Feasibility and Effectiveness of Automated Geriatric Co-Management Program on Improving the Perioperative Care of Older Patients With Solid Mass or Nodule Suspicious for Cancer
Phase: NA
Conditions: Cancer
Sponsor: Memorial Sloan Kettering Cancer Center

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MSK PROTOCOL COVER SHEET 
Feasibility and Effectiveness of Automated Geriatric Co Management Program on Improving the Perioperative 
Care of Older Patients with Solid Mass or Nodule Suspicious for Cancer 
Principal Investigator/Department: Armin  Shahrokni, MD, MPH /Medicine 

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Table of Contents 
1.0 
PROTOCOL SUMMARY AND/OR SCHEMA ........................................................................ 4 
2.0 
OBJECTIVES AND SCIENTIFIC AIMS ................................................................................. 5 
3.0 
BACKGROUND AND RATIONALE ....................................................................................... 6 
4.1 
OVERVIEW OF STUDY DESIGN/INTERVENTION ...................................................................... 12 
4.2 
Design................................................................................................................................. 12 
4.3 
Intervention .................................................................................................................................... 15 
5.1 
CRITERIA FOR SUBJECT ELIGIBILITY ...................................................................................... 16 
5.2 
Subject Inclusion Criteria ......................................................................................................... 17 
5.3 
Subject Exclusion Criteria ....................................................................................................... 17 
6.0 
RECRUITMENT PLAN ........................................................................................................ 17 
7.0 
ASSESSMENT/EVALUATION PLAN .................................................................................. 18 
8.0 
TOXICITIES/SIDE EFFECTS ......................................................................................................... 20 
9.0 
PRIMARY OUTCOMES ..................................................................................................... 21 
10.0 
CRITERIA FOR REMOVAL FROM STUDY .................................................................................. 21 
11.0 
BIOSTATISTICS ............................................................................................................... 22 
12.1 
RESEARCH PARTICIPANT REGISTRATION AND RANDOMIZATION PROCEDURES 
25 
12.2 
Research Participant Registration ........................................................................................... 25 
12.3 
Randomization ......................................................................................................................... 25 
13.1 DAT AM ANAGEMENT ISSUES ......................................................................................... 26 
13.2 
Quality Assurance ............................................................................................................... 26 
13.3 
Data and Safety Monitoring ......................................................................................................... 26 
14.1 PROTECTION OF HUMAN SUBJECTS .................................................................................... 27 
14.2 
Privacy ................................................................................................................................ 27 
14.3 
Serious Adverse Event (SAE) Reporting ................................................................................. 28 
15.0 
INFORMED CONSENT PROCEDURES........................................................................................ 29 
16.0 
REFERENCES ................................................................................................................................. 30 
17.0 
APPENDICES .................................................................................................................... 32 

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1.0 
PROTOCOL SUMMARY AND/OR SCHEMA 
 
Title: Feasibility and  Effectiveness of  Automated  Geriatric Co-Management 
Program on Improving the Perioperative Care of Older Patients with Solid Mass or 
Nodule Suspicious for Cancer 
Study Center: MSKCC 
Expected Time to Study Completion: 24 months 
Objectives: 
Primary objective: 
To determine the feasibility of automated geriatric co-management program in the 
care of geriatric oncology patients. 
Secondary objectives: 
• 
To compare the effect of automated geriatric co-management program with in- 
person geriatric co-management on adverse surgical events. 
• 
To compare the effect of automated geriatric co-management program with in- 
person geriatric co-management on postoperative functional recovery. 
Study Design: 
• 
Prospective Randomized Trial 
• 
Patients will be randomized 1:1 to receive either automated geriatric co- 
management during surgery visit when they are considered  for surgery, or to 
be referred to geriatrics service for in-person geriatric co-management which 
can be done either in the clinic or via telemedicine. 
Study Population 
Patients with a solid mass or nodule aged 65 or older who are presenting to 
MSKCC’s surgery clinics for consideration of surgery. 
Number of patients: 77 patients evaluable in the automated arm, estimated to be 
200 patients in the study 
Inclusion and Exclusion Criteria: 
Inclusion: 
1) Solid mass or nodule suspicious for cancer, 
2) Aged 65 or older, 
3) Being considered for surgical resection of the solid mass or nodule, with 
anticipated hospital length of stay of at least two  days, 
4) Completed Electronic Rapid Fitness Assessment 
Exclusion: 
1) Unable to read or comprehend English 
2) Not having a completed electronic Rapid Fitness Assessment within 2 
months of surgery 
3) Being discharged in one day or earlier from thehospital 

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Figure 1- Study schema 
 
 
 
2.0 
OBJECTIVES AND SCIENTIFIC AIMS 
 
Aim 1: To determine the feasibility of automated geriatric co-management program in 
the care of geriatric oncology patients. 
 
The feasibility of the program will be assessed by the percentage of patients in whom  at least 
half of the recommendations made by the program are followed by the surgical team. 
Our program will be deemed feasible if at least 50% of recommendations are followed in at 
least 70% of patients with impairments. 
 
We based our cutoff based on multiple studies. A study done on surgeons’ attitude toward 
assessment and management of older cancer patients, Ghignone et al[1], showed  that  only 
6.4% of surgeons use geriatric assessment in their daily practice and only 36% collaborate 
with geriatricians in some form. Studies on geriatric comanagement of older adults who are 
receiving chemotherapy also showed that the pickup rate of interventions  by the medical 
oncologists is around 35% [2]. Given these findings, we hypothesized that a more than 50% 
adoption of recommendations would be a reasonable rate for  then refining the intervention 
and conducting an R01 study in the future. 

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Aim 2: To compare the effect of automated geriatric co-management program with in- 
person geriatric co-manage ment on adverse surgical events. 
 
Aim 3: To compare the effect of automated geriatric co-management program with in- 
person geriatric co-manage ment on postoperative functional recovery. 
 
