Ambulatory Cancer Care Electronic Symptom Self-Reporting for Surgical Patients
Conditions: Patient Reported Outcomes
Sponsor: Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Cancer Center 
IRB Number: 17-293 A(7) 
Approval date: 04-Dec-2019 
Page 1 of 34 
 
 
 
 
Ambulatory  Cancer Care Electronic Symptom Self-Reporting  for Surgical 
Patients 
 
PROTOCOL FACE PAGE FOR 
MSK NON THERAPEUTIC PROTOCOL 
 
Principal Investigator/Department: 
Brett Simon, MD 
Surgery 
Co-Principal  Investigator(s)/Department: 
Andrea Pusic, MD, MHS 
Jeanne Carter, PhD 
Surgery/Plastic & Reconstructive 
Surgery/ Gynecology 
Investigator(s)/Department: 
Andrew Vickers, PhD 
Daniel Stein, MD, PhD 
Oliver Zivanovic,  MD 
Peter Stetson, MD, MA 
Vincent Laudone, MD 
Nicole Connor, RN 
Roberta Baron, RN 
Epidemiology & Biostatistics 
Health Informatics 
Surgery/Gynecology 
Office of Physician-in-Chief 
Surgery/Urology 
Nursing 
Nursing 
Consenting  Professional(s)/Department: 
Andrew Vickers, PhD 
Brett Simon, MD, PhD 
Daniel Stein, MD, PhD 
Jeanne Carter, PhD 
Oliver Zivanovic,  MD 
Peter Stetson, MD, MA 
Vincent Laudone, MD 
Nicole Connor, RN 
Roberta Baron, RN 
Cara Stabile, MPH 
Taylor McCready, BA 
Elizabeth Encarnacion, BA 
Michele Cavalli, BA 
Christina Ashby, BA 
Epidemiology & Biostatistics 
Surgery 
Health Informatics 
Surgery/ Gynecology 
Surgery/ Gynecology 
Office of Physician-in-Chief 
Surgery/Urology 
Nursing 
Nursing 
Surgery/Plastic & Reconstructive 
Surgery/Plastic & Reconstructive 
Surgery/Plastic & Reconstructive 
Surgery/Plastic & Reconstructive 
Surgery/Plastic & Reconstructive 
 
 
 
 
Participating Institutions  – If 
multicenter study  coordinated by MSK: 
PI's Name 
Site's Role 
Brigham and Women’s Hospital 
Andrea Pusic, MD, MHS 
Consulting 
University of Rochester 
Larissa Temple, MD 
Consulting 
Weill Cornell Medical College 
Jessica Ancker, PhD 
Consulting 
Private Consultant 
Amylou Dueck, PhD 
Consulting 
Private Consultant 
Ethan Basch, MD, PhD 
Consulting 
Private Consultant 
Debra Paget 
Consulting 

Memorial Sloan Kettering Cancer Center 
IRB Number: 17-293 A(7) 
Approval date: 04-Dec-2019 
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Private Consultant 
Jaime Blanda 
Consulting 
Private Consultant 
Paul Carter 
Consulting 
Private Consultant 
Thomas Chiusano 
Consulting 
Private Consultant 
James Guttridge 
Consulting 
Private Consultant 
Amy Malale 
Consulting 
Private Consultant 
Magen Miranda 
Consulting 
Private Consultant 
Christine Nippes, PA-C 
Consulting 
Please Note: A Consenting Professional must have completed the mandatory Human 
Subjects Education and Certification Program. 
 
 
 
Memorial Sloan Kettering Cancer Center 
1275 York Avenue 
New York, New York 10065 

Memorial Sloan Kettering Cancer Center 
IRB Number: 17-293 A(7) 
Approval date: 04-Dec-2019 
Page 3 of 34 
 
 
 
 
 
Table of Contents 
1.0 
PROTOCOL SUMMARY AND/OR SCHEMA ....................................................................... 4 
2.0 
OBJECTIVES AND SCIENTIFIC AIMS ................................................................................ 5 
3.0 
BACKGROUND AND RATIONALE ..................................................................................... 6 
4.0 
OVERVIEW OF STUDY DESIGN/INTERVENTION ................................................................... 9 
4.1 
Design...................................................................................................................................9 
4.2 
Intervention .............................................................................................................................. 11 
5.0 
CRITERIA FOR SUBJECT ELIGIBILITY ............................................................................... 16 
5.1 
Subject Inclusion Criteria ..................................................................................................... 16 
5.2 
Subject Exclusion Criteria ................................................................................................... 16 
6.0 
RECRUITMENT PLAN .................................................................................................................... 16 
7.0 
ASSESSMENT/EVALUATION PLAN ................................................................................. 17 
8.0 
TOXICITIES/SIDE EFFECTS .................................................................................................... 18 
9.0 
PRIMARY OUTCOMES ..................................................................................................... 18 
10.0 
CRITERIA FOR REMOVAL FROM STUDY ....................................................................... 19 
11.0 
BIOSTATISTICS ............................................................................................................... 19 
12.0 
RESEARCH PARTICIPANT REGISTRATION AND RANDOMIZATION PROCEDURES 
22 
12.1 
Research Participant Registration ....................................................................................... 22 
Confirm eligibility as defined in the section entitled Criteria for Patient/Subject Eligibility .............. 23 
12.2 
Randomization .................................................................................................................... 23 
13.0 
DAT A M ANAGEMENT ISSUES ........................................................................................ 24 
13.1 
Quality Assurance............................................................................................................... 27 
13.2 
Data and Safety Monitoring .................................................................................................... 27 
14.0 
PROTECTION OF HUMAN SUBJECTS ............................................................................ 27 
14.1 
Privacy ................................................................................................................................ 28 
14.2 
Serious Adverse Event (SAE) Reporting ................................................................................ 29 
14.2.1 .........................................................................................Error! Bookmark  not defined. 
15.0 
INFORMED CONSENT PROCEDURES................................................................................... 30 
16.0 
REFERENCES ....................................................................................................................... 32 
17.0 
APPENDICES ................................................................................................................... 34 

Memorial Sloan Kettering Cancer Center 
IRB Number: 17-293 A(7) 
Approval date: 04-Dec-2019 
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1.0 
PROTOCOL SUMMARY AND/OR SCHEMA 
 
Patients undergoing ambulatory cancer surgery at Josie Robertson Surgery Center (JRSC) 
at MSKCC will be eligible to participate in a randomized controlled trial comparing two 
different methods of symptom monitoring while recovering from ambulatory surgery. The 
study will evaluate the differences in patient-centered outcomes and experiences between 
Team Monitoring (symptom monitoring by the clinical team, with nursing outreach if 
symptoms exceed normal limits) and Enhanced Feedback (real-time feedback to patients 
about expected symptom severity, with nursing outreach if indicated) in response to the 
patients’ daily  symptom reporting. 
A total of 2,750 adult patients and 1,375 caregivers will be recruited for this study at the 
JRSC. All potential participants will be informed of their rights as a volunteer in a research 
study. Patient disease types will include breast, urologic, gynecologic, and head and neck 
cancers, as well as benign diseases. Randomization will take place through the Clinical 
Research Database (CRDB). Patients will complete a symptom assessment (Recovery 
Tracker) for the first 10 days after surgery. Over the following 20 days, patients can tailor 
the survey to their needs by choosing when they complete the survey. Between days 11- 
30, patients can report symptoms on any day. By leaving the survey open after day 10, 
patients who develop new or worsening symptoms will have the ability to report these 
symptoms electronically whenever they wish. Conversely, patients not experiencing any 
symptoms will not be burdened by additional surveys. Outcomes will be measured for up to 
60 days and will include patient anxiety, patient engagement, caregiver burden, urgent care 
visits, detection of adverse events, and nursing interventions. 
The proposed study will not evaluate any investigational agents or methods that are not 
considered standard of care for this patient population. Therefore, there are minimal risks 
to the patient population. In both groups, if a patient reports severe symptoms, they are 
instructed to immediately contact their physician’s office or seek medical attention, as is 
the current standard of care. Alternatives to participation in this study include the standard 
of care, which includes completing the Recovery Tracker (the Team Monitoring arm of 
the study), or not completing any surveys at all. 

Memorial Sloan Kettering Cancer Center 
IRB Number: 17-293 A(7) 
Approval date: 04-Dec-2019 
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2.0 
OBJECTIVES AND SCIENTIFIC AIMS 
 
We will perform a prospective,  two-armed, randomized controlled trial of postoperative 
daily  symptom  reporting  among  patients  undergoing  ambulatory  cancer surgery,  to 
determine which of two approaches to management of patient-reported  symptom data 
is most effective  from a patient and caregiver  perspective: (1) symptom monitoring  by 
the  clinical  team,  with  nursing  outreach  if  symptoms  exceed  normal  limits  (Team 
Monitoring), or (2) feedback to patients about expected symptom severity, with patient- 
activated  care as needed (Enhanced Feedback). For symptom self-reporting,  we will 
use a 20-question survey that includes  11  items  from  a validated instrument,  the 
Patient Reported Outcomes Common Terminology Criteria for  Advers e  Events 
(PRO-CTCAE1), three additional surgical symptom questions, and two questions about 
seeking urgent care or a doctor. The information  provided  to patients  in the Enhanced 
Feedback group will be procedure-specific  and based on continuously  updated PRO- 
CTCAE  data  from  previous   patients  who  have  completed  PRO-CTCAE  data.  We 
hypothesize  that Enhanced  Feedback about expected symptom  severity will  be 
more  effective than  Team Monitoring  in improving  patient-centered  outcomes 
(SA1)  and the patient/caregiver experience (SA2). 
 
