked about ACP conversations (Appendix I, bottom of page 3). 
 
Data collection protocol: Based on our prior work, data collection is estimated to take 
no longer than 40 minutes (10 minutes for informed consent and screening; 10 minutes 
for baseline assessment; 10 minutes for ACP modality; 10 minutes for immediate follow-
up interview) and will be conducted in the outpatient setting. The relatively brief 
interviewing time (40 minutes) in which the survey is conducted should assure 
completion of the interview without burdening participants. We do not foresee the 
additional time to complete the survey to be a barrier to successful recruitment and 
completion of the protocol.  
 
Participants will be provided written copies of the questions or the questions will be 
shared with them over zoom (using the “share screen” feature) in order to follow along 

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during the face-to-face or virtual interviews. The RA will collect baseline data, 
randomize patients and caregivers as a dyad to either the video or control arm via 
concealed envelopes, and administer the intervention. After this baseline interview and 
randomization, the RA will collect the remaining outcomes data regarding preferences, 
knowledge, and decisional uncertainty from both the patient and caregiver. For those 
participants randomized to the video intervention, they will also be asked questions 
regarding the usefulness of the video and their comfort with the video. If patients express 
interest in creating their own video, RA’s may provide an information sheet to guide 
them through the process (Appendix J).  Both patients and caregivers will be contacted at 
3 months and assess their preferences and ACP conversations at that time. These phone-
based interviews will be conducted independently to reduce influence on the outcome of 
concordance and will be audio recorded for later analysis. 
 
KEY: RA: Research Assistant; PO: Primary Oncologist; EHR: Electronic Health Record; SPMSQ: Short 
Portable Mental Status Questionnaire; DCS: Decisional Conflict Scale; ACPE: Advance Care Planning 
Engagement Questionnaire. 
Table 1: Data Element and Sources 
Data Collected 
Purpose 
SOURCE 
Tool 
By 
Whom 
From 
When 
Note 
1. Eligibility screen 
Advanced 
Cancer 
target sub-population 
identification, covariate 
 
RA, PO 
EHR 
Daily 
HIPAA 
waiver 
Cognitive 
Assessment 
screening 
SPMSQ 
RA 
interview 
Outpatient/Vir
tual 
 
2. Baseline Assessment 
 
Preferences 
2o outcome 
 
RA 
interview 
Outpatient/Vir
tual 
 
Knowledge 
2o outcome 
 
RA 
interview 
Outpatient/ 
Virtual 
 
Randomization followed by video intervention or enhanced usual care 
3. Post-video or informational sheet 
Preferences 
2o outcome 
 
RA 
interview 
Outpatient/ 
Virtual 
 
Preference 
concordance 
1o outcome 
 
RA 
interview 
Outpatient/ 
Virtual 
 
Knowledge 
2o outcome 
 
RA 
interview 
Outpatient/ 
Virtual 
 
Decisional 
conflict 
2o outcome 
DCS 
RA 
interview 
Outpatient/ 
Virtual 
 
ACP 
engagement 
2o outcome 
ACPE 
RA 
interview 
Outpatient/ 
Virtual 
AYA only 
Comfort with 
video 
2o outcome 
 
RA 
interview 
Outpatient/ 
Virtual 
Video arm  
4. Follow-up at 3 months 
Preferences 
2o outcome 
 
RA 
telephone 
 
 
ACP 
conversations 
2o outcome 
 
RA 
telephone 
 
 

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Page 15 of 22 
 
 
 
