Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2
Phase: NA
Conditions: Critical Illness, Oncology, Communication
Sponsor: Weill Medical College of Cornell University

Page # i 
 
 
 
 
TITLE: Giving Information Strategically and Transparently in Solid Tumor Cancer 
 
NCT # (Phase 1): NCT04158908 
NCT # (Phase 2): NCT04179305 
IRB Protocol #: 19-07020392 
Version Date: April 25th, 2022 
Funding Source(s): National Institutes of Health, National Cancer Institute, Weill Cornell Medical College 
 
Principal Investigator: 
Holly G Prigerson, PhD 
420 E 70th St., 3rd Floor, Suite B 
(646) 962-2882 
(646) 962-0812 
hgp2001@med.cornell.edu 
 
Co-Investigators: 
 
Paul K. Maciejewski, PhD 
420 E 70th St., 3rd Floor, Suite B 
(646) 962-7169 
(646) 962-0812 
pam2056@med.cornell.edu 
Heather Derry, PhD 
420 E 70th St., 3rd Floor, Suite B 
(646) 962-7149 
(646) 962-0812 
hmd2002@med.cornell.edu 
Ashish Saxena, MD, PhD 
420 E 70th St ., 3Rd Floor 
(646) 962-2066 
(646) 962-1603 
ahs9018@med.cornell.edu 
Manish A. Shah, MD 1305 
York Ave., 12th Floor (646) 
962-6200 
(646) 962-1607 
mas9313@med.cornell.edu 
Sophia Kakarala 
420 E 70th St., 3rd Floor, Suite B 
(646) 962-5637 
sok4004@med.cornell.edu 
Andrew Epstein, MD 
1275 York Ave. 
(646) 888-4313 
epsteina@msckcc.org 
ane9006@med.cornell.edu 
 
 
Medical Monitor: 
N/A 
 
Participating Sites: 
N/A 

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Table of Contents 
LIST OF ABBREVIATIONS ....................................................................................................................... V 
1. PROTOCOL SUMMARY .......................................................................................................................1 
1.1 Study Objectives ........................................................................................................................... 3 
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 Interviews, Focus Groups, Surveys, and/or Observations ............................................................ 5 
4.1 Study Population ........................................................................................................................... 7 
4.2 Inclusion Criteria............................................................................................................................ 7 
4.3 Exclusion Criteria ........................................................................................................................... 8 
4.4 Strategies for Recruitment and Retention .................................................................................... 8 
5. REGISTRATION PROCEDURES ............................................................................................................9 
5.1 Subject Registration (WCM only) .............................................................................................. 9 
5.2 Subject Registration (Sub-sites) .................................................................................................... 9 
6. STUDY PROCEDURES .........................................................................................................................9 
6.1 Schedule of Assessments .............................................................................................................. 9 
7.1 DATA REPORTING / REGULATORY CONSIDERATIONS ................................................................. 11 
7.2 Data Collection ............................................................................................................................ 11 
7.2.1 REDCap 
11 
7.3 Regulatory Considerations .......................................................................................................... 11 
7.3.1 Institutional Review Board/Ethics Committee Approval 
11 
7.3.2 Ethical Conduct of the Study 
12 
7.3.3 Informed Consent 
12 
7.3.4 Compliance with Trial Registration and Results Posting Requirements 
12 
7.3.5 Record Retention 
12 
8. STATISTICAL CONSIDERATIONS ...................................................................................................... 13 
8.1 
Sample Size/Accrual Rate ....................................................................................................... 13 
8.2 Stratification Factors ................................................................................................................... 13 
8.3 Analysis of Endpoints .................................................................................................................. 13 
8.3.1 Analysis of Primary Endpoints 
13 
9.1 Adverse Event Definition ............................................................................................................ 14 
9.1.1 Adverse Event Characteristics and Related Attributions 
14 
9.1.2 Recording of Adverse Events 
14 

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9.1.3 Reporting of AE to WCM IRB 
14 
9.1.4 Reporting Events to Participants 
14 
9.1.5 Events of Special Interest 
14 
9.1.6 Reporting of Pregnancy 
15 
10. UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS ............................... 15 
10.1 Definition of Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO)15 
10.1.1 Unanticipated Problem Reporting 
15 
11. SAFETY STOPPING RULES………………………………………………………………………………………………………15 
REFERENCES ............................................................................................................................................... 15 

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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 WCM. 