Specific Aim  1 (SA1): To compare the effectiveness  of Team Monitoring and 
Enhanced Feedback with regard to patient-centered  outcomes, including: 
SA1a – urgent care, emergency department visits, and readmissions up to 30 days 
SA1b – symptom-triggered  interventions. 
Patient registered on 
MyMSK pre-op 
Sample of patients and 
caregivers participate in 
Focus Groups & Qualitative 
interviews post-study 
CRC approaches 
pre-op OR day of 
surgery 
Yes 
Consent 
No 

Memorial Sloan Kettering Cancer Center 
IRB Number: 17-293 A(7) 
Approval date: 04-Dec-2019 
Page 6 of 34 
 
 
 
 
Specific Aim  2 (SA2): To compare the impact of Team Monitoring  and Enhanced 
Feedback on the health care experience of patients  and their caregivers, including: 
SA2a – patient  engagement 
SA2b – patient anxiety 
SA2c – caregiver  burden 
 
 
3.0 
BACKGROUND AND RATIONALE 
 
More than 1.5 million people were diagnosed with cancer in the US in 20152; most 
underwent surgery as a component of their treatment. With health care cost constraints and 
recent technical innovations, increasing numbers of these surgeries are performed as 
ambulatory procedures.3 This new model of short-stay surgery adds new complexities to 
the delivery of high-quality, patient-centered care. Although there are many advantages to 
shorter hospital stays, there is also an increased burden on patients and their caregivers. 
Postoperative symptoms, such as pain and nausea, are common4 and represent a major 
source of morbidity5 and distress for patients. After discharge, patients may have difficulty 
distinguishing normal and expected symptoms from potentially dangerous ones.6 This may 
lead to unnecessary worry and health care use for normal symptoms, or worse, to 
unnecessary suffering and serious adverse events, when worrisome symptoms are 
unrecognized and neglected. 
There is abundant evidence that patient self-reporting of symptoms improves quality of 
care,7-9 and thus patients are increasingly being asked to provide this information10 as a 
component of routine clinical care. A key knowledge gap in patient-centered care, however, 
is that we don’t know the most effective way to monitor and manage suchdata.11 To address 
this gap, we will conduct a randomized clinical trial among a diverse patient population, 
using an established informatics platform and well-validated symptom assessment 
questions developed by the National Cancer Institute PRO-CTCAE. We will compare two 
approaches, each of which has demonstrated effectiveness: (1) Team Monitoring— 
symptom monitoring by the clinical team, with nursing outreach if symptoms exceed normal 
limits, and (2) Enhanced Feedback—real-time feedback to patients about expected 
symptom severity, with patient-activated care as needed. The information provided to 
patients in the Enhanced Feedback group will be procedure specific and based on 
continuously updated PRO-CTCAE data from previous patients. We hypothesize that 
Enhanced Feedback about expected symptom severity will be more effective than Team 
Monitoring because patients will feel greater self-efficacy and engagement in their care. We 
will evaluate the following outcomes: Aim 1— urgent care and emergency department visits 
and symptom-triggered interventions; Aim 2—patient engagement, patient anxiety, and 
caregiver burden (Aim 2), as measured by validated patient-reported outcomes (PROs) 
measures and qualitative interviews. 
Impact on the health of individuals and populations 
 
Ambulatory surgery is increasingly common, and it places new burdens on patients and 
caregivers. Enabled by technical innovations in surgery and anesthesiology, and driven by 
pressures to reduce costs, ambulatory procedures account for increasing proportion of 
surgeries.3 In the US in 2015, patients underwent approximately 50 million short-stay (23- 

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IRB Number: 17-293 A(7) 
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hour) or ambulatory surgery procedures.12 Although this approach may help to contain 
health care costs, it places new burdens on patients and caregivers. Patients no longer have 
the physical and psychological support of 24-hour care by nurses and allied professionals, 
nor do they receive daily visits by their surgeon. Instead, they are expected to manage the 
recovery process largely at home, with access to their clinical team only when they perceive 
that a complication may be occurring. In addition, their caregivers are asked to provide 
support without the benefit of knowledge or clear expectations about what symptoms are 
normal during postoperative recovery. Focus group and survey data from our institution 
suggest that caregivers experience tremendous burden, which significantly affects the 
primary caregiver’s health, psychological well-being, and schedule. 
Cancer patients undergoing surgery are especially vulnerable to this new model of care. 
The lifetime risk of developing cancer is approximately 40%,11 and most patients undergo 
surgery as part of their treatment.13 Major 
procedures, such 
as mastectomies, 
prostatectomies, and hysterectomies, are now being performed as ambulatory procedures, 
and patients often leave the surgical center while still experiencing symptoms.5 Patients 
undergoing cancer surgery are particularly at risk in this new model of care, as they are 
often preoperatively compromised both physically and psychologically by their diagnoses 
and neoadjuvant treatments.14,15 From a psychological perspective, these patients and their 
caregivers are often still struggling to adjust to a new cancer diagnosis at the time of surgery; 
they may thus feel heightened anxiety, which may overwhelm coping skills. 
Potential benefits and relevance for patients 
 
Patients experience postoperative symptoms at home but may not be able to distinguish 
expected from worrisome symptoms. Following ambulatory cancer surgery, symptoms are 
very common and are a source of considerable patient distress. Patients are expected to 
self-interpret symptoms and distinguish expected postoperative symptoms from those of 
concern—which is especially difficult when patients and caregivers have no way to know 
what is normal and expected. There is strong evidence that physicians may underestimate 
patient symptoms, and patients are often reluctant to report them.6,16-19 This may lead to 
unnecessary suffering and serious adverse events when worrisome symptoms are 
unrecognized and neglected. Symptom self-reporting can improve safety by identifying 
problems that might have otherwise been unrecognized and can facilitate more efficient 
care before complications progress. Symptom self-reporting with feedback about expected 
symptom severity may also decrease anxiety and inefficient health care use. 
Gaps in evidence and national interest 
 
Our study addresses a high-priority knowledge gap. We do not yet know what is the most 
effective method to monitor and manage patient symptom data after ambulatory cancer 
surgery. Monitoring of symptoms, with outreach by the clinical team when severity 
exceeds the expected range, may  identify problems at an earlier stage, to avoid or 
minimize adverse events, but it is resource intensive.11,20,21 Alternatively, providing patients 
with feedback about expected symptom severity and allowing them to activate care as 
needed may allow for the identification of adverse events before they progress, while 
also decreasing patient anxiety  and unplanned  care, such as unnecessary visits to the 

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IRB Number: 17-293 A(7) 
Approval date: 04-Dec-2019 
Page 8 of 34 
 
 
 
 
emergency department. In addition, patient focus groups have reported to us that 
feedback about expected symptoms increases patient engagement in their care and gives 
them a sense of empowerment. 
A systematic review of randomized controlled trials that evaluated  electronic reporting 
of symptoms confirmed that this is a major limitation in our knowledge. Although progress 
has been made to better understand how symptom data might be best incorporated 
into clinical care among nonsurgical ambulatory patients, little work has  been  done 
among patients having surgery. Notably, none of the 32 randomized controlled trials 
identified in this review evaluated symptom assessment in surgical patients. Furthermore, 
dual PIs Pusic and Temple organized an Agency for Healthcare Research and Quality– 
funded conference on PROs in surgery in January 2015. This meeting, cohosted by the 
American College of Surgeons, engaged a broad group of surgeons, patient advocates, 
quality of life researchers, and health informatics experts. At this meeting,  a  Delphi 
survey was conducted, which identified optimal evaluation and reporting of patient- 
reported symptoms for clinical care as a top research priority.22  Our study  thus provides 
a unique opportunity to address a critical evidence gap of utmost importance to patients 
and the surgical stakeholder  community. 
Our study addresses an evidence gap that is directly in line with the aims of the Institute 
of Medicine.23-25 By determining which of these two approaches to monitoring and 
managing surgical patients’ symptoms is the  most effective, we will promote care that 
is timely, equitable, efficient, and coordinated. We may also improve patient safety and 
outcomes. Through earlier detection of worrisome symptoms, we can prevent serious 
adverse events. By communicating normative data on symptom burden to patients, 
reassuring them when they are on track and encouraging them to seek appropriate 
resources if problems develop,  we can foster effective, patient-centered care. 
The potential of this study to be adopted into clinical practice and improve delivery 
of care 
Collection of PRO data in routine care is rapidly expanding, with data being collected 
in many different clinical scenarios and used in many different ways. We don’t, however, 
know how to optimally use this information to maximally improve patient care. We 
hypothesize here that unnecessary emergency department visits and serious adverse 
events can be reduced if patients are provided with feedback about expected symptom 
severity and that this will be more effective than standard PRO monitoring by the clinical 
team. If we are correct, Enhanced Feedback, with its resulting patient-activated care, 
could easily be adopted by other facilities and could benefit large numbers of patients 
undergoing cancer and noncancer surgery alike, in both large- and small-volume 
centers. A system that features feedback based on normative data would be less costly 
than clinical team monitoring and would require less infrastructure and personnel for 
monitoring and follow-up phone calls. These  savings—along  with  reduced 
complications, readmissions, and emergency department visits and improved outcomes 
and patient experience—would offset upfront costs 
for information technology 
infrastructure and implementation. We thus anticipate that our findings will be rapidly 
adopted  in  a  variety  of  ambulatory surgery  environments, including  smaller  centers 

