Improving Advanced Cancer Patient-Centered Care by Enabling Goals of Care Discussions
Phase: NA
Conditions: Primary Stage IV Hepatobiliary, Esophageal, Colorectal Cancer, Glioblastoma, Cancer of Stomach, Cancer of Pancreas, Melanoma, Head or Neck Cancer, Stage III, Stage IV, Lung Cancers, Pancreatic Cancers
Sponsor: Icahn School of Medicine at Mount Sinai

Improving Advanced Cancer Patient-Centered Care by Enabling Goals of Care Discussions
Dr. Nina Bickell
NCT02374255
Date: 08/23/2018

 
Protocol Title: 
Improving Advanced Cancer Patient-Centered Care by 
Enabling Goals of Care Discussions 
Principal Investigator 
Name/Contact Info:  
Nina Bickell, MD, MPH 
Primary Contact 
Name/Contact Info 
Sylvia Lin 
Date Revised: 
8/17/18 
Study Number: 
GCO#14-0082; HS#14-01018 
 
1 
Revised  9/2/14 
MSSM Protocol Template HRP-503a 
Instructions: 
1. Prepare a document with the following sections. Note that, depending on the nature of your research, 
certain sections below may not be applicable. Indicate N/A as appropriate, explaining where possible. 
2. For any items described in the sponsor’s protocol, grant application or other source documents 
submitted with the application, you may reference the title and page numbers of these documents rather 
than cutting and pasting into this document. Do NOT refer to any derived documents, such as the 
Sample Consent document, or other internal documents required with the submission. 
3.  If you reference page numbers, attach those pages to this protocol. 
4. When you write a protocol, keep an electronic copy. You will need to modify this copy when making 
changes. 
 
Brief Summary of Research (250-400 words): 
We propose to enable oncologist and their patients with advanced cancer to have a Goals of 
Care (GoC) discussion. To achieve this and ensure that we capture patients’ experiences and 
preferences, we have recruited stakeholders representing cancer patients and providers 
experienced in the challenges faced by patients and their caregivers. Patient stakeholders will 
be invited to participate in team meetings to provide their insights to: inform our tools, study 
design and aid with interpretation of the findings. Our goal is to develop approaches that 
enable GoC discussions to occur that are effective in different practice settings. Toward that 
end, we have recruited a tertiary referral, community and municipal hospital in different health 
systems. All serve inner city populations but their structures, organizational characteristics & 
supports differ. We will assess the feasibility of conducting GoC discussions and explore the 
cultural and experiential differences in practice. We will train oncologist to conduct GoC using 
Oncotalk and 4 joint visits and an Oncotalk trainer-palliative care physician.  
1) Objectives: 
Aim 1: Describe patients’ perspectives about GoC discussions & oncologists’ perspectives 
about barriers & facilitators of GoC discussions. 
Aim 2: Determine the efficacy of the innovation of joint oncologist-palliative care 
communication training in real life settings to improve communication skills and assess its 
feasibility. 
Aim 3: Block randomize oncologists in a municipal, 3ary referral and community hospital 
to the Oncotalk- joint Pall Care-Oncologist GoC visit & assess the effects on patient 
perceived and experienced quality of care. 

 
Protocol Title: 
Improving Advanced Cancer Patient-Centered Care by 
Enabling Goals of Care Discussions 
Principal Investigator 
Name/Contact Info:  
Nina Bickell, MD, MPH 
Primary Contact 
Name/Contact Info 
Sylvia Lin 
Date Revised: 
8/17/18 
Study Number: 
GCO#14-0082; HS#14-01018 
 
