Perioperative Telemonitoring to Optimize Cancer Care and Outcomes
Phase: NA
Conditions: Malignant Digestive System Neoplasm
Sponsor: City of Hope Medical Center

IRB Protocol No. 20717 
 
05-24-2023 
Packet:  10 
CITY OF HOPE NATIONAL MEDICAL CENTER 
1500 E. DUARTE ROAD 
DUARTE, CA 91010 
DEPARTMENT OF Surgery 
TITLE:  Perioperative Telemonitoring to Optimize Cancer Care and Outcomes 
 
CITY OF HOPE PROTOCOL NUMBER: 20717           PROTOCOL DATED: 05/24/2023 
 
DATE(S)/ OF AMENDMENT(S)/REVISION(S): 
 
COH Initial Approval 
Protocol dated 03/24/21 
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SPONSOR/IND NUMBER:  
NR019866-01 
DISEASE SITE: 
 
 
GI  
STAGE (if applicable):  
 
NA 
MODALITY: 
 
 
Intervention 
PHASE/TYPE: 
 
 
Pilot/Feasibility 
ClinicalTrials.gov identifier: 
NCT04986566 
 
PRINCIPAL INVESTIGATORS:  
Laleh Melstrom, MD 
 
COLLABORATING INVESTIGATORS: Virginia Sun, PhD, RN, Darrell Fan, Kristen Limbach, 
MD, Marta Jankowska, PhD, Calvin Tribby, Sarah 
Alismail, PhD  
 
PARTICIPATING CLINICIANS:  
Loretta Erhunmwunsee MD,  Jae Kim MD, Dan Raz 
MD, Andreas Kaiser MD, Lily Lai MD, Kurt Melstrom 
MD, Gagandeep Singh MD, , Yanghee Woo MD, 
Yuman Fong MD  
 

IRB Protocol No. 20717 
 
05-24-2023 
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STUDY STATISTICIANS:  
Joycelynne Palmer, PhD, Timmy Okunowo, MS, Yan 
Wang, MS 
 
NON-PHYSICIAN CONSENTERS: 
Fernanda Perez, BS, Evelyn Leyva, BSN, RN, 
Randy Lee, MHA, , Jacqueline Carranza, BS, , 
Elizabeth Bustamante, BS, Rosemary Prieto, RN, 
BSN, Patricia Esslin, PhD, APRN-CNS, CNE, 
Maricela Haj, RN, Maria Pakhdikian, M.A.  
 
 
 
 
 
 
 

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IRB Protocol No. 20717 
 
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Packet:  08 
CITY OF HOPE NATIONAL MEDICAL CENTER 
1500 E. DUARTE ROAD 
DUARTE, CA 91010 
DEPARTMENT OF Surgery 
TITLE:  Perioperative Telemonitoring to Optimize Cancer Care and Outcomes 
 
CITY OF HOPE PROTOCOL NUMBER: 20717           PROTOCOL DATED: 05/24/2023 
 
DATE(S)/ OF AMENDMENT(S)/REVISION(S): 
 
COH Initial Approval 
Protocol dated 03/24/21 
Packet 00 
COH Amendment 01 
Protocol dated 09/15/21 
Packet 01 
COH Amendment 02 
Protocol dated 12/15/21 
Packet 02 
COH Amendment 03 
 
 
 Protocol dated 12/15/21(tp) 
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COH Amendment 04 
 
 
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COH Amendment 05 
 
 
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SPONSOR/IND NUMBER:  
NR019866-01 
DISEASE SITE: 
 
 
GI  
STAGE (if applicable):  
 
NA 
MODALITY: 
 
 
Intervention 
PHASE/TYPE: 
 
 
Pilot/Feasibility 
ClinicalTrials.gov identifier: 
NCT04986566 
 
 
PRINCIPAL INVESTIGATORS:  
Laleh Melstrom, MD 
 
COLLABORATING INVESTIGATORS: Virginia Sun, PhD, RN, Darrell Fan, Kristen Limbach, 
MD, Marta Jankowska, PhD, Calvin Tribby 
 
 
 
PARTICIPATING CLINICIANS:  
Loretta Erhunmwunsee MD, Jae Kim MD, Dan Raz 
MD, Andreas Kaiser MD, Lily Lai MD, Kurt Melstrom 
MD, Benjamin Paz MD, Gagandeep Singh MD, , 
Yanghee Woo MD, Yuman Fong MD  
 

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IRB Protocol No. 20717 
 
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STUDY STATISTICIANS:  
Joycelynne Palmer, PhD, Timmy Okunowo, MS, Yan 
Wang, MS 
 
NON-PHYSICIAN CONSENTERS: 
Fernanda Perez, BS, Evelyn Leyva, BSN, RN, 
Randy Lee, MHA, , Jacqueline Carranza, BS, , 
Elizabeth Bustamante, BS, Rosemary Prieto, RN, 
BSN, Patricia Esslin, PhD, APRN-CNS, CNE, , 
Jennifer Tee, BSN, RN, Maricela Haj, RN, Maria 
Pakhdikian, M.A.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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IRB Protocol No. 20717 
 
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Protocol Synopsis 
Protocol Title: 
Perioperative Telemonitoring to Optimize Cancer Care and Outcomes 
Brief Protocol Title for the Lay Public (if applicable): 
NA 
Study Phase: 
Pilot/Feasibility 
Participating Sites: 
Duarte Campus  
Rationale for this Study: 
The most common and successful component of cancer treatment is surgery. However, 
patients experience abrupt declines in functional capacity after major surgical procedures. 
In addition to postoperative functional decline, patients experience an increase in 
symptoms, such as pain, fatigue, and distress.1-3 Postoperatively, these symptoms 
contribute to a dramatic decline in quality of life (QOL).4-6 Recovery from these 
challenges is compounded by healthcare systems-related trends, including pressures to 
reduce readmissions and length of stay. As a result, the majority of postoperative care and 
recovery takes place at home. Unfortunately, while at home physical function can decline 
severely before the surgical team is notified. This means that about one third of patients 
will become symptomatic from a complication and may require hospital readmission.2, 7-9 
A promising approach to early identification of post-discharge complications is 
through remote, real-time perioperative telemonitoring of patient-generated health data 
(PGHD) and electronic patient-reported outcomes (ePROs). In our preliminary studies, 
telemonitoring was feasible and acceptable in the perioperative setting.10 We found that 
patient-generated daily steps data was associated with the risk for postoperative 
complications.10 However, the current perioperative care model is largely reactive and 
does not address the need for monitoring and supporting postoperative recovery. 
Therefore, remote and scalable telemonitoring approaches are urgently needed to 
improve perioperative cancer care in a healthcare system that demands early discharge 
and reduced hospital readmissions. 
 
Objectives: 
1. Feasibility Retention and acceptability of the intervention through statistics of 
participation, intervention, completion (retention) rates and qualitative data from 
exit interviews. 
2. Surgical outcomes (post operative complications), healthcare utilization 
(postoperative complications, readmissions), PROs (symptoms, QOL) and 
functional recovery (pedometer) will be examined by treatment arm 

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Study Design: 
Pilot RCT (1:1 randomization)  
Endpoints: 
Primary: severity (grade) of postoperative complications from discharge to day 30 post 
discharge.  
Sample Size: 
160 patients (80 per arm)  
Estimated Duration of the Study 
30 months 
Summary of Subject Eligibility Criteria: 
Study eligibility criteria include:  
• Cancer patients scheduled to undergo major abdominal surgery for GI malignancies. 
GI procedures include esophagectomy, gastrectomy, colectomy, abdominoperineal 
resection/low anterior resection, hepatectomy, pancreatectomy (distal or 
pancreaticoduodenectomy), and cytoreductive surgery for peritoneal carcinomatosis. 
We will include patients scheduled for an ostomy (colostomy or diverting ileostomy), 
•  Age 18 years or older, 
• Ability to read and understand English or Spanish. 
Investigational Product Dosage and Administration: 
NA 
Clinical Observations and Tests to be Performed: 
NA 
Statistical Considerations: 
We will need 128 patients (64 per arm) to detect an effect size of 0.5 in the  primary outcomes as 
described in Aim 2 (postoperative complications, lower readmission rates, improved symptoms, 
QOL, and functional recovery) between the two groups, with a two-sided 0.05 significance level 
using a two-sample t-test and at least 80% power. We will enroll a total of 160 (80 per arm to 
account for an expectation of 20% attrition. Thus, we will have sufficient power for all primary 
outcomes, including our primary endpoint of postoperative complications.   
 