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List of Abbreviations 
 
 
ACP 
Advanced Care Planning 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CwC 
Coping with Cancer 
CRF 
Case Report Form 
CTSC 
Clinical Translational Science Center 
DSMC 
Data Safety Monitoring Committee 
DSMP 
Data Safety Monitoring Plan 
EoL 
End of Life 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GIST 
Giving Information Strategically and Transparently 
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 
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 
WCM 
Weill Cornell Medicine 

Protocol # 19-07020392 
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Version Date: October 5th, 2021 
 
1. Protocol Summary 
 
Full Title: 
Giving Information Systematically and Transparently in Solid Tumor 
Cancer 
Short Title: 
Oncolo-GIST 
Principal Investigator: 
Holly G. Prigerson, PhD 
Study Description: 
The study will develop, refine and pilot test the Oncolo-GIST clinician 
training intervention. The training is aimed at enhancing the clinician’s 
communication with patients by teaching to relay information both 
sensitively and in simple terminology. 
Sample Size: 
Phase 1 Interviews: N=20 (N=10 clinicians, N=10 bereaved caregivers) 
 
Phase 2: N= 54 (N=50 patient subjects, N=4 clinician subjects) 
Enrollment: 
This study will enroll 74 subjects and screen up to 250 subjects. 
Study Population: 
Phase 1 Interviews: Bereaved Caregiver subjects will be caregivers of 
patients who died in the past year with a primary diagnoses of GI or 
lung cancers. Clinician subjects will be either oncologists, palliative care 
physicians, nurses, nurse practitioners, social workers and psychologists 
who care for patients with metastatic GI and lung cancers. 
 
Phase 2: Patient subjects will be adults (18+) diagnosed with lung, head 
and neck, or GI cancer, with a progression of their disease after one line 
of therapy. Clinician subjects will be Lung, Head and Neck, or GI 
oncologists. All subjects’ primary language will be English and will have 
full mental capacity. 
Enrollment Period: 
Phase 1 (Interviews): 12 months 
Phase 2: 19 Months 
Study Design: 
Phase 1 (Interviews): Intervention manual development 
Phase 2: Intervention phase (two-group pilot randomized trial). 
Participants: 
Participants will be recruited at Weill Cornell Medical College/ 
New-York Presbyterian Hospital, at the Lung and GI Cancer centers. 
Study Duration: 
31 months 
Start date: Jan 22, 2020 
End date: July 25, 2022 (end enrollment); January 25th, 2023 (end data 
analysis and all other activities) 
 
Participant Duration: 
Phase 1 Interviews: 2 hours 
 
Phase 2: 4 months (with patient status monitoring up to 12 months) 
Primary Objective: 
To assess the effectiveness of the Oncologist intervention by examining 
the patient’s degree of prognostic understanding after discussing 

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prognosis with either Oncolo-GIST trained or non-Oncolo-GIST trained 
clinicians. 
 
 
 
Secondary Objectives: 
To examine the effects on patients of having better prognostic 
understating, including its effect on their quality of life, the type of care 
they choose to receive and whether or not the care they received was 
consistent with the patient’s preferences and values. 
Endpoints: 
Outcome will be a training manual for clinicians that teaches the 
Oncolo-GIST methods of communication. The efficacy of the 
intervention will be determined by measuring the patient’s prognostic 
understanding using our validated 4-item assessment. The assessment 
will determine if the patient understood the scan results as well as the 
expected outcomes of treatments offered. Outcomes will also include 
whether a DNR order was completed for the patient, the patients 
quality of life (McGill Quality of Life measure) , patient performance 
status (e.g., Eastern Cooperative Oncology Group, ECOG), as well as the 
type care received (e.g., anticancer, intensive, palliative care). 

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1.1 Study Objectives 
1.1.1 Objectives 
Objective 1: To develop and refine Oncolo-GIST, an intervention aimed at enhancing clinicians’ 
communication with patients by teaching to relay information both sensitively and in simple 
terminology, by receiving feedback from clinicians as well from bereaved family members of 
cancer patients. 
 
Objective 2: To determine feasibility and acceptability of Oncolo-GIST in a cluster trial in 50 
patients with advanced cancer and 4 clinicians. 
 
Objective 3: To test the preliminary efficacy of Oncologist on the 1) patients prognostic 
understanding 2) Other aspects of patient care including type of care, quality of life, and “value 
consistent” care. 
 
1.1.2 Hypotheses / Research Questions 
 
Hypothesis 1: The Oncolo-GIST intervention will be demonstrated to be feasible and acceptable 
to both clinicians and patients. 
 
Hypothesis 2: The Oncolo-GIST intervention will be associated with advanced cancer patients’ 
understanding of their scan results and prognosis (i.e., that they likely have months, not years, 
left to live). 
 