 
 
3.1 
BACKGROUND AND  RATIONALE 
 
Surgery remains the mainstay of cure for many older cancer patients.[3] As cancer incidence 
increases with age and with an aging population, it is expected that more older adults will be 
diagnosed with cancer.[4] Further, with the approval of lung cancer screening by Medicare, in 
addition to other cancer screening recommendations such as colonoscopy, it is  expected  that 
more older patients be diagnosed with cancer at an earlier stage.[5] 
Older Cancer Patients and Surgical Outcomes; Prediction 
 
Older and especially older frail cancer patients  are at a highest risk for adverse surgical 
events and slower functional recovery following cancer surgery.[6]  In  an  attempt to assess 
and lower the risk of a procedure for a patient, the American College of Surgeons and the 
American Geriatrics Society recommend incorporating geriatric assessment (GA) into the 
preoperative evaluation.[7] The goal of the GA is to identify geriatric  syndromes  and manage 
them perioperatively.[8] Studies have shown that components of GA are associated with the 
surgical outcomes. For example, a study of 120 patients  aged 60 years  or older who 
underwent thoracic surgery (85 of whom had lung cancer)  showed  that  patients  with 
dependency for performing basic activities of daily living (bADL) and those with  dementia 
were more likely to develop postoperative complications.[9] 
 
The Modified Frailty Index  (m-FI)  is a frailty index based on the American College of 
Surgeons National Surgical Quality Improvement Project.[10] It is a mix of 10 comorbid and 
medical conditions and one item on the level of independenc y for bADL and  instrumental 
activities of daily living (iADL). The score runs from 0 to 11 and the score of 3 or higher is 
considered as frail. A study of 1940 patients  who underwent  thoracotomies and lung 
lobectomy showed that 5.6% of frail patients died after surgery compared to just 1% of fit 
patients. Moreover, major complications occurred in 4.2% of fit patients  compared to 14.4% 
of frail patients.[11] 
In addition to studies specific for oncologic thoracic surgery procedures,  other  studies  have 
shown the same correlation with postoperative  outcomes  of  other  oncologic  surgical 
procedures. A recent systematic review found that six separate  prospective  studies  assessed 
the correlation between components  of the GA and adverse surgical outcomes  of  older 
cancer patients. These studies  confirmed that impairments in bADL, iADL and cognitive 
function are associated with an increased risk of postoperative complications.[12] 

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Interventions Aimed at Improving Surgical Outcomes of Older Patients; Collaboration 
between Surgeons and Geriatricians 
 
It is important to note that identification of geriatric   syndromes  without appropriate 
perioperative   interventions to manage the detected deficits  will not improve surgical 
outcomes. In non-oncologic surgery setting, collaboration between   surgeons  and  geriatricians 
has led to significant improvement in surgical outcomes by identifying and managing geriatric 
syndromes. In a study on 297 patients aged 70 years or older  who underwent hip surgery, 
patients were randomly assigned to postoperative care in a geriatric ward vs. routine care in a 
surgical ward. At one and  four months  after surgery, patients in the geriatric  ward showed 
more improvement in their mobility as measured by Short Physical Performance Battery, than 
patients in the surgical ward.[13] In another  trial, 162 patients with hip fractures  were 
randomized to geriatric consultation and care before and after  surgery during the hospital 
course vs. care by the surgical team alone.[14] Patients in the  intervention group experienced 
better performance on  iADL, recovery of walking ability, fewer  falls, fewer depressive 
symptoms and better quality of life during the first 24 months after  hospital  discharge.  Another 
study on 319 patients aged 65 years or older who underwent hip fracture surgery showed that 
geriatric co-management after surgery can  reduce  in-hospital mortality from  5.8% to  0.6%, 
and reduce complication rates from 61% to 45%. Notably, this  study showed that 57% of 
patients in the intervention group achieved partial or complete recovery compared to 44% in 
the control group.[15] 
Limitations of Current Evidence in the Cancer Setting: 
 
There is only very limited data on the effectiveness of such collaborations between surgical 
oncologist and geriatricians. In one  study  on oncologic  surgeons’ attitude   toward 
perioperative care for older adults with cancer, among  11%  who responded to the survey, 
only one out of three surgeons stated that they routinely collaborate withgeriatricians. 
The reasons for such a low rate of collaboration is likely multi-faceted. First, there is  a 
shortage of geriatricians with only 7000 practicing in the United States.[16] Second, with 
geriatricians involved in various other critical initiatives such as long-term care or  caring  for 
older patients with Alzheimer, only limited time may be available  to provide  postoperative 
geriatric co-management for older cancer patients routinely. 
The shortage of geriatricians could be addressed in two ways: 
 
1- by training more providers, either geriatricians or  geriatric nurse practitioners:  This  will 
be costly, requires significant amount of time and effort, and will not be  available to 
provide an immediate answer to such need. 
2- by providing surgeons with easy to administer GA and developing an  Automated 
Geriatric Co-management Program, which will automatically provide geriatric 
recommendations basedon impairments found via the GA to the surgical team. If this 

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program is shown to be feasible, acceptable to treating clinicians, and as effective in 
improving surgical outcomes as in-person geriatric co-management, then it can be 
adopted by all institutions that have limited or no geriatric service resources. 
 
In summary, the rationale for this project is as follows. 
 
1- The US population is aging. 
2- The Incidence of cancer increases with age. 
3- The introduction of cancer screening such as lung cancer screening will further 
increase the number of older adults with early stage cancer increases in the near 
future. 
4- Surgery is the mainstay of cure for early stage cancer patients. 
5- The likelihood of adverse surgical events and slow functional recovery  increases  in 
older adults, and especially older frail adults with cancer. 
6- Geriatric Assessment can assess patient frailty and identify potentially manageable 
geriatric syndromes. 
7- Management of geriatric syndromes can lead to improved surgical outcomes. 
8- Collaboration between non-oncologic  surgeons and geriatricians  to manage geriatrics 
syndromes have substantially improved surgical outcomes. 
9- Even if such collaboration is effective, it may not be scalable  due to a limited number 
of geriatric healthcare providers. 
 
As a result, an automated geriatric co-management program, if shown to be feasible and as 
effective as in-person geriatric co-management,  could  be  used to provide  peri-operative 
geriatric care routinely in institutions that have limited or no geriatrics services. 
The Electronic Rapid Fitness Assessment (the eRFA) at Memorial Sloan Kettering 
Cancer Center (MSKCC) 
The eRFA was developed at MSKCC  through collaboration  between the Geriatrics  Service 
and the Web Survey Core Facility (Webcore)  in 2015. During the eRFA  development 
process, the Geriatrics Service held multiple discussions to determine which GA domains to 
assess and which validated assessment methods to use. The name “Electronic Rapid Fitness 
Assessment” was selected to reflect the  purpose of the GA,  which is to distinguish patients 
who are fit from those who are frail. 
Administration and Reporting of the eRFA: 
 
The eRFA was first implemented in the Geriatrics clinic. In 2016, the Thoracic surgery clinic 
implemented the eRFA at the point of care.  All patients  who present to MSKCC  geriatric 
clinics or thoracic surgery clinics complete the eRFA while they  are  waiting to be seen  by 
their healthcare providers for their  initial consultation.  Patients may complete the eRFA  on  
their own or with assistance from others (e.g., a caregiver), or they may allow someone else 

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(e.g., a caregiver) to complete the  assessment  for  them. Patients  may also complete  the 
eRFA at home, before their appointment, if they have Internet  access and an e-mail account. 
After the assessment has been completed, a registered nurse (RN) performs a cognitive 
assessment using the Mini-Cog[17,  18] and establishes the  patient's mobility using the Timed 
Up and Go (TUG)[19] test, the results of which are then entered into the eRFA by the RN. The 
Mini-Cog and TUG assessments will be omitted if the patient is being seen via telemedicine. 
The eRFA contains 28 questions about functional status, cognition, social support, social 
activity interference, emotional status, nutrition,  vision, hearing and polypharmacy. On 
average, it takes between 10 to 20 minutes to complete. The eRFA is accessible using 
computers, tablets, and smartphones. It is partially integrated with the electronic medical 
record (EMR), with patients' names and medical record numbers pulled from the EMR as 
patient-specific questionnaires are generated. 
 