Sponsor/Licensee: 
NINR 
Case Report Forms 
NA 

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Table of Contents 
 
SECTION .............................................................................................................................. PAGE 
1.0 
Goals and Objectives (Scientific Aims) .............................................................................. 9 
2.0 
Background ....................................................................................................................... 10 
2.1 
Introduction/Rationale for Development ............................................................. 10 
2.2 
Overview of Proposed Study ...................................................................................  
2.3 
Preclinical Studies ....................................................................................................  
2.3.1 
[Name of Agent] ......................................................................................... 
2.4 
Human Studies .........................................................................................................  
2.4.1 
[Name of Agent] ......................................................................................... 
3.0 
Patient Eligibility .............................................................................................................. 13 
3.1 
Inclusion Criteria ................................................................................................. 13 
3.1.1 
Disease Status ......................................................................................... 14 
3.1.2 
Age Criteria, Performance Status and Life Expectancy ......................... 14 
3.1.3 
Child Bearing Potential ........................................................................... 14 
3.1.4 
Protocol-Specific Criteria ....................................................................... 14 
3.1.5 
Informed Consent/Assent ....................................................................... 14 
3.1.6 
Prior Therapy .......................................................................................... 14 
3.2 
Exclusion Criteria ................................................................................................ 14 
3.2.1 
Study-Specific Exclusions ...................................................................... 14 
3.2.2 
Non-Compliance ..................................................................................... 14 
3.3 
Inclusion of Women and Minorities .................................................................... 14 
4.0 
Screening and Registration Procedures............................................................................. 14 
4.1 
Screening Procedures ........................................................................................... 14 
4.2 
Informed Consent ................................................................................................ 15 
4.3 
Registration Requirements/Process ..................................................................... 15 
4.4 
Randomization and/or Dose Level Assignment................................................... 15 
5.0 
Treatment Program ........................................................................................................... 15 
5.1 
Treatment Overview ............................................................................................ 15 
5.1.1 
Schedule ......................................................................................................  
5.2 
Planned Duration of Therapy ............................................................................... 19 
5.3 
Criteria for Removal from Treatment .................................................................. 19 
5.4 
Subject Follow-Up ............................................................................................... 19 

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5.5 
Supportive Care, Other Concomitant Therapy, Prohibited Medications ............. 19 
5.6 
Additional Studies ................................................................................................ 20 
5.6.1 
Laboratory Studies .................................................................................. 20 
5.7 
Definition of Dose-Limiting Toxicity (DLT) ...................................................... 20 
6.0 
Dose Delays/Modifications for Adverse Events ............................................................... 20 
7.0 
Data and Safety Monitoring, Unanticipated Problems and Adverse Event Reporting ..... 20 
7.1 
Data and Safety Monitoring ................................................................................. 20 
7.2 
Monitoring and Personnel Responsible for Monitoring ...................................... 20 
7.3 
Definitions ...............................................................................................................  
7.4 
Reporting of Unanticipated Problems and Adverse Events ................................. 20 
8.0 
Agent Information and Risks ............................................................................................ 21 
8.1 
{Insert name of Agent} ............................................................................................  
8.1.1 
Description .................................................................................................. 
8.1.2 
Toxicology .................................................................................................. 
8.1.3 
Pharmacology – Handling, Storage, Dispensing and Disposal ................... 
9.0 
Correlative/Special Studies ............................................................................................... 22 
10.0 
Study Calendar .................................................................................................................. 23 
11.0 
Endpoint Evaluation Criteria/Measurement of Effect ...................................................... 24 
11.1 
Response Criteria ................................................................................................. 24 
12.0 
Data Reporting/Protocol Deviations ................................................................................. 24 
12.1 
Data Reporting ..................................................................................................... 24 
12.1.1 Confidentiality and Storage of Records .................................................. 24 
12.1.2 Subject Consent Form ............................................................................. 25 
12.1.3 Data Collection Forms and Submission Schedule .................................. 25 
12.2 
Protocol Deviations .............................................................................................. 26 
12.2.1 Deviation Policy ..................................................................................... 26 
12.2.2 Reporting of Deviations .......................................................................... 26 
12.2.3 Resolving Disputes ................................................................................. 26 
13.0 
Statistical Considerations .................................................................................................. 27 
13.1 
Study Design ........................................................................................................ 27 
13.2 
Sample Size Accrual Rate .................................... Error! Bookmark not defined. 
13.3 
Statistical Analysis Plan ....................................................................................... 27 
14.0 
Human Subject Issues ....................................................................................................... 29 
14.1 
Institutional Review Board .................................................................................. 29 
14.2 
Recruitment of Subjects ....................................................................................... 29 

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14.3 
Advertisements .................................................................................................... 29 
14.4 
Study location and Performance Sites ................................................................. 29 
14.5 
Confidentiality ..................................................................................................... 29 
14.6 
Financial Obligations and Compensation ............................................................ 29 
14.7 
Informed Consent Processes ................................................................................ 30 
15.0 
References ......................................................................................................................... 31 
 

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Abbreviations 
Abbreviation 
Meaning 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
COH 
City of Hope 
CTCAE 
Common Terminology Criteria for Adverse Events 
DSMC 
Data Safety Monitoring Committee 
ECOG 
Eastern Cooperative Oncology Group 
ERAS 
Enhanced Recovery After Surgery 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
KPS 
Karnofsky Performance State 
LOS 
Length of Stay 
MDASI 
MD Anderson Symptom Inventory 
MIPS 
Merit-Based Incentive Payment System 
NCI 
National Cancer Institute 
PGHD 
Patient-Generated Health Data 
PI 
Principal Investigator 
PMT 
Protocol Monitoring Team 
PRO 
Patient Reported Outcomes 
QOL 
Quality of Life 
SAE 
Serious Adverse Event 
 
 
 
 
 
 

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1.0 
Goals and Objectives (Scientific Aims) 
The most common and successful component of cancer treatment is surgery. However, patients 
experience abrupt declines in functional capacity after major surgical procedures. In addition to 
postoperative functional decline, patients experience an increase in symptoms, such as pain, 
fatigue, and distress.1-3 Postoperatively, these symptoms contribute to a dramatic decline in 
quality of life (QOL).4-6 Recovery from these challenges is compounded by healthcare systems-
related trends, including pressures to reduce readmissions and length of stay. As a result, the 
majority of postoperative care and recovery takes place at home. Unfortunately, while at home 
physical function can decline severely before the surgical team is notified. This means that about 
one third of patients will become symptomatic from a complication and may require hospital 
readmission.2, 7-9 
A promising approach to early identification of post-discharge complications is through 
remote, real-time perioperative telemonitoring of patient-generated health data (PGHD) and 
electronic patient-reported outcomes (ePROs). In our preliminary studies, telemonitoring was 
feasible and acceptable in the perioperative setting.10 We found that patient-generated daily steps 
data was associated with the risk for postoperative complications.10 However, the current 
perioperative care model is largely reactive and does not address the need for monitoring and 
supporting postoperative recovery. Therefore, remote and scalable telemonitoring approaches are 
urgently needed to improve perioperative cancer care in a healthcare system that demands early 
discharge and reduced hospital readmissions. 
The primary objective of this proposal is to conduct a pilot randomized trial of a remote, 
perioperative telemonitoring intervention to improve patient-centered outcomes, surgical 
outcomes, and healthcare resource use in English and Spanish-speaking patients scheduled to 
undergo major abdominal gastrointestinal (GI) cancer surgery. The intervention includes: 1) 
objective, device monitoring of physiologic parameters (temperature, blood pressure, heart rate, 
pulse oximetry, weight); 2) objective, wristband pedometer monitoring of functional activity 
(daily steps taken); 3) ePROs (symptoms, QOL); and 4) a real-time, alert/feedback system. 
Telemonitoring will begin before surgery, during hospitalization, and end at 30 days post-
discharge. The feedback system is triggered by deviations from predetermined clinical 
thresholds, and results in telehealth nursing assessment, triage, and management. Our central 
hypothesis is that remote telemonitoring of PGHD and ePROs are feasible and acceptable to 
patients, and will enhance surgical outcomes, reduce undesirable healthcare utilization, and 
improve PROs compared to the enhanced usual care condition. We will test our central 
hypothesis and accomplish our overall objective by pursuing the following specific aims: 
Specific Aim 1: Assess the feasibility, retention, and acceptability of the remote perioperative 
telemonitoring intervention as measured by the percentage of patients who a) agree to 
participate; b) complete ≥70% of the telemonitoring; and c) report satisfaction with the 
intervention through structured exit interviews. 
Specific Aim 2: Determine the preliminary efficacy of the remote perioperative telemonitoring 
intervention on surgical outcomes, healthcare utilization, PROs, and functional recovery. 
Hypothesis 2.1: Patients randomized to the telemonitoring arm will experience reduced severity 
(grade) of postoperative complications, lower readmission rates, and improved symptoms, QOL, 
and daily steps. 