 
2. Background and Significance 
Informed consent requires an individual to have a clear understanding of the facts, implications, and 
consequences of an action.1 2 3 Bioethical principles, rooted in a respect for human dignity, necessitate 
that patients have a basic understanding of their illness and the risks and benefits of treatments 
proffered. Patients cannot make informed decisions about their care in the absence of knowledge of 
their prognosis or expected outcomes of treatments under consideration. It is alarming how unaware of 
their prognosis the vast majority of patients in our NCI-funded Coping with Cancer (CwC) R01s proved to 
be. Among CwC advanced cancer patients with a median survival of 5 months from our baseline 
assessment, we found only 5% accurately understood that they had incurable cancer, were terminally ill, 
were at a late- or end-stage of their illness, and likely had months, but not years, left to live.4 These 
findings highlight the ethical imperative of ensuring that patients have sufficient understanding of their 
prognosis, and expected risks/benefits of treatments being offered to them, for making informed 
choices. Preliminary evidence from CwC has shown that patients who get the gist that death is near are 
more likely to: a) engage in advance care planning (ACP) 5 6 b) receive less burdensome, intensive, and 
unbeneficial EoL care (e.g., fewer ICU stays, inappropriate palliative chemotherapy),5 6 7 8 and c) more 
value-consistent EoL care.6 Although we found that 71% of these patients state that they would want 
their oncologist to tell them their prognosis, only 17.6% stated that their oncologist had discussed their 
prognosis (i.e., life-expectancy) with them.9 We find that patient prognostic understanding is improved 
by oncologist discussions of prognosis,4 10 7 but that the manner of communication matters for patients 
to “get the gist” that death is near.10 

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These results suggest a compelling need for interventions that: a) promote oncologist discussions of 
prognosis with their advanced cancer patients, b) prove feasible to implement in clinic, c) are acceptable 
to oncologists, and d) improve patients’ prognostic understanding. We believe that the Oncolo-GIST 
approach has enormous potential to address each of these needs. By enabling more patients to make 
informed medical choices, the Oncolo-GIST approach is expected to uphold bioethical principles by 
promoting patients’ capacity to engage in truly informed medical decision-making which, based on prior 
findings, is also expected to result in better EoL outcomes (e.g., less intensive, more palliative and more 
value-consistent EoL care). 3 7 11 
 
3. Study Design and Methods 
3.1 Overall Design 
The overall goals are to refine and demonstrate the feasibility of implementing the Oncolo-GIST 
intervention, determine its acceptability to oncologists, and potential for improving advanced cancer 
patients’ prognostic understanding. In pursuing these goals, this studyaims to determine the   
promise of the Oncolo-GIST approach for affecting the targeted outcomes and given positive results, 
to position us for a larger RCT. We, thus, propose to examine key aspects of intervention 
development, to evaluate the NIH’s Stage I activities of the Stage Model of Behavioral Therapies (e.g., 
intervention refinement, adaptation, and pilot testing),12 13 and to explore Oncolo-GIST’s 
preliminary efficacy. 
Both qualitative and quantitative methods will be used in Phase 1. During the Phase 1 interviews 
(Aim #1) we will obtain feedback from relevant stakeholders/key informants (bereaved caregivers 
and clinicians) on an early draft of the Oncolo-GIST manual and proposed approach using a version of 
the Delphi method 14 in which we interview bereaved family caregivers of advanced cancer 
patients (n=10) and oncology clinicians who care for patients with advanced gastrointestinal (GI) and 
thoracic (lung) cancers (n=10). The participants will have the option of completing a recorded phone 
interview or answering identical questions via a link to REDCap. Participants will also be asked 
demographic and oncology based communication questions specific to either clinicians or caregivers. 
 
In Phase 2, for the pilot cluster RCT study (Aim #3), we will recruit adult patients (n=50) with 
metastatic GI, head and neck, or lung cancers with scan results that reveal progression (worsened 
disease) on an initial systemic treatment; that is, patients whose life-expectancy can reliably be 
estimated to be months, not years. 5 9 Medical oncologists (n=4) who care for these patients will also 
be consented for study participation and half (n=2) will be randomized to receive the brief “Oncolo- 
GIST communication” training. The Oncolo-GIST training will provide instruction in how to introduce 
the topic of prognosis, describe scan results as “worse,” prognosis as “likely months, not years,” and 
expected treatment outcomes (e.g., “not expected to be cured by treatment,” and expected impact 
on quality of life – that is, whether the anticancer treatment is likely to make them feel overall  
better or worse). We expect 12-13 patients will be clustered within each of the 4 oncologists. 
Hierarchical Linear Modeling (HLM) techniques will be employed to address the non-independence 
of patient assessments within each cluster. Patients (n=25) will be seen by either an Oncolo-GIST 
trained oncologist or an oncologist not trained in the intervention; that is, usual care (n=25). 
Patients in both arms will have met the same eligibility criteria (i.e., have similar prognoses). 
Thus, we will get initial feedback on the Oncolo-GIST intervention from relevant stakeholders and 
key informants, obtain information on the patient and oncologist experience with the intervention 
and evaluate its feasibility and acceptability. Finally, we will obtain preliminary effect size estimates 