The components of the eRFA, the 12 major instruments utilized, and the cutoff for 
significantly abnormal values are shown in figure 2. 
Figure 2. Twelve major instruments of Electronic Rapid Fitness Assessment 
(the eRFA) 
 
Domain 
Instrument 
Completed 
by 
Description 
Score range 
Frail 
values 
Functional 
Domain 
Activities of 
Daily Living 
(ADL) [20] 
Patient 
Basic Activities of Daily Living  (bADL or 
ADL) assesses patients’ level  of 
independence  in 7 activities: bathing, 
dressing, grooming,  feeding,  bladder and 
bowel control, and walking inside and 
outside of the house. 
Answer choices to each are: limited a lot 
(0), limited a little (1), not limited (2). 
0-14 
≤13 
Instrumental 
Activities of 
Daily Living 
(iADL) [21] 
Patient 
Instrumental  Activities of Daily Living 
(iADL) assesses patients’ level  of 
independence  in 8 activities: telephone 
use, doing laundry, shopping,  preparing 
meals, doing housework,  handling own 
medications, handling  money and 
finances, and transportation. 
Answer choices to each are: unable to 
do (0), able with some help (1), able 
without help (2). 
0-16 
≤15 
Karnofsky 
Performance 
Status (KPS) 
[22] 
Patient 
Karnofsky  Performance  Status rates 
patient’s  functional  independence  in 
performing  ordinary  tasks. The score 
ranges from 100 (Normal with no 
symptoms) to 0 (Dead) in increments of 
10. 
30-100 
≤80 

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The patient-rated KPS in answered  in 8 
levels: 

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100- Normal,  no symptoms 
90- Able to carry on normal activity, 
minor symptoms 
80- Normal  activity, with effort,  some 
symptoms of disease 
70- Can care for self, but unable to do 
normal activity or work 
60- Require  occasional assistance, but 
able to care for most needs 
50- Require  considerable  assistance 
40- Disabled, require special care and 
assistance 
30- Severely  disabled, require 
continuous nursing care 
Fall inthe 
past year 
Patient 
The number of falls in the past year 
None, 
One  time, 
More than 
one time 
≥1 time 
Timed Up 
and Go test 
[19] 
Nurse 
Patients are asked to stand from the 
chair, walk ten feet, turn and return to the 
chair. The total time is recorded. 
<10 seconds, 
10-19 
seconds, 
≥20 seconds 
≥10 
seconds 
Social 
support/ 
activity 
Social 
support 
survey [23] 
Patient 
The Medical Outcome Study- Social 
Support Survey-  4 item asks 4 questions 
on how often patients have  someone to 
receive  support from: All the time (5), 
Most of the time (4), Some of the time 
(3), A little of the time (2), Not at all (1). 
Higher scores mean better social 
support. 
4-20 
≤16 
Social 
activity 
limitation 
[24] 
Patient 
The Medical Outcome Study- Social 
Activity Survey  asks how much patients’ 
social activity is limited and how much/ 
often it has become limited/ interfered 
with recently. 
3 questions with 5 answers (1-5) are 
counted. Higher scores mean more 
limited social activity. 
3-15 
≥8 
Cognition 
Mini Cog 
test [17, 18] 
Nurse 
Patients are told three words to 
memorize. Then they are asked to draw 
a clock with hands showing ten past 
eleven. Then they are asked to recall the 
three  words. 
Clock draw is evaluated  either normal 
with 2 points or abnormal with 0 point. 
Each correctly recalled word  has 1 point 
(0-3). 
0-5 
≤2 

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Emotional 
wellbeing 
Distress  [25] 
Patient 
The Distress Thermometer  ranges from 
1 (no distress) to 10 (extreme distress). 
1-10 
≥4 
Depression 
[26, 27] 
Patient 
The Geriatric Depression Scale- 4 item is 
a yes/no questionnaire. 
Patients receive 1 point for each answer 
that indicates depression. 
0-4 
≥1 
Poly- 
Poly- 
Patient 
The number of medications currently 
1-4 
≥5 
pharmacy 
pharmacy 
taken 
medications, 
medications 
[28] 
5-9 
medications, 
≥10 
medications 
Nutritional 
status 
Weight 
change 
Patient 
Weight change in the past 6 months 
no change or 
weight gain, 
lost < 5 lbs, 
lost 5-10 lbs, 
lost 10-20 lbs, 
lost ≥20 lbs 
lost ≥10 
pounds 
 
 
The eRFA in the Thoracic Surgery Clinics as a Model for other Surgical Clinics: 
 
After development and successful implementation of the eRFA  in  all MSKCC  Geriatric 
clinics[29], more than 4000 older cancer patients with a median age of 80 have completed the 
eRFA. Patients have shown very high levels  of satisfaction with the  instrument, and, as a 
result, thoracic surgery clinics have implemented the eRFA in  their clinics  as  a  routine care 
for the new patients. We have shown that implementation  of  eRFA in  the  thoracic  surgery 
clinics is feasible and can yield useful clinical  information that can be managed 
perioperatively.[30] 
For the purpose of this study, thirteen comorbid conditions are queried and combined as one 
item in addition to the 12 items in the eRFA report. 
Throughout the study, we have realized the most limiting factor  in efficiently accruing  patients 
was very strict inclusion and exclusion criteria that required a significant amount of time from 
research coordinators, and healthcare  providers  to properly assess these  patients.  Because 
this is a pilot study, based on R21 study, we have realized that such strict inclusion and 
exclusion criteria are not needed at this time. 
 
Thus far, we have made significant improvements  in the study process itself. For example, in 
the beginning, the electronic Rapid Fitness Assessment was on the Webcore platform  with 
limited resources. Over the past months, we  have moved to  MSK  Engage platform, and 
further enhanced our collaboration  with the Engage team, which has  more supportive staff 
than the Webcore platform. 

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During the course of the study, The PI has  given lectures  to various  surgery services  about 
the importance of assessing fitness/frailty of older adults with cancer before surgery and  the 
need to properly optimize the status of these patients. These lectures  were met with 
significant enthusiasm and surgeons expressed the desire  to be able to accrue patients  for 
this study. 
 
Finally, proper assessment of fitness/frailty of older adults with cancer  is not unique to one 
disease or one surgery service. In fact, frailty is considered a global syndrome without 
sociodemographic or clinical boundaries. As a result, in  order  to allow  patients  with other 
diseases who are going to undergo various surgeries to be accrued, we would like to broaden 
the study. 
 