2 
Revised  9/2/14 
 
2) Background 
Please refer to pages 1-2 of the protocol. 
3) Setting of the Human Research 
This is a multi-site study which will be conducted at Mount Sinai, Mount Sinai Beth 
Israel, Yale University and Kings County Hospital Center.   IRB approval will be sought 
at respective sites. 
4) Resources Available to Conduct the Human Research 
Please refer to page 7 in the protocol where you will find a table with SPARCS data 
indicating number of patients seen at each hospital site with a metastatic cancer 
diagnosis code as well as sample size calculations, to which we apply rates of 
ineligibility and refusal. 
We have submitted biosketches describing qualifications for the principal investigator 
and co-investigators.   
The study will have a project manager and assistant project manager who will have 
experience in managing research grants.  We will also have two research assistants 
for the study who will be trained in study protocols and data collection procedures.  
Research conducted at the 4 hospital sites will be coordinated with MSSM’s study 
team.  The research assistants will support the work conducted at the 4 hospital sites.  
Dr. Schulman-Green from Yale University will serve as our qualitative expert and 
will analyze the interview data.  Dr. Back from the University of Washington will 
help support the study by consulting on the design of the OncoTalk training. 
5) Study Design 
a) Recruitment Methods 
Pre-Intervention Interviews 
At each site, we will work with a research assistant to identify eligible patients with 
advanced cancer (primary stage IV hepatobiliary, esophageal, colorectal, glioblastoma, 
gastric, pancreatic, melanoma, head & neck, kidney, bladder, liver or locally advanced 
stage IIIor IV lung) for pre-intervention interviews. We aim to recruit 30 patients across 
the 3 hospital sites. Patients will be selected to have varied representation across different:  
age groups, cancers, and number of treatments. We will also recruit Spanish & Chinese 
speaking patients to be able to capture cultural differences.  We will require research 
assistants at each site with the aid of the site PI, to review pathology and the EHR record 
in order to identify eligible patients.  Once eligible patients are identified, they will be 

 
Protocol Title: 
Improving Advanced Cancer Patient-Centered Care by 
Enabling Goals of Care Discussions 
Principal Investigator 
Name/Contact Info:  
Nina Bickell, MD, MPH 
Primary Contact 
Name/Contact Info 
Sylvia Lin 
Date Revised: 
8/17/18 
Study Number: 
GCO#14-0082; HS#14-01018 
 
3 
Revised  9/2/14 
contacted via a letter from their treating oncologist explaining the study.  Patients will be 
approached by the research assistant at the next upcoming visit in order to discuss the 
study and if interested, proceed with consent process.  For those patients who agree to be 
involved, informed consent will be obtained in person at which point we will schedule a 
time for the interview. The interview may take place at the local hospitals or clinic, 
whichever is more convenient. The research team at Mount Sinai will consent and conduct 
interviews with all patients at the sites.  Keeping this process with the research team at 
Mount Sinai allows us to maintain quality control and oversight capabilities. 
Recruit Oncologists: We will obtain a list of oncologists who treat the aforementioned 
advanced cancers from the Division of Hematology and Medical Oncology at each 
participating hospital with the aid from each site’s PIs and oncology leadership.  We will 
recruit the eligible oncologists to participate in this study by giving Grand Rounds and 
presenting the project at meetings of the Oncologist Attending staff.  Site PIs know and 
work closely with key personnel needed for this project to succeed, pathologists, 
radiologists, nurses, clerical & administrative personnel. We will recruit and consent 
oncologists who see at least 2 new advanced cancer patients per month to participate.   
Patient Identification for the Intervention: At each site, we will work with a research 
assistant to identify eligible patients with advanced cancer (primary stage IV 
hepatobiliary, esophageal, colorectal, glioblastoma, gastric, pancreatic, melanoma, head & 
neck, kidney, bladder, castrate resistant prostate cancer, liver or locally advanced stage III 
or IV lung). We aim to recruit 280 patients across the 4 hospital sites. Research assistants 
at each site will be required to review pathology and the EHR record in order to identify 
eligible patients.  Once eligible patients are identified, they will be contacted via a letter 
from their treating oncologist explaining the study. Site research assistants will identify 
eligible patients’ upcoming oncology visits. Patients will be approached by the research 
assistant at that visit in order to discuss the study and if interested, proceed with the 
consent process. Research assistants at Mount Sinai will consent and survey patients at the 
sites.  Keeping this process with the research team at Mount Sinai allows us to maintain 
quality control and oversight capabilities.  Patients may be surveyed at the local hospitals, 
clinic or via telephone, whichever is more convenient for patients. 
b) Inclusion and Exclusion Criteria 
Inclusion Criteria: Men or women who are at least 21 years of age and diagnosed within 
one month with a pathologically confirmed advanced cancer who have an average of <2 y 
life expectancy (primary stage IV hepatobiliary, esophageal, colorectal, glioblastoma, 
gastric, pancreatic, melanoma, head & neck, kidney, bladder, castrate resistant prostate 
cancer liver or stage III or IV lung) and are being treated at one of the participating 
hospital sites and speak English or Spanish.  Oncologists who treat at least 2 advanced 
cancer patients per month at a study participating hospital will be enrolled into the study.   