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IRB Number: 17-293 A(7) 
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Page 9 of 34 
 
 
 
 
that do not have the personnel resources necessary to provide intensive monitoring of 
patient  symptoms. 
Although symptoms may differ by condition and treatment, the key lessons learned in 
our study will support the implementation of wider strategies for population health 
management for any treatment with burdensome side effects or symptoms. We expect 
that these tools will be highly relevant in designing coordinated care models that target 
improved health care value, such as the Oncology Care Model and the Perioperative 
Surgical Home. Thus, we believe that the knowledge gained here will be highly 
generalizable and will have a broad impact on surgical care overall. 
There is abundant and broad evidence that routine collection of PROs and symptoms 
improves quality of care.7-10 Such studies have confirmed that PRO data can improve 
communication with the clinical team, symptom control, quality of life, and patient 
satisfaction. As an example, study consultants Basch and Dueck reported on a large 
randomized trial that compared routine collection of PROs with usual care during 
chemotherapy.11 In this study, nurses received and responded to email alerts when 
symptoms exceeded expected values or were noted to be worsening. Among patients 
who received the PROs intervention, quality of life improved (34% v 18%), and these 
patients were less likely  to be seen in the emergency department (34% v 41%; P = 
0.02) or hospitalized (45% v 49%; P = 0.08). This study and others provide a substantial 
foundation for the design of our study and the selection of our outcome measures. 
PROs measurement is rapidly becoming a standard of care, and our study represents 
an essential step to ensuring that patient-reported data  is  optimally  integrated  into 
health care systems to provide the greatest benefit to surgical patients  and caregivers. 
Our team has tremendous experience collecting and monitoring PROs data in routine 
clinical care. Using an informatics platform developed by our study team (Vickers, 
Stetson, Stein, Basch, Pusic, and Temple), patients complete validated PRO measures 
at regular postoperative intervals at MSKCC, and this information is used during clinical 
visits to improve patient-centered care. In the MSKCC Department of Surgery, more 
than 50,000 patients have completed such PRO assessments in routine clinical care. 
For example, on the MSKCC Breast Surgery Service, 8000 patients have participated, 
completing more than 22,000 BREAST-Q surveys (a PRO measure developed by study 
dual PI Pusic). Nurses use this information to monitor postoperative pain and physical 
function and to provide referrals for physical therapy and pain management as needed. 
On the Urology Service, more than 6,000 patients have participated, using validated 
urology-specific  PRO  instruments. 
 
 
4.1 
OVERVIEW OF STUDY DESIGN/INTERVENTION 
 
4.2 
Design 
 
Our study model is predicated on the hypothesis that daily symptom assessment with 
normative data (Enhanced Feedback) will increase patients’ self-efficacy26 and their 
confidence  that  they  can  manage  their  symptoms  in  the  recovery  period.27    Without 

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Page 10 of 34 
 
 
 
 
information and risk awareness, patients may delay seeking care, with severe 
consequences, and/or they may experience unnecessary anxiety and fail to cope with their 
health conditions.28 The normative data provided by the symptom monitoring modules in the 
patient portal will empower our patients, resulting in increased self-efficacy, and will help the 
patients to form realistic expectations, which has been shown to be a predictor of decreased 
symptoms and better physical function.27,29 On the basis of this model, we predict that 
patients may avoid unnecessary emergency department visits by better understanding 
expected symptoms and by achieving more efficient and effective communication with their 
health care team. The aims our study and the outcomes measures selected reflect this 
model. 
 
 
 
Methodological approach 
The study is a parallel group trial, with 1:1 procedure-stratified randomization between the 
Team Monitoring and Enhanced Feedback arms. The two groups will differ by how their 
self-reported symptom information is handled: Enhanced Feedback (system displays the 
patient’s self-reported symptom data alongside expected norms for that procedure, and 
patient initiates care escalation) vs. Team Monitoring (the patient completes self-reported 
symptom assessment as per standard care at MSKCC; the clinical team contacts the 
patient if symptoms are above expected levels or appear to be worsening). Note: When 
patients report severe symptoms in either group, the care team will receive an alert and 
patients will also be instructed to immediately contact the clinical team. (Alerts to the clinical 
team can only be monitored during business hours, so all patients must seek care after 
hours in the current standard care fashion.) Our study design follows CONSORT30 and 
PCORI standards, including  patient  engagement,  research methods, data integrity  and 

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analysis (including stratification by surgical procedure), handling of missing data, and 
heterogeneity  of treatment effect. 
Primary outcome: The primary outcome for Aim 1, emergency department visits up to 
30 days after ambulatory cancer surgery, is important to patients because emergency 
department visits are time-consuming and may increase anxiety  and caregiver  burden. 
It is relevant to health care systems and clinicians because such visits are inefficient and 
costly and may erode trust between the patient and provider. 
 
Secondary outcomes: 
SA1: We will evaluate symptom-triggered interventions  (nursing  follow-up  calls, 
unplanned clinic visits and phone referral to clinic, pain management referrals,  and 
adverse event detection) and rates of adverse events up to 30 days after ambulatory 
cancer surgery. We will also evaluate the number of readmissions up to 30 days. Adverse 
events will be defined according to the nomenclature established in the MSKCC Surgical 
Secondary Events Grading  System. 
 
 
SA2: We will evaluate patient engagement, patient anxiety, and caregiver burden with 
the experience  of care using validated  PROs measures and qualitative  interviews. 
• 
Patient engagement will be evaluated preoperatively and at 2 weeks and 2 months 
postoperatively using the Patient Activation Measure (description below). 
• 
Patient anxiety will be measured on a daily basis for 10 days following surgery using 
three PRO-CTCAE Anxiety questions. 
• 
Caregiver burden will be evaluated at 2 weeks and 2 months postoperatively among 
consenting caregivers using the Caregiver Reaction Assessment (description below). 
Each participating patient will be asked to identify a caregiver, who will then be invited 
to participate. 
• 
Patient engagement and caregiver burden will also be evaluated using qualitative 
interviews, with a sample of each of the randomized cohorts, as described below. 
4.3 
Intervention 
 
The intervention in our study will allow us to determine which approach to the 
management of patient-reported symptom data is most effective from a patient and 
caregiver perspective. In both groups, if a patient reports severe symptoms, they are 
instructed to immediately contact their physician’s office or seek medical attention. 
Cohort 1: Team Monitoring 
 
Team Monitoring is the current standard of care for patients at JRSC. In this cohort, the 
electronic system will provide advanced informatics support for push notifications to the 
care team based on the severity of the symptoms reported. This platform promotes early 
detection and intervention. The care team is alerted when patients experience symptoms 
out of the expected range or if symptoms are worsening. Nurses receive secure message 
notifications and will contact the patient by phone depending on symptom severity. If a 
patient responds with a moderate-severe answer, the office team gets an alert and calls 

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the patient during business hours. Although nurses endeavor to call patients within 24 
hours, this may not occur if symptoms are reported on weekends or holidays. If the patient 
reports very severe symptoms, they get a bold red alert instructing them to call the office 
(or call team after hours) immediately or seek medical attention. The actual response 
thresholds (i.e., when to give which alert) for each question are set individually and have 
been refined based on feedback from the office practice nurses. The workflow associated 
with Team Monitoring has been vetted by all teams at JRSC and has been operationalized 
for urology, breast, and gynecologic oncology patients. 
Cohort 2: Enhanced Feedback 
 
In this cohort, the electronic system will provide tailored normative data visualizations that 
offer context and education to patients regarding expected symptom severity. The 
information provided to patients in the Enhanced Feedback group will be  procedure 
specific and based on continuously updated PRO-CTCAE data from previous patients. 
Patients are thus able to see their own recovery trajectory relative to that of patients who 
have undergone the same procedure. Care is patient-activated in that patients will use 
the information about expected symptoms to decide whether they should call the care 
team (e.g., if they are experiencing symptoms that are more severe or more prolonged 
than expected). If a patient reports severe symptoms, they are instructed to immediately 
contact their physician’s office or seek medical attention. In addition, when patients in the 
Enhanced Feedback group report severe symptoms, the care team will receive an alert but 
as noted above, alerts to the clinical team can only be monitored during business hours, so 
all patients must seek care after hours in the current standard care fashion. 
The JRSC Recovery Tracker Platform 
 