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This research builds on informative preliminary evidence from our team.10, 11 The proposal 
addresses a key strategic plan of the National Institute of Nursing Research (NINR) to “explore a 
wide range of technologies that can be used to support real-time clinical decisions to improve 
health.”12 It is a response to the 2013 Institute of Medicine call for high-quality, patient-centered 
cancer care.13 It addresses two key priorities of the American College of Surgeons (ACS): 1) the 
critical role of patients as integral members of the surgical team, and 2) that the active 
involvement of patients in care can decrease complications through early identification of risks.14 
 
This application is significant because we are addressing a “critical challenge” to quality 
perioperative care in the current healthcare environment that calls for the development and 
testing of novel approaches to early and safe hospital discharge. Our long-term goal is an R01 
submission to conduct a Phase III trial of the proposed intervention to establish efficacy. We will 
use the findings from this R21 to further refine and develop the Phase III trial design, 
infrastructure, and implementation strategy. This includes identifying the effect size needed for 
calculating sample size, and procedures for intervention implementation, data collection, and 
data analysis. 
 
2.0 
Background 
2.1 Introduction/Rationale for Development 
Surgeons and cancer centers are increasingly asked to provide evidence of the quality and 
value of their care. Historically, medical outcomes, including surgical outcomes, are measured 
by disease- and systems-related parameters, such as length of hospital stay, morbidity, 
readmission rates, and mortality.2,3 While important, these measures do not accurately reflect the 
surgical care experience from a patient’s perspective. Patient-generated health data (PGHD) and 
patient-centered outcomes, including patient-reported outcomes (PROs), are increasingly being 
used in routine cancer care as quality and value indicators.3-5 However, these outcomes are not 
adequately understood and routinely integrated in surgical oncology.  
More than 45 million Americans undergo surgery each year, with expenditures exceeding 
$500 billion (40% of national healthcare spending).6 Expenditures for cancer care, including 
surgery, were $127 billion in 2013; this cost is projected to increase to $158 billion in 2020.7  
More than 60% of cancer patients undergo surgical interventions8, and surgery is often used as 
either the sole treatment modality or in combination with radiation and/or chemotherapy. 
Surgical interventions account for the most cures after a cancer diagnosis.9  
Due to changes in the healthcare system and advances in surgical techniques, surgeons 
are asked to discharge patients earlier and earlier after surgery. Operations that were previously 
associated with 10-20 day hospital stays are now either outpatient procedures or short-stay 
procedures. Given increasing incentives that mandate shorter hospital stays, postoperative 
complications that traditionally arise in the hospital are also developing, potentially unnoticed, in 
the community and at home.  
 
 
In recent years, surgical care is increasingly focused on using enhanced recovery after 
surgery (ERAS) pathways to improve surgical outcomes.10 ERAS pathways are created to 
include standard, prescribed tasks in the perioperative care setting to shorten length of hospital 
stay (LOS) and contain cost.11 A typical ERAS pathway includes the following tasks: 1) pre-op 
food and fluid intake; 2) analgesics/pain management; 3) hypothermia precautions; 4) DVT and 
antibiotic prophylaxis; 5) parameters for postoperative labs; 6) bowel care; and 7) early 

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ambulation. A critical gap in ERAS pathways is the lack of remote recovery monitoring 
capabilities after discharge. Perioperative care provided through ERAS pathways should also 
include remote monitoring and real-time interventions after hospital discharge and until full post-
surgical recovery. 
 
 
The current delivery model for post-discharge care and monitoring is largely inefficient, 
not proactive, and not cost-effective.12 Visiting home health nurses are often dispatched for 
patients with unresolved acute problems (i.e. surgical wound infections, rehabilitation needs). 
Patients may contact the hospital when acute problems arise. This often requires hours or days to 
resolve, and is burdensome for patients, families, as well as the healthcare system. In critical 
situations, visits to the emergency room or paramedics care are accessed, either within the same 
healthcare system or at a different institution; these are costly and inefficient. Delays in 
communicating critical conditions may escalate problems beyond outpatient care. These 
emergency problems may also result in patients being cared for outside of the index medical 
system and increase cost.  
The past 50 years have seen an explosion in biomedical knowledge, dramatic innovations 
in surgical procedures, and management of complex medical conditions, with ever more exciting 
clinical capabilities on the horizon. Yet, the American healthcare system is falling short on key 
components of quality, outcomes, and cost.13 The overarching imperatives for healthcare include 
the need to develop ways to manage its ever-increasing complexity, and curb ever-escalating 
costs. Opportunities now exist to address these problems; these include 1) computational power 
that is affordable and widely available; 2) connectivity that allows information to be accessed in 
real-time virtually anywhere; 3) human and organizational capabilities that improve the 
reliability and efficiency of care processes; 4) the recognition that effective care must be 
delivered in a patient-centric fashion; and 5) the recognition that, regardless of incentive 
structures, penalties, and payment reforms, nothing about the experiences and outcomes/value of 
care will improve until progress is made to revolutionize the care delivery system.7,13,14  
Improving outcomes after cancer surgery relies on symptom management, complication 
avoidance, and readmission prevention.15 Modern-day wearable and digital patient engagement 
technology has the potential to transform the current surgical care paradigm.16-18 It allows 
individuals to track and store measurable health parameters. This phenomenon allows surgeons 
to access patient-centered data that can help with care decisions in a timely fashion. In the 
clinical setting, wearable technology can assist surgeons with evaluating physical function to 
guide and monitor perioperative care.12 The technology has the following advantages compared 
to current care delivery models: 1) they are highly scalable; 2) they do not depend on a patient’s 
cognition, language, or health status; 3) they serve as an efficient and unobtrusive method for 
monitoring postoperative recovery; 4) they complement and augment ERAS care pathways; and 
5) they are deployable in various geographic locations and communities. Importantly, it has the 
potential to identify patients who are in need of interventions to optimize recovery and 
outcomes.19-21  
From a policy and reimbursement perspective, there are major reimbursement avenues 
for remote patient monitoring in 2018 and beyond. In 2017, the following telehealth-related 
milestones were reached: 1) 48 states, including California and the District of Columbia, 
provided reimbursement for live video consults in their Medicaid fee-for-service programs; 2) 21 
Medicaid programs reimbursed for remote patient monitoring; and 3) 36 states (including 
California) and the District of Columbia had laws governing coverage by private payers of 
telehealth services. Furthermore, beginning in 2018, CMS will support providers who leverage 

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remote monitoring tools, such as wearables and smart devices at home, and use patient-generated 
health data in care coordination and management. Providers will soon be able to receive 
reimbursement separately for time spent on collection and interpretation of health data that is 
generated by a patient remotely, digitally stored, and transmitted to the provider. The changes 
would enable providers utilizing “non-face-to-face chronic care management using remote 
monitoring and or telehealth technology” to receive Advance Care Information (ACI) program 
points for activities like collecting, monitoring and reviewing patient physiological data and 
prescribing patient education. ACI is one of the four performance categories under the Merit-
Based Incentive Payment System (MIPS). 
Our partnership with an existing home health monitoring and digital patient engagement 
infrastructure (mTelehealth™ and Aetonix) leverages a “real world” platform, which will 
enhance the successful implementation of this study and enhance future adoption into clinical 
surgical oncology practice.  Our study design moves away from traditional clinic-based care 
paradigms to telehealth patient engagement. The challenges of the US healthcare system demand 
an innovative, transformed approach to perioperative and post-discharge care.13  
 
2.2  
Overview of Proposed Study 
This is a pilot RCT (1:1 randomization) of a remote perioperative telemonitoring 
intervention in major abdominal cancer surgery. We will focus on GI malignancies, because the 
surgical procedures, extent of resection, and expected surgical outcomes are similar. In Aim 1, 
we will assess the feasibility, retention, and acceptability of the intervention through statistics of 
participation, intervention completion (retention) rates, and qualitative data from exit interviews.  
In Aim 2, surgical outcomes (post-operative complications), healthcare utilization (postoperative 
complications, hospital readmissions), PROs (symptoms, QOL), and functional recovery 
(pedometer steps) will be examined by treatment arm.  Our primary endpoint is severity (grade) 
of postoperative complications from discharge to day 30 post-discharge. This study will be 
conducted in compliance with the protocol, Good Clinical Practice (GCP) and the applicable 
regulatory requirements. 
 