 
Protocol Title: 
Improving Advanced Cancer Patient-Centered Care by 
Enabling Goals of Care Discussions 
Principal Investigator 
Name/Contact Info:  
Nina Bickell, MD, MPH 
Primary Contact 
Name/Contact Info 
Sylvia Lin 
Date Revised: 
8/17/18 
Study Number: 
GCO#14-0082; HS#14-01018 
 
4 
Revised  9/2/14 
Exclusion criteria: We will exclude patients who have seen an oncologist after undergoing 
first line treatment imaging as this group has a higher likelihood of having received a 
goals of care discussion. Men or women who do not speak English or Spanish will be 
excluded. 
c) Number of Subjects 
30 pre-intervention patient interviews; 25 oncologist interviews; 315 patients for 
intervention (see table with breakdown of intervention patients below).  Given the high 
number of screen failures, we had to increase the number of consented patients to 315 to 
have a total of 280 eligible enrolled patients.  Based on initial discussions with the 
oncology departments at all the sites when the grant was being developed, we expect 25 
oncologists to be recruited across the 4 sites.  However, this number may differ given that 
there is constant turnover in physicians at each of the sites and actual number of 
oncologists will not be determined until the study has begun. 
 
Name of Hospital 
Number of Patients  
Beth Israel Mount Sinai 
40 
Kings County Hospital Center 
27 
Mount Sinai Hospital 
201 
Yale University 
47 
Total Expected to Be Enrolled 
315 
d) Study Timelines 
Study patients were followed for 6 months and completed two surveys; one at baseline 
and one at 6 months. Over the course of the study, we enrolled 315 patients across all 
sites.  Upon conclusion of previously collected data, we are now adding an additional 
intervention oncologist interview. Intervention oncologists will be consented to participate 
in a <1 hour interview. We expect this will take a few months to enroll 10 oncologists 
across all sites. 
e) Study Endpoints 
Primary endpoints are patient’s perceptions that goals of care discussions occurred and 
patient’s satisfaction with the discussion.  Secondary outcomes include patients’ 
perspectives about goals of care discussions & oncologists’ perspectives about barriers & 
facilitators of goals of care discussions.  We will evaluate change in oncologist’s 
communication skills and assess feasibility of the intervention.   In addition, we will 
assess healthcare utilization at the end of life and whether goals of care led to care in line 
with patient preferences. 
f) Procedures Involved in the Human Research 

 
Protocol Title: 
Improving Advanced Cancer Patient-Centered Care by 
Enabling Goals of Care Discussions 
Principal Investigator 
Name/Contact Info:  
Nina Bickell, MD, MPH 
Primary Contact 
Name/Contact Info 
Sylvia Lin 
Date Revised: 
8/17/18 
Study Number: 
GCO#14-0082; HS#14-01018 
 
5 
Revised  9/2/14 
Prior to Intervention Phase. 
Prior to the intervention phase of the study, we will conduct pre-intervention interviews 
with oncologists and patients.    To obtain experiences and perspectives on goals of care 
discussions, including barriers and facilitators of these discussions and the influence of 
organizational culture on goals of care discussions we will recruit 20 oncologists across 
the 4 hospital sites (Beth Israel, Kings County, Mount Sinai, Yale) for a 30 minute 
audiotaped interview and survey.  We will briefly survey oncologists about 
communication skills training experience & comfort conducting goals of care discussions.  
In addition, we will assess all oncologists’ baseline communication skills by audiotaping 
the visit with an advanced cancer patient after the imaging study following the first line of 
chemotherapy.  
 