As the current standard of care, patients undergoing surgery at JRSC are asked to report 
on 11 items from a validated instrument, the Patient Reported Outcomes Common 
Terminology Criteria for Advers e Events ( PRO-CTCAE1), three additional surgical 
symptom questions, and two questions about seeking urgent care or a doctor during the 
first 10 days after surgery. Over the following 20 days, patients can tailor the survey to 
their needs by choosing when they complete the survey. Between days 11-30, patients 
can report symptoms on any day. By leaving the survey open after day 10, patients who 
develop new or worsening symptoms will have the ability to report these symptoms 
electronically whenever they wish. Conversely, patients not experiencing any symptoms 
will not be burdened by additional surveys. This system is currently being further refined 
within the JRSC PRO Workgroup. 
Invitations to complete questionnaires are triggered automatically on the basis of visit and 
operative schedules and sent via secure message to patients through the Patient Portal. 
The interface is built with a responsive design, so participants have the option of using 
the system via computers, tablets, or smart phones. Questionnaires are available in both 
English and Spanish. Nurses receive secure message notifications when patients’ 
symptoms exceed expected values or worsen and will contact the patient by phone within 
24 hours, depending on symptom severity. Patient symptom responses integrate directly 
into our electronic health record in two ways: (1) into nursing documentation templates 

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for point-of-care verification and (2) into the electronic health record reports after review 
of the data by the care team. 
The PRO-CTCAE symptom  questions 
 
The JRSC platform is based on the PRO-CTCAE symptom questions. In cancer clinical 
trials, adverse events are collected and reported using the National Cancer Institute’s 
CTCAE. To improve precision and patient-centeredness in the capture of symptomatic 
adverse events, the NCI funded a team of investigators led by Dr. Basch to develop a 
library of PRO items to supplement the CTCAE, called the PRO-CTCAE.1 Of the 790 
adverse events in the CTCAE, 78 were identified as amenable to patient self-report. 
For each of these adverse events, PRO items were created reflecting the attributes of 
presence, frequency, severity, interference with usual or daily activities, and/or amount. 
One to three attributes were selected for any given adverse event, depending on the 
nature of that particular adverse event. In total, 124 individual items represent the 78 
symptomatic adverse events in the PRO-CTCAE item library. Each item includes a 
plain-language term for the adverse event, the attribute of interest, and the standard 
recall period of “the past 7 days” (in the current study, we plan to use a 1-day recall 
period since patients are asked to report daily). Cognitive interviews previously 
determined a high level of patient understanding and  meaningfulness of the items,31 
and a national multisite validation study led by Dr. Dueck showed that items were valid, 
reliable, and sensitive to change.32 Additional development work by the team of Drs. 
Basch and Dueck included testing administration  mode equivalence,33  relationship 
among various recall periods,34 and a Spanish translation.35 PRO-CTCAE items were 
selected for the symptom monitoring system and are now a component of routine clinical 
care for MSKCC patients undergoing surgery at JRSC. Eleven PRO-CTCAE items, plus 
9 additional questions that were specifically targeted to capture important post-operative 
problems, evaluate the symptoms of patients recovering from ambulatory surgery in the 
MyMSK Patient Portal. Patients, nurses, surgeons, and anesthesiologists participated in 
the selection of these items. The items assess symptoms such as pain, nausea, fatigue, 
constipation, vomiting, fever, chills, dyspnea, swelling, discharge, and redness . 
Study outcomes 
 
Aims 
Meas ure 
Data Source(s) 
Assessment Time Point 
Patient-Centered  Outcomes 
SA1 
Em ergency Department Visits SA1a 
UCC visit at MSKCC 
MSK institutional database 
Up to 30 days after surgery 
SA1a 
Emergency department visit 
outside MSKCC 
Patient self-reporting via Patient 
Portal and corroborating phone call 
to patient by study team; MSK 
institutional database 
Up to 30 days after surgery 
Readmissions 
SA1a 
Readmission to MSK 
MSK institutional database 
Up to 30 days after surgery 
SA1a 
Admission outside MSK 
Patient self-reporting via Patient 
Portal and corroborating phone call 
to patient by study team; MSK 
institutional database 
Up to 30 days after surgery 
Symptom-Triggered 
Interventions 
SA1b 
Nurse calls due to alerts 
Documented in EMR via clinical 
information system 
Up to 30 days after surgery 
SA1b 
Unplanned clinic visits and 
phone referral to clinic 
Documented in EMR 
Up to 30 days after surgery 

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SA1b 
Pain managem ent  referrals 
Documented in EMR 
Up to 30 days after surgery 
SA1b 
Adverse event 
detection 
EMR and MSKCC Surgical 
Secondary Events Database 
Up to 30 days after surgery 
Patient and Caregiver Health 
Care Experience 
SA2 
Patient Engagement 
SA2a 
The Patient Activation 
Measure36 
Patient self-report 
Preoperatively (day of consent-
POD1), 2 w eeks (+7/-3 days), 
60 (+/- 14) days after surgery 
SA2a 
Qualitative data 
Semistructured patient interview s 
30 (+/- 10) days after surgery 
Patient Anxiety 
SA2b 
PRO-CTCAE Anxiety Items 
Patient self-report via symptom 
monitoring module in the Patient 
Portal 
Daily for 10 days after surgery 
Caregiver Burden 
SA2c 
Caregiver Reaction 
Assessment49 
Caregiver self -report 
2 w eeks (+7/-3 days), 60 (+/- 
14) days after surgery 
SA2c 
Qualitative data 
Semistructured caregiver interview s 30 (+/- 10) days after surgery 
 
 
Patient-centered  outcomes 
 
We will evaluate the frequency of urgent care center (UCC) visits, readmissions and 
symptom-triggered interventions (pain management referrals, nursing calls) through triggers 
generated from the informatics platform as well as through thorough chart extraction by the 
clinical research coordinator (CRC) for 30 days after surgery. 
Patient and caregiver health care experience 
 
The Patient Activation Measure. The Patient Activation Measure36 is a validated PRO 
measure developed to evaluate the engagement of patients in their care. The 
development process included conceptual definition and item  generation  through 
patient focus groups, literature review, and expert panel consensus. Psychometric 
evaluation of the scales was performed using Rasch psychometric methods, and 
further validation was completed in a large national sample. This measure includes 
items querying patients about their confidence (self-efficacy) and knowledge to take 
action specific to their health.36 Items include “I am confident I can tell when I need to 
get medical care” and “I am confident I can take actions that will prevent or minimize 
symptoms or problems.” This PRO measure was selected because it evaluates a key 
concept of interest in our study, was rigorously developed with qualitative and 
quantitative methods, and has strong psychometric properties. PAM yields only a total 
score that will be used in the analysis. 
The Caregiver Reaction Assessment. The Caregiver Reaction Assessment is a 
validated instrument designed to assess the impact of caregiving on disrupted 
schedules, self-esteem, and financial and health problems.37 The Caregiver  Reaction 
Assessment assesses specific aspects of the caregiving situation, including both 
negative and positive dimensions of caregiving reactions. The Caregiver Reaction 
Assessment (CRA) consists of 5 subscales, 4 of which are negative and 1 positive. The 
negative subscales have higher scores indicating higher level of burden, rated from 1 
(strongly disagree) to 5 (strongly agree).  The four negative subscales are: Impact on 

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Schedule (5 items), Impact on Health (4 items), Lack of Family Support (5 items) and 
Impact on Finances (3 items). The positive subscale, Caregiver’s Self Esteem (7 items), 
has lower scores indicating higher levels of burden rated from 1 to (strongly disagree) to 
5 (strongly agree). 
Five dimensions of caregiver reactions were identified through exploratory factor 
analysis: the impact of caregiving on disrupted schedules, financial problems, lack of 
family support, health problems, and self-esteem. Reliability analyses show that 
standardized Cronbach’s alphas vary between 0.62 and 0.83 for the  separate 
subscales, indicating sufficient internal consistencies and that construct validity is 
supported. This measure was selected because it is well-targeted to our outcomes of 
interest and was developed among partners of patients with cancer.38 
The PRO-CTCAE Anxiety Items. The PRO-CTCAE Anxiety scale consists of three items 
scored 0–4, for a full-scale range of 0–12 (see pages 11 and 12 for PRO-CTCAE 
development and validation). These include: “How often do you feel anxiety?” “What was 
the severity of your anxiety at its worst?” and “How much did anxiety interfere with your 
usual or daily activities?” 
Qualitative patient and caregiver interviews will be conducted in a subsample of 
patients and their caregivers throughout the study. After study consent, patients and 
caregivers will be invited to volunteer for possible future in-depth, semistructured 
qualitative interviews (either individual or in group form). We will approach patients (and 
caregivers) numerous times throughout the course of the study until data saturation. We will 
select patients from both randomized cohorts and will seek to interview a heterogeneous 
patient sample (i.e., patients representing the full spectrum of established potential 
participants (patients and caregivers) for possible interviews in order to examine and 
evaluate both patient engagement and caregiver burden (SA2a, SA2c) throughout the study. 
We will ensure that we have a selection of volunteers that represent a range of procedure 
types and ages for all qualitative interviews. 
 
The entire study team, including patient and caregiver partners and advocacy organization 
members will contribute to the development of the interview guide (see Appendices I and 
J). Dr. Jeanne Carter will conduct the interviews, which will be recorded and transcribed 
verbatim. The data will be coded using a line-by-line approach, where all concepts will 
be labeled by major and minor themes. Coding will take place as soon as possible after 
an interview so that findings can inform subsequent interviews in an iterative fashion. 
Codes (i.e., patient quotations) and their major and minor themes will be organized and 
analyzed 
using NVivo 
qualitative analysis 
software 
(QSR 
International). Patient 
characteristics (e.g., age, disease condition, procedure) will also be incorporated into the 
qualitative database to help identify groups that might experience the system differently 
(e.g., elderly patients or those with lower education levels). Interviews will continue until 
data saturation is reached (i.e., no new themes identified). On the basis of our team’s 
previous experience with qualitative research studies, we anticipate reaching data 
saturation  after approximately  30 patient and 30 caregiver interviews. 