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on the Oncolo-GIST Version 2.0’s effect on our primary outcome – patient prognostic understanding 
– to inform the planning of a future larger scale efficacy randomized controlled trial (RCT). Patients 
will be assessed by trained research staff in the week prior to a scheduled meeting with their 
oncologist to discuss the scan results. This will provide patients’ baseline levels of prognostic 
understanding and enable us to determine how the intervention relates to pre-post scan visit 
changes in prognostic understanding. Although the first scheduled scan after study enrollment may 
not reveal progressive disease, we have been assured by Drs. Epstein and Saxena that only 
exceptional cancer patients will not progress within 12 months of baseline. We thus propose to 
follow patients for 12 months or until a progression is detected in the scan, whichever comes first. 
Patients will be assessed pre-scan, post-scan within a week of that progressive scan visit and after 
their two next scans, if applicable. [see Human Subjects section for Study Timeline & Assessment 
Schedule and details of assessment procedures]. Although not all patients are expected to die within 
the study observation period, given a median life expectancy of ~4-5 months from baseline,9 we 
expect nearly half of the enrolled patients will die 4 months from baseline, and that the vast  
majority will die during the study observation period. Thus, for all patients enrolled in this study, the 
medical care that they receive can reasonably be considered end-of-life care, whether they die 
during the study observation period or not. 
Informed consent of participants will occur in-person or will be conducted remotely by sending the 
participants the consent form by mail or secure file transfer (transfer.weill.cornell.edu) or via a 
REDCap Informed Consent form (see attached) The REDCap form will be implemented in the 
following manner to ensure informed consent: a research assistant will send the form to a 
participant prior to a scheduled phone call, go through the consent with the participant over the 
phone, and answer any questions. The participant will need to type the correct name of the person 
who recruited them in the REDCap form: a wrong answer will be counted as “not consented.” 
REDCap has been automatically set up with the e-consent framework to auto-archive consents and 
email a PDF copy of the signed form to the participant. A research assistant will then call the 
participants to go over consent and answer any questions they may have prior to any assessments. 
Participants will keep one copy of the consent form and send one copy back by mail or secure file 
transfer prior to any assessments/data collection. 
Phase 2 documents will be submitted upon completion of the Phase 1 Interviews and the Phase 1 
Open Trial respectively. No participants will be enrolled without IRB approval of these documents. 
 
3.2 Interviews, Focus Groups, Surveys, and/or Observations 
A. Administration 
 
Timing and Frequency 
Phase 1 Interviews: Clinicians and bereaved caregivers will complete a one-time, 2 hour 
phone study session or REDCap survey (including embedded intervention manual) link. 
Phase 2: Patients will be assessed in the week prior to their scheduled scan, within 1 
week of the clinic visit in which progressive scan results are discussed, and then after 
their next two scans, if they have them, to explore intervention effects on primary and 
secondary outcomes, respectively. Oncologists will be assessed in the week following 
that same clinic visit to obtain their impressions of the discussion of prognosis and the 
patient’s prognostic understanding. All these assessments will take 20-30 minutes. 
Trained oncologists will complete a brief (5-minute) post-training quiz, and all 
oncologists will complete a brief (5-minute) survey on Oncolo-GIST at the end of the 

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study. Additionally, patients will be monitored via EPIC for progression of disease up to 
12 months. 
 
Location 
Phase 1 interviews of caregivers and clinicians will take place at a location convenient to 
the participant over the phone or via REDCap. Assessments of patients and clinicians in 
the pilot stage will take place in-person in clinic, at a time convenient for the participant 
at a different appointment, or over the telephone. Patients in Phase 2 will also have the 
option of completing the surveys themselves via a secure web link if this is more 
convenient to them. 
 
Person Identifiers 
Co-investigators may review EPIC to identify potential participants who meet eligibility. 
Contact information and appointment information will also be collected for either in- 
person or letter (postal and email) recruitment. Only data from potential participants 
will be stored on secure servers. Patient subjects will also have data collected via 
medical chart abstraction including diagnoses, medications, advanced directives, and 
types of care received (e.g. hospice). These data will be deleted upon completion of the 
study. 
 