We will also recruit 40 patients across the 4 sites for a 45 minute audiotaped interview to 
gather information on patient perspectives of goals of care discussions including when 
discussion should take place, patient/family concerns, cultural beliefs, and preferences. 
 
Intervention Phase 
Oncologist Participation 
For the intervention phase of the study, we will work with each site’s PI to identify and 
obtain a list of oncologists treating at least 2 eligible patients per month in each 
participating hospital.  Following oncologist engagement by site PIs and Grand Rounds 
presentations, we will consent interested oncologists. All participating oncologists will 
receive a one-hour didactic training during Oncology Grand Rounds.  The session will 
acknowledge the changing nature of goals of care discussions and emphasize the 
importance of starting these discussions at the 1st visit following imaging during 1st line 
treatment.  Oncologists will be randomized to the intervention or usual care group.   
 
Intervention oncologists will receive a two hour basic training; first hour focuses on 
practicing skills of goals of care discussions; the second hour focusing on choreographing 
joint consultants with the Palliative Care specialist trained in Oncotalk facilitation. We 
will conduct a total of 4 joint patient visits over a two month accrual period for each 
intervention oncologist.  We chose 4 sessions to allow adequate time to model and tailor 
feedback to the oncologist. We will pair intervention oncologists with a palliative care 
specialist trained in Oncotalk facilitation to ensure that role modeling and tailored 
feedback occur in real time and in real settings.  Immediately prior to the joint consult, the 
palliative care specialist will review the “choreography” of that visit – which physician 
will cover specified elements of the GoC talk, reinforcing the 2h role play session. We 
envision that during the initial joint visit, the oncologist will cover the Knowledge portion 
and the palliative care specialist, the remainder, thus modeling how to approach the more 
difficult parts of the conversation. With each successive session, additional portions will 
be led by the oncologist so by the 4th joint consult, most, if not all the session will be led 

 
Protocol Title: 
Improving Advanced Cancer Patient-Centered Care by 
Enabling Goals of Care Discussions 
Principal Investigator 
Name/Contact Info:  
Nina Bickell, MD, MPH 
Primary Contact 
Name/Contact Info 
Sylvia Lin 
Date Revised: 
8/17/18 
Study Number: 
GCO#14-0082; HS#14-01018 
 
6 
Revised  9/2/14 
by the oncologist with the palliative care specialist providing backup. Each joint consult 
will fill a 40 minute visit slot with 30 minutes of patient visit, 5 minutes pre-visit planning 
and 5 minute post-visit assessment & feedback.  During each joint consult, the palliative 
care specialist will complete a checklist of skills performed. Immediately following each 
joint consult, the palliative care specialist will review with the oncologist the GoC areas 
performed, what went well, and together, plan corrective approaches for the next session. 
The pre- and post-visit planning & feedback times are based on prior OncoTalk feedback 
assessments. 
At 12-months or after the OncoTalk training for intervention oncologists, all oncologists 
will have an audiotaped patient visit to assess changes in goals of care discussions. 
 
Patient Participation  
We will work with the research assistant at each site to identify patients using the EHR.  
Once eligibility has been determined, patients will be contacted via a letter from their 
treating oncologist explaining the study and informing them that a research team member 
will be contacting them. Patients will be approached by the research assistant at the next 
upcoming visit in order to discuss the study and if interested, proceed with consent 
process.  This consent will be done in person.  Once the patient has been consented, the 
research assistant will contact them over the telephone after their first imaging is done to 
schedule a 1 hour baseline survey immediately following their next oncologist visit (which 
we will ask to audiotape) or over the telephone whichever is more convenient for the 
patient.  Baseline survey will assess whether goals of care discussion took place, their 
satisfaction with the discussion and whether the discussion helped them identify their 
preferences in care. Audiotape will confirm conduct of a goals of care discussion.  The 
patients will be surveyed 6 months after the baseline survey either in person or over the 
phone.  Six months later, patients (if alive) or their caregivers will be surveyed to assess 
whether the care received was in line with their preferences and determine hospice and 
health care utilization at other sites.  In the event, the patient is deceased, we will call the 
caregiver and ask them if they are willing to participate, consent him/her and conduct 
survey over the phone or at a place convenient to them.  We will conduct a chart review of 
consented patient’s records to determine treatments received for their cancer. 
 