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5.0 
CRITERIA FOR SUBJECT ELIGIBILITY 
 
All patients scheduled for ambulatory cancer surgery at JRSC will be eligible. For patients 
with disabilities that make it difficult to complete the electronic surveys (e.g., visual 
impairment, hand function problems), we will train caregivers to help with completion of the 
survey. The PRO-CTCAE questions have already been tested to ensure that they will be 
easily understood by patients with low literacy levels. 
Additionally, patients will be asked to identify a caregiver to participate in a 2-week and 2- 
month follow-up questionnaire and possibly in a qualitative interview. Caregivers will be 
approached and consented to participate. 
5.1 
Subject Inclusion Criteria 
 
• 
All patients >18 years of age who are scheduled for ambulatory cancer surgery at 
JRSC, and their caregivers, will be eligible for study participation. 
5.2 
Subject Exclusion Criteria 
 
The following criteria apply to both patients and their caregivers: 
 
• 
Inability to speak English 
• 
Inability to access a computer, tablet, or mobile phone 
• 
For patients: not interested in/unable to sign up for the MyMSK Patient Portal 
• 
For caregivers: Unable to provide an email address 
• 
Cognitive impairment that prohibits informed consent or understanding of the study 
protocol 
6.1 
RECRUITMENT PLAN 
 
Patient Recruitment Plan 
 
All patients who are scheduled for surgery at JRSC will receive IRB/PB-approved written 
educational materials that describe the study (see Appendices D and H) via the MyMSK 
Patient Portal, by email, or by a letter mailed to their home (see Appendices F and G). If a 
patient is not yet signed up for the MyMSK Patient Portal, the study team will also include a 
brief document that instructs patients how to register (see Appendix K). 
Patients will be advised that they will be approached to participate in this study by phone 
prior to surgery, at their next clinic appointment, or in person on the day of their surgery. 
They will be encouraged to read through the information carefully and to also consider 
whether there is a caregiver in their life who can be approached to participate in the 
caregiver portion of the study. The materials will provide contact information for the CRC 
and the PI of the study in case patients have questions they would like addressed before 
the day of surgery. The CRC will then attempt to contact eligible patients by phone before 
surgery. Using an IRB-approved verbal consent script, the CRC will explain the study to 

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patients. Written consent will not be obtained; rather, the CRC will document the patient’s 
verbal consent. 
If the CRC is not able to contact the patient by email, Patient Portal, or phone prior to the 
day of surgery, she/he will approach the patient at one of their upcoming clinic appointments 
or when they arrive at JRSC for surgery. The CRC will describe the study in person, again 
using the IRB-approved verbal consent script. Patients will be approached on the day of 
their surgery in the waiting area, and the consent discussion will happen in a private 
consultation room on the third floor at JRSC. Patients will not be approached in the pre- 
operative area, and will be given as much time as needed to decide whether or not they will 
participate in the study. 
Caregiver Recruitment Plan 
 
Patients will be asked at the time of consent to identify a caregiver whom they would like to 
be actively involved in their recovery and may be interested in participating in the study. The 
CRC will obtain the caregivers’ contact information from the patient. 
Caregivers can be contacted in several ways: 
 
1 )  If the caregiver is present in clinic with the patient, the CRC will approach the caregiver 
at that time. 
2 )  If the patient suggests contacting the caregiver by email or phone, the CRC will proceed 
to contact the caregiver using the preferred method of contact provided by the patient. 
a .  If personal email is preferred, the caregivers will be provided written education 
materials regarding the study via email (see Appendices E and H). Caregivers 
will be advised that they will be approached to participate in this study by phone 
prior to surgery or in person on the day of the patient’s surgery. The materials 
will also provide contact information for the CRC and the PI for the study, in case 
caregivers have questions they would like addressed before the day of surgery. 
b .  If phone is preferred, the CRC will call the caregiver and invite them to 
participate. 
3 )  If no contact is made prior to surgery, or if the patient/caregiver requests to be 
approached on the day of surgery, the CRC will approach the caregiver on the day of 
surgery. 
Given the extent to which caregivers are already integrated into the clinical experience at 
JRSC, we estimate that more than 50% of caregivers (n=1,375) will agree to participate in 
the study. 
7.0 
ASSESSMENT/EVALUATION PLAN 
 
The Recovery Tracker will be completed by all patients for up to 30 days following their 
surgery. Patients will be sent the Patient Activation Measure (PAM) through the MyMSK 
Patient Portal (see Appendices A and H). In the event the electronic PAM survey is not 
available, a hardcopy version will be provided to the patient to complete. 

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Caregivers will be asked to provide their email and will be sent the Caregiver Reaction 
Questionnaire and a brief demographic questionnaire through REDCap (see Appendices B, 
C, and H). In the event the electronic survey is not available, a hardcopy questionnaire will 
be provided to the caregiver to complete. 
 
# of 
Items 
Pre-Op 
(day of consent 
– POD1) 
POD 1-10 
POD14 
(+7/-3 days) 
POD30 
(+/-10 days) 
POD60 
(+/- 14 days) 
Patient 
Recovery  Tracker 
(including  PRO- 
CTCAE  symptoms 
and anxiety items, 
and additional 
questions) 
20 
Daily 
Available  to 
complete if 
desired 
(POD11-30) 
Emergency 
Department  Visits 
X 
Readmission 
X 
Adverse  Events 
X 
Patient Activation 
Measure 
10 
X 
X 
X 
Patient Interviews 
X 
Caregiver 
Caregiver   Reaction 
Assessment 
24 
X 
X 
Caregiver   Interviews 
X 
 
 
8.0 
TOXICITIES/SIDE EFFECTS 
 
There are minimal risks to all subjects involved in any phase of the study. Patients who 
indicate excessive anxiety or distress will be offered a referral to an MSKCC psychiatry 
professional.  If severe symptoms are reported, patients in both groups will be instructed 
to immediately contact their physician’s office or seek medical attention and the clinical 
team be alerted. 
9.0 
PRIMARY OUTCOMES 
 
The primary outcome for SA1, emergency department visits up to 30 days after 
ambulatory cancer surgery, is important to patients because emergency department visits 
are time-consuming and may increase anxiety and caregiver burden.  It  is  relevant  to 
health care systems and clinicians because such visits are inefficient and costly and may 
erode trust between the patient and provider. 

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10.0 
CRITERIA FOR REMOVAL FROM STUDY 
 
Participants will be considered off-study if they do not undergo an eligible procedure, their 
surgery is not performed at the Josie Robertson Surgery Center or they are not discharged 
within 48 hours of their surgery (POD2). All other participants will remain on study to be 
analyzed using an intent-to-treat approach. 
11.0 
BIOSTATISTICS 
 
The data analysis plan corresponds to our Specific Aims as described on pages  9 and 
10. All statistical analyses will be led by coinvestigator Dr. Andrew Vickers (who has been 
an investigator on more than 20 randomized trials and has written extensively on trial 
methodology) and study consultant Dr. Amylou Dueck (who contributed  to  the 
development and is experienced in analysis of the PRO-CTCAE items). The enrollment 
time frame for this protocol is three years. 
Power calculation 
 
Sample size and power calculations were based on the primary outcome, the difference 
in emergency department visits without admission, between the Enhanced Feedback and 
Team Monitoring arms. On the basis of current MSKCC data, we expect for every 1,000 
eligible patients treated surgically at JRSC, 69 patients will make emergency department 
isits. We also estimate that of these 69 patients, 28 will require readmission, and hence 
41 will have visits the emergency department unnecessarily. The majority of such 
unnecessary visits are related to concerns about symptoms, which might be avoided if 
patients have a better understanding of expected symptom severity. Using a traditional 
alpha of 5% and an event rate of 4.1% in the control group, the power to detect different 
relative risk reductions is given below for a total sample size of 2,750 patients. 
 
 
 
Relative Risk Reduction 
Power 
33% 
45% 
40% 
64% 
50% 
85% 
67% 
96% 
 
 
The primary analysis will compare, between groups, the proportion of patients with at 
least 1 emergency department visit without admission within 30 days (SA1a) of surgery 
by logistic regression with randomization strata as covariates. A difference between 
proportions will be calculated along with a 95% CI by applying the odds ratio from the 
regression to the event rate in the control group. A similar statistical approach will be 
taken for the proportion of patients referred to pain management and unplanned clinic 
visits (SA1b). For nursing follow-up calls (SA1b), phone referrals (SA1b) and rates of 
adverse events (SA1b), we will use both a binary approach (e.g., at least 1 nursing call 
vs. no nursing call) and analysis of count data using negative binomial regression with 
randomization strata as covariates. For all binary endpoints, an event will be counted 
only if it occurs within 30  days of surgery. 