DATA ANALYSES 
 
Aim 1: H1: AYA with advanced cancer and caregivers randomized to the video will have 
higher concordance between patients and caregivers (Primary Outcome), and more 
likely to have higher knowledge, make decisions for less burdensome care (i.e., limited or 
comfort care, no CPR, no ventilatory support), have lower decisional conflict, and 
engagement, than those randomized to the control group. Preference concordance 
between patient and caregiver will be treated as a dichotomized variable and compared 
between the two study arms using a chi-square test.  We will conduct separate analyses 
for patients and caregivers for secondary outcomes. Knowledge score, decision conflict 
scale, and ACP engagement will be considered as continuous variables. We will use two-
sample t-tests or Wilcoxon rank sum tests, whichever more appropriate, to compare the 
distribution between the two study arms. Chi-square tests will be used to compare the 
proportion of patients/caregivers choosing less burdensome care between the two study 
arms. We will explore the effect of patient characteristics (age, sex, etc.) in choosing less 
invasive care using a logistic regression model. In this study, we will treat sex as self-
reported gender and will conduct a sex-based analysis of intervention effects to explore 
sex as a biological variable. Power analysis: Assuming 50% of control arm achieve 
preference concordance between patients and caregivers, the study will have 80% power 
to detect a 41% difference (50% vs. 89%) in concordance. Assuming 68% of control 
patients/caregivers choose non-life prolonging care, the study will have 82% power to 
detect a 31% difference (68% vs. 99%) in preferences between the two arms. For the 
continuous outcomes (knowledge, decisional conflict, ACP engagement), the study will 
have 80% power to detect an effect size of 0.81 with 25 subjects per group.   
 
Aim 2: H2. Patients randomized to the video will have more ACP conversations and 
documentation after 3 months. We will treat conversations and documentation as 
continuous variables. Assuming 50% of controls achieve ACP 
conversations/documentation between baseline and three-month follow-up, the study will 
have 81% power to detect a 27% difference (50% vs. 77%) between the two study arms.   
 
Missing Data: We do not anticipate having substantial amounts of missing data on the 
initial survey; however, we expect some patients and caregivers to not complete the 
three-month follow-up surveys. The analyses will initially focus on the study completers 
(3 months) to estimate the effect of the video intervention on patients who completed the 
protocol as intended without imposing assumptions about missing data. We will also use 
the intention-to-treat principle, conducting sensitivity analyses to explore how various 
assumptions about missing data and differences between completers and non-completers 
affect the estimated outcomes. If data appear to be missing at random, we will employ 
multiple imputation methods,(55) maximum likelihood estimate approach with EM 
algorithm,(56) and mixed-effects modeling(57) that can adequately account for data 
missing at random. If we find that data are not missing at random, we will employ pattern 

PROTOCOL TITLE: Videos for Advance Care Planning in Young Adults 
 
 
 
Page 16 of 22 
 
mixture modeling to handle incomplete data, and perform sensitivity analysis to assess 
the impact of missing data 
 
 
9.0 
Risks to Subjects 
 
Limitations, potential problems, and alternative strategies: (1) We are limiting this study 
to English-speaking patients because our video is only available in this language 
presently. Should the study prove successful, we will adapt the video into other 
languages. (2) Another potential limitation we considered in developing this study 
proposal pertains to the lack of blinding of research investigators and clinicians to the 
intervention assignment, which may introduce bias. Blinding research staff to the 
intervention assignment is not practical and rarely accomplished in ACP trials. We have 
implemented rigorous procedures to minimize the risk of bias. 
 
Subjects may feel uncomfortable while watching the video or during the interview.  
Subjects will always have the option of taking a break at any point during the study or not 
answering a question that may provoke anxiety or distress. Additionally, all subjects will 
also have the option of terminating the study at any point if feeling uncomfortable 
throughout the study.  
 
Procedures to Minimize Risk: Subjects are informed that they may refuse to answer any 
questions if they wish and may choose to stop participating at any time. Effort is taken to 
identify and minimize the risk of emotional distress for study participants in a 
standardized fashion 
 
10.0 Potential Benefits to Subjects 
 
This project’s results will investigate preferences that lead to decision-making in EOL 
care. AYAs and their caregivers may uniquely benefit from use of visual video 
technology to augment the ACP process. The minimal risk of potential psychological 
distress that may be provoked with discussing decision-making is clearly outweighed by 
the benefits and impact of this study’s results. 
 
11.0 Vulnerable Populations 
 
Inclusion of Women and Minorities: This study does not focus on any race, 
ethnicity, or gender. No potential research subjects will be excluded from 
enrollment based on race, ethnic origin, or gender. Patients will be recruited from 
patients at DFCI/BCH/BWH that have advanced cancer and are expected to 
reflect the racial and ethnic diversity of this hospital-based population.   
 