In the proposed study, we will continue to advance the eRFA. We will assess whether 
performing eRFA along with automated recommendation for each eRFA impairment is 
feasible, and to collect preliminary data on its impact of patients’ surgical outcomes and 
functional recovery compared to in-person geriatric co-management. 
Our intervention, if feasible, will be scalable, and will likely improve care for hundreds of 
thousands of older cancer patients who are evaluated every year for their fitness for 
undergoing surgery. 
 
 
4.1 
OVERVIEW OF STUDY DESIGN/INTERVENTION 
 
4.2 
Design 
 
The proposed study is a randomized  controlled trial study.  The  primary  aim  of this 
study is to assess the feasibility of an automated geriatric co-management program for 
perioperative management of patients with solid mass  or nodule who  present to 
MSKCC Surgery Service clinics, and being considered for surgery. 
Secondary aims are to collect preliminary data on its impact on postoperative adverse 
surgical outcomes, and functional recovery compared to in-person geriatric co- 
management. 
The first visit (surgery clinics when patients are being considered for surgical 
resection of their solid mass or nodule  suspicious   for cancer): In surgery  clinics, 
all patients complete the eRFA as a routine care. 
Inclusion criteria are: 1) solid mass or nodule suspicious for cancer, 2) aged 65 or 
older, 3) being considered for surgical resection of the solid mass or nodule with 
anticipated hospital length of stay of at least two days, 4) completed  eRFA. 

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Exclusion criteria: 1) unable to read or comprehend English, 2) not having a completed 
eRFA within the two months of undergoing surgery, 3) being discharged in one day or 
earlier from the hospital. 
Note) To avoid excluding patients based on item 2, patients have to complete  another 
eRFA within two months of surgery. 
Following patients’ consent to participate in the study, patients will also complete a 4- 
Meter walk test (4MWT)[31]. Their sociodemographic characteristics will  also be 
recorded. 
Subsequently, they will be randomized either to in-person  geriatric  co-management  or 
the automated geriatric co-management program, using MSKCC’s Clinical Research 
Database, a secure randomization system ensuring full allocation concealment. 
The automated geriatric co-management program  group:  Through  literature 
review, consideration of American  College of  Surgeons and  American Geriatrics 
Society recommendation[32], and our years of collective experience for postoperative 
care for older adults with cancer, we have developed perioperative geriatric 
recommendations for each of the 12 eRFA impairments and comorbid conditions 
(appendix 1). 
Following completion of the eRFA, the summary of impairments as well as the 
recommendations generated by the study  team  (hard-copy or  email) will  be provided 
in real-time to the thoracic  surgery team  for their attention. A sample  is  provided 
below. In this case, patient has  impairments in various domains that ranges from  KPS 
to number of medications. 

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Subsequently, the research staff member clicks on various impairments and  would  be 
able to view and print the recommendations for each impairment. For example,  the 
following are the recommendations for a Timed Up and Go test impairment. 
 
 
 
 
 
A copy of the recommendations will be available in EMR. After  preoperative clearance 
by patients’ primary care  providers, general internal  medicine service, or other 
services such as cardiology, patients will undergo surgery. The geriatrics service will 
see patients before or after surgery if the  consult is  requested by the surgery  service. 
The automated co-management program is not expected to lengthen the patients’  first 
visits. 

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The in-person geriatric co-management group. Patients randomized  to  the  in-  
person geriatric management will be seen  by  MSKCC’s  geriatrics service for 
preoperative evaluation. The evaluation may be done either in clinic or via telemedicine. Based 
on the eRFA results and other issues found during the preoperative  evaluation,  
geriatricians   will make  recommendations to be executed in the postoperative period. 
Patients  are  then co-managed  by the  geriatrics  service during hospital course after 
surgery. The geriatrics  service sees  these patients  for at least 2 postoperative days,  if 
deemed clinically necessary by the geriatrician.  During the inpatient hospital course, the 
geriatrics service will ensure  the  execution of preoperative recommendations and will 
discuss  with the  surgical  team, who  will act as a primary team, any additional 
recommendation in order  to improve  postoperative care.[33] 
The 2nd study visit (outpatient  follow-up visit by the surgery  team, usually within 
2 weeks after  hospital discharge):  During this  meeting, once again patients 
complete the eRFA as a routine care, and perform 4MWT. The 2nd visit may also be 
conducted via telemedicine, depending on patient preference. 
Patients’ follow up continues  until day 30 after surgery with hospital length of stay of 
at least two days  in which the  surgical adverse events  (surgical complications  grade 
2+, disposition to any place other than home, length of stay, and readmission), surgery 
characteristics, cancer characteristics, and preoperative lab  results  will be collected  by 
the study team. 
Patients go off-study either at the 2nd study visit or 30 days after surgery, 
whichever happens later. 
4.3 
Intervention 
 
The automated geriatric co-management   program group:  Through  literature 
review, consideration of American  College of  Surgeons and  American Geriatrics 
Society recommendation[27], and our years of collective experience for postoperative 
care for older adults with cancer, we have developed perioperative  geriatric 
recommendations for each of 12 eRFA  impairments and comorbid conditions 
(appendix 1) 
Following completion of the eRFA, the summary of impairments as well as the 
recommendations generated by the study team  (hard-copy or email)  will  be provided 
in real-time to the surgery team for their attention. 
It will be up to the surgeons and the surgical team whether they follow the 
recommendations or not. The rate of follow up of the recommendation  is  the primary 
aim of this study. 
A sample is provided below. In this case, patient  has  impairments in various domains 

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that ranges from KPS to number of medications. 

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Subsequently, the research staff member clicks on various impairments and  would  be 
able to view and print the recommendations for each impairment. For example,  the 
following are the recommendations for a Timed Up and Go test impairment. 
 
 
 
A copy of the recommendations will be available in EMR. After  preoperative clearance 
by patients’ primary care  providers, general internal  medicine service, or other 
services such as cardiology, patients will undergo surgery. The geriatrics service will 
see patients before or after surgery if the  consult is  requested by the surgery  service. 
The automated co-management program is not expected to lengthen the patients’  first 
visits. 
 
 
5.1 
CRITERIAFOR SUBJECT  ELIGIBILITY 

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Patients who present to MSKCC surgery clinics for consideration of surgery for  their 
solid mass or nodule will be selected. 
5.2 
Subject Inclusion Criteria 
 
1) Solid mass or nodule/lesion suspicious for cancer, 
 
2) Aged 65 or older, 
 
3) Being considered for surgical resection of solid mass / nodule/lesion with 
anticipated hospital length of stay of at least two  days, 
4) Completed the eRFA per routine care 
 
5.3 
Subject Exclusion Criteria 
 
1) Unable to read or comprehend English 
 
2) Not having a completed eRFA within the two months of undergoing surgery 
 
Note) To avoid excluding patients based on item 2, patients have to complete  another 
eRFA within two months of surgery. 
3) Being discharged in one day or earlier from thehospital. 
 