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For the endpoints of patient engagement (SA2a) and caregiver burden (SA2c), we will 
use linear regression with randomization strata as covariates for each subscale 
separately. For all analyses, we will report an estimate of the difference between groups 
along with a 95% CI and a two-sided P value for the null hypothesis of no difference 
between groups. For the endpoint of patient anxiety (SA2b), as measured by the PRO- 
CTCAE, we will enter daily anxiety scores as  a continuous  outcome variable  into 
a longitudinal mixed effects model with time, treatment, and treatment by time 
interaction as predictors and randomization strata as covariates. As all data are 
collected after randomization, both the treatment term and the treatment by time 
interaction term are valid indicators of a treatment effect. We hypothesize that initial 
anxiety will be similar between groups and will be related to immediate postoperative 
concerns. Subsequent anxiety may be related to emergent symptoms, whether they 
are considered worrying and how they are dealt with. Hence, we will treat the time by 
treatment interaction as the primary hypothesis for the purpose of establishing the 
treatment effect of enhanced feedback on patient anxiety. 
In exploratory analysis, the mean of each PRO-CTCAE item (0–4 scale) will be 
compared between groups during the 10-day post-surgery daily reporting period using 
the same longitudinal mixed effects model described above for anxiety with time, 
treatment, and treatment by time interaction as predictors and randomization strata as 
covariates. All available data will be used in these models. This likelihood-based 
approach to the analysis of longitudinal PRO data provides valid estimates of 
intervention effects in the presence of ignorable missing data and is known to be robust 
to nonignorable missing data if covariates and previous values of the outcome explain 
much of the missingness. 
Supplemental  analysis  will  also  employ  longitudinal  mixed  ordinal  logistic  models  to 
compare ordinal PRO-CTCAE scores between  arms. 
Data sources and data linkage plans 
 
Many of the study endpoints will be obtained from MSKCC’s institutional database. 
Endpoints such as MSKCC emergency department visits, nursing follow-up calls, clinic 
visits, and intrainstitutional referrals are automatically captured as part of electronic 
medical record (EMR)–enabled care management. Emergency department visits at 
outside institutions will be captured by a question on our daily symptom surveys and 
routine follow-up surveys. Responses to the follow up surveys will be captured 
electronically via MSK Engage. Patients describing an emergency department visit at an 
institution other than MSKCC are contacted by clinical staff for further details as a routine 
part of follow-up care. Adverse events are captured by the MSKCC Secondary Surgical 
Event database. Outside emergency department visits and admissions for patients 
participating in MSKCC’s electronic health information exchange will also be utilized. 
Electronic health information exchange is carried out through organizations known as 
Health Information Exchanges (HIEs) or Regional Health Information Organizations 
(RHIOs). This data is captured within MSKCC’s institutional database. Data for all patients 
who choose to opt out of the health information exchange program will not be used. To 
note: MSK may join additional HIEs or RHIOs in the future. Any available HIE or RHIO 
data for participating patients will be collected. PROs are obtained through MSKCC’s 
symptom monitoring software, the same software used to implement symptom self- 
reporting. Covariates such as age, sex, and race are routinely captured in the MSKCC 
EMR. Comorbidities are captured by an MSKCC platform used to take the baseline 
medical history in all surgical patients potentially eligible for ambulatory cancer surgery. 
Caregivers’  responses  to  the  Caregiver  Reaction  Assessment questionnaires  will  be 

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collected via REDCap, a secure web application for building and managing online 
surveys and databases. In the event the REDCap survey is unavailable, a hardcopy form 
will be provided to caregivers to complete. 
Sensitivity analyses to determine the impact  of key assumptions and missing  data 
 
The primary threat to validity is a larger than expected number of emergency department 
visits to outside institutions and reporting that varies systematically between groups (e.g., 
if patients in the Enhanced Feedback group are less likely to report a visit to a non- 
MSKCC emergency department).  We will conduct sensitivity analyses by first 
examining whether the proportion of visits to MSKCC vs. non-MSKCC sites varies 
between groups. We will then determine the number and distribution of unreported 
emergency department visits that would need to have occurred to change our 
conclusions (e.g., if we reject the null hypothesis in favor of the experimental arm, we 
will determine the number of excess unreported visits in the experimental arm that 
would result in a P value ≥ 0.05). 
Approach  to missing  data for questionnaire items 
 
Baseline characteristics between those with and those without missing data will also be 
compared to assess for bias. The rate of missing data is expected to be low. The main 
threat to data completion involves the caregiver and patient questionnaires obtained at 2 
weeks and 2 months, respectively. In addition to automated electronic reminders, a 
research assistant will follow up with patients who have missingdata. Patients from whom 
no data are obtained will be classified as “unable to contact,” “too busy/uninterested,” or 
“intervention related” (e.g., a patient who declines to complete the questionnaires 
because of an experience earlier in the trial). Patterns of missing data will be compared 
by treatment arm. In the unlikely event that the rate of missing data is more than 5%, we 
will impute missing data using multiple imputation by chained equations, with results 
combined using Rubin’s rules. The principle assumptionof such a method is that the data 
are “missingat random” or “missingcompletely at random.” It seems at least possible that 
any missingness will be nonignorable on the grounds that a patient with a poor level of 
patient activation will be less likely to complete surveys. We will therefore repeat multiple 
imputation, except instead of missing activation measures being sampled from a 
distribution centered on the mean they will be sampled from the 25th and, alternatively, 
10th percentiles. A similar approach will be taken for the caregiver measure, for 
comparable reasons. 
Heterogeneity of  treatment effect 
 
It is possible that the effects of Enhanced Feedback vary predictably between patients. 
Although it is common to assess computer literacy as an effect modifier in trials of 
patient-facing software, we believe that this is inappropriate  for the current proposal. 
This is because both groups will interface with the software, and the difference between 
the two groups is not highly software dependent. It does, however, seem plausible that 
patient willingness to make proactive decisions about their postoperative  care in the 
light of data about expected symptoms would be mediated by age, educational status, 
and the type of procedure they undergo. We will therefore repeat all analyses including 

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interaction terms between allocation and age, education, and procedure. Educational 
status is obtained routinely at baseline for all MSKCC surgery patients and will be coded 
as a binary variable: education after high school/high school only. The models will be of 
the following form (with a linear case being shown for the sake of simplicity): 
 
y=β1 Allocation + β2 Age + β3 Allocation × Age + β(Randomization stratum) + c 
 
Allocation is coded 1 for Enhanced Feedback and 0 otherwise; randomization stratum 
is a categorical variable. A similar model will be used for educational status and 
procedure type. We have no particular reason to believe that response to Enhanced 
Feedback would vary by race and ethnicity, but as a check to ensure that our approach 
does not inadvertently discriminate, we will conduct exploratory analyses of race and 
ethnicity using the structure of the model described above. 
Reporting plan with assessments of internal and external validity 
 
This is a randomized trial with good allocation concealment, and therefore  selection 
bias can be discounted. Patients, however, will not be blinded. This is not an important 
issue for the primary endpoint, which is emergency department visits, as this is 
objectively measured and not susceptible to reporting bias.  The  question  of 
performance bias in terms of differential patient  behavior  is complicated by the fact 
that the aim of the trial is to change behavior.  Performance bias by  clinicians  is, 
however, a concern. For instance, it is plausible that a nurse speaking to a study patient 
by phone in the days after discharge might make differential recommendations about 
the necessity of an emergency department visit depending on patient assignment. 
However, this is an unlikely scenario given the context of nursing care at MSKCC. 
Nurses call large numbers of patients, both those eligible for the trial (ambulatory care 
surgery) and those ineligible (e.g.,  complex operations  requiring  an in-patient  stay), 
and they are unlikely  to know which patients are and are not on trial. Patients might 
potentially reveal allocation to nurses during the phone call (e.g., “I saw on the website 
that…”). But, again, as a large number of nurses will be dealing with a large volume of 
patient calls, it is unlikely that allocation will bias the advice given to a significant extent. 
Regarding external validity, the system is currently in use by MSKCC patients, but it is 
possible that these patients (a referral population in a major urban center) may have 
higher computer literacy, health literacy, or numeracy than the general population. We 
recognize that usability barriers that might seem trivial to a highly technology-focused 
audience can sometimes seem insurmountable for patients facing stress due to illness 
or treatment or for patients who face preexisting hurdles in terms of computer literacy, 
health literacy, or numeracy.39-41 As a result, we have built in a brief user-centered design 
stage supervised by coinvestigator Dr. Jessica Ancker to review the  existing platform in 
a systematic fashion, elicit constructive feedback from representative users, and perform 
rapid-cycle modifications to ensure usability and utility for users. We anticipate that this 
intensive user-centered design  project will successfully adapt the existing instrument. 
12.1 
RESEARCH PARTICIPANT REGISTRATION AND RANDOMIZATION PROCEDURES 
 
12.2 
Research Participant Registration 

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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 will confirm 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). 
All participants will be registered through the Clinical Trial Management System. The 
completed signature page of the verbal script/RA, a completed Eligibility Checklist and other 
relevant documents will be uploaded via to CTMS. 
12.3 
Randomization 
 