Post-Data Collection Phase 
Oncologist Participation 
We will interview the same intervention oncologists that had been enrolled in the study at 
post-intervention using a semi-structured  survey to obtain feedback about the 
Communication Skills Training to understand what they got from the training and whether 
they used the skills obtained.  
 
g) Specimen Banking 

 
Protocol Title: 
Improving Advanced Cancer Patient-Centered Care by 
Enabling Goals of Care Discussions 
Principal Investigator 
Name/Contact Info:  
Nina Bickell, MD, MPH 
Primary Contact 
Name/Contact Info 
Sylvia Lin 
Date Revised: 
8/17/18 
Study Number: 
GCO#14-0082; HS#14-01018 
 
7 
Revised  9/2/14 
N/A 
h) Data Management and Confidentiality 
We will be collecting advanced cancer patients’ treatment information and physician 
interviews. All study personnel are instructed on proper confidentiality and data 
safeguarding procedures.  Data will be stored on a secure password protected computer 
maintained by our IT specialists in the Department of Population Health Science and 
Policy at the Icahn School of Medicine at Mount Sinai.  Any hard copy materials will be 
maintained in locked cabinets when they are not in use.  Study subjects are assigned 
unique identification numbers and we will strip the files of identifiers once data analysis is 
complete.  We will remove names, addresses and other direct identifiers from hardcopy 
and computer readable data after they are not necessary for patient and physician tracking, 
and we will use an encrypted link file for subsequent identification of patients and 
physicians. The research assistant will place the audio recorder in the clinic room and 
collect the recorder at the end of the visit. The research assistant will not be present in the 
room during the visit.  We will ensure that all patient audio recordings do not contain any 
personal identifiers and they will be stored with unique identifiers for analysis purposes.  
Once data analysis is complete the recordings will be deleted.  The recordings will be 
stored in a password protected computer maintained by our IT specialists in the 
department.  We will ensure that all communication contain no confidential information 
and will only refer to participants using their unique study number. The Principal 
Investigator, Project Manager, Data Analyst, Chart Abstractor and Research Assistants 
will have access to the data base. 
i) Provisions to Monitor the Data to Ensure the Safety of subjects 
We will follow the basic DSMP procedures. 
j) Withdrawal of Subjects 
This study involves chart review, communication of GoC training for oncologists, 
oncologist and patient interviews and surveys. No treatment will be administered to study 
subjects. If participants ask to withdraw from the study, we will only use the information 
that has already been collected.  
6) Risks to Subjects 
This study involves training, interviews and surveys.  Minimal risk is involved. The only 
foreseeable risk is that questions asked during the interview might make the patients or 
oncologists uncomfortable. We will reiterate that they can refuse to answer any questions they 
wish. Patients who appear psychologically distressed will be promptly reported to Drs. Smith 
and Bickell. 
7) Provisions for Research Related Injury 

 
Protocol Title: 
Improving Advanced Cancer Patient-Centered Care by 
Enabling Goals of Care Discussions 
Principal Investigator 
Name/Contact Info:  
Nina Bickell, MD, MPH 
Primary Contact 
Name/Contact Info 
Sylvia Lin 
Date Revised: 
8/17/18 
Study Number: 
GCO#14-0082; HS#14-01018 
 
8 
Revised  9/2/14 
None- N/A 
8) Potential Benefits to Subjects 
There is no direct benefit for participants for taking part in the study. 
9) Provisions to Protect the Privacy Interests of Subjects 
We will only reach out to patients after initial contact is made by their oncologist via a letter. 
We will speak with the patients when they appear at their scheduled appointment to discuss 
the study and if interested initiate consent process. We will ensure that all communication  
among the study team contain no confidential information and will only refer to participants 
using their unique study number. 
 