B. Study Instruments 
 
Phase 1 Interviews for both clinician and bereaved caregiver subjects will consist of 
a survey including demographics and oncology based communication questions 
specific to either the clinicians or caregivers. After each section of the Oncolo-GIST 
manual, participants will answer open-ended questions about the module they just 
reviewed. 
 
Phase 2 patients will be screened with a mental status questionnaire and health 
literacy assessment. At the first visit they will answer an assessment battery 
including but not limited to questions about treatment and mental status prior to 
discussing their scan results. After the scan results, patients will answer questions to 
assess prognostic understanding and treatment preferences at 3 post-scan time 
points (1 week after initial scan, one week after second scan, one week after third 
scan from enrollment)). Trained co-investigators will also collect data via medical 
chart abstraction. Clinicians (Phase 2) will answer an initial demographic survey and 
surveys including prognosis questions, patient understanding, and patient medical 
status for each patient participant. Clinicians trained in Oncolo-GIST will also 
complete a short post-training quiz to assess their understanding of the Oncolo-GIST 
manual. All clinicians will complete a brief study completion questionnaire to assess 
the feasibility and acceptability of the Oncolo-GIST method. 

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 
Referral information 
Data collected/received from participants will be reviewed within 24-48 hours and 
research study staff will be responsible for addressing elevated psychological 
symptoms/suicidality identified on the assessments so that timely and appropriate 
psychiatric assessment and care can be provided. If a participant at acute risk of 
self-harm or harm to others cannot be reached by the study team within 3 hours 
(after at least two phone call attempts and an email requesting a call back), the 
participant‘s emergency contact(s) will be contacted. 
 
4. Study Design 
4.1 Study Population 
 
Phase 1 Interviews: Bereaved Caregiver subjects will be caregivers of patients who died in 
the past year with a primary diagnoses of GI or lung cancers. Clinician subjects will be 
oncologists, palliative care physicians, nurses, nurse practitioners, social workers, or 
psychologists who care for patients with metastatic GI and lung cancers. 
 
Phase 2: Patient subjects will be adults (18+) diagnosed with lung or GI cancer, with a 
progression of their disease after one line of therapy. Clinician subjects will be Lung, Head 
and Neck, or GI oncologists. All subjects’ primary language will be English and will have full 
mental capacity. 
 
4.2 Inclusion Criteria 
Phase 1 Interviews: 
Bereaved Caregivers: 
1. Caregivers of patients who died in the past year with a primary diagnoses of GI or lung 
cancer 
2. Fluent in English 
Clinicians: 
1.   Currently care for patients with metastatic GI and lung cancers as an oncologist, palliative 
care physician, nurse, nurse practitioner, social worker, or psychologist 
 
Phase 2: 
Patients: 
1. Male or female ≥ 18 years of age. 
2. Receiving ongoing care (≥ 2 visits) that includes regular scans 
3. Progression on at least 1 line of systemic cancer therapy 
4. Prognosis from an oncologist of less than 12 months 
5. Receiving care from an oncologist participating in the Oncolo-GIST study 
6. Fluent in English 
Clinicians: 
1. Specialize in Lung, Head and Neck, and GI cancers 
2. Currently provide care at the WCM Lung, Head and Neck, and GI cancer clinics 
3. Fluent in English 

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4.3 Exclusion Criteria 
Phase 1 Interviews: 
Bereaved Caregivers: 
1. Caregivers of patients who died longer than 1 year from the time of enrollment 
2. Caregivers of a patient that did not have a primary diagnoses of GI or lung cancer 
3. Not fluent in English 
Clinicians: 
1.   Does not currently care for patients with metastatic GI and lung cancers as either an 
oncologist, palliative care physician, nurse, nurse practitioner, social worker, or psychologist 
 
Phase 2: 
Patients: 
1. Under 18 years of age 
2. Not receiving ongoing cancer care (≥ 2 visits) that includes regular scans 
3. Not progressing on at least 1 line of systemic cancer therapy 
1.   Prognosis from an oncologists of 12 months or more 
4. Not receiving care from an oncologist participating in the Oncolo-GIST study 
5. Not fluent in English 
6. Cognitive impairment, as indicated by a score of <8 on the Short Portable Mental Status 
Questionnaire or a diagnosis of dementia or a related condition 
Clinicians: 
1. Does not specialize in Lung, Head and Neck, and GI cancers 
2. Does not currently provide care at the WCM Lung, Head and Neck, and GI cancer clinics 
3. Not fluent in English 
 