At the time of protocol consent, it will be explained to patients that they will be 
completing symptom self-reported questionnaires for up to 30 days after surgery (daily 
for postoperative days 1 to 10 and then at tailored time points) as a component of 
routine care, and they will be asked whether they are willing to be randomized to 
potentially receive additional information that may help them interpret the severity of their 
symptoms. Randomization will be implemented through CRDB, a fully secure, 
password-protected database that ensures full allocation concealment. It will be 
performed within 1 week of the patients’ surgical visit. Randomization will be stratified by 
procedure and will be implemented by randomly permuted blocks of random length. 
The trial will not be blinded, as it relies on patient knowledge (i.e., how a patient’s scores 
compare with other patients’ scores) as a key part of the intervention. 
Stratification will be based the following surgical procedure types: 
• 
Gynecologic 
o Laparoscopic or robotic procedure 
o Laparotomy 
o Other 
• 
Breast/Plastics 
o Mastectomy alone (with or without sentinel node and axillary node dissection) 
o Lumpectomy (with or without sentinel node and axillary node dissection) 
o Tissue expander  placement 
o Other 
• 
Urology 
o Prostatectomy laparoscopic or robotic 
o Partial or total nephrectomy- laparoscopic or robotic 
o Laparotomy 
o Other 
• 
Head and Neck 
o Thyroidectomy 
o Other 

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13.1 
DATA MANAGEMENT ISSUES 
 
A Clinical Research Coordinator (CRC) and a Research Project Manager (RPM) will be 
assigned to the study. The responsibilities of the CRC and RPM include project compliance, 
data reporting, regulatory monitoring, problem resolution and prioritization, and coordinating 
the activities of the protocol study team. 
The data collected for this study, including patient demographic data, treatment variables, 
and survey responses  will be recorded by the research team in a secure password- 
protected database. 
Data collected for this study will be entered into and managed via a secure REDCap 
Database. REDCap, Research Electronic Data Capture, is an open source platform that 
allows for the collection of research data in a secure manner over a web based interface. 
Usage of the platform is contingent on an open source license. The platform was developed 
by Vanderbilt University which MSK has a standing agreement with to allow the usage of 
REDCap for academic/research purposes. 
For this protocol, electronic data entry forms may be completed online by study staff. [If 
applicable], electronic participant responses will also be collected either by sending 
participants a direct link or having the participants fill out the electronic survey on site. 
Data will be housed in the Memorial Sloan Kettering Cancer Center’s (MSKCC) Jersey data 
center. REDCap has been approved by MSKCC’s Information Security to store PHI. The 
MSKCC Information Systems group is responsible for applying all operating system patches 
and security updates to the REDCap servers. All connections to REDCap utilize encrypted 
(SSL-based) connections to ensure data is protected. The server is backed up nightly in 
the event that disaster recovery would be necessary, and the system would need to be 
rolled back. Members of the Clinical Research Administration supporting the REDCap 
software will have access to REDCap projects for the purpose to ensuring the proper 
functioning of the database and the overall software system. 
Permissions to the database for both internal and external users will be managed by the 
REDCap project manager or study staff. User access to the data is contingent on those a 
part of the study team and data sharing agreements in place with third party entities if 
applicable. Project managers are responsible for regularly auditing these permissions to 
ensure changes in staff are reflected appropriately. 
REDCap has the ability  maintain an audit trail of changes to the database providing a 
timestamp as well as the user making the update. In addition, a data resolution module 
offers the ability of opening and closing queries optionally requiring justification when data 
is being updated. Permission roles for data resolution are integrated in REDCap. 
Comprehensive system logs are also maintained of user activity and when changes to the 
database are made. 
Source documentation will be available to support the computerized patient record. A 
minimal data set will be entered into CRDB. 

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13.0.1 Participating Sites Regulatory Document 
 
Prior to implementing this protocol at MSK, the protocol, informed consent form, HIPAA 
authorization and any other information pertaining to participants must be approved by the 
MSK Institutional Review Board/Privacy Board (IRB/PB). There will be one protocol 
document, and each participating site will utilize that document. Participating sites that are 
consulting should submit this protocol to their IRB according to local guidelines. Copies of 
any site IRB correspondence should be forwarded to MSK. 
The below describes the roles of each consultant named to the protocol: 
 
Andrea Pusic, MD, Attending Surgeon in the Department of Surgery  at Brigham and 
Women’s Hospital, will serve as a Co-Principal Investigator on the IRB protocol. As a 
consultant to MSK, Dr. Pusic will have access to PHI (any identifiers relevant to 
study/participant management or analysis of study outcomes), and study data (i.e., 
participant disease and demographic characteristics and survey response data). 
Larissa Temple, MD, Attending Surgeon in the Department of Surgery at University of 
Rochester will serve as an investigator on this protocol. As a consultant to MSK, Dr. Temple 
will have access to PHI (any identifiers relevant to study/participant management or analysis 
of study outcomes), and study data (i.e. participant disease and demographic characteristics 
and survey response data). 
Jessica Anker, PhD is a consultant per the PCORI contract (IHS-1602-34355). Dr. Anker is 
an expert in the effects of health information technology on decisions and healthcare quality. 
She is an associate professor at Weill Cornell Medicine. In year one, she will supervise the 
user-centered design project. In years two and three, Dr. Anker will collaborate on any 
continued adaptations of the instrument suggested  by analysis of the qualitative and 
quantitative data. Participant identifiers will not be shared, but she will have access to study 
data pertinent to her work in making the necessary instrument adaptations. 
Amylou Dueck, PhD, is a consultant per the PCORI contract (IHS-1602-34355). Dr. Dueck 
has expertise in the design and analysis of cancer studies involving patient-reported 
outcomes. She contributed to the development and is experienced in the analysis of the 
PRO-CTCAE items used in the Recovery Tracker survey. Dr. Dueck will offer her 
professional expertise in patient-reported outcomes research and data analysis to help 
inform the study design, data collection and analyses, and future manuscripts for 
publication. She will assess the validity and reliability of the Recovery  Tracker data. 
Participant identifiers will not be shared (all data will be de-identified and she will not have 
access to PHI), but she will have access to study data pertinent to her work in performing 
Recovery Tracker analyses. 
Ethan Basch, MD, PhD is a consultant per the PCORIcontract (IHS-1602-34355). Dr. Basch 
is an expert in the development and evaluation of patient-reported outcomes systems. He 
will offer his professional expertise in patient-reported outcomes research to help inform the 
study design, recruitment efforts, study materials, and future manuscripts for publication. 
Participant identifiers will not be shared. De-identified data will be shared if it is necessary 
for the analysis of study outcomes and preparation of study manuscripts. 

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Debra Paget is a stakeholder and consultant per the PCORI contract (IHS-1602-34355). 
She is a 17-year volunteer at the patient advocacy group, Support Connection, which 
provides emotional, educational, and social support ot women and families affected by 
breast and ovarian cancer. Ms. Paget is also an ovarian cancer survivor and has been a 
caregiver for two cancer patients. She will offer personal insight and constructive feedback 
on certain aspects of the study design, recruitment efforts, study materials, and future 
manuscripts for publication. De-identified data will be shared if it is  necessary for the 
analysis of study outcomes and preparation of study manuscripts. 
Jaime Blanda is a stakeholder and patient partner consultant per the PCORI contract (IHS- 
1602-34355). As a former patient, she will offer personal insight and constructive feedback 
on certain aspects of the study design, recruitment efforts, study materials, and future 
manuscripts for publication. De-identified data will be shared if it is  necessary for the 
analysis of study outcomes and preparation of study manuscripts. 
 
Paul Carter is a stakeholder and patient partner consultant per the PCORI contract (IHS- 
1602-34355). As a former patient, he will offer personal insight and constructive feedback 
on certain aspects of the study design, recruitment efforts, study materials, and future 
manuscripts for publication. De-identified data will be shared if it is necessary for the 
analysis of study outcomes and preparation of study manuscripts. 
Thomas Chiusano is a stakeholder and caregiver partner consultant per the PCORI contract 
(IHS-1602-34355). As a former patient, he will offer personal insight and constructive 
feedback on certain aspects of the study design, recruitment efforts, study materials, and 
future manuscripts for publication. De-identified data will be shared if it is necessary for the 
analysis of study outcomes and preparation of study manuscripts. 
James Guttridge is a stakeholder and patient partner consultant per the PCORI contract 
(IHS-1602-34355). As a former patient, he will offer personal insight and constructive 
feedback on certain aspects of the study design, recruitment efforts, study materials, and 
future manuscripts for publication. De-identified data will be shared if it is necessary for the 
analysis of study outcomes and preparation of study manuscripts. 
Christine Nippes, PA-C is a stakeholder and patient partner consultant per the PCORI 
contract (IHS-1602-34355). As a former patient, she will offer personal insight and 
constructive feedback on certain aspects of the study design, recruitment efforts, study 
materials, and future manuscripts for publication. De-identified data will be shared if it is 
necessary for the analysis of study outcomes and preparation of study manuscripts. 
Amy Malale is a stakeholder and patient partner consultant per the PCORI contract (IHS- 
1602-34355). As a former patient, she will offer personal insight and constructive feedback 
on certain aspects of the study design, recruitment efforts, study materials, and future 
manuscripts for publication. De-identified data will be shared if it is necessary for the 
analysis of study outcomes and preparation of study manuscripts. 
Magen Miranda is a stakeholder and patient partner consultant per the PCORI contract 
(IHS-1602-34355). As a former patient, she will offer personal insight and constructive 
feedback on certain aspects of the study design, recruitment efforts, study materials, and 

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future manuscripts for publication. De-identified data will be shared if it is necessary for the 
analysis of study outcomes and preparation of study manuscripts. 
13.2 
Quality Assurance 
 
Weekly registration reports will be generated to monitor patient accruals and completeness 
of registration data. Routine data quality reports will be generated to assess missing data 
and inconsistencies. Accrual rates and extent and accuracyof 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 compliance audits will be conducted by the study 
team at a minimum of two times per year, and more frequently if indicated. 
Regular meetings will be held by the study team to discuss progress and to ensure that 
the study timeline is being followed. The data will be stored carefully in computer form, 
with several forms of backup. Data will be available immediately when a patient 
completes the surveys, which will allow for follow-up collection of missing or incorrect 
data. 
 