2.3  
Preclinical Studies 
Not Applicable 
 
2.4  
Human Studies 
This proposal builds on over 15 years of research in patient-centered outcomes in gastrointestinal 
(GI) cancer populations. Our interdisciplinary team includes expertise in surgical oncology (Melstrom - 
PI), technology-driven intervention methodology (Sun), and perioperative outcomes (Melstrom, Sun). 
The investigators have designed and tested rigorous telehealth intervention trials. Study team roles and 
responsibilities are described in Section 3.5 of the PHS Human Subjects and Clinical Trials Information 
form.  
Preliminary Studies - We assessed the feasibility and acceptability of perioperative telemonitoring of 
functional activity, PGHD and ePROs (N=20).10 Patients were given a wristband pedometer (Vivofit 2) to 
monitor daily steps and completed ePROs (MD Anderson Symptom Inventory - MDASI and EQ-5D-5L). 
Daily steps and ePROs were monitored 3-7 days prior to surgery, during hospitalization, and up to two 
weeks after discharge. A real-time alert/feedback system was initiated when an encounter fell beyond the 

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following predetermined thresholds: 1) symptom score of 4/10 or higher (high severity); 2) QOL score of 
2/5 or higher (indicates problem). Nurses contacted the patient for further assessment, triage and 
management.  
 
 
Figure 1 depicts the number of daily steps from before surgery to 2 weeks post –discharge. 
Exploratory analysis (Figure 2) revealed a correlation between the number of daily steps and 
risk for postoperative complications (as measured by the comprehensive complications index – 
CCI) (r=-0.64, p<0.05). Patients with fewer daily steps were at higher risk for complications 
(higher CCI score).  Telemonitoring was feasible; 88% of patients wore the pedometer device 
during hospitalization (median = 6 days), and 83% after discharge (median=15 days); 65% 
completed all symptom assessments, and 75% completed all QOL assessments.  Average time to 
complete MDASI and EQ-5D-5L were 7 and 4 minutes respectively. Pain, fatigue, sleep and 
appetite had the highest symptom severity at day 5 post discharge. Correspondingly, QOL scores 
worsened at discharge and day 5 post–discharge. Of the total 160 PRO monitoring encounters, 
54 (34%) generated an email alert during the first week post-discharge. The majority of alerts 
were encounters (72%) related to symptom management, with pain being the most commonly 
reported symptom issues during encounters. Overall, patients were highly satisfied with 
telemonitoring.  
 
3.0 
Patient Eligibility 
3.1 Inclusion Criteria  
Study eligibility criteria include:  
• Cancer patients scheduled to undergo major abdominal surgery for GI malignancies. GI 
procedures include esophagectomy, gastrectomy, colectomy, abdominoperineal 
resection/low anterior resection, hepatectomy, pancreatectomy (distal or 
pancreaticoduodenectomy), and cytoreductive surgery for peritoneal carcinomatosis. We 
will include patients scheduled for an ostomy (colostomy or diverting ileostomy), 
• Age 18 years or older, 
• Ability to read and understand English or Spanish. 
Figure 2. Association between 
CCI and daily steps at post-op 
day 7 
Figure 1. Median daily steps measured using Vivofit 2 
before surgery (pre-op), hospitalization, and recovery (post-
discharge) 

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3.1.1 Disease Status 
We are targeting patients across all stages of disease.   
 
3.1.2 Age Criteria, Performance Status and Life Expectancy  
Age criterion for this study is based on the NIH’s age criteria, which defines an adult as 
individuals aged 18 years and over. There are no restrictions related to performance status or life 
expectancy.  
3.1.3 Child Bearing Potential 
Not applicable. 
3.1.4 Protocol-Specific Criteria 
Not applicable. 
3.1.5 Informed Consent/Assent 
All subjects must have the ability to understand and the willingness to sign a written informed 
consent. 
3.1.6 Prior Therapy 
Not applicable.  
 
3.2 Exclusion Criteria 
 
3.2.1 Study-Specific Exclusions 
Not applicable. 
3.2.2 Non-Compliance 
Subjects, who in the opinion of the investigator, may not be able to comply with the safety 
monitoring requirements of the study. 
3.3 Inclusion of Women and Minorities 
The study is open to anyone regardless of gender or ethnicity.  
4.0 
Screening and Registration Procedures 
4.1 Screening Procedures 
All eligible patients who meet study inclusion criteria will be identified through the Division of 
Thoracic Surgery, Division of Surgical Oncology, Division of Urologic Oncology, and the 
Division of Gynecologic Oncology outpatient clinics. Clinical Research Nurses and CRAs will 
work with surgeons to identify eligible patients. Surgeons will notify the research staff, and staff 
will contact eligible patients to explain the study purpose, answer any questions, and ascertain 
interest in participation. If the patient agrees to participate, informed consent will be obtained in 
person or via mail, electronic mail, or other electronic applications (i.e. DocuSign) to obtain 

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electronic signatures from each patient per standard practice. Clinical Research Nurses and 
CRAs will be responsible for obtaining informed consent and study implementation. 
 
4.2 Informed Consent  
The investigational nature and objectives of the trial, the procedures and treatments involved and 
their attendant risks and discomforts, and potential alternative therapies will be carefully 
explained to the subject and a signed informed consent will be obtained in person or via mail, 
electronic mail, or other electronic applications (i.e. DocuSign) to obtain electronic signatures 
from each patient per standard practice.   Documentation of informed consent will be maintained 
in the subject’s research chart and electronic health records.   
4.3 Registration Requirements/Process 
Not applicable. 
4.4 Randomization and/or Dose Level Assignment  
Each patient will be randomly assigned to either the remote perioperative telemonitoring or 
enhanced usual care arm. The assignments will be placed in sealed envelopes and opened 
sequentially. The PI, co-Is, participating clinicians and study CRN will be blinded to 
randomization assignment until envelopes are opened.  The study CRN will share randomization 
assignement information with consented participants. 
5.0 
Treatment Program 
5.1 Program Overview 
 
The perioperative telemonitoring intervention includes four key components. The first 
component involves objective assessment of functional activity. Patients will receive a Vivofit 4 
to wear for daily steps monitoring. Vivofit 4 is a commercially-available wristband pedometer 
(Garmin Company). It functions as a watch, but also can track activity level such as the number 
of steps taken. Vívofit 4 stores this data in the device. The device follows activity progress 24/7 
and can stay on for more than a year without a battery change. It is waterproof and can be worn 
in the shower and while swimming. 
 
The second component involves subjective, electronic assessment of PROs (symptoms, 
QOL). We will deploy the Aetonix A Touch Away™ digital engagement platform to remotely 
capture PROs in real-time. The A Touch AwayTM platform is a HIPAA compliant, multi-faceted 
patient engagement system that remotely connects and conveys critical health information 
between patients and clinicians. The Aetonix application has been utilized in several clinical 
settings including monitoring patients with chronic obstructive pulmonary disease and 
congestive heart failure. Patients will use the application on a smart device (phone, tablet), home 
computer, or study tablet to complete ePROs and share with the surgical team.  
 
The third component involves objective, remote assessment of physiologic patient generated 
health data (PGHD).  Physiologic parameters of interest include pulse oximetry, temperature, 
blood pressure, heart rate, and weight assessed from the patient’s home. Patients will be given a 
package that contains the following FDA-cleared devices: Nonin 3230 Bluetooth Smart Pulse 
Oximeters, FORA IR20 Ear Thermometer, A&D Medical Blood Pressure Monitor, and A&D 
Medical Weight Scale.  