4.4 Strategies for Recruitment and Retention 
Phase 1 Interviews: Clinicians and bereaved caregivers will be recruited by targeted sampling. We 
will use WCM’s EPIC system as well request referrals from Weill Cornell Medicine (WCM) clinicians 
to recruit 10 bereaved caregivers of GI and lung cancer patients who died within the past year. 
Trained research co-investigators will screen deceased patients using EPIC after referral. If deemed 
eligible, caregivers will be contacted by either phone or email by non-clinician co-investigators. 
Oncology clinicians including oncologists, palliative care physicians, nurses, nurse practitioners, social 
workers, and psychologists who care for patients with GI and lung cancer, will be identified for 
recruitment via convenience and snowball sampling by either phone or email. These clinicians are 
known by co-investigators and/or their affiliates. Recruitment emails will include an attached flyer. 
Flyers will also be distributed on WCM/NYP properties. Phone recruitment will be by script and will 
include information from the flyer. Participants will not be contacted more than twice if there is no 
response and if at any point, a potential participant asks not to be contacted, study staff members 
will thank them for their time, and be put on a do not contact list. Participants will receive $100 
compensation via a ClinCard after the interview is completed. 
 
Phase 2: Patients will be identified from weekly reviews of patient charts and discussions with the 
WCM GI, Head and Neck, and lung clinic staff working alongside Dr. Manish Shah and Dr. Ashish 
Saxena, respectively. Trained research assistants (RA) will screen patients at the Lung and GI Clinics 
for eligibility, using WCM’s EPIC system. If deemed eligible (see eligibility and exclusion criteria), the 
research assistant will approach the patient in clinic, to explain the study, and the study procedures. 
Flyers will also be distributed on WCM/NYP properties. Patient subjects will receive $25 
compensation via ClinCard after each interview is completed, with a possible total of $100 by the 

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end of the study. 
 
• 
Anticipated accrual rate 
o Phase 1 Interviews 
 
Recruit and enroll 10 oncology clinicians and 10 bereaved in the 1st 6 months of 
the study 
o Phase 2 
 
Recruit and enroll 50 patients (3/month for ~ 18 months) 
 
5. Registration Procedures 
5.1 Subject Registration (WCM only) 
Subjects will be registered within the WRG-CT as per the standard operating procedure for 
Subject Registration. 
 
5.2 Subject Registration (Sub-sites) 
Not Applicable 
 
6. Study Procedures 
6.1 Schedule of Assessments 
 
Table 1. Schedule of trial events for Phase 1 Interviews (Bereaved Caregivers and Clinicians) 
 
Pre-study 
 Visit 1 
(Interview)
Screening 
X 
Informed Consent (see note) 
X 
Review of Oncolo-GIST intervention 
X 
Demographics 
X 
Oncology Based Communication Questions 
X 
Semi-structured Interview 
X 

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Table 2. Schedule of trial events for Phase 2 
 
Arm 
Pre- 
Study 
Pre- 
Scan 
Post-Scan 1 
(approx. 1 
week) 
Post-Scan 2 
Post-Scan 3 
Post-Scan 4 
(up to 12 
months) 
Short Portable Mental Status 
QuestionnaireS 
P 
X 
Health Literacy Assessment 
(REALM)S 
P 
X 
Informed Consent 
B 
X 
Oncolo-GIST Training (Clinicians) 
C* 
X 
Demographics 
P 
X 
4 Item Illness Understanding 
P 
X 
Treatment Intent 
P 
X 
Treatment Preferences 
P 
X 
CWC II Psychological questions 
P 
X 
NCCN Distress Thermometer 
P 
X 
The Human Connection Scale 
P 
X 
X 
X 
X 
HADS 
P 
X 
X 
X 
X 
McGill Quality of Life Questionnaire 
P 
X 
X 
X 
X 
PSWQ-Ultra Brief 
P 
X 
PANAS 
P 
X 
Primary Appraisal Secondary 
Appraisal (PASA) items (Threat and 
Challenge subscales only) 
P 
X 
Post Scan Clinician Questionnaire 
C 
X 
Medical Chart Abstraction 
C 
X 
X 
X 
Post Scan Patient Questionnaire 
P 
X 
X 
X 
Training Quiz 
C* 
X 
Post-Study Questionnaire 
C 
X 
C = Clinicians, P = Patients, B = Both, S= Screening, * = Intervention Arm Only 
 
Note: The Post-Scan 4 Chart Abstraction will occur when monitoring if progression of the disease is found 
after Post-Scan 3 or the patient is deceased; up to 12 months. 