13.3 
Data and Safety Monitoring 
 
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://cancertrials.nci.nih.gov/researchers/dsm/index.html. The DSM Plans at MSKCC were 
established and are monitored by the Clinical Research Administration. The MSKCC Data 
and 
Safety 
Monitoring 
Plans 
can 
be 
found 
on 
the 
MSKCC 
Intranet 
at  
https://one.mskcc.org/sites/pub/clinresearch/Documents/MSKCC%20Data%20and%20Saf  
ety%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, compliance 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 
 
The following safeguards will be used with respect to protection of human subjects: 

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IRB Number: 17-293 A(7) 
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Recruitment and Informed Consent: All potential patients will be informed as to their rights 
as volunteers in a research study. The right to refuse or withdraw at any point during the 
study, without compromising medical and other care will be explained. Verbal consent will 
be obtained. The purpose of the study and potential risks and benefits associated with it will 
be stated. If patients or caregivers withdraw consent prior to completing the study, they will 
no longer be prompted to complete the Patient Activation Measure/Caregiver Reaction 
Assessments. They will only be sent the Recovery Tracker, which is sent to all patients are 
part of the standard of care at MSKCC. 
Confidentiality Safeguards: Patients will be informed that information collected during 
their participation in this study is considered confidential. All data gathered will be kept in a 
secured location. Patients will be assigned code numbers, so that names  will not be 
connected to any information. Confidentiality of each patient’s data will be protected with 
utmost care with all questionnaire data identified solely by a code number. A list matching 
subject names and code numbers will be maintained on a separate sheet of paper kept in 
locked storage. 
Sources of Materials: Patient information will be obtained from existing patient records. 
Patient responses to surveys will be the main source of research material. Some of the data 
being collected is already part of the standard care patients get after their surgery at JRSC. 
Any additional information will be collected for research purposes only and not used for any 
other purposes. 
Potential Risks: There will be minimal risks to subjects involved in the study. If a patient 
reports s ever e symptoms, they are instructed to immediately contact their physician’s 
office or seek medical attention. Patients may feel some anxiety or stress when they 
complete the daily surveys. They will be encouraged to contact the study coordinator, who 
will ensure that the patient is contacted by one of the surgeons involved in the study and 
given the opportunity to discuss any concerns that they might have. 
Potential benefits of the proposed research to the subjects: There will not be any direct 
benefit to subjects involved in the study. 
Financial Costs: There will not be any financial cost to patients. 
 
14.2 
Privacy 
 
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 

Memorial Sloan Kettering Cancer Center 
IRB Number: 17-293 A(7) 
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Page 29 of 34 
 
 
 
 
stated in the Research Authorization  that their research data may be shared with other 
qualified  researchers. 
14.3 
Serious Adverse Event (SAE) Reporting 
 
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 
• 
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: Only SAEs specifically related to the protocol intervention (Recovery Tracker and 
PAM/CRA survey completion) will be reported. Hospital admission for a planned 
procedure/disease treatment is not considered an SAE. 
 
SAE 
reporting 
is 
required 
as 
soon 
as 
the 
participant 
starts 
investigational 
treatment/intervention. SAE reporting is required for 30-days after the participant’s last 
investigational treatment/intervention. Any event that occur after the 30-day period that is 
unexpected and at least possibly related to protocol treatment must be reported. 
Please note: Any SAE that occurs prior to the start of investigational treatment/intervention 
and is related to a screening test or procedure (i.e., a screening biopsy) must be reported. 
 
All SAEs must be submitted in PIMS. If an SAE requires submission to the HRPP office per 
IRB SOP RR-408 ‘Reporting of Serious Adverse Events’, the SAE report must be submitted 
within 5 calendar days of the event. All other SAEs must be submitted within 30 calendar 
days of the event. 
 
The report should contain the following information: 
• The date the adverse event occurred 
• The adverse event 
• The grade of the event 
• Relationship of the adverse event to the treatment(s) 
• If the AE was expected 
• Detailed text that includes the following 
o An explanation of how the AE was handled 
o A description of the participant’s condition 
o Indication if the participant remains on the study 
• If an amendment will need to be made to the protocol and/or consent form 

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• If the SAE is an Unanticipated Problem Version Date: 12/21/2018 For IND/IDE protocols: 
The SAE report should be completed as per above instructions. If appropriate, the report 
will be forwarded to the FDA by the IND Office 
 
15.1 
INFORMED CONSENT PROCEDURES 
 
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. 
The investigators are requesting to waive the documentation of informed consent for this 
study for the following reasons: 
Patients 
 
1. The research involves no more than minimal risk to the participants. The majority of 
the protocol is part of the standard care and evaluation that patients at JRSC receive. 
The only exception is that additional features of the system will be available to 
patients who are randomized to the Enhanced Feedback arm. They will receive 
additional information about expected symptoms after their surgery. In addition to 
symptom assessment, all patients will be asked to complete 1 survey at 3 different 
time points and possibly to participate in a 30–60-minute qualitative interview at a 
convenient time. 
 
2. The waiver will not adversely affect the rights and welfare of the research 
participants, as they will willingly engage in the research. Even if they provide verbal 
consent, if they later decide not to participate, they do not have to complete the 
questionnaires. Participation will be entirely voluntary. 
 
3. If deemed appropriate by the PI and granting organization, the patients  will be 
provided with additional pertinent information after participation. We will be actively 
following these patients, so we will be able to contact them easily. 
 
4. The research cannot be practicably carried out without this waiver. Patients would 
normally be consented to this protocol during a routine clinic visit to consent to their 
surgery. Patients are sent to JRSC by surgeons who have clinics at several locations 
in the city. It will be physically impossible for the CRC assigned to this study to 
consent all of the patients in this manner. 
 
We anticipate that the CRC will approach 30–40 patients per day at JRSC, and it is 
not feasible for this person to have a full consent discussionwitheach of the patients. 
We feel that our proposed solution of providing educational materials to the patients 
prior to their surgery date and having a member of the research team available to 
answer any questions that arise will allow us to take all necessary precautions to 
ensure the comfort and safety of the patients who will participate in this protocol. 

Memorial Sloan Kettering Cancer Center 
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Page 31 of 34 
 
 
 
 
 
5. The research is not regulated by the FDA. 
 
Caregivers 
 
1. The research involves no more than minimal risk to the participants. Caregivers will 
only be approached if they are identified by the patient. They will be asked to 
complete 1 survey at 3 different time points and possibly to participate in a 30–60- 
minute qualitative interview at a convenient time. The questionnaire and qualitative 
interview are not expected to have any serious psychological impact on the 
caregiver. 
 
2. The waiver will not adversely affect the rights and welfare of the research 
participants, as they will willingly engage in the research. Even if caregivers provide 
verbal consent on the date of surgery, if they later decide not to participate, they do 
not have to complete the questionnaire when it is sent to them. Participation will be 
entirely voluntary. 
 
3. If deemed appropriate by the PI and granting organization, the caregivers will be 
provided with additional pertinent information after participation. 
 
4. The research cannot be practicably carried out without this waiver. For the same 
reason that this would not be feasible with patients, documenting consent for all 
caregivers would be extremely challenging, as we expect a high volume of 
caregivers (30–40 per day) to be approached for participation. Because the CRC will 
be approaching 30–40 patients and 30–40 caregivers, we feel it is clearly impractical 
to require documentation of consent for a study with sucha vast scope but that poses 
no more than minimal risk to any of the participants. 
 
5. The research is not regulated by the FDA. 
 
All participants must provide their consent to participate. This IRB/PB-approved consent 
script meets the requirements of the Code of Federal Regulations and the Institutional 
Review Board/Privacy Board of this Center. The consent script and the education 
materials provided to the patient will include the following: 
 
1. The nature and objectives, potential risks and benefits of the intended study. 
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. 

Memorial Sloan Kettering Cancer Center 
IRB Number: 17-293 A(7) 
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Page 32 of 34 
 
 
 
 
The member of the research team who has the consent discussion with the patient will sign 
the verbal form and have it scanned to the patient’s medical record. 
 
 
16.0 
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17.0 
APPENDICES 
 
Appendix A: Patient Activation Measure (PAM) – Short Form 
Appendix B: Caregiver Reaction Assessment (CRA) 
Appendix C: Caregiver Demographic Questionnaire 
Appendix D: Study Information_Patients 
Appendix E: Study Information_Caregivers 
Appendix F: Recruitment Letter_Patients 
Appendix G: Recruitment Letter_PFACQ 
Appendix H: Correspondence Templates 
Appendix I: Qualitative Interview Script_Patients 
Appendix J: Qualitative Interview Script_Caregivers 
Appendix K: MyMSK  Brochure 
Appendix L: Recruitment Voicemail Script 
Verbal Consent_Patients 
Verbal Consent_Caregivers