12.0 Setting 

PROTOCOL TITLE: Videos for Advance Care Planning in Young Adults 
 
 
 
Page 17 of 22 
 
 
Research sites will include Dana-Farber/Boston Children’s Hospital and Brigham and 
Women’s Hospital as well as Massachusetts General Hospital. 
 
13.0 Recruitment Methods 
13.1 Patients will be recruited in the inpatient units, outpatient oncology 
clinics, or over the phone. The RA will approach or call the patient 
and ensure they have sufficient time to hear about the study and 
review the consent form if needed (Approach script, Appendix K). If 
potential participants are contacted virtually, the RA will call them 
up to three times approximately one week after the pre-notice letter 
is mailed. If the participant is interested, we will send them a consent 
form to review. Before the scheduled Zoom visit, we will ask if they 
have any questions and ask for verbal consent from the AYA. 
13.2 Patients between the ages of 18-390 on the inpatient and outpatient 
rosters of all sites will be screened on a regular basis, and additional 
potential participants will be identified through collaboration with 
the center for young adult oncology (CAYAO) and the Young Adult 
Program (YAP). 
13.3 Information about the study and along with the study team’s contact 
information may be included in patient-facing materials (newsletters, 
young adult program (YAP),_ application, fliers) to help spread 
awareness and better identify eligible participants. 
13.4 We may also ask providers if any of their patients would be good 
candidates for this study. 
13.5 For any subject who is being seen in clinic on the day of screening or 
who is admitted to the oncology services and is between the ages of 
18-39, the RA will open their record and review primary language, 
diagnosis, and disease status. These components will be noted in a 
tracking log with the patient’s name, MRN, and date of birth. If the 
patient meets all eligibility requirements, an opt-out email will be 
sent to the primary oncology attending. If the oncologist has not 
responded within 72 hours or gives permission to approach, the RA 
will plan to approach the family. Additionally, the study team at 
DFCI will receive a list of eligible patients, who have passed the 
provider opt-out phase, from Massachusetts General Hospital for 
which the Dana-Farber staff will mail a letter to and approach for 
research participation.   
13.6 The RA will plan to approach the patient at their next clinic 
appointment, or if they are inpatient, at their next available 
opportunity. If it is not possible to reach them in-person, the RA will 

PROTOCOL TITLE: Videos for Advance Care Planning in Young Adults 
 
 
 
Page 18 of 22 
 
call them. Up to 3 attempts at contacting eligible participants will be 
made. They will be given a brief overview of the study. 
13.7 Participants who complete all study materials will be given an $20 
Amazon gift card. Participants that complete follow-up interview 
questions will receive an additional $10 Amazon gift card. 
 
14.0 Consent Process 
 
This study contains no more than minimal risk and written consent or verbal consent will 
be obtained from each study participant. Consent will be obtained by the RA in outpatient 
clinics, inpatients units at DFCI/BCH/BWH/MGH, or over the phone/Zzoom. Prior to 
explaining the study, the RA will ensure that the time and location are okay. Eligible 
patients will not be approached if the RA or provider considers them to be in a time of 
high stress. If inpatient, consent will be obtained in the patient’s room. In the outpatient 
clinic, exam rooms, infusion suites, consult rooms, or quiet areas of the waiting area may 
be used. If the patient is interested in participating, consent may occur at the time of study 
introduction, or if they would like to take time to think about participating, a follow-up 
meeting will be scheduled. The RA will follow the processes outlined in “Policy: 
Informed Consent Process (CON-100)” to obtain informed consent (Appendix L).  
 
We request a waiver of documentation of consent for participants that are accrued 
virtually because the study presents no more than minimal risk and all study procedures 
will be deidentified. 
 
We also request a waiver of documentation of consent for oncology providers who 
participate given that their participations represent no more than minimal risk and their 
recordings/surveys will be deidentified. 
 
 
 
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