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7.1 Data Reporting / Regulatory Considerations 
7.2 Data Collection 
The data collection plan for this study is to utilize REDCap to capture all treatment, toxicity, efficacy, 
and adverse event data for all enrolled subjects. 
7.2.1 REDCap 
REDCap (Research Electronic Data Capture) is a free data management software system that is 
fully supported by the Weill-Cornell Medical Center CTSC. It is a tool for the creation of 
customized, secure data management systems that include Web-based data-entry forms, 
reporting tools, and a full array of security features including user and group based privileges, 
authentication using institution LDAP system, with a full audit trail of data manipulation and 
export procedures. REDCap is maintained on CTSC-owned servers that are backed up nightly 
and support encrypted (SSL-based) connections. Nationally, the software is developed, 
enhanced and supported through a multi-institutional consortium led by the Vanderbilt 
University CTSA. 
 
7.3 Regulatory Considerations 
7.3.1 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. 
 
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 IEC/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 IEC/IRB together with the approved ICF must be filed in the study files. 
 
The Investigator will report promptly to the IEC/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 IEC/IRB 
will be notified that the study has ended. 
 
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 IEC/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, Weill 
Cornell Medicine, updated documents will be provided to participating sites. Weill Cornell 
Medicine 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. 

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7.3.2 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. 
 
7.3.3 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/IEC requirements, applicable 
laws and regulations. 
 
7.3.4 Compliance with Trial Registration and Results Posting Requirements 
Under the terms of the Food and Drug Administration Modernization Act (FDAMA) and the Food 
and Drug Administration Amendments Act (FDAAA), the Sponsor-Investigator of the trial is solely 
responsible for determining whether the trial and its results are subject to the requirements for 
submission to http://www.clinicaltrials.gov. Information posted will allow subjects to identify 
potentially appropriate trials for their disease conditions and pursue participation by calling a 
central contact number for further information on appropriate trial locations and trial site contact 
information. 
 
7.3.5 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. 
 
7.3.6 Data Safety and Monitoring Plan 
Monitoring 
A medical monitor is not appointed for this study as the risk level to participants is extremely low. 
Patients are only approached with the express approval of their treating oncologist. Furthermore, 
co-investigator Dr. Epstein will consult on the suitability of the study for individual patients, when 
this is in doubt, as well as any unexpected medical events that occur during patients’ participation 
in the study. Participants’ responses to study assessments will be monitored for severe 
psychological distress. Patients’ participation will be discontinued if they experience severe 
distress  attributable  to  the  study,  as  determined  by  the  co-investigators  or  their  treating 

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physician. Participants may also withdraw from the study at any time with no effect on their 
treatment. 
 
Reporting to DSMC 
Due to the low clinical risk involved in this study, we propose reporting to the Weill Cornell DSMC 
on an annual basis. Annual reports will comprise: recruitment and retention totals, including 
voluntary patient withdrawals; a summary of progress since the previous DSMC report; and 
accounts of any and all adverse events (AEs). For the purpose of this study, an AE is defined as a 
participant experiencing severe psychological distress, regardless of attribution. 
 
8. Statistical Considerations 
8.1 Sample Size/Accrual Rate 
Phase 1 Interview: Sample size will be 10 clinicians and 10 bereaved caregivers recruited over 6 
months. 
 
Phase 2: The pilot clustered RCT will enroll 4medical oncologists (2Oncolo-GIST Version 2.0 trained; 
2usual care) and 50 patients (25 will receive care from an Oncolo-GIST Version 2.0- trained 
oncologist, 25 will receive usual care) within an 18-month recruitment period. Based on past 
recruitment yields in the GI and lung cancer clinics at WCM (e.g., recruitment of 60 advanced GI 
cancer patients alone in 18 months), we are confident that we can recruit this number of eligible 
patients within an 18- month period. Given this is an oncologist communication intervention, we 
expect the patient drop-out rate to be low. Fifty participants will ensure fairly stable estimates of 
intervention effects and confidence intervals and indicate if there is a “signal” that the intervention 
is helpful for promoting prognostic understanding. Using our validated 4-point prognostic 
understanding score4 as a continuous outcome, if Cohen’s d is large (0.8), with 48 patients and 4 
oncologists, the power will be > 80%. If the effect size is medium (0.5), power will drop to 30%. 
 
8.2 Stratification Factors 
25 patients will be recruited to Oncolo-GIST trained clinicians, and 25 patients will be recruited to 
usual care clinicians in Phase 2. 
 
8.3 Analysis of Endpoints 
8.3.1 
Analysis of Primary Endpoints 
Phase 1 Interviews: We will obtain feedback on the current version of Oncolo-GIST (Version 1.0). 
Morse’s guidelines15 for rigorous qualitative research (e.g., audit trail, saturation) will be followed 
and Atlas.ti software used. 16 Themes emerging will be quantified (re: frequency, 
priority) and considered to inform revisions to the Phase 1 Open Trial Oncolo-GIST intervention. 
 