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The fourth and final component involves a real-time, alert/feedback system based on pre-
determined outcome/clinical thresholds. All PGHD and ePRO data captured via the devices and 
patient engagement application will be streamed in real-time to a dashboard accessible from any 
device for the surgical team to monitor. The dashboard provides a graphic visualization over 
time of all patients and their data to identify outcome trends, including onset, 
worsening/improving measures, and sporadic vs. consistent measures. 
Figure 3 provides a graphic depiction of the perioperative telemonitoring care design. 
 
Patient
RN/Surgical Team
Alert/Feedback 
System
Cloud-Based 
Data Storage
Clinical Dashboard
PGHD & ePROs
Pre-Determined 
Thresholds

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Study Procedures 
Before Surgery:   
 
The study schema is presented in 
Figure 3. Patients will be recruited from the 
surgical clinics at COH’s Duarte campus 
only. Research staff will explain the study 
purpose, answer questions, and obtain 
informed consent. Patients will be enrolled at 
least 3-7 days before surgery. Following 
informed consent, the study CRA will assist 
patients with identifying a patient-owned 
engagement device (smartphone, tablet, 
computer), and assist with setup and initial 
testing of the Aetonix application on the 
device of choice. For patients who do not have 
an engagement device or have poor 
connections at home, a study Samsung tablet 
will be provided for the duration of the study. 
In our previous experience, only about 1.5% of 
patients had no device or inadequate internet 
access.48 All patients will be provided with a 
Vivofit 4 and instructions. The study CRA will 
setup the device for patients and conduct 
initial testing to insure successful data 
transmission. Patients will wear the Vivofit 4 
on their non-dominant wrist. Patients in both 
arms will receive a package with the Aetonix physiologic PGHD home monitoring devices 
described previously. The study CRA will provide instructions (both verbal and in writing) on 
device use. All patients will be instructed to complete baseline assessment (T1) of PGHD and 
ePROs while at home.  
 
Following completion of baseline assessment, participants will be randomly assigned to 
either the telemonitoring or enhanced usual care arm, using stratified and blocked randomization.  
Strata will be defined by diagnosis (upper GI, colorectal, hepatobiliary) and surgical technique 
(minimally-invasive versus open). Variable block sizes will be used to maintain approximate 
balance and pre-assignment masking. A pre-established randomization log will be created by the 
project biostatistician. The study staff will communicate group assignments to the patients.  
For patients assigned to the telemonitoring arm, the alert/feedback system, monitored by 
the CRN, will be initiated for each patient. The system will be triggered on the occurrence of 
predetermined threshold events for physiologic PGHDs and ePROs, as described previously. 
Patients assigned to the enhanced usual care arm will use the Aetonix application to report 
GI Cancer Patients Scheduled for Major Abdominal Surgery 
Informed Consent 
Vivofit 4 and Aetonix Setup and Instructions 
Baseline Assessment (T1) 
Randomization 
TELEMONITORING ARM 
 
 
Vivofit 4 (Functional 
Recovery) 
 
 
Aetonix Application and 
Devices (physiologic 
PGHDs and ePROs) 
 
 
Alert/feedback system 
based on predetermined 
thresholds 
 
 
RN Monitoring 
ENHANCED USUAL CARE 
ARM 
 
 
Vivofit 4 (Functional 
Recovery) 
 
 
Aetonix Application and 
Devices (physiologic 
PGHDs and ePROs) 
 
 
Standard procedures for 
reporting problems  
 
 
Figure 3: Study Schema 
Pre-Discharge Assessment 
(T2) 
Pre-Discharge Assessment 
(T2) 
SURGERY 
HOSPITAL DISCHARGE 
Post-Discharge Day 2 (T3) 
Post-Discharge Day 2 (T3) 
Post-Discharge Day 7 (T4) 
Post-Discharge Day 7 (T4) 
Post-Discharge Day 14 (T5) 
Post-Discharge Day 14 (T5) 
Post-Discharge Day 30 (T6) 
Post-Discharge Day 30 (T6) 

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physiologic PGHD and ePROs, but will be informed via electronic messages that their data will 
be used for research purposes only and would not be monitored. They will be instructed to 
follow the standard institutional procedure for reporting concerns and issues. This includes 1) 
contacting their surgical team if symptoms become severe and physical function worsens 
between clinic visits; and 2) use of the hospital call line to report problems between visits.  
After Surgery and Before Hospital Discharge: After surgery, research staff will ensure that 
patients resume wearing the Vivofit 4 as soon as possible and no later than post-op day 2. 
Patients will complete repeat electronic PROs prior to discharge (T2). The surveys will take 
about 20 minutes to complete. Patients will be given instructions, prior to discharge, on when to 
use the home monitoring device.  
 
After Hospital Discharge: After discharge, all patient-generated physiologic data and PRO 
assessments will be repeated day 2 (T2), day 7 (T3), day 14 (T4), and 30 days (T5) post-discharge. 
At day 30, patients randomized to the telemonitoring arm will participate in a brief exit interview. 
All patients will receive a $25 remuneration after completion of the day 7, 14, and 30 assessments 
($75 per patient total). 
All devices and loan study tablet will be returned upon study completion via postage-paid 
packages or in-person during a routine scheduled clinic visit. They will be cleaned with alcohol-
based cleansers following standard protocols prior to re-use. Patients have the option of keeping 
the Vivofit 4 wristwatch or returning it to the research team. Patients will not be responsible for 
replacing lost study devices. 
 
Feedback/Alert System and Thresholds: The following thresholds will be used to trigger the 
feedback and alert system monitored by the Research RNs.  
 
1.  Physiologic Health Parameters: 
 
a.  Weight – decrease in 2 kg since discharge or increase of 2 kg since discharge 
 
b.  Temperature - >38 C with heart rate >110 or systolic blood pressure <90 or >180; >38.3 
C independent of other vital signs 
 
c. Oxygen saturation - <90% oxygen saturation - Nurses should confirm that waveform data 
on heart rate and oxygen saturation are adequate (i.e not artifact) 
 
d. Heart rate - >110 beats per minute (>120 if last heart rate at discharge was >100) 
 
e. Blood pressure – systolic blood pressure <90 (<85 if last systolic blood pressure at 
discharge was <100) or >180; diastolic blood pressure ≥ 95 (low alert) and ≥ 100 (high 
alert). 
 
f. Functional activity - daily steps of ≤ 1500. 
 
2. Patient-Reported Outcomes:  
 
a.  One or more symptoms rated 4 or greater (moderate-severe intensity) 
 
b.  One or more QOL questions rated moderate, severe, or unable to accomplish 
Pathway for RN Triage and Management: 
1.  Patients will measure their vital signs once a day after discharge at 9 AM. Patients will have 
the option of measuring their vitals again at 3PM if they choose to 
2.  If RN identifies deviations from a priori thresholds, they will: 

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i. 
Call the patient, and ask them to repeat all vital signs.   
ii. 
Ask the patient if they are having: nausea, vomiting, fevers worsening pain, spreading 
redness around their incision, new or worsening drainage from their incision, chest 
pain, shortness of breath, difficulty breathing.  Also ask if the patient is drinking at 
least 1.5 liters of fluid a day. 
3.  If vital signs on re-check are beyond threshold values but all the above patient-generated 
metrics are normal/negative, relay information to the on-call physician or health care 
provider for further determination of next course of action. 
4. If vital signs on re-check are beyond threshold values and at least one of the patient-
generated metrics is abnormal/positive, the patient should be evaluated within the next 24 
hours.  Relay information to the on-call physician or health care provider to determine 
exactly when/how evaluation should take place.   
5. Evaluation within the next 24 hours may be: 
i. 
Repeat vital signs in a pre-defined period of time to be reviewed by a health care 
provider  
ii. 
Planned repeat phone conversation with the patient 
iii. 
Clinic visit that day or the next business day 
iv. 
Evaluation in the evaluation and treatment center or other urgent care/emergency 
department 
5.2 Planned Duration of Therapy 
Study participation is planned for approximately 2-3 months. The timeframe covers 
before surgery, postop acute care, and up to 30 days post-discharge.   
 
5.3 Criteria for Removal from Treatment 
The only criterion for disenrollment is if participants desire to discontinue with study 
participation. 
 