6.0 
RECRUITMENT PLAN 
 
The patients’ surgeons and nurse practitioners  who will have an  established medical 
relationship with potential participants will identify potentially eligible patients  for  the  proposed 
study in advance of their consultations. Patients of both genders and all ethnicity will  be 
considered for participation in the proposed study. Patient eligibility will be determined by the 
clinical  research staff.  A consenting professional will comprehensively go through the details 
of the study with patients and provide patients with time to ask questions  and have them 
answered fully. Patients  will be encouraged to take adequate time before making their 
decision regarding participation in the study. For those  that indicate a desire  to  participate in 
the study, they will be consented by a consenting professional  and the first study visit 
assessment will take place at that time. The surgery  team  will also  be  informed of the  data 
they will be required to collect and document from  their consultation with the patient. For 
patients  that require more time to make  their decision  regarding participation,  subjects  may 
be enrolled at any time prior to their surgery. They will be  informed that they will  be contacted 
by a member of the research team in the coming days to learn of their decision. 
 
During the initial conversation between the investigator/research staff  and  the patient,  the 
patient may be asked to provide certain  health information that is  necessary to the 
recruitment and enrollment  process. The  investigator/research staff  may also review  portions 
of their medical records at MSKCC to further assess eligibility. They will use the information 
provided by the patient and/or medical record to confirm that the patient is  eligible and to 
contact the patient regarding study enrollment. If the patient turns out to be ineligible for the 

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research study, the research staff will destroy all information collected on the patient during the 
initial conversation and medical records review, except for any information that must be maintained 
for screening log purposes or processes. 
 
For patients that are not interested in taking part in the proposed study, an expression of 
thanks will be offered for the opportunity to discuss potential study enrolment with them. 
Patients will be asked if they would be willing to provide their primary reason for declining 
participation. They will be informed that this answer will be anonymously recorded for the 
purpose of understanding factors that influence  patient  decisions regarding participation  in 
the study. If a patient declines to offer a reason this will be recorded  as “patient declined to 
offer a reason for non-participation in the study”. 
Payment to Participants Study participants will not receive any payment for their 
participation in the proposed study. 
 
 
7.1 
ASSESSMENT/EVALUATION  PLAN 
Assessment and Measurement Instruments: 
In this study, the data will be collected using the following instruments and measurements 
methods: 
- 
Electronic  Medical  Record review: 
1- For patients in the intervention group (automated geriatric  co-management),  we 
will assess the percentage of recommendations that were followed by the surgery 
team. For example, if  automated  geriatric  co-management  recommends 
consultation with physical therapy perioperatively,  we will  assess whether  the 
consult has been obtained. 
2- For patients in both groups, we will assess the adverse surgical events by day 30 
following surgery. Adverse surgical event is a composite of  surgical  complications 
grade 2 or higher, mortality after surgery, or discharge to any place  other than 
home, or prolonged length of stay (defined as length of stay longer than 75% of the 
cohort who underwent the same surgical procedure), or readmission to the hospital 
within 30 days from surgery. 
MSKCC’s secondary surgical events database in the EMR has been shown to 
accurately record major postoperative complications within the 30 days after 
surgery[34]. 
3- to assess sociodemographic characteristics (age, gender, ethnicity), 
4- to assess routine preoperative blood work (complete blood cell counts, chemistry 
panel). 
5- To assess cancer characteristics (stage, receipt and type of neoadjuvant 
treatment) 

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6- To assess surgical characteristics (type of surgery: minimally invasive vs open, 
duration of surgery, intraoperative blood loss, and American Society of 
Anesthesiologist Physical Status classification) 
- 
Four Meter Walk Test: In order to assess functional recovery, the 4-meter walk test will be 
performed. In the 4-meter walk test, the time that it takes patients to walk 4 meters in their 
usual pace will be recorded in seconds by the clinical research staff. (This portion will be 
skipped for patients being seen via telemedicine.) 
Assessment and Evaluation Plan 
 
Patients  will be  screened for study eligibility at the time of attending their  surgery appointment 
at MSKCC for consideration of surgery. The inclusion and exclusion criteria will  be  reviewed 
by the clinical research staff firstly to confirm the patients’ eligibility status.  Once eligibility has 
been determined and informed consent has been obtained, patients will undergo baseline 
assessments and subsequently randomization will occur. 
There will be two study visits for patients  in both groups; baseline or pre-op visit (1st) and the 
2nd visit. Baseline visit occurs at the time of new visit by the surgery  team, or in the  case that 
two months has passed since baseline, at the pre-op  visit.  2nd  visit occurs at the time of follow 
up after hospital discharge by the surgeons. Both baseline and 2nd visit may be conducted via 
telemedicine if preferred. 
Baseline Study Visit/Pre-op Visit: In this visit, following assessments will be performed. 
 
- 
The 4-Meter Walktest. 
- 
Sociodemographic   characteristics. 
- 
eRFA  completion per  routine care 
 
2nd Study visit: In this visit, following assessment will be performed. 
 
- 
The 4-Meter Walktest. 
- 
eRFA completion per routine care 
 
Study participant follow up: 
Thirty days after surgery: 
- 
Collection of adverse surgical events (grade 2 or more complications, length of stay, 
readmission, disposition plan), surgery and cancer characteristics, and preoperative blood 
work results. 
 
Screening & 
Baseline study 
visit 
Pre-operative visit 
2nd study 
visit (within 
2 weeks of 
surgery) 
30 Day post- 
surgery 
follow up 

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Informed consent 
✓ 

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8.0 
TOXICITIES/SIDE  EFFECTS 
 
There are minimal adverse events  or risks associated with participation in this  study. Staff will 
be adequately trained to identify any signs of distress that may be  experienced   by a patient 
during the course of their participation in the study. 
Burden of Assessment 
 
It is possible that patients may not be able to or willing to do  4-Meter walk test. This 
test will only be performed if patients are comfortable with them. Study participants 
will be given contact details of the clinical research staff dedicated to this study in case 
they have any questions or concerns regarding study. 
Patient Identification of Unmet Clinical Needs 
Eligibility 
determination 
Randomization 
(if 
proceeding 
with 
surgery in 
2 months) 
(if two months 
have passed 
by from 
baseline visit) 
eRFA completion, 
per SOC 
(if two months 
have passed 
since 
baseline visit) 
Automated geriatric 
co-management 
program 
In-person geriatric 
co-management 
program 
4 MWT 
(if two months 
have passed 
by from 
baseline visit) 
Sociodemographic 
data 
Preoperative lab 
results 
Cancer 
characteristics 
Surgical 
characteristics 
Adverse events 

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If thoracic surgeons and/or other healthcare providers are concerned about the  unmet 
needs of patients before or after surgery, they are encouraged  to obtain proper 
medical and non-medical consultations. 
9.0 
PRIMARY OUTCOMES 
 