 
Phase 2: We will generate preliminary effect size estimates to inform the planning of the larger, 
efficacy randomized controlled trial (RCT). Hierarchical Linear Modeling (HLM)17 will be used to 
evaluate intervention effects. HLM is statistically appropriate because it accounts for the 
clustering of patients within oncologists, creating nonindependence of clustered assessments. 
HLM will model oncologists as a random effect as has been done in prior RCTs.18 19 Baseline 
covariates known to affect study outcomes (e.g., patient health literacy) will be included in 
models to increase the precision of effect size estimates.20 This will provide a preliminary effect 
size estimate of Oncolo-GIST Version 2.0’s ability to improve patients’ prognostic understanding 
for a future, larger study. Linear and logistic regression models will estimate effects of the 

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Oncolo-GIST intervention on secondary and exploratory outcomes. 
 
9. Adverse Event Reporting Requirements 
Adverse event (AE) monitoring and reporting is a routine part of clinical research. Safety is monitored 
by evaluation of adverse events reported by subjects or observed by investigators or research staff, as 
well as by other investigations such as clinical laboratory tests, x-rays, electrocardiographs, etc. 
 
9.1 Adverse Event Definition 
An adverse event (also referred to as an adverse experience) can be any unfavorable and 
unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally 
associated with the use of a drug, and does not imply any judgment about causality. An adverse 
event can arise with any use of the drug (e.g., off-label use, use in combination with another 
drug) and with any route of administration, formulation, or dose, including an overdose. In the 
case of this study, which does not administer any drugs, the only potential AE is psychological 
distress. Any case of severe psychological distress, as indicated by regular study assessments (see 
Section 6.1) or by a participant’s self-report, will be noted in the AE log, reported to the IRB, and 
included in the annual DSMC report. AEs will be reported regardless of attribution, which will 
be determined by the co-investigators according to the schedule below (section 9.1.1). 
 
9.1.1 Adverse Event Characteristics and Related Attributions 
CTCAE term (AE description) and grade: The descriptions and grading scales found in 
the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 
will be utilized for AE reporting. A copy of the CTCAE version 4.0 can be downloaded 
from the CTEP web site (http://ctep.cancer.gov). 
• 
Attribution of the AE: 
- Definite – The AE is clearly related to the study treatment. 
- Probable – The AE is likely related to the study treatment. 
- Possible – The AE may be related to the study treatment. 
- Unlikely – The AE is doubtfully related to the study treatment. 
- Unrelated – The AE is clearly NOT related to the study treatment. 
 
9.1.2 Recording of Adverse Events 
All adverse events will be recorded on a subject specific AE log. The AE log will be 
maintained by the research staff and kept in the subject’s research chart. 
 
9.1.3 Reporting of AE to WCM IRB 
All AEs occurring on this study will be reported to the IRB according to the IRB policy, 
which can be accessed via the following link: 
http://researchintegrity.weill.cornell.edu/forms_and_policies/forms/Immediate_Report  
ing_Policy.pdf. 
 
9.1.4 Reporting Events to Participants 
Not Applicable 
 
9.1.5 Events of Special Interest 
Not Applicable 

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9.1.6 Reporting of Pregnancy 
Not Applicable 
 
10. Unanticipated Problems Involving Risks to Subjects or Others 
Not Applicable 
 
10.1 Definition of Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO) 
Not applicable 
 
10.1.1 Unanticipated Problem Reporting 
Not applicable 
 
11. Safety Stopping Rules 
We would stop the study if patients in the intervention arm became psychologically distressed and their 
distress was attributable to the way we are training oncologists to communicate, though it is our 
hypothesis and aim to demonstrate the emotional and cognitive benefits of our approach. Psychological 
distress is here defined as self-reported distress on the part of the subject or distress as evaluated by the 
researcher (defined as an AE in section 7.2.6). As we administer multiple psychometric assessments per 
interview and enquire about the patient’s wellbeing, there is ample opportunity to catch and discuss 
psychological distress. 
 
References 
 
 
 
 
 
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3 WHO | Informed Consent Form Templates". who.int. Retrieved 14 September 2014 
 
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Illness Understanding in Patients with Advanced Cancer. J Clin Oncol. 2016 Jul 10;34(20):2398-403. doi: 
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15 Morse JM: Designing funded qualitative research. Handbook of qualitative research, Denzin and 
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16 https://atlasti.com/ 
 
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18 
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Analysis 18:265-283, 1996 
 
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