5.4 Subject Follow-Up 
Subjects will be followed for approximately 2 months. 
5.5 Supportive Care, Other Concomitant Therapy, Prohibited Medications 
The study Clinical Research Nurses and CRAs will review participant’s responses to all 
outcome measures and alert the attending surgeon if participants show risk of self-harm or other 
serious conditions. These participants will be referred to supportive care and social work as 
necessary after evaluation by the attending surgeon and/or other healthcare providers. Otherwise, 
there are no restrictions to the use of supportive care medications, other concomitant therapy and 
no prohibited medications.  
 

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5.6 Additional Studies 
Not applicable. 
5.6.1 Laboratory Studies 
Not applicable. 
5.7 Definition of Dose-Limiting Toxicity (DLT) 
Not applicable. 
6.0 
Dose Delays/Modifications for Adverse Events 
Not applicable. 
7.0 
Data and Safety Monitoring, Unanticipated Problems and Adverse 
Event Reporting  
7.1 Data and Safety Monitoring 
Definition of Risk Level 
This is a low risk study, as defined in the City of Hope Institutional Data and Safety Monitoring Plan 
(DSMP), because it involves questionnaires assessing QOL and general functional status, use of 
pedometer, and assessment of physiologic health parameters that are routine vital signs during 
perioperative car. The study Principal Investigator is responsible for monitoring protocol conduct and 
reporting all reportable events to the City of Hope (COH) Data and Safety Monitoring Committee 
(DSMC) and Institutional Review Board (IRB) in accordance with the City of Hope Institutional 
Deviation policy, and Clinical Research Adverse Event and Unanticipated Problem policy.  
All reportable events occurring at external sites will be reported to the study Principal Investigator per 
City of Hope institutional policies, and per their local institutional policies, as applicable.  
 
7.2 Monitoring and Personnel Responsible for Monitoring 
Monitoring and Personnel Responsible for Monitoring 
The Principal Investigator (PI) is responsible for monitoring protocol conduct and reporting to 
the City of Hope (COH) Data and Safety Monitoring Committee (DSMC) and Institutional 
Review Board (IRB) as indicated in the sections below. 
7.3 Reporting of Unanticipated Problems and Adverse Events 
Unanticipated Problems (UP) Involving Risks to Subjects or Others 
An unanticipated problem is any incident, experience or outcome that meets all three of the 
following criteria: 
1. Unexpected (in terms of  nature, severity, or frequency) given the following: a) the 
research procedures that are described in the protocol-related documents such as the IRB 
approved research protocol, informed consent document or Investigator Brochure (IB); 
and b) the characteristics of the subject population being studied; AND 
2. Related or possibly related to participation in the research (possibly related means there is 
a reasonable possibility that the incident, experience, or outcomes may have been caused 
by the procedures involved in the research); AND 

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3. Suggests that the research places participants or others at greater risk of harm (including 
physical, psychological, economic, or social harm) than previously known or recognized. 
 
Any UP that occurs during the study conduct will be reported to the DSMC and IRB in 
accordance with the Clinical Research Protocol Deviation policy [policy effective date:  
05/14/14] using the electronic submission system, iRIS. 
 
Deviations 
A deviation is a divergence from a specific element of a protocol and that occurred without prior 
IRB approval.  Deviations from the approved protocol should be avoided, except when necessary 
to eliminate an immediate hazard to a research participant.  A Corrective and Preventative 
Action (CAPA) plan should be developed by the study staff and implemented promptly to avoid 
similar issues in the future.  All deviations from the protocol must be documented in study 
source documents and promptly reported to the DSMC and IRB.   
 
Reporting Deviations 
Investigators may deviate from the protocol to eliminate immediate hazards for the protection, 
safety, and well-being of the study subjects without prior IRB approval.  For any such deviation, 
the PI will notify the DSMC and IRB, within 5 calendar days of its occurrence by electronic 
submission of a Deviation Notice via iRIS. 
 
Single Subject Exception (SSE) Amendment Request 
Deviations from the written protocol that are not done to eliminate an immediate hazard(s) for 
the protection, safety and well-being of study subjects but may increase risk and/or alter the 
protocol integrity require prior IRB approval.  The deviation is submitted as a Single Subject 
Exception (SSE) amendment request.  An IRB approved SSE does not need to be submitted as a 
protocol deviation to the DSMC.  The SSE should be submitted according to the IRB guidelines 
and Clinical Research Protocol Deviation policy [policy effective date:  11/07/11] and submitted 
via iRIS. 
 
A deviation that is not an SSE (i.e., discovered after the occurrence) must be reported to the 
COH DSMC and IRB according to the Clinical Research Protocol Deviation policy [policy 
effective date:  11/07/11] and submitted via iRIS. 
8.0 
Information and Risks 
The devices that will transmit the data will not store any data and are FDA approved.  There is 
therefore minimal risk. The devices are the following: Physiologic parameters of interest include 
pulse oximetry, temperature, blood pressure, heart rate, and weight assessed from the patient’s 
home. Patients will be given a package that contains the following FDA-cleared devices: Nonin 
3230 Bluetooth Smart Pulse Oximeters, FORA IR20 Ear Thermometer, A&D Medical Blood 
Pressure Monitor, and A&D Medical Weight Scale.  
 
For the steps data, patients will be wearing a Vivofit 4. Patients will sign up on the Garmin 
website for the Vivofit and they will agree to the terms of use as per the Garmin company.  This 
is noted in the consent form as per advice from the cybersecurity team. Their steps data would 

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not be linked to any clinical data that Garmin can capture and their  terms of use will be separate 
from the study. 
  
9.0 
Correlative/Special Studies 
No correlative studies will be performed during this study. 

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10.0 Study Calendar 
X= Standard of care, R =Research 
 
 
Baseline 
(T1) 
Before 
Surgery 
Treatment 
Before  
Discharge 
(T2) 
Day 2 Post-
Discharge 
(T3) 
Day 7 Post-
Discharge 
(T4) 
Day 14 Post-
Discharge 
(T5) 
Day 30 Post- 
Discharge 
(T6) 
Informed Consent 
X 
 
 
 
 
 
 
 
Baseline Assessment 
R 
 
 
 
 
 
 
 
DAY OF SURGERY 
 
 
X 
 
 
 
 
 
Post-Operative Complications – 
Comprehensive Complications 
Index (CCI)131, 132 
 
 
 
R 
R 
R 
R 
R 
Hospital Readmissions 
 
 
 
 
R 
R 
R 
R 
General Symptoms - MD Anderson 
Symptom Inventory (MDASI)55, 120 
R 
 
 
R 
R 
R 
R 
R 
Disease-Specific Symptoms – 
MDASI Symptom Library 
R 
 
 
R 
R 
R 
R 
R 
QOL – EQ-5D-5L10,113,121-125 
R 
 
 
R 
R 
R 
R 
R 
Semi-Structured Exit 
Interview/Satisfaction Tool 
 
 
 
 
 
 
 
R 
Functional Activity (daily steps 
taken)127-130 
Throughout study period 

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11.0 Endpoint Evaluation Criteria/Measurement of Effect 
11.1 Response Criteria  
Outcome Measures – Outcomes are assessed before surgery (baseline), before discharge, 
and until 30 days post-discharge (Table 1). Measures were selected based on reliability/validity, 
our preliminary studies, and brevity to minimize burden. ePROs will take about 4-7 minutes to 
complete. We will also obtain sociodemographic, clinical (diagnosis, tumor stage, neoadjuvant 
treatments, Charlson-Deyo co-morbidity index, time to adjuvant treatment), and surgical (Pre-op 
ECOG performance score, procedure, open or minimally invasive, ASA classification, date of 
surgery, post-op admission status and date, ICU days, post-operative events, discharge date, 
discharge status) data for all patients.  
 