 
 
 
 
10.1 
CRITERIAFOR REMOVAL FROM  STUDY 
Baseline study 
visit 
Preoperative 
visit (if two 
months 
have passed 
by from 
baseline 
study visit) 
30-day post- 
surgery follow up 
eRFA (including 
Karnosky Performance 
Status, basic Activities of 
Daily Living, instrumental 
Activities of Daily Living, 
Timed-up-and-Go test) 
4 MWT 
Sociodemographic 
characteristics 
Preoperative lab results 
Cancer characteristics 
Surgical characteristics 
Adverse events 
Hospital Length of Stay 
Discharge/Disposition 
location 
30-day readmission to 
hospital 
Number of geriatric 
recommendations 
followed 

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Patients will have completed their participation in this study after the 30-day post-surgery 
follow-up or the 2nd study visit, whichever occurs later, and will be considered off-study. 
Participants will be removed from the study if: 
✓ He/she chooses to withdraw consent for continued participation at any time 
✓ The participant reports intolerable distress due to study participation 
✓ He/she becomes ineligible for study participation as designated by the 
inclusion/exclusion  criteria 
 
 
11.0 
BIOSTATISTICS 
 
This is a prospective, randomized trial of automated geriatric co-management in patients 
presenting to the surgery clinic for surgery compared with standard in-person geriatric co- 
management. Patients will be randomized 1:1 to either arm according to section 12.2. 
Primary Aims 
 
Feasibility of the automated geriatric co-management program in the care of geriatric 
oncology patients. 
Among patients  randomized to the automated geriatric arm of the study  we will 
calculate the proportion of patients  for whom  at least half of the  recommendations 
made were followed by the surgical team. Our program will be deemed feasible if at 
least 50% of recommendations are followed in at least 70% of patients with 
impairments. We based our cutoff based on multiple studies. A study done on surgeons’ 
attitude toward assessment and management of older cancer patients, Ghignone et al[1], 
showed that only 6.4% of surgeons use geriatric  assessment in their  daily practice and 
only 36% collaborate  with geriatricians  in some form. Studies  on geriatric comanagement 
of older adults who are receiving chemotherapy also showed that the pickup rate of 
interventions by the medical oncologists is around 35%[2]. Given these findings, we 
hypothesized that a more than 50% adoption of recommendations would be a reasonable 
rate for then refining the intervention and conducting an R01 study in the future. 
We will first report the number of patients that were randomized to the automated geriatric 
comanagement arm but were subsequently referred to the geriatric in-person 
comanagement arm and report the distribution of recommendations made for these 
crossover patients. We will analyze 77 patients with at least one eRFA impairment who 
adhere to the automated geriatric comanagement arm and are not seen by geriatrics 
service for preoperative evaluation (crossover). In all  analyses  for  the primary aim, we 
will exclude those who do not have any  baseline impairment or have crossed over to 
the in-person geriatric comanagement arm. An interim  analysis  will be conducted after 
38 patients are accrued. If 50% of recommendations were followed for  21 or  fewer 
patients, the trial will be stopped for futility. Otherwise, accrual of 77  eligible patients 
will be completed, after which accrual will be closed to additional patients. The 

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intervention will be deemed feasible if recommendations are followed for 50 patients. 
Finally, we will present the distribution of number of recommendations  made  and 
followed in the automated geriatric comanagement arm. 
 
Secondary  Aims 
 
Effect of the automated geriatric co-management program compared to the in-person 
geriatric co-management on adverse surgical events. 
All between-group comparisons will be by modified intent-to-treat  (complete case 
analysis), with patients analyzed  according to randomization,  irrespective  of  whether 
they were proceeded to automated geriatric co-management or in-person geriatric co- 
management. To compare, by intervention arm, the proportion of  patients  with a 
composite outcome (“adverse surgical event”) of  either  surgical complications  grade 2 
or higher, or prolonged hospital length of stay, or discharge  to another care  facility 
rather than home, or 30-day readmission to the hospital. Prolonged   hospital length of 
stay will be defined as hospital length of stay greater than 75% of the  cohort who 
underwent the similar  procedure. We will  test the  association between intervention 
arm and adverse surgical event  using  logistic regression with the randomization stratum 
as the covariate. 
It is plausible that the relative value of in-person vs. automated geriatric co- 
management depends on baseline risk, for instance, it could be  that average risk 
patients are adequately managed by the automated approach, but those  at  high  risk 
require individualized care. To this end, we will use a logistic regression with adverse 
surgical event as the outcome, study arm as the predictor, randomization strata as the 
covariate, and adjust for  continuous  baseline  risk  using the MSK-FI, with restricted 
cubic splines with knots at the tertiles  to allow for non-linearity. We will  then visualize 
the risk in both  intervention arms across baseline risk to provide an individualized 
estimate of benefit for a given level of baseline deficit. The MSK-FI is a frailty index 
defined by ten sets of comorbidities, and one component related to dependency on five 
activities of daily living. The former will be queried from  the  institutional   database, and 
the latter is assessed using the bADL and iADL measures on the eRFA.[35] 
Effect of the automated geriatric co-management program with in-person geriatric co- 
management on postoperative functional recovery. 
To compare, by intervention arm, postoperative functional recovery. We will consider 
postoperative functional recovery as reported by the patient, as well as assessed by the 
study team during the 2nd study visit. Patient-reported recovery will be measured by 
three domains reported on both pre and post-operatively: Karnofsky Performance Status, 
basic activities of daily living, and instrumental activities of daily living. 
Clinician-evaluated functional recovery will be assessed through the Timed Up and Go 

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test and the 4MWT. This analysis will only be done for patients who have completed the 
assessment during in-person visit with the surgery team. Recovery of Karnofsky 
Performance status, defined as the same or better Karnofsky Performance status during 
the 2nd study visit compared to baseline, will be compared between groups using a 
logistic regression with randomization strata as covariates. Basic activities of daily living, 
instrumental activities of daily living,  Timed up and Go test and 4MWT will be compared 
between groups by ANCOVA,  with baseline score and randomization strata as a 
covariate. 
In the case that patient’s  surgery occurs after two months of completing the  eRFA, either 
the patient has to complete another eRFA within two months of surgery, which then will be 
the patient’s new preoperative baseline eRFA, or in case of not completing the eRFA, the 
patient will be excluded from thestudy. 
We are additionally interested in using the three components, of the patient-reported 
functional recovery in three categories: complete recovery (defined as all three post- 
operative measurement score being greater than or equal to the pre-operative 
measurement score), partial recovery (defined as at least one, but not all three, post- 
operative measurement scores being greater than or equal to the pre-operative 
measurement score), or no recovery (defined as  none of  the post-operative 
measurement scores being greater than or equal to the pre-operative  measurement 
score). Similarly we will use two components of the clinician-evaluate  functional  recovery 
to define three categories: complete recovery (defined as all both post-operative 
measurement score being greater than or equal to within 10% of the pre-operative 
measurement score), partial recovery (defined as at least one, but  not  both,  post- 
operative measurement scores being greater than or equal to within 10% of the pre- 
operative measurement score), or no recovery (defined  as  neither of the post- 
operative measurement scores being greater than or equal to within 10% of the pre- 
operative measurement score). We will test the association  between intervention   arm 
and degree of recovery by using  ordinal  regression with randomization strata as 
covariates. 
As it is likewise plausible that the relative value of in-person vs. automated geriatric co- 
management depends on baseline risk, we will repeat the analysis described above, 
related to baseline risk, for the outcomes of patient-reported functional recovery and 
clinician-assessed functional recovery. 
Sample size 
With a null hypothesis of 55% and the alternative hypothesis  of 70% of patients with 
recommendations followed, and a one-sided α of 5%  and a power  of 85%, we require 
77 eligible patients to be accrued in  the in  the automated geriatric co-management 
arm for a two-stage Simon minimax design. We expect about 25% of patients to be 
excluded for the primary aim due to no impairment (5%) or crossover to the in-person 