10) 
Economic Impact on Subjects 
There are no costs directly associated with participation in this study. 
11) 
Payment to Subjects 
In this research study, oncologists were given a $50 incentive for interviews, pre-intervention 
patients received $40, and intervention study patients received $80 for their participation in 
the study. 
12) 
Consent Process 
We propose to obtain standard written consent from the participants across all sites.  
Consent will be obtained by the research team at Icahn School of Medicine at Mount 
Sinai. We will be following the informed consent process for research as indicated in SOP 
HRP-090.  We will consent Spanish & Chinese speaking patients using the Spanish & 
Chinese approved standard consent forms as appropriate. In the event that the subject is 
deceased and their caregiver will be interviewed instead, we will attempt to set up an in-
person meeting with the caregiver. If consent and the interview must take place by 
telephone, we will contact the caregiver and arrange to send them a copy of the caregiver 
consent form, either by email or post. After he or she has had a chance to review the 
consent form, the informed consent process will take place over the telephone. The signed 
consent form will be mailed back to the study team by the caregiver. 
 
Waiver or Alteration of the Consent Process for Review of Pathology Reports and 
Electronic Health Record in Preparation for Research 
 
We request a waiver of informed consent to identify eligible patients via electronic health 
record and scheduling systems.  Once eligibility is determined we will consent patients 
into the study.  The use of PHI will be minimal and will only be used to identify eligible 

 
Protocol Title: 
Improving Advanced Cancer Patient-Centered Care by 
Enabling Goals of Care Discussions 
Principal Investigator 
Name/Contact Info:  
Nina Bickell, MD, MPH 
Primary Contact 
Name/Contact Info 
Sylvia Lin 
Date Revised: 
8/17/18 
Study Number: 
GCO#14-0082; HS#14-01018 
 
9 
Revised  9/2/14 
cases and to mail a letter from their oncologists informing them of the study.  We will not 
collect patient data without their consent.   
 
There is no reliable alternative method to identify patients in real-time who have recently 
been diagnosed with an advanced cancer.  Without access to pathology and imaging 
reports and the electronic health record, we will not be able to determine patients’ true 
diagnosis & stage and the optimal moment at which patients are eligible to have goals of 
care discussions.  Before collecting additional information, patients will be asked to give 
consent and HIPAA authorization.  We cannot initiate this consent process unless we first 
identify patients by reviewing pathology reports and the electronic health record. 
13) 
Process to Document Consent in Writing 
Consent will be obtained using standard PPHS consent forms. 
14) 
Vulnerable Populations 
Include 
Exclude 
Vulnerable Population Type 
 
X 
Adults unable to consent 
 
X 
Individuals who are not yet adults (e.g. infants, 
children, teenagers) 
 
X 
Wards of the State (e.g. foster children) 
X 
 
Pregnant women 
 
X 
Prisoners 
Pregnant women may be eligible to participate. 
15) 
Multi-Site Human Research (Coordinating Center) 
Ichan School of Medicine at Mount Sinai is the prime institution for this proposal. The PI will 
monitor data collection and management to ensure data quality and adherence to the study 
protocol across all sites. Any unanticipated problems will be discussed between the site 
principal investigators and the principal investigator at Mount Sinai. Any protocol 
modifications at a site will be discussed with the principal investigator prior to submission. 
16) 
Community-Based Participatory Research 
N/A 
 

 
Protocol Title: 
Improving Advanced Cancer Patient-Centered Care by 
Enabling Goals of Care Discussions 
Principal Investigator 
Name/Contact Info:  
Nina Bickell, MD, MPH 
Primary Contact 
Name/Contact Info 
Sylvia Lin 
Date Revised: 
8/17/18 
Study Number: 
GCO#14-0082; HS#14-01018 
 
10 
Revised  9/2/14 
17) 
Sharing of Results with Subjects 
Results from the study will be shared with the surviving patients and oncologists participating 
in the study.  
18) 
IRB Review History 
We are currently working on IRB submissions to the participating sites.  
 
19) 
Control of Drugs, Biologics, or Devices 
Note: The IDS has its own forms that must be completed and a review process 
that must be followed before the IDS representative will sign off on Appendix B 
for submission to the PPHS. 
N/A