12.0 Data Reporting/Protocol Deviations 
12.1 Data Reporting 
12.1.1 Confidentiality and Storage of Records 
The original data collection forms will be sent to PI and stored in a locked cabinet and office in 
Electronic data will be stored in encrypted, password protected, secure computers that meet all 
HIPAA requirements.  When results of this study are reported in medical journals or at meetings, 
identification of those taking part will not be disclosed.  Electronic health records of subjects will 
be securely maintained in the strictest confidence, according to current legal requirements.  They 
will be made available for review, as required by the FDA, HHS, or other authorized users such 
as the NCI, under the guidelines established by the Federal Privacy Act and rules for the 
protection of human subjects. 
Table 1. Outcome Measures by Aims and Assessment Time Points 
 
Measures 
Before Surgery 
(T1) 
Pre-
Discharge 
(T2) 
Day 2 
(T3) 
Day 7 
(T4) 
Day 14 
(T5) 
Day 30 
(T6) 
SA 1 
(Feasibility, 
Retention and 
Acceptability) 
Participation Rate - % of eligible consented, 
reasons for non-participation, dropout and lost to 
follow-up rates, reasons for dropout, differential 
dropout by treatment arm. 
Throughout study period 
Telemonitoring Completion Rate – number of 
PGHD and ePRO assessments completed (≥70%) 
Throughout study period 
Patient Experience – Semi-Structured Exit 
Interview Guide 
 
 
 
 
X 
SA 2 
(Preliminary 
Efficacy) 
Post-Operative Complications – Comprehensive 
Complications Index (CCI)131, 132 
 
X 
X 
 
X 
 
X 
 
X 
Hospital Readmissions 
 
 
X 
X 
X 
General Symptoms - MD Anderson Symptom 
Inventory (MDASI)55, 120 
X 
X 
X 
X 
X 
X 
Disease-Specific Symptoms – MDASI Symptom 
Library 
X 
X 
X 
X 
X 
X 
QOL – EQ-5D-5L10,113,121-125 
X 
X 
X 
X 
X 
X 
Functional Activity (daily steps taken)127-130 
Throughout study period 

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12.1.2 Subject Consent Form 
At the time of registration, the original signed and dated Informed Consent form, HIPAA 
research authorization form, and the California Experimental Subject’s Bill of Rights (for the 
medical record) and three copies (for the subject, the research record, and the Coordinating 
Center) must be available.  All Institutional, NCI, Federal, and State of California requirements 
will be fulfilled. 
12.1.3 Data Collection Forms and Submission Schedule  
All data will be collected from home monitoring devices, wearable devices (pedometer), and 
electronic PROs.  Data will be sent to the location identified in Section 12.1.1 and stored in a 
secure location. 
EQ-5D-5L - This validated tool evaluates five QOL variables: mobility, self-care, usual 
activities, pain/discomfort, and anxiety/depression. One final item evaluates overall health state 
using a visual analogue scale with the end points labeled best to worst imaginable health state (0-
100 numeric value). The EQ-5D has been widely used in clinical trials and also used in quality-
adjusted survival analysis.24-27  
MD Anderson Symptom Inventory (MDASI) - This is a brief, validated measure of 13 common 
cancer-related symptoms with severity of each rated on a 10-point scale. Patients also rate how 
much their symptoms interfered with 6 common functional domains. The MDASI has several 
advantages over other symptom-assessment scales in that it applies broadly across cancer types 
and treatments, is easy for patients to complete, and includes items related to symptom 
interference with daily life. Cronbach alpha reliability ranges from 0.82 to 0.94.28,29  
Sociodemographic and health status – This tool covers social and demographic factors, including 
patient’s age, sex, race/ethnicity, education, marital status, living situation, employment, income, 
religious preference, tobacco history, and symptoms. Patients will complete the tool at baseline. 
Satisfaction Tool – This patient self-reported measure contains 13 questions designed to assess 
satisfaction with the electronic assessment. Data captured include: 1) ease of use of web-based 
surveys and wristband device; 2) Feedback on items in the web-based surveys that are distressing 
or difficult to comprehend; 3) Feedback on length of surveys and timing of administration; and 
4) Suggestions for items that were not covered but should be added. It will be administered at the 
Day 30 post-discharge assessment. Both arms of the study will undergo this.  
 
Surgical Outcomes: Comprehensive Complications Index (CCI) - The CCI® summarizes the 
entire patient postoperative experience with respect to complications (on a scale from 0 to 100), 
and is based on the established Clavien-Dindo classification. The CCI® was validated in a study 
with 1299 participants, and external validity was tested in a randomized trial evaluating 
pancreas, esophageal, and colon resections.31,32  
 
Medical Chart Audit Form and Healthcare Resource Use - Electronic health record audits will 
capture: 1) 30, 60, and 90 day inpatient readmissions, 2) reasons for readmissions, and 3) ER 
visits. The chart audits will also capture clinical (stage of disease) and surgical characteristics. If 
the patient seeks emergent care outside of the primary institution, the patient’s permission will be 
obtained to review these records. 

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Semi-Structured Interview Guides - The semi-structured questions for exit interviews and focus 
groups are designed to solicit patient and surgeon/provider’s perspective on the following: 1) on-
boarding and setup process; 2) use of telemonitoring application for communication; 3) use and 
setup process of accelerometer; 4) use of telemonitoring dashboard to guide clinical care; 5) 
value of monitoring PROs and functional activity; 6) likes/dislikes of the program; 7) challenges 
and limitations of telemonitoring; and 7) suggestions on areas for improvement.  
 
12.1.3.1 Eligibility Checklist 
The Eligibility Checklist must be completed by the Research Nurse and CRA and signed by an 
authorized investigator prior to registering the subject.  See Section 4.3 for the registration 
procedure. 
 
12.2 Protocol Deviations 
12.2.1 Deviation Policy 
This protocol will be conducted in accordance with COH’s “Clinical Research Protocol 
Deviation Policy” located at 
http://www.coh.org/dsmc/Documents/Institutional%20Deviation%20Policy.pdf. 
 
 Deviations from the written protocol that could increase patient risk or alter protocol 
integrity require prior IRB approval of a single subject exception (SSE) request.  In addition, if 
contractually obligated, the sponsor must also approve the deviation.  IRB pre-approved SSE 
protocol modifications are considered an amendment to the protocol and not a deviation.  The 
submission of a deviation report is not required. 
 
Brief interruptions and delays may occasionally be required due to travel delays, airport 
closure, inclement weather, family responsibilities, security alerts, government holidays, etc.  
This can also extend to complications of disease or unrelated medical illnesses not related to 
disease progression.  The PI has the discretion to deviate from the protocol when necessary so 
long as such deviation does not threaten patient safety or protocol scientific integrity.  Examples 
include, but are not limited to:  a) dose adjustments based on excessive patient weight; b) 
alteration in treatment schedule due to non-availability of the research participant for treatment; 
c) laboratory test results which are slightly outside the protocol requirements but at levels that do 
not affect participant safety.  These instances are considered to be deviations from the protocol.  
A deviation report will be submitted to the DSMC/IRB within five days. 
12.2.2 Reporting of Deviations 
All deviations will be reported to the COH DSMC within five days.  The DSMC will forward to 
report to the IRB following review. 
12.2.3 Resolving Disputes 
In situations where there is misperception or dispute regarding a protocol deviation among the 
persons involved in implementing the protocol, it is the responsibility of the PI to resolve the 
dispute and the PI may consult with the DSMC chair (or designee) to arrive at resolution. 

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13.0 
Statistical Considerations 
13.1 Study Design 
13.1.1 Sample Size Calculation and Power Analysis 
 
We will need 128 patients (64 per arm) to detect an effect size of 0.5 in the  primary outcomes as 
described in Aim 2 (postoperative complications, lower readmission rates, improved symptoms, QOL, 
and functional recovery) between the two groups, with a two-sided 0.05 significance level using a two-
sample t-test and at least 80% power. We will enroll a total of 160 (80 per arm to account for an 
expectation of 20% attrition. Thus, we will have sufficient power for all primary outcomes, including our 
primary endpoint of postoperative complications.   
13.2 Statistical Analysis Plan 
13.2.1 Managing Data 
 
PGHD, PROs and data on actionable patient care based on alert/feedback system and CRN 
monitoring (i.e. educated or counseled the patient, scheduled visits) will be initially stored in a secure, 
HIPPA-compliant cloud-based data storage system through Aetonix. We expect a total of 20 physiologic 
PGHD and ePRO evaluations per participant over the approximate 2 month study duration. With a total 
sample of 160, this yields more than 3,200 data collection encounters overall. We expect a large number 
of daily steps data observations per subject because functional recovery data will be continuously 
recorded on a daily basis over the study duration. 
 
Data will be transferred on a daily basis from Aetonix to a REDCap (Research Electronic Data 
Capture) study database housed within COH and accessible only to the research team. The study 
biostatistician will work closely with Aetonix to coordinate  real-time data transfer, auditing, and data 
cleaning. In the process of data transfer and mergers, the study biostatistician and Aetonix representatives 
will audit the data, clean the data, apply necessary formats in SAS statistical software, and export data 
into the REDCap database. A query system will be developed to address data validity and integrity by 
early identification of data collection inconsistency, data inaccuracy or incompleteness. This will be 
monitored by the biostatistician on a weekly basis throughout the project. Where feasible, validation rules 
(e.g. logic checks, format restrictions, min/max range, etc.) will be added to ensure that the data 
transferred and entered is valid and accurate. 
 