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geriatric comanagement arm (20%) suggesting a total accrual close to 100 per group. 

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Assuming a correlation of 0.5 between baseline and follow-up, and a standard deviation of 
1.8 (as seen in our preliminary dataset for the basic activities of daily living, the score of 
which ranges from 0 to 14), with ~95 patients per arm (after an estimated 5% loss of 
patients due to drop out), the power for various effect sizes for our continuous secondary 
endpoints when analyzed using ANCOVA are shown in the  table,  where it can be seen 
that we have high power to detect small differences between groups. Sensitivity analyses 
will be conducted where missing outcome data will be imputed by Multiple  Imputation 
using Chained Equations. 
 
Difference between groups 
Power 
0.5 
60% 
0.67 
84% 
0.8 
94% 
 
 
In 2017, the surgical services had completed surgical procedures on more than 5000 
patients aged 65 or older with  a hospital length of stay of 2 days  or longer. Therefore, 
we expect to enroll the 200 patients for our study in  less  than two-years.  We expect 
most patients to be older (75+) but to ensure that younger patients are not overly 
represented, we will cease accrual of patients 65 – 74 after 60 are accrued (i.e. 30%). 
12.1 
RESEARCH PARTICIPANT  REGISTRATION AND RANDOMIZATION 
PROCEDURES 
12.2 
Research Participant Registration 
 
Confirm eligibility as defined in the section entitled Inclusion/Exclusion Criteria. Obtain 
informed consent, by  following   procedures defined in section entitled Informed 
Consent Procedures. During the registration process registering individuals will  be 
required to complete a protocol specific Eligibility Checklist. The individual  signing the 
Eligibility Checklist is confirming whether or not the participant is eligible to enroll  in the 
study. Study staff are responsible for ensuring  that all institutional   requirements 
necessary to enroll a participant   to the study  have been completed.  See  related 
Clinical Research Policy and Procedure #401 (Protocol Participant Registration). 
12.3 
Randomization 
 
Randomization to either in-person geriatric co-management or automated geriatric co- 
managements will be accomplished by the method of randomly permuted  blocks  of 
random length. Patients will be stratified by planned procedure type (minimally- 
invasive surgery vs open surgery), age (65-74 vs. 75+) and baseline number of eRFA 
impairments (<4 vs. ≥4: anticipated median number of  eRFA  impairments) 
Randomization will be conducted by use of the Clinical Research Database (CRDB) at 
MSKCC. 

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13.1 
DATA MANAGEMENT  ISSUES 
 
MSKCC clinical research staff will be assigned to this  protocol. The responsibilities  of 
the clinical research staff include project adherence, data  collection,  abstraction  and 
entry, data reporting, regulatory monitoring,  problem resolution and prioritization,  and 
coordinating the activities  of the protocol study team.  Data gathered for this  study  will 
be obtained from  enrolled patients by thoracic surgery providers, clinical research 
staff, clinical research nurse specialists. The data collected  for this  study will be 
entered into REDCap database to  be accessed only by study  staff. All  data collected 
will be de-identified to maintain participants’  confidentiality.   Participants will be 
assigned unique identification numbers, which will be used to identify all the data. All 
participant related data will be identified only with a study code number. A list of  the 
names and assigned identification number will be kept in a password protected log on 
the MSKCC share drive accessible only to relevant research staff. 
 
Study findings will be presented in aggregate form only, with no reference  made  to 
individual participant’s data. The Principal Investigator and their research team will be 
responsible for identifying, reviewing and reporting all necessary adverse events to the 
institutional IRB as appropriate. The data will be used  specifically  for  the  purposes 
outlined in this proposal and not for any  other purpose. All study related  documents 
and will be stored in a secure location until the  study  has  ended and all data analyses 
are complete. At that time, all study  material will be  placed in a secured long-term 
storage facility until it is deemed appropriate to destroy the study material. 
 
 
13.2 
Quality Assurance 
 
Reports will be generated to monitor patient accruals and completeness of  registration 
data. Data quality reports  will be  generated to assess missing data and 
inconsistencies. Accrual rates and extent and accuracy of evaluations and follow-up 
will be monitored periodically   throughout the study period and potential problems will 
be brought to the attention of the study  team  for discussion and action. Random- 
sample data quality and protocol adherence audits will be conducted by the study 
team. Additionally, audits will be conducted by the Department of surgery  to review 
consent documents and procedures. Data  audits  will begin after the first ten 
participants are enrolled; study staff will  assess protocol adherence and review 
accuracy of data entry into all central tracking systems/databases. 
13.3 
Data and Safety Monitoring 

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The Data and Safety Monitoring (DSM) Plans  at  Memorial  Sloan-Kettering  Cancer 
Center were approved by the National Cancer Institute in September 2001. The plans 
address the new policies set forth by the NCI in the document entitled “Policy of the 
National Cancer Institute for Data and Safety  Monitoring of Clinical Trials” which can 
be  found at: http://www.cancer.gov/clinicaltrials/conducting/dsm-guidelines/page1. 
The DSM Plans at MSKCC were established and are monitored by the  Office of 
Clinical Research. The MSKCC Data and Safety Monitoring Plans can be found on the 
MSKCC Intranet at: 
https://one.mskcc.org/sites/pub/clinres  earch/Doc  uments/MSKCC%20Data%20and%2 
0Safety%20Monitoring%20Plans.pdf. 
There are several different  mechanisms  by 
which clinical trials are monitored for data, safety and quality. There are institutional 
processes in place for quality assurance (e.g. protocol monitoring, adherence and data 
verification audits, therapeutic response, and staff  education on clinical  research  QA) 
and departmental procedures for quality control,  plus there are two institutional 
committees that are responsible for monitoring the activities of our  clinical trials 
programs. The  committees: Data and Safety  Monitoring Committee DSMC)  for  Phase 
I and II clinical trials, and the Data and Safety Monitoring Board (DSMB) for  Phase  III  
clinical trials, report to the Center’s Research Council and Institutional Review Board. 
During the protocol development and review  process, each protocol will be assessed 
for its level of risk and degree of monitoring required. Every type of protocol (e.g., NIH 
sponsored, in-house sponsored, industrial sponsored, NCI cooperative   group,  etc.)  will 
be addressed and the monitoring procedures will be established at the time of protocol 
activation. 
14.1 
PROTECTION OF HUMAN SUBJECTS 
 