 
In order to protect PHI data the patients will be labelled as Subject # e.g. Patient001, Patient002.  
Only the PI on the study and CRAs and CRN will have access to Patient Identifiers. The CRNs will have 
the ability to document any response to the alerts of abnormal patient generated health data as a research 
progress note in EPIC.  The PI and the CRAs and CRNs will have access to the Aetonix app on their 
COH provided devices.  There will be no data integration into EPIC. The devices used to transmit the 
patient generated health data (blood pressure, weight, temperature, pulse oximetry and heart rate) do not 
store any of the data and are not linked to any patient identifiers. The vivofit4 used to capture the patient 
steps will require that patients sign up on the Garmin website and agree to the company terms of use. 
These will not be linked to clinical data in any way.  
 
13.2.1.1 Handling Missing Sessions and Data 
 
Subjects with missing items among dependent variables will be compared with subjects having non-
missing items to determine whether there is any bias underlying the missing data (i.e., whether data are 

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missing at random or can be accounted for by other variables). We will consider multiple imputation (MI) 
for estimating missing responses and covariables, which can be done using PROC MI in the SAS 9.4 
system of software for analysis. The estimates obtained across (10 to 20) multiply imputed data sets can 
be combined using proc MIANALYZE, which provides valid standard errors for making inferences using 
the missing at random assumption. 
13.2.1.2 Statistical Methods by Study Aims 
We are proposing a two-group, randomized control design in which participants recruited into the 
study will be randomly assigned into the enhanced usual care (control) arm or the telemonitoring 
(intervention) arm. Both groups will be followed over the same time period which includes preoperative 
measurements and then up to 30 days post discharge. Data will be collected at five time points (T1: 
baseline, T2: pre-discharge, T3: 7-day post-discharge, T4: 14-day post-discharge, T5: 30-day post 
discharge). The primary outcomes for hypothesis testing are found in Aims 2, including postoperative 
complications, lower readmission rates, improved symptoms, QOL, and functional recovery. The primary 
endpoint is severity (grade) of postoperative complications from discharge to day 30 post-discharge. 
Descriptive statistics will be used to summarize all variables. For continuous variables, we will provide 
mean ± standard deviation (SD), median, range, and sample size. For categorical variables, we will 
include sample size and proportion. 
Specific Aim 1: Assess the feasibility, retention, and acceptability of the remote perioperative 
telemonitoring intervention as measured by the percentage of patients who a) agree to participate; b) 
complete ≥70% of the telemonitoring; and c) report satisfaction with the intervention through structured 
exit interviews. 
      Feasibility will be assessed through: 1) the ratio of eligible participants to those enrolled and 
those who declines participation; 2) reasons for non-participation; 3) number of scheduled study 
encounters completed; 3) attrition rate between pre- and post-discharge; 4) reasons for 
attrition/dropout; 5) the ratio of all participants to those who completed ≥70% of the study; These 
data will be descriptively reported and analyzed. Qualitative data on acceptability from exit interviews 
will be analyzed using the conventional content analysis approach.65 This approach is used to describe a 
phenomenon where existing theory or research literature is limited. Data from the audio-recorded 
interviews will be transcribed and analyzed using HyperRESEARCH™ qualitative software. Transcripts 
will be imported allowing for the development of analytic categories, data coding, and review of coded 
data. All data will be read repeatedly to achieve immersion and obtain a sense of the whole. Then, data 
will be read word by word to derive codes. Codes will then be sorted into themes based on links and 
relationship. Separate investigators (Dr. Melstrom and Dr. Sun) will conduct a final validation review of 
the codes and themes to ensure consistency and clarity across all qualitative data. Data discordantly coded 
will be discussed for refinement and consensus purposes. 
Specific Aim 2: Determine the preliminary efficacy of the remote perioperative telemonitoring 
intervention on surgical outcomes, healthcare utilization, PROs, and functional recovery. 
Hypothesis 2.1: Patients randomized to the telemonitoring arm will experience reduced severity (grade) 
of postoperative complications, lower readmission rates, and improved symptoms, QOL, and daily steps. 
 
For Specific Aim 2, the primary endpoint is the change in Comprehensive Complications index (CCI) 
from discharge to day 30 post-discharge. First, change in CCI will be computed. A two-sample t-test will 
be conducted to determine if there is significant difference between mean CCI of the intervention arm and 
the control arm. Trends in CCI scores will be explored over time (T2-T5). Exploratory within subjects’ 
correlation will be examined using Pearson correlation between adjacent time points. A random-effects 
model will be used to study group differences in mean over time. Other variables (e.g., age and sex) may 
be included in the model to adjust for possible confounding. 

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Similar analysis will be carried out for repeatedly measured secondary endpoints (symptom severity 
score, QOL). Generally speaking, we expect better scores in the intervention arm than the control arm.  
Healthcare resource use (e.g., hospital readmission) is a secondary endpoint. At each time point, we will 
estimate the ER visits/readmission rates and provide confidence intervals for each arm. Further, a 
binomial test for comparing two proportions will be conducted to see if there is significant difference 
between the readmission rates of the two arms. For simplicity, Bonferroni correction will be used both in 
the proportions comparisons test and the confidence intervals construction. 
 
 
 
 
 
14.0 
Human Subject Issues 
14.1 Institutional Review Board 
In accordance with City of Hope policies, an Institutional Review Board (IRB) that complies 
with the federal regulations at 45 CFR 46 and 21 CFR 50, 56 and State of California Health and 
Safety code, Title 17,  must review and approve this protocol and the informed consent form 
prior to initiation of the study.  All institutional, NCI, Federal, and State of California regulations 
must be fulfilled. 
14.2 Recruitment of Subjects 
Subjects will be recruited on COH’s campus and through the Department of Surgery. 
14.3 Advertisements  
No advertisements will be used for study accrual. 
14.4 Study location and Performance Sites 
This study will be performed at COH.   
14.5 Confidentiality  
This research will be conducted in compliance with federal and state of California requirements 
relating to protected health information (PHI). Confidentiality is maintained by ensuring that all 
data collection forms contain only ID numbers rather than personal identifiers. All study files are 
maintained in password-protected computers or locked file cabinets (both included behind 
locked doors). Electronic data will be stored in encrypted, password protected, secure computers 
that meet all HIPAA requirements.  All participant identifiers are removed from tracking 
spreadsheets. In addition, confidentiality is maintained in communications (emails and meetings) 
and only ID numbers are referenced. The PI and research team will have access to this 
information, but all information will be treated confidentially.  No identifiers will be used in any 
subsequent publication of these results.   
14.6 Financial Obligations and Compensation 
There are no financial obligations.  Participants may receive up to $75 for their participation in 
this study. 

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14.7 Informed Consent Processes  
The Principal Investigator or IRB approved named designate will explain the nature, duration, 
purpose of the study, potential risks, alternatives and potential benefits, and all other information 
contained in the informed consent document.  In addition, they will review the experimental 
subject’s bill of rights and the HIPAA research authorization form.  Research subjects will be 
informed that they may withdraw from the study at any time and for any reason without 
prejudice, including as applicable, their current or future care or employment at City of Hope or 
any relationship they have with City of Hope.  Research subjects will be afforded sufficient time 
to consider whether or not to participate in the research. 
Should sufficient doubt be raised regarding the adequacy of comprehension, further clarifications 
will be made and the questionnaire repeated until a satisfactory result is obtained.  Prospective 
research subjects who cannot adequately comprehend the fundamental aspects of the research 
study with a reasonable amount of discussion, education and proctoring will be ineligible for 
enrollment.  For those subjects who do comprehend the fundamental aspects of the study, 
consent will be obtained and documented, followed by eligibility testing.  The research team will 
review the results of eligibility testing and determine if the subject is a candidate for study 
enrollment.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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15.0 References 
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patient-reported symptoms and clinical syndromes in outpatient workflow of medical 

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oncologists: E-MOSAIC, a multicenter cluster-randomized phase III study (SAKK 
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30. 
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