Participants will be informed that participation is voluntary and that they have the  right to 
withdraw from the study at any  point. Given the nature of this study, the  ratio of risk to benefit 
is quite low and reasonable. Confidentiality of each subject’s self-reported  information  and 
medical information will be protected with the utmost care.  Each  study  participant   will be 
given a unique numeric identifier upon study entry. Electronic patient data and any hard copy 
data sheets collected from each subject will be identified solely by a code number. A  list 
matching subject names and code numbers  will be  maintained separately and kept in a 
secure area. IRB and HIPAA  regulations concerning confidentiality will be strictly enforced. 
Through the use of password security measures, restrictions will be applied to each user 
commensurate with their needs  to  access  the data. Confidential information will not be 
routinely available to all members  of the research  team  but rather on a “need to know‟ basis. 
All current and new  personnel will be instructed  in the  ethics of electronic  data access, as well 
as receive training in both HIPAA issues and human subjects training. 
 
 
14.2 
Privacy 

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MSK’s Privacy Office may allow the use and disclosure of protected health information 
pursuant to a completed and signed Research Authorization   form. The use and 
disclosure of protected health information will be limited to the  individuals described in 
the  Research Authorization form. A Research Authorization form must be completed 
by the Principal Investigator and approved by the IRB and Privacy Board (IRB/PB). 
The consent indicates that individualized de identified information collected for the 
purposes of this study may be shared with other qualified researchers. Only 
researchers who have received approval from MSK will be allowed to access this 
information which will not include protected  health  information, such as the 
participant’s name, except for dates. It is also stated in the  Research Authorization 
that their research data may be shared with others at the time of study publication. 
 
 
14.3 
Serious Adverse Event (SAE) Reporting 
 
Due to the nature of this study, we do not anticipate any SAEs. 
 
An adverse event is considered serious if it results in ANY of the following outcomes: 
• 
Death 
• 
A life-threatening adverse event 
• 
An adverse event that results in inpatient hospitalization or prolongation of existing 
hospitalization 
• 
A persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions 
• 
A congenital anomaly/birth defect 
• 
Important Medical Events (IME) that may not result in death, be life threatening, or 
require hospitalization may be considered serious when, based upon medical 
judgment, they may jeopardize the patient or subject and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition 
Note: Hospital admission for a planned  procedure/disease treatment  is  not considered 
an SAE. 
 
SAE reporting is required as soon as the participant signs consent. SAE reporting is 
required for 30-days after  the participant’s  last investigational treatment or 
intervention. Any events that occur after the 30-day period and  that are at least 
possibly related to protocol treatment must be reported. 
 
If an SAE requires submission to the IRB office per IRB SOP RR-408 ‘Reporting of 
Serious Adverse Events’, the SAE report must be sent to the IRB  within 5 calendar 
days of the event. The IRB requires an electronic  SAE  report be submitted 
electronically to the SAE Office through PIMS. 

Memorial Sloan Kettering Cancer Center 
IRB Number: 19-066 A(3) 
Approval date: 10-Dec-2020 
MEMORIAL SLOAN KETTERING CANCER CENTER 
IRB PROTOCOL 
Page 33 of 35 
 
 
 
 
 
 
The report should contain the following information: 
Fields populated from PIMS: 
• 
Protocol number and title 
• 
Protocol status 
• 
Sponsoring  department 
• 
Principal investigator 
• 
Protocol type and category 
• 
MSK  IND 
Fields  populated  from CTMS: 
• 
Medical record number 
• 
Disease/histology (if applicable) 
• 
Date of birth and gender 
Data needing to be entered: 
• 
External reporting required 
• 
Treating physician 
• 
The date the adverse event occurred 
• 
The adverse event 
• 
The grade of the event 
• 
Relationship of the adverse event to the treatment (drug, device, or intervention) 
• 
If the AE was expected 
• 
The severity of the AE 
• 
The intervention 
• 
Detailed text that includes the following 
o An explanation of how the AE was handled 
o A description of the subject’s condition 
o Indication if the subject remains on the study 
• 
If an amendment will need to be made to the protocol and/or consent form 
• 
If the SAE is an Unanticipated Problem 
 
The PI’s signature and the date it was signed are required on the completed report. 
 
15.0 
INFORMED CONSENT PROCEDURES 

Memorial Sloan Kettering Cancer Center 
IRB Number: 19-066 A(3) 
Approval date: 10-Dec-2020 
MEMORIAL SLOAN KETTERING CANCER CENTER 
IRB PROTOCOL 
Page 34 of 35 
 
 
 
 
 
 
Before protocol-specified procedures are carried out, consenting professionals will explain full 
details of the protocol and study  procedures  as well as  the risks  involved to participants  prior 
to their inclusion in the study. Participants will also be informed  that they are free  to withdraw 
from the study at any time. All participants must sign an IRB/PB-approved  consent  form 
indicating their consent to participate.   This consent form  meets  the requirements of the Code 
of Federal Regulations and the Institutional Review Board/Privacy Board of this  Center. The 
consent form will include the following: 
 
1. The nature and objectives, potential risks and benefits of the intendedstudy. 
2. The length of study and the likely follow-up required. 
3. Alternatives  to the proposed study. (This will include available standard and 
investigational therapies. In addition, patients will be offered an  option of  supportive 
care for therapeutic studies.) 
4. The name of the investigator(s) responsible for the protocol. 
5. The right of the  participant to accept or refuse  study interventions/interactions   and 
to withdraw from participation at any time. 
 
Before any protocol-specific procedures can be carried out,  the consenting  professional will 
fully explain the aspects of patient  privacy concerning research specific  information.  In 
addition to signing the IRB Informed Consent, all patients must agree to the Research 
Authorization component of the informed consent form. Each participant  and consenting 
professional will sign the consent form. The participant must receive a copy of the signed 
informed consent form. 
16.0 
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Approval date: 10-Dec-2020 
MEMORIAL SLOAN KETTERING CANCER CENTER 
IRB PROTOCOL 
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Approval date: 10-Dec-2020 
MEMORIAL SLOAN KETTERING CANCER CENTER 
IRB PROTOCOL 
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17.0 
APPENDICES 
 
Appendix 1: Recommendations for the impairments in the eRFA